Why Regulatory Affairs Deserves a Seat at the Table
Mike Morton has over thirty years of regulatory, clinical and quality experience in the medical device industry, including serving as Vice President for Corporate Regulatory Affairs at Medtronic, on the Board of Directors for the Regulatory Affairs Professionals Society, and serving on FDA and other regulatory body working groups . In this episode we explore regulatory pathways for devices in the US, Europe and other countries, building relationships with regulators, how things have changed with regulatory agencies worldwide, where companies are launching first and why, what a regulatory affairs professional does throughout the product life cycle, and the importance of regulatory strategy.
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Episode Transcript
This transcript was generated using an automated transcription service and is minimally edited. Please forgive the mistakes contained within it.
Patrick Kothe 00:31
Welcome. medical devices are life saving, life sustaining very serious technologies. So we rely on regulations and regulatory agencies to assure that the products are safe and effective. The professionals who work in our companies in Regulatory Affairs understand the basic processes and procedures for getting and keeping devices on the market. But the best of them understand that there's a lot of nuance and recognize that regulatory strategy is a critical component of of a successful product and a successful company. Our guest today certainly fits that bill. I'm really happy to have Mike Morton join us. Mike has over 30 years of experience in the medical device industry including quality clinical and Regulatory Affairs, and currently consults on things in the regulatory arena. His last position was vice president for corporate Regulatory Affairs at Medtronic where he was responsible for public health policy advocacy, in Regulatory Affairs and for internal regulatory policy. Mike's also worked at CarboMedics Gore Alcon Labs and the Sorin Group. Mike's a fellow of the Regulatory Affairs Professional Society or RAPS, and recently completed four years of service on the wraps board of directors. He's been active in industry groups, including AdvaMed where he chaired the PMA working group, and the pediatric devices working group and was a member of the heart valve Task Force. Mike represented industry at the Global Harmonization Task Force, and is served as the industry representative to the FDA circulatory system devices advisory panel. In addition to his professional accomplishments, Mike's just a nice guy. I had the pleasure to work with him at carbon medics when he was just young and getting started. And really at the beginning of a fantastic career. Here's our conversation. Mike, it is great to have you on a mastering medical device podcast. Welcome.
Michael Morton 02:53
Thanks, Pat. Thanks for inviting me, I'm excited to be a part of this.
Patrick Kothe 02:58
Great to get things kicked off. Let's talk about Regulatory Affairs. What is regulatory affairs?
Michael Morton 03:06
Well, you know, it's probably one of the more or less understood functions of a company, what I like to think of regulatory is that it's a function that opens doors, it opens doors to the commercialization of a product. Not only that, you know, it gets a product out there to your customers to the doctors, it gets that technology gets a good, safe and effective technology out to the patients, it really creates an opportunity for the business. And that's on the pre market side on the post market side. It keeps those doors open, keeps the company in compliance keeps the company aware of changes that might be happening, you know, you always have to think not just the here and now but the total product lifecycle so it keeps an eye on that ultimately can expand indications and and ultimately you retire or supersede the product.
Patrick Kothe 04:11
You've been involved in regulatory for a long period of time. How did you get into the medical device field and why regulatory?
Michael Morton 04:19
I had a lot of doors open for me and I'm very appreciative of that. I had a background after college of doing several things spend a little time in the military, got out of the military looked around within Austin, Texas and there was a promising company Carbo medics, where I went in and he interviewed and, and was brought into the quality department and I worked with with some really strong people. And I'm remembering now people like Jerome Morrison, who thought I had some aptitude for regulatory and as the company vertically integrated and moved from being an OEM supplier Prior to developing their own proprietary product, Carol and others thought that my skills could be used in regulatory. So I transitioned more out of quality and was had the opportunity to work with some really skilled clinical people also through the trials and the ID process. And then eventually, for the rest of my career focused on the regulatory function.
