The Best of Jon & Mike Through the Years

Today’s episode is a little different than usual. This will be Jon Speer’s last podcast for Greenlight Guru, as he’ll be moving on to future ventures as of December 31^st.

In honor of many podcast episodes featuring Jon and Mike Drues, this episode is a tribute to some of the best episode topics that the two of them have tackled. They review some of their favorite episodes and throughlines of their discussions throughout the time they’ve been podcasting together. Listen to Jon and Mike discuss how they met, which episodes stuck out for them, and what thoughts they want to leave the audience with.

Listen now:

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Some of the highlights of this episode include:

• How Mike and Jon met

• Interpreting regulations

• Communicating with the FDA

• FDA plans to modernize 510K

• Developing a regulatory strategy

• The most important thing to remember

• Understanding all your pathways to market

• Usability testing and how it applies in the real world

• The Emergency Use Authorization for medical devices

Links:

Mike Drues LinkedIn

Jon Speer LinkedIn

MedTech Excellence Community

Greenlight Guru Academy

Greenlight Guru

Memorable quotes from Mike Drues:

“When the rules make sense, follow them, but when they don’t make sense should we follow them?” 

“Regulation is about two things: it’s about the interpretation of words and our ability to defend our interpretation.”

“You need to know what all of your options are.”

“Tell don’t ask, lead don’t follow.”

Transcript

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 in companies.

Jon Speer: Hello and welcome to the Global Medical Device Podcast. This is the founder at Greenlight Guru Jon Speer, and joining me on this, well, it's a pretty significant occasion and I'll give you some more details about that here in a few moments, but recurring guest and good friend of mine, Mike Drues with Vascular Sciences. So Mike, welcome to the Global Medical Device Podcast.

Mike Drues: Thank you, Jon. Always a pleasure to be here.

Jon Speer: It's a little bittersweet moment, and you and I were chatting just briefly right before we hit the record button. This will be my last podcast with Greenlight Guru as of December the 31st. I am moving on to explore other adventures. I don't really know what those are going to be just yet.

Mike Drues: You've finally gotten sick and tired of hanging out with this whackadoodle Drues character, and you're moving on to bigger and better things.

Jon Speer: Well, I don't know mean, maybe Mike Drues will be part of those future adventures to be determined, so stay tuned. With that being said, when I chatted with Mike the other day. Mike, let's do kind of a, I don't know best of or culmination or put a nice wrapper on this relationship that he and I have had over the past seven and a half, eight years, something like that. And I did a little bit of digging into some of the details. Did you know that Mike Drues and I have recorded, I think if I counted correctly, 107 episodes on the Global Medical Device podcast?

Mike Drues: Amazing, Jon. And putting that number into perspective, I always try to give somebody a basis of comparison for statistics like this. If you do a little bit of arithmetic, if you assume most of our podcasts were between 40 and 45 minutes each, that means that we had between 70 and 80 hours of podcasts. Or if you convert that to days, you and I have talked to each other for more than three full 24- hour days. Can you imagine, Jon, if you and I sat down and talked directly for three days plus as a marathon? I think we could actually do it. I think it would be fun.

Jon Speer: Yeah, I think I could actually imagine that. Of course, was a little important, but it's been a great relationship. And looking back through the archives, if you will, our first episode we recorded was back in April of 2015. And during those days of the Global Medical Device Podcast, actually even before that first episode, a couple of us at Greenlight were just sitting around talking about different ideas and brainstorming about some things. And someone, I don't remember who, suggested, " Hey, what do you guys think about doing a podcast?", " Sure, let's do it." And that first I went back and listened to that first episode. That was a little rough. I'd like to say we've refined our approach and delivery a great deal from then'til now.

Mike Drues: But we were, in many ways, Jon, not to toot our own horn here, but we were pioneers because close to a decade ago, podcasts were not nearly as common as they are today.

Jon Speer: Well, not just that, but in our industry, pretty much unheard of. There were a few podcast episodes here and there over the years, but nothing with the recurring frequency that we managed to keep up with the Global Medical Device podcast. So yeah, totally.

Mike Drues: And can you imagine from the perspective of a normal person, not to regulatory and quality geeks like us doing this for so long, and most importantly, having such a following? I give our audience all of the credit because they seem to continue to listen to us. I don't always know why, but they simply to do it.

Jon Speer: Well, that's the great point. It's because of all of you continuing to tune in and listen. If you didn't do so, there would be no purpose or meaning or reason for us to continue to do this over the years. So thank you all for continuing to tune in. And of course, hopefully you've continued to tune in to Global Medical Device Podcast episodes that do not feature Jon and Mike. There's still quite a few out there, so check that out. I know Etienne Nichols has been doing a fantastic job carrying that torch further, so keep up on the listening and spreading the word. So a couple other things that I jotted down. We actually added video to our podcast back a little about a year and a half ago. So I think that was a nice addition. It's always great to see your face, Mike, when we're chatting and our geographic locations make that a little bit difficult to do that in the same room at the same time. So the video's been a nice addition, at least from my perspective.

