Lean By Design
Lean by Design delves into the dynamic world of biotech, pharma, and life sciences, focusing on operational excellence through effective workflow and process optimization. Join hosts Oscar Gonzalez and Lawrence Wong as they engage with industry leaders who share their insights, innovative strategies, and real-world experiences in transforming complex challenges into streamlined, efficient solutions. Through thought-provoking conversations, you’ll gain practical tips and inspiration to drive continuous improvement and success in your organization. Produced by Sigma Lab Consulting, Lean by Design empowers you to enhance productivity and innovation, one process at a time. Listen on Spotify, iTunes, Apple Podcasts, or wherever you get your podcasts.
Lean By Design
0208. It’s Not the Science — It’s the System
Why Operational Excellence is Biopharma’s Next Competitive Advantage
In this special cofounder episode of Lean by Design, Oscar Gonzalez and Lawrence Wong pull back the curtain on the ideas behind Oscar’s upcoming book—and the operational realities that inspired it.
The core message? The biggest risks in biopharma often don’t come from the science. They come from fragile systems, tribal knowledge, and disconnected processes that silently slow teams down or bring them to a grinding halt.
With over 30 years of combined experience spanning R&D, clinical ops, and facilities management, Oscar and Lawrence unpack:
- Why innovation collapses without operational infrastructure
- How legacy behaviors and workflow inconsistency compound into massive risk
- What “owning a process” really means—and why most orgs get it wrong
- How early-stage companies fall into the trap of ad hoc systems and band-aid solutions
- Why consistency and connectivity—not heroics—are the foundation for scalable success
Plus, they preview the framework at the heart of Oscar’s forthcoming book: a practical guide for process owners, system stewards, and leaders ready to build resilient operations without boiling the ocean.
If you’ve ever tried to fix a broken workflow while juggling 10 others, or wondered why your cross-functional projects keep stalling—this episode is for you!
Join the book waitlist: https://sigmalabconsulting.fillout.com/t/cjWN43iBNWus
Learn more about us by visiting: https://sigmalabconsulting.com/
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We're back with an episode of Lean by Design podcast. I'm your host, oscar Gonzalez, alongside my co-host, lawrence Wong. Today we have a special topic that we wanted to discuss with folks, and that is that we are continuing to evolve our understanding of what it means to lead with operational excellence, lead with curiosity, innovate in our operations and expose the risk that is within the biopharma space and other complex industries. This has been something that has really moved our business model to where it is today. It's how we started. We initially started really leaning into no pun intended the Lean Six Sigma space to really solve and reconcile these challenges that are just ever so plentiful in the biopharma space, and it led us to a moment in our journey where we needed to write these things down. We needed to codify the things that we're seeing, and how are we using those insights as a consultant to deliver transformative solutions to our clients?
Speaker 1:For the last couple of months, I have been working on a book. This book is really the perspective from the last 15 years of my experience as a wet lab, as a bench lab worker, running a lab manager, going into program management, into the clinical space, becoming an entrepreneur and a consultant. It's really culminating now into this structured book. And I emphasize structure because a lot of times there are things that we see and we can't quite put a finger on why these things are important, how they affect us in the workplace. You know business decisions and even more technical decisions. How are they all connected? Why do some companies flourish and others struggle? And it's not always about the science, it's about how well you can manage the operations as a business, Because at the end of the day, these organizations are businesses. You are developing a product or a service, and so when we understand those and we consider those deeply into how we structure our organization, from the data we're producing to how we're going to govern ourselves, to the language that we use to describe what we do at the organization, and how it's all connected from function to function.
Speaker 1:We know in today's day and age most projects are incredibly complex. They require a number of cross-functional representatives that are very, very technical in their work, and somehow we need to connect that technical work into a strategy that connects the strategy from leadership into action. That's where people struggle, that's where those things are left unclear and sort of have these trickle-down effects. So that's what this book represents and today we're going to talk a little bit about that and that journey. Lawrence has been a part of it and has been an advocate for me to put these things down on paper because it felt so clear in the moment.
Speaker 1:It felt so crystallized but it was all in my head. I had no chart to explain it, I had no figure. I had some white papers and research and things like that that were available, although when you peel back an onion, a lot of that really nasty stuff you don't tend to see written and publicized on the Internet. So it makes it challenging to find out what are people really feeling. And I think when readers from the entry level or new to the industry, to mid-level managers, to leadership, I think they're going to read the book and they're going to look at the examples and look at the case studies and say, yeah, I've experienced a lot of those things and hopefully it will empower folks to go a step further and say I want to change something. So I don't want to go too deep into there because it might just be a monologue and this is intended to be a conversation about that journey.
