Requirements
Clinical Pilot
Initial trials that are intended to provide input and design direction and not statistically robust safety or efficacy information
Clinical Trial Endpoints
The key end points that you expect to establish in the Pivotal clinical study
Feedback from 100+ Clinical Stakeholders
Documented feedback on the proposed solution’s value proposition from >100 interviews with clinical stakeholders
Feedback from 5+ KOLs
Feedback from recognized Key Opinion Leaders (KOLs)
Medical Advisory Board
A group of advisors, preferably KOLs and "Lead Users" that can help set the direction of the development program and priorities