{"version":"1.0.0","segments":[{"speaker":"Aaron Moncur","startTime":0.719,"endTime":4.109,"body":"Hey everyone, the"},{"speaker":"Aaron Moncur","startTime":0.719,"endTime":4.109,"body":"next PDX event is coming up. So"},{"speaker":"Aaron Moncur","startTime":4.139,"endTime":7.979,"body":"mark your calendars for"},{"speaker":"Aaron Moncur","startTime":4.139,"endTime":7.979,"body":"Thursday, July 18. And this one"},{"speaker":"Aaron Moncur","startTime":7.979,"endTime":13.649,"body":"is free and online. And this"},{"speaker":"Aaron Moncur","startTime":7.979,"endTime":13.649,"body":"event simulation expert and 35"},{"speaker":"Aaron Moncur","startTime":13.649,"endTime":16.919,"body":"year veteran of the industry"},{"speaker":"Aaron Moncur","startTime":13.649,"endTime":16.919,"body":"Krishna right tour will teach"},{"speaker":"Aaron Moncur","startTime":16.919,"endTime":20.609,"body":"you the basics of setting up"},{"speaker":"Aaron Moncur","startTime":16.919,"endTime":20.609,"body":"running at evaluating results of"},{"speaker":"Aaron Moncur","startTime":20.639,"endTime":25.259,"body":"FPGA simulations. That's finite"},{"speaker":"Aaron Moncur","startTime":20.639,"endTime":25.259,"body":"element analysis, you'll learn"},{"speaker":"Aaron Moncur","startTime":25.259,"endTime":28.439,"body":"how early stage simulation can"},{"speaker":"Aaron Moncur","startTime":25.259,"endTime":28.439,"body":"help reduce development times"},{"speaker":"Aaron Moncur","startTime":28.469,"endTime":31.619,"body":"decrease warranty costs and"},{"speaker":"Aaron Moncur","startTime":28.469,"endTime":31.619,"body":"reduce part weight through"},{"speaker":"Aaron Moncur","startTime":31.649,"endTime":36.299,"body":"topology optimization. This is"},{"speaker":"Aaron Moncur","startTime":31.649,"endTime":36.299,"body":"not a sales pitch. As with all"},{"speaker":"Aaron Moncur","startTime":36.299,"endTime":39.989,"body":"PDX events, the training will"},{"speaker":"Aaron Moncur","startTime":36.299,"endTime":39.989,"body":"focus on practical skills you"},{"speaker":"Aaron Moncur","startTime":39.989,"endTime":43.619,"body":"can apply to your work right"},{"speaker":"Aaron Moncur","startTime":39.989,"endTime":43.619,"body":"away. Krishna will also be doing"},{"speaker":"Aaron Moncur","startTime":43.619,"endTime":47.609,"body":"q\u0026a To answer your real world"},{"speaker":"Aaron Moncur","startTime":43.619,"endTime":47.609,"body":"simulation questions at the end."},{"speaker":"Aaron Moncur","startTime":48.179,"endTime":51.569,"body":"The webinar will cover what"},{"speaker":"Aaron Moncur","startTime":48.179,"endTime":51.569,"body":"simulation is and how you can"},{"speaker":"Aaron Moncur","startTime":51.569,"endTime":54.299,"body":"leverage it in your product"},{"speaker":"Aaron Moncur","startTime":51.569,"endTime":54.299,"body":"development work, how you can"},{"speaker":"Aaron Moncur","startTime":54.299,"endTime":57.809,"body":"save time and money for your"},{"speaker":"Aaron Moncur","startTime":54.299,"endTime":57.809,"body":"company by doing simulations"},{"speaker":"Aaron Moncur","startTime":57.839,"endTime":60.989,"body":"early in the product design"},{"speaker":"Aaron Moncur","startTime":57.839,"endTime":60.989,"body":"cycle, how to make what if"},{"speaker":"Aaron Moncur","startTime":61.019,"endTime":64.799,"body":"design changes, and quickly see"},{"speaker":"Aaron Moncur","startTime":61.019,"endTime":64.799,"body":"their effects on product"},{"speaker":"Aaron Moncur","startTime":64.859,"endTime":68.789,"body":"performance, and how to optimize"},{"speaker":"Aaron Moncur","startTime":64.859,"endTime":68.789,"body":"your design for things like"},{"speaker":"Aaron Moncur","startTime":68.789,"endTime":73.709,"body":"weight, strength and size."},{"speaker":"Aaron Moncur","startTime":68.789,"endTime":73.709,"body":"Again, this PDX event is online"},{"speaker":"Aaron Moncur","startTime":73.739,"endTime":79.499,"body":"and happening Thursday July 18."},{"speaker":"Aaron Moncur","startTime":73.739,"endTime":79.499,"body":"Register for free on the wave"},{"speaker":"Aaron Moncur","startTime":79.529,"endTime":85.289,"body":"dot engineer. That's the wave"},{"speaker":"Aaron Moncur","startTime":79.529,"endTime":85.289,"body":"dot engineer. See you there."},{"speaker":"Aaron Moncur","startTime":99.28,"endTime":102.73,"body":"Hello, and welcome to the being"},{"speaker":"Aaron Moncur","startTime":99.28,"endTime":102.73,"body":"an engineer Podcast. Today we"},{"speaker":"Aaron Moncur","startTime":102.73,"endTime":106.03,"body":"have the privilege of speaking"},{"speaker":"Aaron Moncur","startTime":102.73,"endTime":106.03,"body":"with Steve Gompertz, who is a"},{"speaker":"Aaron Moncur","startTime":106.18,"endTime":110.11,"body":"highly experienced leader in"},{"speaker":"Aaron Moncur","startTime":106.18,"endTime":110.11,"body":"quality systems management and"},{"speaker":"Aaron Moncur","startTime":110.11,"endTime":114.58,"body":"regulatory compliance, currently"},{"speaker":"Aaron Moncur","startTime":110.11,"endTime":114.58,"body":"serving as a partner as QRx"},{"speaker":"Aaron Moncur","startTime":114.58,"endTime":118.27,"body":"partners. With a career spanning"},{"speaker":"Aaron Moncur","startTime":114.58,"endTime":118.27,"body":"over 30 years he has held"},{"speaker":"Aaron Moncur","startTime":118.27,"endTime":121.36,"body":"significant roles in various"},{"speaker":"Aaron Moncur","startTime":118.27,"endTime":121.36,"body":"companies including Pelican"},{"speaker":"Aaron Moncur","startTime":121.51,"endTime":126.04,"body":"Biothermal, St. Jude Medical,"},{"speaker":"Aaron Moncur","startTime":121.51,"endTime":126.04,"body":"Boston Scientific and Medtronic."},{"speaker":"Aaron Moncur","startTime":126.34,"endTime":129.61,"body":"At QRx partners, Steve"},{"speaker":"Aaron Moncur","startTime":126.34,"endTime":129.61,"body":"specializes in quality systems"},{"speaker":"Aaron Moncur","startTime":129.61,"endTime":133.06,"body":"development, project management"},{"speaker":"Aaron Moncur","startTime":129.61,"endTime":133.06,"body":"and engineering, automation,"},{"speaker":"Aaron Moncur","startTime":133.09,"endTime":136.39,"body":"helping companies navigate"},{"speaker":"Aaron Moncur","startTime":133.09,"endTime":136.39,"body":"complex regulatory environments"},{"speaker":"Aaron Moncur","startTime":136.39,"endTime":139.66,"body":"and enhance their quality"},{"speaker":"Aaron Moncur","startTime":136.39,"endTime":139.66,"body":"management systems. Steve, thank"},{"speaker":"Aaron Moncur","startTime":139.66,"endTime":142.39,"body":"you so much for being with us on"},{"speaker":"Aaron Moncur","startTime":139.66,"endTime":142.39,"body":"the podcast today."},{"speaker":"Steve Gompertz","startTime":142.81,"endTime":143.8,"body":"Thanks for"},{"speaker":"Steve Gompertz","startTime":142.81,"endTime":143.8,"body":"having me."},{"speaker":"Aaron Moncur","startTime":144.76,"endTime":147.52,"body":"All right, well,"},{"speaker":"Aaron Moncur","startTime":144.76,"endTime":147.52,"body":"what made you decide to become"},{"speaker":"Aaron Moncur","startTime":147.52,"endTime":148.15,"body":"an engineer?"},{"speaker":"Steve Gompertz","startTime":151.93,"endTime":155.14,"body":"It was almost"},{"speaker":"Steve Gompertz","startTime":151.93,"endTime":155.14,"body":"more of a whim But it stemmed"},{"speaker":"Steve Gompertz","startTime":155.14,"endTime":158.95,"body":"from growing up, I liked"},{"speaker":"Steve Gompertz","startTime":155.14,"endTime":158.95,"body":"anything technology. You know, I"},{"speaker":"Steve Gompertz","startTime":158.95,"endTime":163.96,"body":"kind of grew up at the beginning"},{"speaker":"Steve Gompertz","startTime":158.95,"endTime":163.96,"body":"of the space age. So I wanted to"},{"speaker":"Steve Gompertz","startTime":163.96,"endTime":168.55,"body":"be an astronaut. Yeah. And then"},{"speaker":"Steve Gompertz","startTime":163.96,"endTime":168.55,"body":"somehow I ended up wanting to be"},{"speaker":"Steve Gompertz","startTime":168.55,"endTime":170.95,"body":"a geologist. And then I found"},{"speaker":"Steve Gompertz","startTime":168.55,"endTime":170.95,"body":"that they don't make any money."},{"speaker":"Steve Gompertz","startTime":171.97,"endTime":174.94,"body":"I'm gonna get into cars. And I"},{"speaker":"Steve Gompertz","startTime":171.97,"endTime":174.94,"body":"thought, oh, I want to design"},{"speaker":"Steve Gompertz","startTime":174.94,"endTime":178.27,"body":"cars. I guess you you're you"},{"speaker":"Steve Gompertz","startTime":174.94,"endTime":178.27,"body":"become an engineer to do that."},{"speaker":"Steve Gompertz","startTime":178.39,"endTime":182.98,"body":"And so you went off to college,"},{"speaker":"Steve Gompertz","startTime":178.39,"endTime":182.98,"body":"actually, initially, I applied"},{"speaker":"Steve Gompertz","startTime":182.98,"endTime":185.89,"body":"to be an electrical engineer."},{"speaker":"Steve Gompertz","startTime":182.98,"endTime":185.89,"body":"And I ended up graduating as"},{"speaker":"Steve Gompertz","startTime":185.89,"endTime":188.35,"body":"mechanical engineer. So I mean,"},{"speaker":"Steve Gompertz","startTime":185.89,"endTime":188.35,"body":"our lives always take these"},{"speaker":"Steve Gompertz","startTime":188.35,"endTime":191.11,"body":"weird turns. And when you're"},{"speaker":"Steve Gompertz","startTime":188.35,"endTime":191.11,"body":"that age, you're not"},{"speaker":"Steve Gompertz","startTime":191.11,"endTime":195.43,"body":"particularly mature yet. I don't"},{"speaker":"Steve Gompertz","startTime":191.11,"endTime":195.43,"body":"think a lot of thought goes into"},{"speaker":"Steve Gompertz","startTime":195.43,"endTime":198.58,"body":"it. It's just sort of where does"},{"speaker":"Steve Gompertz","startTime":195.43,"endTime":198.58,"body":"the breeze take this leaf?"},{"speaker":"Steve Gompertz","startTime":198.58,"endTime":198.67,"body":"Right?"},{"speaker":"Steve Gompertz","startTime":200.94,"endTime":203.7,"body":"And during"},{"speaker":"Steve Gompertz","startTime":200.94,"endTime":203.7,"body":"freshman year, we had this"},{"speaker":"Steve Gompertz","startTime":203.7,"endTime":216.45,"body":"engineering 101 class. And part"},{"speaker":"Steve Gompertz","startTime":203.7,"endTime":216.45,"body":"of that was every week, they"},{"speaker":"Steve Gompertz","startTime":216.45,"endTime":219.18,"body":"brought in a different"},{"speaker":"Steve Gompertz","startTime":216.45,"endTime":219.18,"body":"department head to talk about"},{"speaker":"Steve Gompertz","startTime":219.57,"endTime":222.03,"body":"the life of that type of"},{"speaker":"Steve Gompertz","startTime":219.57,"endTime":222.03,"body":"engineer. And like I said, I had"},{"speaker":"Steve Gompertz","startTime":222.03,"endTime":226.8,"body":"gone in as an electrical"},{"speaker":"Steve Gompertz","startTime":222.03,"endTime":226.8,"body":"engineer, and two weeks in the"},{"speaker":"Steve Gompertz","startTime":226.8,"endTime":228.51,"body":"head of the electrical"},{"speaker":"Steve Gompertz","startTime":226.8,"endTime":228.51,"body":"engineering, electrical"},{"speaker":"Steve Gompertz","startTime":228.51,"endTime":231.9,"body":"engineering department does his"},{"speaker":"Steve Gompertz","startTime":228.51,"endTime":231.9,"body":"presentation. And that's when I"},{"speaker":"Steve Gompertz","startTime":231.9,"endTime":234.51,"body":"was first in a panic because it"},{"speaker":"Steve Gompertz","startTime":231.9,"endTime":234.51,"body":"was like, that doesn't sound at"},{"speaker":"Steve Gompertz","startTime":234.54,"endTime":241.56,"body":"all like anything I want to hear"},{"speaker":"Steve Gompertz","startTime":234.54,"endTime":241.56,"body":"at college, and I hate the idea"},{"speaker":"Steve Gompertz","startTime":241.56,"endTime":246.09,"body":"of when I signed up. And then"},{"speaker":"Steve Gompertz","startTime":241.56,"endTime":246.09,"body":"luckily, the next week was the"},{"speaker":"Steve Gompertz","startTime":246.09,"endTime":249.27,"body":"mechanical engineering"},{"speaker":"Steve Gompertz","startTime":246.09,"endTime":249.27,"body":"department head. And I went, Oh,"},{"speaker":"Steve Gompertz","startTime":249.33,"endTime":253.8,"body":"that sounds really good. Nice to"},{"speaker":"Steve Gompertz","startTime":249.33,"endTime":253.8,"body":"switch over to mechanical"},{"speaker":"Steve Gompertz","startTime":253.8,"endTime":256.59,"body":"engineering. But then what's"},{"speaker":"Steve Gompertz","startTime":253.8,"endTime":256.59,"body":"funny is I've never held a"},{"speaker":"Steve Gompertz","startTime":256.59,"endTime":258.09,"body":"position as a mechanical"},{"speaker":"Steve Gompertz","startTime":256.59,"endTime":258.09,"body":"engineer."},{"speaker":"Aaron Moncur","startTime":258.48,"endTime":260.97,"body":"Okay, I was going"},{"speaker":"Aaron Moncur","startTime":258.48,"endTime":260.97,"body":"to ask you kind of got into"},{"speaker":"Aaron Moncur","startTime":260.97,"endTime":264.69,"body":"engineering because of cars. Did"},{"speaker":"Aaron Moncur","startTime":260.97,"endTime":264.69,"body":"you ever work in automotive?"},{"speaker":"Steve Gompertz","startTime":264.87,"endTime":267.72,"body":"I did not. So,"},{"speaker":"Steve Gompertz","startTime":264.87,"endTime":267.72,"body":"you know, what I was in love"},{"speaker":"Steve Gompertz","startTime":267.72,"endTime":271.35,"body":"with, I think was the shape of"},{"speaker":"Steve Gompertz","startTime":267.72,"endTime":271.35,"body":"cars. Not like, I mean, I'm a"},{"speaker":"Steve Gompertz","startTime":271.35,"endTime":275.73,"body":"Motorhead. I have a high"},{"speaker":"Steve Gompertz","startTime":271.35,"endTime":275.73,"body":"performance car. But I wanted to"},{"speaker":"Steve Gompertz","startTime":275.73,"endTime":278.43,"body":"design the shape of cars. And at"},{"speaker":"Steve Gompertz","startTime":275.73,"endTime":278.43,"body":"the time, I didn't realize there"},{"speaker":"Steve Gompertz","startTime":278.43,"endTime":281.31,"body":"was like this thing called"},{"speaker":"Steve Gompertz","startTime":278.43,"endTime":281.31,"body":"industrial engineering or"},{"speaker":"Steve Gompertz","startTime":281.31,"endTime":284.52,"body":"industrial design that just"},{"speaker":"Steve Gompertz","startTime":281.31,"endTime":284.52,"body":"wasn't major than was really"},{"speaker":"Steve Gompertz","startTime":284.52,"endTime":287.4,"body":"what I probably should have"},{"speaker":"Steve Gompertz","startTime":284.52,"endTime":287.4,"body":"gotten into. And I got out of"},{"speaker":"Steve Gompertz","startTime":287.4,"endTime":291.84,"body":"college and I got a job as a"},{"speaker":"Steve Gompertz","startTime":287.4,"endTime":291.84,"body":"software engineer, developing"},{"speaker":"Steve Gompertz","startTime":292.8,"endTime":295.74,"body":"Computer Aided Engineering"},{"speaker":"Steve Gompertz","startTime":292.8,"endTime":295.74,"body":"applications for electrical"},{"speaker":"Steve Gompertz","startTime":295.74,"endTime":299.97,"body":"design. So I never really got"},{"speaker":"Steve Gompertz","startTime":295.74,"endTime":299.97,"body":"away from the electrical side"},{"speaker":"Steve Gompertz","startTime":300.0,"endTime":302.82,"body":"thing, but here I am with my"},{"speaker":"Steve Gompertz","startTime":300.0,"endTime":302.82,"body":"mechanical degree. And I'm"},{"speaker":"Steve Gompertz","startTime":302.82,"endTime":307.05,"body":"coming up with tools for"},{"speaker":"Steve Gompertz","startTime":302.82,"endTime":307.05,"body":"electrical engineers. It all"},{"speaker":"Steve Gompertz","startTime":307.05,"endTime":307.62,"body":"worked out."},{"speaker":"Aaron Moncur","startTime":309.059,"endTime":313.349,"body":"So looking back"},{"speaker":"Aaron Moncur","startTime":309.059,"endTime":313.349,"body":"over your career, if you had it"},{"speaker":"Aaron Moncur","startTime":313.349,"endTime":317.339,"body":"to do all over again, would you"},{"speaker":"Aaron Moncur","startTime":313.349,"endTime":317.339,"body":"make any different choices as"},{"speaker":"Aaron Moncur","startTime":317.339,"endTime":320.699,"body":"far as like, fundamentally what"},{"speaker":"Aaron Moncur","startTime":317.339,"endTime":320.699,"body":"you know what your expertise,"},{"speaker":"Aaron Moncur","startTime":321.059,"endTime":322.169,"body":"your background is in?"},{"speaker":"Steve Gompertz","startTime":322.98,"endTime":325.38,"body":"No, I mean, it's"},{"speaker":"Steve Gompertz","startTime":322.98,"endTime":325.38,"body":"been a great career, it's been"},{"speaker":"Steve Gompertz","startTime":325.38,"endTime":328.29,"body":"fun, it's been a great ride,"},{"speaker":"Steve Gompertz","startTime":325.38,"endTime":328.29,"body":"we've gotten a chance to do a"},{"speaker":"Steve Gompertz","startTime":328.29,"endTime":331.71,"body":"lot of really interesting things"},{"speaker":"Steve Gompertz","startTime":328.29,"endTime":331.71,"body":"and become an expert in a number"},{"speaker":"Steve Gompertz","startTime":331.71,"endTime":335.22,"body":"of areas. And I've been able to"},{"speaker":"Steve Gompertz","startTime":331.71,"endTime":335.22,"body":"change that, you know, over"},{"speaker":"Steve Gompertz","startTime":335.22,"endTime":337.8,"body":"time, so no, I wouldn't I"},{"speaker":"Steve Gompertz","startTime":335.22,"endTime":337.8,"body":"wouldn't change a thing. I"},{"speaker":"Steve Gompertz","startTime":337.8,"endTime":340.62,"body":"suspect if I, like I said, if I"},{"speaker":"Steve Gompertz","startTime":337.8,"endTime":340.62,"body":"had been aware that there was"},{"speaker":"Steve Gompertz","startTime":340.62,"endTime":343.5,"body":"this concept of industrial"},{"speaker":"Steve Gompertz","startTime":340.62,"endTime":343.5,"body":"design, I probably would have"},{"speaker":"Steve Gompertz","startTime":343.5,"endTime":347.37,"body":"gone down that path, and maybe"},{"speaker":"Steve Gompertz","startTime":343.5,"endTime":347.37,"body":"stayed in that. But I wouldn't"},{"speaker":"Steve Gompertz","startTime":347.37,"endTime":349.62,"body":"have ended up where I am today,"},{"speaker":"Steve Gompertz","startTime":347.37,"endTime":349.62,"body":"loving what I'm doing."},{"speaker":"Aaron Moncur","startTime":349.89,"endTime":353.19,"body":"Yeah, yeah. Well,"},{"speaker":"Aaron Moncur","startTime":349.89,"endTime":353.19,"body":"one of the things that you are"},{"speaker":"Aaron Moncur","startTime":353.19,"endTime":357.63,"body":"an expert in is regulatory"},{"speaker":"Aaron Moncur","startTime":353.19,"endTime":357.63,"body":"compliance. Can you tell us just"},{"speaker":"Aaron Moncur","startTime":357.63,"endTime":360.72,"body":"a little bit about what what"},{"speaker":"Aaron Moncur","startTime":357.63,"endTime":360.72,"body":"even is regulatory compliance"},{"speaker":"Aaron Moncur","startTime":360.72,"endTime":364.41,"body":"within the context of medical"},{"speaker":"Aaron Moncur","startTime":360.72,"endTime":364.41,"body":"devices? And then what have been"},{"speaker":"Aaron Moncur","startTime":364.41,"endTime":367.41,"body":"some of the big changes that"},{"speaker":"Aaron Moncur","startTime":364.41,"endTime":367.41,"body":"you've seen in that field? Over"},{"speaker":"Aaron Moncur","startTime":367.41,"endTime":368.7,"body":"the years? Yeah,"},{"speaker":"Steve Gompertz","startTime":368.27,"endTime":370.7,"body":"yeah. So the"},{"speaker":"Steve Gompertz","startTime":368.27,"endTime":370.7,"body":"idea is, right, when you're"},{"speaker":"Steve Gompertz","startTime":370.7,"endTime":374.9,"body":"doing something that can have,"},{"speaker":"Steve Gompertz","startTime":370.7,"endTime":374.9,"body":"you know, adverse effects on"},{"speaker":"Steve Gompertz","startTime":375.8,"endTime":379.04,"body":"patients, and the people using"},{"speaker":"Steve Gompertz","startTime":375.8,"endTime":379.04,"body":"things like medical devices, to"},{"speaker":"Steve Gompertz","startTime":379.04,"endTime":382.49,"body":"your medical professionals, or"},{"speaker":"Steve Gompertz","startTime":379.04,"endTime":382.49,"body":"even lay people, you know,"},{"speaker":"Steve Gompertz","startTime":382.49,"endTime":384.95,"body":"obviously, the government steps"},{"speaker":"Steve Gompertz","startTime":382.49,"endTime":384.95,"body":"in and goes, Look, we need to"},{"speaker":"Steve Gompertz","startTime":384.95,"endTime":387.14,"body":"make sure you're doing this"},{"speaker":"Steve Gompertz","startTime":384.95,"endTime":387.14,"body":"right, right. The word safe and"},{"speaker":"Steve Gompertz","startTime":387.14,"endTime":390.47,"body":"effective are what drive"},{"speaker":"Steve Gompertz","startTime":387.14,"endTime":390.47,"body":"everything in that industry. And"},{"speaker":"Steve Gompertz","startTime":390.5,"endTime":393.92,"body":"to make sure that there's no,"},{"speaker":"Steve Gompertz","startTime":390.5,"endTime":393.92,"body":"you know, wiggle room there,"},{"speaker":"Steve Gompertz","startTime":393.92,"endTime":395.84,"body":"they're gonna go, we're gonna"},{"speaker":"Steve Gompertz","startTime":393.92,"endTime":395.84,"body":"give you the regulations and"},{"speaker":"Steve Gompertz","startTime":395.84,"endTime":399.5,"body":"tell you exactly how we want"},{"speaker":"Steve Gompertz","startTime":395.84,"endTime":399.5,"body":"that done. Or at least, here's"},{"speaker":"Steve Gompertz","startTime":399.5,"endTime":402.14,"body":"the guardrails, right, and the"},{"speaker":"Steve Gompertz","startTime":399.5,"endTime":402.14,"body":"constraints you have to operate"},{"speaker":"Steve Gompertz","startTime":402.14,"endTime":405.17,"body":"with. And so as a consultant,"},{"speaker":"Steve Gompertz","startTime":402.14,"endTime":405.17,"body":"what I do is to help make sure"},{"speaker":"Steve Gompertz","startTime":405.17,"endTime":408.74,"body":"companies understand how to"},{"speaker":"Steve Gompertz","startTime":405.17,"endTime":408.74,"body":"interpret that in med device, is"},{"speaker":"Steve Gompertz","startTime":408.74,"endTime":411.98,"body":"actually pretty hard. Because"},{"speaker":"Steve Gompertz","startTime":408.74,"endTime":411.98,"body":"the concept of a med device is"},{"speaker":"Steve Gompertz","startTime":411.98,"endTime":415.49,"body":"so broad, the regulations are"},{"speaker":"Steve Gompertz","startTime":411.98,"endTime":415.49,"body":"not not particularly"},{"speaker":"Steve Gompertz","startTime":415.73,"endTime":419.84,"body":"prescriptive. You know,"},{"speaker":"Steve Gompertz","startTime":415.73,"endTime":419.84,"body":"everything from a tongue"},{"speaker":"Steve Gompertz","startTime":419.84,"endTime":424.94,"body":"depressor to a piece of software"},{"speaker":"Steve Gompertz","startTime":419.84,"endTime":424.94,"body":"as a med device. Right? So how"},{"speaker":"Steve Gompertz","startTime":424.94,"endTime":428.06,"body":"would you write prescriptive"},{"speaker":"Steve Gompertz","startTime":424.94,"endTime":428.06,"body":"rules for how to manage those"},{"speaker":"Steve Gompertz","startTime":428.06,"endTime":431.66,"body":"different things, and pacemakers"},{"speaker":"Steve Gompertz","startTime":428.06,"endTime":431.66,"body":"and heart valves and catheters."