SSI Strategy

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


  • 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


  • 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


  • 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

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