Pharmaceutical Industry

Digital Biomarkers on the Wrist: What Wearables Mean for Pharma

By Noah Pines

From Rolex to Garmin: A Personal Shift

I used to be a “watch guy.” Traveling constantly for work, moderating interviews and focus groups across continents, you’d rarely find me without a Rolex or Panerai on my wrist. Those watches were a statement of style and endurance — tools of a road warrior.

These days, though, it’s a Garmin. As I train for the Philadelphia Distance Run this September, this simple but technology-packed device is indispensable. Every mile logged, every heart rate trend captured, every sleep cycle reviewed — and the feedback loop is addictive. That’s the real power of wearables for consumers: not just the data itself, but the immediacy and integration into daily life. Increasingly, these devices don’t just tell us the time; they tell us about ourselves.

Whoop and the FDA: A Case Study in Regulatory Friction

My wife, on the other hand, prefers a Whoop to support her triathlon training. Whoop provides another interesting example illustrating how wearables are quickly blurring the line between “wellness” and “medical.” In July 2025, the FDA accused the company of illegally marketing its blood pressure insights feature without clearance. Whoop pushed back, saying the tool was meant for wellness, not diagnosis.

The FDA disagreed, arguing that blood pressure data inherently relates to hypertension and carries clinical consequences. This clash matters for the entire sector. If every new biometric requires full device approval, innovation may slow. Yet without oversight, consumers could be misled or, worse, harmed.

For pharma and medtech strategists, the Whoop case highlights the regulatory tightrope. Companies must continue innovating while at the same time anticipating how regulators will define the boundaries between lifestyle enhancement and medical intervention.

Political Tailwinds: “Every American in a Wearable”

Meanwhile, Washington DC is fueling the momentum. Health Secretary Robert F. Kennedy Jr. recently declared his vision: within four years, every American wearing a wearable. HHS is preparing one of the largest ad campaigns in its history to promote devices that track heart rate, glucose, and more.

His rhetoric frames wearables as a low-cost alternative to expensive drugs like GLP-1s, suggesting that an $80 sensor could rival a $1,300-a-month prescription. Device makers like Abbott and Dexcom have already seen their stock prices jump in anticipation.

The commercial implications are profound. If policymakers lean into wearables as national health tools, payers may follow — potentially expanding coverage to populations previously excluded. But it also risks overselling unproven benefits, especially for healthy individuals where evidence is still emerging.

Beyond Fitness: The Research Frontier

Wearables aren’t just consumer gadgets or political talking points. Increasingly, they’re research engines. Studies once limited to clinical centers are now enrolling tens of thousands of participants remotely, creating unprecedented datasets.

Take the Apple Women’s Health Study, a 10-year effort with Harvard and the NIH that has already enrolled over 100,000 participants. By using wearables to track menstrual cycles and lifestyle factors, the study is advancing understanding of reproductive health — an area long underfunded and underserved.

Similarly, Parkinson’s research at Verily has shown that wrist-based exams can produce reliable digital biomarkers, while UCSF researchers are developing noninvasive wearables like CardioTag to monitor heart failure pressures with accuracy rivaling implantable systems.

For pharma and biotech, this opens a new frontier: digital biomarkers that can accelerate trials, enrich real-world evidence, and potentially become companion tools to therapies. The ability to remotely capture granular, longitudinal data broadly across a population has the potential to be a commercial game-changer.

The Feedback Effect: Consumer Engagement and Anxiety

Consumers love wearables because of the feedback loop - I know that's why I love my Garmin. It's not just the constant reinforcement that one is in control, its the reward and evidence of 'hey, I've run 10 miles today.' Training for a half marathon, I can attest to the motivation that comes from seeing yesterday’s recovery score or last night’s resting heart rate. Multiply that across millions of users, and you have a cultural shift: people expect their bodies to be measurable in real time.

But feedback has a dark side. At HLTH Europe 2025, experts warned of “data overload” and unnecessary anxiety. Athletic twenty-somethings are showing up in cardiology clinics because their device flagged a perfectly normal low resting heart rate. Physicians, already stretched thin, must triage which alerts matter. Indeed, my wife talks with her PCP about her Whoop data when she goes in for her annual checkups.

For health systems, this raises costs and inefficiencies. For industry, it raises reputational questions: how do we ensure wearables empower without overwhelming? The answer likely lies in algorithms that filter noise and in careful integration with clinical workflows.

Equity and Access: Those In Need Don't Have Them

Another sobering reality is that wearables remain disproportionately in the hands of the affluent. Those who could benefit most — elderly patients, lower-income populations, people with chronic disease — are least likely to use them. Without reimbursement strategies and simplified user experiences, wearables risk widening rather than narrowing health disparities.

This matters commercially. Payers and policymakers are watching closely. For wearables to fulfill their promise, they must move beyond the “happy few” to the populations driving the bulk of healthcare costs. That means affordable devices, intuitive interfaces, and coverage models that incentivize use.

Implications for Pharma, Biotech, and Medtech

For commercial and insights professionals, wearables present four strategic imperatives:

  • Evidence over hype: Differentiate between compelling consumer stories and clinically validated outcomes. Avoid conflating empowerment with efficacy.
  • Partnership models: Explore collaborations where wearables serve as digital companions to therapies — in diabetes, neurology, cardiovascular, and beyond.
  • Data integration: Build strategies to harness wearable-derived real-world evidence in regulatory submissions and value-based contracting.
  • Equity focus: Design solutions that address access gaps, ensuring devices reach the populations who need them most of all.

Conclusion: The New Health Interface

As I've seen my own personal shift to Garmin, and my wife's obsession with her Whoop data, wearables represent a profound shift in how people engage with health. They are at once empowering and anxiety-inducing, evidence-backed and hype-driven, democratizing and inequitable.

For industry leaders, the opportunity is not just to track the technology but to shape its responsible adoption. The next phase of wearables will be defined by those who can balance innovation with evidence, personalization with regulation, and empowerment with equity.

In that balance lies the future of digital health — not just on our wrists, but woven into the very fabric of how healthcare is delivered.