},{"speaker":"Steve Gompertz","startTime":432.56,"endTime":435.26,"body":"So the device side of things is"},{"speaker":"Steve Gompertz","startTime":432.56,"endTime":435.26,"body":"actually pretty complex. And"},{"speaker":"Steve Gompertz","startTime":435.26,"endTime":438.05,"body":"that's where consultants like"},{"speaker":"Steve Gompertz","startTime":435.26,"endTime":438.05,"body":"myself come in is the guy, when"},{"speaker":"Steve Gompertz","startTime":438.05,"endTime":442.22,"body":"you look at your situation, read"},{"speaker":"Steve Gompertz","startTime":438.05,"endTime":442.22,"body":"between the lines ago, here's"},{"speaker":"Steve Gompertz","startTime":442.22,"endTime":445.04,"body":"what they're going to expect, or"},{"speaker":"Steve Gompertz","startTime":442.22,"endTime":445.04,"body":"how they're gonna expect you to"},{"speaker":"Steve Gompertz","startTime":445.04,"endTime":449.96,"body":"apply this rule, which doesn't"},{"speaker":"Steve Gompertz","startTime":445.04,"endTime":449.96,"body":"give you a lot of detail. Yeah,"},{"speaker":"Steve Gompertz","startTime":450.02,"endTime":453.5,"body":"make it work and drive you to"},{"speaker":"Steve Gompertz","startTime":450.02,"endTime":453.5,"body":"make sure that you've got a safe"},{"speaker":"Steve Gompertz","startTime":453.5,"endTime":457.16,"body":"and effective device. I think"},{"speaker":"Steve Gompertz","startTime":453.5,"endTime":457.16,"body":"what's changed a lot, obviously,"},{"speaker":"Steve Gompertz","startTime":457.76,"endTime":462.08,"body":"34 years into med device, after"},{"speaker":"Steve Gompertz","startTime":457.76,"endTime":462.08,"body":"seven years in computer"},{"speaker":"Steve Gompertz","startTime":462.08,"endTime":466.52,"body":"software. I think, you know,"},{"speaker":"Steve Gompertz","startTime":462.08,"endTime":466.52,"body":"there's obviously has been a lot"},{"speaker":"Steve Gompertz","startTime":466.52,"endTime":470.54,"body":"of change. One that comes to"},{"speaker":"Steve Gompertz","startTime":466.52,"endTime":470.54,"body":"mind is kind of the"},{"speaker":"Steve Gompertz","startTime":470.54,"endTime":475.7,"body":"globalization of regulations"},{"speaker":"Steve Gompertz","startTime":470.54,"endTime":475.7,"body":"used to be, you know, it wasn't"},{"speaker":"Steve Gompertz","startTime":475.7,"endTime":479.84,"body":"that other countries didn't have"},{"speaker":"Steve Gompertz","startTime":475.7,"endTime":479.84,"body":"their own regulatory processes,"},{"speaker":"Steve Gompertz","startTime":479.84,"endTime":484.01,"body":"but not all of them did. And"},{"speaker":"Steve Gompertz","startTime":479.84,"endTime":484.01,"body":"whatever countries did have them"},{"speaker":"Steve Gompertz","startTime":484.01,"endTime":488.63,"body":"basically just copy the FDA"},{"speaker":"Steve Gompertz","startTime":484.01,"endTime":488.63,"body":"USFDA. Now, over time, as"},{"speaker":"Steve Gompertz","startTime":488.63,"endTime":490.73,"body":"they've matured, and they've"},{"speaker":"Steve Gompertz","startTime":488.63,"endTime":490.73,"body":"started to realize what do they"},{"speaker":"Steve Gompertz","startTime":490.73,"endTime":493.76,"body":"want out of this? They're not"},{"speaker":"Steve Gompertz","startTime":490.73,"endTime":493.76,"body":"all going oh, FDA doesn't always"},{"speaker":"Steve Gompertz","startTime":493.76,"endTime":496.97,"body":"get it correct, at least from"},{"speaker":"Steve Gompertz","startTime":493.76,"endTime":496.97,"body":"our perspective. And so we're"},{"speaker":"Steve Gompertz","startTime":496.97,"endTime":500.51,"body":"seeing, you know, a lot more"},{"speaker":"Steve Gompertz","startTime":496.97,"endTime":500.51,"body":"proliferation of regulations"},{"speaker":"Steve Gompertz","startTime":500.51,"endTime":503.63,"body":"where countries have taken the"},{"speaker":"Steve Gompertz","startTime":500.51,"endTime":503.63,"body":"time now, to understand what"},{"speaker":"Steve Gompertz","startTime":503.69,"endTime":507.8,"body":"they think it requires to"},{"speaker":"Steve Gompertz","startTime":503.69,"endTime":507.8,"body":"protect their population, find"},{"speaker":"Steve Gompertz","startTime":507.8,"endTime":509.78,"body":"the manufacturers make sure the"},{"speaker":"Steve Gompertz","startTime":507.8,"endTime":509.78,"body":"manufacturers do the right"},{"speaker":"Steve Gompertz","startTime":509.78,"endTime":514.79,"body":"thing. So it's been interesting"},{"speaker":"Steve Gompertz","startTime":509.78,"endTime":514.79,"body":"to see that evolution of the"},{"speaker":"Steve Gompertz","startTime":514.79,"endTime":518.96,"body":"regulations in different"},{"speaker":"Steve Gompertz","startTime":514.79,"endTime":518.96,"body":"geographies. And to see some of"},{"speaker":"Steve Gompertz","startTime":518.96,"endTime":522.47,"body":"them like particularly the in"},{"speaker":"Steve Gompertz","startTime":518.96,"endTime":522.47,"body":"Europe, to see it really"},{"speaker":"Steve Gompertz","startTime":522.47,"endTime":526.4,"body":"starting to take the lead, you"},{"speaker":"Steve Gompertz","startTime":522.47,"endTime":526.4,"body":"know, we're now that's kind of"},{"speaker":"Steve Gompertz","startTime":526.4,"endTime":528.59,"body":"what everybody's copying and"},{"speaker":"Steve Gompertz","startTime":526.4,"endTime":528.59,"body":"where things are going. And"},{"speaker":"Steve Gompertz","startTime":528.59,"endTime":532.22,"body":"where it's a lot harder. Used to"},{"speaker":"Steve Gompertz","startTime":528.59,"endTime":532.22,"body":"be was considered the FDA was"},{"speaker":"Steve Gompertz","startTime":532.22,"endTime":535.07,"body":"pretty tough, and it was hard to"},{"speaker":"Steve Gompertz","startTime":532.22,"endTime":535.07,"body":"get devices into the US market."},{"speaker":"Steve Gompertz","startTime":535.25,"endTime":538.04,"body":"So you always went somewhere"},{"speaker":"Steve Gompertz","startTime":535.25,"endTime":538.04,"body":"else first, we're actually"},{"speaker":"Steve Gompertz","startTime":538.04,"endTime":541.07,"body":"seeing that is now completely"},{"speaker":"Steve Gompertz","startTime":538.04,"endTime":541.07,"body":"switched. A number of our"},{"speaker":"Steve Gompertz","startTime":541.07,"endTime":544.97,"body":"clients are your base, and they"},{"speaker":"Steve Gompertz","startTime":541.07,"endTime":544.97,"body":"don't want to get on the market."},{"speaker":"Steve Gompertz","startTime":545.0,"endTime":547.16,"body":"They want to get on the US"},{"speaker":"Steve Gompertz","startTime":545.0,"endTime":547.16,"body":"market because it's now the"},{"speaker":"Steve Gompertz","startTime":547.16,"endTime":548.99,"body":"easier market to get into."},{"speaker":"Aaron Moncur","startTime":549.77,"endTime":552.56,"body":"I've heard a"},{"speaker":"Aaron Moncur","startTime":549.77,"endTime":552.56,"body":"number of people comment about"},{"speaker":"Aaron Moncur","startTime":552.56,"endTime":559.37,"body":"the increasing. What's the word"},{"speaker":"Aaron Moncur","startTime":552.56,"endTime":559.37,"body":"I'm looking for? Severity is not"},{"speaker":"Aaron Moncur","startTime":559.37,"endTime":562.91,"body":"quite the right word. But I"},{"speaker":"Aaron Moncur","startTime":559.37,"endTime":562.91,"body":"guess strictness of the"},{"speaker":"Aaron Moncur","startTime":562.91,"endTime":569.21,"body":"guidelines imposed by regulatory"},{"speaker":"Aaron Moncur","startTime":562.91,"endTime":569.21,"body":"bodies, the FDA. Do you think"},{"speaker":"Aaron Moncur","startTime":569.21,"endTime":573.17,"body":"that we strike a good balance at"},{"speaker":"Aaron Moncur","startTime":569.21,"endTime":573.17,"body":"this point? Or is the balance"},{"speaker":"Aaron Moncur","startTime":573.17,"endTime":580.64,"body":"tipped? towards the side of"},{"speaker":"Aaron Moncur","startTime":573.17,"endTime":580.64,"body":"maybe it being too robust, a set"},{"speaker":"Aaron Moncur","startTime":580.64,"endTime":583.52,"body":"of regulations and it's impeding"},{"speaker":"Aaron Moncur","startTime":580.64,"endTime":583.52,"body":"innovation?"},{"speaker":"Steve Gompertz","startTime":583.0,"endTime":584.5,"body":"No, I don't"},{"speaker":"Steve Gompertz","startTime":583.0,"endTime":584.5,"body":"think it is impeding innovate. I"},{"speaker":"Steve Gompertz","startTime":584.5,"endTime":585.73,"body":"mean, the you know, the"},{"speaker":"Steve Gompertz","startTime":584.5,"endTime":585.73,"body":"manufacturers are always scream,"},{"speaker":"Steve Gompertz","startTime":585.73,"endTime":586.81,"body":"oh, this is going to slow us"},{"speaker":"Steve Gompertz","startTime":585.73,"endTime":586.81,"body":"down and you're just going to"},{"speaker":"Steve Gompertz","startTime":586.81,"endTime":588.13,"body":"make it harder for patients to"},{"speaker":"Steve Gompertz","startTime":586.81,"endTime":588.13,"body":"get the benefits. But I don't"},{"speaker":"Steve Gompertz","startTime":588.67,"endTime":596.35,"body":"think there's any data that"},{"speaker":"Steve Gompertz","startTime":588.67,"endTime":596.35,"body":"actually supports that. That"},{"speaker":"Steve Gompertz","startTime":596.98,"endTime":600.79,"body":"that's happened. When you look"},{"speaker":"Steve Gompertz","startTime":596.98,"endTime":600.79,"body":"at like I said the EU medical"},{"speaker":"Steve Gompertz","startTime":600.79,"endTime":605.38,"body":"device regulations are certainly"},{"speaker":"Steve Gompertz","startTime":600.79,"endTime":605.38,"body":"more prescriptive. And you might"},{"speaker":"Steve Gompertz","startTime":605.38,"endTime":607.33,"body":"consider they're more"},{"speaker":"Steve Gompertz","startTime":605.38,"endTime":607.33,"body":"burdensome, they're taught they"},{"speaker":"Steve Gompertz","startTime":607.33,"endTime":610.99,"body":"are definitely tougher. But when"},{"speaker":"Steve Gompertz","startTime":607.33,"endTime":610.99,"body":"you study them and you go, but"},{"speaker":"Steve Gompertz","startTime":610.99,"endTime":615.82,"body":"they're right. It shouldn't be"},{"speaker":"Steve Gompertz","startTime":610.99,"endTime":615.82,"body":"hard. Right? If I'm going to put"},{"speaker":"Steve Gompertz","startTime":615.82,"endTime":618.73,"body":"a pacemaker in somebody's body,"},{"speaker":"Steve Gompertz","startTime":615.82,"endTime":618.73,"body":"that shouldn't be an easy thing"},{"speaker":"Steve Gompertz","startTime":618.73,"endTime":621.79,"body":"to get on the market, right?"},{"speaker":"Steve Gompertz","startTime":618.73,"endTime":621.79,"body":"Yeah. And as we advanced the"},{"speaker":"Steve Gompertz","startTime":621.79,"endTime":625.66,"body":"technologies, and now you add in"},{"speaker":"Steve Gompertz","startTime":621.79,"endTime":625.66,"body":"things like AI and ML, it's"},{"speaker":"Steve Gompertz","startTime":625.66,"endTime":628.33,"body":"getting much more complex and"},{"speaker":"Steve Gompertz","startTime":625.66,"endTime":628.33,"body":"you go on, yeah, there probably"},{"speaker":"Steve Gompertz","startTime":628.33,"endTime":631.78,"body":"should be some really tight"},{"speaker":"Steve Gompertz","startTime":628.33,"endTime":631.78,"body":"rules about this. So I think"},{"speaker":"Steve Gompertz","startTime":631.78,"endTime":633.79,"body":"they're on the right track. And"},{"speaker":"Steve Gompertz","startTime":631.78,"endTime":633.79,"body":"that's why other countries are"},{"speaker":"Steve Gompertz","startTime":633.79,"endTime":637.72,"body":"now following the US lead, and I"},{"speaker":"Steve Gompertz","startTime":633.79,"endTime":637.72,"body":"suspect the US we will as well,"},{"speaker":"Steve Gompertz","startTime":638.29,"endTime":644.17,"body":"in the not too distant future."},{"speaker":"Steve Gompertz","startTime":638.29,"endTime":644.17,"body":"It might have some impact, you"},{"speaker":"Steve Gompertz","startTime":644.17,"endTime":649.27,"body":"know, on cost of design and"},{"speaker":"Steve Gompertz","startTime":644.17,"endTime":649.27,"body":"development for new devices. But"},{"speaker":"Steve Gompertz","startTime":649.27,"endTime":652.93,"body":"again, it's long yet it probably"},{"speaker":"Steve Gompertz","startTime":649.27,"endTime":652.93,"body":"shouldn't be hard for certain,"},{"speaker":"Steve Gompertz","startTime":652.93,"endTime":655.81,"body":"right? And everything gets"},{"speaker":"Steve Gompertz","startTime":652.93,"endTime":655.81,"body":"classified, right? So if your"},{"speaker":"Steve Gompertz","startTime":655.81,"endTime":658.24,"body":"class one low risk, you're"},{"speaker":"Steve Gompertz","startTime":655.81,"endTime":658.24,"body":"making tongue depressors, the"},{"speaker":"Steve Gompertz","startTime":658.24,"endTime":661.33,"body":"rules haven't changed. And"},{"speaker":"Steve Gompertz","startTime":658.24,"endTime":661.33,"body":"everywhere, it's still pretty"},{"speaker":"Steve Gompertz","startTime":661.33,"endTime":664.42,"body":"easy. You get the class two,"},{"speaker":"Steve Gompertz","startTime":661.33,"endTime":664.42,"body":"class three, and then some go to"},{"speaker":"Steve Gompertz","startTime":664.42,"endTime":667.03,"body":"four levels or five levels. But"},{"speaker":"Steve Gompertz","startTime":664.42,"endTime":667.03,"body":"as you go up, the risks go up."},{"speaker":"Steve Gompertz","startTime":667.36,"endTime":670.78,"body":"Yeah. And not surprisingly, them"},{"speaker":"Steve Gompertz","startTime":667.36,"endTime":670.78,"body":"yeah, the hurdles get higher as"},{"speaker":"Steve Gompertz","startTime":670.78,"endTime":675.58,"body":"they should. And if you want to"},{"speaker":"Steve Gompertz","startTime":670.78,"endTime":675.58,"body":"play in that field, then yeah,"},{"speaker":"Steve Gompertz","startTime":675.61,"endTime":678.19,"body":"you should be prepared for what"},{"speaker":"Steve Gompertz","startTime":675.61,"endTime":678.19,"body":"it's going to take to get there"},{"speaker":"Steve Gompertz","startTime":678.49,"endTime":683.2,"body":"sure, can't come up with a new"},{"speaker":"Steve Gompertz","startTime":678.49,"endTime":683.2,"body":"implantable device, and think"},{"speaker":"Steve Gompertz","startTime":683.2,"endTime":686.44,"body":"that that's going to happen in"},{"speaker":"Steve Gompertz","startTime":683.2,"endTime":686.44,"body":"six months. I know your"},{"speaker":"Steve Gompertz","startTime":686.44,"endTime":689.2,"body":"engineers could probably do a"},{"speaker":"Steve Gompertz","startTime":686.44,"endTime":689.2,"body":"design in six months, but they"},{"speaker":"Steve Gompertz","startTime":689.2,"endTime":691.87,"body":"have to prove that it works."},{"speaker":"Steve Gompertz","startTime":689.2,"endTime":691.87,"body":"Right. And that it doesn't do"},{"speaker":"Steve Gompertz","startTime":691.87,"endTime":692.32,"body":"any harm."},{"speaker":"Aaron Moncur","startTime":692.5,"endTime":694.81,"body":"Yeah. So let's"},{"speaker":"Aaron Moncur","startTime":692.5,"endTime":694.81,"body":"talk about that, that the trade"},{"speaker":"Aaron Moncur","startTime":694.81,"endTime":699.19,"body":"off between speed aggressiveness"},{"speaker":"Aaron Moncur","startTime":694.81,"endTime":699.19,"body":"of your development, innovation,"},{"speaker":"Aaron Moncur","startTime":699.43,"endTime":704.17,"body":"and and the need for, you know,"},{"speaker":"Aaron Moncur","startTime":699.43,"endTime":704.17,"body":"rigorous quality control. Is"},{"speaker":"Aaron Moncur","startTime":704.17,"endTime":708.43,"body":"there a project that you're able"},{"speaker":"Aaron Moncur","startTime":704.17,"endTime":708.43,"body":"to share where you had to help a"},{"speaker":"Aaron Moncur","startTime":708.43,"endTime":712.24,"body":"company strike some balance"},{"speaker":"Aaron Moncur","startTime":708.43,"endTime":712.24,"body":"between the rigorous quality"},{"speaker":"Aaron Moncur","startTime":712.24,"endTime":716.11,"body":"control and innovation and"},{"speaker":"Aaron Moncur","startTime":712.24,"endTime":716.11,"body":"developing something quickly?"},{"speaker":"Aaron Moncur","startTime":716.11,"endTime":718.18,"body":"And how do you find that"},{"speaker":"Aaron Moncur","startTime":716.11,"endTime":718.18,"body":"balance?"},{"speaker":"Steve Gompertz","startTime":718.53,"endTime":722.58,"body":"Yeah, wow. Yeah,"},{"speaker":"Steve Gompertz","startTime":718.53,"endTime":722.58,"body":"I would say every branch,"},{"speaker":"Steve Gompertz","startTime":724.35,"endTime":728.31,"body":"everybody, like businesses are"},{"speaker":"Steve Gompertz","startTime":724.35,"endTime":728.31,"body":"in business to make money. On"},{"speaker":"Steve Gompertz","startTime":728.31,"endTime":730.29,"body":"the opposite side, the"},{"speaker":"Steve Gompertz","startTime":728.31,"endTime":730.29,"body":"regulatory bodies couldn't care"},{"speaker":"Steve Gompertz","startTime":730.29,"endTime":733.5,"body":"less how much money you make, as"},{"speaker":"Steve Gompertz","startTime":730.29,"endTime":733.5,"body":"long as what you do doesn't"},{"speaker":"Steve Gompertz","startTime":733.5,"endTime":739.05,"body":"cause any harm. So it's always"},{"speaker":"Steve Gompertz","startTime":733.5,"endTime":739.05,"body":"that balancing act. And, you"},{"speaker":"Steve Gompertz","startTime":739.05,"endTime":743.22,"body":"know, part of what we hope we"},{"speaker":"Steve Gompertz","startTime":739.05,"endTime":743.22,"body":"provide is finding the correct"},{"speaker":"Steve Gompertz","startTime":743.22,"endTime":745.74,"body":"pathway. Because there are"},{"speaker":"Steve Gompertz","startTime":743.22,"endTime":745.74,"body":"multiple pathways, there's not a"},{"speaker":"Steve Gompertz","startTime":745.74,"endTime":749.16,"body":"one size fits all on the"},{"speaker":"Steve Gompertz","startTime":745.74,"endTime":749.16,"body":"regulatory world. And you can"},{"speaker":"Steve Gompertz","startTime":749.16,"endTime":752.19,"body":"definitely put yourself on a"},{"speaker":"Steve Gompertz","startTime":749.16,"endTime":752.19,"body":"pathway that's too hard or"},{"speaker":"Steve Gompertz","startTime":752.19,"endTime":756.15,"body":"harder than it needs to be. So"},{"speaker":"Steve Gompertz","startTime":752.19,"endTime":756.15,"body":"we help companies try to see the"},{"speaker":"Steve Gompertz","startTime":756.15,"endTime":759.33,"body":"right place. But then, once we"},{"speaker":"Steve Gompertz","startTime":756.15,"endTime":759.33,"body":"realize, look, this is the"},{"speaker":"Steve Gompertz","startTime":759.33,"endTime":762.03,"body":"appropriate pathway for you,"},{"speaker":"Steve Gompertz","startTime":759.33,"endTime":762.03,"body":"then it's like, there's no"},{"speaker":"Steve Gompertz","startTime":762.03,"endTime":765.42,"body":"getting around this. And that's"},{"speaker":"Steve Gompertz","startTime":762.03,"endTime":765.42,"body":"when you get a chance to"},{"speaker":"Steve Gompertz","startTime":765.42,"endTime":769.29,"body":"challenge you know, their"},{"speaker":"Steve Gompertz","startTime":765.42,"endTime":769.29,"body":"company ethics on things, you"},{"speaker":"Steve Gompertz","startTime":769.29,"endTime":771.48,"body":"know, that they get it that"},{"speaker":"Steve Gompertz","startTime":769.29,"endTime":771.48,"body":"they're gonna have to do the"},{"speaker":"Steve Gompertz","startTime":771.48,"endTime":776.4,"body":"right thing here. The, my"},{"speaker":"Steve Gompertz","startTime":771.48,"endTime":776.4,"body":"experiences, most companies"},{"speaker":"Steve Gompertz","startTime":776.43,"endTime":779.28,"body":"understand that and are fine"},{"speaker":"Steve Gompertz","startTime":776.43,"endTime":779.28,"body":"with that, and they might make"},{"speaker":"Steve Gompertz","startTime":779.28,"endTime":781.83,"body":"the right decisions. But you"},{"speaker":"Steve Gompertz","startTime":779.28,"endTime":781.83,"body":"definitely see where they"},{"speaker":"Steve Gompertz","startTime":781.83,"endTime":786.72,"body":"struggle with, you know, should"},{"speaker":"Steve Gompertz","startTime":781.83,"endTime":786.72,"body":"we really reduce that risk?"},{"speaker":"Steve Gompertz","startTime":786.75,"endTime":790.41,"body":"Well, the requirement is that"},{"speaker":"Steve Gompertz","startTime":786.75,"endTime":790.41,"body":"you will, you can try to dance"},{"speaker":"Steve Gompertz","startTime":790.41,"endTime":793.65,"body":"around it, but the end of the"},{"speaker":"Steve Gompertz","startTime":790.41,"endTime":793.65,"body":"day, you can either deal with it"},{"speaker":"Steve Gompertz","startTime":793.65,"endTime":796.65,"body":"now, or you can go down the"},{"speaker":"Steve Gompertz","startTime":793.65,"endTime":796.65,"body":"pathway, and at the last second"},{"speaker":"Steve Gompertz","startTime":796.65,"endTime":799.26,"body":"of FDA deny you access to the"},{"speaker":"Steve Gompertz","startTime":796.65,"endTime":799.26,"body":"market, because he didn't do the"},{"speaker":"Steve Gompertz","startTime":799.26,"endTime":802.62,"body":"right thing. And that usually,"},{"speaker":"Steve Gompertz","startTime":799.26,"endTime":802.62,"body":"if you've got people around,"},{"speaker":"Steve Gompertz","startTime":802.65,"endTime":805.62,"body":"he's going to do the right thing"},{"speaker":"Steve Gompertz","startTime":802.65,"endTime":805.62,"body":"for the right reasons. And that"},{"speaker":"Steve Gompertz","startTime":805.62,"endTime":807.93,"body":"threat of that they're going to"},{"speaker":"Steve Gompertz","startTime":805.62,"endTime":807.93,"body":"put all this money there,"},{"speaker":"Steve Gompertz","startTime":807.93,"endTime":811.26,"body":"because it's not cheap to get a"},{"speaker":"Steve Gompertz","startTime":807.93,"endTime":811.26,"body":"device on the market. And"},{"speaker":"Steve Gompertz","startTime":811.26,"endTime":815.76,"body":"there's that possibility that"},{"speaker":"Steve Gompertz","startTime":811.26,"endTime":815.76,"body":"the FDA will say, No, they that"},{"speaker":"Steve Gompertz","startTime":815.76,"endTime":818.43,"body":"hammers on pretty quickly, they"},{"speaker":"Steve Gompertz","startTime":815.76,"endTime":818.43,"body":"get that and they go, yeah, I"},{"speaker":"Steve Gompertz","startTime":818.43,"endTime":821.82,"body":"could have dropped millions of"},{"speaker":"Steve Gompertz","startTime":818.43,"endTime":821.82,"body":"dollars, by not taking the right"},{"speaker":"Steve Gompertz","startTime":821.82,"endTime":825.48,"body":"advice, and suddenly find that"},{"speaker":"Steve Gompertz","startTime":821.82,"endTime":825.48,"body":"I'm nowhere near the finish"},{"speaker":"Steve Gompertz","startTime":825.48,"endTime":829.71,"body":"line. Where Yeah, yeah, they"},{"speaker":"Steve Gompertz","startTime":825.48,"endTime":829.71,"body":"usually get it. So you can"},{"speaker":"Steve Gompertz","startTime":829.71,"endTime":834.51,"body":"usually turn that you want to"},{"speaker":"Steve Gompertz","startTime":829.71,"endTime":834.51,"body":"use the word greed, or desire"},{"speaker":"Steve Gompertz","startTime":834.51,"endTime":838.44,"body":"fake money into the driver that"},{"speaker":"Steve Gompertz","startTime":834.51,"endTime":838.44,"body":"gets them to do the right thing."