Patrick Kothe 05:30
What is it about regulatory, that's so interesting to you,
Michael Morton 05:33
it truly is a strategy. It is that you see everything from the beginning to, again, if the products ever retired, you see, you see why it's superseded, or, or retired. And I really love that love that you are able to interact with a whole lot of really smart people, that from the very beginning, when you're sitting around a table, and the marketing team comes in, and they're excited about one thing or another. And then the engineers begin to challenge it, the manufacturing, people begin to say, how would we manufacture that or we're going to have to source one thing or another. And you as the regulatory specialists can kind of look at things and see what's out there already, quite some of the rig history might have been who's had problems with something similar who's been successful with something similar. So you get to make a contribution to, to me nothing, nothing really like the excitement of finally bringing something to market. As you know, I've spent most my time in the with the high risk devices in the class three space. To me, there's nothing like an FDA advisory panel where all that work comes together in just one day. And you are presenting to a group of experts, and your competitors are there and the financial community is there. You put your data out there presented as best you can. Usually at the end of the day, you you're rewarded for that. And it to me, it's it's a great, it's a great, great experience,
Patrick Kothe 07:24
the Superbowl of regulatory,
Michael Morton 07:26
it's been been described like that certainly has.
Patrick Kothe 07:31
So Mike, you've worked in in smaller companies and larger companies, what's the difference in the regulatory function in smaller companies versus larger companies?
Michael Morton 07:40
That is, as you know, it's it's always given that in the smaller companies, you wear a lot of hats, the smaller companies simply cannot have the headcount to have every one is as specialized that as maybe a larger company can. So quite often, when you're talking about regulatory in a smaller company, those job responsibilities might be shared. Also, with quality, sometimes, clinical regulatory, I've had that those three responsibilities at one time. More rarely, you will also see reimbursement tossed in there. But I bet I've seen that part of it is indeed the size of the company. And how many people can they afford to have on the on that headcount? Also, as a real critical factor is what type of device Are you trying to get to market. And obviously, with the higher risk devices, especially those that are going to require clinical evidence, maybe it makes less sense to have all those job functions put into one job description. Sometimes it's better to bring someone in with clinical experience or you know, med tech experience or veterinarian animal study, experience and get them to sharing some of those job responsibilities. You also, as a business leader, asked the question, well, what kind of talent? Could we bring in from the outside on a temporary basis? So you just hire it in? If there is going to be a strategic question or you do need to meet with the FDA? Do you just bring in a representative on a part time basis to do that, meanwhile, you've got your more junior people who are actually on the payroll, they're FTA ease of the company, they're continuing to do that very critical work, you know, to keep the documentation in order, keep the project running, but those are ways to, those are ways to approach that.
Patrick Kothe 09:53
So you go from a small company that may have a fractional regulatory person that they're paying, as you said, consultant to large companies like what you are at at Medtronic, approximately how many people were in regulatory at Medtronic.
Michael Morton 10:09
Globally, we had about 900 people at the time I was there.
Patrick Kothe 10:14
That's a lot of people.
Michael Morton 10:15
So a lot of people, we could fill up a room. Here's a story about that. I remember, in the early 90s, a professional society that I'm part of, and, and have have really appreciated their contributions for a long time is called reg affairs, professional society or raps. I was fortunate to go to a raps convention in the early 90s. And it was held in Amsterdam at one of the nice hotels, Iran damn square, the entire wraps conference pretty much filled the hotel. Well, let's fast forward 1518, let's just say 20 years. And I was there with a Medtronic regulatory meeting, and we filled the hotel.
Patrick Kothe 11:07
So why, why 900 people? What are all those people doing? Because there's not that many new submissions every year, there's a lot of things that go into the regulatory affairs function aren't there?
