Episode Thumbnail
Episode 161  |  40:50 min

How Jon Speer Met His Most Frequent Guest: Mike Drues

Episode 161  |  40:50 min  |  08.26.2020

How Jon Speer Met His Most Frequent Guest: Mike Drues

00:00
00:00
This is a podcast episode titled, How Jon Speer Met His Most Frequent Guest: Mike Drues. The summary for this episode is: Reminiscing about past and present lessons learned from listening to conversations with this show’s most frequent guest, one important principle emerged: Teach others how to think, not what to think. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues, president of the medical device consultancy firm, Vascular Sciences. Anyone who’s listened to the show knows that Jon and Mike are passionate about the world of medical devices, particularly design controls, regulatory affairs, and prudent engineering practices. Listen to this episode where they revisit how they met in December 2014 and what they have shared and learned through the years.

Reminiscing about past and present lessons learned from listening to conversations with this show’s most frequent guest, one important principle emerged: Teach others how to think, not what to think.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues, president of the medical device consultancy firm, Vascular Sciences.

Anyone who’s listened to the show knows that Jon and Mike are passionate about the world of medical devices, particularly design controls, regulatory affairs, and prudent engineering practices. Listen to this episode where they revisit how they met in December 2014 and what they have shared and learned through the years.

Some highlights of this episode include:

  • Do you make these design control mistakes? Original podcast content triggered a reaction by Jon to connect with Mike, only to discover they shared more similarities than differences.
  • Medical device companies continue to make mistakes and get in trouble with the FDA by focusing more on what regulations say, rather than understand and follow the intent of design controls.
  • Design controls are vague and purposely written that way to be applied to the broad medical device industry—from Band-Aids to artificial hearts.
  • Biocompatibility Testing: What’s that? Medical device professionals should know what and how to do things, not be spoon fed to follow a recipe.
  • How can a sponsor prove that a medical device’s design inputs/outputs and verification/validation are correct? Ask the right question to solve the right problem that meets users’ needs, but don’t assume users know what they need.
  • Different Pathways: Why take the easier and straightforward path to market? Design controls and regulations tend to encourage evolutionary, not revolutionary product development.
  • Design Changes: As products are in use, keep learning, iterating, and evolving to make products safer, better, and more effective for patients.
  • Risk: How it relates to off-label use and anticipated misuse is a major benefit of following design controls and risk management practices.

Memorable quotes from this episode:

“What I appreciate most about my relationship with Mike Drues is that he has caused me to think about the world a lot differently, specifically within the med device space.” Jon Speer

“We are passionate about medical device product development and design controls and prudent engineering.” Jon Speer

“Companies getting in trouble with the FDA is because they try to focus more on what the regulation says, as opposed to trying to understand and follow the intent of the regulation.” Mike Drues

“Design controls were very vague, and they were written purposely very vague because the medical device industry is a very broad industry.” Mike Drues

“I’m not saying, don’t follow the rules. I’m not advocating anarchy.” Mike Drues

Warning: This transcript was created using AI and will contain several inaccuracies.

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 off and companies on this episode of the global medical device podcast. I have familiar guest Mike Drew's with vascular Sciences join me. And this one was kind of fun because we went into a time machine of sorts and off Revisited sort sort of I guess our origin story. If you will the the moment that connected Mike and I and went to all of the things that you all had grown to appreciate that we share on the global medical device podcast. So I really want to you enjoy this episode. It was fun for me. It was fun for Mike. But before you do I didn't have a choice.

Jon Speer: Especially this on the podcast, you know, the first time that he and I connected was back in late 2014 and what I appreciate most about my relationship with my cruise is that he has caused me to think about the world a lot differently as specifically with and of course within the med device space, but just because there is a rule or regulation. It's not black and white and I need to think for myself and I need to to understand what's important to to the patient that's involved with the thing that I'm doing and so on and so forth. I mean to quote something that my talk about a paraphrase. Anyway, he sees his role largely as teaching others how to think not want to think I think that's really profound. So again, enjoy this episode of the global medical device podcast. Hello and welcome to the global medical device podcast. This is your host and found or a green light crude John Speer and thought we would I don't know have a little fun today. I hope that's okay with all of the month.

