January 16, 2023
“Digital impacts our lives all the time in every way, including in medicine.” Jen Seda, M.D.
The day of digital medicine is here.
And while software and digital apps can be created rapidly, historically, the healthcare ecosystem has implemented change at a much slower pace. This contrasting combination, or tension as today’s episode describes it, presents two extremes: immense opportunity and innovation and areas of ambiguity for innovators, payors, and the medical community as a whole.
For biotechs developing in the digital medicine sector, everyone involved in innovation, from founders to developers, needs to balance the quick speed at which they are used to “shipping” and iterating with appropriate, realistic timelines suitable for today's healthcare model.
To help us unpack this topic further, our guest on Episode 10 of the Emerging Biotech Leader is Jen Seda, M.D., Practice Lead and SVP, Medical, for SSI. Together, Jen, Kim, and Ramin discuss digital medicine, its promise and potential, and what steps to take to ensure that ideation is thought through to implementation.
Read along for some of the top takeaways, and subscribe to the Emerging Biotech Leader podcast for upcoming episodes.
While there is a lot of buzz around the term “digital medicine,” and its definition is quite broad, Jen helps break it down into these digestible buckets:
What digital medicine does at its core:
Digital medicine can create better efficiencies and help support what happens between doctor visits/office visits.
What digital medicine includes:
Digital biomarkers, digital therapeutics (Software as a device), digital diagnostics.
What To Keep In Mind:
There is a wide range of uses for digital medicines, from artificial intelligence to Software as A Medical Device. We are just now seeing the tip of the iceberg as biotech innovators, regulators, and payors explore digital medicine in the “here and now” while working to streamline adoption in the future.
A key skill for biotech teams and leaders is seeing long-term use/value while having a clear, forward-thinking vision when pitching to investors, planning for R&D, and understanding the total addressable patient population.
While it’s true that there has never been more data available to accelerate product development and meet patients' ongoing expectations and needs, further fueling the demand for digital healthcare, the system can’t change overnight.
As you design and create digital medicine, Jen emphasizes just how important it is to answer this question “How is this going to integrate into clinical workflow today? You must consider how this would be implemented today or tomorrow.”
In other words, plan with today’s barriers and bottlenecks at the top of your mind, not what you envision being possible five or even 10 years from now.
To help you stay in today, consider:
Kim, Ramin, and Jen all agree that as part of their work and impact at SSI, it’s been essential to think about what evidence base will move the needle for all stakeholders in digital medicine.
On the topic of stakeholders and change, traditionally, developers in digital medicine were often hyper-focused on regulators. Lessons and best practices have been learned from those who have gone before. Organizations that are relatively newer to the space, or who are bringing new products are now being thoughtful about their clinical development plans. “They're bringing in health economics from day one to say, what are all of the potential outcomes that we can measure?”
According to Jen, the following are the new steps to take into account and design for:
“Step 1 is, ‘How do I get this across the finish line for regulatory?
Step 2 is, ‘How do I get this reimbursed and paid for? How do we get the clinicians paid for?’
Step 3 is, ‘How do we drive clinical pull-through?’
These are ALL of the stakeholders to now consider when starting to develop a product.”
It’s not just developers and biotechs that are undergoing an evolution. Payers and manufacturers are adopting creative pricing models and maturing as well.
Similar to Episode 9., this episode also approaches the topic of equitable care and shares a perspective on the future of digital health.
To round out the conversation and help listeners keep up to date as things progress, here’s a helpful resource that was mentioned. Kim and Jen participate in and recommend the Digital Therapeutics Alliance. (DTA)
This organization is dedicated to providing patients, clinicians, payors, and policymakers with the necessary tools to evaluate and utilize DTx products. “DTA’s members – including organizations dedicated to manufacturing, evaluating, supporting, and utilizing DTx products in clinical practice – work to enable expanded access to DTx products to improve clinical and health economic outcomes.”
As we come to a close on this episode recap, we thank you for reading and for listening to the Emerging Biotech Leader podcast. Stay tuned for our next guest and topic.