#391: Creating a Regulatory Roadmap for MedTech Market Success with Adnan Ashfaq

Adnan Ashfaq: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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n has founded SimplyMedica in: 2011

Adnan Ashfaq: Wonderful. One small corrections over 25 years now in the medical device industry.

Etienne Nichols: 25 years. My research needs help. Okay, all right, very cool. Well, talk to us a little bit about developing a regulatory roadmap, and maybe we could talk just to start out, what is a regulatory roadmap? How do you define it?

Adnan Ashfaq: Sure. So I think before going to a regulatory roadmap, I would also just like to differentiate between a regulatory strategy and a regulatory roadmap. So regulatory strategy is actually a requirement from the medical device regulations, the European medical device regulations. It's actually written into the regulations that there's now a requirement for European CE marking that you write up a regulatory strategy and it outlines how you're developing your device and what regulations you need to follow, what standards you need to follow, and how you're complying with that. So your regulatory strategy will fit in that format. So that's more to do with the regulatory strategy. Now what we really want to be focusing on a regulatory roadmap, which is a slightly different document. And what that's really doing is it's all the homework which a legal manufacturer would be doing at the outset when they're developing a medical device and they're looking to legalize and commercialize that device into a market or several markets. And as part of that homework, they've outlined the costs of the regulatory submissions, which markets of regions of interest that they have, the outlining the timelines to the markets, any resources that they need to achieve success, and all those costs. And what it really becomes is it becomes a perfect document for investors or stakeholders to review when they want to dig deep into their pockets. They know that these guys have done their homework because very often VC funders or investors, they want to see milestones within a project timeline that the legal manufacturers have hit these milestones by specific times. And it then gives them confidence that they're on trajectory. And the roadmap gives you that outline at the outset and it gives that piece of confidence to the potential investor that this is really exciting because you've got regions of interest where we can commercialize the market analysis has been done. It's quite clear what the market share is and exactly how that's going to be achieved. So the market access and the success is outlined in the roadmap.

Etienne Nichols: So I can see that definitely being a benefit from a investment standpoint and making sure and communicating it. Are there other benefits that you can see from a regulatory roadmap, having that in your back pocket and understand, I mean, obviously a roadmap, you want to be following that roadmap. Is it a living document or tell us a little bit more about it?

Adnan Ashfaq: Yeah, so what it will do is it will feed into the other documents once you start your development of your life cycle. So once you get onto the, let's call it the official life cycle, you know, rather than kind of just doing your background research, when you hit that development life cycle, you're going to go back to that, the roadmap at which you developed at the outset, and use that as a pivotal point to kickstart the project and to then feed into the different areas, because of course, we're going to be looking at things like a broad overview of the phase developments of the device and the development lifecycle. But we're not going into detail at this point because that's what you'll do ultimately in another document like the design development plan. So the design development plan, you will then go into more detail about the project, what milestones you're achieving, when you're achieving those milestones in further granularity. But what we're Doing here at the regulatory roadmap is that would then feed into that sort of document, into the development plan.

Etienne Nichols: When would you say companies need to have this?

Adnan Ashfaq: Once the market analysis has been done and there's been any legal IP filings, it might even be done before legal IP filings, to be honest, if you've got intellectual property, you might do it before that. Because really, when a concept has been thought of, somebody's done some market analysis and they've identified that we want to enter this market because we've done some market analysis, we see that there's a global market and we can take a share of that, of X share in these regions. I mean, let's just take for example, a mental health software or something like, or cardiovascular or diabetes. Now you can quite easily do, if you do your market research, you'll be able to geographically see where those apps or devices are better suited. You know, where, where is diabetes the highest, where's mental health the highest? You know, these sort of things. And I've worked with clients that have done that before, so they've, they've been quite clear right from the beginning which markets they want to access. Japan, for instance, as a very long life expectancy. So, you know, Alzheimer's and mental health, that's something that they want to target. You know, so the device developers want to target countries like Japan and in that region. So. And diabetes, you know, places like the US and Europe and where other countries where there's statistically there's a lot of diabetes, cardiovascular. So those type of activities, you want to be able to look at where the markets are and when you've identified that market analysis, that will then feed directly into your regulatory roadmap. So it is really quite early on into the whole process.