Speaker 2:So here we are. One of the early things that we had talked about, when you were on the way to thinking about even deciding to go down this road of writing a book, was does something like this already exist and we have spent so long just searching for something that it's a blend of your experience in the industry, but also all the mistakes that you've made. And then we want to sprinkle in some of these lean concepts, but we also want to add some risk management in there.
Speaker 2:But then you want to also discuss you know what the world is today, in 2025, as opposed to some of these other you know, very generic, I would say business management books that don't really give you that insight on some of the things that we've both felt in working in this industry. Right, and so the book is really a piece of art that has combined a lot of these different sources of information and, like you said before, we're still in the process of transforming our business because we've gone down this road of your, you know, developing the book and that's going to be something that everybody's going to be able to witness at the beginning of next year when we roll out some of these products. But, you know, let's go back to talking about the book itself and before we even talk about the idea of the book, what does writing a book mean to you personally, and how were you hesitant at first, Like what was kind of going through your mind when you decided to do this?
Speaker 1:Of course I was hesitant. Are you kidding me? A book is revealing. You are putting your brain, the way you think, how you feel, in a nonfiction book. You are putting it all out there for anyone to essentially discredit, to agree with, to criticize. So there's always this imposter syndrome and that's just a factor of this or that. Well, you know there's a part of it that makes you question yourself because in this sense, things feel very clear to you and that is a factor of all of your experiences where I've seen this game before. I've seen how this plays out. I know that kind of employee, I know that kind of leader, and so when you write those into a book, you start to ask yourself sometimes am I the only one that thinks this way? Am I the only one that recognizes these challenges? Am I the only one that believes that this is the path forward? Sometimes we can't see it and I think a lot of times you'll see that folks are reluctant to take on a task like that. It didn't always start that way.
Speaker 1:There's a lot of high energy going into the type of work that led into creating a book like this. It's such a journey and we're used to doing social media content, little blurbs, either opinion, or we take some data that was brought in and we put our thoughts on it and those things are pockets of knowledge that we're putting into there, and what this book is is an entire framework it's for successful operations in biopharma and other complex industries. What are those real core things that you need to put your finger on and where are those struggles most often happening? So, when it came into writing the book, I'm using book launchers who help you self-publish, founded by Julie Broad, who's fantastic. She has tons of videos on YouTube on tips and tricks in self-publishing and they have been really a source to help me pull even more out what I had turned into. Them was so surface level and I didn't realize it.
Speaker 1:I thought, man, I have a book right here, and as soon as they told me, yeah, you're going to want to end up with I believe it was somewhere between like 30 and 50, 60,000 words, and I turned in about 10,000 words and I thought that was all that I have, and so there was this moment of do I even have enough to say about this? But of course, I had to add in case studies, I have to add in more details and these things are a little bit tough. So when the book becomes published and people start to read these stories, just know that I, reading the editing that we're going through right now my body has visceral responses, I have goosebumps or my heart starts racing, because these were crazy moments that I thought is this really biopharma? Is this really what's happening?
Speaker 1:But there's so many things that lead up to the complexity in biopharma and other industries that it's really difficult to innovate your operations when your focus is on the data-driven science, on that experimentation, on that R&D that is the source of all of your capital coming from venture firms, coming from angel investors. They're not doing it because you know how to run a good business. They're doing it because you have a stellar idea that is novel, innovative, et cetera. But when we don't pay attention to the operations, we can't tell the story, we can't manage the business, we can't manage our resources. And then what happens? Well, you tell the story. We can't manage the business, we can't manage our resources and then what happens?
Speaker 2:Well, you know the story, so let's dive into the book. So you talked a lot about R&D and how it's other complex industries. As somebody who's within the industry and they are working in this space how should they frame the ideas within this book? Is it more so? This is how your company should be structured. This is how you should be making decisions. This is how I should be hiring certain departments. What is the intended use of a book like this? Is it like a textbook, where it's very prescriptive, or more of a reference manual where, like here are some examples? And this is some of the things you might want to think about as you're going about making some decision related to X? Right, you know, I think that's going to help a lot of our audience and future readers get a sense of who this is really intended for and how they should be using it.
Speaker 1:That's a great question. So there's a couple of layers in the book related to the things that you're talking about. It's not going to be a prescription. It's not going to tell you these are the things that you need to do. If you want to do that, just use any AI system and say, hey, give me ideas on how I can do X, and it's going to give you very valid ideas. I think how well you can execute those ideas is a direct reflection on whether or not it's going to work.