},{"speaker":"Steve Gompertz","startTime":838.44,"endTime":840.96,"body":"You might want to do that"},{"speaker":"Steve Gompertz","startTime":838.44,"endTime":840.96,"body":"sooner. But you got to well, we"},{"speaker":"Steve Gompertz","startTime":840.96,"endTime":844.65,"body":"could jeopardize the entire"},{"speaker":"Steve Gompertz","startTime":840.96,"endTime":844.65,"body":"investment. Yeah, right. They"},{"speaker":"Steve Gompertz","startTime":844.65,"endTime":845.49,"body":"usually get that"},{"speaker":"Aaron Moncur","startTime":846.62,"endTime":848.9,"body":"You've worked at"},{"speaker":"Aaron Moncur","startTime":846.62,"endTime":848.9,"body":"some large medical device"},{"speaker":"Aaron Moncur","startTime":848.9,"endTime":853.1,"body":"companies, Boston, scientific"},{"speaker":"Aaron Moncur","startTime":848.9,"endTime":853.1,"body":"Medtronic, who of course have"},{"speaker":"Aaron Moncur","startTime":853.1,"endTime":856.67,"body":"their own procedures and"},{"speaker":"Aaron Moncur","startTime":853.1,"endTime":856.67,"body":"protocols for how they do"},{"speaker":"Aaron Moncur","startTime":856.88,"endTime":860.18,"body":"quality and adherence to"},{"speaker":"Aaron Moncur","startTime":856.88,"endTime":860.18,"body":"regulatory requirements, things"},{"speaker":"Aaron Moncur","startTime":860.18,"endTime":864.11,"body":"like that. There are also lots"},{"speaker":"Aaron Moncur","startTime":860.18,"endTime":864.11,"body":"of companies out there who are"},{"speaker":"Aaron Moncur","startTime":864.14,"endTime":867.86,"body":"small, you know, startup medical"},{"speaker":"Aaron Moncur","startTime":864.14,"endTime":867.86,"body":"device companies who have to go"},{"speaker":"Aaron Moncur","startTime":867.86,"endTime":875.39,"body":"through the same have to adhere"},{"speaker":"Aaron Moncur","startTime":867.86,"endTime":875.39,"body":"to the same FDA regulations. But"},{"speaker":"Aaron Moncur","startTime":875.39,"endTime":878.36,"body":"I have to imagine that in a"},{"speaker":"Aaron Moncur","startTime":875.39,"endTime":878.36,"body":"small startup, things are a"},{"speaker":"Aaron Moncur","startTime":878.36,"endTime":883.49,"body":"little bit different than in a"},{"speaker":"Aaron Moncur","startTime":878.36,"endTime":883.49,"body":"giant company like Medtronic or"},{"speaker":"Aaron Moncur","startTime":883.49,"endTime":887.15,"body":"Boston Scientific. How is your"},{"speaker":"Aaron Moncur","startTime":883.49,"endTime":887.15,"body":"experience working for these"},{"speaker":"Aaron Moncur","startTime":887.15,"endTime":892.67,"body":"larger companies influence your"},{"speaker":"Aaron Moncur","startTime":887.15,"endTime":892.67,"body":"overall approach to quality"},{"speaker":"Aaron Moncur","startTime":892.67,"endTime":894.8,"body":"management and regulatory"},{"speaker":"Aaron Moncur","startTime":892.67,"endTime":894.8,"body":"compliance?"},{"speaker":"Steve Gompertz","startTime":895.68,"endTime":897.21,"body":"Yeah, it's"},{"speaker":"Steve Gompertz","startTime":895.68,"endTime":897.21,"body":"important to understand that"},{"speaker":"Steve Gompertz","startTime":897.27,"endTime":901.11,"body":"there isn't a one size fits all"},{"speaker":"Steve Gompertz","startTime":897.27,"endTime":901.11,"body":"and when I Uh, before I became a"},{"speaker":"Steve Gompertz","startTime":901.11,"endTime":904.95,"body":"consultant, you know, when I've"},{"speaker":"Steve Gompertz","startTime":901.11,"endTime":904.95,"body":"worked or applied for jobs at"},{"speaker":"Steve Gompertz","startTime":904.95,"endTime":909.6,"body":"smaller companies, they'd often"},{"speaker":"Steve Gompertz","startTime":904.95,"endTime":909.6,"body":"you know, meet with the CEO or"},{"speaker":"Steve Gompertz","startTime":909.6,"endTime":912.18,"body":"the, you know, the head of"},{"speaker":"Steve Gompertz","startTime":909.6,"endTime":912.18,"body":"quality wherever he's going to"},{"speaker":"Steve Gompertz","startTime":912.18,"endTime":915.36,"body":"report to. And they'd always"},{"speaker":"Steve Gompertz","startTime":912.18,"endTime":915.36,"body":"say, you're not going to come in"},{"speaker":"Steve Gompertz","startTime":915.36,"endTime":918.21,"body":"here and put a Medtronic size"},{"speaker":"Steve Gompertz","startTime":915.36,"endTime":918.21,"body":"quality surveys, because we're"},{"speaker":"Steve Gompertz","startTime":918.21,"endTime":923.28,"body":"not. And I go, I understand"},{"speaker":"Steve Gompertz","startTime":918.21,"endTime":923.28,"body":"that, right? And no, there isn't"},{"speaker":"Steve Gompertz","startTime":923.28,"endTime":926.25,"body":"a one size fits all I'm not just"},{"speaker":"Steve Gompertz","startTime":923.28,"endTime":926.25,"body":"because there was at Medtronic"},{"speaker":"Steve Gompertz","startTime":926.25,"endTime":929.04,"body":"doesn't mean that that's all I"},{"speaker":"Steve Gompertz","startTime":926.25,"endTime":929.04,"body":"know. And I'm gonna put their"},{"speaker":"Steve Gompertz","startTime":929.04,"endTime":931.05,"body":"system in place here, because"},{"speaker":"Steve Gompertz","startTime":929.04,"endTime":931.05,"body":"you're right, that won't work"},{"speaker":"Steve Gompertz","startTime":931.05,"endTime":934.17,"body":"for you. And as part of what we"},{"speaker":"Steve Gompertz","startTime":931.05,"endTime":934.17,"body":"offer to our clients today,"},{"speaker":"Steve Gompertz","startTime":934.2,"endTime":938.1,"body":"where we focus direct focuses on"},{"speaker":"Steve Gompertz","startTime":934.2,"endTime":938.1,"body":"small to medium companies, and"},{"speaker":"Steve Gompertz","startTime":938.1,"endTime":941.55,"body":"we make it clear that we're, we"},{"speaker":"Steve Gompertz","startTime":938.1,"endTime":941.55,"body":"see this as an evolution, when"},{"speaker":"Steve Gompertz","startTime":941.55,"endTime":943.71,"body":"you're in the pre revenue"},{"speaker":"Steve Gompertz","startTime":941.55,"endTime":943.71,"body":"stages, and you don't even have"},{"speaker":"Steve Gompertz","startTime":943.71,"endTime":947.16,"body":"a prototype yet, you do need"},{"speaker":"Steve Gompertz","startTime":943.71,"endTime":947.16,"body":"some parts of your quality"},{"speaker":"Steve Gompertz","startTime":947.16,"endTime":950.19,"body":"system, you don't need the whole"},{"speaker":"Steve Gompertz","startTime":947.16,"endTime":950.19,"body":"thing. And the parts you have"},{"speaker":"Steve Gompertz","startTime":950.19,"endTime":954.54,"body":"don't need to be quite as robust"},{"speaker":"Steve Gompertz","startTime":950.19,"endTime":954.54,"body":"yet, that will come over time"},{"speaker":"Steve Gompertz","startTime":954.54,"endTime":958.62,"body":"and will evolve the system with"},{"speaker":"Steve Gompertz","startTime":954.54,"endTime":958.62,"body":"you, as the company evolves and"},{"speaker":"Steve Gompertz","startTime":958.62,"endTime":962.1,"body":"succeeds. And then as you get"},{"speaker":"Steve Gompertz","startTime":958.62,"endTime":962.1,"body":"bigger, that adds different"},{"speaker":"Steve Gompertz","startTime":962.1,"endTime":964.77,"body":"levels of complexity. When you"},{"speaker":"Steve Gompertz","startTime":962.1,"endTime":964.77,"body":"get the multi site multi"},{"speaker":"Steve Gompertz","startTime":964.77,"endTime":968.46,"body":"nations, you know, then yeah,"},{"speaker":"Steve Gompertz","startTime":964.77,"endTime":968.46,"body":"your quality system has to"},{"speaker":"Steve Gompertz","startTime":968.46,"endTime":970.71,"body":"evolve. You know, it's one of"},{"speaker":"Steve Gompertz","startTime":968.46,"endTime":970.71,"body":"those things, one of the"},{"speaker":"Steve Gompertz","startTime":970.71,"endTime":973.23,"body":"requirements is that you have to"},{"speaker":"Steve Gompertz","startTime":970.71,"endTime":973.23,"body":"do periodic reviews of your"},{"speaker":"Steve Gompertz","startTime":973.23,"endTime":975.78,"body":"quality system, and you're"},{"speaker":"Steve Gompertz","startTime":973.23,"endTime":975.78,"body":"looking at the quite the three"},{"speaker":"Steve Gompertz","startTime":975.78,"endTime":979.62,"body":"points are, is it suitable? Is"},{"speaker":"Steve Gompertz","startTime":975.78,"endTime":979.62,"body":"it adequate? And is it"},{"speaker":"Steve Gompertz","startTime":979.62,"endTime":982.56,"body":"effective? Everybody gets the"},{"speaker":"Steve Gompertz","startTime":979.62,"endTime":982.56,"body":"third one effective, right those"},{"speaker":"Steve Gompertz","startTime":982.56,"endTime":986.13,"body":"at work, it's the suitable and"},{"speaker":"Steve Gompertz","startTime":982.56,"endTime":986.13,"body":"adequate is where you're kind of"},{"speaker":"Steve Gompertz","startTime":986.13,"endTime":989.31,"body":"wiggle room is where that's"},{"speaker":"Steve Gompertz","startTime":986.13,"endTime":989.31,"body":"that's the regulatory bodies and"},{"speaker":"Steve Gompertz","startTime":989.31,"endTime":992.31,"body":"the standards bodies saying,"},{"speaker":"Steve Gompertz","startTime":989.31,"endTime":992.31,"body":"we're not going to give you a"},{"speaker":"Steve Gompertz","startTime":992.31,"endTime":995.52,"body":"one size fits all. But you need"},{"speaker":"Steve Gompertz","startTime":992.31,"endTime":995.52,"body":"to figure out what is it you"},{"speaker":"Steve Gompertz","startTime":995.52,"endTime":999.87,"body":"need to achieve the intent of"},{"speaker":"Steve Gompertz","startTime":995.52,"endTime":999.87,"body":"this standard of this"},{"speaker":"Steve Gompertz","startTime":999.87,"endTime":1004.58,"body":"regulation. So it's always about"},{"speaker":"Steve Gompertz","startTime":999.87,"endTime":1004.58,"body":"right sizing it to the company"},{"speaker":"Steve Gompertz","startTime":1004.61,"endTime":1009.44,"body":"and the point in time. But"},{"speaker":"Steve Gompertz","startTime":1004.61,"endTime":1009.44,"body":"there's so many variables,"},{"speaker":"Steve Gompertz","startTime":1009.44,"endTime":1011.96,"body":"things like the risk of the"},{"speaker":"Steve Gompertz","startTime":1009.44,"endTime":1011.96,"body":"device, if you're a small"},{"speaker":"Steve Gompertz","startTime":1011.96,"endTime":1017.69,"body":"startup, and you're developing a"},{"speaker":"Steve Gompertz","startTime":1011.96,"endTime":1017.69,"body":"new neurological device. To some"},{"speaker":"Steve Gompertz","startTime":1017.69,"endTime":1020.6,"body":"degree, it doesn't matter that"},{"speaker":"Steve Gompertz","startTime":1017.69,"endTime":1020.6,"body":"you're not Medtronic, what"},{"speaker":"Steve Gompertz","startTime":1020.6,"endTime":1023.42,"body":"you're doing is just as hard as"},{"speaker":"Steve Gompertz","startTime":1020.6,"endTime":1023.42,"body":"what Medtronic would do in that"},{"speaker":"Steve Gompertz","startTime":1023.42,"endTime":1027.05,"body":"same space. Yeah. So they can't"},{"speaker":"Steve Gompertz","startTime":1023.42,"endTime":1027.05,"body":"really back off, you know, the"},{"speaker":"Steve Gompertz","startTime":1027.05,"endTime":1029.96,"body":"regulatory bodies can't back off"},{"speaker":"Steve Gompertz","startTime":1027.05,"endTime":1029.96,"body":"the rules for you, just because"},{"speaker":"Steve Gompertz","startTime":1030.05,"endTime":1030.77,"body":"you're small."},{"speaker":"Aaron Moncur","startTime":1031.1,"endTime":1033.41,"body":"right? Still has"},{"speaker":"Aaron Moncur","startTime":1031.1,"endTime":1033.41,"body":"to be safe, doesn't matter how"},{"speaker":"Aaron Moncur","startTime":1033.41,"endTime":1034.67,"body":"big you are. Right? Right."},{"speaker":"Steve Gompertz","startTime":1034.67,"endTime":1036.5,"body":"And there's a"},{"speaker":"Steve Gompertz","startTime":1034.67,"endTime":1036.5,"body":"sort of, there's what they call"},{"speaker":"Steve Gompertz","startTime":1036.5,"endTime":1040.85,"body":"the the acknowledged state of"},{"speaker":"Steve Gompertz","startTime":1036.5,"endTime":1040.85,"body":"the art, which is different than"},{"speaker":"Steve Gompertz","startTime":1040.85,"endTime":1044.66,"body":"the normal, you know, definition"},{"speaker":"Steve Gompertz","startTime":1040.85,"endTime":1044.66,"body":"of state of the wire, which we"},{"speaker":"Steve Gompertz","startTime":1044.66,"endTime":1048.86,"body":"think of bleeding edge in"},{"speaker":"Steve Gompertz","startTime":1044.66,"endTime":1048.86,"body":"regulatory space, recognized or"},{"speaker":"Steve Gompertz","startTime":1048.86,"endTime":1052.22,"body":"acknowledged state of the art"},{"speaker":"Steve Gompertz","startTime":1048.86,"endTime":1052.22,"body":"means what's common right now."},{"speaker":"Steve Gompertz","startTime":1052.58,"endTime":1056.39,"body":"And you have to at least do,"},{"speaker":"Steve Gompertz","startTime":1052.58,"endTime":1056.39,"body":"what's the current standard of"},{"speaker":"Steve Gompertz","startTime":1056.39,"endTime":1059.48,"body":"care. And it doesn't matter how"},{"speaker":"Steve Gompertz","startTime":1056.39,"endTime":1059.48,"body":"expensive that's going to be for"},{"speaker":"Steve Gompertz","startTime":1059.48,"endTime":1062.6,"body":"you, and how big you are, what"},{"speaker":"Steve Gompertz","startTime":1059.48,"endTime":1062.6,"body":"your resources are, you can't"},{"speaker":"Steve Gompertz","startTime":1062.6,"endTime":1064.94,"body":"come up with something less than"},{"speaker":"Steve Gompertz","startTime":1062.6,"endTime":1064.94,"body":"what's already on the market."},{"speaker":"Steve Gompertz","startTime":1065.66,"endTime":1068.99,"body":"Right? That's, that's one of the"},{"speaker":"Steve Gompertz","startTime":1065.66,"endTime":1068.99,"body":"barriers, you know, that might"},{"speaker":"Steve Gompertz","startTime":1068.99,"endTime":1071.54,"body":"seem unfair. But on the other"},{"speaker":"Steve Gompertz","startTime":1068.99,"endTime":1071.54,"body":"hand, you go find my patient."},{"speaker":"Steve Gompertz","startTime":1071.81,"endTime":1073.01,"body":"That's kind of what I want."},{"speaker":"Aaron Moncur","startTime":1073.16,"endTime":1078.8,"body":"Yeah. What are"},{"speaker":"Aaron Moncur","startTime":1073.16,"endTime":1078.8,"body":"some of the common pitfalls that"},{"speaker":"Aaron Moncur","startTime":1078.8,"endTime":1081.8,"body":"you see companies falling into?"},{"speaker":"Aaron Moncur","startTime":1078.8,"endTime":1081.8,"body":"And how can they be avoided?"},{"speaker":"Steve Gompertz","startTime":1081.0,"endTime":1087.42,"body":"Yeah, a lot of"},{"speaker":"Steve Gompertz","startTime":1081.0,"endTime":1087.42,"body":"times, you know, or startups are"},{"speaker":"Steve Gompertz","startTime":1131.1100000000001,"endTime":1133.48,"body":"often, you know, some bright"},{"speaker":"Steve Gompertz","startTime":1131.1100000000001,"endTime":1133.48,"body":"engineers, they've got a"},{"speaker":"Steve Gompertz","startTime":1133.48,"endTime":1136.8700000000001,"body":"brilliant technical idea. They"},{"speaker":"Steve Gompertz","startTime":1133.48,"endTime":1136.8700000000001,"body":"don't really understand the"},{"speaker":"Steve Gompertz","startTime":1136.8700000000001,"endTime":1139.78,"body":"quality and the regulatory"},{"speaker":"Steve Gompertz","startTime":1136.8700000000001,"endTime":1139.78,"body":"requirements. And they're not"},{"speaker":"Steve Gompertz","startTime":1139.78,"endTime":1142.3300000000002,"body":"thinking about the why and the"},{"speaker":"Steve Gompertz","startTime":1139.78,"endTime":1142.3300000000002,"body":"how well they're thinking about"},{"speaker":"Steve Gompertz","startTime":1142.3300000000002,"endTime":1145.0,"body":"how you're not thinking about"},{"speaker":"Steve Gompertz","startTime":1142.3300000000002,"endTime":1145.0,"body":"the why and the what behind"},{"speaker":"Steve Gompertz","startTime":1145.0,"endTime":1148.69,"body":"them. And so you get this sort"},{"speaker":"Steve Gompertz","startTime":1145.0,"endTime":1148.69,"body":"of checklist mentality, just"},{"speaker":"Steve Gompertz","startTime":1148.69,"endTime":1151.45,"body":"tell me what they want me to do,"},{"speaker":"Steve Gompertz","startTime":1148.69,"endTime":1151.45,"body":"What documents do I need to"},{"speaker":"Steve Gompertz","startTime":1151.45,"endTime":1156.6100000000001,"body":"produce? What activities do I"},{"speaker":"Steve Gompertz","startTime":1151.45,"endTime":1156.6100000000001,"body":"need to perform? And you want to"},{"speaker":"Steve Gompertz","startTime":1156.6100000000001,"endTime":1159.28,"body":"often see that, and that's how"},{"speaker":"Steve Gompertz","startTime":1156.6100000000001,"endTime":1159.28,"body":"the quality system is built is"},{"speaker":"Steve Gompertz","startTime":1159.28,"endTime":1161.92,"body":"just around sort of this"},{"speaker":"Steve Gompertz","startTime":1159.28,"endTime":1161.92,"body":"checklist, do this, then do this"},{"speaker":"Steve Gompertz","startTime":1161.92,"endTime":1164.65,"body":"to do this. And nobody's"},{"speaker":"Steve Gompertz","startTime":1161.92,"endTime":1164.65,"body":"thinking about the reason why"},{"speaker":"Steve Gompertz","startTime":1164.65,"endTime":1166.8700000000001,"body":"they're doing those things. And"},{"speaker":"Steve Gompertz","startTime":1164.65,"endTime":1166.8700000000001,"body":"that's really, really important"},{"speaker":"Steve Gompertz","startTime":1166.8700000000001,"endTime":1169.93,"body":"slides. Because it isn't just a"},{"speaker":"Steve Gompertz","startTime":1166.8700000000001,"endTime":1169.93,"body":"matter of having these"},{"speaker":"Steve Gompertz","startTime":1169.93,"endTime":1172.96,"body":"deliverables at the end of the"},{"speaker":"Steve Gompertz","startTime":1169.93,"endTime":1172.96,"body":"day. It's how you got there."},{"speaker":"Steve Gompertz","startTime":1173.3500000000001,"endTime":1175.99,"body":"Right? That it should it's part"},{"speaker":"Steve Gompertz","startTime":1173.3500000000001,"endTime":1175.99,"body":"of a process and the whole thing"},{"speaker":"Steve Gompertz","startTime":1175.99,"endTime":1179.8600000000001,"body":"is a system and all the pieces"},{"speaker":"Steve Gompertz","startTime":1175.99,"endTime":1179.8600000000001,"body":"have to work together. And so"},{"speaker":"Steve Gompertz","startTime":1179.8600000000001,"endTime":1183.16,"body":"too often what I see is nobody's"},{"speaker":"Steve Gompertz","startTime":1179.8600000000001,"endTime":1183.16,"body":"taking that process view that"},{"speaker":"Steve Gompertz","startTime":1183.16,"endTime":1186.76,"body":"system view of their quality"},{"speaker":"Steve Gompertz","startTime":1183.16,"endTime":1186.76,"body":"system, and it's just a pile of"},{"speaker":"Steve Gompertz","startTime":1186.76,"endTime":1190.39,"body":"procedures and activities that"},{"speaker":"Steve Gompertz","startTime":1186.76,"endTime":1190.39,"body":"are not really well connected."},{"speaker":"Steve Gompertz","startTime":1190.75,"endTime":1193.3300000000002,"body":"And then they can't figure out"},{"speaker":"Steve Gompertz","startTime":1190.75,"endTime":1193.3300000000002,"body":"why is it not very efficient?"},{"speaker":"Steve Gompertz","startTime":1193.3600000000001,"endTime":1196.93,"body":"Why does it not seem to produce"},{"speaker":"Steve Gompertz","startTime":1193.3600000000001,"endTime":1196.93,"body":"the right results, it produces"},{"speaker":"Steve Gompertz","startTime":1196.93,"endTime":1200.5900000000001,"body":"results, but we still have"},{"speaker":"Steve Gompertz","startTime":1196.93,"endTime":1200.5900000000001,"body":"recalls that we still, you know,"},{"speaker":"Steve Gompertz","startTime":1201.0700000000002,"endTime":1203.5,"body":"you know, run into problems"},{"speaker":"Steve Gompertz","startTime":1201.0700000000002,"endTime":1203.5,"body":"where our tests fail, and it's"},{"speaker":"Steve Gompertz","startTime":1203.5,"endTime":1206.3200000000002,"body":"slowing down our ability to get"},{"speaker":"Steve Gompertz","startTime":1203.5,"endTime":1206.3200000000002,"body":"on the market. And it's because"},{"speaker":"Steve Gompertz","startTime":1206.3200000000002,"endTime":1209.05,"body":"you didn't take a chance to step"},{"speaker":"Steve Gompertz","startTime":1206.3200000000002,"endTime":1209.05,"body":"back and see the bigger picture."