In this episode of the Global Medical Device Podcast, host Etienne Nichols speaks with Vernon Baker, a medical device guru, about key strategies for early-stage MedTech companies, particularly around implementing Quality Management Systems (QMS), supplier management, and compliance.

Vernon shares his experience of transitioning from engineering to quality and regulatory roles, emphasizing the importance of being a "jack of all trades" when hiring early quality managers. They discuss how small companies can navigate the complexities of ISO 13485, supplier audits, and regulatory intelligence. This episode is a must-listen for startup founders and quality professionals seeking to establish a strong foundation in MedTech.

Key Timestamps:

• [00:02] – Introduction: Etienne Nichols introduces the topic of early-stage MedTech QMS implementation and guest Vernon Baker.
• [04:30] – Vernon’s Background: From mechanical engineer to quality expert in MedTech.
• [13:00] – Wearing Many Hats: How early hires in quality roles manage multiple responsibilities in small companies.
• [22:10] – Supplier Management: The importance of supplier audits and choosing the right partners.
• [35:45] – Management Reviews & Communication: Aligning quality efforts with company goals.
• [47:00] – Regulatory Intelligence: Staying updated with regulatory changes and standards.
• [59:20] – Final Advice: Qualities to look for in an early-stage quality manager.

Notable Quotes:

• “You don’t have to be an expert in everything, but you do need to know where to find the answers.” – Vernon Baker on managing quality systems.
• “A good management review should feel like a real conversation about the direction of the company, not just a checkbox exercise.” – Vernon Baker on management reviews.
• “Supplier management is critical in small organizations. You’re outsourcing a lot, and you need to vet and audit your suppliers well.” – Vernon Baker on supplier controls.

Key Takeaways:

MedTech Trends:

1. Focus on Flexibility: Early hires in MedTech quality roles need to be adaptable, covering everything from product development to regulatory compliance.
2. Supplier Audits Are Essential: Strong supplier management, including on-site audits, is vital to mitigate risks and ensure high-quality materials and components.
3. Regulatory Intelligence: Regularly updating your team on changing regulations and standards is crucial for maintaining compliance and avoiding costly mistakes.

Practical Tips:

1. Leverage Consultants: For niche areas like biocompatibility and regulatory changes, hiring external consultants can provide critical insights.
2. Invest in Training: Encourage your team to undergo formal training in ISO 13485, risk management, and process validation to build internal competency.
3. Use Document Templates: Start with pre-existing QMS templates and refine them according to your company’s specific needs.

References:

• ISO 13485: The international standard for medical device quality management systems, which is essential for compliance in various jurisdictions.
• FDA Recognized Standards: Lists that guide device manufacturing and safety, critical for ensuring that products meet U.S. regulatory requirements.
• EU MDR: A sweeping update to European medical device regulations, requiring stricter quality and reporting standards.

Connect with Etienne Nichols on LinkedIn for more insights into quality management in the MedTech industry: Etienne Nichols on LinkedIn

MedTech 101:

• QMS (Quality Management System): A structured system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. For MedTech, this typically involves compliance with ISO 13485.
• Supplier Management: The process of vetting, auditing, and maintaining relationships with external suppliers to ensure they meet your quality and regulatory standards.
• Management Review: A formal meeting where top management reviews the performance of the QMS to ensure its effectiveness and alignment with business objectives.

Questions for the Audience:

1. How do you manage regulatory changes in your MedTech company? What tools or resources do you rely on most?
2. What are your predictions for how supplier management will evolve with advancing technologies in MedTech?

Let us know by emailing your thoughts to podcast@greenlight.guru!

Feedback:

We’d love your feedback on this episode! Please leave us a review on iTunes, or send your thoughts and suggestions for future topics to podcast@greenlight.guru.

Sponsor Message:

This episode is brought to you by Rook Quality Systems, specializing in custom QMS solutions for MedTech startups. Rook helps streamline processes and ensure regulatory compliance. Visit rookqs.com to learn more and start building your ideal QMS today!

Etienne Nichols: Welcome to the global medical Device podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.