Sitting and the fun that I want to have is well first and foremost familiar guests of the global medical device podcast my cruise with vascular Sciences has joined me Mike. Welcome page. You're welcome and the other day you and I were just kind of I guess reminiscing might be the right word or reminding ourselves sort of our origin story house connected to one another and I thought we would dive into that a little bit, you know certainly for maybe a few laughs and memories and things of that nature but more importantly the topic wage that connected us every at least originally still one that's seems to be an area of struggle and challenge for the industry. So there will be something topical and it meaningful and helpful through them as well. But does that sound okay with you?

I think it's great job.

That's one of the questions I get what I meet some of our fans so to speak as they asked the question of how is it that we got it started. How do we get together? So I'm looking forward to today's discussion as well. All right. Well, let's let's take a moment to go in the way back machine. And you know, this was December of 2014 and at that point in time, you know, green light was still pretty new company, but you know, I'm scouring the internet and in consuming all this wonderful content and I come across this podcast titled. Do you make these design control mistakes? And I listen to it and the person on the other end of that podcast was Mike Drew's and it's sort of sparked off or triggered of reaction of me to which I Then followed up with a sort of rebuttal of that. I heard Mike say this and this is what I believe and that sort of thing and page.

I know you remember that pretty well the yeah, John, you know what you're being very scared being very kind. I would say that you you you did to me what the same age trying to do to the map in your column. But seriously, let me explain further and this is you know why I think both of us wanted to have this discussion today. I think that you raised a number of legitimate points, but you know to be fair when I rent your response to my podcast I was my father's were a little ruffled but you know what I'm saying a fan of the old adage keep-your-friends-close-and-your-enemies-closer. I didn't know you at that time. So I said, you know what I'm going to think that I'm a wackadoodle it's not you know worse and you know, maybe it's just, you know, try to better understand and long story short John and I don't want to put words in your mouth. I think that the more we talked after that and then versation and the more we we've spoken since 10 a.m.

You know about six years or so. I think that we're seeing exactly the same songs just maybe in a very very slightly different teeth, but I think fundamentally, you know, we have a lot more similarities than differences. Would you agree totally? I have to give you all the credit in the world because you even though something that I said or or rope might have been a little bit of a Fed a ruffler to your credit you are you reached out you said hey, let's get on the phone and let's talk and and I remember that day that that I remember where I was very vividly the day that you add in the phone and you know, this was a I'll say the more uh, I'll say the more Angry version of John not that I was angry, but I'm certainly those that know me today I'm calm and and at peace with everything but I was prepared for a battle when you when I got on the phone to be quite I don't think I've ever shared this with you and then and then as you and I spoke. Yep.

Back to your point. Yeah, we're we're both on the same page here. We we are passionate about medical device product development and design controls and prudent engineering and all those sorts of things. You know, I'm happy that that was a birth of a wonderful relationship.

Well, I I'm as well John and you know, I don't want to just be reminiscent here. I also want to be pragmatic. What I'd like to do is I've taken a a recently read through your blog that you came in response to my podcast. And if it's okay with you, I'd like to to talk about a few of the points that you made and regrettably as we both know took a lot of companies seem to continue to make these mistakes over and over, you know, even today so I don't want anybody to feel like just because you know, this started six years ago. It's ancient home and it doesn't apply on the contrary. I think it's you know, everything still applies 100% as much today and maybe even more is it did six years ago. Yeah. So one of the points that I made in my podcast job and this is a recurring theme and several of our conversations since then is that I think the root cause to use the engineering for that killer so many companies getting in trouble with the FDA is because they folk they yep.

