Concept to Commercialization: A Roadmap for Successful MedTech Innovation скачать в хорошем качестве

Concept to Commercialization: A Roadmap for Successful MedTech Innovation

The road from medtech startup concept to commercialization is full of obstacles, but with the right strategy and tools, success is achievable. The video highlights common pitfalls such as late regulatory engagement, overestimating progress, and early design oversights. It introduces the trace matrix—a key document linking user needs, design, and verification—to promote cross-functional collaboration and prevent costly mistakes. A solid regulatory strategy is essential for selecting the right FDA pathway, understanding exemptions, and ensuring claims are backed by data. Later chapters cover practical manufacturing and commercialization insights. Startups should anticipate differences between prototype and production materials, choose experienced contract manufacturers, and design with manufacturability in mind. For market entry, leveraging distributors, understanding purchasing systems, and protecting intellectual property through patents and trademarks are vital. The video concludes with actionable success tips: integrate regulatory and market strategies, review IP regularly, plan early, and secure funding. Timestamps 00:36 – Common Mistakes in Medical Device Development 02:48 – The Trace Matrix: A Foundational Tool 24:31 – Regulatory Strategy 40:14 – Prototyping and Manufacturing 46:37 – Commercialization 53:17 – Secrets to Success Listen to this episode on the go on Spotify: https://open.spotify.com/episode/0FmV...