Ep. 19: Bringing Paradigm Changing Devices to Market ft. Shon Chakrabarti

Thank you, Kim. Really excited to be here and really very much looking forward to our discussion today.

Yeah, listen, great question, Kim. I think, as you mentioned, if a lot of your previous episodes were focused on sort of rare disease pharma world, I think devices really, medical device in particular, really keys in on the idea of creating a technology that addresses an unmet need. And I think coming from the world of clinical practice and bedside medicine now to technology, I really helped sort of bridge an understanding of where the big swings are. I've been very fortunate in that I've gotten to work for a couple device companies that have been very much paradigm changing, not just adding a widget to a toolbox or adding a me-too technology, but rather trying to change completely treatment paradigms. In one world, when we first met, you and I at a company called Abiomed, a medical device company focused on mechanical circulatory support, we were taking the old idea that a patient who goes into cardiogenic shock is sort of now in a morbid part of their care pathway that is often unsalvageable, and that company sought to create a non-permanent, temporary implantable pump that would bridge that patient to a place of heart recovery. So going away from the idea of 'hey, this heart's no good, it's kicked out, let's talk about transplant, let's talk about full support permanently' to now a world where a small, innovative, and simple device could bridge that patient to recovery to keep their own heart. And that's paradigm changing and requires a big lift, which I'm sure we'll get into. And now at Inari Medical, totally different device, totally different disease state, but same idea. For the longest time, we've been treating venous thromboembolism a certain way: anticoagulants or lytic therapy. And creating a simple device, a simple solution to get away from the idea of a systemic medical therapy for this disease state to now from this removal and what effects that could have on the patient short and long term. It's again a paradigm shifting, sort of big swing, big unmet need. So having context, having come from the medical side, it's helpful to point out where these sort of big unmet needs can be.

Yeah, it's a great question. And I think that there are themes really on both sides of that coin that are common. When it comes to in particular device technology, there are kind of three things that help physicians turn the tide on doing what they've always done before to shifting that mindset to really explore how technology can improve a disease state. So the first we've already talked about a bit, which is this kind of focusing on big unmet needs area. Right. So when I was in practice and now even on the medical device side, no interest in creating the 20th coronary stent with a slight iterative improvement, right, or the fifth atherectomy device. I think physicians are the same way. Once they see the technology's matured, it's a good solution for something, then the barrier to change is this big chasm that's difficult to overcome. But in your day-to-day practice and in the cath lab and in the OR, it's intuitive. You know when you're using something that hasn't been updated in 30 years, the patient outcomes have been the same, it isn't keeping up with other disease states. Structural heart's a great example of that, where it was apparent that interventional technology is improving, minimally invasive ways were emerging to do this surgery that used to be reserved only for certain people who could undergo a big time cardiac surgery, and now look what's happened to that field. So that's the first. And then the second, and I really came to understand this really well in the last few years in my time with Inari, is seeing is believing. So both of the technologies that I've been fortunate enough to be a part of provide the user with a very tangible, visible evidence of the effect that that device is having on the patient. So in the case of a heart pump, a patient goes from dying to not dying anymore, right. And in the case of thrombectomy, these previous therapies we were talking about, anticoagulation, lytics, who would never actually see that thing, that ugly clot that was causing a problem for this patient, that was going to be left behind in their body for the rest of their lives. And then all of a sudden, with a very simple technology, we started actually extracting these things, and the patients were seeing these big, nasty, ugly snakes that were in their body, and the physicians were seeing them too. And then something clicks right then. You know right away that this is something big and this is something that's quite disruptible and can really change things. And then the third is really the evidence, the data. So when confronted with the current state of the state in certain disease states, shock and PE are great examples, and you see that over the last 20, 30 years there hasn't been this big rampant outcomes that we've seen in areas like aortic valve disease or heart attacks, that's where I think you notice the sort of areas where you could really make a difference, make a change with some of that promising early data. So big unmet needs, tangible visible changes that are obvious to everyone involved, and then good early evidence that you're actually making a difference, because we definitely now live in a culture where evidence-based medicine is the standard of practice, and we're not just trying things just to try them.