Etienne Nichols: Okay, so when you talk about that, the costs, I guess maybe I'm trying to think about what needs to come first. What are the different steps of building one of these regulatory roadmaps? And I know this isn't, we're not going to turn this into a working session or anything like that, but I think cost, region, timelines, resources, all of those get a little bit jumbled sometimes. Is there a good starting point you recommend people go with?

Adnan Ashfaq: Yeah, because the reality is that when you do this piece of homework and you start outlining this, this could be the breaking point of whether the device can actually get to market because it may cost so much regulatory costs. If you've got to do clinical trials, for example, you've identified that you've come up with a device which is so novel you can't find a predicate device. There's no other competitive device which are doing what you're doing. It's so novel, you've got to now start thinking about outlining clinical trials. And that also should be detailed in your regulatory roadmap because again, you don't want to put in front of a potential investor some market analysis or research. And in your regulatory roadmap, you've identified that there are predicate devices when there aren't any predicate devices. Your novel, because they're so novel that there's nothing that you'll be able to claim for. The difference in the cost can be astronomically different, you know. You know, in terms of getting that device to market. And as we know very clearly, you know, most many devices don't make it to market one because of time and many times because of cost. And you know, and these are the sort of things that you want to be outlining quite clearly as best you can, as early as possible in the device before the actual development begins. So it's like, you know, you can actually see that you have something that can go forward or not. You know, it's a bit like here in the UK we have Dragon's Den and think in the US we have something similar.

Etienne Nichols: Yeah, Shark Tank.

Adnan Ashfaq: The Shark Tank, yeah, yeah, exactly. So it's that kind of pitch. It's the, it's that elevator pitch. So for me, the regulatory roadmap is almost that elevator pitch. Like you want to have that in front of those dragons or the sharks and say, this is my roadmap and they can, you know, you have that argument in front of them, they're going to start throwing questions at you and what's your forecasts, what's your market? Where are you going to, how are you going to achieve this? How long is it going to take? That's all going to be in the roadmap. You've got those answers in there.

Etienne Nichols: Yeah, that makes, that makes total sense. Are there any other additional elements that need to go in this? So, because when I'm thinking, okay, so let me see if I can phrase this question a little bit better. If I'm going to be building this out, I've got an idea for a product, maybe the ip, like you said, you've got your IP or some prototype. I know the regions I've analyzed from a global standpoint where the different indications would most likely be applicable. I've identified these regions which then I can backtrack and just kind of Reverse engineer. Okay. It costs so much to get a Class 2 medical device, et cetera, et cetera. If I have to do a clinical investigation, I have all these ideas in mind or these things in place. What about additional elements to your medical device company, qms, additional human resources? Are those involved or what are your thoughts there?

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Etienne Nichols: That makes sense. When you're talking about mdsap, for example, I think that's a great example. If you knew all the regions you're going to go to, maybe you're going to go to, maybe, maybe you're starting in the us, but then for whatever reason, the next logical place is Brazil. And so maybe MDSAP makes sense and then you start thinking, okay, well if I do this, put this in place, what are the other options available to me? Australia now is on the table, or some others. What are your thoughts? Any things like that, where doing this actually opens doors to other opportunities?

Adnan Ashfaq: Yeah, that's a really good point. Because bearing in mind that once you've got FDA submission and CE marking, the doors to the rest of the world open up with some adjustments. Right. We know, for example, you know, Brazil favors fda, Australia favors CE marking. So there's a kind of geographic, geographical, territorial map that you can start outlining. The Middle east, for example, is a big growing market. They've predominantly been more favored towards fda and you can start mapping out the different countries and you can see where it's beneficial. But yes, if you've got the FDA and you've got the door to the ce, the rest of the world will start opening up.

Etienne Nichols: Yeah. And you could be thinking about that when you were talking about the different stakeholders that you need to have. I kind of go Back to the three Ps, the product process and the people. And so you, I guess you would think about this from the process or for the, from the product. Yeah, I guess you would think about this from the product standpoint for your regulatory submission and then you can kind of work backwards as well based on those regions. What processes do you need in place? Like you mentioned, what QMS requirements, what clinical investigation requirements and then maybe what people, whether it's the PRRC or legal.

