Medical Device Path-to-Market

Guiding you along your path to approval.

Medical Device Strategy

  • Strategic Consulting and Go-to-Market Strategy

  • Project Planning & Management

  • Selecting the Right Key Opinion Leaders: Clinical, Regulatory, Quality & Device

Medical Device Path-to-Market

  • Human Factors Usability Testing and Device Validation:¬†Observe and Cognitively Debrief Patients and HealthCare Providers on Device Use and Safety

  • FDA Meetings and Support (Pre-submission / submission)

  • Digital Product Training to Streamline Usability:¬†Product training for Patients and HealthCare Providers
  • Boutique CRO services to execute clinical device validation trials

  • Demonstrating Clinical Utility to Payers and Regulators: Strategy, Submissions and Data Analysis

Clinical Outcomes Optimization

Helping you get the most out of your clinical trail.