RFK Jr. Wants Every American Wearing A Wearable. How Can Pharma Build A Business Around It?
By Smit Patel, PharmD, director of partnerships, Digital Medicine Society (DiMe)
Health Secretary Robert F. Kennedy Jr. has staked out a bold vision: Within four years, every American should be wearing a device that tracks their health. The government has promised one of the largest federal campaigns in history to drive adoption of smartwatches, glucose monitors, and fitness trackers by 2028. On the surface, it may sound like political overreach or even borderline techno-utopianism. But once you do the math, amidst the noise, there is a strong signal: The timing is finally right for pharma to be all-in on using wearables as their new business strategy.
Pharma’s Three-Body Problem: Cost, Risk, And Speed
Today, even the best-positioned pharma can lose ground by being too cautious when strategic pivots and bold decisions are required to remain competitive. The same dynamic is playing out in the clinical trial innovation space, where pressures are staggering: shrinking revenue ops, increasing trial costs, and a technical success rate that remains stubbornly at <5%. Every month of delay in late-stage trials translates to tens or even hundreds of millions of dollars in lost revenue. Every failed trial compounds the cost burden of an already unsustainable model. Operational efficiencies have been squeezed for decades, but the underlying problem is that drug development is slow, risky, and expensive. The irony is that we are sitting on digital strategies and technologies that can make trials faster, more efficient, more inclusive, and more meaningful, yet the industry as a whole is still treating digital as a nice-to-have rather than a core component of drug and device development.
Beyond the regulatory acceptance, just last month, an Elevance Health study showed how wearables can help patients track and manage chronic conditions such as asthma, using real-time biometric data. What’s notable about this study is that payers are pointing to these results as proof that sensors create measurable value. This is what an inflection point looks like: The traditional model is under strain, the field is ready for the change, and repeating the same playbook will not yield better results.
The Wearable ROI You Can’t Ignore
Against this backdrop, the rise of digital endpoints is not a flashy innovation story; it is a business necessity. More than 500 validated digital endpoints have been cataloged across 81 sponsors, with a 15-fold increase since 2019. These endpoints capture high-resolution, continuous data on sleep, physical activity, cardiac function, and other dimensions that traditional clinic-based measures simply miss. This reflects how people actually live daily, not just how they perform during a scheduled doctor visit, yielding richer data and insight into a patient’s condition or treatment efficacy than ever before. Yet the argument against wearables continues with the same tired and faulty reasoning: There is no clear business case nor ROI. Hesitation remains the industry’s default stance.
That hesitation is no longer defensible. Recent analysis from Tufts and the Digital Medicine Society (DiMe), alongside leaders from J&J, Roche and Genentech, UCB, Bayer, Takeda, and MindMed, makes the economics unambiguous. Deploying digital endpoints into Phase 2 and 3 programs can shorten timelines by three to five months and generate between $27 million and-$48 million, translating into four- to seven-fold returns on investment.
When R&D Goes Digital, Profits Become Visible
To start, move digital endpoints into core protocol design, not pilots. Too many digital initiatives sit in “innovation sandboxes” currently. Pharma needs to embed digital endpoints at the center of R&D. Use the Digital Endpoints Value Framework to identify where these measures create the greatest impact across screening, safety monitoring, efficacy testing, and post-market surveillance. The framework gives sponsors a practical way to map value across trial phases and the conditions needed to realize it. Done right, this isn’t just a technology play; it’s a business play for faster trials, lower recruitment costs, and more valuable data streams that can be monetized across multiple programs.
Next, treat digital evidence as a commercial asset, not a checkbox. Digital endpoints don’t just improve trials; they create evidence that payers, providers, and policymakers value. Pharma should reframe digital as a strategic lever in commercial and market access, not just clinical operations. That means integrating digital evidence into pricing dossiers, demonstrating real-world effectiveness to justify premium pricing, and using it to strengthen negotiations with payers who increasingly demand proof of value. The Digital Medicine Society’s ROI Calculator quantifies the financial returns of incorporating digital endpoints into trial design, while the Business Case Template provides a structured way to translate those numbers into compelling proposals for executives and payers alike. Organizations such as AbbVie, Pfizer, Merck, Takeda, and Roche are already pulling ahead by embedding digital into their core development strategies. The successful leaders of the near future will be those who stop treating digital as an experiment and start using it as a competitive advantage.
The Risk Of Waiting
The pharma industry remains a global leader in economic profit, but that position is not guaranteed. I’m optimistic about the role digital endpoints can play in sustaining that edge, especially as wearables shift from speculative hype to strategic infrastructure.
So, yes, RFK Jr.’s wearable push may raise eyebrows, but it’s also accelerating a shift that market forces were already demanding. As patient-generated health data becomes normative with consumers and patients, the future of drug development will be shaped not just in clinics but wherever patients live and by how precisely we measure what matters most to them.
The tools are here. The data is being mined. The business value is clear. The regulatory and payer momentum is on the rise. The only missing piece is the industry’s willingness to treat digital as core to R&D success. The organizations that embrace this shift will build faster pipelines, stronger evidence, and better margins. The ones that hesitate? They’ll be calculating opportunity costs long after their competitors have moved on.
About The Author:
Smit J. Patel, PharmD, serves as the director of partnerships at the Digital Medicine Society (DiMe). Smit’s work focuses on building strategic partnerships to active ecosystems, driving market growth through innovative business models, and advancing the implementation and commercialization of digital health technologies and AI to improve research, care delivery, and public health. Smit is an advisory board member for The Economic Impact and the Brown-Lifespan Center for Digital Health; serves on advisory committees for digital health program(s) at the Association of Community Cancer Centers (ACCC) and American Pharmacists Association (APhA); and is a member of the Harvard Business Review (HBR) Advisory Council.
Smit earned his doctorate in pharmacy from the Ohio State University. He currently holds a faculty position for the Digital Health Innovation Certificate Program at the Brown University School of Professional Studies. Additionally, he is a global shaper at the World Economic Forum, a Forbes 30 under 30 scholar, a TEDx speaker, and MIT-Harvard Health Innovation alumnus.