In this session, panelists discussed common pitfalls that life sciences companies face as they explore ways to incorporate digital-health strategies into product and service offerings, as well as approaches for successful integration and launch. Seasoned veterans in developing and deploying digital-health solutions from within the life sciences ecosystem, the panelists shared lessons learned and offered practical suggestions for listeners addressing similar projects.
David S. Klimstra, MD, Founder and Chief Medical Officer, Paige.AI, Inc.
Suhas Krishna, Vice President, Head of Product Management, Digital Health, Bristol Myers Squibb
Betsy McSheffrey, Head Counsel, Data, Technology and Innovation, Takeda
John Rootenberg, MD, Principal Director, Digital Safety and Decision Support, Genentech (Roche)
Ryan Sysko, Chief Executive Officer, Amalgam RX
Moderator: Jennifer Geetter, Partner, McDermott Will & Emery
Top takeaways included:
Last-mile conundrum. Panelists observed that for typical products manufactured by life sciences companies, a disproportionate amount of the hard work occurs prior to regulatory approval. Once the product is approved (by, for example, the Clinical Laboratory Improvement Amendments (CLIA) or the US Food & Drug Administration (FDA), the company’s most difficult work is done. For digital-health solutions, the inverse is often true. Even sophisticated digital-health products and services typically have a shorter development timeline, but once released in the market, challenges around adoption, adherence, persistence and integration must be addressed. In addition, customers will expect regular software updates. Life sciences companies are not always adequately prepared for this reverse last mile—i.e., the longest mile—of the development and marketing lifecycle.
Risk appetite. Panelists noted that the life sciences industry is typically risk averse. This is in sharp contrast, for example, to the software industry, which is attuned to software innovations and is designed to anticipate missteps and optimize, when necessary, the “fast fail.”
Blurry strategic vision. The panelists discussed “digital-health FOMO” (fear of missing out). Life sciences companies want to offer digital-health products and services because they recognize the strategic value of participating in the market explosion at the intersection of healthcare and data/computing. Sometimes this enthusiasm outpaces the speed with which life sciences companies can develop dedicated digital-health strategies, either as companions to existing products or as complimentary clinical services. Having a clear strategic objective governing the development of a product and realistic investment goals are critical.
Deployment. The panelists emphasized that once a digital health tool is developed, companies should ensure physicians and patients actually adopt and continue to use the tool. Specifically, one panelist stated, “The one who wins is the one who has the right deployment [of the tool].”
Hidden value. Digital-health strategies, such as using the data obtained from digital-health tools to promote research, offer hidden value for life science companies. As a component of development and marketing strategy, life sciences companies need to be prepared to articulate these benefits, especially those that may not be readily apparent or may be ancillary benefits. The successful deployment of a digital-health tool—for example, a patient- or consumer-facing app—is predicated on the persistent adoption of that tool. It must create discernible value for users; otherwise, they would likely not continue to use the app.
Strategy of quick wins. In considering steps companies can take when adopting digital-health strategies, panelists recommended having “quick wins” that demonstrate outcomes that can be reproduced. This creates momentum and builds confidence.
Executive sponsorship. Digital-health products and services typically straddle multiple departments. They require significant cross-functional cooperation and can languish without dedicated executive sponsorship. But the presence of strong leaders who champion these products and services—in particular, individuals with decision-making authority, deep understanding of the regulatory lifecycle for these products, and knowledge of the normative and operational constraints that physicians and patients experience when using them—can pay dividends.
Don’t fear HIPAA. Panelists agreed that life sciences companies distort the risk of Health Insurance Portability and Accountability Act regulation, to the detriment of product design and deployment. HIPAA presents a manageable set of privacy and security standards. If deploying the tool in a HIPAA-regulated capacity has advantages—and, from a data-rights perspective, it often does—life sciences companies should not overestimate the risk of this decision.
Strategize your data plan. Panelists recommended that companies ask questions, up front, surrounding the desired data strategy. Such questions should include the types of information and data rights they wish to collect and use. It is much more difficult to reverse-engineer the collection of information or data rights if they were not captured initially. Companies should build their data strategy into their protocols early in the development process.