How to Think About Quality and Regulatory as Your Company Scales

August 1, 2018

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As companies transition from being a start-up or small company to a more established business and bring new medical devices to market, they tend to not put a lot of thought into their processes, systems, and approaches for regulatory strategies and quality systems.

Regardless of the shape and size of your company, these factors are foundational to the growth and success of your business.

Host Jon Speer and Mike Drues of Vascular Sciences discuss key tips on what to think about regarding regulatory and quality during a transition. It is about doing the right thing - prudent engineering.


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Some highlights of this episode include:

  • Theoretically, regulatory agencies have an independent approach, no matter the nature of the company they are working with.
  • When starting to work with agencies, it is like a first date - and first impressions make a difference. Pre-submission process is a great place to start.
  • FDA is now much more interested in building collaborations with medical device companies, but it still has a responsibility to uphold regulations.
  • Cleaning up after someone else’s mess and doing damage control; bumps in the road with FDA, but let’s start with a clean slate.
  • Eyes glaze over when small companies are told to have a quality management system (QMS). Right size your QMS: There are things you can do now.
  • Evaluate your company’s regulatory strategy and QMS to make sure they can be integrated in a minimally burdensome way.
  • Focus on content/information and intent behind what you are doing. Forms and procedures are important, but focus on what matters most.
  • Companies measure efficacy of a device, but how often is the efficacy of systems and processes measured? Implement failures/errors to measure efficacy.



FDA Medical Devices

FDA Pre-Submission Process

Greenlight Guru

Mike Drues on LinkedIn


Memorable quotes from this episode:

“The vast majority of the medical device industry is the smaller companies...which poses some advantages, but also some challenges, as well.” - Mike Drues

“If you’re a start-up company, you really don’t have a regulatory footprint established...that first interaction is pretty important.” - Jon Speer

“Whether we’re talking about small companies or large, for the first be at the point of submission.” - Mike Drues

“The much more interested in building collaborations with medical device companies.” - Jon Speer


Recorded Intro: 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:        Sometimes companies, as they start to bring new products to market in the medical device space, the process is the systems, the approach that they have. When they're early, they don't put a lot of thought into it quite frankly when it comes to regulatory strategies and quality system approaches and that sort of thing. Oftentimes, there's just an effort to slap things together, but it is important, regardless of the shape and size of your company, that you do spend some time thinking about those things, because they are important and they are foundational to the growth and the success of your business. Whether you're a small company, a large company, a start-up, an established company, I'll encourage you to listen to this episode of the Global Medical Device Podcast, where Mike Drues and I talk about some of the key tips and things that you should be thinking about when it comes to quality and regulatory.

Jon Speer:        Hello, and welcome to the Global Medical Device Podcast. This is your host, founder, and VP of Quality and Regulatory at Greenlight Guru Jon Speer, and this morning I brought my good friend Mike Drues back to the podcast. Mike, welcome to the Global Medical Device Podcast once again.

Mike Drues:     Well thank you Jon. It's always terrific to share the stage with you and to speak to your audience. I look forward to our conversation.

Jon Speer:        All right, and I know in your work with vascular sciences that you work with a lot of different companies, shapes and sizes, big and small, and one of the things that ... We do as well, but one of the things that I see that can be challenging for a lot of companies is really making that transition from being that start-up, that small company, to being more of an established larger company, and I thought you and I, maybe we could take a few moments today and talk about making that transition from being a small company to a larger company. Or maybe a better way to say it is transition from a start-up company to a more established company. We could dive in and talk about some tips that might help these companies who are in that transition phase. What do you think?

Mike Drues:     I think that would be great Jon, and you're exactly right. One of the cool things about my job and my regulatory practice is that I do get a chance to work with the entire span, the entire spectrum of companies from the smallest of the small, literally one or two people still working in their garage or their basement, all the way up through to the biggest of the big, the Fortune 50 and Fortune 100 companies that have been around for decades if not longer.