Speaker 1:Now, the underlying theme behind all of the major components that I discuss and go deep into is this idea of systems thinking. So to position yourself to read this book and this book is intended to be a reference manual, sort of a pocket guide so you can read it on through and then I hope that you can come back later and say let me revisit this chapter, let me take a look at this framework and understand those first principles so that I can apply those here into the things that I'm doing, let me understand the shared themes a little bit more and make sure that I'm doing that internally. So there's a couple of different spaces in here and I'm sure we'll have some call-out boxes and stuff like that. That'll be really impactful for the reader to quickly reference. The reason why I bring up systems thinking is because this isn't just an idea that a single person can just push on through without any involvement of anybody else. It requires everyone, and when I say everyone, it could be your team, your department or your function, everyone eventually in your organization. The idea behind thinking that biopharma and these other complex industries are all part of a system In order for the organization, the business, to progress, it's not just the science, it's everything else as well.
Speaker 1:It's how well you can manage your budget, the resources, external vendors, many smaller R&D. They're going to focus on the talent that can directly impact in-house. However, you will find from early R&D through mid-stage, through late stage, you're going to need other expertise that does not exist at your organization and you may only need them for a short period of time. So, in lieu of hiring a full-time employee that might cost you $200,000, you're going to go get a vendor. Now how well you can manage the vendor to either provide technical expertise as a consultant or animal model husbandry, experimentation that uses equipment that you do not have in-house, implementation that uses equipment that you do not have in-house, how well you can plan that, coordinate that, manage the budget, communicate the budget back to the team and the project managers, communicate the right expenses to finance, to create these projected views of your resources, of who's being involved. How much headcount is being required in each of these spaces. These are all critical to how successful the organization is going to be.
Speaker 1:It's not just about the science. You still have to connect all the other pieces and I want to emphasize from this book with systems thinking is that your data, your work product, whatever you do in your job, whether it's processing paperwork, doing experimentation, creating presentations, whatever it is you do, your work product is critical for leadership to make decisions. It may not be the thing right before they make the decision, but it is somewhere in that chain of events. Perhaps you get raw data and you have to analyze it. Well, you have to make sure that analysis has a good handoff to the person who's going to be presenting it, because you're not a part of that team meeting or you're not a part of that governance meeting.
Speaker 1:The central theme in this entire book is connectivity, is that these things need to move together, and it's rare to find especially early companies that are growing at the same pace along their departments. You know you'll hire somebody and say, okay, now you're VP, I want you to create this group and go off and do it, but you never talk about the data. How are you going to connect it? Who are going to be the stakeholders in your workflows? Find out what the company is doing already. What are the tools you're using? Who are the subject matter experts? How are you describing the projects as they move through? How are you connecting the raw data of an experiment that has a cost, that has a person associated with performing it, that has an analysis timeframe? Back to the timeline, back to the project manager, back to leadership, so that they can make the most informed decisions informed, data-driven decisions, not just using data, but creating context to that data. That is what the central theme of this book is about.
Speaker 2:Yeah, and as you were talking, it reminded me and I'm going to use an analogy to really simplify some of the things that you just mentioned is it almost sounds like you were talking.
Speaker 2:It reminded me and I'm going to use an analogy to really simplify some of the things that you just mentioned is it almost sounds like you were like any company. You know, when you start out smaller, even when you're really big, it's essentially a small village or a large city and you have all these different buildings and different people interacting with each other, but you really have to establish certain roadways right for this flow of information to get anywhere, and so it's much easier to construct and, you know, tear down a building than it is to rebuild a road, because once you build the road there, it's kind of there, and so it sounds like the book is really it's not going to give you specific answers on this is how you should build the road. It sounds like it's more. These are the questions you should be asking before you go about setting those things up to connect certain systems and people and processes together, if I get that right.
Speaker 1:That's exactly right. You know, this book is not designed to be the one solution that you can buy and it's going to prescribe to you how you're supposed to be going through it. Because, guess what, every organization is different. If you're in agri-tech and you are developing for specific crops that grow in your region, in your state, your regulations are going to be different. The people state like your regulations are going to be different. The people that are on your team are going to be different. The functions that you have are going to be different, but there are core components of that organization as a complex industry that requires cross-functional technical expertise, that requires deep strategic initiatives, that requires very complex equipment and all has to be manufactured or produced according to regulations. These are things that make them complex, make biopharma complex, but there are core functions and spaces that you need to run, that you need in order to run a successful business. So what this talks about is how you should be connecting those spaces and what they look like and what happens when you don't. What happens when you disconnect them, the amount of time people spend, the errors that you find, the lag, that you have weeks to make a simple decision that should have been done right from the onset. So, again, I hope that this book helps people pause and reflect and start to ask questions.
