The Long and Winding Road to Innovation

• Main Author: Rafael Beyar
• Format: Article
• Language: English
• Published: Rambam Health Care Campus 2015-07-01
• Series: Rambam Maimonides Medical Journal
• Subjects: Animal experiments; early feasibility studies; innovations; inventions; medical technology; regulatory approval
• Online Access: http://rmmj.org.il/Pages/ArticleHTM.aspx?manuId=516

Medicine is developing through biomedical technology and innovations. The goal of any innovation in medicine is to improve patient care. Exponential growth in technology has led to the unprecedented growth of medical technology over the last 50 years. Clinician-scientists need to understand the complexity of the innovation process, from concept to product release, when working to bring new clinical solutions to the bedside. Hence, an overview of the innovation process is provided herein. The process involves an invention designed to solve an unmet need, followed by prototype design and optimization, animal studies, pilot and pivotal studies, and regulatory approval. The post-marketing strategy relative to funding, along with analysis of cost benefit, is a critical component for the adoption of new technologies. Examples of the road to innovation are provided, based on the experience with development of the transcatheter aortic valve. Finally, ideas are presented to contribute to the further development of this worldwide trend in innovation.