Authors:
- Ramona Galantonu, PhD, Director, Medical Strategy, Veeva MedTech
- Marceline Treneff, Director, Medical Strategy, Veeva MedTech
Key Takeaways:
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MedTech Medical Affairs is shifting from a support role to a more strategic function.
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Industry leaders are exploring whether its responsibilities and workflows can be standardized across the field.
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The discussion at the MAPS Americas 2026 Annual Meeting reflects growing interest in defining clearer, more consistent expectations for the function.
Medtech medical affairs has historically been seen as a support function – brought in to approve a slide deck or handle technical queries. Today, that perception is shifting. As the regulatory landscape tightens and the “value-based” model takes hold, medical affairs is transforming into a strategic engine designed to drive the business from product conception to patient outcome.
At a recent medtech roundtable at the MAPS Americas 2026 Annual Meeting, industry leaders gathered to tackle a foundational question: Can we standardize a set of responsibilities and a high-level operational process flow across medtech medical affairs? While there wasn’t a singular consensus, the group underscored the need for a standardized framework as reference and emphasized that this foundation must be coupled with the flexibility to serve the diversity of medtech organizations, allowing the industry to stop reacting and start optimizing.
Translating influence into resources
The discussion highlighted the significant diversity in how medtech organizations operate, revealing that challenges are rarely uniform across the industry. Recent survey data suggests that obtaining strategic influence and visibility is a primary concern, with securing sufficient resources and budget being the second.
However, the group underscored that this struggle is not universal. For some medical affairs leaders, visibility is not the hurdle as they’re already recognized as a strategic function. Instead, the true challenge lies in translating that “seat at the table” into actual headcount and budget. As one executive noted, the CEO and Board are well aware of the medical team’s presence, but the difficulty remains in articulating value clearly enough to unlock further resources. Interestingly, these differences in experience do not seem to follow specific categories such as company size, product type, or organizational maturity.
“The CEO and Board of Directors know who my medical directors are. The problem is highlighting the value, so that I can get more budget.”
One of the primary challenges is that a significant portion of medical affairs’ impact is preventative, making its value less apparent compared to other functions. In medtech, a significant portion of the workload involves sustaining business-critical processes – such as navigating EU MDR requirements, clinical evaluations, and safety compliance.
Because the success of these initiatives is defined by the absence of crises, it can be difficult to secure the broader investment necessary for the medical department to thrive. This creates a paradox: medical is expected to act as a strategic partner, but the team is often consumed by foundational risk-mitigation – essential work that only gets executive attention when a problem occurs.
New growth drivers
When discussing which elements of the medical function are the most important to accelerate growth, survey data shows an emphasis on strengthening evidence generation and real-world data initiatives.
The roundtable attendees agreed but pointed out that the focus is dependent on market maturity. For more mature product areas, medtech organizations are focused on adoption and reimbursement; for newer areas, the focus remains on foundational evidence.
A significant recent development discussed is the evolution of medical affairs’ role in mergers and acquisitions (M&A). Historically, medical affairs was brought in post-deal to integrate clinical teams. Today they are the “tip of the spear” during the due diligence phase.
“The medical directors at the ‘tip of the spear’ are responsible for de-risking investments.”
As the industry moves away from simple “tuck-in” acquisitions toward complex “structural deals,” medical affairs is now responsible for de-risking the investment before the deal is even signed.
Standardizing the medtech medical affairs flow
The leaders reviewed a proposed operational flow, tracing the journey from unmet medical need to patient outcomes. The goal isn’t just to draw a diagram but to help teams further define roles and responsibilities. The critical question: Should we standardize or be flexible?
The consensus was that while every medtech has its own unique “nuance,” there is a collective need to optimize workflows and determine joint pain points and KPIs. By standardizing at a high level, medical affairs leaders can better identify where the “train goes off the tracks” – specifically addressing the consultative gap between the scientific narrative and commercial execution.
A primary example of this gap is seen in the Medical-Legal-Regulatory (MLR) review process. Without a standardized process, medical is often regulated to a late stage “policing” role in the promotional review process rather than acting as a co-developer of the scientifically credible narrative. As one leader noted:
“There’s this handoff gap – it hits publications and then it shows up again in MLR review. What happened in between? We could have helped create a science-credible narrative, but we don’t have good roles for that yet.”
Standardizing the MLR review flow ensures that:
- The “Scientific Tether” remains intact: Preventing marketing teams from losing the link to clinical data as they scale up consumer-facing content.
- Bandwidth is optimized: Moving away from manual one-off reviews towards a systematic approach – potentially aided by AI and automated claims matrices – that allows medical to focus on high-value strategy.
- Process-driven inclusion: Transitioning from a reactive “inclusion-by-request” model to a proactive, process-led partnership that embeds medical as core stakeholder in the development flow.
The group reimagined the traditional linear operating model as a continuous strategic circle featuring:
- The Target Product Profile (TPP): Acting as the central blueprint where all functions align on requirements, de-risking the launch before it begins.
- Evidence feedback loops: Ensuring real-world evidence and patient outcomes feed directly back into the medical strategy, refining the narrative and the next generation of devices.
- Clinical claims ownership: Empowering medical to own the clinical claims matrix ensuring that as products move through the cycle, they remain anchored in substantiated science.
INTERESTED IN HOSTING A ROUNDTABLE?
This article summarizes a Roundtable hosted by a MAPS Partner Circle member that brought together leading experts from across the industry. If you are a solution provider interested in hosting your own Roundtable – in-person or virtually – please check out our Media Planner or contact Luke with MAPS: [email protected].