Focus more on what the regulation says as opposed to trying to understand and follow the intent of the regulation or what I call the regulatory electric and you responded in your in your blog John and this is a direct quote from you to state that the root cause of why companies are confused about design controls because the focus is on regulation is just wrong close quote wage. And so I'm just wondering John do you think maybe you've had a little bit of an epiphany since then or is that still what your belief that it's sufficient for companies to focus found the the what the regulation says I either letter of the law as opposed to its intent the spirit of the law. Yes, I think yeah, that's a really good point and thanks for reminding me and my words and puts me on the spot. My my intention behind that statement was not that it's not wasn't about interpretation of or following the Reagan.

Missions per say one way or the other it was more about I don't think that's the problem that companies are struggling with I think there's almost the the scene that I see a lot. It's not that there's a resistance to compliance but there's maybe they're sort of is you know, it's like it's like companies are they sort of ignore the regulations more than anything else. It's changed a lot of companies that are trying to strictly interpret each of the design control regulations to the letter. I see there's like this this exercise more so that not that they're trying to avoid it either. It's just that it's almost like they don't even know the regulations exist, you know, well if they don't the regulations exist that's indicative of a whole other set of problems. But yeah, let's let's check the peel this onion back a little bit a little bit further another of the the comments that I made in that original podcast was that the design controls were very vague and they were written purposely. Yep.

Sake because the medical device industry is a very broad industry and they need to be able to be applied to everything from Band-Aids to artificial hearts in response to that John. You said that if I can get this is a direct quote medical device companies confused about our our confused about design controls because the regulations are to move a so again, the question to you is do you think that that vagueness is a good thing or a bad thing? In other words, I view you know vague nebulous not specific regulation to be a huge Advantage for many reasons as we've talked about over the last six years John but I guess my question to you is do you think that because they're vague is is that good or bad for medical device companies? I think it's good too. And I agree with your point. May I say the The Challenge and it's not this isn't necessarily my belief. I'm just sharing anecdotes of what I hear for people a lot of medical device professionals off.

Lot of times even medical device product development professionals. I think they're looking to be spoon-fed and you and I have talked a lot about sort of this theme in the past like they want FDA to tell them what to do when to do it down to do or at least that's what they say. And as you and I have talked over the years. I would doubt that if that became the reality that people would would actually like that. I think the challenge that people have with the vagueness of the regulations is they're not thinking you know, they don't they don't take it to the next level. They don't take the take the big regulations and interpret what those mean to them accompanied. I think that's the challenge. So does that make sense? Yes, and and you know taking it a step or two further regrettably. I do agree with you that it seems to me and of course, this is aster karyotype, you know, there are exceptions but more and more people they literally want to be spoon-fed. They want to be led like sheep. They want me to be told wage.

To do how to do it when to do it. Whether it's from the FDA or somebody else and I see this nevermind in companies in an industry and an FDA. I see it in my academic teaching a graduate students who you know, we're we're not teaching people how to think anymore. We're teaching people how to you know, just simply follow a recipe and let me just remind you John is something I've said in many of our conversations wage know when we meet the regulatory requirements, that's just being a c student, you know, so the question is do we and I'll leave this as a rhetorical question. Do we want we need anybody and putting the SD office to tell us to do things that as you know, as medical device professionals we should know to do these things anyway, and I'm sorry if this sounds a bit harsh on but people that don't know certain basic things. They shouldn't need business. I mean, I had a situation once I don't know if I shared this in a previous I I don't know if I shared this in a certain in a previous conversation. I had a company called me they were working on an implant the device wage.

Going to go inside somebody's body and among other things. I asked them. Well, where are you under biocompatibility testing and they said what's that? I mean there are certain things that have you tried. You're laughing. I wish I could say that I was making good enough. I am not making this up, you know, this is exactly why we have a lot of the application that we have right? But anyway, let's let's let's move on cuz I think you know again I want to use this as constructively as I can so that people, you know, stop quite frankly making the same mistakes over and over again. So another of the things that I talked about in my podcast is design inputs and outputs and verification and validation and one of the things that you pointed out in your in your block response, is that what the sponsor should do is prove that the medical device that they designed and developed is designed and developed correctly. And the question that I have for you John is what does correctly mean wage?

