Despite significant advances in biomedical research, translating academic innovations into commercial medical devices (MDs) remains a formidable challenge. Many academic teams achieve promising results but lack the regulatory and strategic expertise required for successful commercialization. To address this critical gap, the key factors influencing MD development within current regulatory frameworks in Europe and the US are examined, combining insights from the existing literature with the authors’ direct experience. The article provides practical tools and a systematic roadmap grounded in five essential pillars: target product definition, risk reduction through testing, intellectual property (IP) protection, multidisciplinary collaboration, and industry partnerships. This structured process begins with creating a clear target product profile (TPP) and progresses through prototyping, strategic IP management, and comprehensive testing to finalize the device design. Recognizing the iterative nature of MD development, continuous refinement based on clinical data, regulatory requirements, and user feedback is essential. Multidisciplinary collaboration among researchers, clinicians, regulatory specialists, and industry partners is emphasized as crucial for success. The development of a partially resorbable arteriovenous graft (AVG) for hemodialysis is presented as a comprehensive case study, illustrating practical challenges and effective strategies for translating academic innovation into meaningful clinical solutions.
Oldani et al. (Mon,) studied this question.