},{"speaker":"Steve Gompertz","startTime":1209.05,"endTime":1213.16,"body":"It's hard to see the whole"},{"speaker":"Steve Gompertz","startTime":1209.05,"endTime":1213.16,"body":"system, right. But we often talk"},{"speaker":"Steve Gompertz","startTime":1213.16,"endTime":1215.5900000000001,"body":"about, you know, companies will"},{"speaker":"Steve Gompertz","startTime":1213.16,"endTime":1215.5900000000001,"body":"sub optimize, right, because"},{"speaker":"Steve Gompertz","startTime":1215.5900000000001,"endTime":1219.4,"body":"they get focused on one process"},{"speaker":"Steve Gompertz","startTime":1215.5900000000001,"endTime":1219.4,"body":"ago, make that perfect. And I"},{"speaker":"Steve Gompertz","startTime":1219.4,"endTime":1222.22,"body":"was just on another webinar"},{"speaker":"Steve Gompertz","startTime":1219.4,"endTime":1222.22,"body":"today, and I've been using this"},{"speaker":"Steve Gompertz","startTime":1222.43,"endTime":1225.49,"body":"in an article I've got coming"},{"speaker":"Steve Gompertz","startTime":1222.43,"endTime":1225.49,"body":"out soon, where I talked about"},{"speaker":"Steve Gompertz","startTime":1225.49,"endTime":1228.7,"body":"it's kind of like, you know, I"},{"speaker":"Steve Gompertz","startTime":1225.49,"endTime":1228.7,"body":"want my car to go higher"},{"speaker":"Steve Gompertz","startTime":1228.7,"endTime":1232.15,"body":"performing and I'm driving an"},{"speaker":"Steve Gompertz","startTime":1228.7,"endTime":1232.15,"body":"economy car. Putting racing"},{"speaker":"Steve Gompertz","startTime":1232.15,"endTime":1235.1200000000001,"body":"slicks on the back of that"},{"speaker":"Steve Gompertz","startTime":1232.15,"endTime":1235.1200000000001,"body":"economy car isn't gonna make it"},{"speaker":"Steve Gompertz","startTime":1235.1200000000001,"endTime":1238.3300000000002,"body":"go any faster, or perform any"},{"speaker":"Steve Gompertz","startTime":1235.1200000000001,"endTime":1238.3300000000002,"body":"better. Matter of fact, that"},{"speaker":"Steve Gompertz","startTime":1238.3300000000002,"endTime":1242.02,"body":"might work against you. As a"},{"speaker":"Steve Gompertz","startTime":1238.3300000000002,"endTime":1242.02,"body":"mechanical engineer, I could"},{"speaker":"Steve Gompertz","startTime":1242.02,"endTime":1243.94,"body":"think of the stresses you're"},{"speaker":"Steve Gompertz","startTime":1242.02,"endTime":1243.94,"body":"gonna put on the axle. wasn't"},{"speaker":"Steve Gompertz","startTime":1243.94,"endTime":1246.7,"body":"the drive train? And will they"},{"speaker":"Steve Gompertz","startTime":1243.94,"endTime":1246.7,"body":"fit in the wheel wells, things"},{"speaker":"Steve Gompertz","startTime":1246.7,"endTime":1249.5800000000002,"body":"like that. And too often, that's"},{"speaker":"Steve Gompertz","startTime":1246.7,"endTime":1249.5800000000002,"body":"what happens in quality systems"},{"speaker":"Steve Gompertz","startTime":1249.5800000000002,"endTime":1253.18,"body":"is we don't take a look at the"},{"speaker":"Steve Gompertz","startTime":1249.5800000000002,"endTime":1253.18,"body":"entire car, we look at this one"},{"speaker":"Steve Gompertz","startTime":1253.18,"endTime":1256.96,"body":"piece that's maybe not working"},{"speaker":"Steve Gompertz","startTime":1253.18,"endTime":1256.96,"body":"well, or we, that's the part we"},{"speaker":"Steve Gompertz","startTime":1256.96,"endTime":1259.18,"body":"know. And we want to make that"},{"speaker":"Steve Gompertz","startTime":1256.96,"endTime":1259.18,"body":"better. And that's the only"},{"speaker":"Steve Gompertz","startTime":1259.18,"endTime":1261.8200000000002,"body":"thing we focus on. And then"},{"speaker":"Steve Gompertz","startTime":1259.18,"endTime":1261.8200000000002,"body":"we're wondering, why doesn't"},{"speaker":"Steve Gompertz","startTime":1261.8200000000002,"endTime":1263.8600000000001,"body":"that work with the rest of the"},{"speaker":"Steve Gompertz","startTime":1261.8200000000002,"endTime":1263.8600000000001,"body":"system was because you didn't"},{"speaker":"Steve Gompertz","startTime":1263.89,"endTime":1266.3500000000001,"body":"think about the system and"},{"speaker":"Steve Gompertz","startTime":1263.89,"endTime":1266.3500000000001,"body":"connect it all together?"},{"speaker":"Aaron Moncur","startTime":1267.19,"endTime":1272.38,"body":"So talking about"},{"speaker":"Aaron Moncur","startTime":1267.19,"endTime":1272.38,"body":"the entire system? Obviously,"},{"speaker":"Aaron Moncur","startTime":1272.8,"endTime":1275.65,"body":"quality control system is is a"},{"speaker":"Aaron Moncur","startTime":1272.8,"endTime":1275.65,"body":"large, complex thing, or at"},{"speaker":"Aaron Moncur","startTime":1275.65,"endTime":1280.27,"body":"least it can be, and the scope"},{"speaker":"Aaron Moncur","startTime":1275.65,"endTime":1280.27,"body":"of our conversation today will"},{"speaker":"Aaron Moncur","startTime":1280.27,"endTime":1283.48,"body":"not allow us to get into every"},{"speaker":"Aaron Moncur","startTime":1280.27,"endTime":1283.48,"body":"detail of that. But if you"},{"speaker":"Aaron Moncur","startTime":1283.48,"endTime":1287.41,"body":"could, can you kind of pick out"},{"speaker":"Aaron Moncur","startTime":1283.48,"endTime":1287.41,"body":"like the main components and"},{"speaker":"Aaron Moncur","startTime":1287.41,"endTime":1291.64,"body":"walk us through? What does it"},{"speaker":"Aaron Moncur","startTime":1287.41,"endTime":1291.64,"body":"look like establishing a quality"},{"speaker":"Aaron Moncur","startTime":1291.64,"endTime":1295.3300000000002,"body":"system. And earlier you"},{"speaker":"Aaron Moncur","startTime":1291.64,"endTime":1295.3300000000002,"body":"mentioned that, you know, pre"},{"speaker":"Aaron Moncur","startTime":1295.3300000000002,"endTime":1299.23,"body":"revenue, early stage development"},{"speaker":"Aaron Moncur","startTime":1295.3300000000002,"endTime":1299.23,"body":"phase, you don't need the full"},{"speaker":"Aaron Moncur","startTime":1299.26,"endTime":1301.99,"body":"system in place, but you need"},{"speaker":"Aaron Moncur","startTime":1299.26,"endTime":1301.99,"body":"some parts in place. So So kind"},{"speaker":"Aaron Moncur","startTime":1301.99,"endTime":1305.8300000000002,"body":"of walk us through the evolution"},{"speaker":"Aaron Moncur","startTime":1301.99,"endTime":1305.8300000000002,"body":"of, you know, starting a new"},{"speaker":"Aaron Moncur","startTime":1306.1000000000001,"endTime":1309.88,"body":"medical device design, and what"},{"speaker":"Aaron Moncur","startTime":1306.1000000000001,"endTime":1309.88,"body":"what are the kind of the core"},{"speaker":"Aaron Moncur","startTime":1309.91,"endTime":1312.76,"body":"elements we need to have in"},{"speaker":"Aaron Moncur","startTime":1309.91,"endTime":1312.76,"body":"place? And at what points do we"},{"speaker":"Aaron Moncur","startTime":1312.76,"endTime":1315.13,"body":"need to start putting those core"},{"speaker":"Aaron Moncur","startTime":1312.76,"endTime":1315.13,"body":"elements in place?"},{"speaker":"Steve Gompertz","startTime":1315.5,"endTime":1317.93,"body":"Yeah, so it's"},{"speaker":"Steve Gompertz","startTime":1315.5,"endTime":1317.93,"body":"funny that I mentioned I was"},{"speaker":"Steve Gompertz","startTime":1317.93,"endTime":1320.24,"body":"working on a webinar today, it"},{"speaker":"Steve Gompertz","startTime":1317.93,"endTime":1320.24,"body":"was one that our company was"},{"speaker":"Steve Gompertz","startTime":1320.24,"endTime":1322.76,"body":"putting out, and we were talking"},{"speaker":"Steve Gompertz","startTime":1320.24,"endTime":1322.76,"body":"about all the foundational or"},{"speaker":"Steve Gompertz","startTime":1322.76,"endTime":1327.89,"body":"fundamental issues behind all"},{"speaker":"Steve Gompertz","startTime":1322.76,"endTime":1327.89,"body":"the standards and regs. And one"},{"speaker":"Steve Gompertz","startTime":1327.89,"endTime":1333.0800000000002,"body":"of the core, you know, pieces of"},{"speaker":"Steve Gompertz","startTime":1327.89,"endTime":1333.0800000000002,"body":"that are tenets is this process"},{"speaker":"Steve Gompertz","startTime":1333.0800000000002,"endTime":1338.18,"body":"approach. And what that comes"},{"speaker":"Steve Gompertz","startTime":1333.0800000000002,"endTime":1338.18,"body":"out, as you know, a lot of"},{"speaker":"Steve Gompertz","startTime":1338.18,"endTime":1341.3,"body":"people are familiar with this"},{"speaker":"Steve Gompertz","startTime":1338.18,"endTime":1341.3,"body":"concept of Plan, Do Check Act"},{"speaker":"Steve Gompertz","startTime":1341.3600000000001,"endTime":1347.18,"body":"PDCA cycle, known also as the"},{"speaker":"Steve Gompertz","startTime":1341.3600000000001,"endTime":1347.18,"body":"Deming short cycle. And that's"},{"speaker":"Steve Gompertz","startTime":1347.18,"endTime":1350.8700000000001,"body":"what every quality standard and"},{"speaker":"Steve Gompertz","startTime":1347.18,"endTime":1350.8700000000001,"body":"regulation is trying to tell you"},{"speaker":"Steve Gompertz","startTime":1350.8700000000001,"endTime":1354.8,"body":"to do. You have to plan for what"},{"speaker":"Steve Gompertz","startTime":1350.8700000000001,"endTime":1354.8,"body":"you're going to do, right? You"},{"speaker":"Steve Gompertz","startTime":1354.8300000000002,"endTime":1359.0,"body":"You know, you have to then do"},{"speaker":"Steve Gompertz","startTime":1354.8300000000002,"endTime":1359.0,"body":"it. Right execute to your plan,"},{"speaker":"Steve Gompertz","startTime":1359.45,"endTime":1362.6000000000001,"body":"monitor what you're doing, get"},{"speaker":"Steve Gompertz","startTime":1359.45,"endTime":1362.6000000000001,"body":"some data and check, and then"},{"speaker":"Steve Gompertz","startTime":1362.6000000000001,"endTime":1367.19,"body":"act on that and make an"},{"speaker":"Steve Gompertz","startTime":1362.6000000000001,"endTime":1367.19,"body":"improvement. Update the plan. Do"},{"speaker":"Steve Gompertz","startTime":1367.19,"endTime":1370.19,"body":"it again, check it again, right."},{"speaker":"Steve Gompertz","startTime":1367.19,"endTime":1370.19,"body":"And it's the that's where"},{"speaker":"Steve Gompertz","startTime":1370.19,"endTime":1373.31,"body":"continuous improvement comes in."},{"speaker":"Steve Gompertz","startTime":1370.19,"endTime":1373.31,"body":"That's the basis for every"},{"speaker":"Steve Gompertz","startTime":1373.31,"endTime":1376.01,"body":"quality system is and that's why"},{"speaker":"Steve Gompertz","startTime":1373.31,"endTime":1376.01,"body":"you need to see the connection"},{"speaker":"Steve Gompertz","startTime":1376.01,"endTime":1379.7,"body":"points. Now getting started,"},{"speaker":"Steve Gompertz","startTime":1376.01,"endTime":1379.7,"body":"right, yeah, you don't need all"},{"speaker":"Steve Gompertz","startTime":1379.7,"endTime":1383.27,"body":"of the components yet. And maybe"},{"speaker":"Steve Gompertz","startTime":1379.7,"endTime":1383.27,"body":"you're not ready to do, right."},{"speaker":"Steve Gompertz","startTime":1383.78,"endTime":1386.1200000000001,"body":"And maybe there's certain pieces"},{"speaker":"Steve Gompertz","startTime":1383.78,"endTime":1386.1200000000001,"body":"of checker hack that aren't"},{"speaker":"Steve Gompertz","startTime":1386.1200000000001,"endTime":1390.26,"body":"ready yet. But there are certain"},{"speaker":"Steve Gompertz","startTime":1386.1200000000001,"endTime":1390.26,"body":"basics. We like to say in the"},{"speaker":"Steve Gompertz","startTime":1390.26,"endTime":1393.8,"body":"regulated space. If it isn't"},{"speaker":"Steve Gompertz","startTime":1390.26,"endTime":1393.8,"body":"documented, it didn't happen. So"},{"speaker":"Steve Gompertz","startTime":1393.8,"endTime":1397.04,"body":"doc control and records control"},{"speaker":"Steve Gompertz","startTime":1393.8,"endTime":1397.04,"body":"is one of the first things you"},{"speaker":"Steve Gompertz","startTime":1397.04,"endTime":1399.23,"body":"put in place. First, you"},{"speaker":"Steve Gompertz","startTime":1397.04,"endTime":1399.23,"body":"architect your system, you write"},{"speaker":"Steve Gompertz","startTime":1399.23,"endTime":1402.14,"body":"a quality manual, and you say"},{"speaker":"Steve Gompertz","startTime":1399.23,"endTime":1402.14,"body":"this is what we think our"},{"speaker":"Steve Gompertz","startTime":1402.14,"endTime":1405.38,"body":"quality needs to look like, so"},{"speaker":"Steve Gompertz","startTime":1402.14,"endTime":1405.38,"body":"that it's suitable and adequate"},{"speaker":"Steve Gompertz","startTime":1405.38,"endTime":1408.05,"body":"for what we're doing. And then"},{"speaker":"Steve Gompertz","startTime":1405.38,"endTime":1408.05,"body":"the next thing is we have to"},{"speaker":"Steve Gompertz","startTime":1408.05,"endTime":1412.22,"body":"control documentation records"},{"speaker":"Steve Gompertz","startTime":1408.05,"endTime":1412.22,"body":"have to be ready for that it's"},{"speaker":"Steve Gompertz","startTime":1412.22,"endTime":1414.29,"body":"while we're going to design"},{"speaker":"Steve Gompertz","startTime":1412.22,"endTime":1414.29,"body":"something, so then we need"},{"speaker":"Steve Gompertz","startTime":1414.29,"endTime":1416.8700000000001,"body":"design controls, what is the"},{"speaker":"Steve Gompertz","startTime":1414.29,"endTime":1416.8700000000001,"body":"design and development process"},{"speaker":"Steve Gompertz","startTime":1416.8700000000001,"endTime":1420.05,"body":"going to look like? But we don't"},{"speaker":"Steve Gompertz","startTime":1416.8700000000001,"endTime":1420.05,"body":"need to worry yet about"},{"speaker":"Steve Gompertz","startTime":1420.0800000000002,"endTime":1424.31,"body":"production controls, we probably"},{"speaker":"Steve Gompertz","startTime":1420.0800000000002,"endTime":1424.31,"body":"don't yet need supplier"},{"speaker":"Steve Gompertz","startTime":1424.31,"endTime":1427.73,"body":"management until we start"},{"speaker":"Steve Gompertz","startTime":1424.31,"endTime":1427.73,"body":"farming any work out. Because"},{"speaker":"Steve Gompertz","startTime":1427.73,"endTime":1429.38,"body":"we're probably not going to"},{"speaker":"Steve Gompertz","startTime":1427.73,"endTime":1429.38,"body":"build a factory right away,"},{"speaker":"Steve Gompertz","startTime":1429.38,"endTime":1432.14,"body":"we're probably gonna bring in"},{"speaker":"Steve Gompertz","startTime":1429.38,"endTime":1432.14,"body":"contract manufacturers. But"},{"speaker":"Steve Gompertz","startTime":1432.14,"endTime":1435.14,"body":"that's what I mean the evolution"},{"speaker":"Steve Gompertz","startTime":1432.14,"endTime":1435.14,"body":"right, first, get our stuff"},{"speaker":"Steve Gompertz","startTime":1435.14,"endTime":1438.1100000000001,"body":"under control, does management"},{"speaker":"Steve Gompertz","startTime":1435.14,"endTime":1438.1100000000001,"body":"understand its responsibilities?"},{"speaker":"Steve Gompertz","startTime":1438.3500000000001,"endTime":1441.56,"body":"Do we know how to manage our"},{"speaker":"Steve Gompertz","startTime":1438.3500000000001,"endTime":1441.56,"body":"documents in our records? Do we"},{"speaker":"Steve Gompertz","startTime":1441.56,"endTime":1445.79,"body":"know how to do the right things"},{"speaker":"Steve Gompertz","startTime":1441.56,"endTime":1445.79,"body":"in designing and developing our"},{"speaker":"Steve Gompertz","startTime":1445.79,"endTime":1449.27,"body":"product or device that it's"},{"speaker":"Steve Gompertz","startTime":1445.79,"endTime":1449.27,"body":"like, Okay, now we think we've"},{"speaker":"Steve Gompertz","startTime":1449.27,"endTime":1452.42,"body":"got a design and we want to"},{"speaker":"Steve Gompertz","startTime":1449.27,"endTime":1452.42,"body":"start building it. Now we need"},{"speaker":"Steve Gompertz","startTime":1452.42,"endTime":1454.88,"body":"to engage contract"},{"speaker":"Steve Gompertz","startTime":1452.42,"endTime":1454.88,"body":"manufacturers, component"},{"speaker":"Steve Gompertz","startTime":1454.88,"endTime":1457.88,"body":"suppliers. So now we need our"},{"speaker":"Steve Gompertz","startTime":1454.88,"endTime":1457.88,"body":"supplier management process in"},{"speaker":"Steve Gompertz","startTime":1457.88,"endTime":1461.03,"body":"place. That's the next step. And"},{"speaker":"Steve Gompertz","startTime":1457.88,"endTime":1461.03,"body":"maybe at some point, then we're"},{"speaker":"Steve Gompertz","startTime":1461.03,"endTime":1464.81,"body":"going to go to full production,"},{"speaker":"Steve Gompertz","startTime":1461.03,"endTime":1464.81,"body":"either ourselves or we're at our"},{"speaker":"Steve Gompertz","startTime":1464.99,"endTime":1467.5700000000002,"body":"contract manufacturers, but"},{"speaker":"Steve Gompertz","startTime":1464.99,"endTime":1467.5700000000002,"body":"we're going to do production"},{"speaker":"Steve Gompertz","startTime":1467.5700000000002,"endTime":1470.45,"body":"controls, you know, and then you"},{"speaker":"Steve Gompertz","startTime":1467.5700000000002,"endTime":1470.45,"body":"keep building those pieces we"},{"speaker":"Steve Gompertz","startTime":1470.45,"endTime":1474.0800000000002,"body":"don't need. We don't need"},{"speaker":"Steve Gompertz","startTime":1470.45,"endTime":1474.0800000000002,"body":"complaint management yet,"},{"speaker":"Steve Gompertz","startTime":1474.1100000000001,"endTime":1475.91,"body":"because there's nothing on the"},{"speaker":"Steve Gompertz","startTime":1474.1100000000001,"endTime":1475.91,"body":"market for people to complain"},{"speaker":"Steve Gompertz","startTime":1475.91,"endTime":1479.45,"body":"about. Right. So don't implement"},{"speaker":"Steve Gompertz","startTime":1475.91,"endTime":1479.45,"body":"that until you're actually a"},{"speaker":"Steve Gompertz","startTime":1479.45,"endTime":1481.6100000000001,"body":"market. We don't need post"},{"speaker":"Steve Gompertz","startTime":1479.45,"endTime":1481.6100000000001,"body":"market surveillance, because"},{"speaker":"Steve Gompertz","startTime":1481.6100000000001,"endTime":1484.31,"body":"we're not on the market yet. But"},{"speaker":"Steve Gompertz","startTime":1481.6100000000001,"endTime":1484.31,"body":"when I talk about the evolution,"},{"speaker":"Steve Gompertz","startTime":1484.31,"endTime":1487.49,"body":"that's what it looks like. Cool"},{"speaker":"Steve Gompertz","startTime":1484.31,"endTime":1487.49,"body":"some point once you're on the"},{"speaker":"Steve Gompertz","startTime":1487.49,"endTime":1490.76,"body":"market than the entire system"},{"speaker":"Steve Gompertz","startTime":1487.49,"endTime":1490.76,"body":"has to exist."},{"speaker":"Aaron Moncur","startTime":1491.3200000000002,"endTime":1493.93,"body":"Yeah, great"},{"speaker":"Aaron Moncur","startTime":1491.3200000000002,"endTime":1493.93,"body":"summary. All right, I'm going to"},{"speaker":"Aaron Moncur","startTime":1493.93,"endTime":1497.14,"body":"take a short break and share"},{"speaker":"Aaron Moncur","startTime":1493.93,"endTime":1497.14,"body":"with the listeners that the"},{"speaker":"Aaron Moncur","startTime":1497.14,"endTime":1499.75,"body":"being an engineer podcast is"},{"speaker":"Aaron Moncur","startTime":1497.14,"endTime":1499.75,"body":"brought to you by pipeline"},{"speaker":"Aaron Moncur","startTime":1499.75,"endTime":1503.3500000000001,"body":"design and engineering where we"},{"speaker":"Aaron Moncur","startTime":1499.75,"endTime":1503.3500000000001,"body":"don't design pipelines, but we"},{"speaker":"Aaron Moncur","startTime":1503.3500000000001,"endTime":1506.65,"body":"do help companies develop"},{"speaker":"Aaron Moncur","startTime":1503.3500000000001,"endTime":1506.65,"body":"advanced manufacturing"},{"speaker":"Aaron Moncur","startTime":1548.52,"endTime":1552.99,"body":"processes, automated machines"},{"speaker":"Aaron Moncur","startTime":1548.52,"endTime":1552.99,"body":"and custom fixtures complemented"},{"speaker":"Aaron Moncur","startTime":1552.99,"endTime":1556.71,"body":"with product design, and r\u0026d"},{"speaker":"Aaron Moncur","startTime":1552.99,"endTime":1556.71,"body":"services. You can learn more at"},{"speaker":"Aaron Moncur","startTime":1556.74,"endTime":1562.9199999999998,"body":"Team pipeline.us. The podcast is"},{"speaker":"Aaron Moncur","startTime":1556.74,"endTime":1562.9199999999998,"body":"also sponsored by the wave an"},{"speaker":"Aaron Moncur","startTime":1562.95,"endTime":1567.06,"body":"online platform of free tools,"},{"speaker":"Aaron Moncur","startTime":1562.95,"endTime":1567.06,"body":"education and community for"},{"speaker":"Aaron Moncur","startTime":1567.06,"endTime":1572.31,"body":"engineers. Learn more at the"},{"speaker":"Aaron Moncur","startTime":1567.06,"endTime":1572.31,"body":"wave dot engineer. All right, we"},{"speaker":"Aaron Moncur","startTime":1572.31,"endTime":1576.1799999999998,"body":"have the privilege of speaking"},{"speaker":"Aaron Moncur","startTime":1572.31,"endTime":1576.1799999999998,"body":"with Steve Gompertz, Gompertz"},{"speaker":"Aaron Moncur","startTime":1576.1799999999998,"endTime":1580.86,"body":"today, and Steve can Steve can"},{"speaker":"Aaron Moncur","startTime":1576.1799999999998,"endTime":1580.86,"body":"you share with us maybe a couple"},{"speaker":"Aaron Moncur","startTime":1580.86,"endTime":1585.69,"body":"of the the key trends in medical"},{"speaker":"Aaron Moncur","startTime":1580.86,"endTime":1585.69,"body":"device regulation that companies"},{"speaker":"Aaron Moncur","startTime":1585.69,"endTime":1588.36,"body":"As should be aware of in the"},{"speaker":"Aaron Moncur","startTime":1585.69,"endTime":1588.36,"body":"coming years."