The digital health ecosystem has grown at a tremendous pace in the last decade; not only when it comes to technological advancements, but also on patient adoption, traction from life sciences, and the global regulatory and compliance environment front. What began as a tool, limited for academia and technology research, has now shifted into being used as a full-fledged viable treatment option, Software as a Medical Device (SaMD), that can augment health outcomes on the ground, backed by clinical and real-world evidence.
With the increasing pricing pressures, the need to create value beyond drug discoveries, and the steady incline in chronic and complex diseases all around the globe, digital health solutions have caught the eye of big pharmaceutical organizations, who have started to invest and form strategic alliances with digital health companies.
- In 2013, the first FDA-approved digital prescription program aiming to help diabetes patients manage their condition via the mobile app was launched by WellDoc. In a span of just four years, it was announced that digital therapeutic programs for Diabetes Prevention Program (DPP), would be reimbursed by the U.S. Department of Health and Human Services, and in the same year, the first prescription digital therapy launched by Pear Therapeutics’ to combat substance abuse was also authorized by the FDA.
- In the USA, Noom and Novo Nordisk have collaborated on digital health solutions focusing on weight management followed by a successful 8-month pilot that combined Noom’s behavior change programs with Novo Nordisks’ experience with chronic conditions.
- In 2019, Happify and Sanofi signed a US-based deal focused on developing app-based solutions for the improvement of mental health outcomes in people with multiple sclerosis.
- In Europe, Kaia health has partnered with Chiesi Group to commercialize its chronic obstructive pulmonary disease (COPD) rehabilitation app; this solution aims to support pulmonary rehabilitation through behavioral change.
- Ireland-based medical device firm Medtronic developed a partnership with Novo Nordisk, to develop solutions based on insulin dosing data and smart insulin devices.
- In Europe, Ferrer and Wellthy Therapeutics partnered to co-create and commercialize a CE-marked, prescription digital therapeutic product for cardio-pulmonary rare diseases. The SaMD enhances patients’ autonomy in the management of disease and provides structured training and support. Currently, the solution is being tested in a clinical study to measure its impact on clinical outcomes and health-related quality of life in patients with pulmonary arterial hypertension.
“There is no debate that the digital health sector is firmly in the spotlight and likely to remain so for some time. Whilst the pandemic definitely fuelled the investment dollars, the number of product offerings, the app downloads, and the active minutes in-app, we need to watch the space to understand the true extent of the uptake. There is a big difference between ‘implementation’ and ‘embedded adoption’ and it is only the latter that will drive the scalable transformation of the healthcare sector. This includes the role of pharmaceutical manufacturers as they continue to explore the digital health sandbox and navigate the tensions and trade-offs between building their own digital therapies, buying from an external DTx platform developer, or partnering with an established DTx innovator. There are several important points that tend to get missed in the debates between ‘to buy, to build, or to license’. – Aahuti Rai, Strategic Advisor to Wellthy Therapeutics
Today, if we look at the pharma-digital health solutions universe, there has been tremendous growth and uptake in digital health solution development across therapies. However, as pharmaceutical companies embark on their digital health journeys, they come across some real challenges, ranging from development to real-world adoption and value creation.
- The world of tech offers infinite choices and hence the formulation of a comprehensive digital health strategy is a critical starting point wherein, the business problems and gaps in the treatment journey and patients’ experiences need to be mapped with the appropriate solutions – this strategy serves as an anchor for downstream choices.
- The next decision point for pharmaceutical organizations is to build or buy a digital health solution. Building custom solutions from scratch might seem ideal, but it’s time-consuming and cost-intensive and requires capabilities that are different from those typically found in pharmaceutical organizations.
- Pharmaceutical organizations are particularly skilled in matters concerning regulatory affairs, however, with the evolving law paradigms in different geographies around privacy, regulatory, and security of an SaMD, maintaining a digital health solution becomes challenging.
- Engaging patients with their health, and having clinicians prescribe the target drug treatment has been a challenge even with drug treatment options and this challenge doesn’t immediately dissipate because the therapy is being offered digitally. Additional interventions rooted in behavioral science and change management are needed to ensure real-world adoption and success of the solution – building a robust platform and product do not instantly guarantee adoption and success of the solution.
- The advantage offered by technology is the ability to innovate, scale, and change as the need and opportunity dictates and therefore creating long-term value through the use of a digital health solution to ensure long-term commercial viability requires a mode of innovation and experimentation to co-exist whilst driving ongoing adoption and commercialization of the existing version of the solution. This mode of operating can present pharmaceutical organizations with a dichotomy.
“Digital health as an enabler will become scalable and sustainable when we can make life easier for patients and providers alike. The tech, the regulation, the need for interoperability, and the sensitivities related to security and privacy are the bread and butter of the digital health industry. Platform providers that sell on these points alone will soon stop shining as these operational capabilities become mature and commoditized in the sector. The differentiators will be the platform providers that solve for: patient engagement, clinician adoption, pathway integration, value-based benefit models and biomarkers and measures which serve to align patients and their doctors on outcomes beyond clinical scales and endpoints.” – Aahuti Rai, Strategic Advisor to Wellthy Therapeutics
Pharmaceutical companies need to invest in a proven regulatory compliant digital health solutions platform that can support their innovative and evolving use cases ranging from unregulated to regulated use cases and allows them to focus on building novel health IP and improving outcomes while ensuring speed to market. A platform-driven approach makes scaling the digital health solutions to different use cases, adding more therapeutic areas/indications, and entering new markets easier and faster.
A robust platform combined with a cross-functional team that has experience in supporting pharma’s digital health solution initiatives from discovery to development to real-world operations could be the key to success.
About the Author
Malvika is AVP – Strategy and Business development at Wellthy Therapeutics and focuses on driving commercial success by developing strategic partnerships with key stakeholders like pharmaceutical organizations, biotech companies in Europe and Asia to lead the development and commercialization of digital health solutions through outcome-focused business models.
malvika.sharma@wellthy.care
About the Author
Aahuti works with health tech startups as a Strategic Advisor, Board Member, or Interim Executive, helping them to figure out how to succeed and scale in their target markets. Her domain expertise includes commercial strategy development; the creation of go-to-market plans and testing them with market entry tactics; and importantly, a focus on approaches to create patient engagement and clinical adoption.
aahuti.rai@wellthy.care
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