Yeah, it's a great observation, Kim. It's one thing to bring patients along on this journey and say used to be treated one way, now you can be treated another. It's one thing to talk to administrators, payers about taking that journey. It's a totally different thing when it comes to your customers, your physicians, right. Because in many cases, you're taking the primary intervention for this patient from one type of doctor and moving it to another. Right. In the example of cardiogenic shock, you may be primarily dealing with cardiac intensivists, non-interventional physicians that really manage pressers and ICU care, to now interventionalists who would be doing the primary intervention, or perhaps cardiac surgery who previously utilized things like ECMO, etc., and moving it to interventionalists. In the thrombectomy space, PE patients were usually managed by a lieu of different types of physicians: ER docs, pulmonologists, hematologists. They still are, but now we've introduced a new player into that mix: the interventional cardiologists in many cases, interventional radiologists in many cases, vascular surgeons do these procedures. So how do you do that without having anyone feel like they are being excluded or don't have a voice in the process? And I think that from a medical affairs perspective, the answer sounds simple, which is be collaborative, include all stakeholders, include them both in the evidence generation and the device development, in the shared outcomes that you produce. But I'll tell you, it's a difficult dance when it comes to doing this in the real world, and it's something that I still, I won't say struggle with, but still I'm challenged by even today.

Yeah, Kim, as you know, I'm someone that relatively early career made this sort of transition from clinical bedside medicine to practice, so I get this question a lot from colleagues, people interested in sort of getting involved in technology or industry. And I'll tell you, it's a tough one. The thing about being a physician, particularly a sub-specialist or a proceduralist where you have a really long training pathway, it kind of becomes your primary identity. I always used to say it was really easy back in the day to tell people what I did at a cocktail party. They'd be like, 'What do you do?' I'd say, 'I'm a cardiologist,' and that would pretty much be it. They would clearly know what that means, ends the conversation. It's really comfortable and anodyne about that. They can picture what that is. And it was also really easy to feel good about your day. After a day of seeing patients in the office or the wards or in the cath lab, if you didn't have complications, if you saw a lot of patients and got a lot of smiles and hugs, you could hang your hat on a good body of work and sleep really well, assuming your pager isn't going off, right. And so that's a lot to give up, because you have to really sort of think about those same wins and then scaling them and how you can do that in this relatively short career path that we have. What do we have? We have 30, 40, 50 years to make an impact in our lives on these patients. So I think that certain people self-select themselves and sort of get comfortable with discomfort and the idea of coloring outside the lines. How can I impact more patients on the longer arc of my career? And I dealt with those identity changes head on early on. However, when I talk to folks about this, my primary advice is kind of get comfortable with discomfort right away and sort of open your mind to how your particular skill set can benefit patients on this tremendously big scale. One thing about medical affairs leaders is that a good medical affairs leader is critical, as you know, to the success of a device or a pharma company. So there's a really important role there. It's not something that you dabble in or dip your toe in the water on; it's something you dive into. So you also ask how does direct patient care sort of inform and optimize what I do in my day-to-day job. And I would say there's something about having been on the patient care side that adds a really critical context to sort of everything you do. There's a certain perspective you get from taking direct care of patients. It's hard to describe, but it sort of involves this deep empathy and understanding of needs from a patient perspective. It also involves familiarity with healthcare delivery and the nuances of that and patient journeys. I'd almost compare it to like speaking a language. You can functionally survive in an environment where you don't speak the language, but there's a lot lost in terms of context. I think it's very much similar. So my experiences impact things like design considerations, they impact good market strategies, they impact clinical research plans. There is really nothing that isn't touched by having been on that side.

Yeah, really good question, Kim. And you're right, I didn't do formal business training earlier in my career. Public health work, but certainly wasn't well versed in a lot of these concepts, and now they're my primary job, as you mentioned, interfacing with R&D, upstream and downstream marketing, product development and strategy. So a couple things I would say in answer to your question. One is you have to kind of enjoy it. I do, so I feel like I'm almost at another training program, another residency here in these early years in industry, and learn every day. And the sort of interactions that I just described, interfacing with upstream marketing or working on strategy or interfacing with the business development team and M&A team about other technologies that are out there, I love it. I think it's a ton of fun, probably because it's all new learnings for me. So I think I chose to join companies that were not necessarily in the startup phase but a little more mature in terms of the teams they've developed, and that was probably good luck, but it resulted in an environment where I could safely insert myself into projects and learn from really great leaders around me: commercial leaders, marketing leaders, business and strategy leaders. And five-ish years in now, I still feel like I'm learning every day. You can't read a manual on something like investor relations, and you can't read a manual on things like go-to-market strategies in the med device world. You really have to experience it. You really need to get in the weeds, work with the regulatory team, figure out all those sort of variables and pathways from an idea from a prototype to actually going to market and patients successfully. And what's been great about my experience so far is I've had probably dozens and dozens of case studies of how this is done with different products. So as opposed to maybe an MBA where you do a case study, it's really on-the-job, real-world learning. And there's really no substitute, Kim, for time. I'm learning that there's no substitute for time and immersion and learning from those that have done it before.

