Digital health initiatives, from smart inhalers to digital diagnostics, are usually built in silos. Without the clinical relevance provided by medical affairs, those efforts rarely scale. “Technology teams can build features. Only medical affairs can make them clinically meaningful and relevant,” says Dr. Paul Mastoridis, Pharmaceutical Executive.
Medical affairs sits closer to the lived experience of care than any other function. Medical affairs teams are embedded in real clinical workflows, speaking directly with physicians and patients about what works, what does not, and why. They understand adherence behavior, unmet needs, and evidence gaps long before those issues surface in dashboards or post-launch reports.
“Every successful digital or smart device innovation begins with a deep understanding of patient behavior, clinical reality, and evidence,” Mastoridis says. “That is exactly where medical affairs lives. It is the engine that makes innovation clinically meaningful.”
Medical Affairs is the only function that reliably connects clinical reality with digital ambition. Digital solutions should enhance our products, strengthen our value story, and deliver real patient impact and Medical Affairs knows how to build the proof. Digital tools rise or fall on evidence that regulators, payers, and clinicians trust, and Medical Affairs is uniquely positioned to integrate clinical development, regulatory strategy, real‑world data, and commercial needs into one coherent evidence narrative. That vantage point lets the function define not just what can be built, but what should be built.
Non-Negotiables of Digital Transformation in Medical Affairs
Because of its integral role in translating clinical reality into actionable insight, medical affairs must be positioned upstream in digital decision-making. For leaders who want to reposition medical affairs within 18 to 24 months, Mastoridis points to three non-negotiables.
The first is people and proximity. A small, credible core team from medical affairs must be embedded directly into product, data science, and engineering groups as co-owners of problem definition and evidence strategy. “Not as reviewers,” he says, “but as partners defining what matters.”
The second is data discipline. Digital programs often fail because evidence is fragmented. Mastoridis argues for a unified data backbone that integrates real-world behavior, clinical endpoints, device signals, and patient-reported outcomes.
The third is an operational reset. Medical affairs must lead the why and the what of every digital initiative, not just the review. No project should start without the function defining unmet needs, clinical use cases, adoption barriers, and evidence plans. “AI needs data,” Mastoridis says. “Good data in is good data out.”
From Evidence Communicators to Intelligence Engines
Looking ahead, Mastoridis sees medical affairs evolving into a real-time intelligence function. As real-world data ecosystems mature and generative AI advances, teams will move beyond communicating evidence to generating and operationalizing it continuously.
Future medical affairs leaders will need fluency in data translation, behavioral analytics, and AI governance. New roles will emerge, from digital evidence leads to AI-augmented medical directors, responsible for validating algorithms and ensuring clinical, ethical, and regulatory integrity.
The underlying mission, however, remains unchanged. Medical affairs exists to serve patients by aligning innovation with clinical reality. “Digital fails when it is built in isolation,” Mastoridis says. “It scales when medical affairs drives it.”
As healthcare becomes more connected and data-driven, that insight may define which organizations lead and which fall behind.
Follow Paul Mastoridis on LinkedIn for more insights.