Michael Morton 11:20
Right there. There are in in your right, if we look just at the PMA space, the PMA space in the United States, so this is everyone submitting all types of PMA is when you look at the original submissions, they're running about 40 to 50, new original PMA is a year, that's not that many at all. There's 100, more 510 Ks, there's about 4000 of those. And then of course, with PMA supplements, there's a lot more PMA supplements that there than there are but you're raising a good point, there really are not an overwhelming number of new submissions that that go out. So then what are people doing? Well, a lot of it does have to do with the total product lifecycle, quarter changes, what are product iterations that need to be either evaluated, and then some of them are going to require a submission either a new 510 K, as you know, 510 Ks are not supplemented, you either have to do another one, because you've made a change, or you carefully evaluate that you put to file the rationale of why a new 510 K is not needed. So all those things take quite a bit of work. And then this is not the case in the United States. But in an awful lot of regulated economies, the licenses have to be renewed. So that is something that you very clearly have to keep your eye on, you don't want to let those licenses expire. So that and you know generally what we call reg intelligence, looking at the changes that are going on, and how many of those changes need to be actionable. There, there's a lot to do, there's a lot to do a lot to
Patrick Kothe 13:14
do. In addition, we've got and we'll get into kind of Europe a little bit. But there's, there's some post approval, things that need need to be taken into consideration at this point, too. Let's focus on the US marketplace and different types of approval processes, different classifications of devices. And if you could just quickly go through what classifications are for the US and then we'll get to Europe and rest rest of the world. But what are the classifications of devices in the US
Michael Morton 13:45
why in the US it's a risk based system dates back to 1976. With the medical device amendments, it's straightforward. It's a three class system. So you start with the very lowest risk devices, the class ones, the class one exams. And with those, the requirements really are that you just add he as a manufacturer, you adhere to what are called general controls, which means you have a quality system, you register you recognize you've got a device, and you act accordingly. Then you move into the medium to low risk devices. And those are called class two. And it's a very unique system in the United States were class twos were grandfathered in, in 1976. So the way those class twos came onto the market was if you could identify that you were what's called a pre amendment device. Well what about devices that are like those that come after 1976 so the route to market is called the 510 k which is named for Section 510 k of the Act. And that's a premarket notification. With that you identify a predicate you use, say, Hey, I'm like this. And here's some data to prove that I'm like that. So those are the class two devices. And then the highest risk devices, things like pacemakers, heart valves, hips, drug eluting stents, things like that. Those are the class three devices, the highest risk in the United States, they will nearly always require clinical data. So a clinical study to get those on the market, the route to market is the pre market approval, which is different than a clearance which is on the class to device, these class three devices are actually approved and the route to market to PMA.
Patrick Kothe 15:54
Okay, and as far as a timeframe goes, of a 510 k exempt product class one 510 k exempt product, that's just a registration process, right? You once you're done with with your product development and doing all of your internal quality system, then you register with FDA and you're on the market 510 K, what is the timeframe that someone once they submit, or they get clearance?
Michael Morton 16:22
Right? Once you once you submit and the agency comes back to you and they say, yeah, we've accepted this for review. And by the way, here's your key number, you can expect at about 45 days to get what's called a substantive interaction, which means the reviewer is going to likely will have been on the telephone with you, and will either tell you, hey, things are looking really good. Or, look, we've got some questions that we'd like you to respond to. And what happens there administratively is when that letter goes out the agency, the review team, can what's called stop the clock, which means they're not counting FDA days at that time, then the ball gets tossed over to the sponsor, and the sponsor wants to scurry around and come up, maybe they need a different test report, maybe they just need to clarify some things. But they need to get that information back to the agency and get that review started. Again, because of user fees. Now, the agency has targets has metrics for their performance goals on this, I can't tell you off the top of my head what the current performance goal is for the five team decays, but just in general terms, the target is to get that clearance or an ultimate decision back to the sponsor within 90 days. Now, the agency works really hard. And when things are able to be cleared earlier than that they will I'll tell you in some research I was doing I found a 510 k recently that went in and was received on one day and cleared that very day. I'd never seen anything like that before.
18:17
That's amazing. Yeah,
Michael Morton 18:19
yeah. Yeah.
Patrick Kothe 18:20
So so the target is 90 days. And as you said, the clock frequently gets stopped, when there are questions that go back to the company. So let's talk about PMA. And what type of timeframes are we talking about there because with a PMA, you've got significant clinical trials that are occurring, right more data
Michael Morton 18:39
to to review, but the process is pretty similar, where the submission goes in, gets reviewed for adequacy gets filed, it gets a p number. And then the review starts at about the 100th day and this needs to be requested by the sponsor to have actually what's called the day 100 meeting, where you can have a telephone call with the review team, basically to say what are we missing, just look good does not the the target is to get the PMA approved or a final decision within 190 days. Now, if it's a panel track, PMA or PMA supplement, there's a different metric for that and is you know, just the complexity of a PMA, especially with a panel you have to find a date where you can get people in plus with the PMA is quite often you also have to have a pre approval inspection. So that needs to be scheduled. And sometimes these things get out of sequence. Sometimes they panel meeting and the approval go really well but that inspection is still kind of hanging out there. But again, the target is within about 180 days to get these things clear.
Patrick Kothe 20:06
Approved. So I saw that and I think it's interesting because you hear people say the wrong things with a 510 K, you're not getting approved, it's being cleared. It's a 510 k clearance with a PMA, it's getting approved. There's several other more esoteric types of pathways for regulatory boat, one that's kind of in between the 510 K and a PMA is a de novo. And I think that that's probably the the fourth category that has has the most most submissions in it. Can you explain what the de novo is?
