Launching a medical device in the next 1-3 years?
Seeking funding for your medtech startup?
Investing in a startup company?
Here are pivotal milestones and their significance.
- Commerical due diligence is essential at this stage to clearly prepare for accurate funding and resources. Sadly, many companies encounter funding challenges by milestone
- Reg and Clinical strategies are key by this stage as they are critical to be prepared for FDA pre-submissions and mitigate any potential risks.
- Engaging investigators and proactively gathering all required data are vital as FDA negotiations and site selections can consume up to a year.
- Be ready to kick off your clinical study as soon as receiving the FDA (or ethics committee) greenlight.