Vernon Baker: In this episode, we talk a lot about implementing a QMS and what you need to do at the very early stages of building out a medical device company. But before we get too far, I wanted to say if you're looking for assistance in implementing a QMS, rook quality system specializes in quality management, system design, customization and implementation. Their experts create tailored solutions that streamline your processes and ensure compliance. So if you're interested in building your ideal qms, contact rookqs.com dot. Hey, everyone. Welcome back to the podcast. My name is Etienne Nichols. I'm the host for today's episode. We're going to be talking to a specific audience. I think it could be applicable to a lot of people, but I particularly want to approach an audience of early stage companies. Maybe the CEO, maybe the founder, maybe someone who needs to hire a quality manager. And this is going to be one of your first quality hires. And so I brought in Vernon Baker. He's one of our medical device gurus. First of all, how are you doing, Vernon?

Etienne Nichols: Good. Great to be with you. Good morning.

Vernon Baker: Great to be with you as well. You've gotten a lot of praise across the company from me. I've heard a lot of good things about you because of your background and the way you hold yourself. And just learning a little more about your background makes it make a lot more sense, just the where you came from and what you've done. And so we were going to talk about all of the different hats you've worn and the tiny companies. I want to get into that. But before we do, let's talk about your background a little bit. You want to just tell us a little bit about yourself, Vernon?

Etienne Nichols: Sure. Thank you so much, first of all, and I am really glad to be with you. I'll try to be brief on the background, but I am a mechanical engineer by training, came from a family of engineers. My dad was in the pharmaceutical industry for many years, and then I've got some brothers that are also engineers of various types. My first couple jobs out of college were not medical device. Worked for the naval nuclear propulsion program, a DoD contractor working on reactor equipment for Virginia class submarines. So totally different, but I guess sharing in what's a regulated industry. But I was living in Pittsburgh at the time, and I met a founder CEO of a very small medical device company, Super Nice guy. I met him at a wedding, and we just hit it off over cocktails, and he invited me to work for him. And so I made the jump. I actually, at the time, it was like, it was a crazy decision because I lost all of my government ish benefits. They had a pension at the time, which is like unheard of now. But, yeah, my wife was super supportive. She's go do this exciting thing, take a pay cut. And, yeah, I started out as a mechanical designer for this really tiny medical device company in Pittsburgh. And it was such a fun organization and experience, and I learned just absolutely tons. So started up just doing cad modeling, mechanical design, autodesk inventor stuff. It was a head mounted display device that, like an oculus rift type of look. So head mounted display that did pupil tracking for mild traumatic brain injury, MTBI or concussion. So just really fascinating to me. Totally new. And then after a couple of years there, my wife's from Minneapolis, and so we were looking to make a move. I took a job at another similarly sized startup just outside Minneapolis, Minnesota, which as was like big kind of med device hub. I was totally ignorant to that at the time, actually. I had no idea. Cause I was still, like, relatively uninitiated. So, yeah, and that's where most of my career in med device has been. I spent nine years there in a variety of roles. I started as like a. I don't even know why. It was like product specialist, spending time working with distributors, more on the business side, traveling, going to conferences, spent a lot of time in the or meeting surgeons who were implanting the device. And then due to the departure of one of the senior engineers on that team, was like, who here is an engineer and can do engineering? Like, okay, I'll give it a try. I'm ready to stop traveling so much. My wife and I were just in the early part of having our children at that point, so I needed to stop traveling to Europe. So then the story from there was stepping into an engineering role, and then engineering is such a generic term. It was like quality regulatory and product development engineering, and then slowly got the resourcing to hire additional engineers for the team. And I had just an absolutely killer, awesome team of smart engineers, and we all just learned from each other and figured it out as we went along, quite honestly. So that's how I ended up in the more quality regulatory space from, like, straight mechanical design.

Vernon Baker: So what were the size of the companies that you worked for when you were working in those early stage startups?

Etienne Nichols: The first one, it was like I said, I think I was like the 6th maybe 7th employee. There was the CEO and founder and then I think there was an office manager, maybe a finance guy and then a couple software engineers and we did use consultants but I think I was like the 6th or 7th employee and then at the second organization I was referring to where I spent most of my time, I was awesome. Maybe like number ten, something like that. We had our own clean room and were doing our own manufacturing, injection molding and so there were a few production people who were working on that. So it hovered around ten maybe at our maximum. We were like twelve or 15 left there and came to GG.

Vernon Baker: So I cant imagine how many hats you had to wear. Early stage especially. But lets say a companys expecting to get into the quality or to really start to ramp up a lot of their quality activities and they hire someone like you, what is it they're looking for or expecting this person to do?