Speaker 1:That's where all of this started. I couldn't stop asking questions why are we doing it this way? Do we have to do it like that? Is there another way that we can do it, where it's faster? But maybe we can only do so many per week? Or anything related to changing how things were done when those things led to friction points. You know, what we're trying to do is establish a map, and the map for Moderna looks different than Novartis, looks different than Amgen, looks different than Vertex, looks different than J&J. Everybody has a different map, but I guarantee you they all have R&D, they have business functions, they have legal teams, they have finance teams, they have projects with project managers and they have technical staff. All these things are universal across the board. We're trying to show them how to build their map to make their organization successful and reduce the exposed risk that their operations are posing.
Speaker 2:I love the idea that you know this is really meant to raise questions about how people are thinking, about how their departments are structured or how their processes are set up or how their workflows are designed, and it really speaks to you know. There's not a right answer for any of this right, and the idea is you should be questioning how things are set up so that you can improve it, because I think early on, especially when you're new to the industry, you come in and you think that, oh yeah, somebody put a lot of thought into building this thing and this makes complete sense. And then you quickly realize that that's bullshit and that is not how things are set up. And people are in and out of companies pretty frequently within our industry and it's always like we have a running joke that it's a very incestual because people go from one company to the other and people tend to know each other, so they build a lot of the same things and when that happens, you have a lot of similar problems across the board.
Speaker 2:But I think what makes it unique is that we obviously have a very diverse set of business constraints, depending on the company and their portfolio and what your budget is going through and the people that are involved. So it gets very messy in that sense, no-transcript flow of my data, or how my department should be connected, or some of the risks involved with making certain decisions. Right? How do you, you know, play with that idea of we're looking at, obviously, a lot of very distinct departments and, depending on the company, right, they're at different stages of development, right? So you'll have companies that are maybe more early stage and they have a, let's say, a less mature portfolio, but then you have other companies that have a massive portfolio, they have huge groups of departments. Is the questions going to change depending on the context of these companies and where they are? And, if so, like how do we think about standardizing the, the questions or the, the thought process behind how those things are built?
Speaker 2:Right, this is a very loaded question because it introduces this, this and this concept that we've been toying around with randomness. Right, like we don't want certain strategies to only work because it's a very specific environment, some of these things are that are coming out of the book. They're applicable to both sides, whether you're a large company, a small company, if you're early or late stage development, but you have to look at it from a different lens that people are typically used to. So I think, to no surprise, people in our industry are very siloed and chances are if you work in R&D, you're probably going to stay in R&D and chances are if you work in manufacturing, you're going to stay in manufacturing, right? So it may be very foreign to people to understand. You guys deal with the same issues, but you really have to understand how things are laid out to be able to ask those questions that you're bringing up.
Speaker 1:Yeah, there's a lot into what you're asking there. If we take a step back and we say what are the questions? That sort of ignore the facility itself, whether it's a business facility where a lot of folks are working on their computers with a little bit of science, a laboratory here or there, or a large manufacturing facility that is 40,000 square foot with tanks and valves and all these different things to measure output, in one case you have something that's very discreet. You have something that will say oh, here's an issue, the valve is detecting a pressure that's too high or it's too hot or it's too cold. Those are going to be very discreet, very easy to say hey, here's a problem.
Speaker 1:Earlier in the process and I'm using process that's actually going to roll into my response here there are more fluid processes that are developed at organizations. Whoever comes into the role or to the position gets to decide how those things are going to be done. Often what happens is that those do not carry guardrails. So that's where you start to create these really big forks. And how things are done at the organization. Oh, we have nine different softwares that all manage a timeline and those people just use Microsoft Word, those people use Excel, those people use Smartsheet, those people use Trello, that one uses Notion I mean, you can just name it, it's all over. It's important and critical for us to have those guardrails. I think that you see more often in manufacturing and facilities. You have to have the right permitting certifications and all of that requires very finite, discrete measures across the build, the transfer, the handoff and the functioning of those spaces.
Speaker 1:When you're earlier non-clinical in your preclinical work, you can set things up however you want. However you think that a business should be ran Now, in many cases we're bringing folks that are industry veterans Doesn't necessarily mean they've built a business before, right. So what do they do? They hire another industry veteran to come in and say, okay, you've done this over here, we want you to do it here. But building from the ground up and keeping something status quo are two very different things.