Mike Drues: Well, I appreciate your kind words, Jon, as I just reminded one of my customers earlier today in a video conference. My son who was actually in broadcast journalism, he tells me I have a face for radio. But on a more serious note, FDA did announce their new policy just about a month ago regarding, quote unquote, in- person meetings. And one of the things that they said was, you have to have your videos turned on. Well, long story short, Jon, I just did a pre- sub with FDA just last week, this was several weeks after this new policy came out, and several of the reviewers had their videos turned off. And when I said, " Are you familiar with this new policy?", they said, " Yeah, that new policy is optional." So it's like...

Jon Speer: Sorry, I choked on my water.

Mike Drues: Welcome to my world.

Jon Speer: Yeah, well...

Mike Drues: But I'm in the sense that like you, I like to see people when I'm talking to them, not just for personal reasons, but because so much of communication is nonverbal.

Jon Speer: Nonverbal. Yeah, 100%. I know a lot of statistics are made up, but I think I heard once something like 80% of communication is nonverbal.

Mike Drues: And I wouldn't be surprised, Jon, if you hadn't heard that from me, because this is one of our many recurring themes that you and I have talked about over the last 107 episodes.

Jon Speer: Absolutely.

Mike Drues: So, yeah.

Jon Speer: The other thing some folks may not realize sort of how you and I came to meet one another. I think that's always a great story. And if you're curious to listen to a more in depth conversation about that, I think we talked about that in episode number 161, the genesis of Mike Drues and Jon Speer. But I'll give you the recap. This was early days of Greenlight Guru, and I had of course been in the industry for quite a bit before that, Mike as well. And I was consuming all this content, articles, information that's being published through the various channels and outlets and things. And I came across an article that as I read it at the time, I'm like, " Oh my goodness. I don't agree with all these points of view. I-"

Mike Drues: Heresy.

Jon Speer: ...Well, I wouldn't go for as far as say heresy, but I didn't agree with all the points of view. So I fired up my computer, I wrote a guess, an editorial op- ed piece in response to that, and the person who wrote the original article reached out to me and said, " Hey, let's get on a call." Well, that person was Mike Drues. I think especially in this day and age. What I appreciated about that moment, Mike, is we didn't see eye to eye on everything. In fact, over the years, if you've been a listener to podcast, we share more in common probably than we don't, but there are some things that we don't agree with or we're not 100% on the same page about. But what I love about our relationship is we can have civil conversations and discussions about this, and I think hopefully folks listening can apply that to their everyday lives. Because man, right now on this day and age, it feels like if you don't agree with somebody, you have to fight them. And that's just silly. That's just really silly.

Mike Drues: So Jon, thank you for reminding everybody of that story. Just for the benefit of our audience that are not familiar with it, add just a tiny bit more color to that. And I do suggest listening to that episode that Jon just highlighted a moment ago where we go into more detail. But as I recall, Jon, the essence of my column that you responded to was on the design controls. And as a matter of record, I don't think there's anybody that knows more about the design controls than you do. And one of the premises that I tried to make in that column was when the design controls, or indeed when the rules make sense, then we should follow them. But if the rules don't make sense and we follow them anyway and we agree that they don't make sense and yet we follow them anyway, is that a problem with the system or is that a problem with us? And Jon, I put this word in your mouth, but I did so on purposely many people, and I think you illustrated this a moment ago, you viewed this as heresy, " This guy's saying don't follow the rules." And so, I reached out to Jon and to his credit, we had a discussion, and it turned out that although as Jon said, we didn't agree on every single thing, we agree on lots of things. And that's what led to almost 10 years later and 107 episodes later, not to mention how many webinars and everything else, joint presentations at conferences and so on. So yeah, I think that's an interesting story, and it's another of the many recurring themes that you and I have talked about over the years, at least from my perspective, when the rules make sense, follow them, but when they don't make sense, should we follow them? No, I don't think we should, but many companies do. Or should we work with the FDA and try to figure out a way that does make sense?

Jon Speer: Absolutely. Yeah. I can remember my mindset as a medical device professional at that point in time just prior to meeting with you, and probably even a few months after we became friends and talked on a frequent basis, I was pretty narrow minded and pretty narrowly focused when it came to dealing with regulators and FDA and that sort of thing. And I'm thankful that because of in large part of exposure to your thoughts on ideas and working with you that have been able to open my horizons, and I hope listeners have had that same opportunity over the years. This isn't a black and white world that we live in, in med device and FDA regulations and other regulations from other regulatory bodies around the world. It's not black and white. There's a ton left up to interpretation. Don't just follow blindly. And I appreciate being able to learn these sort of lessons and different mindsets and approaches from our interaction. So, I appreciate that.