How do we show it? Yeah, for example, you know when we get into verification and validation it's as you know, it's all about showing that we met the needs of the user and so on in other words did we did did we design the right device? Did we design the device? Right but here's a question for you John where in the design controls or anywhere in the regulation? Does it ask us the question? Should we ask the right question? Did we solve the right problem? In other words? What good is getting the right answer if we're asking the wrong question thoughts on that one John cuz I see it so many times you know that I used to say to my medical students to surgery went perfectly but the patient died. Anyway, well the the engineering equivalent we designed the medical-device perfectly, but the patient died anyway the real life story or quality of equipment. We follow the regulation perfectly, but the patient died anyway, so so how do we know that we're designing and developing the device correctly to use birth?

Works. Yeah, and and this is a great point that if someone were to follow a literal interpretation of regulations and not think for themselves, they they may have a perfect design history file a perfect set of inputs and outputs and and verification that shows that they perfectly did everything to me. This is all about understanding the the core of why the device is being designed and developed to begin with what problem are you trying to solve what clinical issues trying to address and and I think this is an area where a lot of people really miss the Mark is because they forget about capturing the user needs. I mean, if you go to the eight twenty Thirty regulations, there's no suction that's explicitly States user needs. There is one for design inputs. There are four outputs etcetera etcetera, but there's nothing that explicitly says user needs Thou shalt do this per say now if you go to the gym,

The FDA design control guidance document which I still think to this day is a really really good guidance document. There's this Infamous waterfall diagram that shows user needs starting off Cascade of things. But a lot of people sort of forget about that and I and I think that that leads to problems. I mean they they don't understand what's important to the end-user. They don't understand what's important wage the patient perspective. They don't capture that information, they make assumptions and and I think when people make assumptions like they, you know, I did this for for the first couple of years of my career, I would start a Project based on what I thought I understood I would put my heads down for for literally months defining requirements and building prototypes and doing testing and so on and so forth and I became a verification and see look look at my my device meets. I designed it correctly. It meets all those requirements that I defined and then you start to put it in the hands of the of users and you realize page.

Oh, wow. I really missed something here. I forgot about that voice a user and I think that's a a problem.

Hey, everyone, kind of Amelie here from Green Light Guru. Have you ever implemented a paper-based quality system with a customer and just know once the project ends. They're going to struggle maintaining compliance on pay per month. If so, check out our partner programs page and let's chat about changing the future quality management.

I agree with you John. I think that's that is a problem. No doubt. However, I would offer that there's an even bigger problem here that happens before we get to any of the stuff that you just mentioned and that is you know, one of the other lining tenants of the entire design controls is as you just described to make sure that our device meets the needs of the user while they are acting us sumption. There is that the user knows what they need and I learned as a biomedical engineer a long time ago not to make that assumption in other words. Why would we assume that that are user knows in fact what they really need they probably know what they think they need but they but do they know what they really need and I'll give you one or two quick examples to illustrate if I have a catheter for example user a cardiologist or some other kind of position might say gee this is a pretty good catheter or stent. But if I take this catheter and make a little longer or shorter little better a little thinner I can use it for something totally different.

That's What I Call evolutionary product development on the contrary, what is the likely hood of a cardiologist or a physician saying this is a pretty good catheter this is not a good stent but if I take a gene that can turn off hyperplasia and put it inside of a virus and deliver that on the surface of a stand now I can do something really as we would say as I'm coming from Boston Josh could cool that is revolutionary product development so one of the most significant limitations of the design controls is that it makes the assumption that the user knows in fact what they really need or to use and even simpler metaphor John and I may have mentioned this in some of our other discussions today cars are ubiquitous but back in the day there were no cars and everybody was I was riding horses so imagine we were, you know diligent Engineers following the design controls and we were trying to come up with a better mode of transportation than than a horse and we surveyed our dog

Mike Drues: There's we asked our users what what they'd like to see in a better mode of transportation while I'm pretty sure John most people are going to say I want a stronger horse. I want a bigger Force. I want a faster horse, but they're all going to walk. You know, look like horses. Most of them are not going to say she would of course is pretty good. But what I really want is a car. There's two limitations that I just want to point out and you can say you agree or you disagree, Jon. One is the underlying assumption is that the user knows what they really want and then the second and even more frustrating to me as an engineer is that most of the regulation and took the design controls it pretty much encourages revolutionary product development. And at the same time, it doesn't encourage or maybe even discourages revolutionary product development team. That's that's what I think John. Would you agree or disagree? You know, I I guess I hadn't thought of it exactly the way you just framed it. And as you were sharing that I had a a thought will leave it off.

