Ep 19: Bringing Paradigm Changing Devices To Market – Shon Chakrabarti

The Emerging Biotech Leader
The Emerging Biotech Leader
Ep 19: Bringing Paradigm Changing Devices To Market - Shon Chakrabarti

“My primary advice is to get comfortable with discomfort right away and open your mind to how your particular skill set can benefit patients on this tremendously big scale.’” Shon Chakrabarti MD MPH, Vice President, and General Manager Chronic Venous Therapies, Inari Medical.

Episode 19 of the Emerging Biotech Leader commemorates a milestone. This interview features one of our first guests with a background in medical devices.

Unlike previous episodes, our guest also works outside of rare disease and targets a wider population of patients with unmet needs. And now for the big reveal on who this guest is: Shon Chakrabarti MD MPH, Vice President, and General Manager Chronic Venous Therapies, Inari Medical. Shon is an Interventional Cardiologist by training, bringing his education, experience, and expertise to Inari–they design tools to treat both Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT), focusing on the critical vessels of venous disease.

Kim hosts this episode solo which gives her and Shon ample time to cover a lot of ground, particularly:

  • His career transition from bedside physician to physician leader working across medical affairs, product development, GTM, and more at Inari
  • How past experience in treating patients helps Shon understand and approach changing the care pathway
  • The impact of evidence-based medicine on physician adoption and
  • The most surprising areas he has learned on the job

Whether you work in medical devices yourself or are considering a change from clinical practice to industry, this episode will help you understand how to think about a career pivot, what it takes to bring a medical device to market, and why it’s so critical to “listen to the evidence and the effects that your medical device has in the real world.”

We cover a few highlights here, but of course, the full interview contains so much more. Listen along and let us know, do you read these recaps before or after each episode? We’re open to gathering some data of our own.

Nothing Changes if Nothing Changes: From Practice to Product

Treating patients one-on-one and providing bedside care seems like the complete opposite of working in the medical device space, but Shon threads his two roles, that of Physician and Physician Leader now in industry, together under the theme of change.

In fact, Inari isn’t the first medical device company Shon has worked for. While the devices may be different, and the disease states may be different, the idea in this sector of biotech is to help patients fully address their issues through advancements and innovations that demonstrate improved efficacy.

On this topic, Kim wanted to know Shon’s POV from the clinician side, specifically going against the “status quo” of current treatment modalities and what shift is required to, as she put it, “think about trying a new technology in a patient, whether it’s a person in a study or speaking to other physicians about why they should adopt something that that is new?”

Shon cites three things that will help change occur.

  • Focus on the big, unmet needs
  • Provide tangible, visible evidence of the effect that the device is having on the patient
  • Show concrete data

Shon also shares that physicians do start to see the unmet need early on in various ways. “In your day-to-day practice, and in the cath lab and in the O.R., it’s intuitive. You know when you’re using something that hasn’t been updated in 30 years where patient outcomes have been the same, and it isn’t keeping up with other disease states.”

Listen in for more details and context as to how Shon has observed his three bullet points transforming physician adoption and patient outcomes in the cardiovascular field.

On Medical Affairs for Med Device

The role and significance of Medical Affairs continues to be an important theme for biotechs, and it’s especially important for medical devices. As Kim touched on with Shon, “You’re in the position where you’re not just speaking about the modality and the science and educating on why this therapy is better than this one, but you’re also hands-on training on the device itself.”

Listen to episode 13: “Making A Mark In Medical Affairs” 

Given Shon’s expertise in this and navigating the patient-physician-payer matrix, Kim was curious to hear more. “You’re educating different segments in the medical community as well as the different sub-specialties that have trained in different ways over these decades, I would love your thoughts on all of this from a medical affairs perspective.”

Shon’s answer was perfect for the entire biotech industry: “One thing about medical affairs leaders–a good medical affairs leader is critical to the success of a device or 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.” 

Once again, this is where Shon’s prior experience treating patients comes into play.

“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 health care delivery and the nuances of that and patient journeys, and to almost compare, it’s like seeing 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, and I think it’s very much similar. So my experiences impact things like design considerations, they impact go to market strategies, they impact clinical research plans. There is really nothing that isn’t touched by having been on that side of patient care.”

Learning On The Job: The Real-World Residency

After a significant amount of time in med school and providing patient care, Kim was curious, where else did Shon learn GTM, product development, and even marketing for med devices?

He shared that he’s learned on the job. Here’s why that’s been an advantage. Compared to peers who went a more traditional path for biotech, i.e. business school, Shon hasn’t just worked on one case study or one aspect of biotech. The same learner’s mindset and drive that got him through rigorous med school training at Harvard is still alive and well.

“I feel like I’m almost in another training program, another residency here in these early years. I learn every day! And the interactions of interfacing with upstream marketing or reporting 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 learning 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.”

The main takeaway here is to follow that calling if you’re being pulled towards industry. Throughout this interview, Shon does clarify how there is still an impact on patients–this time, via scale vs. those face-to-face, daily interactions. Be forewarned; there is an identity shift that you undergo. Listen for his cocktail party story specifically. 

One final word of encouragement Shon has for those contemplating the leap who are nervous about a lack of biz school background: “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, you know, work with the regulatory team, figure out all the variables and pathways from an idea, from a prototype to actually going to market in patients successfully.”

Of course, this agile, flexible mindset is very different from the more methodical, linear approach to practicing medicine, but it is possible to embrace and adapt, as Shon demonstrates.

Circling Back To The Data

As their conversation carried on, Kim brought up the concept of making it to the point of a successful launch, something that isn’t always guaranteed in biotech or Big Pharma, for that matter. In med device, however, the odds are more favorable regarding commercial success with launches.

Kim was curious, what are the learnings from med device, which, as she described, is “further along on that front than traditional pharma and biotech?”

Shon brought it back to the data. No matter how great the idea is, no matter how promising the concept, you have to stay objective.

“At some point, you need to listen to the evidence and the effects that device has in the real world. Look at postmarket data and postmarket surveillance. What that does is it allows a medical leader to understand the real-world impact of their device that’s distinct from pre-market performance. Right? You’ll understand that preclinical data and even clinical data in the early phases in the device world, which can be variable, are often best-case scenarios. They’re often very controlled, highly trained users–controlled and trained environments. It’s important to see how your device is in the real world, in the hands of the everyman. And that’s where I think this market data can be really helpful.”

Shon digs into more specifics about FDA warning letters, product registries, and even leveraging social media for more insights. He also strongly expresses that “doing the bare minimum” for data collection is not enough.

“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.”

Another case Shon makes for thinking bigger in terms of patient impact and avoiding the “bare minimum” has to do with future expansion. This isn’t just about making a small change; this is about a seismic shift in changing the standard of care.

“That’s where being really aggressive in terms of your clinical affairs strategy can be beneficial. Look–you’ve got to be smart about it. You have to create a clinical affairs strategy that isn’t bulky as an owner, isn’t going to take a ton of time, and isn’t going to suck up all of your resources, right? Because you need to survive as a company. But again, get smart people in the room, collaborate with the 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 technology or other modes of providing this care to this disease state and then, see change occur.”

As the interview began to close, Kim asked one final question specific to career path advice for others who aspire to move from physician to physician leader in biotech. Shon provided a few approaches and ideas.

Want to know his answers? Hit that play button and listen in.

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