Mike Drues: Absolutely. And I would say that nothing in the regulatory or the quality world is black and white. There's an infinite number of shades of gray, and in my opinion, it's in those shades of gray that are really the advantages for us because we can interpret, to use the proper word, interpret the regulation in the way that we think is appropriate given our circumstances, given our goals, our technology, our risks, and so on and so on. As I often say, and I've said it in many of our discussions before, regulation is about two things: it's about the interpretation of words and our ability to defend our interpretation. There are almost an infinite number of ways that anybody can interpret a particular set of words. And I find it fascinating how so many people seem to think that the way that the FDA interprets a set of words is the only way or the best way to interpret them. When my interpretation is consistent with FDA, then great. But if my interpretation is different, then I will be the first to go to FDA and say, " Hey, here's what the words say, here's what the regulation says, and this is why my particular interpretation is important." In my opinion, Jon, that's exactly the way this game is supposed to be played because as I'm sure many in our audience, remember coming from a medical background, and I used to teach med school back in the day, I used a lot of medical metaphors, you know the adage, Jon, the surgery went perfectly, but the patient died anyway. Well, the regulatory equivalent, you've heard it many times before, the regulatory equivalent, we followed the regulation perfectly that as we did all the FDA or Health Canada, whoever asked us to do, we did all that FDA asked us to do, and yet the patient died anyway. Unfortunately, these things happen more frequently than some people would like to admit.

Jon Speer: Yeah, absolutely. So as Mike and I prepared for our discussion today, one of the things that we talked about doing is sort of a, I guess a synopsis or a summary if you will, of some themes and maybe some of our favorite moments over the years in doing the global medical device podcast, as well as Mike mentioned numerous webinars and another speaking engagements. And so I have a list of a few of my favorite podcasts that we've done with one another, and I know Mike's got a few themes that he's identified as reflecting back over the years. So, maybe I'll start and just dive in and I'll talk about one of my favorite episodes that we did together, and then I'll throw it to you and we can kind of go play a little game of medical device regulatory quality nerd ping pong or whatever.

Mike Drues: I think that would be great, Jon, and before you share your first one, I just wanted to tell our audience to give my friend Jon Speer a little bit of credit here. When Jon and I spoke a few days ago to talk about how we were going to organize this last podcast discussion, I was the one that suggested, " Well, why don't each of us pick our top five or so podcasts of those 107?", and just a few minutes before we started the recording, I threw my friend Jon an audible, I said, " I want to change the play. You come up with your top five podcasts, and I'll come up with my top five recurring themes or lessons to be learned," because it was very difficult, probably a possible for me to identify my top five favorite podcasts, because it's like asking me, what is my favorite regulatory pathway to market? 510(k) HDE, PMA. I like all of them for different reasons. It's like asking a parent to choose their favorite child. So I think this is going to be an interesting and hopefully a fun discussion, Jon. Why don't you start it out?

Jon Speer: Yeah, sure. And I think as I describe each of my five favorite episodes, there is a theme for sure. But let's just dive in. So my first one on my list was one we recorded relatively recently. It was episode 291. It's called Developing a Regulatory Strategy. And folks, all the links that I mentioned to different episodes, we'll be sure to hopefully get those into the show notes so you can easily click those and go right to them without having to search. But episode 291, developing a regulatory strategy. And this was far from the first time that Mike and I spoke about the importance of a regulatory strategy. I picked this one in particular because I think there was an amount of clarity, at least for me in this topic. I think prior to meeting Mike, I was big on thinking that I was a strategic person, especially when it came to regulatory. And, in fact, I probably pull up a handful of examples of documents that I created back in the day that I titled, quote, regulatory strategy documents. And basically when I look at those documents, they alliterated or enumerated the different pathways that I was going to choose, whether it was 510( k) or a file in EU or whatever the case may be. And I think this is a really important topic for med device professionals to understand is, your submission is not your strategy. So that's why I chose that particular one. Again, that's for me, I looking back over the 107 episodes, we probably talked about the variations of this topic easily a handful of times. So what about you? What was one of the themes that you picked up from the conversation?

Mike Drues: So my corresponding theme to your regulatory strategy podcast reference there is my poker metaphor because Jon, I get frustrated when I ask people, " What is your regulatory strategy?", and they say, " 510( k)." That's not a strategy, that's an end goal, but that's not a strategy in how you get there. As you've heard me characterize many times, Jon, I characterize the entire relationship between the company and the FDA as a poker game in every sense of the word talking about strategy. And just because the rules of poker doesn't necessarily mean you're going to be a good poker player, doesn't mean that you're going to win the game. I want to do everything that I can, legal, of course, I don't want to be wearing any orange jumpsuits in order to win the game. In other words, you could read 50 books on the rules of poker. Does that mean that you're going to be a good poker player? Does that mean that you're going to win the game? Absolutely not. Two players can be holding exactly the same cards in their hand, and yet one will win and the other will lose. So it's not just about knowing the cards in your hand, you have to know them, but as the song goes, you have to know when to hold them and when to fold them and blah, blah, blah. So this is the equivalent, substantially equivalent perhaps Jon, to your pickup on one of your favorite topics of podcast discussion is regulatory strategy. That's my lesson to be learned from that.