},{"speaker":"Steve Gompertz","startTime":1589.879,"endTime":1593.089,"body":"So like I said,"},{"speaker":"Steve Gompertz","startTime":1589.879,"endTime":1593.089,"body":"I think the EU is going to drive"},{"speaker":"Steve Gompertz","startTime":1593.089,"endTime":1597.349,"body":"a lot of the direction here. And"},{"speaker":"Steve Gompertz","startTime":1593.089,"endTime":1597.349,"body":"one of the one of the big things"},{"speaker":"Steve Gompertz","startTime":1597.349,"endTime":1601.4289999999999,"body":"that changed with the new"},{"speaker":"Steve Gompertz","startTime":1597.349,"endTime":1601.4289999999999,"body":"medical device regulations that"},{"speaker":"Steve Gompertz","startTime":1601.4289999999999,"endTime":1607.849,"body":"came out 2017 was more of a"},{"speaker":"Steve Gompertz","startTime":1601.4289999999999,"endTime":1607.849,"body":"lifecycle view. If you look at"},{"speaker":"Steve Gompertz","startTime":1607.849,"endTime":1611.119,"body":"the FDA regulations, and a lot"},{"speaker":"Steve Gompertz","startTime":1607.849,"endTime":1611.119,"body":"of countries regulations, and"},{"speaker":"Steve Gompertz","startTime":1611.149,"endTime":1614.899,"body":"what was in place in you,"},{"speaker":"Steve Gompertz","startTime":1611.149,"endTime":1614.899,"body":"before, he was all about, how do"},{"speaker":"Steve Gompertz","startTime":1614.899,"endTime":1617.4489999999998,"body":"I get on the market, and then"},{"speaker":"Steve Gompertz","startTime":1614.899,"endTime":1617.4489999999998,"body":"there was a little bit what"},{"speaker":"Steve Gompertz","startTime":1617.4489999999998,"endTime":1619.6989999999998,"body":"happens after the market, right,"},{"speaker":"Steve Gompertz","startTime":1617.4489999999998,"endTime":1619.6989999999998,"body":"and then they started to go,"},{"speaker":"Steve Gompertz","startTime":1619.6989999999998,"endTime":1624.079,"body":"Well, your responsibilities"},{"speaker":"Steve Gompertz","startTime":1619.6989999999998,"endTime":1624.079,"body":"don't end, when you cash a check"},{"speaker":"Steve Gompertz","startTime":1624.079,"endTime":1627.349,"body":"to somebody bought your device,"},{"speaker":"Steve Gompertz","startTime":1624.079,"endTime":1627.349,"body":"you have a responsibility once"},{"speaker":"Steve Gompertz","startTime":1627.349,"endTime":1630.649,"body":"that device is on the market out"},{"speaker":"Steve Gompertz","startTime":1627.349,"endTime":1630.649,"body":"there in somebody's body, or"},{"speaker":"Steve Gompertz","startTime":1630.649,"endTime":1635.2089999999998,"body":"being used over time. So they"},{"speaker":"Steve Gompertz","startTime":1630.649,"endTime":1635.2089999999998,"body":"definitely added a lot more"},{"speaker":"Steve Gompertz","startTime":1635.2089999999998,"endTime":1638.749,"body":"requirements around so yeah,"},{"speaker":"Steve Gompertz","startTime":1635.2089999999998,"endTime":1638.749,"body":"post market. Now, here's a whole"},{"speaker":"Steve Gompertz","startTime":1638.749,"endTime":1641.869,"body":"bunch of other things, you're"},{"speaker":"Steve Gompertz","startTime":1638.749,"endTime":1641.869,"body":"nowhere near done with your"},{"speaker":"Steve Gompertz","startTime":1641.869,"endTime":1646.759,"body":"responsibilities. And it's"},{"speaker":"Steve Gompertz","startTime":1641.869,"endTime":1646.759,"body":"actually pretty complex now. And"},{"speaker":"Steve Gompertz","startTime":1646.759,"endTime":1648.349,"body":"then, like I said, I think"},{"speaker":"Steve Gompertz","startTime":1646.759,"endTime":1648.349,"body":"that's where everybody's gonna"},{"speaker":"Steve Gompertz","startTime":1648.349,"endTime":1652.339,"body":"go, because they realize, yeah,"},{"speaker":"Steve Gompertz","startTime":1648.349,"endTime":1652.339,"body":"these devices, they last longer,"},{"speaker":"Steve Gompertz","startTime":1652.369,"endTime":1656.089,"body":"right? You know, when you get an"},{"speaker":"Steve Gompertz","startTime":1652.369,"endTime":1656.089,"body":"orthopedic implant, now, they"},{"speaker":"Steve Gompertz","startTime":1656.089,"endTime":1660.049,"body":"can easily last 20 years, you"},{"speaker":"Steve Gompertz","startTime":1656.089,"endTime":1660.049,"body":"get a pacemaker and the battery"},{"speaker":"Steve Gompertz","startTime":1660.049,"endTime":1663.379,"body":"technology keeps getting better."},{"speaker":"Steve Gompertz","startTime":1660.049,"endTime":1663.379,"body":"And the the intelligence in the"},{"speaker":"Steve Gompertz","startTime":1663.379,"endTime":1666.979,"body":"firmware keeps you from"},{"speaker":"Steve Gompertz","startTime":1663.379,"endTime":1666.979,"body":"overusing the, the available"},{"speaker":"Steve Gompertz","startTime":1667.279,"endTime":1670.579,"body":"energy in the in the battery. So"},{"speaker":"Steve Gompertz","startTime":1667.279,"endTime":1670.579,"body":"now, you know, the Pacemakers"},{"speaker":"Steve Gompertz","startTime":1670.579,"endTime":1674.899,"body":"can easily last 1215 or more"},{"speaker":"Steve Gompertz","startTime":1670.579,"endTime":1674.899,"body":"years, wow, that's a long time,"},{"speaker":"Steve Gompertz","startTime":1674.899,"endTime":1677.239,"body":"you know, that that's going to"},{"speaker":"Steve Gompertz","startTime":1674.899,"endTime":1677.239,"body":"be in somebody's body, you know,"},{"speaker":"Steve Gompertz","startTime":1677.299,"endTime":1680.089,"body":"you need to account for, how are"},{"speaker":"Steve Gompertz","startTime":1677.299,"endTime":1680.089,"body":"you going to deal with that"},{"speaker":"Steve Gompertz","startTime":1680.119,"endTime":1684.9189999999999,"body":"future. And stay on top of how"},{"speaker":"Steve Gompertz","startTime":1680.119,"endTime":1684.9189999999999,"body":"that device performs, because of"},{"speaker":"Steve Gompertz","startTime":1684.9189999999999,"endTime":1688.099,"body":"course, it performs great when"},{"speaker":"Steve Gompertz","startTime":1684.9189999999999,"endTime":1688.099,"body":"it goes out the door, and it's"},{"speaker":"Steve Gompertz","startTime":1688.099,"endTime":1691.129,"body":"first implant their first use."},{"speaker":"Steve Gompertz","startTime":1688.099,"endTime":1691.129,"body":"But once that pacemaker is in"},{"speaker":"Steve Gompertz","startTime":1691.129,"endTime":1693.469,"body":"somebody's body, what is it"},{"speaker":"Steve Gompertz","startTime":1691.129,"endTime":1693.469,"body":"doing five years from now?"},{"speaker":"Steve Gompertz","startTime":1693.6789999999999,"endTime":1697.069,"body":"Right? How do you prove that it"},{"speaker":"Steve Gompertz","startTime":1693.6789999999999,"endTime":1697.069,"body":"will continue to do that, that"},{"speaker":"Steve Gompertz","startTime":1697.069,"endTime":1701.869,"body":"will perform as designed for"},{"speaker":"Steve Gompertz","startTime":1697.069,"endTime":1701.869,"body":"that time. So I think that's,"},{"speaker":"Steve Gompertz","startTime":1702.109,"endTime":1706.759,"body":"you know, that that shift in"},{"speaker":"Steve Gompertz","startTime":1702.109,"endTime":1706.759,"body":"thinking is a big deal. And, of"},{"speaker":"Steve Gompertz","startTime":1706.759,"endTime":1709.6689999999999,"body":"course, the one that's you know,"},{"speaker":"Steve Gompertz","startTime":1706.759,"endTime":1709.6689999999999,"body":"hot off the presses right now,"},{"speaker":"Steve Gompertz","startTime":1709.6689999999999,"endTime":1714.529,"body":"of course, is AI and ML, every"},{"speaker":"Steve Gompertz","startTime":1709.6689999999999,"endTime":1714.529,"body":"device, every segment of the"},{"speaker":"Steve Gompertz","startTime":1714.529,"endTime":1720.559,"body":"device market is now affected by"},{"speaker":"Steve Gompertz","startTime":1714.529,"endTime":1720.559,"body":"this. Devices that before, never"},{"speaker":"Steve Gompertz","startTime":1720.559,"endTime":1724.6689999999999,"body":"saw, you know, a volt of"},{"speaker":"Steve Gompertz","startTime":1720.559,"endTime":1724.6689999999999,"body":"electricity, now have sensors"},{"speaker":"Steve Gompertz","startTime":1724.6689999999999,"endTime":1727.6989999999998,"body":"and software associated with"},{"speaker":"Steve Gompertz","startTime":1724.6689999999999,"endTime":1727.6989999999998,"body":"them. Things like, you know,"},{"speaker":"Steve Gompertz","startTime":1727.6989999999998,"endTime":1731.089,"body":"implantable orthopedic,"},{"speaker":"Steve Gompertz","startTime":1727.6989999999998,"endTime":1731.089,"body":"orthopedic implants, were always"},{"speaker":"Steve Gompertz","startTime":1731.089,"endTime":1733.549,"body":"purely mechanical, it was all"},{"speaker":"Steve Gompertz","startTime":1731.089,"endTime":1733.549,"body":"about, you know,"},{"speaker":"Steve Gompertz","startTime":1733.579,"endTime":1736.849,"body":"biocompatibility and mechanical"},{"speaker":"Steve Gompertz","startTime":1733.579,"endTime":1736.849,"body":"stuff. Now, they're building"},{"speaker":"Steve Gompertz","startTime":1736.849,"endTime":1740.569,"body":"sensors. So they can transmit"},{"speaker":"Steve Gompertz","startTime":1736.849,"endTime":1740.569,"body":"information about your movements"},{"speaker":"Steve Gompertz","startTime":1740.569,"endTime":1744.049,"body":"and your joints, to software."},{"speaker":"Steve Gompertz","startTime":1740.569,"endTime":1744.049,"body":"And that software is probably"},{"speaker":"Steve Gompertz","startTime":1744.049,"endTime":1747.499,"body":"now going to have an AI element"},{"speaker":"Steve Gompertz","startTime":1744.049,"endTime":1747.499,"body":"or machine learning element. So"},{"speaker":"Steve Gompertz","startTime":1747.499,"endTime":1750.769,"body":"it can interpret what it's"},{"speaker":"Steve Gompertz","startTime":1747.499,"endTime":1750.769,"body":"getting from you. We are"},{"speaker":"Steve Gompertz","startTime":1750.769,"endTime":1755.329,"body":"starting right to see the device"},{"speaker":"Steve Gompertz","startTime":1750.769,"endTime":1755.329,"body":"start to take on some of the"},{"speaker":"Steve Gompertz","startTime":1755.329,"endTime":1758.6889999999999,"body":"role of the medical"},{"speaker":"Steve Gompertz","startTime":1755.329,"endTime":1758.6889999999999,"body":"professional. And that"},{"speaker":"Steve Gompertz","startTime":1758.809,"endTime":1762.4389999999999,"body":"definitely scares the pants off"},{"speaker":"Steve Gompertz","startTime":1758.809,"endTime":1762.4389999999999,"body":"of the regulatory bodies."},{"speaker":"Steve Gompertz","startTime":1763.129,"endTime":1766.6989999999998,"body":"Machine learning in particular,"},{"speaker":"Steve Gompertz","startTime":1763.129,"endTime":1766.6989999999998,"body":"ai ai is interesting. little"},{"speaker":"Steve Gompertz","startTime":1766.6989999999998,"endTime":1771.259,"body":"short, aside here. AI is not"},{"speaker":"Steve Gompertz","startTime":1766.6989999999998,"endTime":1771.259,"body":"new, we think it's new, because"},{"speaker":"Steve Gompertz","startTime":1771.259,"endTime":1773.809,"body":"it's an all the press, but the"},{"speaker":"Steve Gompertz","startTime":1771.259,"endTime":1773.809,"body":"term itself goes back to like"},{"speaker":"Steve Gompertz","startTime":1773.809,"endTime":1779.779,"body":"the 1930s. And really any"},{"speaker":"Steve Gompertz","startTime":1773.809,"endTime":1779.779,"body":"advanced, you know, or complex"},{"speaker":"Steve Gompertz","startTime":1779.779,"endTime":1783.739,"body":"piece of software could be"},{"speaker":"Steve Gompertz","startTime":1779.779,"endTime":1783.739,"body":"considered AI, right? It's the"},{"speaker":"Steve Gompertz","startTime":1783.739,"endTime":1786.499,"body":"machine learning that makes the"},{"speaker":"Steve Gompertz","startTime":1783.739,"endTime":1786.499,"body":"difference. And in the"},{"speaker":"Steve Gompertz","startTime":1786.499,"endTime":1788.839,"body":"regulatory world, what they're"},{"speaker":"Steve Gompertz","startTime":1786.499,"endTime":1788.839,"body":"used to doing is having you"},{"speaker":"Steve Gompertz","startTime":1788.839,"endTime":1792.4089999999999,"body":"prove my device does this within"},{"speaker":"Steve Gompertz","startTime":1788.839,"endTime":1792.4089999999999,"body":"these constraints. And they go"},{"speaker":"Steve Gompertz","startTime":1792.4089999999999,"endTime":1796.279,"body":"yes, that's what we agree to we"},{"speaker":"Steve Gompertz","startTime":1792.4089999999999,"endTime":1796.279,"body":"approve or clear you just for"},{"speaker":"Steve Gompertz","startTime":1796.279,"endTime":1799.789,"body":"those things, what's called the"},{"speaker":"Steve Gompertz","startTime":1796.279,"endTime":1799.789,"body":"intended use. And it stays that"},{"speaker":"Steve Gompertz","startTime":1799.789,"endTime":1801.979,"body":"way. And if you want to change"},{"speaker":"Steve Gompertz","startTime":1799.789,"endTime":1801.979,"body":"any of that, you have to go back"},{"speaker":"Steve Gompertz","startTime":1801.979,"endTime":1804.6789999999999,"body":"through the process. Now you're"},{"speaker":"Steve Gompertz","startTime":1801.979,"endTime":1804.6789999999999,"body":"telling us you're gonna give us"},{"speaker":"Steve Gompertz","startTime":1804.6789999999999,"endTime":1807.469,"body":"device that on its own will"},{"speaker":"Steve Gompertz","startTime":1804.6789999999999,"endTime":1807.469,"body":"change go outside those"},{"speaker":"Steve Gompertz","startTime":1807.469,"endTime":1810.979,"body":"guardrails? The regulatory"},{"speaker":"Steve Gompertz","startTime":1807.469,"endTime":1810.979,"body":"bodies don't know what to do."},{"speaker":"Steve Gompertz","startTime":1811.549,"endTime":1815.569,"body":"Yeah, yeah. And that's kind of"},{"speaker":"Steve Gompertz","startTime":1811.549,"endTime":1815.569,"body":"the new frontier. It's all very"},{"speaker":"Steve Gompertz","startTime":1815.569,"endTime":1817.999,"body":"exciting, because there's a lot"},{"speaker":"Steve Gompertz","startTime":1815.569,"endTime":1817.999,"body":"of good that can come out of"},{"speaker":"Steve Gompertz","startTime":1817.999,"endTime":1823.249,"body":"that. But like there's, it's"},{"speaker":"Steve Gompertz","startTime":1817.999,"endTime":1823.249,"body":"it's stuff we don't fully"},{"speaker":"Steve Gompertz","startTime":1823.249,"endTime":1827.119,"body":"understand yet. We see it if you"},{"speaker":"Steve Gompertz","startTime":1823.249,"endTime":1827.119,"body":"play at all with any of the, the"},{"speaker":"Steve Gompertz","startTime":1827.119,"endTime":1829.999,"body":"AI tools out there, and they"},{"speaker":"Steve Gompertz","startTime":1827.119,"endTime":1829.999,"body":"talk about now they hallucinate,"},{"speaker":"Steve Gompertz","startTime":1830.389,"endTime":1833.089,"body":"right, they come up with"},{"speaker":"Steve Gompertz","startTime":1830.389,"endTime":1833.089,"body":"information that's not really"},{"speaker":"Steve Gompertz","startTime":1833.089,"endTime":1838.1889999999999,"body":"reliable. I just saw a term"},{"speaker":"Steve Gompertz","startTime":1833.089,"endTime":1838.1889999999999,"body":"slop, that they don't"},{"speaker":"Steve Gompertz","startTime":1838.1889999999999,"endTime":1842.2089999999998,"body":"necessarily get it wrong, but"},{"speaker":"Steve Gompertz","startTime":1838.1889999999999,"endTime":1842.2089999999998,"body":"the data they're basing it on is"},{"speaker":"Steve Gompertz","startTime":1842.2089999999998,"endTime":1844.849,"body":"not particularly good, right?"},{"speaker":"Steve Gompertz","startTime":1842.2089999999998,"endTime":1844.849,"body":"garbage in garbage out kind of"},{"speaker":"Steve Gompertz","startTime":1844.849,"endTime":1849.019,"body":"thing. So, you know, the"},{"speaker":"Steve Gompertz","startTime":1844.849,"endTime":1849.019,"body":"technology itself is not really"},{"speaker":"Steve Gompertz","startTime":1849.019,"endTime":1853.6989999999998,"body":"advanced far enough. And we"},{"speaker":"Steve Gompertz","startTime":1849.019,"endTime":1853.6989999999998,"body":"don't have control over it. And"},{"speaker":"Steve Gompertz","startTime":1853.6989999999998,"endTime":1856.729,"body":"I think, you know, that's that's"},{"speaker":"Steve Gompertz","startTime":1853.6989999999998,"endTime":1856.729,"body":"what worries, regulatory bodies."},{"speaker":"Steve Gompertz","startTime":1856.729,"endTime":1860.4189999999999,"body":"And I think that's the next big"},{"speaker":"Steve Gompertz","startTime":1856.729,"endTime":1860.4189999999999,"body":"challenge here. The other one"},{"speaker":"Steve Gompertz","startTime":1860.4189999999999,"endTime":1864.4389999999999,"body":"that's really a hot topic these"},{"speaker":"Steve Gompertz","startTime":1860.4189999999999,"endTime":1864.4389999999999,"body":"days is cybersecurity. That's"},{"speaker":"Steve Gompertz","startTime":1864.4389999999999,"endTime":1870.289,"body":"become a huge requirement with"},{"speaker":"Steve Gompertz","startTime":1864.4389999999999,"endTime":1870.289,"body":"FDA and I'm sorry, my camera"},{"speaker":"Steve Gompertz","startTime":1870.289,"endTime":1876.559,"body":"just went fuzzy there for some"},{"speaker":"Steve Gompertz","startTime":1870.289,"endTime":1876.559,"body":"reason. But they're very serious"},{"speaker":"Steve Gompertz","startTime":1876.559,"endTime":1881.239,"body":"now about making sure that if"},{"speaker":"Steve Gompertz","startTime":1876.559,"endTime":1881.239,"body":"you're using any sort of"},{"speaker":"Steve Gompertz","startTime":1881.239,"endTime":1885.049,"body":"software, with your device that"},{"speaker":"Steve Gompertz","startTime":1881.239,"endTime":1885.049,"body":"you have addressed the security"},{"speaker":"Steve Gompertz","startTime":1885.1689999999999,"endTime":1887.779,"body":"issues But regardless of whether"},{"speaker":"Steve Gompertz","startTime":1885.1689999999999,"endTime":1887.779,"body":"it's connected to the internet,"},{"speaker":"Steve Gompertz","startTime":1887.809,"endTime":1892.1589999999999,"body":"right, there's still the worry"},{"speaker":"Steve Gompertz","startTime":1887.809,"endTime":1892.1589999999999,"body":"somebody walks up to it and gets"},{"speaker":"Steve Gompertz","startTime":1892.1589999999999,"endTime":1894.9489999999998,"body":"into the software and changes"},{"speaker":"Steve Gompertz","startTime":1892.1589999999999,"endTime":1894.9489999999998,"body":"things. Sure, yeah, that's"},{"speaker":"Steve Gompertz","startTime":1894.9489999999998,"endTime":1897.529,"body":"become a big part of doing your"},{"speaker":"Steve Gompertz","startTime":1894.9489999999998,"endTime":1897.529,"body":"submissions to the regulatory"},{"speaker":"Steve Gompertz","startTime":1897.529,"endTime":1900.559,"body":"bodies, is demonstrating how"},{"speaker":"Steve Gompertz","startTime":1897.529,"endTime":1900.559,"body":"you're dealing with"},{"speaker":"Steve Gompertz","startTime":1900.559,"endTime":1901.489,"body":"cybersecurity."},{"speaker":"Aaron Moncur","startTime":1902.3,"endTime":1906.26,"body":"Going back to AI"},{"speaker":"Aaron Moncur","startTime":1902.3,"endTime":1906.26,"body":"for a second, you may or may not"},{"speaker":"Aaron Moncur","startTime":1906.26,"endTime":1910.28,"body":"have any direct experience with"},{"speaker":"Aaron Moncur","startTime":1906.26,"endTime":1910.28,"body":"surgical robotics. But I think"},{"speaker":"Aaron Moncur","startTime":1910.28,"endTime":1913.58,"body":"that's a really interesting area"},{"speaker":"Aaron Moncur","startTime":1910.28,"endTime":1913.58,"body":"where AI is going to play a huge"},{"speaker":"Aaron Moncur","startTime":1913.58,"endTime":1917.4199999999998,"body":"role, because now you have"},{"speaker":"Aaron Moncur","startTime":1913.58,"endTime":1917.4199999999998,"body":"intelligence in these these"},{"speaker":"Aaron Moncur","startTime":1917.4199999999998,"endTime":1923.45,"body":"surgical robots that can assist"},{"speaker":"Aaron Moncur","startTime":1917.4199999999998,"endTime":1923.45,"body":"the physicians, the surgeons in"},{"speaker":"Aaron Moncur","startTime":1923.96,"endTime":1927.3799999999999,"body":"making decisions, right, the"},{"speaker":"Aaron Moncur","startTime":1923.96,"endTime":1927.3799999999999,"body":"robot might see something in the"},{"speaker":"Aaron Moncur","startTime":1927.3799999999999,"endTime":1932.54,"body":"body that it connects with 87."},{"speaker":"Aaron Moncur","startTime":1927.3799999999999,"endTime":1932.54,"body":"Other things it knows about this"},{"speaker":"Aaron Moncur","startTime":1932.54,"endTime":1936.71,"body":"data that it's been programmed"},{"speaker":"Aaron Moncur","startTime":1932.54,"endTime":1936.71,"body":"with, and the surgeon might not"},{"speaker":"Aaron Moncur","startTime":1936.71,"endTime":1939.9199999999998,"body":"necessarily make those"},{"speaker":"Aaron Moncur","startTime":1936.71,"endTime":1939.9199999999998,"body":"connections, but the AI and the"},{"speaker":"Aaron Moncur","startTime":1939.9199999999998,"endTime":1944.69,"body":"surgical robotics might, and"},{"speaker":"Aaron Moncur","startTime":1939.9199999999998,"endTime":1944.69,"body":"then either suggest something or"},{"speaker":"Aaron Moncur","startTime":1944.69,"endTime":1949.6699999999998,"body":"just do something. Do you have"},{"speaker":"Aaron Moncur","startTime":1944.69,"endTime":1949.6699999999998,"body":"any, any anecdotes or any"},{"speaker":"Aaron Moncur","startTime":1949.6699999999998,"endTime":1953.24,"body":"commentary about AI,"},{"speaker":"Aaron Moncur","startTime":1949.6699999999998,"endTime":1953.24,"body":"specifically within the context"},{"speaker":"Aaron Moncur","startTime":1953.24,"endTime":1954.83,"body":"of surgical robotics?"},{"speaker":"Steve Gompertz","startTime":1955.58,"endTime":1957.86,"body":"Yeah, I don't"},{"speaker":"Steve Gompertz","startTime":1955.58,"endTime":1957.86,"body":"know that. It's that it's"},{"speaker":"Steve Gompertz","startTime":1957.9199999999998,"endTime":1960.32,"body":"pertains only to surgical"},{"speaker":"Steve Gompertz","startTime":1957.9199999999998,"endTime":1960.32,"body":"robotics, I think that is a good"},{"speaker":"Steve Gompertz","startTime":1960.32,"endTime":1965.21,"body":"example, right? The AI again,"},{"speaker":"Steve Gompertz","startTime":1960.32,"endTime":1965.21,"body":"has great promise for things it"},{"speaker":"Steve Gompertz","startTime":1965.21,"endTime":1967.76,"body":"can do, right? Because it can"},{"speaker":"Steve Gompertz","startTime":1965.21,"endTime":1967.76,"body":"pull together pieces of"},{"speaker":"Steve Gompertz","startTime":1967.76,"endTime":1972.29,"body":"information at a faster rate and"},{"speaker":"Steve Gompertz","startTime":1967.76,"endTime":1972.29,"body":"see trends that the human might"},{"speaker":"Steve Gompertz","startTime":1972.29,"endTime":1976.73,"body":"not pick up on. But in the end,"},{"speaker":"Steve Gompertz","startTime":1972.29,"endTime":1976.73,"body":"it's not much different than"},{"speaker":"Steve Gompertz","startTime":1976.73,"endTime":1979.6699999999998,"body":"being the surgeon themselves,"},{"speaker":"Steve Gompertz","startTime":1976.73,"endTime":1979.6699999999998,"body":"right? Every surgeon doesn't"},{"speaker":"Steve Gompertz","startTime":1979.6699999999998,"endTime":1983.09,"body":"operate at the same level of"},{"speaker":"Steve Gompertz","startTime":1979.6699999999998,"endTime":1983.09,"body":"proficiency, and competency."},{"speaker":"Steve Gompertz","startTime":1983.51,"endTime":1985.61,"body":"They've all had different"},{"speaker":"Steve Gompertz","startTime":1983.51,"endTime":1985.61,"body":"experiences based on their"},{"speaker":"Steve Gompertz","startTime":1985.61,"endTime":1990.44,"body":"different, you know, patients,"},{"speaker":"Steve Gompertz","startTime":1985.61,"endTime":1990.44,"body":"and what they know, is"},{"speaker":"Steve Gompertz","startTime":1990.44,"endTime":1992.84,"body":"different, right? And then they"},{"speaker":"Steve Gompertz","startTime":1990.44,"endTime":1992.84,"body":"do their best to share that"},{"speaker":"Steve Gompertz","startTime":1992.84,"endTime":1995.75,"body":"information through articles and"},{"speaker":"Steve Gompertz","startTime":1992.84,"endTime":1995.75,"body":"conferences, the way all of us"},{"speaker":"Steve Gompertz","startTime":1995.75,"endTime":2000.58,"body":"do. I think the benefit is AI"},{"speaker":"Steve Gompertz","startTime":1995.75,"endTime":2000.58,"body":"can at least put all that"},{"speaker":"Steve Gompertz","startTime":2000.58,"endTime":2004.12,"body":"together and not lose it right?"