Why Engagement is the New Efficacy in Digital Health

When the first wave of digital therapeutics (DTx) entered the market, the mission was clear: demonstrate clinical efficacy through randomized controlled trials (RCTs), secure regulatory approval, and unlock payer reimbursement. And for a time, that was enough.

The digital health landscape and the expectations of payers, patients, and healthcare systems have since evolved. Today, clinical efficacy alone is no longer sufficient. To deliver real-world impact and unlock sustainable value, digital interventions must also engage patients meaningfully and consistently over time. In short: engagement has become the new efficacy.

This article explores why engagement is critical to the success of regulated digital health interventions, the economic and clinical consequences of poor engagement, and what pharmaceutical companies can do to lead the next generation of digital health innovation by prioritizing engagement science.

The Engagement Gap: A Challenge for Digital Health

In clinical trials, many DTx interventions have demonstrated impressive outcomes: lowering blood pressure, improving glycemic control, and reducing depressive symptoms. Still, their performance in the real world often falls short. Why?

A major factor is patient disengagement. Systematic reviews report that an average of around 43% of patients drop out of app-based digital health interventions, often before the intervention has had time to deliver its intended clinical benefits [2]. This “engagement gap” undermines the value proposition of digital health and threatens the long-term viability of these products in a competitive and value-conscious marketplace.

For pharmaceutical companies investing in DTx as part of their portfolios, poor engagement isn’t just a usability problem; it’s a strategic and commercial risk. If patients don’t engage with the product as prescribed, outcomes suffer, payer confidence declines, and brands lose differentiation.

Why Engagement Enables Outcomes

The link between engagement and outcomes is well-established in behavioral medicine. Sustained behavior change, whether it’s medication adherence, lifestyle modification, or therapy completion, depends on more than access to a tool or information.

It requires:

Motivation and readiness to change.
Social and environmental support.
Feedback, reinforcement, and habit formation over time.

A meta‑analysis focused on digital mental health apps found that greater engagement was associated with a medium effect size in clinical improvement compared to less‑engaged users, underscoring the real-world value of engagement-driven design [3]. Similarly, a payer case study of Wellframe found that members who engaged with the app had 33% fewer hospital admissions at 30 days—and at 90 days, continued users showed 18% fewer inpatient admissions and a 25% reduction in ER visits (Wellframe case study) [4]

For DTx to fulfill their potential, and for pharma brands to deliver on their value-based care commitments, engagement cannot be an afterthought.

Why Payers Care About Engagement

Payers are increasingly scrutinizing not just the clinical efficacy of digital products but also their real-world adherence and retention rates. After all, they are paying for outcomes, not just access.

Engagement data can strengthen the value proposition to payers in several ways:

Demonstrating return on investment through reduced hospitalizations and improved outcomes.
Supporting value-based reimbursement models tied to actual patient use and behavior change.
Differentiating a product in competitive formulary negotiations by showing superior patient satisfaction and adherence metrics.

In short, engagement is no longer just a usability metric, it’s a key determinant of market access and reimbursement.

The Economic Cost of Poor Engagement

The consequences of poor engagement extend beyond clinical outcomes and payer relationships, they carry real economic costs.

In the United States, nonadherence to long-term medication regimens has been estimated to cost the healthcare system approximately $290 billion annually, due in large part to avoidable complications, hospitalizations, and suboptimal disease control [5].

For digital health products, disengagement can also erode the return on investment for pharma:

Wasted marketing and education efforts to drive uptake.
Lost opportunities to capture behavioral and clinical data for evidence generation.
Increased risk of negative patient experiences and brand erosion.

Investing in engagement, by contrast, can protect and amplify the ROI of digital health initiatives.

Designing for Engagement: Behavioral Science and HCD

So how can pharma and its partners improve engagement in regulated digital health products?

The answer lies in embedding behavioral science and human-centered design (HCD) principles into every stage of product development.

