Development of medical devices driven by academia-industry collaboration: An internal audit.

Abstract

Rapid and efficient processes are essential for medical device research and development. To address this need, we established an open innovation research and development platform involving clinicians, manufacturers, sales companies, and experts in intellectual property and regulatory, aiming to develop new medical devices for minimally invasive treatment. The purpose of this study is to retrospectively and internally evaluate the research and development activities and outcomes of this platform to identify factors contributing to successful development of medical devices. A retrospective analysis of our team was conducted, focusing on successful device development, device classification, development duration, targeted medical areas, intellectual property rights, and manufacturer involvement. The study also evaluated external funding, academic publications, and international market expansion. Data were extracted from our team's project database and analyzed using descriptive statistical methods. The platform facilitated the development of 28 medical devices, achieving a successful device development rate of 50%. These devices primarily targeted endoscopy (48.2%) and laparoscopy (25%),with an average development of 36 months. The intellectual property acquisition rate was 50%, including patents (39.3%) and trademarks (44.6%). Collaboration with sales companies and manufacturers was high at 82.1% and 71.4%, respectively. External funding supported 44.6% of projects, and academic publications were associated with 32.1%. In addition, 12.5% of the projects achieved international market expansion. Key success factors included intellectual property acquisition (P < .001), external funding (P = .003), academic publications (P = .003), and involvement of sales companies in research and development (P = .03). Our team has shown successful in research and development through collaborative efforts across academia, industry, and government. It highlights the importance of open innovation and interdisciplinary collaboration in addressing global health care challenges.