Michael Morton 20:37
de novo? First of all, the agency deserves a lot of credit for working with de novo, what the de novo pathway does is provide a bucket for a device that is not really high risk. But on the other hand, we were talking about pre 1976, there's nothing out there that's either pre amendment or has a 510 k predicate that a new sponsor can come along and say, Hey, here's the predicate. And here's my 510 k application. It's pretty apparent or fairly, fairly, certainly apparent to the sponsor. And the agency wants to take a look also to say, is this really not a high risk device? Could we have this as a de novo device? So you're seeing that, for instance, in the digital space, where everything that's digital now is very innovative? And you know, you're not going to find a lot of predicates for that. So they're falling in the de novo bucket also. So once you get that de novo, it's called the de novo classification, actually, because you're being classified then as a class two, once that happens, then your competitors can use your device as a predicate. So that's, that's that pathway.
Patrick Kothe 22:05
And then there's the Nova with clinicals. And without clinicals. Right? Yeah.
Michael Morton 22:10
True. True. Depends on what the agency feels that they need to see there are five Gen games that have clinicals. Also.
Patrick Kothe 22:19
So you've been in the regulatory business for 30 years, and there's a lot of urban legends about what you shouldn't shouldn't do with FDA and what FDA is and isn't. And a lot of opinions of different people saying Gz Oh, you don't go ask FDA. anything, you just submit, you find out what your and you and you just submit, let's talk about a relationship with the FDA and what what it's been in the past and what it is today.
Michael Morton 22:44
Well, one thing that I'll I'll say, Pat, is that the relationships are long lasting, you are working with people. And if as you and I have done, we have moved from one good company to another in our career, I'm telling you, the FDA reviewers are still there. You know, one day you're wearing a red hat The next day, you're wearing a blue hat, but you're dealing with the same people at the agency. I think that it's it's been important, always, not just for me, but for everyone, for the agency always to know that they're getting the full story from you. You know, another point is responsiveness that when the agency says they have a question, or perhaps they approve an ID E, and then they say, but you know what, there are these questions out there that we want you to consider. They really mean it. And that you as the regs specialist, representing the company you're working for, needs to have people kind of focused on that. So that when you do provide those responses or new submissions to the agency, that the agencies getting the data that they that they need. Let's go back and and talk about, you know, what you asked CFDA? And what do you share? I have an awful lot of friends. So I've had a lot of bosses, or I've had a few bosses who were lawyers. And of course, one thing that lawyers live by is don't ask a question when you don't know the answer. I think that's good. And regulatory internal policy also is the more you know, when you walk into this, you know, let's say you're, you're talking about a de novo pathway that you think you really do have a de novo pathway. It's good that you've exhausted your research also, before you go in and you just throw something out on the on the table. So being prepared and treating your FDA counterparts as equals is always a good thing. That as for completeness, one thing that that I have always tried to get my teams to Be honest with themselves about and that is, where are we going with this? What kind of claims are we wanting to make? What kind of indications Do we want. And that matters, of course, especially as you're setting up the clinical studies and the endpoints, and the inclusion and exclusion criteria. And you don't want that to be a moving target to you want to know, as an internal team, where you're headed with that. And as the reg representative, you want to be very clear to the agency, here's where we're headed, and not have a lot of surprises down the road.
Patrick Kothe 25:41
I think one of the key things that you talking about there's you're not going to FDA to ask their opinion, you're going there with your strategy, and confirming that strategy. And if there are any concerns that they will bring up the concerns, but you're not going to ask them what you're supposed to do.
Michael Morton 25:57
Right, very, very much so. And you know, another thing that I've noticed throughout the COVID period that that we've had, two years ago, if you went to the agency for a pre submission meeting, you'd get a big team of FDA reviewers in there, you'd get medical officers, you get the senior review team, you get branch chiefs and whatnot, you get a wide group of people, and you pick up an awful lot from that meeting, as you began to talk about your device and the indications for your device and how you were going to test the device, you'd get a lot of feedback. Well, since we're not meeting face to face, now, you're losing an awful awful lot of that because it's it's done through webinar type meetings. And, and that's a little little unfortunate, but to your point paps, you want to go to the agency, with a pretty clear strategy, something that you have fought out, obviously, you're going to look for the least burdensome pathway, you're doing that both for your company, you're doing it for the patients, you're trying the best way and the fastest way to get this product on the market. You need to have a good solid rationale for that. And, you know, sometimes the agency says no, you know, I don't think we can go that way. Quite frankly, I have known people to walk in with a pathway that they had thought and the agency's given them a lease a less burdensome pathway, being as thorough as you can be often pays off.