Maybe as a rhetorical question for now or maybe want to explore it at a later time. But you know, I do think that you're spot-on with something here. It's almost like you know, you would have talked about regulatory off data G and Regulatory submissions and and things of that nature a few times in the past and there is a preponderance for people to want to go down this 510k path because it's well for a Litany of reasons some of which I could speculate they perceive it's easier and more straightforward yada yada. So on and so forth from which to your point, I think that illustrates your point faith upon rents for people to to lean into or or to prefer the 510 K regulatory path lends itself. Very well to your theory. Yeah, I think you know, they you're right. That's the regulatory equivalents on the quality side to what we're talking about in terms of design controls. And you might remember John, you know moment ago. I asked you the question, you know, you said in your in your blog to make sure that it off.

Is designed and developed correctly and I asked you how to do that. Yeah, it was a little bit of a loaded question job because you provided an answer in your Counterpoint. You said the purpose of Designing validation is to demonstrate that the device meets. The user needs designed validation is proved that product designed and developed is the correct product on closed quote. So what you said in your blog job six years ago was as long as you meet the needs of your user then you are designing the correct product in my question and I cannot leave this is a rhetorical one of em want is just because we show via vallen we meet the needs of the user does that necessarily imply that we've designed to correct device either honestly don't think so, But maybe you were the people might have a different View and one other thing. I would just say in addition to that. I find it interesting how so many companies they do validation page.

Choir, you know for for so many things but rarely ever do I see a company validated staying there validation? Yeah. And in fact, you may remember fairly recently. I did one of my webinars for green light off on exactly that topic validating the validation because I see it and maybe you see it to John. I don't know. I see a lot of companies doing validations that in my opinion are totally meaningless because they're doing the wrong valid. So what could is doing a validation and passing your validation showing that you've validated if you're doing the wrong validation? What do you what do you think of that. Sounds like a check box song sounds like I'm just trying to get a check mark so I can move on to something else. But yeah, you know, it's it's a fair point and you know, and you know just just say not that my thinking is completely different from what it was back in December of 2014, but it will say it has evolved. I don't think in 2014. I appreciated the whole notion of total product wage.

Cycle such that I do today and you know, I guess sort of in that that bucket of total product life cycle are things like design changes, you know and and age, you know, and and it's it's a really good point, you know, validating your validation methods how do you know that this result of this validation study activity trial offer case baby. How do I know that? It's actually valid and and I think there's this this this whole feedback loop that sometimes we as an industry forget about, you know, call it design changes, whatever you want to call it. But you know as your product is in use in you should be learning, you know, there's no such thing as a perfect medical device. I mean I should be doing The Prudent engineering and and the necessary due diligence to make sure that the product that I'm putting out there is is safe and effective to the best of my knowledge in once people start using it. I'm going to learn something and guess what? You're probably not dead.

Our new thing that you captured in your design history file or that you already thought of in your risk assessment, etc. Etc. These you're going to learn things that you never thought of before and couldn't have imagined and you know, wouldn't it have been maybe two of uncovered that before went to Market maybe but the point is keep learning keep iterating keep evolving keep making your products safer and better and more effective for patients. I absolutely agree on but on the other hand, you know, the words are easy to say, but what do they really mean in the in reality of the real world and just to close the loop on what I call validating the validation because I just have one more topic. I wash bring up based on my original podcast in your blog response. A lot of the recommendations that I make come not just from my experience and Regulatory and quality, but in my product liability experience if I can show and I've done this in a number of cases that the company validate the product in the FDA brought in on their validation, but if I can show that they did the wrong valid. Yep.

