Improving Patient Safety at The Point of Care with Joan Melendez of Xcelrate UDI

Did you know about $6 billion is spent each year in medical device recall management?

Having a product recall is probably a medical device companies, worst nightmare, but once something gets recalled, the communication between the FDA and manufacturers and healthcare facilities, all involved in the workflow of that product ,often break down or are slow to respond. This results in patients becoming highly at risk. 

To solve this, Joan created Xcelrate UDI with a goal to improve patient safety at the point of care, by leveraging the power of the unique device identification system for medical devices and biological tissues. 

Xcelrate UDI uses innovative barcode scanning technology to capture the data required by the FDA and digitally document. The patient health record with precision and accuracy.
Joan has over 25 years building and optimizing healthcare applications specializing in perioperative, anesthesia, and trauma workflows.

She shares some great insights with us today by starting a couple of, with a big mission. And it was an 800% increase in recalls in recent years, a byproduct of companies increasingly moving faster in this space over time, there has never been a more important time than now to focus on quality and alerting and patient safety.

Show notes:

• https://www.xcelrateudi.com/
• https://www.linkedin.com/company/xcelrate-udi/

Music by keldez

Qualio website:
https://www.qualio.com/

Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast

Apply to be on the show:
https://forms.gle/uUH2YtCFxJHrVGeL8

Music by keldez

Transcript

Robert Fenton: 0:21

Hi, everyone. I'm delighted to have you join us for today's conversation with John Melendez, CEO of Xcelrate UDI. Did you know about$6 billion is spent each year in medical device recall management? Having a product recall is probably a medical device companies, worst nightmare, but once something gets recalled, the communication between the FDA and manufacturers and healthcare facilities, all involved in the workflow of that product,often break down or are slow to respond. This results in patients becoming highly at risk. To solve this, Joan created Xcelrate UDI with a goal to improve patient safety at the point of care, by leveraging the power of the unique device identification system for medical devices and biological tissues. Xcelrate UDI uses innovative barcode scanning technology to capture the data required by the FDA and digitally document. The patient health record with precision and accuracy. Joan has over 25 years building and optimizing healthcare applications specializing in perioperative, anesthesia, and trauma workflows. She shares some great insights with us today by starting a couple of, with a big mission. And it was an 800% increase in recalls in recent years, a byproduct of companies increasingly moving faster in this space over time, there has never been a more important time than now to focus on quality and alerting and patient safety. I hope you enjoy this one. I'd love to learn, you know, about the work you're doing with Xcelrate and from there, I have a ton of questions about how you got here. You know, lessons learned some challenges, some interesting things that that happened along the path. I think the journey of people who are. You know, start companies, lead companies, grow companies, build companies, and often it looks hard to understand how do you get there? What is it like to do that? So appreciate you sharing some of your story with us today.

Joan Melendéz: 2:22

And of course, my pleasure.

Robert Fenton: 2:24

Maybe to kick off and tell us a bit about Xcelrate and, and, um, your product like Xcelrate UDI.

Joan Melendéz: 2:31

Yeah, well, again, thanks so much for having me on your show. Um, Xcelrate UDI, we're actually a minority and women certified business, which is really exciting. Thanks to Debbie, our assistant. Uh, she did a lot of work on certification, um, and we specialize in safety, patient safety, um, surrounding medical device and biologic usage. And, um, how we do that is we sit on top of any of the electronic health records. Um, and we scan the manufacturer's barcode, um, on the, on the medical device and validate the, you know, whether it's recalled if it's been reported correctly to the FDA. So we do a lot of analytics just with that little scan that actually prevents the use of unsafe items.

Robert Fenton: 3:20

How, how do you solve that problem? How do you get that unified identifier? And for context, maybe kick off with, can you explain to people some of the stats or detail about the defragmentation and as somebody who's worked in drug development, I get it. But for those of you, people who aren't and devices in particular, maybe tell us a bit about the supply chain and its complexity.

Joan Melendéz: 3:42

Yeah. So I'm, I think that people are starting to understand the complexity of medical device management, just because of the vaccine insanity that's happening right now. Right. So really when you're looking at medical device, The supply chain, you know, how do you know when it's shipped? You have your supply chain department who's in charge of that piece. Then you have your operating room, who's in charge of other pieces. So there's really not that communication of the product. People think, well, why isn't it like Walmart? It's just not, we don't the systems haven't been in place. And so, you know, when you get these medical devices in, you know, one of the things that we work with our hospital clients is that we want to make sure that. We get the product in-house that has the longest shelf life. Right? So if it's, if it's manufactured, uh, date is, you know, five years prior to the expiration. We want that five years prior. We don't want something that's expiring within the next couple of weeks. So we make sure that whatever's coming into the hospital facilities. We scan the products to make sure they're not. Recalls are counterfeit. Um, and then at that last moment, right, when we're handing off that surgical device and implantable device and mesh a breast implant, anything like that, we're scanning it at the last opportunity to, again, validate has this just been recalled? You know, so today is a great example of, um, the problem that we have in the industry with, um, manufacturers working with the FDA, thinking they're doing the right thing and notifying the hospitals at the same time. One thing I don't think people realize is, uh, medical devices are voluntarily recalled. Um, yeah. So we can get into that piece later, but so the manufacturer sent out a recall notification to the hospitals you know, that it's sold to, and also notify the FDA at the same time, but the FDA hasn't updated their website yet. So what happens? It introduces that timeframe where that device can be being used on a patient.

