If you are in the business of medical devices, then you must eat, breathe, and live quality management systems. In order to get to market and sell your products successfully, your quality system needs to be in compliance, and meeting all of the regulations can be one of the hardest hurdles to cross in this business.
Our guest today is here to talk about how you can surpass these hurdles, and David’s insight and resources will help you manage your quality system in the best way possible.
Managing the quality of your products is something that needs to be taken care of when you’re starting your business.
“The bigger your company gets, the more scrutiny you’re going to get from the FDA and the higher the expectation is from the FDA.” – David Amor
That’s why finding the right-size system for you right now is extremely important. Tune in now to find out how you can build your business and your management systems at the same time.
Today’s topics discussed:
- What startups should do to succeed in the medical device realm
- Understanding where your business fits within the field and the FDA’s regulations
- Practical implementation of quality systems and its regulations
- Finding the right size for your quality management system
- How to manage your quality systems while still focusing on the development of your medical devices
Additional resources mentioned:
David built his consultation website – www.myquickconsult.com – exclusively for startups, giving you access to Med Tech execs who can answer your questions and give you reviews on your quality systems. Email David at firstname.lastname@example.org for a discount.
And don’t forget to visit greenlight.guru for your quality management system needs.
- When does the ‘R’ end and the ‘D’ begin in medtech?
- Why Getting FDA 510(k) Clearance Alone is Not Enough (And 6 Things You Can Do About It)
Announcer: 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.
Jon Speer: Welcome to the Global Medical Device podcast. This is your host and founder and VP of Quality and Regulatory at greenlight.guru, Jon Speer. Each and every episode of the podcast, we are focusing on some content and information that's gonna help you through your medical device journey. Today, the topic is an important one. It's about the quality management system. Yeah, it's something that you're gonna have to eat, breathe, live. It's something that you're gonna have to put in place, manage effectively, and constantly approve and evaluate in order to continue to design, manufacture, and sell medical devices.
Jon Speer: My guest today, David Amor. David is from Medgineering and myquickconsult.com. David and I talk about the important aspects of a quality management system. It's definitely applicable to any med device company for sure, but David and I get into some finer points and details on things that are especially geared towards startups. A startup, you've got a lot on your plate for sure, and a quality system may not be one of them, but I tell you, it needs to be one of them. And David and I give you a few key tips and pointers for how you can manage your quality system, while focusing on the design and development of your new medical device. So be sure to check in and listen to David and I talk about quality management system on this episode of The Global Medical Device podcast.
Jon Speer: Hello. This is Jon Speer, the founder and VP of Quality and Regulatory at Greenlight.guru, and today, you are listening to the Global Medical Device podcast. Folks, I have another great guest on our show today. We have David Amor. David is a medtech... Biotech consultant and mobile health entrepreneur, who founded Medgineering, a company focused on remote compliance, regulatory, and quality systems consulting for larger companies, and startups, alike. David is a graduate of the prestigious Innovation Fellows Program at the University of Minnesota's Medical Device Center and was named a Top 40 Under 40 Medical Device Innovator in 2012, and a 35 Under 35 Entrepreneur in 2015 by the Minnesota Business Magazine.
Jon Speer: Recently, David co-founded and helped launch Remind Technologies, a Texas-based mobile health company developing smartphone-based remote medication management system, which you can find at remind-technologies.com. He is also a co-inventor on several issued utility patents and co-pioneered a disruptive e-consulting platform for the medical and pharma industries called Quick Consult. We're gonna talk a little bit about that here in a moment as well, but that's myquickconsult.com. Lastly, David also serves as an adjunct professor at Saint Cloud State University in Maple Grove, Minnesota, where he teaches courses on quality risk management and design control. The current focal points of his consulting practice are specializing in quality management systems, risk management, design controls, combination products and in health.
Jon Speer: And a little bit about David's company, Medgineering. Medgineering is a quality and regulatory consulting firm based in the twin cities of Minneapolis Saint Paul. Medgineering uses a remote model to save clients time, money, and procurement. Visit medgineering.com, and it's just like it sounds, folks. And try out the new online platform at myquickconsult.com. So David, quite impressive, and welcome to the show today.
David Amor: Greetings, Jon. Thanks for having me on. This has been a very great opportunity here with you guys.
Jon Speer: David, you and I, we found each other I think through Twitter or LinkedIn, or you were a fan of some of my writing and...
David Amor: Yeah. [chuckle]
Jon Speer: It turns out I was a fan of some of yours, as well. And I think some of the pieces that each of us... When I read one of your recent posts about quality systems for startups, I found myself saying "yes, yes, yes" and we connected and we talked, and it was eerily similar how much our minds were alike, as far as what startups should do.
