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 on design #4.”
Early Clinical Experience is Worth Gold
The value of early FIM data cannot be overstated. While preclinical testing and simulations are essential, they can never fully replicate real-world clinical scenarios. Once your product is in the hands of surgeons and used in actual patients, you’ll encounter challenges and limitations that you never anticipated.
At Ellipse, our first surgeries were performed in Honk Kong, Australia and India well before the submitting with the FDA. Although the initial clinical outcomes were positive, they still revealed areas for improvement. This feedback was invaluable in refining the implant system and making it truly market-ready.
You need this type of feedback, and you need it early. Waiting until your product is “perfect” will only slow you down. By then, you might find out that your design still doesn’t quite work in real-life situations, and you’ve wasted time that could have been spent iterating and improving.
Research the fastest market for your FIM.
In addition to the traditional markets in the U.S. and EU, startups can look to several other regions globally that are more accessible for First-in-Man (FIM) clinical trials. Countries like New Zealand, Colombia, and certain Eastern European nations offer a favorable regulatory environment for early-stage medical device testing. These regions often have streamlined processes and experienced clinical teams willing to collaborate on cutting-edge technologies. In New Zealand, for instance, the regulatory pathway for early clinical trials is well-established and relatively efficient. Colombia has become an emerging hub for medtech innovation, boasting high-quality healthcare systems and less bureaucratic complexity compared to larger markets. Meanwhile, countries in Eastern Europe, such as Poland and the Czech Republic, offer experienced surgeons and hospitals, with less restrictive approval processes, making them attractive destinations for startups eager to accelerate their product development. Expanding your FIM strategy beyond traditional markets can provide faster access to crucial clinical data and offer a diverse range of feedback to refine your product for global success.
Early Isn’t Easy—But It’s Necessary
Getting your product into clinical settings early is not without challenges. You’ll face regulatory hurdles, logistical complexities, and possibly even resistance from within your own company. However, the benefits far outweigh the risks.
When you gather FIM data early, you’re doing more than just testing a product—you’re building a feedback loop that will accelerate your development process. You’ll iterate faster, refine your design based on real-world data, and ultimately bring a better product to market in less time.
Final Thoughts
For medtech startups, time is of the essence. Your first product design will almost certainly need improvement, and waiting too long to collect clinical data could cost you the market advantage. You cannot afford to launch a product in the US or EU that is sub-par. It’s a small world and your reputation will be tarnished. Do not make the mistake of a TranS1 that lose critical sales traction early from early clinical complications in the US.
Instead of trying to perfect your product before it ever sees a patient, focus on getting it into the hands of early adopter surgeons as soon as it’s safe. Let their real-world feedback guide your next iterations, and embrace the messy, iterative nature of product development.
The sooner you gather FIM data, the sooner you can make the necessary refinements and launch a product that truly meets clinical needs. Remember, your first product design is probably not right—and that’s okay. What’s not okay is waiting too long to find that out.