Jon Speer: All right, let's move right along. So my next podcast that I picked out is episode 86, and the title of this episode is FDA Plans to Modernize 510( k). The reason I picked this one out is, well, 510( k) has been around, I think it was 1976 when that came out, if I recall, correct me if I'm wrong, Mike, but I think-

Mike Drues: No, that's correct.

Jon Speer: ...I think if the story I heard about the 510( k) process is accurate, it was never intended to be a mechanism or a pathway that was permanent, but yet pretty much probably 90% plus of medical device professionals are younger than the 510( k) provision of 1976. It's been around for a long period of time, and I'm not saying it's timeless per se, but the topic of 510( k) reform has been consistent pretty much throughout my entire career. And I think it's interesting that from time to time, we'll get a new guidance or a new spin or a new take from FDA on a variation of a 510( k) or a, quote, new type of 510( k) K and whatnot. But all in all, a 510( k), that continues to be the workhorse of the med device industry, at least when you're bringing products to the market in the FDA. So while there's talk of reform, it seems like that's something that's probably, it is going to stick around for quite some time.

Mike Drues: Well, I would agree, Jon, there's been a lot of talk of reform and talk for nearly a half a century since in fact, the 510(k) was created in 1976. And by the way, Jon, you made reference to something that I think a lot of our listeners may not be aware of, and that is one of the former FDA commissioners, David Kessler, who was one of my former bosses years ago, who was a commissioner at FDA for most of the decade of the nineties. He said very famously or infamously that the 510( k) pathway provision was meant to be an exception rather than the rule when it was originally created 1976. And fast forward to now 2022, almost 2023, as you and your audience know Jon, now it's become the rule rather than the exception. So, it was never intended to be that way. And so, my corresponding lesson to be learned is a little bit more broad than that. And that is, don't just simply focus on the letter of the law. In other words, what does the regulation say in the literal sense? Try to focus and understand and apply the spirit of the law, the philosophy of the law. So many times I see companies both on the regulatory side as well as on the quality side, they get in trouble because they're focusing on the letter of the law, but not on the spirit of the law. And remember, as I alluded to a few minutes ago, Jon, that famous adage, the surgery went perfectly, but the patient died anyway. Well, the regulatory or the quality equivalent is we followed the regulation perfectly. That is, we did all that FDA asked us to do, and yet the patient died anyway. And in terms of wrapping up the theme on the 510(k), the only significant change to the 510( k) really in the last few years anyway, and if you want to consider this to be a significant change, I'll leave that up to our audience to decide, is the formation of what's called the safety and performance or SP 510(k) K, which in my opinion, Jon is really nothing new. It's substantially equivalent, pun intended, to the abbreviated 510( k), which has been around for a very long time, about almost 25 years now. But those are some of the things that I would remind the audience to keep it when they talk about changing of the 510(k) or any regulation in general.

Jon Speer: Yeah, absolutely. Just one other thought about that topic in general: back when we recorded that episode, and I should have looked at or written down the date, I don't remember, but episode 86 tells me it was probably, I don't know, five years ago or so. I recall in that moment in time, it seemed like there was a lot of pressure or political pressure. I don't remember what was entirely going on at the world at that time, but it seemed as though there was some knee- jerk response from FDA that they had to be part of the narrative so things didn't spin out of control. And I think that's an interesting thing, sort of a side point we can riff on here for a moment if you'd like, but in the time that you and I have been doing this, I've seen the FDA be much more engaging and much more interactive than maybe they did in the 10 or 20 years prior to that. And I think that's a good thing for us in industry too.

Mike Drues: Well, in terms of politics, Jon, I think you said it politely. I'll go a little more: I don't think it was anything except politics. I think the politics was largely, if not completely, the driving factor for the formation of this quote unquote, new 510(k) K pathway. And when I say politics here, it's the competition, the friendly competition, if you will, between the US and the EU, and which products come onto the market first, and so on and so on. And as an aside note, Jon, it's not one of the recurring themes that I did and I fight in advance, but it's one that I'm thinking about now. It's amazing to me how many people they try to separate regulations from politics, because to me, that makes absolutely no sense. Where does the regulation come from? It comes from the politicians, right? So to separate the regulation in politics doesn't make sense. That's not necessarily a bad thing, right? It's not a criticism, but it's a reality. So why shouldn't people just say, you know what? Regulation, just like most things is, there is a political component to it. I don't know why people are hesitant to go that far, but that's my two bits, Jon. By the way, I think you and I will never have a career in politics because we've got too much of an established history. There's too many podcasts floating around out there that somebody could use to our disadvantage.