Patrick Kothe 27:41
That's really great. advice, Mike. But it's also very interesting, because it appears that you're approaching this as a group effort and and not an ad, not an adversarial effort. This is what we believe it is and then using them as more or less consultants, but not consultants. I mean, they they have the ultimate responsibility to approve, not approve. But you're you're not going in at with an adversarial relationship?
Michael Morton 28:11
Well, you're exactly right, Pat, I never think that pays off. And just having a real good understanding with everyone on the team about what we're trying to accomplish. Now, I'll give you an example. I was recently working with a team of really well funded Jane. And we were getting ready to go to an FDA pre sub meeting. And one of the people on the team was clearly getting overly excited about this. And was really insisting that we go out we we bring in an MD to go to the to the meeting with us. And he kept making the statement, we've got to be the smartest people in the room. Got to be the smartest people in the room. And, you know, finally I had to have a conversation with him and say, you know, let's, let's take a step back and ask what is it that we're really trying to get out of the meeting. And in this particular meeting, we didn't really have any, any contentious items. We didn't have anything that we were really worried about negotiating that was gonna make or break the either the timeline or the project or anything, basically, it was just that we were going to go in and you know, have this conversation and get either a check or maybe suggestions on a different way to go. You know, I had to kind of work through that and work through what's our approach going to be to the meeting. And it turned out we really didn't even need a doctor to accompany us because of the questions that we were going to ask. So again, that fall out of we have to be the smartest people in the room. It's No, not really, because there's going to be a lot of smart people in the room.
Patrick Kothe 30:05
So I want to get to regulatory strategy. But before we get there, let's quickly go through, because we focus on FDA, but there's a world out there. So let's, let's quickly talk about Europe, CE mark, and then some of the rest of the world. Thanks. So let's, let's talk about Europe. Now.
Michael Morton 30:23
Yeah, and of course, as we all know, the environment in Europe has really changed drim, dramatically the past past few years, because they've gone from a medical device directive to a much more restrictive medical device regulation. Because Europe is not just one country, that a number of countries, it's got a system that relies primarily on two really important elements. One is what's called a notified body. And that's a private sector company. And we have experts who will do the reviews and the quality system certification. And then of course, there are the competent authorities for each individual nation. So that's unlike the United States or Canada, where you're working with directly with regulatory authority. So in Europe, if you are a sponsor, and you want to bring a device to market, you identify the notified body that you want to work with, you do a couple things, you get a quality certification, usually called an ISO 1345 certification, and then depending upon the risk of the product, you send a submission into the notified body. And they will review that assuming that that goes well. The notified body then gives you what's called the CE mark, which includes the number the identification of that notified body, and then you can can then go to market. So it's a little different process.
Patrick Kothe 32:08
And as far as classifications of devices,
Michael Morton 32:12
most of the rest of the world adopts what's called of, for class system, risk based systems very similar to the United States. But where we have three classes, others will have class 123, and four, Europe has class one, two, A to B in three, it's still the same thing. It's risk based.
Patrick Kothe 32:36
So with this change over the last three years, I think it was announced three or four years ago, and it's just being implemented, I think, this month or this past month, what types of changes have occurred or what types of repercussions have occurred as a result of this change,
Michael Morton 32:54
the expectations for what's called clinical evidence has really ramped up. And I think that's caused a lot of concern that devices that previously might not have needed clinical evidence. Now that's got to be part of the submission, whether that actually means a clinical study or not, can depend on the risk of the device or what the expectations of the notified body are. But that's one of the big changes, also the number of notified bodies, the EU specifically wanted to cut back on the number of these private firms that were authorized to establish a CE mark. So there's fewer of the notified bodies, the ones that are out there are extremely good, that there's fewer of them. And that is caused the notified bodies to become even more cautious and more protective, more cognizant of their responsibilities as a notified body.
Patrick Kothe 34:00
So as a result of this, it is taking longer to get products into Europe is a change the you know, the aware where a company would enter the market, whether it be Europe or us initially.
