“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 not reversible.
For Ramin, success all starts with the proper training. “Practice makes perfect, and training is a must with devices. I use training deliberately because it's slightly different from education, right? Education with pharma and with drugs is really important. But in the devices, not only you are educating, but also physicians need to have hands-on experience to feel comfortable with the procedure. And they have to do enough of it to feel comfortable to also start referring or talking about or being an advocate for that particular procedure. That doesn't necessarily happen once or twice, or three times. Physicians need to have enough experience with that.”
Listen in for more of Ramin’s thoughts on the frequency of training, conducting training, and the modalities that training can be delivered.
As one last best practice on this topic, Kim drives home that training also reinforces the tangible benefits of this entirely new approach altogether. You’ll hear her share specifics from Episode 19 around physicians seeing the removal of a clot vs. not being able to tangibly, visibly see the equivalent impact of an anticoagulant.
The Effectiveness of Evidence
As their conversation transitioned, the topic of evidence took center stage.
At first, evidence is heavily focused on demonstrating safety and efficacy. But here’s one of those distinctions between pharma and med device where strategy and data use comes into play courtesy of Kim.
“The burden post-market is significantly higher than traditional pharma in a lot of ways. There's a lot of post-market surveillance from safety and effectiveness that we're consistently doing a lot of organizations around having product-related registries and other kinds of formats. But especially in recent years, I'd say the last one to three years, we've seen pharma move more towards this model of trying to increase real-world evidence. What are some perspectives we can learn from the medical device industry–who has been working more in the post-market space relative to real-world evidence and data generation–and what we can apply more broadly across the industry?”
Ramin points out that two to three clinical trials are a starting point, not a place to stop. In other words, evidence-based medicine is a welcomed disruption, too.
“If you think about it, and I think Shon also alluded to this too, it's difficult to conduct a double-blind study with a device, right? It's going to be challenging to do a head-to-head type of study. It's extremely expensive, right? In pharma, once you have the drug approved, at least there is some level of comfort and confidence that it works and it's safe. But with devices, that's just the beginning. That's why you see a lot of medical device companies doing tremendous amounts of work to generate additional data and gathering additional information that is useful for the practitioners.”
Don’t gloss over what Ramin shares about the correlation between incremental improvements and generating better data specific to med device–listen in for how initial use may vary after 6 months of data collection and analysis.
Using Ramin’s points as a springboard for this topic, Leah adds a new vocabulary term and tactic into the mix: lifecycle management.
“The device industry is so much faster at lifecycle management–indication, expansions, and new potential labels because of real-world evidence. We've worked with clients and project teams where they're actively exploring 5-10 different label expansions or new indications for a product that's already on the market. And they're able to do that because they have a team of trusted physicians that they work with who are actively innovating and exploring new ways to potentially use their device, on or off label.”
The main takeaway here is that pharma can leverage this very approach to “continuously be iterating and making our products or our drugs more useful.”
As an add-on, Kim points out one final distinction between med device and pharma to keep in mind with regard to evidence generation. “In traditional pharmaceuticals, you're thinking about the decision maker being the physician and the user being the patient, and they're almost two separate parts of the equation. Whereas in device, it is the same equation, and you have to be a lot more integrated in the care pathway and the decision-making and in the data generation efforts that enable folks to make the right decisions for their patients at a given point in time.”
As the interview started to wind down, Kim and Leah did share their final thoughts on what’s required to go from pharma to device or vice versa. Once you hear it, let us know your thoughts and advice if you’ve navigated this career change as well.
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