Robert Fenton: 5:49

Great. Great explanation of, I believe why the unique identity, a unique device identifier, it can be a mouthful or UDI, which we of course like to call it. It's why it's important. You also mentioned that you're talking about arriving at the facility to health care facility and right before the point of use and you also work directly with the manufacturers. That's correct. So you kind of fall along the full spectrum. How did you do that? I want to get to your journey, the certifications you have, but as somebody, you know, at Qualio, we're a software company and we know our customers and you sound like you have a lot of different stakeholders like to get this product built and design it as one thing. But how did you get everybody? Playing ball along the way. And, but they're in different incentives and that surgery place, they're busy and hospital, they are getting into a different person than you. Manufacturer's completely different as well.

Joan Melendéz: 6:39

Right. It's, it's still, you know, an ongoing challenge and you have some manufacturers who embrace you and you have some manufacturers to be sending you threatening letters, but I personally have not gotten a threatening letter. Thank God. But, um, you know, once you you tell the manufacturers, what you're doing? Ours is all about patient safety. The reason they have notified, um, They're clients of that recall were adverse to the, you know, the buildup of adverse events is because they want it removed. They want to make sure that they don't have products on the market as well. It's like$6 billion recall management for a year,$600 billion just for the management. Yeah. So, you know, and that's why, you know, a lot of money and there's, so you have, you have the supply chain, uh, you have the use. So where are you sending that recall notification? Right. So once we work with both sides, they see the importance because we're giving the manufacturer back real time data. So as soon as they send out announcement, we were able to pull four products today. And so what did we do today? We prevented the use of four items and these, and that one has not been broadcasted. The FDA hasn't released it yet.

Robert Fenton: 7:57

That's Insane.

Joan Melendéz: 7:58

Yeah we get on the horn. And we notify like, ECRI, who's one of our competitors. But when we know of a recalled item, we're going to notify everybody in our industry. We're going to make sure that everybody knows that there is a device that's that's on the market that the manufacturer wants removed. Mm. So, you know, they're, they have a stake in it. And so they're very excited that we're partnering with them.

Robert Fenton: 8:20

6 billion is a big number in an area that a lot of people are unaware of. I will come back to a little bit of the costs of this today and, and getting it wrong and how you help get it right. But I want to talk a bit about you, right? So this is, it's a niche area or a niche area you could see from outside of the industry. What was your path to, to this?

Joan Melendéz: 8:43

You know, I started this path when I was really young. I started working in a medical office when I was 11, so my mom was a nurse. So I was put in charge as, uh, the vaccines in fact. So making sure that we had that follow through yeah. Of everything. So, and it also then went to the administration of, um, making sure that the patients had the the correct info sent to the hospital to make sure that that encounter was safe. I've seen too many patients die because there were medical record information missing between the time that they, you know, like fell and hit, and hurt their hip, which is basically really an elective surgery, but they ended up having surgery and their heart condition is what killed them. So that's how I got involved. So when you're starting to look at, you know, at the prevention from just records, I started seeing these, these recall events just stacking up and the FDA, um, opened up, um, for innovation. You know, everybody knows that term novel. Now we have that novel virus, so they have novel medical devices, right. So you can take a band-aid. And you can say that, Oh, now I'm using it as a, um, as a medical, like a biologic without actually in repair on the bone, but they don't have to go again through, um, the five, 10 K process for approval. They are grandfathered in. So, you know, and that's when you're starting to see these recalls, um, increase, I think it's between 2016 and 2018, there was an 800% increase in recalls. So again, you know, it's all these things that I was seeing even, you know, years ago, um, that there were falling through the cracks. So how could I help. Um, as a, small person, you know, to be a town crier

Robert Fenton: 10:37

800 percent is another big statistic. I'm curious, is that because of better responsiveness or more products or more problems or combination?

Joan Melendéz: 10:52

It's because of innovation. It's because there's, there's really no accountability. In my opinion. I'm sure there are other opinions as well, but that's just statistically what I'm seeing when I'm looking at the data.