David Amor: Yeah, absolutely. We've been recommending as part of our startup coalition, we're working with a lot of startups in the Twin Cities on the West Coast, we're very familiar with Greenlight.guru and really have used that as an example of a really great way of implementing a lean QMS. I think it fits right in line with what we're gonna be talking about today.
Jon Speer: Yes. The whole idea behind Greenlight.guru started from an idea that I had many years ago. I mean, for the past nine or so years, I've been working with startups, and startups have a very... Well, many of them share several common issues, and it all seems to boil down to resources, both in the form of people and capital, and the knowledge and expertise necessary to comply with FDA and other regulations in order to bring that new product to market.
David Amor: Exactly. I think the key thing with quality systems that there's two ways of looking at it, right? A lot of startups that I work with, it's either one of two things. A, They don't even know what a quality system is, right? They have this napkin sketch that they wanna take to market and they think that the battle is done, once they get to market. And when they realize that what you actually take to market is what's gonna be sold and commercialized and sold to customers, and you have to have a quality management system in place, that's when the freakout mode occurs a little bit.
David Amor: But I think the opposite on the spectrum is folks that really overestimate the amount or the depth and robustness of a quality system that's necessary for a startup. I think the key there is, not every company is Medtronic, and nor does the FDA or any notified body in Europe really require or expect that a startup that is pre-revenue really has a quality system in place that is comprised of a billion documents. I think that's one of the other factors in this quality system world, is understanding where you really fit in the FDA and the regulators eyes, and what you have to do to meet those requirements.
Jon Speer: Right. I'll share a short story about my first, I guess, consulting [chuckle] experience when I started my consulting practice many years ago. I was working for a startup. And the key term, you really covered it very well, explaining it very well, but the key term I've always used is you want your quality system to be right-sized.
David Amor: Exactly.
Jon Speer: Right? But this short story, it was a startup, pre-revenue. They had some funding mostly in the form of grants but let's just say they were operating on mostly a shoestring budget, and they asked me to come in and assist with some quality system initiatives and a lot of the foundation for this quality system had been laid by a consultant before me and the quality system was beautiful, it was very thorough, very complete. The trouble is, the company wasn't following it because it was too too...
David Amor: Complex.
Jon Speer: Too overly burdensome. Yeah, too complex.
David Amor: Yeah. No, that's a great story. That highlights the problem. Right? I think you often have this one size fits all approach where, a lot of folks like to copy... A lot of these people in startups are ex-employees at different organizations, so they think, "Oh, I worked at Boston Scientific, so let's take what we did there and really fit it into this company." And you're absolutely right. By the time you know it, you're looking at processes that become too expensive or too burdensome for companies. And look, let's be honest, Jon. I think it's just as important that companies get to market as having a robust quality management system in place. If you break the bank trying to get to market because you're spending all this time and effort and money on your quality system, and you can't get to market, patients are ultimately impacted. They're not gonna receive the therapies that you set out to give them.
David Amor: It really is a fine line between knowing exactly what you need to know in order to actually have a quality system that meets the requirements and also makes sense. As an example, one of the things that I usually recommend to people is there's one common question. It's, well, what is enough? What are the really big quality system elements that need to be in place? And I think an easy answer to that is, "Well, let's just see what the FDA says."
Jon Speer: Right.
David Amor: The FDA literally publishes the Quality System Inspection Technique, otherwise known as QSIT amongst ourselves, that really tells you... This is basically a training manual for their inspectors that are reviewing quality systems, and it really identifies four main key areas, four to five, but I'm gonna focus on four, that are extremely critical for companies. Management controls, it makes sense. You have to ensure that your management is aware of what's going on in your company, that they have significant control over resources, that resources are qualified. That's a very, very big key. That's one of them. Second one of them is design controls. And I think we've shared a lot of articles on design controls on LinkedIn and everything, because it really is critical. Complying with 820.30 is the key to developing a product, which is frankly the primary focus of these companies getting their first products to market.
David Amor: CAPA. CAPA is the agency's window into your company, so that's the third really big area and focal point, having a robust CAPA system that's gonna correct and prevent any form of non-conformances, discrepancies, and end product issue. That's really key. And the last one is, the same thing as design control. Once you're actually in post production, it's controlling your process, so production and process controls. It makes sense. You gotta control who your management is, how you're designing products, how you're controlling processes to build that product, and then at the end of it, if any of that goes wrong, how you're controlling it through CAPA. I think that's kind of the way that I would recommend approaching that.
