Transforming FDA Strategy Through Adaptive Marketing Research: The Pivot That Paid Off
- Federico Somaini
- Jul 16
- 3 min read
Updated: Nov 12
In a recent project for a stroke diagnostic device, we partnered with a MedTech client to generate clinical insights in support of their FDA submission. The device was designed to detect intracranial bleeds very early in hospital settings, reducing the time from a patient being admitted to a hospital to having a CT scan for diagnosis.
The original research plan, per the client's request, focused exclusively on clinicians at Comprehensive Stroke Centers (CSCs), the gold standard in stroke care. These institutions are staffed by some of the most experienced stroke specialists, managing complex cases in high-volume, protocol-driven environments. The thinking was straightforward: interviews with these experts would yield the most informed, up-to-date perspectives on stroke care pathways and help pressure-test the device's clinical relevance.
Early interviews with these physicians showed that CSCs already had robust workflows, rapid access to imaging, and little need for a new triage tool. The device was seen as interesting but redundant; something that might slow workflows rather than improve them.
This emerging pattern in the feedback raised a red flag: were we talking to the right segment of the market?
A Strategic Pivot, Guided by Early Insight
CSCs represent fewer than 300 of the 5,500+ emergency departments across the U.S. - just 5% of the hospital landscape. The clinicians in these centers were evaluating it from a position of a carefully constructed diagnostic process that was time efficient and highly effective. This didn’t reflect the reality in more typical stroke settings: Primary Stroke Centers (PSCs), rural hospitals, and community EDs where imaging may not be immediately available and EMS teams face tougher decisions in the field.
By pivoting our research and broadening the sample to include these under-represented settings, we surfaced clinical and operational insights that fundamentally changed the perception of the product’s customer value proposition:
Pre-hospital triage support: Use by EMS teams to identify hemorrhagic stroke earlier
Improved transport decisions: Better routing to thrombectomy-capable centers, minimizing time lost
Operational fit in resource-limited hospitals: Where access to rapid neuroimaging is not guaranteed
We surfaced clinical and operational insights that fundamentally changed the perception of the product’s customer value proposition
Many of these facilities operate under different incentives and constraints, from reimbursement for tPA administration to limited access to neurosurgery, which make the device far more impactful than it appeared in the CSC context.
Adapting Marketing Research Quickly Helped Bring Clarity and Saved the Client Time and Money
Had we remained committed to the original interview plan, we likely would’ve concluded that the product had limited incremental clinical value, which would have hurt the company’s position in regard to obtaining FDA approval. We would have misrepresented the product’s true clinical utility and hurt the company’s investor messaging.
By listening to early signals and acting quickly, we helped the client clarify where the device could make a meaningful difference in care.
The View from the Crow’s Nest
Market research often starts with a methodology agreed upon by both client and supplier. But this project highlighted the importance of flexibility, and of having a research partner who can quickly identify when a change is needed and proactively bring that to the client’s attention to enable a timely pivot.
Good marketing research means listening closely to customers’ early signals and having the discipline and willingness to follow where they lead.
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