Adnan Ashfaq: Yeah, yeah. So I mean, I think at the True Quality Summit recently, the online with Greenlight, I recently did the intended use statement. There was a presentation that I did on that. And the thing is that you need to try and get your intended use statement as early as possible. But the thing is that in the intended use statement, as I mentioned during that presentation, is much more than just the indications for use, which is what the US would look for, and the intended use, which is what's defined in the EU mdr. The intended use statement is much broader than that. Now, to try and define the intended use statement with your intended user's intended use and intended operating environment, whether the device is going to be portable or whether it's going to be kind of installed. And all these questions that come around with the user requirements is great to have that information as early as possible. So when you've got your regulatory roadmap, which you're defining, if you can have that, then great. But if you've got the broad intended use, then that's also okay. Because the problem is that you may not be able to define the level of granularity that we're looking for in the intended use statement at that early stage. Because it might, that's. That may come afterwards. You're going to start prototyping and developing and you might realize that, well, maybe we can actually use this in a home environment as well as a clinical environment. But when we did the reg to roadmap, we only identified that was going to be in a clinical environment. But now we're changing things. So the goalposts can change and very often will change, as we know. You know, if anybody has done any development of any medical device, the goalposts will completely go right. At some point you've got to put that down. You know what we call design freeze? We're going to freeze the design.

Etienne Nichols: It makes me think of the. There's an Eisenhower quote. I think it's attributed to Ivesen Howard. Primarily, planning is everything. Plans are nothing, which isn't really true in medical devices. The plans actually do matter. But it does make me think if the goalposts are going to change, you still need to be planning. But having said that, I want to ask another question that is okay, you've talked about the benefits, you've talked about what it is and why you should have one. What if you don't have one?

Adnan Ashfaq: Yeah, I think the danger is when you don't have one, you go in thinking that you know everything, it's in somebody's head and maybe in the stakeholders that they've discussed this in meetings, that we're going to go into this market or that market, but where is it documented and when do you document that? And the thing is that not only like we said, will this assist with investors and stakeholders to know where the legal manufacturers going with the device, but also is going to be a steer and a guide for the company to where they need to get to and how they need to get to it. So it's almost like going back to that pivotal point of this document of what was being discussed. Otherwise it's going to remain in people's heads. They've Discussed it somewhere. It may be in some meeting minutes, documented somewhere. But those goalposts, when they're changing, you know, you've got to try and work towards something, you know.

Etienne Nichols: Yeah.

Adnan Ashfaq: And that this basically becomes that something, you know, you've kind of defined things up front in a way. It's almost like you use the requirements, you begin early as possible. Right. You use the requirements, but user requirements can also change with your development. So with the same thing with the regulatory roadmap, like we said, you know, if your markets change and you start adding on further markets, I would say update the regulatory roadmap as well. So it's sensible to try and revision controller, even if you don't have a quality management system at this stage, just do some good documentation practice on it and update the documentation, have a second revision, have a third revision. And that will only benefit you, I think, when you're going back. And you can also then see at what point in time did you actually make changes and add on other markets or make any changes to that. So it's also good traceability for in an audit trail. It's a good thing.

Etienne Nichols: Absolutely. And getting a second pair of eyes, if you have an approval process, you have to go through that and most of the time, if you don't have to do it, other people are not necessarily going to approve it to the point where they say, yes, I read it, and so on. Another thought, even if you don't have anyone else reading it, one of the things that I've learned is there's a phrase that comes to mind, I never knew what I thought until I wrote it down. And I sometimes wonder if this communication, the biggest problem with communication is we think it happened. So I agree with you there. Any other thoughts?