Mike Drues:     There are a lot of similarities and a lot of differences. One thing, as we get started Jon, I'd like to just point out it's not just the company size in terms of employees that really matters as much anymore, because there are some companies that are quite small in terms of head count, but because of outsourcing, they're essentially running as a large company. One of the companies that I work with actually, they only have about a dozen people on the payroll directly, but it's a publicly held company, and they basically farm out everything. It's not just simply the company size that we need to think about here, but anyway, let's continue.

Jon Speer:        No, I think that's a really good point, because I think it's easy to think that, "Oh, I'm a small company," or "Oh, I'm a large company," or what have you, and back in the day, we used to judge or gage the size of a company almost exclusively by the number of employees that they have, but you just cited a really good example where the company itself may only have 12 employees, but it sounds like they have several products to market, and it sounds like they're working with a lot of other third party resources, contract manufacturers and the like, that really makes them much bigger than their employee head count.

Jon Speer:        And I think that's probably a good place to start, because I think that there's ... I'll give you an example. I talked to this IBD company a few years ago, and they had a few products to market and had a pretty healthy pipeline of other products that they were planning to bring to market over the next several years, and they said to me, they said, "Jon, we're a really small start-up." I'm like, "Oh wow, how big are you?" They said, "Well, we have 150 employees and we're looking to hire another 50 employees in the next two months. We're really small." And I scratched my head a little bit, because I'm like, "Mike, these guys aren't small. That's ..."

Mike Drues:     How do you define small?

Jon Speer:        Yeah, how do you define small?

Mike Drues:     Bigger than a bread box kind of a thing.

Jon Speer:        I think an interesting statistic that very few realize is that something like 80% of medical device companies have less than 50 employees, and I think very few people realize that.

Mike Drues:     I think you're right Jon, and that's a statistic that I use many times myself, and I know obviously this is ... We speak to mostly a medical device audience, but this is one of the big differences between the medical device industry versus the drug or even the biotech industry, and that is the vast majority of medical device companies out there, with all due respect to my many friends at Medtronic and Boston Scientific and so on, that's not the bulk of this industry. What you just mentioned, that 80% of companies have 50 or fewer employees, it's the very small, a couple of dozen or in some cases literally a couple of people, sometimes even still working in somebody's garage or basement that makes up the vast majority of this business.

Mike Drues:     And perhaps this might ruffle the feathers of a few folks in our audience from the larger companies, but I think as a general rule, that's where usually, and you can agree or disagree with this Jon, but that's where usually the coolest and the most innovative ideas come from. There's, without getting into a lot of the business issues, there's obviously a lot of advantages of a medium or a large company investing in a small company, taking what's called first right of refusal and letting that small company take the risk, so you're exactly right. The vast majority of the medical device industry is the smaller companies, and as we'll get into today Jon, that poses some advantages but also some challenges as well.

Jon Speer:        Yeah, and maybe this is, as we talk a little bit today, whether it's that transition from small to large, maybe it's a mindset thing, and maybe really what we can dive into today is how do companies make necessary transitions based on the stage or type of company that they are, regardless of size? The company that you mentioned, 12 people, I'm sure they didn't start with 12 people. They probably started with a couple of people and it grew from there, but they've evolved over time, and as they've evolved, they've had different needs or different systems or different approaches that they've needed to establish from a business strategy standpoint across a number of different areas.

Jon Speer:        I guess one question, and I know you deal a lot with different regulatory agencies in addition to working with the actually med device companies, in your opinion do regulatory agencies have a difference of opinion or a different view or approach when working with a small start-up versus a large established company?

Mike Drues:     That's a great question Jon, and thanks for the opportunity to have this discussion. Short answer is theoretically, according to the regulation, the regulatory burden that a company has to satisfy, in other words the number of hoops that they have to jump through to get their particular product on the market, is totally agnostic. It's totally independent of the nature of the company, be it size or revenue or how long they've been around or anything like that. In other words, theoretically whether the company is two people, employees, or two million employees, that should not make a difference to the FDA or to any other regulatory agencies in the world. Notice I'm saying theoretically. That's not always reality, and perhaps we can talk about some examples as we continue.

Jon Speer:        Yeah, and I've always heard if you're a start-up company and you really don't have a regulatory footprint established with FDA or Health Canada or what have you, the first submission or that first interaction is pretty important, because you're starting to, in a manner of speaking, you're really starting to establish a baseline with the agency. Would you agree with that sentiment?