Robert Fenton: 11:03

Yeah. I would share just part of our hypothesis of what would we do and why Qualio was important. And I won't talk about it, not as much, but I'll talk about the, the theme that something that we monitor quite a lot is this concept that. You know, speed and velocity and versus Qualio products in, in the modern world. And we're seeing this great of innovation across like software biology. That's really ramped up. It feels like you're opposing forces and in order to move it to velocity. Companies are products of the need to, it's hard to maintain the quality standards. So I think it's, it's no surprise. You start to see more recall activity and it's a very unfortunate tension. I think that gets done. It gets graded. What's your moment when you said that, you know, you know what I can be part of solving this.

Joan Melendéz: 11:54

Yeah. Yeah. When I did an analysis of the current application, um, in 2015, um, for one of my healthcare clients, um, the nurses left, um, the demo of how their workflow would change, um, using their existing EHR. Um, they left the room crying hysterically. And saying that you have to do something for us. So I took that challenge on and created an application that you know, is really a game changer in the industry.

Robert Fenton: 12:25

How did you get started from that moment? I'm curious as to like, I, it doesn't sound like you have a background in technology, you get your product, I guess, use like utilizing some hardware and software. It totally the factory supply chain of itself.

Joan Melendéz: 12:37

Yeah. I actually do have a background in technology as well. Um, I started off, I have my degree in management information systems, so, you know yeah. So I have that medical and IT background. So yeah, it totally helped. And for me, I just had that innate ability to really look at workflows and how can I streamline and optimize a workflow that's being impeded by something.

Robert Fenton: 13:07

Yeah. When did you launch?

Joan Melendéz: 13:10

Uh, we launched back in UPFC and, and Pennsylvania. That was my first client. So I had a big client for the first quarter.

Robert Fenton: 13:18

Yeah, that's a big first client.That's a lot, a lot of pressure. Also. When was that? What year?

Joan Melendéz: 13:26

2015. Yeah.

Robert Fenton: 13:30

Start to four recalls in one day. So far is it's like 11:15 AM here in Pacific time for where we both are. So the, yeah,

Joan Melendéz: 13:39

I know I've been going since five o'clock this morning because I have clients to support on the East coast. So I apologize for that.

Robert Fenton: 13:49

No problem. What were some of the biggest lessons learned along that path?

Joan Melendéz: 13:54

Yeah, there were a lot of lessons learned. Right. Cause you know, we had to figure out, um, you know, when you looked at all of the regulations we're, you know, we're very science-based. Um, so the last four years have been challenging. Cause it, it, it's amazing how it affects your, your psyche when there's so much. Um, negativity about science. So, um, we look at all of the FDA regulations. We make sure that we're, um, following the regulations to the T. So looking at that, making sure that the processes are, are well groomed and then working with the manufacturer was a challenge was how, how, as a woman of one with, with two assistants, you know, how, how can we really do that? So it was a challenge in the beginning, but you know, we, we made it through it. The good thing is I have great friends who are really good sounding boards who helped, um, in, you know, the trajectory of the business.

Robert Fenton: 14:53

Yeah. And along the past, in addition to the launching, you mentioned you focused on science and also thinks that it looks like you focus on quality as a lot of group work. And, you know, you got, you got certified for the EHR technology certification.

Joan Melendéz: 15:07

Right. Right. Exactly. We are the only C H R T certified, uh, technology company by the ONC, uh, the other ones, the big ones, you know, the epics, the Cerners of the world. Uh, they are certified. The certification for us, you know, again, we took it, literally, we went through step one through step five. And if we didn't, if we wouldn't have passed on step one, we wouldn't have gone further where some of the EHR has actually said that they passed all those and they have, and because it's on their roadmap. Yeah. So I feel really good about where we are.

Robert Fenton: 15:43

Congratulations!

Joan Melendéz: 15:44

Thanks. We just, um, you know, because of the problems, uh, that were happening globally with COVID, um, you know, our application again is for medical devices and biologics, right? So vaccine is a biologic. So there are critical steps that you have to take, especially with the Pfizer vaccine, because you have a deal, you aren't that you have to add into it. So you have the temperatures, you have the timings, there are three different timings. If at any part of that time, it can become expired. And you have to toss it and it's, it's no longer valid or valuable, um, product as you, you know, with quality. So we're looking at all those quality steps along the way. Um, so we were able to retool our application so that when you know, like the States, they have no idea how much they ordered. Right. So we could actually just grab the data from the dhurna and Pfizer directly. And within our clearing house, we have all that data of what was purchased, what was used, what was wasted, um, and adverse events. So we're pulling all that data into one source. Are you already working with some of the supply chain around the distribution of the COVID vaccines right now? We're trying to break in. It's it's a hard, you know, we're little. So, um, you know, we came in between, um, Microsoft and Salesforce for the first state. So I feel really good because we were Microsoft. The only reason they chose Microsoft was because, you know, Goliath and that's what they said. You guys could do so much more, but we have to go with. And I'm like, well, at least we came in number two, you