Yeah, Kim, you're absolutely right. I've been fortunate to see complete product cycles, even in two to three years, not complete cycles but at least concept to market. And that's a good amount of good luck and probably goes back to some of the things we talked about before about what sort of problems you want to tackle and how you can be successful. So I think probably to distill down to a simple concept, and then I'll get a bit into more of the specifics to your question, you really need to know what you have in medical device. Do you know what I mean? You can't have blinders on. Early on, it's your baby and you really got to believe in it, right. But at some point, you need to listen to the evidence and the effects that device has in the real world. So you mentioned post-market data, post-market surveillance. What that really does is it allows a medical leader to understand the real world impact of their device, distinct from pre-market performance. You'll understand that pre-clinical data and even clinical data in the early phases in the device world, which can be variable, are often best case scenario type looks at it. They're often very controlled, highly trained users, controlled and trained environments. So it's important to see how your device works in the real world, in the hands of the everyman. And that's where I think post-market data can be really helpful. So philosophically, I think any medical leader wants to know what they have. Now what's interesting, and the contrast with maybe the pharma world, is there are different requirements, so to speak, on what happens to your device once it's brought to market. A lot of it depends on the inherent complexity and risk of the device. Some companies, you could take the approach of doing the bare minimum. The EU is a bit more rigorous in terms of bringing more complex devices to market and then more formal post-market surveillance plans better commensurate to the risk of the device. So for class 3 devices, for instance, you can expect a pretty high bar in terms of post-market data you need to collect, including post-market clinical follow-up studies. It may be that for your device, you literally need to create a registry and get investigators and put that resource in to surveil it. On the other end of the coin, you have class 2 less risky devices. In the US, if you use a 510k pathway to get to market, there may not be a required reason for post-market data. But I think the best way to protect against poor outcomes, sub-optimal performance, or in the worst case something like an FDA warning letter, which we know some situations there that have occurred that maybe were avoidable, it means getting smart. And I think utilizing things like product registries, user surveys, focus groups. In 2023, we even have the ability to leverage potentially social media and getting experienced people in the room to build complaint systems and have a solid SOP can save you a ton of headache. So sort of a long-winded answer, Kim, I know, but it's something I'm pretty passionate about. I think you can do bare minimum to get your device to market and keep it there, but for these sort of paradigm shifting technologies that you and I are talking about, that's not nearly enough. And I don't think I'd want to be part of an organization that didn't do a lot more than the bare minimum to prove out their technology and how it benefits patients as sort of a primary goal.

Yeah, absolutely. This kind of fits into a big tenet of how I think a device company should really think in terms of mindset, which is sort of no small plans, right. So a lot of what we talked about before, sort of bare minimum in terms of evidence generation, can get you sort of early adopters, true believers, innovators. But that necessarily doesn't benefit the number of patients that you could potentially benefit, right. So you think about that lofty goal. Well, gee, that requires things like changing the standard of care, right, shifting guidelines and winning over the skeptics. You mentioned earlier some of these new technologies shift the primary user, the interface, the physician that utilizes them. And that's not going to happen unless again you can create a shift in standard of care. And so that's where being really aggressive in terms of your clinical affairs strategy can be beneficial. Look, you got to be smart about it. You have to create a clinical affairs strategy that isn't bulky or onerous, isn't going to take a ton of time, isn't going to suck up all of your resource, right, because you need to survive as a company. But again, get smart people in the room, collaborate with your medical leadership that you're working with, design smart, lean studies that help you generate the evidence you need to not only show that the device is safe and effective, but that it is superior to other technologies or other modes of providing this care to this disease state, and then see that sort of sea change occur.

Yeah, it's a great question, Kim, and it's something that I get asked again often from colleagues, young trainees, and other folks. So I mentioned earlier sort of this being comfortable with discomfort idea, and I think that we need to really reflect on our goals, right, as physician leaders. And once you've established sort of what you want to do in your career path, creating opportunities for yourself by staying interested, collaborating with colleagues both in industry and in other areas of medicine, and really being open-minded to the idea of how you can impact your patients. That's super important. I think that there are opportunities to dive into the world a bit without a full transition away from medicine. I think there are many different avenues of which to do that, whether it's in consulting environments, you could really start on the R&D side, you could explore sabbaticals and spend time in a pharma company or a medical device company. But at some point, really progressing that world might require a bit of a burn the boats mentality and really diving in. The other thing that I really stress to people is patience, because I think a lot of physicians expect, 'What if I jump into industry, I'll get a big leadership position right away in a big company and I'll just know how to do the job, right.' And as I mentioned before, it feels almost like another training program for me. And I think giving people that expectation is really important. But I'll tell you, there's a lot of ways that physicians can impact our world, and when you think about scale, being the leader in medical device or in pharma is a really great way to make that impact over, as I mentioned before, the number of years you have to do so.

Thanks again, and thank you for doing this series. I think it's really great to get this out there for folks, and I'm honored to be a part of it. So thank you.