},{"speaker":"Steve Gompertz","startTime":2000.58,"endTime":2004.12,"body":"And actually, but it also then"},{"speaker":"Steve Gompertz","startTime":2004.12,"endTime":2008.11,"body":"comes down to wait, what were"},{"speaker":"Steve Gompertz","startTime":2004.12,"endTime":2008.11,"body":"the experiences, the AI learned"},{"speaker":"Steve Gompertz","startTime":2008.11,"endTime":2013.78,"body":"from the same as if the surgeon"},{"speaker":"Steve Gompertz","startTime":2008.11,"endTime":2013.78,"body":"only ever, you know, operated on"},{"speaker":"Steve Gompertz","startTime":2013.9299999999998,"endTime":2017.59,"body":"white males? Right? What does it"},{"speaker":"Steve Gompertz","startTime":2013.9299999999998,"endTime":2017.59,"body":"really know about the full"},{"speaker":"Steve Gompertz","startTime":2017.59,"endTime":2020.8,"body":"patient population that that raw"},{"speaker":"Steve Gompertz","startTime":2017.59,"endTime":2020.8,"body":"robot is going to be, you know,"},{"speaker":"Steve Gompertz","startTime":2021.37,"endTime":2025.57,"body":"operating off of and the same"},{"speaker":"Steve Gompertz","startTime":2021.37,"endTime":2025.57,"body":"thing as you feed the data? The"},{"speaker":"Steve Gompertz","startTime":2025.57,"endTime":2029.9199999999998,"body":"training database to AI,"},{"speaker":"Steve Gompertz","startTime":2025.57,"endTime":2029.9199999999998,"body":"diversity is becoming a big"},{"speaker":"Steve Gompertz","startTime":2029.9199999999998,"endTime":2034.3,"body":"concern there. Yeah, garbage in,"},{"speaker":"Steve Gompertz","startTime":2029.9199999999998,"endTime":2034.3,"body":"garbage out. So how do you make"},{"speaker":"Steve Gompertz","startTime":2034.3,"endTime":2039.6399999999999,"body":"sure that the AI is seeing a"},{"speaker":"Steve Gompertz","startTime":2034.3,"endTime":2039.6399999999999,"body":"broad enough spectrum to make"},{"speaker":"Steve Gompertz","startTime":2039.6399999999999,"endTime":2042.85,"body":"these right decisions, and that"},{"speaker":"Steve Gompertz","startTime":2039.6399999999999,"endTime":2042.85,"body":"the information is not being fed"},{"speaker":"Steve Gompertz","startTime":2042.85,"endTime":2046.6599999999999,"body":"any bad information? Because"},{"speaker":"Steve Gompertz","startTime":2042.85,"endTime":2046.6599999999999,"body":"they're certainly you know, I"},{"speaker":"Steve Gompertz","startTime":2046.6599999999999,"endTime":2049.69,"body":"teach at the universities and I"},{"speaker":"Steve Gompertz","startTime":2046.6599999999999,"endTime":2049.69,"body":"warn my students about even just"},{"speaker":"Steve Gompertz","startTime":2049.69,"endTime":2052.6,"body":"getting up pick a pedia. Right?"},{"speaker":"Steve Gompertz","startTime":2049.69,"endTime":2052.6,"body":"Forget about all the AI stuff"},{"speaker":"Steve Gompertz","startTime":2052.6,"endTime":2055.54,"body":"they can do now. But if those"},{"speaker":"Steve Gompertz","startTime":2052.6,"endTime":2055.54,"body":"reminders, uh, you know, you're"},{"speaker":"Steve Gompertz","startTime":2055.54,"endTime":2058.36,"body":"just Googling and you're getting"},{"speaker":"Steve Gompertz","startTime":2055.54,"endTime":2058.36,"body":"a list of white papers. Some of"},{"speaker":"Steve Gompertz","startTime":2058.36,"endTime":2061.36,"body":"them are pretty awful white"},{"speaker":"Steve Gompertz","startTime":2058.36,"endTime":2061.36,"body":"papers from they sound"},{"speaker":"Steve Gompertz","startTime":2061.36,"endTime":2063.67,"body":"wonderful. And the people seem"},{"speaker":"Steve Gompertz","startTime":2061.36,"endTime":2063.67,"body":"to have the right credentials."},{"speaker":"Steve Gompertz","startTime":2064.15,"endTime":2069.13,"body":"And they come to the wrong"},{"speaker":"Steve Gompertz","startTime":2064.15,"endTime":2069.13,"body":"conclusion. Now you've got a"},{"speaker":"Steve Gompertz","startTime":2069.19,"endTime":2071.14,"body":"artificial intelligence, and"},{"speaker":"Steve Gompertz","startTime":2069.19,"endTime":2071.14,"body":"you're if you're letting it"},{"speaker":"Steve Gompertz","startTime":2071.14,"endTime":2074.7400000000002,"body":"gather all of that information,"},{"speaker":"Steve Gompertz","startTime":2071.14,"endTime":2074.7400000000002,"body":"even bad stuff, it's gonna make"},{"speaker":"Steve Gompertz","startTime":2074.7400000000002,"endTime":2077.41,"body":"some bad decisions, right? There"},{"speaker":"Steve Gompertz","startTime":2074.7400000000002,"endTime":2077.41,"body":"was, you know, the article just"},{"speaker":"Steve Gompertz","startTime":2077.41,"endTime":2081.7000000000003,"body":"last week about Google. And its"},{"speaker":"Steve Gompertz","startTime":2077.41,"endTime":2081.7000000000003,"body":"new AI. Right, the question"},{"speaker":"Steve Gompertz","startTime":2081.7000000000003,"endTime":2085.06,"body":"about how can I make sure that"},{"speaker":"Steve Gompertz","startTime":2081.7000000000003,"endTime":2085.06,"body":"the cheese stays on my pizza"},{"speaker":"Steve Gompertz","startTime":2085.06,"endTime":2091.1499999999996,"body":"better? And it suggested glue?"},{"speaker":"Steve Gompertz","startTime":2085.06,"endTime":2091.1499999999996,"body":"That's what I mean, right? And"},{"speaker":"Steve Gompertz","startTime":2091.1499999999996,"endTime":2093.58,"body":"they went back and looked at it."},{"speaker":"Steve Gompertz","startTime":2091.1499999999996,"endTime":2093.58,"body":"And they said, because it picked"},{"speaker":"Steve Gompertz","startTime":2093.58,"endTime":2096.8199999999997,"body":"that up somewhere where, for"},{"speaker":"Steve Gompertz","startTime":2093.58,"endTime":2096.8199999999997,"body":"whatever reason, whether"},{"speaker":"Steve Gompertz","startTime":2096.8199999999997,"endTime":2101.3799999999997,"body":"somebody was being sarcastic in"},{"speaker":"Steve Gompertz","startTime":2096.8199999999997,"endTime":2101.3799999999997,"body":"a post somewhere, we're actually"},{"speaker":"Steve Gompertz","startTime":2101.3799999999997,"endTime":2106.21,"body":"method. And the AI picked up on"},{"speaker":"Steve Gompertz","startTime":2101.3799999999997,"endTime":2106.21,"body":"that one. Well, I saw it online,"},{"speaker":"Steve Gompertz","startTime":2106.21,"endTime":2106.93,"body":"it must be true."},{"speaker":"Aaron Moncur","startTime":2107.6699999999996,"endTime":2110.3999999999996,"body":"Right? It's funny"},{"speaker":"Aaron Moncur","startTime":2107.6699999999996,"endTime":2110.3999999999996,"body":"now when we talk about it, but"},{"speaker":"Aaron Moncur","startTime":2110.3999999999996,"endTime":2113.22,"body":"not so much when the robot cut"},{"speaker":"Aaron Moncur","startTime":2110.3999999999996,"endTime":2113.22,"body":"your spleen out unnecessarily."},{"speaker":"Steve Gompertz","startTime":2113.49,"endTime":2115.3799999999997,"body":"Exactly. Right."},{"speaker":"Steve Gompertz","startTime":2113.49,"endTime":2115.3799999999997,"body":"And that's, that's the"},{"speaker":"Steve Gompertz","startTime":2115.3799999999997,"endTime":2117.39,"body":"challenge. And that's what the"},{"speaker":"Steve Gompertz","startTime":2115.3799999999997,"endTime":2117.39,"body":"regulatory bodies are trying to"},{"speaker":"Steve Gompertz","startTime":2117.39,"endTime":2121.3799999999997,"body":"figure out is how are we going"},{"speaker":"Steve Gompertz","startTime":2117.39,"endTime":2121.3799999999997,"body":"to get control over devices that"},{"speaker":"Steve Gompertz","startTime":2121.3799999999997,"endTime":2124.1699999999996,"body":"are utilizing this, there's a"},{"speaker":"Steve Gompertz","startTime":2121.3799999999997,"endTime":2124.1699999999996,"body":"framework that's being developed"},{"speaker":"Steve Gompertz","startTime":2124.1699999999996,"endTime":2126.45,"body":"around that they don't"},{"speaker":"Steve Gompertz","startTime":2124.1699999999996,"endTime":2126.45,"body":"necessarily have the regulations"},{"speaker":"Steve Gompertz","startTime":2126.45,"endTime":2130.2599999999998,"body":"yet, but they understand the"},{"speaker":"Steve Gompertz","startTime":2126.45,"endTime":2130.2599999999998,"body":"types of controls that are going"},{"speaker":"Steve Gompertz","startTime":2130.2599999999998,"endTime":2133.5,"body":"to need to be in place, you"},{"speaker":"Steve Gompertz","startTime":2130.2599999999998,"endTime":2133.5,"body":"know, what it boils down to,"},{"speaker":"Steve Gompertz","startTime":2133.92,"endTime":2136.98,"body":"we're not going to be able to"},{"speaker":"Steve Gompertz","startTime":2133.92,"endTime":2136.98,"body":"allow device manufacturers to"},{"speaker":"Steve Gompertz","startTime":2136.98,"endTime":2141.39,"body":"have machine learning based"},{"speaker":"Steve Gompertz","startTime":2136.98,"endTime":2141.39,"body":"tools, you know, are devices"},{"speaker":"Steve Gompertz","startTime":2141.66,"endTime":2145.11,"body":"that are just free to update"},{"speaker":"Steve Gompertz","startTime":2141.66,"endTime":2145.11,"body":"themselves as they go. I always"},{"speaker":"Steve Gompertz","startTime":2145.11,"endTime":2147.57,"body":"refer to it, they're going to"},{"speaker":"Steve Gompertz","startTime":2145.11,"endTime":2147.57,"body":"have to phone a home, you have"},{"speaker":"Steve Gompertz","startTime":2147.57,"endTime":2150.81,"body":"to get permission. So they can"},{"speaker":"Steve Gompertz","startTime":2147.57,"endTime":2150.81,"body":"capture this information. And at"},{"speaker":"Steve Gompertz","startTime":2150.81,"endTime":2154.2599999999998,"body":"some point, the manufacturer is"},{"speaker":"Steve Gompertz","startTime":2150.81,"endTime":2154.2599999999998,"body":"going to be required to review."},{"speaker":"Steve Gompertz","startTime":2154.56,"endTime":2157.68,"body":"All right device, what is it you"},{"speaker":"Steve Gompertz","startTime":2154.56,"endTime":2157.68,"body":"think you've learned? And then"},{"speaker":"Steve Gompertz","startTime":2157.68,"endTime":2161.5499999999997,"body":"we through? No, don't use that?"},{"speaker":"Steve Gompertz","startTime":2157.68,"endTime":2161.5499999999997,"body":"Yes, you can leverage that. And"},{"speaker":"Steve Gompertz","startTime":2161.5499999999997,"endTime":2164.13,"body":"then we can go back until FTA."},{"speaker":"Steve Gompertz","startTime":2161.5499999999997,"endTime":2164.13,"body":"Here are the things we're going"},{"speaker":"Steve Gompertz","startTime":2164.13,"endTime":2165.6,"body":"to let the device change."},{"speaker":"Aaron Moncur","startTime":2165.96,"endTime":2166.89,"body":"That makes sense."},{"speaker":"Steve Gompertz","startTime":2166.95,"endTime":2169.02,"body":"You have to"},{"speaker":"Steve Gompertz","startTime":2166.95,"endTime":2169.02,"body":"still control your releases of"},{"speaker":"Steve Gompertz","startTime":2169.02,"endTime":2169.89,"body":"the design changes."},{"speaker":"Aaron Moncur","startTime":2169.83,"endTime":2173.22,"body":"Sure. Right. All"},{"speaker":"Aaron Moncur","startTime":2169.83,"endTime":2173.22,"body":"right. Well, can you talk to us"},{"speaker":"Aaron Moncur","startTime":2173.22,"endTime":2176.82,"body":"about maybe a success story"},{"speaker":"Aaron Moncur","startTime":2173.22,"endTime":2176.82,"body":"where your company QRx Partners"},{"speaker":"Aaron Moncur","startTime":2176.82,"endTime":2181.17,"body":"has has helped a company improve"},{"speaker":"Aaron Moncur","startTime":2176.82,"endTime":2181.17,"body":"their quality management system,"},{"speaker":"Aaron Moncur","startTime":2181.17,"endTime":2185.5499999999997,"body":"their regulatory compliance?"},{"speaker":"Aaron Moncur","startTime":2181.17,"endTime":2185.5499999999997,"body":"Maybe walk us through what that"},{"speaker":"Aaron Moncur","startTime":2185.5499999999997,"endTime":2189.69,"body":"process looks like if you can,"},{"speaker":"Aaron Moncur","startTime":2185.5499999999997,"endTime":2189.69,"body":"in the context of a story that"},{"speaker":"Aaron Moncur","startTime":2189.69,"endTime":2191.19,"body":"you can share. Yeah,"},{"speaker":"Steve Gompertz","startTime":2191.56,"endTime":2196.45,"body":"we had a client"},{"speaker":"Steve Gompertz","startTime":2191.56,"endTime":2196.45,"body":"that was growing pretty quickly."},{"speaker":"Steve Gompertz","startTime":2196.93,"endTime":2199.87,"body":"And they were really outgrowing"},{"speaker":"Steve Gompertz","startTime":2196.93,"endTime":2199.87,"body":"their quality system, what they"},{"speaker":"Steve Gompertz","startTime":2199.87,"endTime":2202.54,"body":"had in there was pretty typical"},{"speaker":"Steve Gompertz","startTime":2199.87,"endTime":2202.54,"body":"of when they were to start off,"},{"speaker":"Steve Gompertz","startTime":2202.54,"endTime":2206.35,"body":"it was almost more of a facade."},{"speaker":"Steve Gompertz","startTime":2202.54,"endTime":2206.35,"body":"Right? That's checklist. Yes, we"},{"speaker":"Steve Gompertz","startTime":2206.35,"endTime":2208.36,"body":"have a quality system. Yes, we"},{"speaker":"Steve Gompertz","startTime":2206.35,"endTime":2208.36,"body":"have procedures for this. And"},{"speaker":"Steve Gompertz","startTime":2208.36,"endTime":2211.27,"body":"they hadn't really thought about"},{"speaker":"Steve Gompertz","startTime":2208.36,"endTime":2211.27,"body":"how to use them and why. And as"},{"speaker":"Steve Gompertz","startTime":2211.27,"endTime":2213.85,"body":"the company was now growing,"},{"speaker":"Steve Gompertz","startTime":2211.27,"endTime":2213.85,"body":"right, that was great. It was"},{"speaker":"Steve Gompertz","startTime":2213.85,"endTime":2216.88,"body":"okay, when they were like 20"},{"speaker":"Steve Gompertz","startTime":2213.85,"endTime":2216.88,"body":"employees, and now there's 250,"},{"speaker":"Steve Gompertz","startTime":2217.69,"endTime":2220.63,"body":"the whole thing is now caving in"},{"speaker":"Steve Gompertz","startTime":2217.69,"endTime":2220.63,"body":"itself. And we're asked to"},{"speaker":"Steve Gompertz","startTime":2221.38,"endTime":2225.73,"body":"revise, you know, revamp this"},{"speaker":"Steve Gompertz","startTime":2221.38,"endTime":2225.73,"body":"quality system. And it was a"},{"speaker":"Steve Gompertz","startTime":2225.73,"endTime":2228.37,"body":"complete rewrite, basically,"},{"speaker":"Steve Gompertz","startTime":2225.73,"endTime":2228.37,"body":"we're gonna burn it down and"},{"speaker":"Steve Gompertz","startTime":2228.37,"endTime":2230.86,"body":"start over thinking about the"},{"speaker":"Steve Gompertz","startTime":2228.37,"endTime":2230.86,"body":"system, and then all the"},{"speaker":"Steve Gompertz","startTime":2230.86,"endTime":2234.97,"body":"processes. Now what was"},{"speaker":"Steve Gompertz","startTime":2230.86,"endTime":2234.97,"body":"indicative was, when we came on"},{"speaker":"Steve Gompertz","startTime":2234.97,"endTime":2239.23,"body":"board, they had just come out of"},{"speaker":"Steve Gompertz","startTime":2234.97,"endTime":2239.23,"body":"an FDA inspection, FDA left them"},{"speaker":"Steve Gompertz","startTime":2239.23,"endTime":2242.17,"body":"with for inspectional"},{"speaker":"Steve Gompertz","startTime":2239.23,"endTime":2242.17,"body":"observations, they were"},{"speaker":"Steve Gompertz","startTime":2242.17,"endTime":2246.0099999999998,"body":"certified to ISO 1345, which the"},{"speaker":"Steve Gompertz","startTime":2242.17,"endTime":2246.0099999999998,"body":"quality standard for medical"},{"speaker":"Steve Gompertz","startTime":2246.0099999999998,"endTime":2248.98,"body":"devices. And so they went"},{"speaker":"Steve Gompertz","startTime":2246.0099999999998,"endTime":2248.98,"body":"through annual audits from their"},{"speaker":"Steve Gompertz","startTime":2248.98,"endTime":2252.85,"body":"certification body. And those"},{"speaker":"Steve Gompertz","startTime":2248.98,"endTime":2252.85,"body":"audits typically produced about"},{"speaker":"Steve Gompertz","startTime":2252.85,"endTime":2256.84,"body":"a dozen to a dozen and a half"},{"speaker":"Steve Gompertz","startTime":2252.85,"endTime":2256.84,"body":"major findings. That sounds"},{"speaker":"Aaron Moncur","startTime":2256.84,"endTime":2259.2999999999997,"body":"like a lot. Is"},{"speaker":"Aaron Moncur","startTime":2256.84,"endTime":2259.2999999999997,"body":"that a lie? That's a lie. Yeah,"},{"speaker":"Aaron Moncur","startTime":2259.33,"endTime":2259.81,"body":"that is a lie."},{"speaker":"Steve Gompertz","startTime":2260.56,"endTime":2262.39,"body":"And then they"},{"speaker":"Steve Gompertz","startTime":2260.56,"endTime":2262.39,"body":"were doing some internal audits,"},{"speaker":"Steve Gompertz","startTime":2262.39,"endTime":2264.13,"body":"and they weren't doing a great"},{"speaker":"Steve Gompertz","startTime":2262.39,"endTime":2264.13,"body":"job with Earl, but even their"},{"speaker":"Steve Gompertz","startTime":2264.13,"endTime":2267.61,"body":"internal audits, were"},{"speaker":"Steve Gompertz","startTime":2264.13,"endTime":2267.61,"body":"identifying, like, 24 issues"},{"speaker":"Steve Gompertz","startTime":2267.7,"endTime":2271.0299999999997,"body":"every year. Wow. Right. So"},{"speaker":"Steve Gompertz","startTime":2267.7,"endTime":2271.0299999999997,"body":"that's a whole bunch of things"},{"speaker":"Steve Gompertz","startTime":2271.0299999999997,"endTime":2274.09,"body":"that need to be fixed. And it's"},{"speaker":"Steve Gompertz","startTime":2271.0299999999997,"endTime":2274.09,"body":"expensive. That's a lot of"},{"speaker":"Steve Gompertz","startTime":2274.09,"endTime":2276.97,"body":"resources, right? It's a lot of"},{"speaker":"Steve Gompertz","startTime":2274.09,"endTime":2276.97,"body":"time to investigate those,"},{"speaker":"Steve Gompertz","startTime":2276.97,"endTime":2279.67,"body":"figure out the root causes,"},{"speaker":"Steve Gompertz","startTime":2276.97,"endTime":2279.67,"body":"figure out the right solution."},{"speaker":"Steve Gompertz","startTime":2279.67,"endTime":2282.88,"body":"But the solution in place, prove"},{"speaker":"Steve Gompertz","startTime":2279.67,"endTime":2282.88,"body":"this a solution work. And this"},{"speaker":"Steve Gompertz","startTime":2282.88,"endTime":2285.91,"body":"is why non conformance is"},{"speaker":"Steve Gompertz","startTime":2282.88,"endTime":2285.91,"body":"expensive. So we came in and"},{"speaker":"Steve Gompertz","startTime":2285.91,"endTime":2288.13,"body":"said, Look, we're gonna burn the"},{"speaker":"Steve Gompertz","startTime":2285.91,"endTime":2288.13,"body":"entire quality system down and"},{"speaker":"Steve Gompertz","startTime":2288.13,"endTime":2291.25,"body":"rebuild a new one that is all"},{"speaker":"Steve Gompertz","startTime":2288.13,"endTime":2291.25,"body":"connected, as I talked about,"},{"speaker":"Steve Gompertz","startTime":2291.58,"endTime":2293.95,"body":"we're going to show you how the"},{"speaker":"Steve Gompertz","startTime":2291.58,"endTime":2293.95,"body":"process interconnect. We're"},{"speaker":"Steve Gompertz","startTime":2294.07,"endTime":2298.12,"body":"teach everybody about the why."},{"speaker":"Steve Gompertz","startTime":2294.07,"endTime":2298.12,"body":"Right? There's a there's a"},{"speaker":"Steve Gompertz","startTime":2298.12,"endTime":2302.38,"body":"difference between education and"},{"speaker":"Steve Gompertz","startTime":2298.12,"endTime":2302.38,"body":"training in an organization. I"},{"speaker":"Steve Gompertz","startTime":2302.38,"endTime":2305.89,"body":"train you to follow a work"},{"speaker":"Steve Gompertz","startTime":2302.38,"endTime":2305.89,"body":"instruction, step one, step two,"},{"speaker":"Steve Gompertz","startTime":2305.89,"endTime":2310.12,"body":"but I have to educate you on why"},{"speaker":"Steve Gompertz","startTime":2305.89,"endTime":2310.12,"body":"you're doing that. Right. Why"},{"speaker":"Steve Gompertz","startTime":2310.12,"endTime":2312.88,"body":"does this regulation exist this"},{"speaker":"Steve Gompertz","startTime":2310.12,"endTime":2312.88,"body":"way? Why doesn't regulation say"},{"speaker":"Steve Gompertz","startTime":2312.88,"endTime":2315.7599999999998,"body":"it that way? Why have we"},{"speaker":"Steve Gompertz","startTime":2312.88,"endTime":2315.7599999999998,"body":"designed it the proper way that"},{"speaker":"Steve Gompertz","startTime":2315.7599999999998,"endTime":2319.84,"body":"creates awareness of what the"},{"speaker":"Steve Gompertz","startTime":2315.7599999999998,"endTime":2319.84,"body":"risks are, right. And risk based"},{"speaker":"Steve Gompertz","startTime":2319.84,"endTime":2322.21,"body":"thinking is a big part of that"},{"speaker":"Steve Gompertz","startTime":2319.84,"endTime":2322.21,"body":"we built that into the quality"},{"speaker":"Steve Gompertz","startTime":2322.21,"endTime":2326.41,"body":"system as well. But we built"},{"speaker":"Steve Gompertz","startTime":2322.21,"endTime":2326.41,"body":"this much more holistic, quality"},{"speaker":"Steve Gompertz","startTime":2326.41,"endTime":2329.56,"body":"system, where now everything is"},{"speaker":"Steve Gompertz","startTime":2326.41,"endTime":2329.56,"body":"interconnected, we've done a"},{"speaker":"Steve Gompertz","startTime":2329.56,"endTime":2334.18,"body":"better job of educating the"},{"speaker":"Steve Gompertz","startTime":2329.56,"endTime":2334.18,"body":"employees on their role, and why"},{"speaker":"Steve Gompertz","startTime":2334.18,"endTime":2336.73,"body":"they're, you know, doing things"},{"speaker":"Steve Gompertz","startTime":2334.18,"endTime":2336.73,"body":"within the quality system,"},{"speaker":"Steve Gompertz","startTime":2337.0299999999997,"endTime":2339.46,"body":"including employees who didn't"},{"speaker":"Steve Gompertz","startTime":2337.0299999999997,"endTime":2339.46,"body":"think they were part of the"},{"speaker":"Steve Gompertz","startTime":2339.46,"endTime":2343.06,"body":"quality system, like sales never"},{"speaker":"Steve Gompertz","startTime":2339.46,"endTime":2343.06,"body":"sees themselves for the quality"},{"speaker":"Steve Gompertz","startTime":2343.06,"endTime":2346.75,"body":"system, yet, they're a huge part"},{"speaker":"Steve Gompertz","startTime":2343.06,"endTime":2346.75,"body":"of the quality system. And now"},{"speaker":"Steve Gompertz","startTime":2346.75,"endTime":2350.29,"body":"you've got everybody truly"},{"speaker":"Steve Gompertz","startTime":2346.75,"endTime":2350.29,"body":"engaged. This takes time, this"},{"speaker":"Steve Gompertz","startTime":2350.29,"endTime":2353.56,"body":"didn't happen quickly. This took"},{"speaker":"Steve Gompertz","startTime":2350.29,"endTime":2353.56,"body":"about three years to make this"},{"speaker":"Steve Gompertz","startTime":2353.56,"endTime":2357.13,"body":"evolution, which