Digital medicine products call for new approaches and capabilities
Preparing for the future of health built around patient centricity, prevention, and personalized therapies calls for biopharma to look at digital medicine products in a new light. Developing and commercializing such products require a clear articulation of how they fit within a company’s product portfolio and the operating and business models needed to support that.
Based on our research and client experience, we recommend biopharma companies:
1. Formulate a vision around digital medicine products
Biopharma companies should articulate a vision of how they will position themselves within the digital medicine product ecosystem. Do they see themselves as preferred partners or leaders in the field? This is the essential starting place for guiding the short- and long-term strategy.
- Consider alignment with the existing product portfolio and future pipeline.
- In the near term, our research suggests that digital companions are likely to become standard offerings around pharmaceutical products for conditions associated with complicated symptoms and comorbidities, requiring complex treatment regimens and monitoring of side effects.
- A drug product’s life cycle (e.g., approaching loss of exclusivity, prelaunch) and competitive position may inform the digital companion strategy.
- In the long term, we expect some companies to explore digital therapeutics; a handful are developing these capabilities today, recognizing that digital therapeutics represent a new frontier of treatment in certain disease states like depression, anxiety, and chronic pain, and this list should grow over time. We also expect that digital companion capabilities will serve as an on-ramp to digital therapeutics.
- We also envision alliances between pharma and medtech companies around development of devices that combine passive and active monitoring, drug delivery, and diagnostics.
- Position within the consumer health journey. Short term, companies are considering how to leverage digital medicine products in TAs where they already play. Long term, some companies are considering how to make digital tools and platforms the connective tissue from wellness and prevention to medical and surgical interventions to postacute care.
2. Play to their strengths and expertise
Pharma companies should apply their expertise in creating and commercializing evidence-driven products to their digital medicine product ambitions: regulatory science in the case of digital therapeutics and market access in the case of both digital therapeutics and companions. This is a significant competitive advantage against consumer tech companies that do not have this as a core competency.
3. Define an operating model that best supports their digital medicine product strategy
Effectively developing digital medicine products can be a steep learning curve for biopharma companies; comparisons to the development and commercialization of traditional medicines reveal just as many differences as similarities. We have outlined a few important considerations:
- Distributed vs. centralized digital expertise
- Our research shows value in centralizing digital expertise. In most cases, we have found examples of concentrating digital resources within R&D, within the commercial function, or as a separate center of excellence. But bridging the traditional R&D and commercial silos remains a challenge.
- Buy vs. build
- The vision will in part dictate decisions on whether to develop products in-house or partner with other stakeholders in the field. As digital medicine product offerings increase in number within a pharma company’s portfolio and as biopharma’s experience grows, we expect the cost benefit will shift in favor of insourcing.
- We also expect that over time, standardization via an enterprisewide platform will be more beneficial than developing ad hoc or bespoke custom-built digital solutions. Given the shift to cloud computing, the cost structure can be elastic and scale with success and adoption.
- Talent requirements
- Even with significant outsourcing, pharma companies should still develop an internal or contract talent pool with technical skills around cloud computing, AI, software development, cybersecurity, and data science.28 These agile development teams should also include professionals who understand clinical measurement and patient and user experience and have access to legal, compliance, and medical device regulatory expertise. And most importantly, they should include individuals with a strong strategy and business acumen who can navigate technical, clinical, and business aspects, and facilitate conversations across multiple parts of the organization and with external partners.
- Many of the existing talent and capabilities within organizations could be leveraged, including rich patient and provider insights and a deep understanding of the health care landscape. Strong connections to regulators and frequent touch points with payers could help drive conversations around holistic therapeutic solutions that include traditional pharmaceuticals, companions, and digital therapeutics.
4. Reinvent the product development life cycle
Incorporating digital medicine products successfully into a company’s portfolio will require a rethinking of traditional drug development processes and:
- A deep understanding of unmet needs and pain points for patients and providers, as well as expertise in the features and development possibilities of digital medicine products.
- An iterative process with evaluation pilots and a feedback loop between user experience in the field and ongoing product improvements. This requires an agile build, test, and learn approach to product development and refinement, which will run on cycles that are different from current drug development models. Some of the initial investment and pilots will fail, but this experience will create learnings and a foundation for standing up robust digital capabilities.
- Digital medicine products can be developed concurrently with drugs, but the timing of product design and availability must be positioned carefully within the standard regulatory and payer review and submission processes. The iterative nature of building software will require tighter coordination between commercial, medical, and product development teams.
- Development teams should leverage insights from commercial teams to identify where digital companion and digital therapeutics would be more useful, anticipate patient needs, and build products accordingly.
- Digital companion developers should be able to reuse or build upon digital tools used in clinical trials of the corresponding drug.
- Clinical development and digital teams should have access to internal and external libraries of validated electronic clinical outcomes assessments (eCOAs), such as those maintained by the Digital Medicine Society29 or FDA.30 There should be a process for identifying which digital endpoints or patient-reported outcomes in the company’s core TAs could be available and appropriate for use in digital companions.
- Access to such libraries could be an important starting point for developing digital therapeutics, as the efficacy of a digital therapeutic could be measured by the same or similar endpoints.
- Commercial teams should have a basic understanding of eCOAs used in clinical development and which ones can be repurposed for digital companions and/or digital therapeutics.
5. Expand the traditional business models
With digital medicine products, the traditional commercialization and acquisition playbook may not be enough. Pharma companies may need to build relationships with new stakeholders or strengthen relationships with existing ones: e.g., care management or population health leaders at health plans; employers as payers or influencers; ambulatory providers as buyers, not just prescribers; and most importantly, patients as the chief health care customer. Identifying digital medicine investment opportunities should be part of business development activities.
- There may be opportunities to use traditional distribution channels in new ways, such as retail and specialty pharmacies, as well as less traditional ones like online prescription platforms.
- Generating demand from patients via DTC is an option for digital companions, whereas digital therapeutics require activation of all stakeholders: patients, providers, payers, pharmacists, and employers.
- Digital therapeutics could be a major change for providers and payers, as they will require adoption of a new standard of care. This will require large awareness and education initiatives, and pharma’s customer-facing personnel will need to learn how to position digital products to these customers.
- Sales needs to articulate value in relation to other products. There should be incentives to promote digital medicine products.
- Field medical personnel will need to become comfortable explaining the development and science behind digital medicine products.
- New types of field-based and market access roles may be required that specialize in digital medicine products.
- New customer support functions and roles may be needed to support digital medicine products
A future built around prevention, early detection, curative and personalized therapies is emerging. Developing a robust digital medicine product strategy is essential to succeed in this future, especially as evidence continues to grow as to their efficacy in improving outcomes and quality of life. Our research shows that although it may be early days, the age of digital medicine products is here. Life sciences companies that can identify a clear place for themselves within this burgeoning ecosystem should see a competitive advantage with their customers, demonstrate more value to the health care system, and ultimately, deliver better outcomes for patients.