Adnan Ashfaq: Yeah, we would be looking at the key markets, like I said, you know, if you're looking at the US and the eu, again, depending on whether your device is an in vitro diagnostic or whether it's a traditional medical device, you know what route you're going to be taking, what you're up against, what standards you've got to follow, what stakeholder engagement you've got to have, what your conformity assessment looks like. There's a number of things that you've got to consider here now, what happens in markets like here in the uk, we've got a framework which is still kind of being developed at the moment. There's some opportunities for companies that want to legalize in the UK because the framework is said to become more aligned to the EU with some Kind of caveats with that. You know, having learned what's happened with the EU mdr, some of the mistakes that's been made with the European mdr, we need to try and learn from some of that. So what happens when you want to try and commercialize in a market like this where the regulations are still half baked? So there's an opportunity here, and this is a clear, this is also, this is a brilliant opportunity in the regular roadmap to identify opportunities like this. So there's an opportunity where you could actually market your device in the UK under a lower classification before the regulatory framework tightens up. Right. Because you understand what. So some of the class ones will become Class 2 as next year. Right now there's an opportunity, we should put that in the regulatory roadmap. So in the regulatory roadmap you outline that and it then becomes not only a response to the legal manufacturer. So very often, I mean, I'll write up the regular roadmap for my clients, my clients will tell me the information that I need, but I'm also at the same time advising them. But hey, maybe you need to think about this market because there's an opportunity here because of a more classification, because there's an easy market access and you can access the market under a Class 1, self declare it, get your device in there. And while the device is being commercialized as a class one, you can have great post market clinical data which can be used for a file in the future, for an NDR application or even for the class 2A when it becomes class 2A when the, the regulations have been tightened up. So there's great benefits in that. So now we're talking about regulatory intel, which also benefits the legal manufacturer. So the regulatory roadmap becomes far more than just documenting what's in people's minds. Yeah, it becomes almost an advisory document as well.

Etienne Nichols: That's a fantastic example. I love that. So it would need to be done in the hands of someone who has kind of that global view and has their feel on the whole world, I would expect, you know, and where we are with the regulations.

Adnan Ashfaq: Absolutely, absolutely. You know, so, you know, there's, there's a legal side of things where people need to know the legislation and understand what's going on. When we're regulatory consultants, we really need to keep on top of things. We know where the goalposts are moving at 100 miles an hour. You know, we really need to kind of see what's going on and where to advise best. And by the time we've written this regulatory roadmap. It's already out of date, but I like that.

Etienne Nichols: It could be almost like that top of the pyramid type of document. Almost like your quality manual streams down to other things. This seems like something very similar that streams down to a lot of different aspects of the device as well.

Adnan Ashfaq: Yeah, it will do. You will also need to look at the, any, any, any constraints.

Etienne Nichols: Okay.

Adnan Ashfaq: From the market access, you know, so if there's an upfront competitor assessment done, we may not be the only ones that are developing a specific device. Somebody else is doing it. How do we get to market before they do?

Etienne Nichols: Yeah.

Adnan Ashfaq: So, you know, you've got to have a look at that, you know, have a look at that competitive assessment and see, you know, what are the claims that we're making of this device that couldn't possibly make a deal breaker of getting the device into the market? Because as we said earlier on, I come across this all the time where there's a new startup company, they've never been in medical devices, they've come up with a really novel idea. They want all the bells and whistles, they want to make all the claims, but they've got a device which is that predicate device that's already on the market, but they're only making claims of, you know, 1, 2 and 3 and not, you know, 10, 20 and 30. So what I often say is that, right, possibly you want to reel back your claims to try and get your device as a predicate device. Otherwise, you know, you have to then really be prepared to ride out this journey because it's going to be a long journey.

Etienne Nichols: Right.

Adnan Ashfaq: If you've got a novel device, it's very likely to be a long journey to get that device into the market. Having a predicate device will speed up that access to market. But that all comes as part of the competitive assessment, which again has to be part of your regulatory roadmap. So now we start seeing the regular roadmap is really quite a broad exercise. You know, it's, and it's quite encompassing. You know, it's quite a complete document.

Etienne Nichols: I would expect there to be some additional market adoption analysis as well. Is that accurate? Because one of the things that I've heard, and I'm curious what your opinion is on this, is class 2 medical device may be easier. Just speaking FDA for a moment, Class two may be easier to get onto the market, but is it a Class 3 that's going to be more easily adopted due to the evidence that you've supplied? Any, any thoughts There.