Mike Drues:     I would absolutely agree with that Jon. Not to be sexist, but to use a metaphor, it's like dating and your first date. It's that first impression that really matters, and chances are obviously if you're working for a well-established company that's been around for awhile that has a number of products on the market, perhaps that might become a little bit less important, because your company does have a history with the FDA whereas if you're working with a start-up or a small company that doesn't have any products on the market, that nobody has ever heard of before, and this is your first interaction with the agency, obviously they're not going to know you from Adam, so to speak.

Mike Drues:     But I've seen it happen a number of times where, even people coming from a large company, it might be, it probably is a different group of people that are going to the FDA as opposed to people that have been dealing with the FDA in the past or maybe a different division of that larger company, so even in large companies, you still have that first date phenomenon.

Jon Speer:        Yeah, and so folks, maybe that's tip number one: realize that your interactions with regulatory agencies are important, and in it establish ... If it's your first interaction that you're establishing that baseline, this is said another way, this is an indicator to regulatory agencies like FDA, this is what they would expect of things to come from you and from your business, so that first interaction's important. Mike and I have talked a great deal about things like pre-submissions in the past. That's a really great way, if you're a start-up bringing your first product to market, a really great way to establish that good baseline is through that pre-submission program.

Mike Drues:     Once again Jon, I agree 100%. I was just going to remind our audience of something very similar. Regrettably, it's still common practice I think across our industry, whether we're talking about small companies or large, for the first impression, the first date if you will, with the FDA to be at the point of submission, whether it's a 510(k) or De Novo or PMA or whatever it is. I think that's ... I don't want to go so far as to say that that's a mistake, but I think you're taking a huge regulatory risk, because I'm certainly a fan, and I think you are as well Jon, of going to the agency in advance of your submission in the form of a pre-sub or something else, and presenting your plan to the agency and making sure that everybody is on the same page, that we're all pulling in the same direction. I think that's good advice.

Jon Speer:        Yeah, and folks, even if you maybe already had your first date with FDA or another regulatory body, and maybe looking back it didn't go as well as you had hoped or as you'd planned, there's some truth in first impressions are a bit lasting, but you have an opportunity to correct the situation and to improve that relationship. I think today, the FDA that we have in the industry today is much more interested in building collaborations with medical device companies. Do remember, at the end of the day, they are a law enforcement agency. They do have a responsibility to uphold regulations as well, but you still have an opportunity to improve that situation, but for those small companies, do focus a great deal of effort and attention and energy on those interactions with the agency. Because ... think about it. As you bring that product to market, this now becomes your stake in the ground, so to speak, of products that are going to enter into the marketplace, that are going to be used for ... a variety of different procedures to help improve lives. And if your product has some sort of issue or you have some sort of challenges or changes that need to be made to your product at that point in time. How good is your relationship with the agency, how well do you work with, collaborate FDA, if and when those types of situations come up.

Jon Speer:        Cause that's really important, too. Let's fast forward to that startup that just launched a product and maybe they're getting a few bumps, maybe they're having a few issues in the field. I can imagine that'll be a pretty important set of behaviors to make sure our employees do for this types of companies because ... once you started ... the pre-market is one thing but once you go to market and start managing post market activities, that's pretty important as well, from a company standpoint.

Mike Drues:     Absolutely agree, John. And before continuing on, I would take that just a half a step forward. Obviously, first impressions matter very much, but if for whatever reason your first impression is not very positive, it doesn't go well in the pre stuff or you're not as prepared or ... FDA just doesn't see it the way you see it, it's not that ... if you have a sub-optimal, to use that medical phrase, first impression. It's not the end of the world, it's not like you have to pack things up, close your business, and go home. You can go back, regrettably, a fairly good chunk of my business is coming in, quite frankly, to companies and cleaning up after somebody else's mess.