They didn't validate their validation. So to speak Country Kitchen in Cucina, right? So it was back to your what you just mentioned when we talked about many times that check box on the form. What good is dead validation. If you're not doing the right validation what could is doing of validation? If you're if you haven't validated your validation and so on and so on the last thing that I thought I would bring up John and it's one of my many favorite topics to talk about that thing that you kind of called me out on and you're in your block response and that is the topic of risk and specifically how it relates to off-label use and anticipated issues. And for the last time John up earlier words back in you you one more time. All right, you said in your in your blog cuz cuz I made the comment, you know, I was talking about how we're broke wired to address associated with awfully will use in the design controls or any of the regulation and you responded by saying you meaning the the Dead

Putting I think much address off label use as part of your risk management documentation. In fact considering how the product will be used correctly and how it could be in use incorrectly wage is a major benefit of following the design control in risk management practices whether we're talking about is 01497 new one or the design controls or or whatever. It is. Here's where it gets interesting because again, this is not a criticism John but I think you are doing what many people are doing here. And that is they're equating what the design controls callback anticipated misuse with off-label use and in my view job. Those are absolutely not the same thing. And here's why because there are many examples where I bought the standard of care. What we teach in medical school is is actually the off-label use of a product. This is not true for just medical devices. This is true for drugs. This is true for biologics combination products. You named Boo.

So if there's something the standard of care in other words what we teach in medical school, it's off label use it might be off label use, but how can we say that's anticipated misuse if that's what we're teaching people to do. Does that make sense to me on how how would you think sort of connect those dots? Yeah, I think so in from you know, December 2014 to present day off. I've talked about this particular topic a fair amount and it is in some veins or some ways of looking at it. It can be a slippery slope. I think I still stand behind what I'm about to say. I'm pretty vehement Lee. I think it's important as I'm designing a product that I have to think about usability. I have to think about you know, how people can can do things the wrong way but to your point that's a little bit different than off-label, but I think at the same time there are cases specific cases and and the classic example in our industry is dead.

Biliary stent device. I remember once upon a time. I I think there were more products that had found the quote loophole in the process if you will and brought to Mom a biliary stent knowing full well that that step was never going to be used for biliary indications knowing full well that the student was going to be used for coronary indication. Yes boss. And and I think that was the point I was trying to emphasize here if I'm designing a product knowing full well that it's going to be used for something completely different than than what I'm labeling it as or what I'm getting clearance or approval for them. Then that is I'm doing the wrong thing as a product developer. Well, it is a form.

First says designer myself John I can tell you back in the day. You mentioned the biliary stent. It's one of my favorite examples 90% was off label use 9% off. Well, which meant that only 10% was was was on labeled. I don't want you or anybody else in my audience to miss my message from engineering perspective, you know, as a professional life in general, I agree one hundred and 10% maybe more that testing our device and designing our device to be used not just the way that it's to be used in the theoretical world of Regulatory Affairs where everybody reads in follows the regulation but in the real world of the practice of medicine, I think that's first and foremost the most important thing, you know know if that's what's about it. However, I'm simply pointing out that from a regulatory such / quality perspective. That's not exactly where we set the bar. Should we, you know adjust wage.

That regulation, you know, I would be the first to say let's have a discussion on exactly how to do that. But that's the point that I'm trying to make here. Yeah, it does make sense. And like I said, there's there's levels life is a levels of Grey for sure. I think the point is you know, number one. I need to make sure I'm designing the device on a way that that factors in misuse either intentional or unintentional. I need to understand what if it's intentional or off-label use and understand what that's all about. And and and and you know, I may or may not address that but but if I know full well that my product is going to be used for something completely different than the way I'm labeling it and that's why I'm bringing this product to market then I need to question my practices. That's that's all I'm trying to say on this that point and then all of the points that we're talking about today John I could not agree more the last thing that I just want to mention in in the block cuz I need to try to correct a little bit wage.

