MDD: Pre-clinical studies of implantable medical devices: Lessons from the front lines

Peter Markham, MS and Rami Tzafriri, PhD. ‘Pre-clinical studies of implantable medical devices: Lessons from the front lines..’

Summary: Surveying three example cases of pre-clinical studies of combination medical devices, the presentation attempts to illustrate 3 key lessons:

  • First follower – Don’t just follow first generation testing paradigm. Speed and differentiation are most important
  • New product in a crowded field – Find a partner that can help you differentiate your technology via key publications and presentations
  • Disruptive innovation – Find the right partner that can help define the correct testing paradigm and highlight attributes

Presented at: Medical Device Development by Harvard Catalyst, December 1-2, 2016, at Cambridge, MA.