Mike Drues:     In other words, they tried to do something themselves, or they had some other regulatory consultant who just did not do a good job and now they're not in a good situation with the FDA, and now we have to go back and do damage control. And that's exactly what it is, it's damage control. One of the first things I'll say in these situations is, look, we understand that in the past, the company had some bumps in the road, but there's a new game in town. Let's start out with a fresh slate. Bottom line, it's always best, if possible, to make that very good first impression and I work very hard with companies to be successful at that.

Mike Drues:     But in those scenarios where somebody did screw up, or at least didn't do as good of a job as they could have, it's not the end of the world.

Jon Speer:        Right, okay.

Jon Speer:        So let's ... imagine that a company is trying to ... they're at this point, they're at this transition whether they're going from small to large or startup to establish or whatever the transition point is, they've been through some pre-submission activities. They've been through some 5, 10ks, or PMAS, whatever the case may be. And they've been successful at getting products into the market.

Jon Speer:        Let's ... give some thought to ... what are those types of things that this company should be focused on now? They've got maybe a pipeline of products that are still in the development, a few on the market. There are certain behaviors that are now expected of a company at this state that would be different if they were just that small, early stage, two person startup working out of a garage. Does the behavior or mindset need to change?`

Mike Drues:     I would submit, john, that if they have the proper mindset, to use your word to begin with, then there is no change in mindset as the company grows. But let me explain what I mean by that. We've talked a little bit about the regulatory side so let's shift over and talk more about something near and dear to your heart, and that is the quality side. And having QMS in place and design controls and all of that. Most very small companies, especially companies that have literally just a few employees, they honestly are not keen on a lot of paperwork, a lot of forms, a lot of red tape, a lot of process. So when you talk about putting together a QMS, having design controls in place into one, I don't know about you, john, but their eyes just sort of glaze over.

Mike Drues:     What I would say to those companies is okay, it might not be necessary at this point to have a full, robust QMS in place. You don't have to have all the design controls, and I'm sure, John, you're thinking oh my go this is heresy, but let me explain what I mean and then I'd love to hear your thoughts.

Mike Drues:     There are things that you can be doing that a small company can be doing now, even if they still are very, very small, in order to make that transition to a larger company if their company is acquired, something like that ... much easier later. I don't know if I'm explaining that very well, john, but maybe there's some examples that you can provide and how small companies can do exactly that.

Jon Speer:        Sure. One of the big things that I talk about, folks, a quality system is something that should always be top of mind if you are a medical device company. Mike is correct, and so let me give you a slightly different perspective to explain the situation, especially as it relates to quality management systems. The thing I always talk about is you need to right size your QMS. And what I mean by that is needs to reflect the shape and size and stage of company you are. If you're that early stage startup, yeah, there's probably a few elements of a quality system that apply to you, but once that company gets into manufacturing and into production and launching your product to the marketplace and selling your products, your quality system should look a lot different at that time. It should have evolved to be in alignment with the shape and size of company that you are at that point in time.

Jon Speer:        Now with respect to things like design controls and risk, there's levels to this for sure. If you're in early feasibility, early research ... design control may not ... you may not be at that point where it makes sense or it applies. But as you start to choose a concept and start to do formal testing and prepare products for animal studies and clinical evaluation and regulatory submissions and so on, you're certainly at a point where your design control practices need to become more formal and need to be better established in the form of processes and procedures. It's an evolution, for sure.

Mike Drues:     I agree, john. And by the way I loved that phrase that you used, I think I've heard you use it before, "right sizing your QMS." I think that's probably a John Spear-ism, I'm guessing [inaudible 00:20:11]

Jon Speer:        Well I don't have a trademark applied to it

Mike Drues:     Well maybe you should

Jon Speer:        Maybe ...

Mike Drues:     You're exactly right, and that's ... thank you for helping to explain what I mean. I've been ... another important part of my business on the regulatory side and to a lesser extent on the quality side, if I'm working with a startup and they're looking to ... they have a potential corporate partner who's looking to acquire them, helping them make themselves attractive, so to speak, to the larger company, to make sure that their regulatory ducks are in order, to make sure that their quality ducks are in order.