Adnan Ashfaq: Yeah, no, that's a good point as well. So the thing is, I mean, at some point the manufacturers want to have to put a stake in the ground and say, you know, this is the device that we're developing.

Etienne Nichols: Right.

Adnan Ashfaq: You know, if it's an implant, it's most likely going to be a Class 3 and it can't be a Class 2 because it is an implant, you know, and we're not going to start manufacturing dental wax if it's an implant. You know, obviously it's, you know, a dental wax is really kind of a, a fairly simple medical, unquote medical device. But the thing about something which is an implant that's going to have a function which is life saving, you know, you've got more risks that you've got to think about and you know that that is what the device is and we can't just change that, you know, so really we have to understand what the devices that the manufacturers want to commercialize and try pitch it the best that we can with the information that we have. So yeah, so there is, it's, we have, you know, legal manufacturers have to work, we have to work together with regulatory consultants.

Etienne Nichols: What other thoughts or piece of advice do you have when it comes to building one of these out?

Adnan Ashfaq: So as we were saying earlier on, you know, having market analysis done is a key thing. You know, making sure that is there, there is a market for the device and also understanding which markets. Because like we were saying, there can be a huge difference between marketing and device in the east versus the west or wherever you're going geographically there can be masses of differences. Very often the devices will have some clinician involved that will understand the clinical benefits of the device that's being developed or to be developed may already have been developed because there's been this cases where you may have a device which was a wellbeing device which is already on the market. And I have a client working doing that at the moment and we're now having to go back and it's a medical device because of the claims that they've made. So we have to now create a technical dossier for a medical device. You know, so we've, we've got so many different possibilities here. Yeah, I mean it's never a dull day in the day of medical devices.

Etienne Nichols: What are the pitfalls that people, where do people mess up when they try to make one of these? But they, you, you look at this like, oh wow, you're going to actually shoot yourself in the foot here.

Adnan Ashfaq: Yeah, I think Classification of the device can be a major pitfall. Right. So I mean. Yeah, yeah. I mean even, not even regions, but they can be misunderstanding the rules of the regulations of what differentiates between one classification to another one.

Etienne Nichols: Okay, yeah.

Adnan Ashfaq: So there are some tools that can be used online, you know, to try and help classify your device to make things easier. And you can use some of those online tools to make things easier and go through those motions of understanding what is the difference. Because as soon as you answer a question differently on one of the rules, does it do this or does it do that, the classification can swing from one class to another one. And if you've got the classification wrong because you answered it incorrectly, your regulatory roadmap is going to look different.

Etienne Nichols: Oh yeah.

Adnan Ashfaq: And the other thing also is, because I was touching on the wellbeing device, you also have to, before you even get on the journey off the regulatory roadmap, be clear that your device actually is a medical device.

Etienne Nichols: Yeah, that makes sense.

Adnan Ashfaq: So does it actually fit the definition of a medical device? Look at the device, that medical device definition. Look at the FDA definition, look at the European definition, the UK definition. Globally, wherever you're looking to market, is it actually a medical device according to that definition? Yeah, and that's really interesting because that can be a big game changer because there are businesses that deliberately want to get into the medical devices market, but there are devices that don't want to be medical devices.

Etienne Nichols: Yeah, right, yeah, that makes sense.

Adnan Ashfaq: You can understand why, I mean, the benefits of the market access, if you can get into the market of medical device financially can be very rewarding. But the path to get to that market, to get to the, to access the market can be very expensive and tiresome and nobody wants to do that. So if you can see the end goal and you can see the benefits, potential benefits at the end of it, you will be prepared to sacrifice that cost and the time up front because there is light at the end of the tunnel.

Etienne Nichols: Yeah. I laughed at first when you said make sure you're a medical device. But when you think about, from a global perspective, maybe you are in this region, but maybe you're not in here and that's changes your strategy and your go to market strategy for that country. That makes. That's really good.