My end one of the things that you included was apparently a direct quote from me. I didn't listen to my podcast over again. Okay, and so what I'll assume that you got the quote right, Let me let me read the quote it says and this is you John quoting me having a design control system in place is holding us back. Don't just follow the rules page rules make sense. Go ahead. If the rules do not make sense that don't follow them if a rule is to my advantage then yes, I will follow it in a me if the rule is not combine a Advantage then I will carve out A New Path now whether or not those where my direct words, I don't know. I haven't learned. I haven't listened to the podcast again, but let me try to explain what I mean or what I tried to main page because this is a very important point is something that some people have asked me about in the past. I'm not saying don't follow the rules. I'm not, you know advocating Anarchy.

My message is very very simple. Use the rules makes sense follow them. But if the rules don't make sense, whether we're talking about the design controls or anything else if the rules don't make sure that we follow them anyway, and we all agree that they don't make sense and yet we follow them anyway, and let's be honest about every single week of my career and sometimes every day I see companies doing things following the law that just simply don't make sense and follow any way. Is there a problem with the system or is it a problem with us? So if you genuinely believe in this is something that I do in my professional practice you on a lot if you just believe that the rules that the guidance that whatever, you know, you're following doesn't make sense. Please take it to the the FDA tell phylactic lie and say Here's what the regulations here's what the guidance says. Here's why it doesn't make sense or it's not possible in our particular case. And here's what we're going to do instead and 90% or more of the time job when I do that job.

It's long as my arguments are based on the biology and the engineering forget about the regulation. That's the least important. I'm going to get myself in trouble now because somebody's going to quote me on this one has a better so that's not what I'm saying. What I'm saying is what you're laughing John but in this thirty-second sound that society that we live in those are the Snippets of the people here that get reported, you know, don't get me started when I'm interviewed by the popular press and they take a 30-minute break and they snap out one or two little sentences from the middle of that are totally out of context. So if the rules don't make sense go to the FDA and work with them to explain. Okay, this is what the rules but it doesn't make sense. And here's what we're going to do instead that in my opinion. John is the way this game is supposed to be played that makes sense. Yeah, I think reading this. I mean it was a certainly a long trip down memory lane reviewing some of this information and you know, again A lot has certainly changed about your and my relationship from 2014 to today and yep.

What I've learned to appreciate about you, you're not saying if the rules don't apply forget it and and don't do anything. You're just saying explain why it doesn't provide rationale and justification. It's not a just because you don't feel that a quote rule applies to you isn't a free ticket to to be an anarchist and say screw it all I'm not doing anything but I still have to make my case. I still have to explain my ration now. It's not an excuse for still being approved engineer and and having the responsibility of Designing and developing a safe product. That's not what you're saying. I don't know that I you know the previous version of myself back in 2014 when I listen to the your podcasts. I don't know that I appreciated that to be quite honest with you certainly not the way that I do today Mike any other thoughts to wrap. Yeah, just to wrap up that I'll I'll leave you with dead.

With two final thoughts one is one of my main any favorite quotes the tie up our our last discussion about following the rules. This is a slide that I end many of these presentations with it's a quote from General Douglas MacArthur who said rules are mostly made to be broken and are too often for the lazy to hide behind. You know, I think that's become a convenient excuse for a lot of people to justify not just what they do, but what they don't do by simply reading and following the rules and again as you just reiterated, you know rules are important no question about it, but we should not be reading and following regulation like a Mindless automaton like a computer executing lines of code one after another without asking does this make sense? And then the last thing that I would offer John especially for the benefit of the the younger folks in our audience, I would just remind everybody when it comes to design controls. You alluded to the design control wage.