Mike Drues:     Similarly, on the large company side, many times, large companies will ask me to help evaluate the regulatory strategy, to help evaluate the QMS of a small company to make sure that they can integrate that small company into that larger company in a ... let's say in a minimally burdensome way. Bottom line, and this is ... going back to the mindset that we talked about a few minutes ago, John, if the company is doing what they should be doing and documenting what they should be documenting, and I don't necessarily mean in a very formal way with the right forms and stuff. This might sound a bit like a heretic in the regulatory or quality world but I don't care about if a company's using the right form or something like that. What I'm much more interested in is the content.

Mike Drues:     So if they have the content in place, that can always be put into the proper form later. But if for whatever reason they don't have the proper content, then, now you start to have problems. Am I wrong, John?

Jon Speer:        You're no wrong. And it's a really great way to say it. I think sometimes when people think about ... quality systems and regulations, the knee jerk response is that that's rigid, that's stifling, that's burdensome, it's red tape. I'll be honest, folks, if you feel that way about your quality management system, you probably have the wrong quality system. You probably don't have a quality system that's right sized for your organization because, Mike makes a terrific point, it's less about making sure you've checked the right spot on the form, it's more about the content that you're capturing.

Jon Speer:        Now, don't miss here anything that mike and I are saying. It is important to document decisions, it's important to document this information, but focus on the content. Don't get so hung up on is it on this or is it on that or is it here or is it there ... do get organized and do make sure that you are focusing on the content and I'd take it maybe even a slight step further. The intent behind what it is that you're doing, make sure that you're documenting your decision making process, your rationale, your explanation. Good, prudent engineering to bring in a Mike Drues- ism a ... that was hard to say, Mike ...

Mike Drues:     Well thank you for reminding the audience of something that you and I have talked about many times over the years, what I call prudent engineering.

Mike Drues:     Just one last tiny bit on that forms issue ... regrettably, after being in this business now for a little over twenty five years, both as a professional biomedical engineer as well as a regulatory consultant, I do meet people in companies. Even in the FDA, who I really think, sometimes they put more emphasis on the forms rather than the content, and what I often remind them, and I've said this, john, at the FDA before, I've said look, there are hundreds of parameters that will affect the safety and efficacy of a medical device. But I guarantee one of them will never be the form that we put that information on.

Mike Drues:     So yes, forms ar important, procedures are important, and so on, but let's not lose track of the big picture. Let's not forget about what matters most.

Jon Speer:        Yeah. Folks I wanna remind you all that I'm talking with Mike Drues. Mike is the president of vascular sciences. He is a regulatory expert that works with medical device companies of all shapes and size, all over the world, as well as regulatory agencies like FDA and Health Canada. As we're talking about this topic about making this transition from ... startup to establish or small to large or however you wanna describe that, some of the things that we're hitting on today is the importance of sound, regulatory practices. We're starting to talk a little bit about the importance of sound quality management systems practices as well. And being focused on the content. The information about your products and processes.

Jon Speer:        And this is a big part of what we're all about at GreenLight Guru, as well. We built the only EQMS software platform for the medical device industry in the world. So if you'd like to learn a little bit more about our software platform and how we might be able to help you transition from being just a check box mentality or a compliance mentality, or I have to do this, fill out this form to really architecting your quality way that is right size for your company, you should go over to to learn more information.

Jon Speer:        So, Mike, I think one of the big mistakes I see a lot of big companies make is they slap a lot of things together ,to kind of revisit what we chatted about this morning, they slap a lot of things together. They go on the internet and they buy a bunch of forms so they can check a bunch of boxes. They don't put any thought or real strategy into the systems that they're establishing in their business. It's like a mad dash to get this product launched.

Jon Speer:        And then they launch it, and they don't ever go back and spend any time on their processes or their systems, and they just keep adding to it, adding to it, adding to it.

Jon Speer:        My favorite example, favorite might not be the best choice of words, but I'll go with it for a moment. I worked with this company a few years ago, and they had really transitioned from being that small start-up to a mid-stage company. They had a handful of products to market, there were around 30 or 40 employees at that point in time.

Jon Speer:        They were a decent-sized company, but they never really focused on the architecture of their quality system. They never focused on the architecture of the regulatory framework for the product, so they just kept adding to, adding to. They would issue themselves a kappa, and the result of the kappa would be to create yet another procedure. They were just throwing paperwork at it, and it just was poor intention.