Speaker 1:In a lot of cases, when you go into these smaller organizations, there is nothing set up. You have to do it. So how do you balance building up the guardrails of the business while trying to push and pursue the science? That is the reason why you got $200 million in your Series A. You know some ungodly amount of money to do science, not to build the business. So there's a little play there that you have to consider at the organization. But I think when we go specifically into what questions we want to ask in that framework, we initially came up with sort of this trio. There's nothing really different than what other folks do. Mckinsey has a 7S, lean, six Sigma, have a number of principles and theories that they add into there to help guide you into that, into Lean, reducing Waste, and Six Sigma, which is mostly on your consistency, like how consistent can you be within given margins? In this case we saw three distinct areas detect and diagnose, contain and simplify, fortify and adopt.
Speaker 2:Yeah, I remember now We've played around with so many different frameworks and trying to find something that fits and then we realized none of these fit and there's a reason why nobody widely adopts them, because they don't make sense for what we're using it for.
Speaker 1:I think what became evident is you want to figure out what the problem is, so you want to be able to diagnose the issue. What we end up finding oftentimes is that people are looking to reconcile symptoms as opposed to the problem. Oh, this happened, so let's fix that. Well, the problem just manifested here, but it started two months ago at this part of the process, very hard to see when you don't have a process mapped out, when you don't have a centralized space that tells you this is what we're supposed to do. You may say we have so many processes, how do we get moving? How do we get started? Focus on the things that are actually going to move your needle. Don't focus on the process that really does not impact. You know that blast radius is so small. Don't focus on things like that. Focus on things that are. You know you're budgeting. How much of a pain is budgeting at the organization when you're trying to get cross-functional numbers that everybody has their own way of managing vendors. Everybody has their own way of maintaining a log. Some people don't even maintain a log, so they have to go back to their emails and look at let me see when payments were made in order to give them an accurate number. That's just a lot of work, and guess what it's going to happen next year and the year after and the year after. When you see something like that, it really is presenting you the opportunity to create something concrete that eliminates that burden of every year. We have two months where we're trying to create a budget, to modify the budget, to understand the budget. There's a cadence that I talk about.
Speaker 1:But let's go back to those three stages the detect and diagnose, contain, simplify and fortify and adopt that first area of detect and diagnose. You have to first detect that there's a problem. If everyone is walking around acting like everything is good, no one is honest, everyone's like yeah, you know, this is fine, it's not perfect, but it'll do, but it is a core part of their operations. Now, what happens? That person leaves and so does that Frankenstein process they created in order to supplement the bad process. Oh, it's fine, because I just take it here and I export it, and then what I do is I transfer it into here and then I use this free version that's online and I take that data and then I go back here and then I scrub it. Okay, try to explain that to somebody who is going to replace that person when they leave. It's unsustainable.
Speaker 1:So you have to detect where the problem is and understand what is the impact of that problem. How bad can it get? How bad has it gotten? You can detect an issue, but if it's an annoyance at the moment and you haven't really seen anything that severely impacts the organization, maybe it's not something we're going to focus on today.
Speaker 1:You can't do everything at once. You can't boil the ocean If you don't know where to look. Look at things that directly affect your company goals. Ask somebody, try to find a strategy map. Try to find some layer of the business that your work directly impacts, and then find all those pieces in there. What are the biggest issues in this workflow? And then you have an open book to diagnose.
Speaker 1:Okay, our problem is this workflow. Why is this important? Because it points to here, here and here. How often does it happen? Once a quarter? How long does it take One month? How long should it take? Seven days? What's the issue behind it?
Speaker 1:It's not about consolidating data more quickly. It's about setting up your systems to answer those questions. You know, a lot of the times we get questions from leadership and we have the data, but what happens? We'll get back to you. We got to go back. We have to pull out data, we have to scrub it, we have to translate it into like what it actually means outside of the raw data. There's all these things. But these questions that we get from leadership a lot of times, they're pretty common how long, how fast? What does it mean? Thumbs up, thumbs down. They have 25, 30, 40 other projects. Thumbs down they have 25, 30, 40 other projects. They don't need the down in the dirt details of everything that you're doing. Once you move from there, you need to contain Something is bleeding. Stop the hemorrhaging, stop the challenges that are happening right now. Contain that so that you're not feeding this issue across the organization.