Adnan Ashfaq: And I think the other thing also is it's regulations is all about language. Right. So, and this is why lawyers are really involved in medical regulations. Why do we think that there's so many legal representatives looking at the regulations? I mean, on, on my LinkedIn profile I see posts all the time by this lawyer or that lawyer or that lawyer talking about the regulations. Because these are legal clauses. Law is about language. You can twist something slightly by having the language written in a different way. So your medical device intended you statement is written in a certain way which makes it a device which befits a Class 1. You can access that market with some features on your medical device which is self declared, you know, with relatively minimal hassle. Right. But then you start going the other way and you start using terms, let's just say for example prediction. When you're predicting something as, or something which is direct diagnosis or direct monitoring, you do all those sort of things. Direct. When you replace that word direct to indirect, it's a game changer. You, all you've changed is you've changed something from direct monitoring or direct diagnosis to indirect diagnosis, indirect monitoring. Because now what happens the risk is lying on a clinician, not on the device itself. Now I'm more talking about AI. Now I'm talking about software because there's loads going on with software which if you place the risk on the collision or healthcare practitioner which is going to make the decision by using, by using the app or the software to aid for diagnosis, the classification lowers and it becomes much easier access, you know, so there's a ton of things that we can look at also in language and the thing about the regulatory roadmap is you've got, it's based on those initial points of the device, the device being a medical device. The device then once it has been identified, that's a medical device deciding then what classification is going to go into. And again that's language.

Etienne Nichols: Yeah, goes back to the intended use, indications for use and so on. Yeah, that's really, really powerful. If we could wrap this up into one thing that the listeners would take away with. What do you want? What, what would you want that one thing people could take away from to be.

Adnan Ashfaq: I think it's probably understanding the benefits of the regulatory roadmap is and having that upfront as early as possible. You know, there's a couple of things in there that I mentioned. Probably not just one, you know, it's doing it as early as possible and outlining the details, you know that those are the important things, you know, what we've talked about today. Hopefully if the listeners try to adopt some of these details then I think they have a much better road and access to their medical device and their journey will be much smoother.

Etienne Nichols: Absolutely. I think those are some fantastic examples that you gave. I know this will be very valuable for listeners who are thinking about putting one of these together. And I'm just going back to that investor conversation. Of course, you should know this information when you're talking to an investor, but I'm guessing it's not. If they do know it, maybe it's not always accurate because they didn't put it on those foundational blocks that you kind of laid out.

Adnan Ashfaq: Yeah, yeah. And that does happen, you know. So, you know, there may be tweaks and adjustments to be. To be had, but I've had a number of occasions where these roadmaps are done. And, you know, they. The organization that I've done this for, they've really kind of seen the benefits of doing this ultimately, or hopefully it should lead towards these investors digging deep in their pockets. Yeah.

Etienne Nichols: Well, okay. Well, thank you so much. I really appreciate you going through all of this. We'll put some links in the show notes so people can find you. Actually, where would you recommend people reach out to you? What's the best way?

Adnan Ashfaq: You can go to my website, simplymedica.com and we can also book a consultation which links to my calendar. And I'm more than happy to have a conversation with anybody. There's a 30 minute, no obligation free conversation that we can have and then we can go from there.

Etienne Nichols: Awesome. And I'll also put a link in the show notes to that virtual summit episode or that virtual summit series that you mentioned where you talked about intended use. We'll try to include that so people can learn a little bit more. But yeah, simply Medica.coms I M P L I M E D I C A. So sometimes just make sure we get the spelling right. But we'll put the link in the show note as well so people can find that. But Adnan, thank you so much. I really appreciate this conversation and all the work that you've put in. I mean, you're drawing from 25 years of experience and hopefully that can help people get to market faster.

Adnan Ashfaq: I hope so. Thank you very much.

Etienne Nichols: All right, everybody, thank you so much for listening. We'll see you next time.

Etienne Nichols: Thank you so much for listening. If you enjoyed this episode, can I ask a special favor from you? Can you leave us a review on itunes? I know most of us have never done that before, but if you're listening on the phone, look at the itunes app. Scroll down to the bottom where it says leave a review. It's actually really easy. Same thing with computer. Just look for that leave a review button. This helps others find us and it lets us know how we're doing. Also, I'd personally love to hear from you on LinkedIn. Reach out to me. I read and respond to every message because hearing your feedback is the only.

Etienne Nichols: Way I'm going to get better.

Etienne Nichols: Thanks again for listening and we'll see you next time.