Jon Speer:        You talked about, you were brought in to help companies that maybe need some mitigation work on regulatory or quality.

Mike Drues:     Clean up somebody else's mess.

Jon Speer:        Clean up somebody else's mess, but for a company that might find themselves in that situation, what should they do?

Mike Drues:     Well, first of all let me say, John, to me, a lot of what we've talked about today, and indeed, a lot of what we've talked about in our many conversations over the years, comes back to mindset, comes back to what I would call "regulatory logic," or perhaps to introduce a spin on that, "quality logic."

Mike Drues:     To me, it's not the forms, it's not the regulatory requirements, it's not even the process. It's the thinking. It's what you referred to earlier as "the prudent engineering." And whether we're talking about a very small start-up, or a very, very large, well-established medical device company, ideally, that regulatory logic, that quality logic, that mindset, whatever you want to call it, that should be the same. That's point number one.

Mike Drues:     Then, second point, what should they do, I think this is something, John, that you and I have talked about in some of our quality discussions. I find it very interesting that all companies are required to have quality management systems in place that meet the regulatory requirements, but why would anybody assume that just because somebody has a QMS that meets the regulatory requirements, that it actually works?

Mike Drues:     I don't make that assumption. Unless, of course, they're using the Greenlight software to [inaudible 00:28:50], then obviously we know for sure it's going to work.

Mike Drues:     The point that I'm trying to make is very simple: we're very used to think about measuring the efficacy of our device. But how often do you hear of people measuring the efficacy of our systems, including our QMS, our kappas, our complaint handling, everything else?

Mike Drues:     I've made the suggestion to a number of companies over the years, why don't you consider purposely injecting a problem into your system somewhere, to see if your system is capable of detecting it? Measuring the efficacy of our system.

Mike Drues:     Think about it this way, John, and I would love to hear your thoughts on this. What good is having a quality management system, even if it meets the regulatory requirements, but the system, for whatever reason, just doesn't work? Or it doesn't work as well as it could.

Mike Drues:     To me, that's just a colossal waste of time and money. Am I just naïve, John, or stupid?

Jon Speer:        Well, I don't think you're naïve nor stupid on this topic, or frankly any other that we've talked about. It's a really good testament.

Jon Speer:        A specific example that I'll hear is, sometimes companies have a little fear of transitioning to an EQMS system, because they can open a drawer, and they can pull out piles of paper, and they can touch and feel, and they can see the binders or what have you. They take comfort in that, in some respects, because they feel that they can see it, it's therefore safer.

Jon Speer:        Sometimes I get challenged with, "Hey, what about backups and disaster recovery and security, all these sorts of things?" And, yeah, we address all these things. Interestingly enough, I would venture to guess that every medical device company today is relying on some sort of electronic documentation or system, whether it be a server, or ERP, or whatever the case may be.

Jon Speer:        The interesting thing that a lot of companies don't think about, they all have procedures in place for disaster recovery, that describe "these are the things we need to do," in the event that there's some sort of disaster. You don't pick the disaster, whatever the case may be.

Jon Speer:        But companies never test that procedure, that disaster recovery procedure until they have to.

Mike Drues:     That's a good example, John. And that's not the time to find out that it doesn't work.

Jon Speer:        No. Short story on this. I was working with a mid-sized company a few years ago. There were some storms, a lot of hail, a lot of wind, and it had ripped a hole into their roof of their manufacturing facility. It happened, as of course these things tend to do, over the weekend when nobody was at the facility and on-site.

Jon Speer:        But what had happened was, for a day straight, rain was coming in through this hole in the roof that had ripped open during a storm. And on Monday morning when the staff arrived, there's puddles of water everywhere. They were making needle products, some of their cannula had already started to rust. Big disaster. That was the first time they had ever tried to apply their disaster recovery procedure, and it had a lot of holes. We had to create process on-the-fly because we weren't prepared.

Jon Speer:        That might be an extreme case, but it does illustrate the point that you're making, institute some failures or some errors into your processes, into your systems, so that you can determine the efficacy of those before it's too late. Before you're forced to and you have to, and now everything's on fire.