Jon Speer: Yeah, and it sounds a little, maybe trivial, but it's just, if you follow the regulations, it's basic blocking and tackling. You gotta just think about it logically. Here's one of the things that I've always recommended to this early stage or pre-revenue startup. Certainly, that CAPA piece is important in a post-production world or go to market world, and as you gear up towards pilot manufacturing and things along those lines, and of course, management responsibility is important. But when you're still in just the product development process, and you haven't even submitted your 510(k), I mean, CAPA. Really, can you do much with CAPA at that point?
David Amor: Right. Right. No, and that's actually a really good point, Jon. I think it is really critical to distinguish between pre-market and then post-market. When you're doing your 510(k), you're really trying to demonstrate safety enough because you're right against the predicate. When you're doing an analysis of technological characteristics, do you need to have a CAPA process in place? Probably not. At this point, this is all pre... During development. You have to be flexible, you have to be lean. You shouldn't be worrying about non-conformances because let's be frank, there are no non-conformances. You don't have a product out the door yet.
Jon Speer: Right
David Amor: Yeah. That's a really... That's a very good point. I think the distinction is important, like you said, to make it between how to get to market, and then after you launch, what you have to implement. And even that there's a period, after post-production when you get to market, to really keep it lean before you start building up your volumes, before you you start building up our sales. And you could probably create a mathematical equation on how robust does my quality system need to be, and that's a variety of factors, as you know. It's the risk of the product. A toothbrush manufacturer's quality system is probably gonna be a lot more lean than a brand new PMA device that's a cardiac pacemaker. Right? I think that comes into play. Your quality system probably needs [chuckle] to be more robust on the cardiac pacemaker side. Product risk, those are important.
Jon Speer: Yeah, and it's funny though, that you see, you and I get to see it from the outside looking in sometimes. And we can always quickly identify, "Well, this should be done, this should be done, and that should be done." And I can imagine from the startup's perspective, it can be a little overwhelming, at times, because if they've never been through the medical device product development process before or haven't implemented a quality system, when you or I are talking to them and advising them, saying "Hey, here's what you need to do from a quality system standpoint," I can imagine it's really difficult to understand the vision that you and I are trying to convey to them. "This is what you do first, and this is the next pile, and then here's your last pile." I can imagine that that could be overwhelming.
David Amor: Absolutely. And I think the key there is really starting with the regs right. I think, compliance is one thing, but I think adequacy of compliance is a secondary thing. If you look at the 820 regulations, if you look at the quality system regulations, you could probably read through it in about 10 minutes. It's not very substantial, it's really lean, just makes some key points. It's really the interpretation of those regulations that becomes critical. Hiring a consultant, or having somebody internal on the team, that can not only regurgitate the regulations, but really give you some practical implementation advice, is really critical so that you avoid issues like you were saying. That's the key thing, I think there.
Jon Speer: Yeah, I think that's the difference makers. I can give you a quality system right now that meets all the regulations. And so what? It's not about just having the quality system at the end of the day, it's about having the documentation, the records, and actually putting it to practice and to use. And then as you mentioned a few moments ago, constantly being... Identifying opportunities for improvement and tweaking and modifying and adjusting that quality management system to align with your particular business needs.
David Amor: Yeah, you're actually right. I think a good example of what happens when you don't maintain a robust quality system is what happened with Theranos. If you look at the Theranos case, there's a lot of talk about the mislabeling and all of that jazz, which is just fine and dandy, but if you look at the 483s, the real keys there are really the lack of a proper design controls process.
Jon Speer: Right.
David Amor: And I'm a big fan of The Theranos company. I'm a huge proponent of them, I love the company, I love what they're doing, but if you look at their 43s, it truly does tell you how critical all of these different pieces of the quality system are. If you're a startup out there and you say, "No, we could probably get away with having a quality system in place." If your company scales to a Theranos-like level, where they have a, whatever multi-billion dollar market cap already.
Jon Speer: [chuckle] Right.
David Amor: You better expect some challenges from regulators on the robustness of your quality systems. Just keep that in mind.
Jon Speer: Well, and I think, here's the other interesting note. Every startup I talk to, they all want to be hundreds of millions of dollars [chuckle] or bigger in revenue, and I think the key take on there is, great. I hope you're successful and able to do that. And keep in mind, the bigger your company gets, the more scrutiny you're gonna get from the FDA and the higher that level of expectation is from FDA that your quality system is thorough, robust, and complete. And I think that the time to build that is when you're small. When you build that foundation, and you lay the groundwork for your quality system, and then just continue to build and scale, and as I said a moment ago, right-size your quality management system to align with this type of company you are at that moment in time.
