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