Mike Drues:     I think, John, for the benefit of our audience, that's absolutely wonderful advice. I highly recommend it. I would just end my part of our discussion today with a very simple, personal example.

Mike Drues:     Obviously we all know today that there's a lot of advantages, and a lot of conveniences of doing electronic records and electronic forms, e-signatures, and all that kind of stuff. But as we talked about before, it really comes back to the content.

Mike Drues:     My personal example, my wife and I are literally in the process of selling our home. We just executed our Purchase and Sale agreement. It was all done electronically. You click here for the initials, you click here for the signature, and you're done.

Mike Drues:     But it's not a substitute for not knowing the content. When we bought our home about 13 or so years ago, of course nobody was using the electronic signatures yet, so we had to go to the attorney's office and we had to physically initial and physically sign.

Mike Drues:     But here's the point that I'm trying to make, John. If there's a problem in the future, I don't think any judge or jury is going to care whether the agreement was executed on paper or electronically. What it comes down to ultimately is the content. That's the most important thing. And that, I think sometimes, gets diminished in the importance of all these things.

Jon Speer:        I agree with you a hundred percent. And I'll leave the audience with one final tip, and we'll wrap up today. One of the things that Mike just stressed is the important of the content. I do want to stress in addition to that, don't mishear what he's saying. It doesn't mean create another document and add to a pile of stuff.

Mike Drues:     I'm sorry to interrupt, John. It just reminds me of the Al Gore Paperwork Reduction Act that was some 30,000 pages long.

Jon Speer:        And you probably have experienced this a time or two, but I've actually heard regulatory professionals that have a scale in their regulatory department to weigh the 510K submission documents before they submit it.

Mike Drues:     Oh, boy, don't get me started on that! That'll be the topic of a different discussion.

Jon Speer:        It's not about just throwing more paper at it. It's about being focused. It really is about right-sizing your company processes and procedures, and your approach to regulatory and quality. Do spend some time on that.

Jon Speer:        And Mike's right. Regardless of if you're paper or electronic, or this or that, focus on content. Make sure that the things that you're documenting are appropriate for the stage of activity that you're involved with.

Jon Speer:        Do not ignore quality. Do not ignore regulatory. Because building your company foundation and business processes with regulatory and quality in mind will help you insure that you're building a better business, and better products in the long run.

Jon Speer:        So, Mike, any parting words?

Mike Drues:     Well, I could not agree with you more, John. And just a tiny one last bit I would add, and then we'll wrap this up. I would like to think that all companies, and all of us working in this business are doing all the things that you and I are discussing today.

Mike Drues:     Not because they're required, not because the U.S. government or some other government in some other place in the world says that you have to do it. But because it is the right thing to do. It does make sense. It is prudent engineering.

Mike Drues:     Call me naïve, John, but that's what our goal should be here.

Jon Speer:        Mike, I'm going to let that be the last word for today. And once again, thank you so much for being a guest of ours on the Global Medical Device podcast.

Jon Speer:        Folks, if you want to connect with Mike Drues, reach out to him. You can find him on LinkedIn. He's with Vascular Sciences. You'll listen to the Global Medical Device podcast. Mike and I have had several conversations over the years, a lot of content, a lot of webinars. He knows his stuff when it comes to regulatory. No better person for you to reach out and talk to about regulatory strategy, whether this is your first interaction with a regulatory agency, or your 100th interaction. It really doesn't matter. Mike is a good guy to have in your corner.

Jon Speer:        As we've talked a little today about quality management systems, we're all about making sure that the processes and procedures and your approach to quality is the right size for your organization. And that's what we do at Greenlight Gurus. So I encourage you, if you have an interest on improving your efficiency, and improving your throughput, and focusing on the content, then you should go over to to request more information.

Jon Speer:        Once again, thank you all for listening. This is the host, founder, MVP of Quality and Regulatory at Greenlight Guru, John Spear, and you have been listening to 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.

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Nick Tippmann is an experienced marketing professional lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, he co-founded and led a media and event production company that was later...

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