The Problem
An angel-backed startup developing a telemedicine-enabling wearable was moving from benchtop to the clinic. In parallel with their pursuit of 510(k) clearance, the company identified a market opportunity for deployment by pharmaceutical companies in clinical studies. This second, more rapid source of revenue led to additional funding, but that funding came with expectations of rapid growth in this new market vertical. On top of that, a big-name CRO had prepared a poor CE Marking dossier, and the company was too small to command a fix from the CRO.
Our Actions
Our team was tasked with helping the company transition from a research and engineering company into the clinic. Our responsibilities included:
- Advising executive management as to strategic direction, including company story, investor pitch, and regulatory clearance strategy;
- Developing and executing a clinical development plan;
- Developing clinical SOPs, working with the existing quality manager to train relevant staff and to ensure compliance with Good Clinical Practice;
- Identifying, helping select, and then training new personnel in clinical trial monitoring and management;
- Managing multiple pre-market clinical studies, including protocol support, monitoring, and IRB interactions;
- Developing relationships with potential pharmaceutical partners, managing device deployment clinical trials through partners; and
- Rewriting the CE Marking dossier for Notified Body review.
Outcome
With our help, this small company was able to enter one vertical (supporting pharmaceutical companies developing novel therapies) and build its clinical team while preparing for 510(k) and CE Marking, both of which the company successfully obtained. After our engagement, the company was generating meaningful revenue as a clinical trial adjunct and was well-positioned to obtain registration on two continents.
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