If you’re an ortho startup, one of the biggest hurdles you’ll face is product development—particularly in refining your product in order to enter the two biggest markets - US and EU. You’ve likely poured hours into R&D, engineering, and testing to craft something that you believe is market-ready.
But here’s the hard truth: your first few product designs are probably not ready. And the sooner you accept that, the sooner you can take steps to fix it.
This is why startups need First-in-Man (FIM) clinical feedback data ASAP. It’s your fastest route to understanding the clinical realities of your product. Way before FDA clearance. Without real-world feedback, you’re flying blind, and chances are your “perfect” design will need significant refinements. Getting clinical experience early—long before your product is polished—is critical to your success.
Take home message - "Your most recent design is not ready for the US or EU markets. I know that you have spent a lot of time and money reaching design iteration #3 through cadaver labs and maybe animal studies, but it's not good enough. Our ego gets in the way. Get human clinical experience ASAP and really listen and learn, then work ...