Vernon Baker: I'm glad you brought that up because we have this tendency, especially as engineers, to think, oh, I have to be the smartest one the, I have to know everything about whatever it is we're talking about, when it's actually not possible. And so really you wind up being a specialist in this class three and plan or whether, wherever your is you're talking about. But I suppose if I was to turn this into maybe a slightly different question, you know what, let me go back in time. So you came to this role maybe not with the knowledge of the medical device industry, and you learned some things. And I'm sitting here thinking, okay, what could he possibly have had to learn really quickly? It sounds like supplier management. You have those contractors, those quality plans with the suppliers.

Etienne Nichols: I did not understand conceptually when I started the overall sort of regulatory framework, and I think that's a great place to start. People think it's like looking at a regulation is boring, you know, a good way to put yourself to sleep. But actually I found it almost like someone had put all the cards on the table when I started, like, showed me how the trick is done, because I'd been working with consultants who were quality regulatory consultants, a lot of good people who were very helpful. And then when I started going to the source of truth directly and interpreting it myself and looking at the guidance, I was like, um, this is where they're getting this. This is not. Obviously experience matters and interpretation matters, and that's where consultants can be so helpful. But as a kind of do it yourself bootstrappy small company, you're trying to one, save money and do as much of it internally. And so going straight to the source, whether it's like, just buy the standard, maybe you seem expensive, it's 300, $500. Like, sometimes those are hard to get approval for in a small company. When you're counting every dollar. But I would just say, oh, buy it, buy the guy. Absolutely. Look at the guidance document, go straight to the source and then go to a consultant for interpretation if you need it. But start with a basic understanding. It can get you a lot of the way there. And so I had to learn that the hard way just before I found all, honestly, just like the website, the documents, to educate myself, like, oh, this is where this is coming from. So, yeah, I guess if I were to put that briefly, it'd be like finding the source of truth for the requirement, the sort of show me the shall mentality. And I would say, really, I learned a lot. And it was very humbling. Just in the manufacturing space and in production, by respecting the operators, like learn from them. I had learned that the hard way, probably as like a kind of brash young engineer who thinks, thought I should know things. I've had machinists show me a drawing that I printed out and be like, how am I supposed to put this right angle at the bottom of the hole? And I was like, she put my tail between my legs and went back to my desk and I learned, okay, sure, you got an engineer, but you need to learn from the people who have done it. And so I think spending time on the floor was extremely helpful to watching manufacturing processes work, understanding the key aspects. And that helps with all those other things like supplier management and with kappas and with management reviews, because if you have a real sort of in the trenches understanding of how things work, you're not trying to manage it in the abstract, that you understand the real sort of inputs to a process. And, yeah, I just, I would say I took a long time to learn that and I'm still learning that. But it was, yeah, I would say like a key thing. So I think humility, honestly, is probably better. I certainly, I had to learn that the hard way, but like someone whos humble, ready to learn, but who has a base knowledge in a lot of the core qms areas and is willing to put in the work on the ground level.

Vernon Baker: Okay, you mentioned qms there at the end there, and core QMS specifically. When you think of a medical device company, the size that you were working for, what are those core QMS activities that are going to be likely this persons responsibility from the very beginning?