happened to"},{"speaker":"Steve Gompertz","startTime":2353.56,"endTime":2357.13,"body":"coincide with the next visit by"},{"speaker":"Steve Gompertz","startTime":2357.13,"endTime":2362.92,"body":"the FDA. And they weren't zero"},{"speaker":"Steve Gompertz","startTime":2357.13,"endTime":2362.92,"body":"findings. Wow. And over that"},{"speaker":"Steve Gompertz","startTime":2362.92,"endTime":2368.2,"body":"three years, they got down to"},{"speaker":"Steve Gompertz","startTime":2362.92,"endTime":2368.2,"body":"the most recent at the time, the"},{"speaker":"Steve Gompertz","startTime":2368.2,"endTime":2371.92,"body":"FDA committed that the most"},{"speaker":"Steve Gompertz","startTime":2368.2,"endTime":2371.92,"body":"recent certification body audit"},{"speaker":"Steve Gompertz","startTime":2372.19,"endTime":2376.75,"body":"found one minor, non"},{"speaker":"Steve Gompertz","startTime":2372.19,"endTime":2376.75,"body":"conformance. Amazing. Now"},{"speaker":"Steve Gompertz","startTime":2376.75,"endTime":2380.38,"body":"internal. And we taught them to"},{"speaker":"Steve Gompertz","startTime":2376.75,"endTime":2380.38,"body":"be more critical of themselves,"},{"speaker":"Steve Gompertz","startTime":2380.38,"endTime":2383.74,"body":"they were still generating a lot"},{"speaker":"Steve Gompertz","startTime":2380.38,"endTime":2383.74,"body":"of internal findings. But we"},{"speaker":"Steve Gompertz","startTime":2383.74,"endTime":2386.77,"body":"were clarify classifying them as"},{"speaker":"Steve Gompertz","startTime":2383.74,"endTime":2386.77,"body":"well. What kind of finding were"},{"speaker":"Steve Gompertz","startTime":2386.77,"endTime":2389.86,"body":"they? Typically, when an auditor"},{"speaker":"Steve Gompertz","startTime":2386.77,"endTime":2389.86,"body":"looks at as three things one,"},{"speaker":"Steve Gompertz","startTime":2390.64,"endTime":2394.33,"body":"did you understand the"},{"speaker":"Steve Gompertz","startTime":2390.64,"endTime":2394.33,"body":"requirements to? Are you"},{"speaker":"Steve Gompertz","startTime":2394.33,"endTime":2397.09,"body":"actually following the"},{"speaker":"Steve Gompertz","startTime":2394.33,"endTime":2397.09,"body":"procedure? And three, does that"},{"speaker":"Steve Gompertz","startTime":2397.09,"endTime":2401.14,"body":"produce good results? You don't"},{"speaker":"Steve Gompertz","startTime":2397.09,"endTime":2401.14,"body":"want number one, because it"},{"speaker":"Steve Gompertz","startTime":2401.14,"endTime":2404.29,"body":"means you don't understand the"},{"speaker":"Steve Gompertz","startTime":2401.14,"endTime":2404.29,"body":"requirements, right. And that"},{"speaker":"Steve Gompertz","startTime":2404.29,"endTime":2407.41,"body":"was a thing, a lot of their"},{"speaker":"Steve Gompertz","startTime":2404.29,"endTime":2407.41,"body":"findings were have that kind of"},{"speaker":"Steve Gompertz","startTime":2407.83,"endTime":2410.17,"body":"first level that they weren't"},{"speaker":"Steve Gompertz","startTime":2407.83,"endTime":2410.17,"body":"even understanding the"},{"speaker":"Steve Gompertz","startTime":2410.17,"endTime":2413.2,"body":"requirements. Number two is not"},{"speaker":"Steve Gompertz","startTime":2410.17,"endTime":2413.2,"body":"great, because it means people"},{"speaker":"Steve Gompertz","startTime":2413.2,"endTime":2415.57,"body":"aren't really paying attention"},{"speaker":"Steve Gompertz","startTime":2413.2,"endTime":2415.57,"body":"to the procedure. They're not"},{"speaker":"Steve Gompertz","startTime":2415.57,"endTime":2420.0099999999998,"body":"executing to what's documented."},{"speaker":"Steve Gompertz","startTime":2415.57,"endTime":2420.0099999999998,"body":"But that's correctable. And then"},{"speaker":"Steve Gompertz","startTime":2420.0099999999998,"endTime":2422.5299999999997,"body":"number three is kind of like"},{"speaker":"Steve Gompertz","startTime":2420.0099999999998,"endTime":2422.5299999999997,"body":"this is where we get refinement"},{"speaker":"Steve Gompertz","startTime":2422.5299999999997,"endTime":2426.46,"body":"and optimization. So you'd"},{"speaker":"Steve Gompertz","startTime":2422.5299999999997,"endTime":2426.46,"body":"prefer that you find mostly in"},{"speaker":"Steve Gompertz","startTime":2426.46,"endTime":2429.0099999999998,"body":"that third level. And that's"},{"speaker":"Steve Gompertz","startTime":2426.46,"endTime":2429.0099999999998,"body":"where they got to so they were"},{"speaker":"Steve Gompertz","startTime":2429.0099999999998,"endTime":2432.49,"body":"finding a lot more stuff on"},{"speaker":"Steve Gompertz","startTime":2429.0099999999998,"endTime":2432.49,"body":"their own. But it was all"},{"speaker":"Steve Gompertz","startTime":2432.49,"endTime":2436.0,"body":"typically at that second and"},{"speaker":"Steve Gompertz","startTime":2432.49,"endTime":2436.0,"body":"mostly at that third level. Yes,"},{"speaker":"Steve Gompertz","startTime":2436.0,"endTime":2439.15,"body":"we understand the requirements."},{"speaker":"Steve Gompertz","startTime":2436.0,"endTime":2439.15,"body":"We're never finding instances"},{"speaker":"Steve Gompertz","startTime":2439.15,"endTime":2441.7,"body":"where we don't understand the"},{"speaker":"Steve Gompertz","startTime":2439.15,"endTime":2441.7,"body":"requirements. We're almost"},{"speaker":"Steve Gompertz","startTime":2441.7,"endTime":2445.93,"body":"always following that procedure"},{"speaker":"Steve Gompertz","startTime":2441.7,"endTime":2445.93,"body":"as written. Or we know how to"},{"speaker":"Steve Gompertz","startTime":2445.93,"endTime":2448.9,"body":"change it as needed, right if"},{"speaker":"Steve Gompertz","startTime":2445.93,"endTime":2448.9,"body":"the conditions change because"},{"speaker":"Steve Gompertz","startTime":2448.9,"endTime":2452.5299999999997,"body":"they will and now we're down to"},{"speaker":"Steve Gompertz","startTime":2448.9,"endTime":2452.5299999999997,"body":"refinement of are we really as"},{"speaker":"Steve Gompertz","startTime":2452.5299999999997,"endTime":2455.89,"body":"efficient and effective as we"},{"speaker":"Steve Gompertz","startTime":2452.5299999999997,"endTime":2455.89,"body":"would like that process? Yeah,"},{"speaker":"Steve Gompertz","startTime":2455.89,"endTime":2460.93,"body":"so that was a huge evolution for"},{"speaker":"Steve Gompertz","startTime":2455.89,"endTime":2460.93,"body":"them. Yeah. When I don't have"},{"speaker":"Steve Gompertz","startTime":2460.93,"endTime":2463.72,"body":"the numbers at hand, but I did a"},{"speaker":"Steve Gompertz","startTime":2460.93,"endTime":2463.72,"body":"workup of the cost savings and"},{"speaker":"Steve Gompertz","startTime":2463.72,"endTime":2465.64,"body":"it was hundreds of 1000s of"},{"speaker":"Steve Gompertz","startTime":2463.72,"endTime":2465.64,"body":"dollars a year."},{"speaker":"Aaron Moncur","startTime":2465.79,"endTime":2469.6,"body":"Wow. Incredible."},{"speaker":"Aaron Moncur","startTime":2465.79,"endTime":2469.6,"body":"That makes it pretty easy for"},{"speaker":"Aaron Moncur","startTime":2469.6,"endTime":2471.88,"body":"you to market right I mean, look"},{"speaker":"Aaron Moncur","startTime":2469.6,"endTime":2471.88,"body":"what we"},{"speaker":"Steve Gompertz","startTime":2472.75,"endTime":2475.12,"body":"cost the poor"},{"speaker":"Steve Gompertz","startTime":2472.75,"endTime":2475.12,"body":"quality and it's just amazing."},{"speaker":"Steve Gompertz","startTime":2475.24,"endTime":2479.2599999999998,"body":"You know what that can cost?"},{"speaker":"Steve Gompertz","startTime":2475.24,"endTime":2479.2599999999998,"body":"Yeah. And versus what it costs"},{"speaker":"Steve Gompertz","startTime":2479.29,"endTime":2481.75,"body":"and it sounds like a lot it was"},{"speaker":"Steve Gompertz","startTime":2479.29,"endTime":2481.75,"body":"my three years of work the"},{"speaker":"Steve Gompertz","startTime":2481.75,"endTime":2485.5299999999997,"body":"burned out quality system. We do"},{"speaker":"Steve Gompertz","startTime":2481.75,"endTime":2485.5299999999997,"body":"it we educate everybody but you"},{"speaker":"Steve Gompertz","startTime":2485.56,"endTime":2490.87,"body":"that, that avoidance of several"},{"speaker":"Steve Gompertz","startTime":2485.56,"endTime":2490.87,"body":"$100,000 a year, easily paid"},{"speaker":"Steve Gompertz","startTime":2490.87,"endTime":2493.6,"body":"for. Yeah. This is why Philip"},{"speaker":"Steve Gompertz","startTime":2490.87,"endTime":2493.6,"body":"Crosby, who was one of the"},{"speaker":"Steve Gompertz","startTime":2493.6,"endTime":2497.0499999999997,"body":"quality guides, his book was"},{"speaker":"Steve Gompertz","startTime":2493.6,"endTime":2497.0499999999997,"body":"quality is free. And that's what"},{"speaker":"Steve Gompertz","startTime":2497.0499999999997,"endTime":2501.5499999999997,"body":"he was on. Yeah, the cost of"},{"speaker":"Steve Gompertz","startTime":2497.0499999999997,"endTime":2501.5499999999997,"body":"poor quality is always going to"},{"speaker":"Steve Gompertz","startTime":2501.5499999999997,"endTime":2504.49,"body":"be more than what it's going to"},{"speaker":"Steve Gompertz","startTime":2501.5499999999997,"endTime":2504.49,"body":"cost you to get it right. And"},{"speaker":"Aaron Moncur","startTime":2504.49,"endTime":2509.29,"body":"that maybe doesn't"},{"speaker":"Aaron Moncur","startTime":2504.49,"endTime":2509.29,"body":"even account the new"},{"speaker":"Aaron Moncur","startTime":2509.29,"endTime":2512.71,"body":"opportunities that may they may"},{"speaker":"Aaron Moncur","startTime":2509.29,"endTime":2512.71,"body":"have been able to pursue because"},{"speaker":"Aaron Moncur","startTime":2512.71,"endTime":2515.86,"body":"those resources were freed up to"},{"speaker":"Aaron Moncur","startTime":2512.71,"endTime":2515.86,"body":"spend time on other stuff."},{"speaker":"Steve Gompertz","startTime":2515.98,"endTime":2518.14,"body":"Exactly right."},{"speaker":"Steve Gompertz","startTime":2515.98,"endTime":2518.14,"body":"Your resources are now not"},{"speaker":"Steve Gompertz","startTime":2518.2,"endTime":2521.83,"body":"distracted with redoing things,"},{"speaker":"Steve Gompertz","startTime":2518.2,"endTime":2521.83,"body":"right? Rework is always bad."},{"speaker":"Steve Gompertz","startTime":2521.86,"endTime":2525.07,"body":"This is a form of rework. I have"},{"speaker":"Steve Gompertz","startTime":2521.86,"endTime":2525.07,"body":"to go in and correct or, you"},{"speaker":"Steve Gompertz","startTime":2525.07,"endTime":2527.83,"body":"know, figure out new corrective"},{"speaker":"Steve Gompertz","startTime":2525.07,"endTime":2527.83,"body":"actions for my processor, there"},{"speaker":"Steve Gompertz","startTime":2527.83,"endTime":2529.93,"body":"should have been right in the"},{"speaker":"Steve Gompertz","startTime":2527.83,"endTime":2529.93,"body":"first place. Yeah, those"},{"speaker":"Steve Gompertz","startTime":2529.93,"endTime":2532.63,"body":"resources are not working on the"},{"speaker":"Steve Gompertz","startTime":2529.93,"endTime":2532.63,"body":"things that would generate"},{"speaker":"Steve Gompertz","startTime":2532.63,"endTime":2534.88,"body":"money. Yeah. Well,"},{"speaker":"Aaron Moncur","startTime":2535.0299999999997,"endTime":2537.85,"body":"I imagine they're"},{"speaker":"Aaron Moncur","startTime":2535.0299999999997,"endTime":2537.85,"body":"going to be folks listening to"},{"speaker":"Aaron Moncur","startTime":2537.85,"endTime":2541.18,"body":"this episode who say to"},{"speaker":"Aaron Moncur","startTime":2537.85,"endTime":2541.18,"body":"themselves, this sounds like an"},{"speaker":"Aaron Moncur","startTime":2541.18,"endTime":2544.75,"body":"interesting path. I might like"},{"speaker":"Aaron Moncur","startTime":2541.18,"endTime":2544.75,"body":"to pursue this or learn more"},{"speaker":"Aaron Moncur","startTime":2544.75,"endTime":2546.73,"body":"about it, what do you think are"},{"speaker":"Aaron Moncur","startTime":2544.75,"endTime":2546.73,"body":"some of the most important"},{"speaker":"Aaron Moncur","startTime":2546.73,"endTime":2552.37,"body":"skills or attributes behaviors"},{"speaker":"Aaron Moncur","startTime":2546.73,"endTime":2552.37,"body":"that quality management"},{"speaker":"Aaron Moncur","startTime":2552.37,"endTime":2555.52,"body":"professionals need to have in"},{"speaker":"Aaron Moncur","startTime":2552.37,"endTime":2555.52,"body":"the medical device industry?"},{"speaker":"Steve Gompertz","startTime":2556.96,"endTime":2559.2999999999997,"body":"So that I talked"},{"speaker":"Steve Gompertz","startTime":2556.96,"endTime":2559.2999999999997,"body":"about the system's thinking,"},{"speaker":"Steve Gompertz","startTime":2559.2999999999997,"endTime":2562.39,"body":"right, you have to be able to"},{"speaker":"Steve Gompertz","startTime":2559.2999999999997,"endTime":2562.39,"body":"see broadly and see the entire"},{"speaker":"Steve Gompertz","startTime":2562.39,"endTime":2566.92,"body":"system. And that's hard, right?"},{"speaker":"Steve Gompertz","startTime":2562.39,"endTime":2566.92,"body":"That's complex. And, you know, I"},{"speaker":"Steve Gompertz","startTime":2566.92,"endTime":2569.32,"body":"always say it's seen as the"},{"speaker":"Steve Gompertz","startTime":2566.92,"endTime":2569.32,"body":"proverbial sweater, you pull the"},{"speaker":"Steve Gompertz","startTime":2569.32,"endTime":2571.6,"body":"thread, the whole sweater comes"},{"speaker":"Steve Gompertz","startTime":2569.32,"endTime":2571.6,"body":"with you, that's what a quality"},{"speaker":"Steve Gompertz","startTime":2571.6,"endTime":2574.66,"body":"system is like. But you have to"},{"speaker":"Steve Gompertz","startTime":2571.6,"endTime":2574.66,"body":"understand, yeah, if I pull this"},{"speaker":"Steve Gompertz","startTime":2574.66,"endTime":2579.07,"body":"part of the thread, what's gonna"},{"speaker":"Steve Gompertz","startTime":2574.66,"endTime":2579.07,"body":"come along with it. So that"},{"speaker":"Steve Gompertz","startTime":2579.07,"endTime":2582.4,"body":"being able to see from a systems"},{"speaker":"Steve Gompertz","startTime":2579.07,"endTime":2582.4,"body":"perspective, and then you're"},{"speaker":"Steve Gompertz","startTime":2582.4,"endTime":2586.48,"body":"always a problem solver. So"},{"speaker":"Steve Gompertz","startTime":2582.4,"endTime":2586.48,"body":"excellent problem solving skills"},{"speaker":"Steve Gompertz","startTime":2586.5099999999998,"endTime":2592.93,"body":"is going to be important."},{"speaker":"Steve Gompertz","startTime":2586.5099999999998,"endTime":2592.93,"body":"Because there is no, there's no"},{"speaker":"Steve Gompertz","startTime":2592.93,"endTime":2596.11,"body":"point at which you declare"},{"speaker":"Steve Gompertz","startTime":2592.93,"endTime":2596.11,"body":"success, and then go, we're"},{"speaker":"Steve Gompertz","startTime":2596.11,"endTime":2599.41,"body":"done. We have the perfect"},{"speaker":"Steve Gompertz","startTime":2596.11,"endTime":2599.41,"body":"quality system, some sort of"},{"speaker":"Steve Gompertz","startTime":2599.41,"endTime":2602.11,"body":"condition, some variable is"},{"speaker":"Steve Gompertz","startTime":2599.41,"endTime":2602.11,"body":"going to change tomorrow, and"},{"speaker":"Steve Gompertz","startTime":2602.11,"endTime":2604.96,"body":"some part of your system is"},{"speaker":"Steve Gompertz","startTime":2602.11,"endTime":2604.96,"body":"going to break, rules are going"},{"speaker":"Steve Gompertz","startTime":2604.96,"endTime":2608.44,"body":"to change, the conditions are"},{"speaker":"Steve Gompertz","startTime":2604.96,"endTime":2608.44,"body":"going to change or whatever. And"},{"speaker":"Steve Gompertz","startTime":2608.44,"endTime":2612.64,"body":"then with problem solving, the"},{"speaker":"Steve Gompertz","startTime":2608.44,"endTime":2612.64,"body":"most critical aspect of problem"},{"speaker":"Steve Gompertz","startTime":2612.64,"endTime":2616.87,"body":"solving is root cause thinking."},{"speaker":"Steve Gompertz","startTime":2612.64,"endTime":2616.87,"body":"And if you don't actually get to"},{"speaker":"Steve Gompertz","startTime":2616.87,"endTime":2621.04,"body":"the correct root, cause your"},{"speaker":"Steve Gompertz","startTime":2616.87,"endTime":2621.04,"body":"solutions will never actually"},{"speaker":"Steve Gompertz","startTime":2621.04,"endTime":2624.25,"body":"solve the problem. And that's"},{"speaker":"Steve Gompertz","startTime":2621.04,"endTime":2624.25,"body":"the hardest one. And that"},{"speaker":"Steve Gompertz","startTime":2624.25,"endTime":2627.82,"body":"actually, that comes back to did"},{"speaker":"Steve Gompertz","startTime":2624.25,"endTime":2627.82,"body":"you even define the problem"},{"speaker":"Steve Gompertz","startTime":2627.82,"endTime":2630.34,"body":"correctly? Right, so those are"},{"speaker":"Steve Gompertz","startTime":2627.82,"endTime":2630.34,"body":"the kinds of skills can we get"},{"speaker":"Steve Gompertz","startTime":2630.34,"endTime":2634.15,"body":"past? Can we get past the"},{"speaker":"Steve Gompertz","startTime":2630.34,"endTime":2634.15,"body":"symptoms, and what I call the"},{"speaker":"Steve Gompertz","startTime":2634.15,"endTime":2638.41,"body":"apparent causes, and see the"},{"speaker":"Steve Gompertz","startTime":2634.15,"endTime":2638.41,"body":"system and figure out where the"},{"speaker":"Steve Gompertz","startTime":2638.41,"endTime":2641.56,"body":"root cause actually was? Because"},{"speaker":"Steve Gompertz","startTime":2638.41,"endTime":2641.56,"body":"the root cause is almost never"},{"speaker":"Steve Gompertz","startTime":2641.59,"endTime":2643.0299999999997,"body":"where you observe the Pro."},{"speaker":"Aaron Moncur","startTime":2644.38,"endTime":2647.71,"body":"Interesting,"},{"speaker":"Aaron Moncur","startTime":2644.38,"endTime":2647.71,"body":"that's great. All right. I think"},{"speaker":"Aaron Moncur","startTime":2647.71,"endTime":2650.38,"body":"just maybe one more question"},{"speaker":"Aaron Moncur","startTime":2647.71,"endTime":2650.38,"body":"here. And then we'll wrap things"},{"speaker":"Aaron Moncur","startTime":2650.41,"endTime":2654.7599999999998,"body":"up. This is one I've been asking"},{"speaker":"Aaron Moncur","startTime":2650.41,"endTime":2654.7599999999998,"body":"most of our guests recently."},{"speaker":"Aaron Moncur","startTime":2655.2999999999997,"endTime":2658.54,"body":"It's something that I'm very"},{"speaker":"Aaron Moncur","startTime":2655.2999999999997,"endTime":2658.54,"body":"interested in what what is one"},{"speaker":"Aaron Moncur","startTime":2658.54,"endTime":2661.21,"body":"thing that you've done to"},{"speaker":"Aaron Moncur","startTime":2658.54,"endTime":2661.21,"body":"accelerate the speed of"},{"speaker":"Aaron Moncur","startTime":2661.21,"endTime":2664.48,"body":"engineering? And most folks,"},{"speaker":"Aaron Moncur","startTime":2661.21,"endTime":2664.48,"body":"when I asked this question,"},{"speaker":"Aaron Moncur","startTime":2664.5099999999998,"endTime":2667.7799999999997,"body":"there's they're answering for"},{"speaker":"Aaron Moncur","startTime":2664.5099999999998,"endTime":2667.7799999999997,"body":"from maybe more of a kind of"},{"speaker":"Aaron Moncur","startTime":2667.7799999999997,"endTime":2674.23,"body":"broader, more more general"},{"speaker":"Aaron Moncur","startTime":2667.7799999999997,"endTime":2674.23,"body":"context. But you and your"},{"speaker":"Aaron Moncur","startTime":2674.44,"endTime":2678.67,"body":"experience that's very specific"},{"speaker":"Aaron Moncur","startTime":2674.44,"endTime":2678.67,"body":"in the quality control world, I"},{"speaker":"Aaron Moncur","startTime":2678.67,"endTime":2682.21,"body":"imagine, you might have some"},{"speaker":"Aaron Moncur","startTime":2678.67,"endTime":2682.21,"body":"answers that are, you know, very"},{"speaker":"Aaron Moncur","startTime":2682.21,"endTime":2685.84,"body":"specific to to quality, and"},{"speaker":"Aaron Moncur","startTime":2682.21,"endTime":2685.84,"body":"regulatory, and how those things"},{"speaker":"Aaron Moncur","startTime":2685.96,"endTime":2688.7799999999997,"body":"actually speed up the"},{"speaker":"Aaron Moncur","startTime":2685.96,"endTime":2688.7799999999997,"body":"engineering process. You talked"},{"speaker":"Aaron Moncur","startTime":2688.7799999999997,"endTime":2691.84,"body":"about how quality is free? Well,"},{"speaker":"Aaron Moncur","startTime":2688.7799999999997,"endTime":2691.84,"body":"that's that's probably because"},{"speaker":"Aaron Moncur","startTime":2691.84,"endTime":2696.7599999999998,"body":"it allows you to move faster, in"},{"speaker":"Aaron Moncur","startTime":2691.84,"endTime":2696.7599999999998,"body":"some sense. But don't let don't"},{"speaker":"Aaron Moncur","startTime":2696.7599999999998,"endTime":2699.43,"body":"let my comments influence you"},{"speaker":"Aaron Moncur","startTime":2696.7599999999998,"endTime":2699.43,"body":"what, what's one thing that"},{"speaker":"Aaron Moncur","startTime":2699.43,"endTime":2701.59,"body":"you've done to accelerate the"},{"speaker":"Aaron Moncur","startTime":2699.43,"endTime":2701.59,"body":"speed of engineering,"},{"speaker":"Steve Gompertz","startTime":2702.7,"endTime":2705.46,"body":"I would actually"},{"speaker":"Steve Gompertz","startTime":2702.7,"endTime":2705.46,"body":"go further back in my career to"},{"speaker":"Steve Gompertz","startTime":2706.6,"endTime":2709.54,"body":"when I was transitioning into"},{"speaker":"Steve Gompertz","startTime":2706.6,"endTime":2709.54,"body":"the medical device industry, and"},{"speaker":"Steve Gompertz","startTime":2709.54,"endTime":2713.71,"body":"I was still doing engineering"},{"speaker":"Steve Gompertz","startTime":2709.54,"endTime":2713.71,"body":"automation tools. But now"},{"speaker":"Steve Gompertz","startTime":2713.74,"endTime":2718.81,"body":"turning that more into project"},{"speaker":"Steve Gompertz","startTime":2713.74,"endTime":2718.81,"body":"management techniques. And these"},{"speaker":"Steve Gompertz","startTime":2718.81,"endTime":2721.9,"body":"were the early days of what we"},{"speaker":"Steve Gompertz","startTime":2718.81,"endTime":2721.9,"body":"call then concurrent"},{"speaker":"Steve Gompertz","startTime":2721.9,"endTime":2725.83,"body":"engineering. Right now, we"},{"speaker":"Steve Gompertz","startTime":2721.9,"endTime":2725.83,"body":"always have multifunction teams,"},{"speaker":"Steve Gompertz","startTime":2725.83,"endTime":2729.58,"body":"right cross cross functional"},{"speaker":"Steve Gompertz","startTime":2725.83,"endTime":2729.58,"body":"development teams, back in the"},{"speaker":"Steve Gompertz","startTime":2729.61,"endTime":2734.59,"body":"in the 90s. That was a new idea."