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
