We spoke with Pierre Leurent, Chief Executive of Voluntis, one of the founding members of the Digital Therapeutics Alliance (DTA), about the future of digital healthcare.
What has caused this boom over the last five years in digital healthcare and telemedicine?
There are a lot of important macro trends that underline the rise of telemedicine. People expect this to be a very important sector.
There are challenges related to chronic disease management, including the growing number of patients with these diseases and the stable, or sometimes declining, number of healthcare professionals available to manage them. However, there are a lot of trends that make the move to telemedicine compelling. Key enablers include the growth of technology, regulatory or market access advances.
We continue to see that as technology evolves, it enables us to do more than in previous eras. For instance, improvements in data processing have enabled better sensing technologies, which in turn have facilitated the rise of improved telemedicine solutions. Patients, providers and payers also rely on clinical evidence and the proven benefits these solutions can bring. A number of digital health companies have got to the point of demonstrating significant clinical and economic benefits that are embedded within their approaches. This has led to new kinds of reimbursement schemes, which are a key enabler for these solutions to scale into mainstream healthcare. Using Voluntis as an example, we were the first company to receive approval for reimbursement for our diabetes digital therapeutic solution by the French national health payer. Similar types of coverage have been secured by other digital therapeutic companies for their respective solutions.
Is this the perfect timing for our aging societies?
There are numerous digital solutions designed specifically for aging societies. It is encouraging to see physicians and other members of the healthcare delivery team, including nurse practitioners, care managers and disease specialists, use these tools to monitor and treat patients between visits to the office. Realising that physicians are not the only people managing interactions with patients, we are developing tools that bring patients together with their entire care team. These technologies are enabling better collaboration among providers and creating a new sense of ownership and empowerment among patients of all ages, during all phases of the care delivery process.
The barrier to entry seems relatively low so we are seeing a lot of newcomers to the industry.
There are a lot of startups in this space. It’s true that this sector is attractive at first glance, but people do not necessarily realise what degree of investment and effort is needed to bring a digital therapeutic product to market.
We see a lot of offerings in the general consumer health space, but there are far fewer companies with clinically-validated products. For example, if you look at the mobile health space, you probably have about 200,000 mobile applications for health or wellness management today. But if you look at those that have achieved regulatory clearance as medical devices, potentially you’re talking about only 200. There is a massive difference.
Digital therapeutic companies operate in a highly-regulated environment. Even in Europe, the regulatory standards continue to rise. While there are many differences between digital therapeutic products on the market, each product is designed, developed and validated according to strict regulatory requirements. Relatively few general digital health products are able to meet these clinical and regulatory standards.
So is this what you are doing with the new trade association, the Digital Therapeutics Alliance?
The purpose of this alliance is to help catalyse the adoption of digital therapeutics solutions by patients, healthcare providers and payers. By bringing together key stakeholders across the industry, we will be able to establish foundational frameworks, further build out real world evidence pilots and encourage the broader utilisation and integration of these treatments.
DTA was founded by a group of digital health pioneers that represent different therapeutic areas and have achieved high levels of clinical validation for their solutions. These leaders are teaming up to share their expertise, learnings and experience to enable success for the broader ecosystem. Our goal is to interact with patients, providers, payers, manufacturers, academics and technology companies, in addition to policy makers and regulators. This alliance will enable us to work collectively to catalyse the impact this particular subsector of digital health will have on patient care and clinical outcomes.
Is setting up a trade federation a sign that the industry is maturing?
I believe so, especially since this would have not been possible two years ago. It’s a reflection that the market place is maturing. Supported by the growing levels of clinical evidence and outcomes, digital therapeutics are being increasingly recognised as a legitimate category and solution in the healthcare industry.
In this move towards digital or telehealth, are there any limits?
Ultimately, what we’re doing is finding the optimal positioning between the technology and human interventions. We are not replacing the care being delivered by care teams. Instead, we are helping to extend it through these technologies, by providing better insights and interfaces for patients to engage with their healthcare team. These technologies are being designed to enhance, not replace human interaction.
Digital therapeutics are sometimes compared to medication therapies. While different in many ways, both of these interventions are designed to provide patients with positive clinical outcomes. Through randomised control trials and real-world evidence pilots, some digital therapeutics companies are achieving comparable results to medication therapies, yet with fewer side effects for patients.
It seems that many of these solutions are optimising workflow in hospitals.
There are different segments of solutions in the digital health space. Most of the digital therapeutic solutions are positioned as consumer-facing solutions, meaning they provide interventions directly to patients. These are intended to link to other systems, like electronic medical records in hospitals and clinics. While they are two very distinct systems, we are seeing increasing interoperability between digital therapeutic solutions and electronic medical records. It is important that these work synergistically to provide the maximum benefit for the patient.
How big is the new alliance?
The Alliance started with four founding members. Our goal is to expand our membership base and collaborate with key stakeholders who are actively supporting the development, promotion and integration of digital therapeutics across the healthcare industry. In the coming months, we will further define the partnership program so other digital therapeutic companies and stakeholders have a structured way to engage with each other as we collectively form the foundation of this new industry.
If you envision yourself sitting down on the 10th anniversary of the alliance, what should have happened for you to think that was really good idea to found DTA?
Ultimately, we want digital therapeutics to be a standard part of healthcare. In ten years, it will be natural for a healthcare provider to prescribe a digital therapeutic solution with, or in place of, a traditional drug therapy. Digital therapeutics will eventually be part of the routine healthcare delivery process, with clinically validated solutions being incorporated into clinical guidelines and delivery systems.
We foresee this happening sooner than ten years. The purpose of the Alliance is to accelerate what could be achieved in 10 or 15 years to a much shorter timeline. We are motivated to leverage digital therapeutic products to improve standards of care and benefit patients across the world.