Why Startups Get Stuck Before First-in-Human and How to Fix It - Powered by 3PH Alliance/HRCRS-Why Startups Get Stuck Before First-in-Human and How to Fix It

Why Startups Get Stuck Before First-in-Human and How to Fix It - Powered by 3PH Alliance/HRCRS

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The roundtable focused on why medical device startups often get stuck before first-in-human studies and how to prevent that. Panelists from founding, clinical, engineering, regulatory, and investing backgrounds agreed that failure usually happens from poor alignment, not just technical flaws.<br /><br />Key themes included: define the question early; understand the device’s stage of development; and align preclinical testing, regulatory strategy, clinical needs, and financing timelines from the start. FDA input early in development was strongly encouraged, with Luke explaining that companies can and should discuss tentative evidence plans before testing begins. Jason noted that new tools like AI can help founders get an early roadmap, but success still requires cross-functional expertise.<br /><br />Clinicians emphasized that devices should be designed for adoption and generalizability, not just for a perfect lab setting. Input should come from both key opinion leaders and busy front-line users. The panel also stressed that a company must decide early whether it is building a product or a lasting business, since that choice affects manufacturing, commercialization, and exit strategy.<br /><br />Overall, the message was clear: involve the right stakeholders early, keep everyone aligned, and use FDA and clinical feedback proactively to avoid costly rework.

Keywords

medical device startups

first-in-human studies

FDA feedback

preclinical testing

clinical adoption

regulatory strategy

cross-functional alignment

commercialization strategy