“There are clear distinctions, as we've talked about, between device and pharma from a medical affairs perspective. I think they each require this special touch and strategic medical affairs plan, but I think what we're also converging on is that they’re almost more similar than we think.’” Leah Damesek, Vice President of Medical Affairs, SSI Strategy.

Disruption. It’s a word that many associate with dramatic or abrupt change. But in order to disrupt something in biotech, particularly shifting a standard of care from one type of treatment to a new protocol using a medical device, there has to be collective, cohesive, methodical buy-in. In Episode 19 of the Emerging Biotech Leader, our interview with Shon Chakrabarti of Inari Medical echoed how disrupting a care pathway has many moving parts.

Now, in Episode 20, Kim Kushner, Ramin Farhood, and a new voice from the SSI team, Leah Damesek, Vice President of Medical Affairs Strategy, continue exploring what it takes to bring disruptive devices to market. Listen in to observe a few overarching themes that emerge and guide the conversation.

• Leah and Ramin share their thoughts and experience on changing a care paradigm to meet an unmet need
• All three discuss the actions required when disrupting a care pathway change the physician base
• And lastly, Kim, Ramin, and Leah circle back on the use of real-world evidence in changing physician behavior

The trio keep no secrets–the medical device industry is more advanced, compared to pharma, when it comes to strategically utilizing real-world evidence. And as you’ll hear, this is brought up not to poke holes but to provoke thought and understanding for anyone looking to shift from one sector or the other.

Throughout this episode, Kim, Ramin, and Leah also discern additional differences and similarities between device and pharma. What’s vital to both–no matter which side of the industry you find yourself on–is that the main goal never deviates from this credo: do right by the patients.

On that note, enjoy these highlights, and as always, we encourage you to listen to the full episode, too.

On Bringing The Medical Community Along 

Right at the top of the interview, Kim asked Leah about the challenges with conversations–from a medical affairs lens–when meeting with the physician community.

Many of these physicians have been treating their patients in a specific way for decades. To that point, Leah shared, “Bringing the medical community along to make a change in their practice that has been so instilled in them for so many years and through so many different variations of guidelines is a really big change. Something that I think about a lot as we're working with our clients is helping all sides of the care continuum and the caregiver team move with the industry change. So, it's not just about bringing new physicians and new specialties on board, but also what's in it for the existing specialists that are treating these patients?”

What else does driving disruption and adoption entail?

• Learning that some patients are more receptive to new technologies while others are slower to adopt or change
• How to get physician buy-in so that none feel displaced by these new care paradigms
• The concepts of patient segmentation, deploying centers of excellence, and understanding the role of all inputs involved to drive change: patients, physicians, nurses, and real-world data

Leah highlights the importance of helping physicians feel like valued participants on the cutting edge of care for new devices or drugs, as opposed to pushing them to the sidelines. Ramin agreed and added this reminder from Episode 19: “It's really, really important early on that you have the customers (doctors)  involved and that they get the right training to feel comfortable using the device and they feel comfortable that they can also make the patient feel comfortable with what they're doing.”

As they navigate a new normal, Doctors must understand device use, who it’s best for, what updates and advancements are coming, post-approval, and more considerations for full adoption. Building on that, Kim points out that a new ecosystem gets created when a treatment pathway is disrupted by a new device or drug.

“It's more than just training the physician who's going to be the user, but it's also training the physician who now has to be a referer, and historically was the person to treat that patient. If we can't actually get the patient to the appropriate, in this circumstance, Interventionalists, where, you know, they've been typically treated in their home cardiology office, that's a really different care pathway for a patient.”

Working In Harmony: More Than A Pipe Dream

With disruption overhauling the “old way of doing things,” how do you mitigate friction to ensure the current physician, new physician, and patient are all aligned?

Ramin describes this unit as a “triangle.” While the talk track and training for both physicians is mostly procedural and straightforward, driving patient confidence and adoption is where there is more variability.

“Maybe you've been on a particular drug for many years, and now maybe it's not working right? Or maybe the side effect profile is not good anymore. So, you have to have that conversation with the patient so that they feel comfortable to be referred and have some type of procedure. Even if it’s not a full-blown operation, it still becomes really scary for them.”

As a best practice, Ramin shares a few things to remember. Nurses need to be included in this training/adoption loop as they spend a significant amount of time with patients as well.

Also, enabling and training both physician groups–former and newer–with aligned messaging is vital. And this all has to be done in harmony, which really falls on the founding team to ensure and plan for from day 1.

On Setting Up A Center of Excellence 

While Kim was hearing these points come up, she requested a few tangible examples of what success looks like when Centers of Excellence are executed flawlessly. “In particular, I'd love to hear what you've seen be successful in setting up those models and what some of the barriers to success have been for industry.”

Leah jumped right in to answer with a success example first: the early adopter approach.

“The successful factor was the early adopter model. What I've seen in setting up that Center of Excellence is that no one wants to feel like they're not on the cutting edge of research. I'm actually thinking about this in a gene therapy context, going from potentially a surgical intervention to moving towards a one-time treatment that

would no longer need potentially any intervention from a surgeon. And so thinking about what, ‘What's in it for the surgeons?’ How can you be an early adopter? How do you want to think about how you're giving a certain device to a patient now, and you're moving towards a different type of surgery, right? That's one way to think about it.”

As for barriers, Leah points out that those can arise from low data volume or if a treatment, even though minimally invasive, is no...