Client Assignment · Digital Health · Medical Wearables
FDA approval in hand. No clear path to market.
A US medical wearable device company with a clinically-grade wearable sensor and FDA approval. The barrier was not the technology. It was the FDA's own skepticism about wearables in clinical trials.
CLIENT
US medical wearable device company
OUTCOME
Global academic entry achieved. Mainstream trials entered.
THE CHALLENGE
A credible technology blocked by the regulator it had already satisfied.
A US medical wearable device company had developed a clinically-grade wearable sensor and achieved FDA approval — a significant regulatory milestone.
The intended market was pharmaceutical clinical trials, where the device could dramatically improve data collection and patient monitoring.
What Made This Different
Enter where the regulator has less jurisdiction — then build the evidence base.
Drawing on deep knowledge of the clinical trials ecosystem built through prior work in life sciences, Vaxa identified a flanking strategy. Academic medical centers run clinical trials in environments where FDA jurisdiction is more limited than in pharmaceutical-sponsored trials.
Entry there would allow the device to build the clinical evidence base — real-world data from real trials — that FDA acceptance would eventually require.
WHAT vaxa DID
A flanking strategy — from academic entry to mainstream clinical trials.
01
Clinical Trials Ecosystem Mapping
Mapped the full clinical trials ecosystem — FDA, pharmaceutical companies, CROs, academic medical centers, and principal investigators. Identified the regulatory dynamics, the decision-making structures, and the points of leverage for an unconventional entry strategy.
02
Academic Medical Center Entry Strategy
Designed the strategy for entry through academic medical centers — identifying the highest-priority institutions globally, the clinical areas where wearable data would be most credible, and the relationship pathway into each institution.
03
Global Seeding Program
Executed a global seeding program — embedding the device in academic clinical trials across multiple geographies. Built the clinical evidence base of real-world data from real trials that FDA acceptance would require.
04
Stakeholder Panel Design & FDA Pathway
Designed and ran a series of stakeholder panels bringing together FDA representatives, pharmaceutical companies, CROs, and academic medical centers. Built the ecosystem consensus around wearable data validity that made mainstream trial acceptance possible.
The Outcome
Academic entry. Evidence built. Mainstream trials entered.
01
Academic medical center entry achieved globally
The device embedded in academic clinical trials across multiple geographies — building the clinical evidence base and the institutional relationships that mainstream acceptance would depend on.
02
Clinical evidence base established
Real-world wearable data from real clinical trials — the evidence that the FDA required and that pharmaceutical companies needed to see before committing to wearable data in their own trials.
03
FDA acceptance for mainstream clinical trials
The stakeholder panel process and the clinical evidence base built through academic entry combined to shift FDA's position. Wearable data was accepted for use in mainstream pharmaceutical-sponsored clinical trials.
04