David Amor: No, that's perfectly stated. You brought up the key point there, which is in the point of time that you are in. The FDA, one of the articles I wrote on how to implement a quality system. I reference this FDA guidance. It's withdrawn now, but it's not withdrawn because it's not applicable anymore. It's just withdrawn for other reasons but one of the things that I thought was very interesting is, if you're ever questioning whether or not a startup needs a quality system that's Medtronics sized, take a look at that guidance.
David Amor: It basically says that FDA recognizes that a small manufacturer may not need the same amount of documentation that a large manufacturer does in order to achieve a state of control, and that some of the records maintained to fulfill the GMP requirements for written procedures may not be as long, as complex for a small manufacturer. That's verbatim. That's literally what regulators are saying. This isn't David and Jon saying, "Hey, [chuckle] recognize where you're at and scale accordingly." This is the regulators that are gonna be sending out great fantastic phenomenal inspectors to review your company's stuff. That just gives you an example of the fact that there is an understanding from regulators and this applies to notified bodies too, that your company's quality system should be as complex as your company, frankly.
Jon Speer: Right, right, right. So yeah. I was just gonna make that point. And I'm glad you mentioned that. We've obviously been speaking somewhat FDA-centric today, but everything that we're talking about applies whether you're in a FDA US, FDA CFR 820 environment, or in an ISO 13485 environment.
David Amor: Yeah, absolutely. And just recently, for example, I was in a stage two audit with one of my startup clients and we had this conversation, and I think one of the auditors from BSI, a notified body in Europe, was saying, one of the things we wish we can tell startups is, and I thought that was very interesting and very apropos, is we care more that you're following your procedures and not that your procedures are the best procedures in the world. I think that's really, resonates with me and really, frankly, makes sense because they wanna see a working quality system that you've addressed, or 13485 requirements required by the directives. 9342, you see for medical device directives. If you go for... If you're looking at using Annex II, which is your quality system demonstration, as long as you can demonstrate that you meet those requirements, in some sort of way as a startup, you're in good shape. So...
Jon Speer: Right.
David Amor: Their comment was really well received. As long as you have a procedure in place, and you follow that procedure, again, [chuckle] follow that procedure, that's better than having these, like you said, Jon, beautiful complex 30-page or 30,000 documents [chuckle] worth of quality system that ultimately doesn't get followed.
Jon Speer: Yeah. Yeah, I spoke to somebody recently, a startup, and bounce a couple of things off you and get your insights here, but... And I'll start with the story, and then let you chime in. But this guy calls me, and they're a startup, and they've already got their 510(k) clearance. And I don't know what the trigger was for this phone call, but the guy suddenly realized that he needed a quality system, that he needed design controls, he hadn't documented any design control activities, that he needed to establish his risk management documentation. And that's not a one-off incident. I've had numerous calls, same sort of thing, in the past six months, so I guess it's...
Jon Speer: I'm confused a little because, to me, you can't put together a 510(k) unless you have design controls. And to me, you can't do design controls unless you've defined a procedure to do that. But again, I've been in this 17 years, so sometimes I can't see the forest for the trees, but I'm just curious what your take is on that type of scenario.
David Amor: It's really funny you asked that. I had a... A very good friend of mine is an ex-FDA reviewer, and we had this conversation because I agree with you 100%. My perspective is the same. It's you're developing essentially, although it's not a formal requirement in the 510(k) that says, "Hey, you need to submit a full design history file, a DHF," as you know, Jon. It does make sense though that you would have to develop a product under design control, which yields a DHF that you would be submitting for your submission. I asked her, and I think her perspective, and something that I think makes sense is that, the FDA, what they're really looking at, at the 510(k) stage, when you're really ready to get a product to market is, that you are the same as your predicate.
David Amor: You've demonstrated substantial equivalence, but from a technical and safety perspective, you're at least equivalent or if you're not equivalent, if you throw in an extra curve ball into the mix here, from a technological characteristics perspective, that you're at least as safe or more safe than your predicate. That's the primary focus. I think, as long as you demonstrate that in your 510(k), by using whatever documentations that you'd like to use, that's really the perspective that they're looking at. But again, I would agree with you that, that usually, and it's easier almost for startups if you think about it, to look at 820.30 and develop a set of documentation against 820.30 even as early as a 510(k).