Michael Morton 34:16
There have been a couple things happen Pat, and you're raising a really good point that you're abused to be the default entry market for an awful lot of devices. Even if you needed clinical studies. You could go through an ethics committee you could get a clinical study started if you had a good relationship with your notified body and by that I mean a truly good when not a shady relationship at all. But you know, if the notified body knew you knew your work and you had that good working relationship, it was generally considered that Europe was the best paying and fastest market to get into Now again, there's a lot of uncertain In about how the MDR is going to shake out what the, you know, the metrics are going to look like. At the same time, the US FDA has really taken a more aggressive stance or recognition that is part of a global medical device economy that the United States is, is a part of that there have been an awful lot of changes made by the FDA to get devices either started in studies early in the United States, and ultimately get them approved in the United States. I'll tell you an anecdote. Pat, I have been fortunate to both do a lot of work globally and also do a lot of work in what's called the harmonization space where different agencies are kind of looking at things to see, are there, more efficient ways that we could perhaps work together. And I've been fortunate to be in conversations often in public meetings with regulators, where I have heard high level FDA lawyers simply make the statement they that they want patients in the United States to be the first to be able to get safe and effective devices. And I've heard that from Japanese authorities. And I've heard that in Taiwan from the Taiwan, FDA, and those who just three. And that's, you know, that's from my personal experience? Well, as a sponsor, you know, you couldn't be in a better situation than that, where you've got several authorities who are saying, we really want to work with you. What's curious about them, Mike, is
Patrick Kothe 36:46
that those that you just mentioned, are looking to move things faster, and it appears in Europe, they've taken the other way. And it's and it's slower, what drove the changes in Europe to be, you know, kind of where we're at right now.
Michael Morton 37:05
Yeah, you know, what we watched over the past six years or more, you remember what was called the P IP breast implant scandal, where there was just simply malfeasance going on where industrial materials were used, instead of medical grade materials and, you know, duplicate manufacturing facilities, it was it was really a not a good story. And, and patients suffered because of that. And it puts a strain on the public health systems in Europe from recipients of that device, and there was an overreaction, everyone should be shocked and not not want that behavior to go on, or those sorts of unsafe devices to be out there. A lot of what you saw was actually fraud. As you know, it's hard to regulate when a company is intent on doing fraud, a lot of the EU legislature is really kind of traced back to the reaction to that and the MDR came into effect, even knowing that it was going to do quite a bit of damage to the device industry in Europe.
Patrick Kothe 38:27
So we've got two main regulatory bodies, the European system, US systems, and then there's other regulatory bodies by different countries. Yeah. Any that kind of stand out? Are they all more or less risk based systems and going to individual countries, the regulatory buys of individual countries,
Michael Morton 38:47
you know, traditionally, economies that have participated in what used to be called the Global harmonization task force that included Europe, Canada, Australia, Japan, and the United States. And yeah, I think you can look at those and say, indeed, you know, there's a lot of similarity of when you're trying to do a regulatory strategy for those other nations are now jumping in also with regulations of their own, for instance, India, which had for the past several decades, regulated pharmaceuticals, but did not have device regulations. Now, they have passed some device regulations. Also, it's hard to make a lot of generalizations about some of these newer regulations. And then, of course, I think for many in the industry, China has been difficult largely because things do change so quickly, whereas for instance, we were talking about the European MDR we You've seen that coming for a number of years, needing to get prepared for that. I think it's more typical in China that a pretty impactful order can come out with a 30 or 60. Day effectivity. So it's much more difficult to to react.
Patrick Kothe 40:20
Well, we've covered the the main areas, the main regulatory body, so to speak, let's spend some time on regulatory strategy. And we've already touched on a number of different things. There's a geographic, you know, where your entry point is, you talked about the claims associated with with a particular product. There's claims over time and how that changes. There's different classifications And should you go after, even though it may be faster to get a 510? k? Would it be better for you raise the bar and the barrier of entry if it was a PMA? So the lot of different different regulatory strategies, so can you just explain to me a little bit about how you view regulatory strategy as a tool that a medical device company uses?
Michael Morton 41:09
Yeah, Pat, that's a good question. And the way that I think a lot of us in the reg field, have articulated this, over the past few years is just to say, there, there needs to be a seat at the table for regulatory, and that needs to happen early on. So that regulatory can be in there vetting some of the opinions that are that are being tossed around and providing real input. And again, looking for those opportunities to get the device that everyone wants into the market as quickly as as they can. When that does not happen, of course, then there can be big disappointments, if assumptions are made. Again, well, there's a competitor out there, there's a predicate, so therefore, this could have a 510 k pathway. And that's a valid, valid assumption. However, if the intent is to broaden indications, or to go out with a different intended use than the 510 k pathway, is no longer really feasible. There needs to be someone there at the table, to help with that discussion early on, before expectations, get set budgets and things like that. And then then it turns out that, you know, it may not be as viable overall a business plan, because the regulatory components been missing.
