For AI-driven medtech companies, regulatory clearance is increasingly just one milestone on a much longer road to commercial success. The real challenge lies in bridging clinical validation, reimbursement, physician adoption and measurable P&L impact — often while managing limited capital and lengthy healthcare buying cycles.
In an interview with MedTech Spectrum, Brittany Berry, Ph.D., Co-founder and COO of Avenda Health, shares lessons from the commercialisation of Unfold AI, the company’s AI-powered prostate cancer mapping platform. Berry discusses why reimbursement strategy should be embedded into product development from the outset, how clinical trials can generate evidence relevant to regulators, CMS, medical societies and payers, and why AI medtech companies must ultimately demonstrate a clear financial case for health systems.