David Amor: If you think about it, if you're preparing your 510(k) submission material and you go through everything in 820.30 and say, "Do we have a design plan? Yes, we do. Do we have design inputs? Yes, we've defined them. Do we have design outputs? Yes. We've done design verification and testing approved that those tech characteristics are the same and that this thing is safe. We validated the product to make sure that the needs are met, etcetera. All those things that are typical of a DHF. You tell me, Jon, does that not seem like a pretty easy and practical way to approach a 510(k)?
Jon Speer: It seems so obvious to me and I'll carry that story that I mentioned a little bit further. The person has asked me to help them put together a design history file for them. And the beautiful thing, I guess, is he provided the 510(k) submission. And I've been able to go through that 510(k) and highlight, and circle and point out, "Okay, you got all the stuff. It's all here. You just didn't capture it in a design history file, so that's what we've got to do now. We've got to extract it from that 510(k), put it in a format that makes sense in a design history file." But yeah, it totally makes sense. Again, I hate to make it sound trivial, but it is basic blocking and tackling. And if you just think about it from a logical perspective, you're designing a brand new medical device that you think is the best thing ever. Shouldn't you have the objective evidence, in the form of some sort of documentation and records, to be able to demonstrate that you designed it properly, that you've tested it and proven that it's safe, and that you've confirmed that it works the way you want it to?
David Amor: 100% agree, and let's not forget why design controls was implemented in 1997 anyway. If you think about it, that's not that long ago, you're kinda surprised sometimes...
Jon Speer: I know.
David Amor: When you think of, "Wow, this is only something that's been around since '97." Let's remember that the reason that it came to be was because most of the field actions, and most of the the MDRs, and the complaints, and the bad adverse events that were happening in the field, those failures were attributed to poor design. Let's just keep the regs out of this for a second. Let's just think about this logically as medical device inventors and engineers, and people who wanna do good in our industry. We should have control of our design. I know that's really silly and very cliche, if you will, but that's literally what design control is. It's showing objectively, like you said, Jon, that you have considered everything from planning out the design, so that you have the right resources and you could talk about a timeline and when you're gonna get this thing done, so the market expects it, all the way through through validating the design to make sure that what you actually built was built right, and that you built the right product. I think those two things are really critical. I think it makes sense to me.
Jon Speer: David, I've enjoyed our conversation today and I'm just gonna put a bug in your ear. It's something that we should do in an upcoming podcast. You recently published an article on LinkedIn, on the topic of research versus development for med device company. [chuckle] And that was a great, great read. But how about this, how about we schedule a time, you and I, and we have a conversation about that particular topic for a future podcast?
David Amor: That sounds fantastic. Maybe we'll do it a debate style where you take the [chuckle] R, I'll take the D and...
Jon Speer: I didn't want the R, but yeah, that's fine. No, that would be fun. Yeah, we should definitely do that. So David, I'll let you have... Tell us a little bit more about where people can find you, about Medgineering, about My Quick Consult.
David Amor: Sure, thanks, Jon. Myquickconsult.com I really suggest everyone take a look at it, especially startups. We really built it for large companies and startups, but if you go to myquickconsult.com, you really can find an on-demand network of experts, med tech experts. These are guys that are ex-FDA, they have been in... Regulators in other industries and have really solid med tech credentials, that you can basically ask questions to about your med tech problems, for a flat rate of $199. It's really a really great way to get some third party reviews of anything that you're going through, confirm your quality system requirements, as we were just speaking about, and really have that network of experts on demand all online. Check out www.myquickconsult.com, and if you email me at email@example.com, M-E-D-G-I-N-E-E-R-I-N-G.com, I'd be more than happy to extend a discount service to all of the listeners of this podcast, really to thank Jon and the wonderful things that he's doing with Greenlight.guru and this podcast.
Jon Speer: Oh David, appreciate that offer. And you can search for David on LinkedIn. Last name, A-M-O-R. He puts out some brilliant, easy to follow, great reads, posts and articles that... On topics that are fresh and relevant to the medical device industry. So definitely check it out, be sure to comment, reach out to David. He's very accessible and willing to help.
Jon Speer: Hey, this is Jon Speer. I'm the founder and the VP of Quality and Regulatory for Greenlight.guru. Greenlight.guru, we're making some pretty kickass software that helps med device companies manage their quality system, their documents and records, keep track of all their design controls and design history files, and we integrate your design and development activities with a pretty slick ISO 14971 compliant risk management feature set. So check us out. Greenlight.guru. This has been Jon Speer and my guest David Amor today on the Global Medical Device podcast.
About The Global Medical Device Podcast:
The Global Medical Device Podcast powered by greenlight.guru is 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.