Behavioral science provides validated techniques to support motivation, adherence, and habit formation, including:

Goal setting and progress tracking.
Positive reinforcement and feedback loops.
Social support mechanisms and accountability.
Framing and nudging to simplify choices and overcome inertia.

HCD complements these techniques by ensuring that the product fits seamlessly into patients’ lives, aligns with their values and preferences, and minimizes friction and cognitive burden.

At Newel Health, we integrate these disciplines to create experiences that are not only clinically effective but also engaging, enjoyable, and sustainable for patients.

The Role of Personalization

Engagement is not one-size-fits-all. Different patients have different barriers, motivations, and contexts that influence their behavior. That’s why personalization is key to maximizing engagement.

Personalization can take many forms:

Tailoring content and messaging to individual preferences.
Adjusting intervention intensity based on real-time behavior and risk profiles.
Delivering support at the right time, in the right channel, with the right tone.

At scale, this level of personalization requires a robust technological backbone, one that can collect, analyze, and act on behavioral data dynamically. At Newel, our Behavioral Intelligence Engine (BIE) is designed to do just that, delivering context-aware, adaptive interventions that keep patients engaged and progressing.

The Regulatory Perspective

Some pharma stakeholders hesitate to fully embrace behavioral engagement strategies for fear of complicating regulatory pathways. But the good news is that behavioral science and engagement optimization are entirely compatible with regulated development.

In fact, regulators increasingly expect developers to define and measure the mechanisms of action by which their interventions influence patient behavior. Behavioral endpoints are acceptable and often necessary as intermediate outcomes. What matters is that the strategies are evidence-based, measurable, and appropriately validated [6].

Pharma companies that work with partners experienced in aligning behavioral science with regulatory expectations can lead the way here.

What’s Next: The Future of Engagement Science

As digital health matures, engagement science will continue to evolve. Emerging trends to watch include:

The integration of generative and agentic AI to deliver even more dynamic, conversational, and human-like support.
Greater use of behavioral and contextual data to predict disengagement and intervene preemptively.
Stronger alignment between engagement metrics and value-based reimbursement models.

Pharma companies that invest now in engagement capabilities will be better positioned to lead in this future.

The Takeaway

The message is clear: Engagement enables outcomes, and outcomes drive value.

For regulated digital health products to succeed clinically, commercially, and ethically, engagement must be treated as a core design goal, not an afterthought. Pharmaceutical companies that partner with behavioral science–driven innovators can deliver interventions that meet the needs of patients, satisfy payers, and strengthen their brands.

At Newel Health, we believe engagement is not a secondary metric, it’s a primary driver of real-world impact. Our behavioral science–powered solutions are designed to deliver both clinical-grade efficacy and best-in-class engagement, helping our pharmaceutical partners succeed in trials and beyond.

Ready to learn more?

Let’s talk about how Newel Health can help you build digital therapeutics that patients use, payers value, and brands can stand behind.

Contact us at info@newel.health

References

[1] Perski, O., et al. (2017). Translational Behavioral Medicine, 7(2), 254–267. https://doi.org/10.1007/s13142-016-0453-1

[2] Meyerowitz-Katz, G., et al. (2020). Journal of Medical Internet Research, 22(9), e20283. https://doi.org/10.2196/20283

[3] Valentine, L., Hinton, J.D.X., Bajaj, K. et al. A meta-analysis of persuasive design, engagement, and efficacy in 92 RCTs of mental health apps. npj Digit. Med. 8, 229 (2025). https://doi.org/10.1038/s41746-025-01567-5

[4] Health Edge 2025 Digital Health Improves Care Transitions for Members. https://healthedge.com/resources/case-studies/digital-health-improves-care-transitions-for-members?utm_source=chatgpt.com

[5] Lemstra, M., Nwankwo, C., Bird, Y., & Moraros, J. (2018). Primary nonadherence to chronic disease medications: a meta-analysis. Patient preference and adherence, 12, 721–731. https://doi.org/10.2147/PPA.S161151

[6] Michie, S., et al. (2014). The Behaviour Change Wheel: A Guide to Designing Interventions.