Speaker 1:Once you have that contained, you want to simplify your approach. What are we doing? Why is it complicated? Why is it not working? Why is it unsuccessful? And it might be the type of file that you're passing on. It might be the handoffs. We have cross-functional work. It goes to one person, then it goes to business operations, for example. You have to identify that, simplify that. How do you improve something? Make it easier, make it easier for anybody to come into the organization and to proceed with that. How do you make sure that this continues, that this doesn't revert back to what it was? Fortifying and adoption are critical, and I will tell you this most of the failure happens at the end.
Speaker 1:We get excited about creating a solution. We get excited about we're doing something new, we're doing changes, and it takes time. And then you get toward the end and you have to ensure adoption. What does that mean? You got to get people into rooms. You got to make sure that there are trainings available, that you are putting them on people's calendars, that you are becoming a vocal advocate for the changes that have happened in your workflow across the organization.
Speaker 1:These are opportunities. These are opportunities for those early entry, entry-level workers. They're going to see something for the first time and that's a beautiful perspective, because then you're going to scratch your head and say, hmm, I thought this would be cleaner than this. What are the constraints? Why do we have to do it this way? Oh, okay, I see we have to change file format at this stage. So we set it up a certain way so it's easier.
Speaker 1:Or maybe you don't. Maybe that's the change. Maybe you make earlier processes more adaptable to what has to happen at the end, so that you don't get to the end and say, okay, now we have a week to make this transfer of stuff. These are the things that we're talking about, and it all ends with the adoption. Because no matter what we do, no matter what changes we make, no matter what we can affect in the moment, if you cannot get the rest of the stakeholders, the organization leadership, in it with you, it's going to be like trekking through mud. You're going to struggle to have people adopt it and you're going to have folks that revert back to legacy stuff. Habit is hard to break. You are creating a new mindset, a new habit, a new infrastructure, and it demands continuous attention so that the people that come in think that's the only way things are being done. Don't see this other terrible Frankenstein effort and the new folks continue to get visibility on how to do things most efficiently to have the biggest impact in their workflow.
Speaker 2:I think the adoption is definitely the most difficult, because you have a lot of human behavior changes that need to go a certain way and you want people to use the new thing that you've built, because you've invested so much time, money and resources into this new way of working and obviously, a ton of different strategies about how you do the adoption, but the idea is that you want to leave it so that whoever is coming in after can understand what has happened and also pick up. If the business decides to change, which it always does, is to allow the next person to come in here and go okay, yeah, we understand how this thing is designed and now we're going to iterate on it.
Speaker 1:Right, you have a baseline.
Speaker 2:You have a baseline right. We have too many things that happen in our industry where the baseline relies completely on an individual working at the company and then, once that individual leaves, the whole thing just falls over like a house of cards. We repeatedly make this mistake over and over and over again, and you got to wonder why and why do people do this and why do companies are set up this way, and I don't think it's necessarily something that they intend to do. But, like you said, it's where we're all being asked to do so many different things throughout the day, throughout our jobs, and it's really this idea of nobody has the time to step back and reflect and take a look at is this sustainable? Is this the right way to do this? And I think the questions that you're going to bring out in the book are really going to help people do that self-reflection and bring those questions out so they can build something that is more sustainable and more user-friendly to everybody that's working with them. Right?
Speaker 2:I think the other part that you mentioned way in the beginning was identifying the problems and being able to detect them, and that is that is not simply hey, what does my manager think about this? Right, it's, it's there. There should be a weight applied to certain things depending on the context of the problem itself. The problem itself and you know that's something that we're actively trying to incorporate in this new product that we're trying to build as well is to understand the context, just like you've outlined in the book, and using that as a multiplier, in a sense, to put weight on certain risks for some of these situations that our clients find themselves in. Obviously, there are a ton of different frameworks that can assign numbers to certain things and give you a score like a failure modes effects analysis. Fmea will do that for you.
Speaker 2:But I think what we're doing is a little bit different in that it's not only scoring things. It's actually there's a lot of open-ended questions that you're asking in the book. Right, that it gives that human element of it incorporated with the scores itself, so that you can really pinpoint how to not only fix things. But is this right, for the team Is like are they going to adopt this? Like there's so many different questions that you have to ask it's not simply a math problem where you go one plus one equals two, but is so-and-so going to be using this? Like, whose life is this going to make harder? Does management have visibility to decisions that need to be made? I think there are a lot of different questions that stem from that approach, that tools that we've seen in the past just don't do that.
