In a perfect world, we should not need technology to be healthy — our local communities would effortlessly create opportunities for healthy living. If we happened to be diagnosed with something that could be mediated by lifestyle, these factors, alongside social determinants of health would be addressed by the communities that were originally designed to promote getting outdoors, walking about, finding locally grown food, interacting with people, easily accessing care, and more.
The reality is many of our communities are inadequately addressing these needs, and for better or worse consumer technology is all around us. It’s time to examine how to harness technologies that provide experiences that makes us happier and healthier. Opportunity lies in the emergent field of digital therapeutics.
I think of digital therapeutics, as a FDA (or EMA) regulated software intervention that is prescribed by a medical professional, employing closed feedback loops that assess and modify disease and behaviors through algorithms, mobile assessments, and sensor inputs. Regardless of how it is ultimately defined by regulators, or the newly formed Digital Therapeutics Alliance, the key thing to note here is that software is the “therapeutically active” component.
There are many preconditions needed to be healthy and manage disease optimally, that are grounded in personal experiences. These bundles of experiences vary significantly and can include “social prescriptions” like meeting up with a friend to reduce feelings of isolation or riding a bike to get some exercise. They also include the supportive services required to help patients track their disease progression, assess how their medication if affecting them, and keep their care team up to date.
Currently, traditional prescription products like drugs and medical devices, largely fail to deliver on the required bundles of experiences that more easily drive positive behavior change and enable a more holistic management of health. It is in this context that I find digital therapeutics super interesting — in their ability to engender positive experiences connected to the underlying devices being utilized.
There are still advancements needed in understanding this complex relationship of technology and real-world experiences, and beyond that we need to understand how to combine the best of digital health tools with the clinical rigor required to formally make medical claims.
Digital therapeutics have the potential to drive disease management to another level, as we move towards the interconnectivity of our biology, our experiences or behaviors, and our environment. We are already seeing this today as digital therapeutics leverage sensor-rich hardware (e.g., smartphones, tablets, wearables, virtual reality headsets, etc.) that can both create novel experiences and but also collect and measure so much information about ourselves and our environment. In the future, the hardware and sensor components may very well reside within automobiles, smart homes, connected spaces, etc.
We’ll have to ensure that we don’t over-medicalize technology around us, but imagine a world in which an automobile or a home could be conveniently transformed into a therapeutic delivery system one day, and fade into their normal functions on another. The longer-term potential is enormous.
For now, as the regulatory path for digital therapeutics becomes better known, we’ll see greater diversity in the indications of use being developed and approved. We’ll also see a ripening ecosystem that will enable the number of prescriptions to climb. But most importantly, we’ll see a major shift in how we think about treating disease — including bundles of experiences that better address our behaviors and integrate into our daily environments.
I’ve spent many years trying to understand the true needs of patients, and the context in which digital therapeutics and digital biomarkers can be applied. Formalizing the development and regulatory path for digital therapeutics will further enable health innovators to also think about other other human factors that will make their products stand out. This type of innovation will impact every stakeholder in unique ways and it will be exciting to watch it all unfold.
Please stay tuned for my follow-on posts where I’ll go deeper into all things digital therapeutics — underlying product components, the novel date sets being included, analysis of key players and partnerships, commercial and distribution models, and more.
Carlos Rodarte (@crodarte) is the Founder & Managing Director of Volar Health, LLC, a strategy and innovation consultancy enabling healthcare organizations, life sciences companies, and leading startups to build and commercialize data-driven products that meaningfully improve the lives of patients. For more information visit www.volarhealth.com.