Investing in stage seed medtech is risky.
Regulations, standards, clinical trials, quality systems, health and wellness products, deNovo, PMA, 510k…What does it all mean?
How does it affect my investment in an early stage medtech company?
And most importantly, how do I not invest in a company that will end up like Theranos?
Investing in medtech has massive upside.
Medtech is everywhere - it’s creeping into our homes disguised as consumer products, and into computers disguised as plain old software. Gone are the days when you could look at a product and very obviously call it a medical device. The lines are blurring and more and more “regular” tech investors are getting into the medtech game.
During this talk Sabrina Varanelli, Founder and CEO of Nemedio will provide a crash course overview on things that investors should know about before considering an investment in a medtech or healthcare company.
You'll walk away with a better understanding of how to evaluate deals with a regulatory component (or how to avoid them entirely if that's what you're into). We'll equip you with the knowledge to ask relevant questions, and provide a list of red flags you might come across that will save you from investing in a company with no clear path to clearance
Some topics we will cover are:
- Identifying Medical Devices vs. Combination products vs. Wellness Products
- Different regulatory pathways and their implications for go to market
- Red Flags when evaluating deals
- Hot to determine if a team has what it takes to make it in a regulated industry
- Using compliance as a moat
- How to think about the costs of compliance as it relates to round size