Speaker 1:We have to also think about, like, who's going to be owning it? Like, when you own a process, these should be the things that you own. I think that there's a lot of people out there that sort of just like. I want to, you know, come here and do what I'm being paid to do, and that's where we direct our attention to. You direct your attention to the clinical trials that are happening. You direct your attention to the R&D work that's happening, and I think that's what we end up seeing is that the solutions that we carry out are in the moment and that's it.
Speaker 1:Oh, we're going to have a single video call that goes over it. There's no documentation that goes anywhere. If there is a slide deck, the slide deck doesn't provide any context at all. It just says here's the dates that we're going to be doing certain things. That's not a training. That's not something that somebody can pick up and say, oh, okay, so what's the template to manage our purchase orders? Oh, we don't have a template, you just do it on your own. Okay, so what are the important things that I need to collect on all my purchase orders or all my vendors?
Speaker 1:When you fail to outline those things, you have to expect very different results across the board. In order for you to be successful with your organization, there has to be some consistency for these very critical data sets. That are not the science, that are your operations. Everything we do, everything you touch, from the dates to the person, to the experiment, to the milestones, to the goals that lead up to those milestones all of those things are your concrete operational data. It's not just that you process so many samples, that you ran so many experiments, that you ran so many iterations, it's also the process. It's also the hard-coded data that is probably already in the systems. And that's the things. Our systems of use LIMS, eln, project management I mean you name it. There's going to be a tag for a date, there's going to be names in there, there's going to be probably ID numbers that are generated. All of these things are useful to connect to the broader system, which is the organization.
Speaker 1:I think what you were describing earlier is, in effect, being given or being told hey, you have a goal, now to fix something, and that fix becomes a one-time point, a point in time that I created a new template and I'm going to share it with folks and that's it. Okay, how much impact did that have? Well, we do that once a year. Okay, what is the plan for next year? Are you going to share it a month earlier? Are you going to remind people about it? Or how does this work in the middle?
Speaker 1:You know, when we look at these workflows that are business operations, uh, sort of centered, we focus so much on the very beginning that we don't do really any kind of training or maintenance on. Hey, let's make sure that everybody is collecting the information the right way, because it's not just having these early processes, it's is your data syncing. How is the integrity of the data? Do the people that are responsible for providing that have the same way of producing and logging that information? Probably not. So what is that going to do? It's just going to add more time at the another part of the workflow and they're going to say we need to get faster at doing that. It's not getting faster, it's getting more consistent. Your consistency will breed your innovation. When you get consistent across the board, you turn the whole company into a machine of everyone that actually knows what they need to be doing and how they're supposed to do it.
Speaker 2:It's interesting and this is something that we haven't talked offline, but it just reminded me that the concept and the intention of the book. It almost seems like it's a how to guide for process owners in our industry, given the context of a business environment. Right, because it's not just owning the process in your little group, it's how does this impact the business overall? And at least I have never seen this, especially in this industry is this is what it means to be a process owner? I don't think I've ever seen that. I don't know if you've seen that. No, no.
Speaker 1:Usually a process owner becomes just the SME. It's like one single person cannot execute this for a company of 10,000 people yeah, this for a company of 10,000 people yeah.
Speaker 2:Yeah, process owner is, I think, something that is more relevant, obviously in all different aspects of biopharma, but I think in R&D it means something different than it would mean in my world of where you have facilities, management and labs and manufacturing.
Speaker 2:I think the term that we use is system owner right. So I think that is also a concept that has been just loosely thrown around and I think it means something different in each company. But until we've standardized what it actually means to own the process to own a system, I think you're just going to get very inconsistent behaviors and outputs from people that have that type of responsibility.
Speaker 1:We talk about that. We talk about that in the book and how, since the dawn of technology, we have seen that we've had that uptick of IT service and anything related to a system goes through IT. Okay, who knows how to do this best IT? Okay, who can train me on this IT? I'm sorry, it has their role, but you are the function that is using this system as a core to your work product. You should be the SME, you should be the system owner, you should be the process owner and you should be involved in how other people train.
Speaker 1:Because here's the issue, lawrence, that I see all the time I go into a group and you have one or two, you know two or three rock stars working on a system. Everybody else is kind of okay. And then you have another group of people that are just terrible at it, and this is their role. And then what do they say? Oh, if anybody has any questions, just reach out. No one is going to have the time or the foresight to reach out. So this is part of the adoption. I'm like when you hammer adoption, just schedule it, schedule and say here's a time that doesn't work. Fine, if you have a problem, you need to come to me. I am putting up very so many opportunities for us to have conversations. The only time people want to learn is when they have a problem, and that's not right. You should be learning to eliminate the issue of troubleshooting any of your systems.