Patrick Kothe 42:47
I think that's really interesting, because a product, even though it is a physical device, you got a physical device, that is not the product, the product is, what is the indication for use? And what are the claims associated with that, because it's the same thing, but you can't market it in a different way.
43:07
Exactly.
Patrick Kothe 43:08
What I've seen a lot with with companies is you're going to build that product. And in some people's mind, it has certain claims in other people's minds, it has other claims. And you've got a wide variety of expectations within an organization. So let's talk about that a little bit. And how regulatory is important in mediating that discussion.
Michael Morton 43:30
Just stay in the 510 k space. One of the big challenges is a company may say, okay, we want to build this. And look, there's already predicates or competitors out there. But what the real business goal, what people see as the market niche, is not to market for that what's called the general indication, but to go to the specific So in other words, there may be a device out there that ablates soft tissue, but what the desire is, is to bring out a device to address a fib. While there's a big difference in making one claim or or another, and the company can end up with difficulties because of things like that.
Patrick Kothe 44:22
And also, it's not only what you go in with, you may have a market entry strategy to go in with a broad and then go to specifics. So you have the opportunity to expand that indication with additional clinical clinical studies, additional data, etc. But that has to be talked about right up front.
Michael Morton 44:42
Absolutely. What is the strategy? Absolutely. You have to be willing to do that to take one step and then know that you're going to be doing other steps and that might mean partnering with kayo wells who are interested in doing that research with you above all, It requires the budget to do that. And again, from the regulatory perspective, as we were talking about a little bit earlier, it's a matter of being upfront with the agency, that this is what our long term goal is. And this is what we're going to do now.
Patrick Kothe 45:20
So you mentioned a seat at the table, what are the challenges that you see that you've seen throughout your career with getting to the table, and having a voice at that table?
Michael Morton 45:31
You know, the good news bad is I've seen this evolve, a lot of the decisions are made by the functions of business development and marketing and sales and business leaders like that. And the assumption is that, yeah, regulatory is a factor in this. And so people would say, well, we need to check with regulatory, but then somebody delegated to do that, who then runs down the hall, and, you know, selectively remembers what was important to them. And they kind of toss that out, they get either a yes or no or whatnot, I think we can see that the completeness of information and the transfer of information is not not really adequate. In a situation like that. I think more and more regulatory can actually sit during those early discussions, and provide the feedback and at least in healthier settings.
Patrick Kothe 46:34
And looking at it from a company standpoint, you've got the stakeholders of the company, within the startup world, its investors. So what are you what are you saying to investors? And what are the expectations because if you've got a broad indication, and you're not able to actually market for a specific indication, your market size is significantly different, your market opportunity is significantly different. So having a clear regulatory strategy, and what it is and isn't from the product claims is so important, because that will affect the financial people as well.
Michael Morton 47:09
Right. And there are a lot of investors who have had experience with a lot of companies, a lot of startups, a lot of successful companies, etc. And they do have a good understanding of regulatory is probably not frequent enough that a reg specialist actually gets to come in and sit at those meetings with the investors or to that the presentations that are being made to the investors, and then you hope that someone there at the table would have the experience to say, yeah, this sounds feasible, or wait a minute, maybe we need to check on that. But that's, that's a good point. Sometimes that's missing.
Patrick Kothe 47:54
So Mike, you've been part of large companies, they make acquisitions as well, part of that process of acquisitions, his due diligence in all different areas, and due diligence and regulatory, I assume is also a very important thing. So how do you view technologies or companies that are coming in, that you're evaluating? How do you evaluate them from a regulatory standpoint?
Michael Morton 48:17
You know, it's an extremely important part of the process. There are two phases in this there should be. And one is obviously the pre acquisition, due diligence. The other is what you should do is post acquisition. Once the non disclosures and, you know, confidentiality issues are done with because the company's been acquired, then you really need to send in a larger team and do a deeper dive. But early on, what you're looking forward, to me is the validity of the data. So you're going to be working shoulder to shoulder with your technical functional partners. So they're looking at the TPS and T RS to say does Does this make sense what you and your regulatory team are looking for? Is have they set this up in a real quality system is documented? Well, from a higher level? reg perspective, the issues that I always have is has there been interaction with the agency and with any agency, but let's just assume FDA, has there been interaction? And has this company really understood what the agency was saying? So therefore, the projections the predictions that they're making to the potential buyer, are those grounded in reality, and in some cases, what you what you find is that the company has not been listening to the agency at all, and the agency is getting tired. Dealing with them. So then when you make that acquisition, even though the technology may be very promising, you're at a big disadvantage in moving a regulatory plan forward because they really haven't had a regulatory plan. And in fact, you know, what you what you find is a pretty difficult setting to work in.