Etienne Nichols: Oh, yeah, absolutely. Supplier management is definitely one of them. And you mentioned that earlier. Thats huge. I had the analogy once presented to me from a notified body auditor. We were working with TUV Sud or TUV Sud, and the auditor said, imagine a perfectly vertically integrated company that does everything from mining the ore out of the ground, from the raw material. That would be a complete legal manufacturer at some point, and nobody does it right. Maybe the big guys come close, but ultimately, you are outsourcing some of your responsibilities at some level, and you could just move that outsourcing level up to, all the way up to, we're a specification developer working with a contract manufacturer, and the game doesn't really change anywhere or how you manage. That was very helpful to me to hear that analogy, because I thought, okay, this is a raw material supplier for our implant device. If we were making this, what controls would it be under? What controls? We want to make sure that this is high quality. Now they're an external organization that I am not the boss of, per se. We have a contract. How do I pass on appropriately all of their requirements, the responsibilities, and put them in a contract? And that just demystified the whole quality agreement. Quality audits sort of things. It's taking a hard look at. Okay, what are the real concrete risks associated with this? Risks to the patient, risk, first of all, of course, risks to the business in terms of disruption and cost, and then mitigating them as well as you possibly can using critical thinking. So supplier management is a huge one, because circling back to your original question, in a small organization, you might be doing very little to none of your own manufacturing. You have a lot of suppliers, and choosing them is extremely important. Vetting them and getting your supplier controls in place, because for an auditor who, or an inspector who's coming to look at your organization, will quickly see from, like, the scope of your quality manual, you basically outsource all of this work other than the top level responsibility. And that's fine and extremely common. You just have to do it. Otherwise, you know that there's a huge portion of your quality management that is really outside of your organization. So I got tremendous value going on site. Supplier audits, I know during COVID like a lot of that went remote, that, man, I learned things I could not have predicted. If you dont know what you dont know, meeting the quality manager for one of my suppliers or the production manager, and things just come out of the woodwork, issues get resolved that you didnt even know you had, or get nipped in the bud. And I know audits are costly. Onsite audits are costly and time consuming to perform, but when theyre carefully selected, meaning youre doing them for a reason, based on risk, and then well conducted, man, I got so much value out of those supplier audits and learned every single time. And so I love that. But you have to have a good supplier management system in place to do all of that, make risk based decisions, because I don't. But, like, we overhauled our supplier management system from scratch during my time. I think we found ourselves initially doing a lot of things that we couldn't find sense in, like non value added activities. Its disheartening, honestly, on a very human level, and it just feels like a waste of time. Its hard to justify the cost. Top management, which is always a factor in small organizations. And so really thinking through critically, why are we going to do this? What are we trying to achieve? What risk is this mitigating? And then you can answer all those questions. All the other questions are easy then, because, you know, youve made good decisions about the why. And so if top management is like, why are we going to pay for a hotel room for three days and a flight for you to do this? And you know exactly why, because this is the risk to the patient. This is the risk to our business. We've put this through a good process that's leaned out and we trust our decision making, and that's a good argument to make. So anyway, yeah, supplier management is for sure key for the small organizations because they're just not going to be doing all of it themselves, but God bless them if they are doing it themselves.

Vernon Baker: I love that example of the vertical integration and vertically integrated company that makes that. That really is helpful to think about from that perspective. And it's almost like a lot of things are going to stem off of that concept. I used to think supplier management, that seems an external process. How important is that? We got to focus on the inside, get the inside done, and then we work on the outside. But really, you're right. You got to get your arms around the entire process. And if that's a, a way of looking at that, there are other processes that are going to impact that process. Root cause analysis, you mentioned getting those problems solved. So root cause analysis, management responsibility, can you touch on some of those and a few other maybe you think that you would call core early stage things?

Vernon Baker: You mentioned that phrase early on, not hiding the ball, and I appreciated what you said about the podcast and how some of the things that you learned, but I want to hear what you learned about not hiding the ball from your experience as well in Q A, R A. Are there some things that you learned regarding that?

Etienne Nichols: Yeah, absolutely. We worked with, in a small organization, we did use consultants. Some were like materials specialists about the implant material that we were using. Like I said, biocompatibility, but also just to supplement my sort of nascent knowledge in Raqa. We had Raqa consultants, and one of the pieces of advice I received early on was about regulatory intelligence. And this is a not hiding the ball thing or putting all the cards on the table. I had worked with regulatory consultants that sort of just pulled a rabbit out of the hat in terms of an answer, and it was like, oh, how do you, like, how do you arrive at that? And I had one consultant we work with that really put all the cards on the table and helped us establish a regulatory intelligence procedure, which was a new concept to me, but it was, you've used, and I think for sure heard the offense versus defense analogy for Ra and QA. Where does your company, or how does it do, like recon of the regulatory landscape? And so there's changing regulations for sure, like QSR to QMSR recently in the US, but that doesn't happen all that often. But of course, EU MDR was a huge transition in the EU, but then there's a constantly changing landscape of state of the art standards. So FDA recognized standards list, it used to be the EU OJ with all their harmonized lists. Feels like it's a little bit in chaos right now. This consultant helped us, helped me like see all the sources. First of all, told me the concept of the official journal. This was under MDD at the time, showed me the recognized standards list, signed us up for it was like the tech street standards tracker, and helped us develop a gap analysis process to take all this incoming information, regulatory information, separate the wheat from the chaff in terms of what is important here, does this guidance document matter to us and how do we apply it? If it does, what, who do we need to tell? What do we need to do internally and then making the changes internally to our qms as a result of that Reg intel. And, yeah, the not hiding the ball thing is just like showing how it's done. Here's the thinking. I feel like a lot of people, and definitely engineers can relate to, like, okay, here's the source of information, here's how I process it. I have a workflow for doing that. And here are the outputs, just like basic process thinking. And so once you have it, like, almost revealed to you, at least this is how it felt to me once I was shown, like, hey, this is how this is done. Here's the sources of the regulatory information. Here's the newsletters, here's how people find out about things. And that's where a lot of sort of the wisdom and experience of the consultants was really helpful. Just saying, yes, it says this, and this is what it means. But there's a constant influx of even MDCG guidance documents on EU MdR. Knowing where to find those is a huge thing. It's okay. This is what's coming out of the medical device coordination group. It influences how you use Udamed, what the time, how you interpret timelines. Those things are really helpful to read for yourself. And then you can work with a consultant or an expert if you still need help after that. But, yeah, that's what I meant by not hiding the ball is just, okay, this is the process. I can understand at least some of this.