Speaker 2:Well, I haven't read the fully edited version of the book yet, but I think we should add in there what it means to be a process owner. It does not mean that you're an application owner, because that's a different thing for our IT partners that are responsible for how the software gets distributed and licensed permissions. That's completely different than how people are engaging with it day to day for their own work, right. So we've kind of bounced around a bit on this episode and hopefully, if you're still listening, you're following us as we close for the episode Um, what can people expect in the coming months for the development of the book? Like um, do you have a timeline that you have in mind? And if people are interested in the book, how do they reach out to you? Is it just the email or is? Is there something going to be developed by the book company itself to really take all of those interests?
Speaker 1:So there's a lot of exciting things that are happening right now. We are looking and sort of aiming for a launch around February, early 2026. Right now, we are pretty deep into the content editing. We've already gotten the first draft out there. It looks great. Obviously, we're going to go through and make sure that the language and everything is a really smooth read, and this is intended to be more of a conversational read. I want the reader to pick this up and feel like they're having a conversation, feel like they're discussing these things and in a way that lets them think about challenges that they're facing currently. So we are planning to create some bonus material that will be coming out at various times leading up to the launch. We have a form for anyone who is interested now. Sign up now so that you can get all of this bonus material, from what the framework looks like to tips and tricks, to releasing a chapter early, too, so that people can get an idea and get a feel for what's happening. So we'll put that in the show notes. If you reach out to my LinkedIn, oscar Gonzalez, there's a link right there at the top of my profile to get onto the book waitlist. That will also give you access to the bonus and the marketing material that's going to come out from that.
Speaker 1:But in the next couple of months we are continuing with editing, planning how we're going to talk about the book and what avenues we're going to be using. We'll talk about it through the podcast, talk about it in other podcasts and then hopefully we'll be designing the cover and stuff. So there's some exciting things that are coming that even I don't even know what it's going to look like. You know, from the spine of the book to the front, to the back, things that esteemed folks are going to be contributing to that. But we are in a space now that the majority of the content is in there. So we'll be doing more design, not just the framework, but we're going to be deconstructing the framework and posing that as images in different spaces so that it can kind of slow people down and say, okay, here are the different areas and how they connect to all the other pillars that we talk about.
Speaker 1:The book discusses five pillars. I'm not going to bring those up yet, but rest assured that I think a majority of the content will start to bring in those pillars and really connect in what it means. So sign up, tell your friends, like you were saying before, we have tried to do a lot of research to look at things that take on biopharma in this manner, and there is nothing out there like it. There is nothing out there that creates this framework of what really pushes these companies forward. We talk about it all the time.
Speaker 1:How much money do you have? How much time do you have? How many resources do you have? Where are you putting that money? All of these things are essential for a business to be successful. You have the data. You just need to connect it the right way, and so this book is hopefully going to be a guide for that entry level new to the industry, to the middle manager that's trying to create action out of strategy, and also to the leader to say hey, leadership, this is also your responsibility. It's not just execution of the science, it's also promoting healthier systems, healthier workflows and stronger collaboration. Work on those handoffs, really talk to the other side and say what makes sense for you, what makes sense for me. Let's find that middle ground so that this part becomes smooth. Those are the important conversations we need to have, and hopefully this book does a great job to outline that for all the future readers.
Speaker 2:Excellent. It sounds like some perhaps merch, or even a poster that you can put in your office with some of these concepts, maybe.
Speaker 1:I know. I know there's a lot there. There's a lot. You know. I've thought about the coffee mug already.
Speaker 1:You once challenged me to think about what I was doing. You even looked at me and said explain it if it was a plant, and that sort of carried through a little bit in the book. So we'll talk about the root system of your organization, how you can produce the fruits, the flowers and the fruits which. What is the fruit? Your data, your real that is what is pushing it out forward. But you got to have a strong stem. You got to have a strong base. You have to be in the right pot.
Speaker 1:If anybody's ever tried to grow plants in the beginning, I'm sure you killed a lot, as did I. You know you get the succulents that people say you don't have to water. Well, you got to water a little bit because they just shrivel up and die Well. Thanks, lawrence. I'm glad we got to talk about it. I'm excited for the launch and we are combining those efforts into bringing a product line that I think is going to benefit a majority of people, especially now in 2025, where things look a little different Budgets look a little different, composition within our organizations is different. There's been a lot of layoffs over the last two or three years, and so we want to make sure that we're still delivering the value to organizations that we know is critical to not just excelling in operational excellence, but surviving and exposing the risk and being able to contain it. Until next time, talk to you soon.