Patrick Kothe 50:22
When you're evaluating these things, are there some big red flags that stick out? Or are there some on the other on the other ciders? Or there's some things that really stand out that this company is doing a fantastic job.
Michael Morton 50:34
Yeah, you know, the good things first, if things are in a good design control system, you know, if it's clear, that they've known where they were trying to get to, and the design process, and that they're testing is made a lot of sense that things are documented, and they're clean. That's great. Even more. So if they've already moved into clinical studies, if they've got a reasonable protocol, if they're in investigators have been doing the right things, if they've been monitoring their study, if if that all looks good, that's all really good news. But what's bad news is kind of getting back to some of those basics that we've talked about earlier, if the agency in their communications to this team are saying one thing, let's just oversimplify it. Let's say that the agency is wanting nine months of accelerated were data. And this team, you know, is trying to give them less than that, you know, they then did that work, you know, maybe it's at a contract lab. So that gets really complicated. Wait, and then how do we go back? How do we start this over again, etc, plus the fact that they've not been listening to the agency. So even though you may be a reputable company, you're suddenly going to be going back to the same review team that's going to be a little bit jaded, it's going to be like, oh, here they come again. And that's, that's kind of a difficult way to start. Fortunately, these cases are really rare, really rare. But we all know that there have been cases where some companies have just, you know, the term is dry labbing, they're generating test results, if they want to see, there have been cases where there's not been good, meaning there's not been accurate and in truthful, clinical data that have been submitted, and that puts an acquiring company in a terrible setting.
Patrick Kothe 52:42
And to be perfectly frank, those people need to pay the price and need to be moved out of the industry, because they're hurting the rest of us.
Michael Morton 52:47
They are.
Patrick Kothe 52:49
Mike, you've had a fantastic career within regulatory and learn quite a bit and talk quite a bit to a lot of us, within within the medical device space, what message would you like to leave with our listeners?
Michael Morton 53:03
First of all, regulatories a great place to work that you get to interact with the best people, you know, you go home, often feeling really enthused about what you've been able to do during the day, it's all that's all very positive. So it's a good place to be, the device industry is a good place to be, as for regulatory, keep regulatory, as a business partner, give ra that seat at the table. And I think the long term benefits of that will be good.
Patrick Kothe 53:43
It was great connecting with Mike and exploring his insights into regulatory a few of my takeaways. First, a seat at the table. If you're that person who says your world will check with regulatory? Well, you may want to rethink how you do business. Regulatory Affairs is significant in its importance to the company. It helps us determine the timeline for market introduction, which directly leads to how much an investment is needed, whether it's a startup or whether it's an existing company. It helps us to determine what we can say about our product, you know, how are you going to sell this product when it's out in the marketplace? What can you actually say about it? And where you can sell it? What countries are you going to be able to sell this product to they'll also help you to continue to sell it when the regulations change because they always do. If you're dealing with these issues, you better believe that they should be at the table, second relationships with FDA and other regulatory people. And I mean people with long memories. So Mike talked about that and the relationships that he's established with different people. The agency is being one of his most valuable assets. Every company has regulatory affairs professionals, and they're in it for the long term. And I've seen it where upper management has occasionally said, you know, hey, go get tough with FDA. And what that translates into is go burn a bridge with FDA. That never works. Never force your people to do something that's going to compromise their integrity. The long term stakes are too high for you, and for them. Finally, treat regulatory as a strategy. Mike really hammered that pretty well. It holds for two things. First of all products, you've got a pre market phase, the initial indications, expanded indications, monitoring the products and retiring the products. All of those things are strategies to be managed within a particular product. But really, let's go back to the company's strategy using regulatory as a strategy overall, and it comes back to the first point, they deserve a seat at the table. Thank you for listening. Make sure you get episodes downloaded to your device automatically by liking or subscribing to the mastering medical device podcast on Apple podcast, Spotify, or wherever you get your podcast. Also, please spread the word tell a friend or two to listen to the mastering medical device podcast. As interviews like today's can help you become a more effective medical device leader. Work hard. Be kind