},{"speaker":"Steve Gompertz","startTime":2729.61,"endTime":2734.59,"body":"And it was not obvious that"},{"speaker":"Steve Gompertz","startTime":2734.59,"endTime":2738.64,"body":"there was a good thing to do, it"},{"speaker":"Steve Gompertz","startTime":2734.59,"endTime":2738.64,"body":"was complex. This idea of like"},{"speaker":"Steve Gompertz","startTime":2738.64,"endTime":2741.16,"body":"getting away from the throat"},{"speaker":"Steve Gompertz","startTime":2738.64,"endTime":2741.16,"body":"over the wall engineering keeps"},{"speaker":"Steve Gompertz","startTime":2741.16,"endTime":2743.2,"body":"engineering until they feel like"},{"speaker":"Steve Gompertz","startTime":2741.16,"endTime":2743.2,"body":"they're done. And then they'll"},{"speaker":"Steve Gompertz","startTime":2743.2,"endTime":2745.84,"body":"throw it to manufacturing and"},{"speaker":"Steve Gompertz","startTime":2743.2,"endTime":2745.84,"body":"operations and get things done."},{"speaker":"Steve Gompertz","startTime":2746.62,"endTime":2748.75,"body":"Why would you want to involve"},{"speaker":"Steve Gompertz","startTime":2746.62,"endTime":2748.75,"body":"them upfront, we're just gonna"},{"speaker":"Steve Gompertz","startTime":2748.75,"endTime":2750.5499999999997,"body":"waste their time because we"},{"speaker":"Steve Gompertz","startTime":2748.75,"endTime":2750.5499999999997,"body":"don't know what this thing is"},{"speaker":"Steve Gompertz","startTime":2750.5499999999997,"endTime":2753.61,"body":"yet and what its gonna look"},{"speaker":"Steve Gompertz","startTime":2750.5499999999997,"endTime":2753.61,"body":"like, now we know better, right?"},{"speaker":"Steve Gompertz","startTime":2753.64,"endTime":2756.19,"body":"And so that right, because"},{"speaker":"Steve Gompertz","startTime":2753.64,"endTime":2756.19,"body":"they're going to learn and"},{"speaker":"Steve Gompertz","startTime":2756.19,"endTime":2758.0499999999997,"body":"they're going to help you come"},{"speaker":"Steve Gompertz","startTime":2756.19,"endTime":2758.0499999999997,"body":"up with a good design that's"},{"speaker":"Steve Gompertz","startTime":2758.0499999999997,"endTime":2761.62,"body":"actually manufacturable,"},{"speaker":"Steve Gompertz","startTime":2758.0499999999997,"endTime":2761.62,"body":"serviceable, you know, whatever"},{"speaker":"Steve Gompertz","startTime":2761.62,"endTime":2765.73,"body":"the downstream needs are going"},{"speaker":"Steve Gompertz","startTime":2761.62,"endTime":2765.73,"body":"to be. And it will accelerate."},{"speaker":"Steve Gompertz","startTime":2766.0,"endTime":2769.0299999999997,"body":"But at the time, this was pretty"},{"speaker":"Steve Gompertz","startTime":2766.0,"endTime":2769.0299999999997,"body":"controversial where I was trying"},{"speaker":"Steve Gompertz","startTime":2769.0299999999997,"endTime":2773.35,"body":"to push for this idea of, we"},{"speaker":"Steve Gompertz","startTime":2769.0299999999997,"endTime":2773.35,"body":"need to engage these downstream"},{"speaker":"Steve Gompertz","startTime":2774.13,"endTime":2778.69,"body":"functions early in the process."},{"speaker":"Steve Gompertz","startTime":2774.13,"endTime":2778.69,"body":"It was it was a tough sell"},{"speaker":"Steve Gompertz","startTime":2778.69,"endTime":2781.42,"body":"project managers. This kind of"},{"speaker":"Steve Gompertz","startTime":2778.69,"endTime":2781.42,"body":"blew their mind because it meant"},{"speaker":"Steve Gompertz","startTime":2781.42,"endTime":2784.39,"body":"that there was going to be work"},{"speaker":"Steve Gompertz","startTime":2781.42,"endTime":2784.39,"body":"that they would throw away. It"},{"speaker":"Steve Gompertz","startTime":2784.39,"endTime":2787.9,"body":"was going to be more iterative."},{"speaker":"Steve Gompertz","startTime":2784.39,"endTime":2787.9,"body":"Right. And so a lot of project"},{"speaker":"Steve Gompertz","startTime":2787.9,"endTime":2791.2599999999998,"body":"managers just balked at it, it"},{"speaker":"Steve Gompertz","startTime":2787.9,"endTime":2791.2599999999998,"body":"sounded kind of risky, because"},{"speaker":"Steve Gompertz","startTime":2791.2599999999998,"endTime":2794.5299999999997,"body":"it wasn't very linear. And how"},{"speaker":"Steve Gompertz","startTime":2791.2599999999998,"endTime":2794.5299999999997,"body":"am I going to manage my budgets"},{"speaker":"Steve Gompertz","startTime":2794.5299999999997,"endTime":2797.0499999999997,"body":"and so trying to convince a VP"},{"speaker":"Steve Gompertz","startTime":2794.5299999999997,"endTime":2797.0499999999997,"body":"of development that they should"},{"speaker":"Steve Gompertz","startTime":2797.0499999999997,"endTime":2800.86,"body":"put their career on the line for"},{"speaker":"Steve Gompertz","startTime":2797.0499999999997,"endTime":2800.86,"body":"this new idea was difficult. I"},{"speaker":"Steve Gompertz","startTime":2800.86,"endTime":2805.63,"body":"eventually found a guy, the"},{"speaker":"Steve Gompertz","startTime":2800.86,"endTime":2805.63,"body":"product development director,"},{"speaker":"Steve Gompertz","startTime":2806.38,"endTime":2809.95,"body":"who had a small project, that"},{"speaker":"Steve Gompertz","startTime":2806.38,"endTime":2809.95,"body":"wasn't really considered"},{"speaker":"Steve Gompertz","startTime":2809.95,"endTime":2813.31,"body":"business critical. And he was"},{"speaker":"Steve Gompertz","startTime":2809.95,"endTime":2813.31,"body":"kind of given carte blanche to"},{"speaker":"Steve Gompertz","startTime":2813.31,"endTime":2818.2,"body":"figure out we do. And, you know,"},{"speaker":"Steve Gompertz","startTime":2813.31,"endTime":2818.2,"body":"this was pacemakers, if a"},{"speaker":"Steve Gompertz","startTime":2818.2,"endTime":2822.13,"body":"typical pacemaker budget at a"},{"speaker":"Steve Gompertz","startTime":2818.2,"endTime":2822.13,"body":"time probably would have been on"},{"speaker":"Steve Gompertz","startTime":2822.13,"endTime":2826.69,"body":"the order of three to $4"},{"speaker":"Steve Gompertz","startTime":2822.13,"endTime":2826.69,"body":"million, over about a three year"},{"speaker":"Steve Gompertz","startTime":2826.7799999999997,"endTime":2830.92,"body":"period. And he was developed, he"},{"speaker":"Steve Gompertz","startTime":2826.7799999999997,"endTime":2830.92,"body":"was supposed to be developing a"},{"speaker":"Steve Gompertz","startTime":2830.92,"endTime":2835.36,"body":"simpler, cheaper pacemaker to go"},{"speaker":"Steve Gompertz","startTime":2830.92,"endTime":2835.36,"body":"into underdeveloped countries"},{"speaker":"Steve Gompertz","startTime":2835.39,"endTime":2837.88,"body":"where they don't have health"},{"speaker":"Steve Gompertz","startTime":2835.39,"endTime":2837.88,"body":"care coverage and insurance,"},{"speaker":"Steve Gompertz","startTime":2837.88,"endTime":2841.27,"body":"right? So how do you how do you"},{"speaker":"Steve Gompertz","startTime":2837.88,"endTime":2841.27,"body":"deliver a pacemaker that's the"},{"speaker":"Steve Gompertz","startTime":2841.27,"endTime":2845.2599999999998,"body":"same cost as a refrigerator, so"},{"speaker":"Steve Gompertz","startTime":2841.27,"endTime":2845.2599999999998,"body":"that the family can decide? Do"},{"speaker":"Steve Gompertz","startTime":2845.2599999999998,"endTime":2847.72,"body":"we get a new refrigerator or you"},{"speaker":"Steve Gompertz","startTime":2845.2599999999998,"endTime":2847.72,"body":"buy grandpa off pacemaker,"},{"speaker":"Steve Gompertz","startTime":2847.81,"endTime":2852.82,"body":"right? And so he had about a"},{"speaker":"Steve Gompertz","startTime":2847.81,"endTime":2852.82,"body":"million dollar budget, and a"},{"speaker":"Steve Gompertz","startTime":2852.82,"endTime":2856.9,"body":"year and a half to figure this"},{"speaker":"Steve Gompertz","startTime":2852.82,"endTime":2856.9,"body":"thing out. And he had heard"},{"speaker":"Steve Gompertz","startTime":2856.9,"endTime":2859.63,"body":"about some of my ideas, and I"},{"speaker":"Steve Gompertz","startTime":2856.9,"endTime":2859.63,"body":"was demonstrating them with some"},{"speaker":"Steve Gompertz","startTime":2859.63,"endTime":2863.08,"body":"of my IT projects of getting"},{"speaker":"Steve Gompertz","startTime":2859.63,"endTime":2863.08,"body":"multiple functions involved. And"},{"speaker":"Steve Gompertz","startTime":2863.08,"endTime":2865.84,"body":"he said, Yeah, I think I get"},{"speaker":"Steve Gompertz","startTime":2863.08,"endTime":2865.84,"body":"this, I'd like to try it on this"},{"speaker":"Steve Gompertz","startTime":2865.84,"endTime":2869.0499999999997,"body":"project. Can you help guide me"},{"speaker":"Steve Gompertz","startTime":2865.84,"endTime":2869.0499999999997,"body":"through it? And so he was very"},{"speaker":"Steve Gompertz","startTime":2869.0499999999997,"endTime":2872.47,"body":"open to taking the risks. And we"},{"speaker":"Steve Gompertz","startTime":2869.0499999999997,"endTime":2872.47,"body":"talked about, you know, here's"},{"speaker":"Steve Gompertz","startTime":2872.47,"endTime":2874.5099999999998,"body":"what the team needs to look"},{"speaker":"Steve Gompertz","startTime":2872.47,"endTime":2874.5099999999998,"body":"like, right up front. And we're"},{"speaker":"Steve Gompertz","startTime":2874.5099999999998,"endTime":2876.43,"body":"going to need to bring these"},{"speaker":"Steve Gompertz","startTime":2874.5099999999998,"endTime":2876.43,"body":"people in, and there were people"},{"speaker":"Steve Gompertz","startTime":2876.43,"endTime":2878.92,"body":"on in those downstream"},{"speaker":"Steve Gompertz","startTime":2876.43,"endTime":2878.92,"body":"functions, who are waiting for"},{"speaker":"Steve Gompertz","startTime":2878.92,"endTime":2881.59,"body":"these invitations. Right, they"},{"speaker":"Steve Gompertz","startTime":2878.92,"endTime":2881.59,"body":"were really happy to hear you"},{"speaker":"Steve Gompertz","startTime":2881.59,"endTime":2884.5299999999997,"body":"finally gonna let us talk"},{"speaker":"Steve Gompertz","startTime":2881.59,"endTime":2884.5299999999997,"body":"upfront. Great. I want to be on"},{"speaker":"Steve Gompertz","startTime":2884.5299999999997,"endTime":2888.58,"body":"that team. So we did that we ran"},{"speaker":"Steve Gompertz","startTime":2884.5299999999997,"endTime":2888.58,"body":"it from everybody's in the pool"},{"speaker":"Steve Gompertz","startTime":2888.58,"endTime":2890.59,"body":"at the same time, right? From"},{"speaker":"Steve Gompertz","startTime":2888.58,"endTime":2890.59,"body":"the start, we're going to"},{"speaker":"Steve Gompertz","startTime":2890.59,"endTime":2893.56,"body":"iterate Yep. You know, that"},{"speaker":"Steve Gompertz","startTime":2890.59,"endTime":2893.56,"body":"didn't go the right direction,"},{"speaker":"Steve Gompertz","startTime":2893.56,"endTime":2896.0499999999997,"body":"we're going to take a step back,"},{"speaker":"Steve Gompertz","startTime":2893.56,"endTime":2896.0499999999997,"body":"oh, my gosh, the Gantt chart"},{"speaker":"Steve Gompertz","startTime":2896.0499999999997,"endTime":2899.59,"body":"went the wrong direction. And"},{"speaker":"Steve Gompertz","startTime":2896.0499999999997,"endTime":2899.59,"body":"then we're gonna go forward"},{"speaker":"Steve Gompertz","startTime":2899.59,"endTime":2902.11,"body":"again, and back again, authority"},{"speaker":"Steve Gompertz","startTime":2899.59,"endTime":2902.11,"body":"and right, and that kind of"},{"speaker":"Steve Gompertz","startTime":2902.11,"endTime":2906.4,"body":"thing. And it sounds like that"},{"speaker":"Steve Gompertz","startTime":2902.11,"endTime":2906.4,"body":"will be really wasteful. At the"},{"speaker":"Steve Gompertz","startTime":2906.4,"endTime":2911.77,"body":"end of the day, the project took"},{"speaker":"Steve Gompertz","startTime":2906.4,"endTime":2911.77,"body":"nine months, did successfully"},{"speaker":"Steve Gompertz","startTime":2911.77,"endTime":2916.93,"body":"produce a device? And I don't"},{"speaker":"Steve Gompertz","startTime":2911.77,"endTime":2916.93,"body":"think you use more than 600,000"},{"speaker":"Steve Gompertz","startTime":2916.93,"endTime":2917.47,"body":"of that budget."},{"speaker":"Aaron Moncur","startTime":2917.46,"endTime":2919.95,"body":"Wow, really? Huge"},{"speaker":"Aaron Moncur","startTime":2917.46,"endTime":2919.95,"body":"saving."},{"speaker":"Steve Gompertz","startTime":2919.95,"endTime":2921.06,"body":"I got people's"},{"speaker":"Steve Gompertz","startTime":2919.95,"endTime":2921.06,"body":"attention."},{"speaker":"Aaron Moncur","startTime":2921.19,"endTime":2924.07,"body":"Yeah. Do you think"},{"speaker":"Aaron Moncur","startTime":2921.19,"endTime":2924.07,"body":"that there was something it was"},{"speaker":"Aaron Moncur","startTime":2924.07,"endTime":2927.64,"body":"a fluke? Was it something"},{"speaker":"Aaron Moncur","startTime":2924.07,"endTime":2927.64,"body":"specific about those people or"},{"speaker":"Aaron Moncur","startTime":2927.64,"endTime":2932.38,"body":"that project? Or in your, you"},{"speaker":"Aaron Moncur","startTime":2927.64,"endTime":2932.38,"body":"know, in your best judgment? Is"},{"speaker":"Aaron Moncur","startTime":2932.38,"endTime":2934.66,"body":"that widely applicable?"},{"speaker":"Steve Gompertz","startTime":2935.2599999999998,"endTime":2936.79,"body":"No, I don't"},{"speaker":"Steve Gompertz","startTime":2935.2599999999998,"endTime":2936.79,"body":"think so. It certainly wasn't"},{"speaker":"Steve Gompertz","startTime":2936.79,"endTime":2939.43,"body":"luck, or fluke, I think it was"},{"speaker":"Steve Gompertz","startTime":2936.79,"endTime":2939.43,"body":"just, it's just natural, you"},{"speaker":"Steve Gompertz","startTime":2939.43,"endTime":2942.37,"body":"start to bring in this cross"},{"speaker":"Steve Gompertz","startTime":2939.43,"endTime":2942.37,"body":"functional team and these other"},{"speaker":"Steve Gompertz","startTime":2942.37,"endTime":2945.52,"body":"areas of expertise. And the"},{"speaker":"Steve Gompertz","startTime":2942.37,"endTime":2945.52,"body":"decisions just get better,"},{"speaker":"Steve Gompertz","startTime":2945.52,"endTime":2949.5099999999998,"body":"because you're not narrowing"},{"speaker":"Steve Gompertz","startTime":2945.52,"endTime":2949.5099999999998,"body":"your review. Right. Yeah, yeah."},{"speaker":"Steve Gompertz","startTime":2949.5099999999998,"endTime":2951.79,"body":"And so I think that's what they"},{"speaker":"Steve Gompertz","startTime":2949.5099999999998,"endTime":2951.79,"body":"figured out. And that's why it's"},{"speaker":"Steve Gompertz","startTime":2951.79,"endTime":2955.45,"body":"suddenly got really the norm."},{"speaker":"Steve Gompertz","startTime":2951.79,"endTime":2955.45,"body":"Because they've had, you know,"},{"speaker":"Steve Gompertz","startTime":2955.48,"endTime":2957.52,"body":"this isn't particularly"},{"speaker":"Steve Gompertz","startTime":2955.48,"endTime":2957.52,"body":"difficult to implement, isn't"},{"speaker":"Steve Gompertz","startTime":2957.97,"endTime":2960.61,"body":"it? No, no, it's gonna be harder"},{"speaker":"Steve Gompertz","startTime":2957.97,"endTime":2960.61,"body":"to manage your project managers"},{"speaker":"Steve Gompertz","startTime":2960.61,"endTime":2962.7999999999997,"body":"have to get more comfortable"},{"speaker":"Steve Gompertz","startTime":2960.61,"endTime":2962.7999999999997,"body":"with a little uncertainty in"},{"speaker":"Steve Gompertz","startTime":2962.7999999999997,"endTime":2966.52,"body":"there. And management has to be"},{"speaker":"Steve Gompertz","startTime":2962.7999999999997,"endTime":2966.52,"body":"forgiving of those iterations."},{"speaker":"Steve Gompertz","startTime":2966.7599999999998,"endTime":2968.95,"body":"But understand, we're gonna hit"},{"speaker":"Steve Gompertz","startTime":2966.7599999999998,"endTime":2968.95,"body":"the finish line earlier,"},{"speaker":"Steve Gompertz","startTime":2969.25,"endTime":2973.36,"body":"upfront, it may look a lot more"},{"speaker":"Steve Gompertz","startTime":2969.25,"endTime":2973.36,"body":"chaotic. And you know, there's"},{"speaker":"Steve Gompertz","startTime":2973.36,"endTime":2976.06,"body":"so much iteration going on, and"},{"speaker":"Steve Gompertz","startTime":2973.36,"endTime":2976.06,"body":"it looks like it's taking too"},{"speaker":"Steve Gompertz","startTime":2976.06,"endTime":2978.82,"body":"long. But all of a sudden, it's"},{"speaker":"Steve Gompertz","startTime":2976.06,"endTime":2978.82,"body":"gonna get more and more"},{"speaker":"Steve Gompertz","startTime":2978.82,"endTime":2981.2799999999997,"body":"efficient as it goes, and you're"},{"speaker":"Steve Gompertz","startTime":2978.82,"endTime":2981.2799999999997,"body":"gonna get that a lot earlier."},{"speaker":"Steve Gompertz","startTime":2981.46,"endTime":2983.92,"body":"And now that's just how right"},{"speaker":"Steve Gompertz","startTime":2981.46,"endTime":2983.92,"body":"now development is done."},{"speaker":"Aaron Moncur","startTime":2984.2799999999997,"endTime":2987.7599999999998,"body":"Yeah. Yeah."},{"speaker":"Aaron Moncur","startTime":2984.2799999999997,"endTime":2987.7599999999998,"body":"Wonderful. All right. Well,"},{"speaker":"Aaron Moncur","startTime":2987.7599999999998,"endTime":2991.21,"body":"Steve, thank you so much for"},{"speaker":"Aaron Moncur","startTime":2987.7599999999998,"endTime":2991.21,"body":"joining us today and sharing so"},{"speaker":"Aaron Moncur","startTime":2991.21,"endTime":2994.15,"body":"much of your experience and"},{"speaker":"Aaron Moncur","startTime":2991.21,"endTime":2994.15,"body":"wisdom with all of the"},{"speaker":"Aaron Moncur","startTime":2994.15,"endTime":2996.4,"body":"listeners, how can people get in"},{"speaker":"Aaron Moncur","startTime":2994.15,"endTime":2996.4,"body":"touch with you?"},{"speaker":"Steve Gompertz","startTime":2998.17,"endTime":3000.36,"body":"The best way is"},{"speaker":"Steve Gompertz","startTime":2998.17,"endTime":3000.36,"body":"through LinkedIn, either just"},{"speaker":"Steve Gompertz","startTime":3000.36,"endTime":3004.11,"body":"through my name, or through my"},{"speaker":"Steve Gompertz","startTime":3000.36,"endTime":3004.11,"body":"company, QRx partners, or"},{"speaker":"Steve Gompertz","startTime":3004.11,"endTime":3007.65,"body":"there's our website"},{"speaker":"Steve Gompertz","startTime":3004.11,"endTime":3007.65,"body":"QRxpartners.com. That pretty"},{"speaker":"Steve Gompertz","startTime":3007.65,"endTime":3010.89,"body":"simple. But LinkedIn is usually"},{"speaker":"Steve Gompertz","startTime":3007.65,"endTime":3010.89,"body":"our best approach. We like to"},{"speaker":"Steve Gompertz","startTime":3010.89,"endTime":3014.67,"body":"encourage people to follow us."},{"speaker":"Steve Gompertz","startTime":3010.89,"endTime":3014.67,"body":"We do a lot of posting of really"},{"speaker":"Steve Gompertz","startTime":3014.67,"endTime":3019.35,"body":"good, interesting information"},{"speaker":"Steve Gompertz","startTime":3014.67,"endTime":3019.35,"body":"every day. Tuesdays is, I think,"},{"speaker":"Steve Gompertz","startTime":3019.35,"endTime":3021.93,"body":"is the comedy days, we put a"},{"speaker":"Steve Gompertz","startTime":3019.35,"endTime":3021.93,"body":"little funny stuff out there."},{"speaker":"Steve Gompertz","startTime":3022.2,"endTime":3024.7799999999997,"body":"But the other days of the week,"},{"speaker":"Steve Gompertz","startTime":3022.2,"endTime":3024.7799999999997,"body":"it's it's useful technical"},{"speaker":"Steve Gompertz","startTime":3024.7799999999997,"endTime":3029.34,"body":"information. Like today was the"},{"speaker":"Steve Gompertz","startTime":3024.7799999999997,"endTime":3029.34,"body":"day we do our warning letter"},{"speaker":"Steve Gompertz","startTime":3029.37,"endTime":3032.4,"body":"review, where we take a look at"},{"speaker":"Steve Gompertz","startTime":3029.37,"endTime":3032.4,"body":"FDA warning letters and explain"},{"speaker":"Steve Gompertz","startTime":3032.4,"endTime":3033.42,"body":"how not to get there."},{"speaker":"Aaron Moncur","startTime":3033.81,"endTime":3036.87,"body":"Mm hmm. That"},{"speaker":"Aaron Moncur","startTime":3033.81,"endTime":3036.87,"body":"sounds tremendously valuable."},{"speaker":"Aaron Moncur","startTime":3037.08,"endTime":3040.56,"body":"Great. Well, Steve, thank you"},{"speaker":"Aaron Moncur","startTime":3037.08,"endTime":3040.56,"body":"again, so much for for being on"},{"speaker":"Aaron Moncur","startTime":3040.56,"endTime":3041.19,"body":"the show today."},{"speaker":"Steve Gompertz","startTime":3041.5499999999997,"endTime":3042.99,"body":"Yeah, thanks for"},{"speaker":"Steve Gompertz","startTime":3041.5499999999997,"endTime":3042.99,"body":"having me. I appreciate the"},{"speaker":"Aaron Moncur","startTime":3042.56,"endTime":3045.59,"body":"I'm Aaron Moncur,"},{"speaker":"Aaron Moncur","startTime":3042.56,"endTime":3045.59,"body":"founder of pipeline design, and"},{"speaker":"Aaron Moncur","startTime":3042.99,"endTime":3043.5299999999997,"body":"opportunity."},{"speaker":"Aaron Moncur","startTime":3045.59,"endTime":3047.6,"body":"engineering. If you liked what"},{"speaker":"Aaron Moncur","startTime":3045.59,"endTime":3047.6,"body":"you heard today, please share"},{"speaker":"Aaron Moncur","startTime":3047.6,"endTime":3055.04,"body":"the episode. To learn how your"},{"speaker":"Aaron Moncur","startTime":3047.6,"endTime":3055.04,"body":"team can leverage our team's"},{"speaker":"Aaron Moncur","startTime":3055.07,"endTime":3058.58,"body":"expertise developing advanced"},{"speaker":"Aaron Moncur","startTime":3055.07,"endTime":3058.58,"body":"manufacturing processes,"},{"speaker":"Aaron Moncur","startTime":3058.7,"endTime":3062.39,"body":"automated machines and custom"},{"speaker":"Aaron Moncur","startTime":3058.7,"endTime":3062.39,"body":"fixtures complemented with"},{"speaker":"Aaron Moncur","startTime":3062.39,"endTime":3068.7799999999997,"body":"product design and r\u0026d services."},{"speaker":"Aaron Moncur","startTime":3062.39,"endTime":3068.7799999999997,"body":"Visit us at Team pipeline.us. To"},{"speaker":"Aaron Moncur","startTime":3068.7799999999997,"endTime":3073.19,"body":"join a vibrant community of"},{"speaker":"Aaron Moncur","startTime":3068.7799999999997,"endTime":3073.19,"body":"engineers online, visit the wave"},{"speaker":"Aaron Moncur","startTime":3073.37,"endTime":3075.65,"body":"dot engineer. Thank you for"},{"speaker":"Aaron Moncur","startTime":3073.37,"endTime":3075.65,"body":"listening"}]}