What are digital health and digital therapeutics, and what role do medical device and pharma companies play?
7:00 in the morning my watch reminds me that yesterday I reached my fitness objective and encourages me to keep going. It tells me my sleep score was 98/100, and my average cardiac frequency is normal for my age. My scale has a body scan connected to a health station that calculates my vascular age and pulse wave velocity clearing me from cardiovascular and blood vessel misfunction. All of this would have sounded like a sci-fi movie some years ago, and yet, today it is reality.
How close are we to becoming the Jetsons?
Little did we know that many of the futuristic technologies featured in the iconic Jetsons cartoon (Los Supersónicos) would come to fruition in our lifetime — video calls, cleaning assistance like the Roombas (not as personable as Rosey) and 3D printing capabilities. What else are we capable of achieving and advancing? Unsurprisingly, in life sciences, digital health and digital therapeutics (DTx) are growing at an exponential rate. As with any great advancement, we like to focus on the opportunities but must not ignore the challenges.
Let’s start with the basics of digital health and DTx
What is digital health? It’s the use of technology — including hardware, software and telecommunications, to manage and improve health. It encompasses a wide range of applications and services, including electronic health records, mobile health apps, telemedicine, wearable devices and health information exchange.
What are digital therapeutics? As a subset of digital health, they are designed to treat or manage a medical condition. They can be used independently but are typically intended to be used in conjunction with traditional medical treatments and often prescribed by healthcare providers. Digital therapeutics are evidence-based, clinically evaluated software and medical devices that can be used to treat a variety of diseases and disorders.
These 2 advances in life sciences are here to stay and transform healthcare as we know it. Opportunities already advancing include:
- Enabling remote monitoring
- Increasing patient engagement
- Improving communications between healthcare providers and patients
- Reducing healthcare costs and expanding access to marginalized communities
- Increasing efficiencies at health facilities
- Improving quality of care and diagnosis through machine learning algorithms
“Around the pill” and DTx standalone are a part of pharma’s and medical device’s future
For pharma and medical device companies, DTx provides an opportunity to create additional value — alongside traditional pharmaceuticals such as optimization of the provider and patient journeys. Those companies that are already exploring digital therapeutics such as Sanofi, Bayer and Boehringer Ingelheim are adopting a variety of strategies that include “around the pill” focus designed to improve the efficacy of your traditional therapeutic and others bet on a standalone digital therapeutic option. Some choose to partner with big companies while others want to control strategic assets. With either choice, there’s long-term potential gain on the horizon.
How will pharma and medical device companies apply these strategies?
Here are 5 typical ways they are progressing:
- Patient monitoring and self-management such as a diabetes smart pen that automatically record patients’ dosing
- Digital behavioral interventions for mental health conditions
- AI and Machine Learning that enable real-time interventions for treatment recommendations or early diagnosis
- Apps connected to sensors and wearables
- Gaming and virtual reality: FDA approved the first video game for treating attention deficit hyperactivity disorder (ADHD)
Clearing up the challenges: necessity brings innovation
Just as quickly as DTx is transforming healthcare, manufacturers are facing numerous challenges such as reimbursement and proving efficacy. Reimbursement models don’t fit neatly into traditional reimbursement schemes; therefore, new and innovative reimbursement models are needed to support DTx. While digital therapeutics can reduce healthcare costs in the long-term, they can be expensive to develop and maintain in the short-term. As a result, it is more difficult to get the desired reimbursement price and overcome the break-even point creating uncertainty around ROI. The nature of fragmented DTx policies creates hurdles for providers, payers and developers worldwide which leads to increased costs.
It's also important to demonstrate clinical efficacy and safety while remaining cost-effective in comparison to traditional treatments. To seek FDA clearance, you must demonstrate efficacy in a regulatory framework that is still evolving and remain focused on trying to surpass your competition. While technology makes it much easier to gather clinical data, the FDA and legislative entities must move quickly to implement scalable processes and policies to assess and regulate medical devices.
Addressing these challenges will help successfully scale DTx and cultivate a digital health environment that focuses on patient access. This will be the topic of my next webinar, where we’ll analyze the current situation in more detail, different pricing scenarios we have and how overcoming these challenges will be critical for digital health, and therapeutics to be widely adopted and reimbursed by payers.