Jon Speer: Well, maybe we'll find a chunk of land somewhere where we can establish our own sovereignty or something, but anyway, that's-

Mike Drues: Where they don't have internet access, one or the other.

Jon Speer: ...For sure. All right, so my next podcast that I wanted to chat a little bit about was episode 101, and the title of this one was How to Make De Novo a Viable Option. And I picked this one in particular because I think my medical device life before getting to know Mike Drues and understanding some of the, I don't know, nuances and intricacies and benefits of these different pathways, that was that tunnel vision. I looked at 510(k) and I probably didn't look at a lot of other pathways. In fact, some companies that I worked for once upon a time, if we determined that the product we were exploring or considering developing was going to be a class three and require a PMA, it almost meant, kill the project, move on. And I think that's a shortsighted way of looking at things. And specific to de novo I remember quite a few years ago I was doing some work with the startup company and they pursued a de novo pathway for the product. And at that point in time, or in the history of the de novo provision, it was a kiss of death for them. Their submission went into a black hole. I mean, I can't remember how long it took. And there was very little dialogue or communication with the FDA. They were stuck. And I think that's what de novo used to be once upon a time, not that long ago. But I've been encouraged through my conversations with Mike over the years that folks should really look at de novo as a very viable and progressive type of submission pathway. Don't look at it as a negative. So I know FDA and folks like Mike Drues have really helped that de novo pathway become more popular than it used to be. So anyway, I wanted to highlight that, 'cause I think it's important for folks. This is a way to be new and refreshing and exciting versus just being a me too.

Mike Drues: I agree. Jon, thank you for highlighting that podcast. And I think to be fair to us, we've done several podcasts on the de novo, either directly or indirectly. And in fact, for our audience, one of the many webinars that I've done for Greenlight over the years, one of my most popular webinars, in fact, was a webinar specifically on the de novo. So, if this is something that you're interested in or want to know more about, I would encourage you to check out those resources. But that brings me to my next recurring theme, Jon, along those lines, and that is know what all of your options are, not just the most common one I mentioned earlier. Usually, the first question that I ask to new customers is, what's your regulatory strategy? And more often than not, they'll tell me, " 510( k)," and as we talked about a moment ago, that's not a regulatory strategy. And then the second question I usually ask them is, " Well, why 510(k)?", and a surprising number of times, Jon, they'll say, " Mike, did I have another option?" So you need to know what all of your options are. And not to go too much into detail on the de novo, because as we've said, there's a lot of other resources that Jon and I have put out there specifically on the de novo. But there are some very significant advantages, including competitive advantages of the de novo over the 510( k). The 510( k), without a doubt, is the workhorse here in the medical device industry in the United States. No question about it. The question is, why is it the workhorse? A lot of people think it's because it's the only way or the best way. Not necessarily. The metaphor that I like to use. Jon, and you've heard me use this before, McDonald's is one of the most successful restaurants in the world. Is it because they make a good hamburger? Not so much. Just because a lot of people go to McDonald's doesn't mean that it's a good restaurant. Just because a lot of people use the 510( k) doesn't necessarily mean it's your best or certainly your only pathway to market. So, know what all of your different options are, not just in the class two or below universe, 510( k) or de novo, but the HDE, the PMA, the CDE, the customer device exemption, the Emergency Use Authorization. Another of my most popular webinars for Greenlight was on the pathways to market where I describe all of the different pathways, and the sub pathways as well. And if you look at all of those different options, Jon, the number of ways that we have to get medical devices onto the market here in the United States is north of 20. Depending on how you count, between 20 and 30 different pathways with all of the different options and the sub options. So, you have to know all of your different options. Otherwise, quite frankly, how can you decide which option is best for you in your particular circumstances? In other words, how can you do your job? So, recurring theme number three for me is, know all of your options. Not just the common, not just the vanilla flavored, but all of them.

Jon Speer: Yeah, absolutely. So, the next podcast I wanted to highlight was episode number 234, and this one was called Setting the Record straight on Usability and Human Factors. And as Mike mentioned about the de novo topic, it wasn't the only time he and I spoke about that. Well, episode 234 was not the only time Mike and I talked about usability and human factors, but I wanted to highlight this one because it's surprising, I guess to me that here at the end of 2022, that so many in industry are still so damned confused about usability and human factors. And I started my career in this industry in the late nineties, and the regulations as we know them today in the US were for all intents and purposes new if you will, at that time. And this concept of design controls was a little befuddling for a lot of product developers. For me, I just, it made perfect sense: oh, I have to define what's important to the user of this product. I have to define the requirements of this product. I have to prove that it works the way I designed it. I have to prove that it works the way it's supposed to at point of use and all these sorts of things. And to me, that's in essence human factors and usability. I have to know that my product is going to work the way I said it was going to buy, the people who are supposed to use it when they're supposed to use all these sorts of things. And why this is so confusing, I have no idea. I could speculate, I think seems like design controls has become its own thing. And then there's this other thing called risk management that's sort of an offshoot to that. And there's this other thing called human factors or usability that seems to be an offshoot of that yet still. And people, stop the madness. These are all the same thing. Maybe they're slightly different views or perspectives, but folks, this industry says a huge learning curve, sadly, when it comes to usability and human factors. So I wanted to highlight this episode and hopefully you'll all will go listen to that, and hopefully there's some light bulbs that'll turn on, and hopefully we can get out of this madness.