Document job which was back to nineteen ninety seven and I agree with you many people have sent to the FDA that that guidance should be should be updated. I take you to not leave it alone. That's that's leave it alone. Oh, you know if it ain't broke don't fix it. What we need to is under people more understanding what's in it as opposed to creating more. Anyway, I just wanted to remind everybody that were not when I started in this business is an R&D engineer in the early 1990s. This was long before the design controls even existed, you know, we had you know, lots less wage relation to the then we do today fast forward almost three decades later. We have thousands and thousands of pages of

Regulation including the design controls, but the question is are are medical devices really any better are they is the world a better place. I'll leave that as a rhetorical question job, but back in those early days. We didn't have a lot of regulations. We didn't have the design controls in place and yet somehow I don't know how this happened John somehow we were able to get reasonably decent medical devices logged onto the market fast forward to today, you know, three weeks later. We've got thousands of pages of regulations. The question is is the world a better place. I'll leave that in political question. John something about. Yeah, absolutely and and Mike thank you so much for for this. Like I said this jog down memory lane. And you know, it's a I think it's one of them as you and I have talked about. It's now almost six years later. It's it's still one of those those topics that unfortunately is is more top of Mind than it should be. I think you know, hopefully maybe this is dead.

A little bit of my altruism coming through but I hope people are starting to realize how important it is to to be thorough and and as complete as you possibly can be and validated way during our product development efforts again, remember patients lives are attended this. I mean you're designing a developing a product to improve the quality of life, but that same sort of rigor and passion and and focus into your design and development efforts. I couldn't agree more and just as a lead into maybe a future discussion, you know in this era of evidence-based medicine or what some people today referred to as comparative effectiveness research. What I'm looking for is evidence that all of this additional regulation including the design control wage is ultimately making the world or at least our industry a better place and regrettably John. I don't see a lot of it and here's why because to this day I still see companies getting 43 observations dead.

Sometimes a warning letters because they don't do some of the most basic things and maybe one of our next conversations we can talk about some specific examples, but I'm talking about things like there was a company that recently in the news a major medical device company that may that makes permanent implants FDA seeing them because they did not have an adequate post-market surveillance system in place major of Fortune 100 medical device companies permanent implants not doing sufficient post-market surveillance. Another company apparently made changes to a device already on the market and never mind, you know Special Forces special python cavers is a letter to file I could care about that. The company apparently did not do the most basic engineering testing to show that those changes they've made in their device did not impact the safety efficacy performance and so on at the device, I'm sorry John, but this is going to sound very very harsh to some people. Maybe I'm just getting old but people don't change.

At the sorry people that don't know that they should do those things whether the required by the FDA or not. They should not be in this business. As you pointed out many times. We're talking about people's lives here wage and some stuff to me is just basic information. Yeah, I agree and you know, we'll let that be the final word. And and I guess I'll just pile on that just a little bit. There's no amount of Regulation that's going to prevent that that's just called being a good human and understanding what's right for for the people that are going to be using our product. So I I agree but yeah, we'll dive into that later folks used to teach an engineering school what I call. Yeah, go ahead. I was just I was just getting red wrap up. But go ahead now on the edge of my seat wondering what they used to teach and engineering school. No that that that's, you know, we can wrap this up. I was just simply going to end by saying, you know as I talked about before I consider everything in the design control rules and and pretty much everything in the regulation overall to be basic engineering job.

Engineering what we used to teach in in general. I'm just not sure John and I do teach, you know an engineering today. I'm just not sure if we still teach that stuff or not, but that's a topic of a discussion at a pub sometime suppose. Yeah, and I think that it probably is folks. Anyway. Yeah. I know Mike. Thanks so much as always. I I look forward to these opportunities to talk about, you know, the things that affecting our industry. So Focus my cruise with vascular sciences and as always I want to thank you all for taking a moment out of your day to listen to this episode of the global medical device podcast off continue to spread the word and and keep the global medical device podcast as the number one podcast in the medical device industry as always. This is your host and founder at Greenlake Guru John Speer and say you've been listening to the mobile medical device podcast.

More Episodes

Crash Course on Greenlight Guru Academy: How Medical Device Professionals Stay Ahead

Building your Brand as a Medical Device Professional

Understanding the Value of a Medical Device Guru

Meet a Guru: Etienne Nichols

Meet a Guru: Laura Court

Regulatory Tips & Pointers from a Former FDA Reviewer