Vernon Baker: The regulatory intelligence is a really good concept, and it's something that, at least in my experience, I don't think I would have seen that very often or known how people put that together. I've built my own type of RSS feed for knowledge.

Etienne Nichols: Yeah.

Vernon Baker: And for incoming things. But how do companies do that? You don't hear that talked about very often.

Vernon Baker: I love that gap analysis in the table with links, especially because if anyone else wants to know where the MDC G's are, those aren't always easy to find. I appreciate whatever stones you want to throw at the FDA. They make their guidance documents pretty easy to get a hold of. The gap analysis is a really interesting concept, and I want to maybe extrapolate that out into a different area of the business. So when you're coming in, there's a lot of things that you don't know, and you don't always know what you don't know. How do you perform that gap analysis on the company level to say, okay, we obviously got to get some supplier controls. How do you know about supplier controls or how do you do the gap analysis to understand that we need a management review, maybe more often than annually or to upgrade our RCA or root cause analysis. What are your thoughts there on gap analysis across the business?

Vernon Baker: You'Re the author of a lot of that now. So no it's just the company itself. Great.

Vernon Baker: Yeah, I've heard sometimes the medical device guru teams been described as the Sherpas that will lead you up the mountain. And so it's always nice to have someone who can, who's been there before and done it and so on. There's a phrase you've used, or maybe an example used a couple times when you're saying, justifying this to management, or if you want them to get on board with this idea or this topic, here's a way to make that case that's a really good. I want to segue into that a little bit and lean into it. Are there communication styles that you recommend? A quality or regulatory person or someone whose boots on the ground making that communication leap to upper management? Any thoughts there?

Vernon Baker: This has been a good conversation. We've covered a lot of ground. Any last piece of advice to someone who's looking for someone who has this, maybe they don't have all of the qualifications yet, maybe they still gotta do that gap analysis on themselves. But what kind of person could really fulfill this kind of role?

Etienne Nichols: Yeah, let me think on that just for a second. I think that there's a lot of different types of people who could fill that role and that they're not by any means all my type of person. I was like, learn along the way. It'd be probably you'd get a better, faster jump start if you hire someone who would already learn. But I think an eagerness to learn is critical and a little bit of boldness to base facts brutally but tactfully within an organization. Willingness, willingness to learn and I think a passion, honestly, a lot a passion for the device or product or at least the mission of the company goes a really long way in covering a lot of other ills or gaps in competency and just hire somebody with a high aptitude, humble, willing to learn, and ideally with a bit of experience, I think, and help resource them as they have communication. If im speaking to a founder, listen carefully to the resource requests, doesnt mean you have to grant all of them. But especially if youre hiring somebody on the younger side and probably then less expensive side, then they may need some help. Theyre probably going to need some help, some guidance, maybe some documents, and thats a reasonable request that theyre going to need. If you hire a total pro, maybe theyre coming in with a lot of that, but theyre probably more extensive. Trey? Yeah. I dont know if I have a single piece of advice altogether, but I.

Etienne Nichols: Absolutely. Absolutely. I hope the conversation was helpful to somebody. And thank you for having me on. I really appreciate it.

Vernon Baker: Well, thank you, Vernon. I really appreciate you sharing your expertise. Those who've been listening look forward to seeing you next time, everybody. Until then, take care. Thank you so much for listening. If you enjoyed this episode, can I ask a special favor from you? Can you leave us a review on iTunes? I know most of us have never done that before, but if you're listening on the phone, look at the iTunes app. Scroll down to the bottom where it says leave a review. It's actually really easy. Same thing with computer. Just look for that. Leave a review button. This helps others find us and it lets us know how we're doing. Also, I'd personally love to hear from you on LinkedIn. Reach out to me. I read and respond to every message because hearing your feedback is the only way I'm going to get better. Thanks again for listening, and we'll see you next time.