Post by Giovanni Verma

Nobody tells you what medical device regulation actually looks like until you're already stuck in it. We found that out trying to build in maternal health, and it's why we're now offering free calls to anyone in medtech or healthtech. We went in because the space genuinely needed it. Maternal health is one of the most underfunded areas in medicine and that felt like reason enough to try. What we didn't see coming was how deep the regulatory complexity goes. Classification, clinical evidence, route to market. Each one a decision that shapes years of your life before a single patient sees the product. We didn't get where we wanted to go. But we know the landscape now and that feels worth sharing with someone earlier in the journey. Stuck on regulation, unsure how to classify your product, not sure where to even start. Get in touch. Happy to sign an NDA if needed.