Mike Drues: Well again, thank you for highlighting that usability episode, Jon, the corresponding recurring theme that I would identify that applies to human factors or usability, but it also applies to other things, and that is you can't anticipate all questions or problems, but you can certainly anticipate many of them. In the 30 years that I've been playing this game, this is one of the many lessons that I've learned: you can't anticipate all questions or problems, but you can anticipate many of them. And when it comes to usability, it fascinates me, Jon, now with such regulation, such requirements on usability testing, and yet we still continue to have usability related issues in medical devices in the real world. And this is something that I talked about a lot in my webinar that I did for Greenlight specifically on usability testing. I think that the root cause of this problem, to put this in engineering terms, because as our audience knows my background is in biomedical engineering, that's what my PhD is in, the root cause of this problem is although we do usability testing, usually before the product is cleared or approved and on the market, it's done in such a contrived way that it's not realistic of the real world. And just as one quick example, and I've shared this story in some of our podcasts before, so it might sound familiar, but I think it bears repeating. I was doing a presentation at a conference a couple of years ago, and coincidentally the woman that was presenting at the conference just before me was talking about the usability study that she did for a laparoscopic device. And one of the things that she said was that the surgeon had to use and follow the DFU, the directions for use. You're laughing, Jon. So where I'm going with this, but for the benefit of the audience, I wanted to have a public discussion on this. I said at the end of her presentation, I posed her the question or the statement rather, " Well, you realize now that you have totally invalidated, completely invalidated your usability testing here because we all know that in the real world, nobody or certainly very few people do that." And she responded to me, and I'll never forget what she said. She said, " Yes, Mike, I agree with you 100%, but it passed mustard at the FDA." So, what good is doing usability testing or a clinical trial or indeed any kind of a testing if it's not realistic of the real world? So my advice somewhat facetious, but also seriously, my advice to companies when they want to do usability testing, my usability testing protocol is very simple. It's only two steps: give your device to the user, to the surgeon, physician, nurse, patient, whoever's going to use it, give it to the user. And then as my wife would say, step two, you can stop talking now. And just simply observe what they do with it. And if they take your DFU out of the box and throw it right into the trash, then you note that down. Now, as you know Jon, in the real world, no company is ever going to want to do a usability study like that for all the obvious reasons. But it begs the question, what good is doing testing if it's not realistic of what we do in the real world? Something to think about.

Jon Speer: Continuing on that topic for a little bit, I think it's not that deep to be honest. It's important. Don't mishear me. I think we complicate this topic way too much. If we followed your two- step protocol...

Mike Drues: That's pretty simple, Jon.

Jon Speer: I wonder what would we learn from that if we just handed it to somebody and then shut up and just watched? I don't know, something-

Mike Drues: I think we would learn a lot.

Jon Speer: ...I think we would learn a ton. Absolutely. All right, so as they say, round and third and maybe working our way toward home a little bit. So my last podcast that I highlighted for today's conversation was episode number 140, and this was recorded back in April of 2020, and it was on the Emergency Use Authorization. And two things that I wanted to highlight about that: I'll confess prior to that period of time, I don't think I ever heard of or was aware of an EUA, what that was and that sort of thing. Granted, it's-

Mike Drues: Would not surprise me, Jon, as a matter of fact, that was commonplace for most people in the medical device industry at that time. In the drug and the biologic world, people did have experience with the EUA for some of the other infectious disease pandemics, but not in the medical device world.

Jon Speer: ...Yeah. The other thing that I'm a little bit proud of throughout the years that Mike and I, the topics we've discussed, and this is a pretty good example of that, is we were some of the first people to talk about this topic. This was April of 2020. I know specifically like our offices, we shut our offices down in person. I think it was March the 13th, 2020. So just a couple weeks later, you and I published a podcast on this particular topic, and we talked about it a few times after that as well. But I think that we were blazing a path. I think we were trying to help educate and inform folk and teach them what EUA is and how this could be beneficial to some of the things that they're working on, and at the same time be beneficial to helping address some of the needs in the pandemic. So anyway, that was my final podcast that I wanted to highlight.