Robert Fenton: 17:25

know what it's, you know, oftentimes the first step one is again on the podium and the steps. Next step, you can kind of finish first. And that, that, that's pretty awesome story. Uh, I'm curious, skim, looking back what you're solving a problem set that. You mentioned a$6 billion a year is, is like, I'll call it a wasted because the goal is to prevent recalls along the way. But of course, when that happened, you want to make sure it says quick and as efficient and as cost-effective as possible to manage and that number, even powered by an ethics, a fold increase in said to me in two years, I'm sure I'm not, no, I'm not sure what it is right now, but is probably bigger.

Joan Melendéz: 18:05

It's much worse. Yeah. Yeah.

Robert Fenton: 18:07

That's a big takeaway I'm taking from this is, this is something that only people who are exposed to this problem set are aware of it, but it's really interesting how big within healthcare in particular, there are so many, like multi-billion dollar opportunities where as a building a product and building a company, you can build a company of meaning, but you can also do something with a really positive net impact. So I think that's takeaway for me, just another data point, supporting that. I'm curious for people who are working across health care in particular, who are kind of end up hitting walls and what they're doing and like this shouldn't be this way. Or I have this fix. I do that. I do with me and my team and my part of a hospital or something, any advice or people kind of have those problems and feel they could solve it, but were unsure about how to get started.

Joan Melendéz: 18:52

Yeah, just reach out to yeah. Reach out. Yeah. I mean, I love it when people contact me and say, Hey, I have this idea when you think, and you know, you have to have mentors, that's the only way you get anywhere in life. Right. So, you know, I'm a big researcher. I, you know, I've reached research, everything there is to know about the vaccines. Um, for example, so, and, and the throughput. So we really know about, about that. Um, That good chain of custody as we call it. Um, so you know, anything even, you know, how, how to, uh, get better acceptance from, you know, some of the more challenged or underserved communities, right? So if you have a great idea of how you can increase that, there's a lot of things you can do with research and, and leaning on people and building better communities, you know?

Robert Fenton: 19:44

Yeah. And we covered some of the downsides of some of the speed right with the increases in recalls. But the positive for that is it does create space and opportunity for people to try new things right and build their products itself. Things that maybe it might not move to bottom line for Pfizer right now, but maybe it's still a really important thing to do. So we see that as part of the, the other side of that scale. So I think that that's excited, um, looking forward, Joan, um, Big year for you. It sounds like recently coming up against some heavyweights and getting close to a few things. I think, I think it sounds like the future is positive, but, uh, if you were to take a step back and kinda look really found four or five, 10 years or whatever timeframe you think about, I mean, where would you, where do you think your company could be in five, 10 years from now?

Joan Melendéz: 20:33

You know, I really think that our company is going to be the clearing house for, uh, adverse events and, uh, recalls. If you look at our, uh, UDI clearing house platform, You know, it really encompasses everything. We have it built so that a manufacturer can go view anything. Any reports back from the hospital, the hospital is, you know, they don't like to share a lot of the information and we're not sharing it across to all manufacturers. So when, you know, a manufacturer comes in, they see the data that their hospitals being used, um, and everything. So I really feel like, you know, we can be, um, Part of that strength, because if you look at the FDA right now, there are 15 plus recall databases across the three divisions that we deal with. So that's a lot of places that people have to go look for a recall event. Um, and they're not in sync. Um, you know, we just, uh, looked, uh, the last update, uh, for the FDA's main source, um, which is where most manufacturers and third-party providers get the information. The last time it was updated was the 10th. So that's 17 days. Yes. Yeah. 17 days of data. Yeah. And we have it since yesterday.

Robert Fenton: 21:56

Yeah. I love how you, um, just described that, that vision for the future. And Joan, I'm really excited for you folks. Um, happier again, that we've got a chance to connect and looking forward to staying in touch along your journey and future. Is there anything else you'd like to share or I think we got some interesting notes to add to the show notes and a couple of interesting links.

Joan Melendéz: 22:15

No I really appreciate the opportunity and you know, everybody please stay safe. We do have a vaccine that is safe. You know, again, it depends on, on the timings. You know, we need to make sure that, uh, you know, people are informed um, from the time that it's taken out of the freezer to when it is actually put in your arm so that you know, that it's safe. We want to hit that 94%. Um, that we're show and, you know, in the trials. And the only reason that it was shown is they followed very strict protocols. So, you know, be safe, be aware, um, and always ask for help.

Robert Fenton: 22:55

Yeah. Joan, thank you very much. Appreciate you joining today. Stay safe and keep in touch. Thank you.

Joan Melendéz: 23:02

Bye bye. Definitely. Thank you.