Case Study
Clinical Development
How we helped one of the fastest growing medical device companies develop a clinical research strategy to build a pipeline for future opportunities
Challenge:
- A large post-market clinical registry with significant feedback from key opinion leaders (KOLs), resulted in many untapped opportunities to expand the reach of their core product
- Client needed to develop a prioritized research strategy that would help define where to focus limited clinical and medical resources
Approach:
- Outlined all potential opportunities and uses for the client’s core product
- Refined the list of opportunities to those that were most viable within the current infrastructure.
- Developed high-level trial designs for each opportunity and a set of objective evaluation criteria to enable leadership to assess the merits of each opportunity
Results:
- Identified and operationalized highest priority pivotal study
- Positioned client to sustainably grow their clinical portfolio
- Engaged SSI to design their pivotal trial, along with evaluation of critical resource needs, protocol development, and IDE submission preparation