Mike Drues: And I'm extremely proud of the fact, as you just pointed out, Jon, that with regard to the Emergency Use Authorization, but with regard to other examples as well, you and I are among the first, or in some cases, the very first people to start talking about these things. As a matter of fact, we did not only that podcast, Jon, but at that same time I did a full webinar for Greenlight, a detailed analysis, a presentation of the Emergency Use Authorization. One of my frustrations with a lot of folks today that do podcasts and webinars is they're not telling me anything that hasn't been around for quite a long time. And when you put yourself out there as you know, the first or one of the first to talk about something that sets you apart from the crowd, we are in that regard, Jon, I don't mean to be arrogant here, but I think we should take credit: we are sheep, we are not shepherds. We're in large ways leading the flock. We're not following along like everybody else. And fast forward today with regard to the EUA, many of the things that I said, not just in that podcast, Jon, but in the webinar that I did for Greenlight on the EUA, many of those things were adopted by the FDA almost three years later in their final guidances as we transition to the post- COVID world. So I think you and I should both be very proud of that. And to wrap this up, Jon, my final recurring theme along the lines of the EUA is communication with the FDA. As you and I have talked about so many times before, there's no bigger fan of communication with the FDA than me. I will communicate with the FDA far more frequently than any regulation will require me to do. But remember my big caveat, Jon, this is one of my regulatory mantras, and that is, tell don't ask. Lead, don't follow. And as you and many in our audience know, in addition to consulting for companies, I also work as a consultant for the FDA as well as Health Canada. So I see in a lot of these issues from both sides. It never ceases to amaze me, Jon, how many people I see come into FDA's door and literally ask FDA, " What do I do? How do I bring this product onto the market? Will you tell me, is it a 510( k) or a de novo? Will you tell me do I need to do a clinical trial?" It amazes me how many people do this. And I think this is terrible strategy, Jon, for a whole bunch of reasons. First of all, it's not FDA's job to tell us what to do. I know it's our job to figure out what to do and then to go to the FDA and sell it to them. And the other reason why I think it's a terrible strategy, Jon, is because you're opening up a Pandora's box and you have no idea what you're going to get in return. If you ask that, and some of you might be thinking this is a hypothetical, but it's not. I see it all the time. If you ask the FDA, " Do I need to do a clinical trial?" What do you think they're going to say?

Mike Drues: "Of course you have to do a clinical trial and we want to see 10 million people."

Jon Speer: Yeah. Right. De-risk your submission and your product for them and that so... Yeah.

Mike Drues: Exactly correct. So on one hand, communicate with the FDA, but on the other hand, tell, don't ask. Lead, don't follow. In other words, go into the FDA very confidently and say, " Look, here's my device. This is what it does. This is how it works. This is the mechanism of action. This is the testing that we're going to do on it, and this is the testing that we're not going to do on it, and why we're going to bring it onto the market as a 510( k), and here are the reasons why, or is it de novo, and here's the reasons why we're going to do a clinical trial and here's the reasons why, or we're not going to do a clinical trial and here's the reasons why." In other words, do you lay all of your cards on the table. There's that poker metaphor. And then FDA says one of two things. They say, " Oh, great, Jon, that sounds terrific. We look forward to seeing your submission in a few months." Or they'll say, " Oh, hold on a second, Jon. We don't quite see it that way," and that's when the poker game begins. So communicate with the FDA, whether it's with FDA, whether it's with an EUA or anything else, but remember that caveat: tell, don't ask. Lead, don't follow.

Jon Speer: Yeah. Well, Mike, I never thought that we would've after that first episode that we did all those years ago, that you and I would've personally recorded another 100 plus episodes. It's been awesome.

Mike Drues: I would say the same thing. As a matter of fact, in hindsight, if somebody said, you're going to record 100 plus episodes, I would say, give me some of whatever it is you're smoking. You must be...

Jon Speer: Yeah, exactly.

Mike Drues: And here's the last thing and perhaps the most important thing that I would like our audience to remember after our 100 plus episodes and webinars and everything else together: regulation aside, everything else aside, would you swallow the pill, or would you have the medical device used in yourself or a family member? At the end of the day, that's the most important thing. Probably the most common question I get from people, I get this question from people in companies every week, sometimes every single day. Companies say to me, " Mike, you work with lots of different companies, you also work as a consultant for the FDA. If we came to the FDA with our new widget, what do you think FDA's going to want to see in terms of benchtop testing, animal testing, clinical testing?", whatever. I say to them, " Look, I say, understand why this is an important question and why you're asking me this question, but let's look at this in a different way. Let's completely remove FDA from the equation. Let's pretend that they do not exist. Sooner or later, a family member, a friend, perhaps your spouse, your child, yourself, or in my case, my seven- year- old grandson might be on the receiving end of your medical device. When that day occurs, what would you, Jon, or what would me, Mike, or whoever want to see to put our own personal stamp of endorsement, I don't want to say approval, clearance, whatever, that's just legal verbiage, but your personal stamp of endorsement to say that this product is okay to use in my spouse and myself, or maybe even in my seven- year- old grandson? Then and only then should we go to the FDA and have an intelligent conversation about what is necessary to be done in order to bring this product onto the market. That's a very different kind of an approach, but it's my approach. In my opinion, Jon, maybe I'm naive. I think it makes a lot of sense. But that's one thing, perhaps the single most important thing that I would like our audience to remember after these 30 or 40 hours of talking that you and I have done over the years. And that's just the stuff that we've put out there that's publicly available. That's not the private stuff, but that's what I would leave our audience with, Jon. It's one final thought.

Jon Speer: Yeah, 100%. And if I were to have a final thought, it's very much in alignment with that. And I had a moment earlier in my career, well, let's just say prior to this moment in time, I had a cool job. I got to design medical devices and it was a lot of fun, but the gravity and the magnitude of what I was doing was lost on me at that point in time. And I had a moment where I was present for the first ever human clinical use of a device that I had designed and developed. I was there and it hit me like, " Oh crap. Did I do this? Did I do that?" I was going through and questioning all the things that I did and didn't do on my head, and I had a panic moment. And I think that was really good for me as a person, but also fantastic for me professionally, because that realization that what I do as a medical device professional has an impact on the quality of life, and I want it to be a positive impact. Every one of us in this industry should understand the gravity and the magnitude and the importance of what we are doing as medical device professionals. As Mike said, would you use this on yourself? Are you improving the quality of life of humanity through your efforts as a medical device professional? And if you wouldn't be willing for your product to be used on yourself or someone that you love and you're not improving the quality of life, then please do all of us a favor and get out of the industry and go do something else.

Mike Drues: Yeah, I couldn't agree more. I think that was a wonderful sentiment. Very well said, Jon. And in many cases, you're right, it's trying to improve the quality of life. But in some cases, for those of us that work in the Class Three universe, it's simply life or death. In other words, if you do your job correctly, the patient lives. If you don't do your job correctly, the patient dies. That's pretty black and white. I know I said earlier, there's nothing black and white, but that's pretty black and white, life or death. So as I say, many times, this is high stakes bingo. We're not designing widgets that if it breaks, it's an inconvenience. You throw it away, you get a new one. But in the medical device world, often the stakes are much higher than that.

Jon Speer: Absolutely. Well, Mike, again, it's been a blast. Thank you. I've enjoyed all these times we've had together. And folks, thank all of you. As Mike and I mentioned earlier, if you guys didn't keep listening, we wouldn't have kept talking for all these years. But it's been great to meet quite a few folks in person face- to- face at events and whatnot over the years. When somebody comes up to you and, " Hey, I love when you and Mike talk about whatever the topic might be," it's weird, to be honest. It's a little weird, but it's cool at the same time that we've had a little bit of an impact and influence on some of the things that are being talked about in our industry. And I've seen so many positive things about this industry. I love the medical device industry. Keep doing the good work. As much as we talk about the errors and the follies over the years. At the same time, there's a lot of terrific things that you all are doing. So keep up the great work. I'll be paying attention from home or wherever I'm at, whatever my next adventure takes me to, to see what's new and exciting in the medical device industry. So I'm looking forward to hearing about those stories. So thank you all.

Mike Drues: Well, Jon, I would just like to echo those sentiments exactly. I want to thank you for being willing to participate in all of these discussions. As you pointed out in the beginning, we agree on many things, but we don't agree on everything. And I think that's partly why our discussions are listened to by so many people, because when you have people that are just talking about the easy stuff or people that are talking about stuff that everybody agrees on, quite frankly, that's boring. That's like why in politics when you have a debate between two different people with differing views, it's interesting to listen and, like a tennis game, you watch the ball go back and forth. So thank you to you, Jon, professionally as well as personally for putting up with all of my whackadoodle-ness. It is kind of strange to get people, I never thought we would have fans, but we both have been at places and people have come up to us, " Hey, are you the guy from that podcast?", or whatever. And I also want to thank the Greenlight family for hosting all of this and for handling all of the behind the scenes stuff of the organization and all that. I know it's not glamorous, but somebody needs to do that. So thank you Greenlight for doing all of that. And I'll still be working in this business, so feel free to continue to reach out to me if there's anything I can do to help.

Jon Speer: Absolutely. So, all right, y'all. Maybe we'll cross paths somewhere along the way. And if you see me out and about, be sure to say hello. Maybe we can grab a beer and sit down and have a chat. So thank you all again. This is Jon Speer, founder at Greenlight Guru... Yeah. Let me try that last... My last line, Jon Speer-

Mike Drues: Last time.

Jon Speer: ...founder at Greenlight Guru, and you have been listening to 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.

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