Designing for Safety and Efficacy: An Assessment of a Medtech Development Platform

Medical device development is Complex. Products must be designed and engineered, keeping safety and performance as priorities. This paper introduces a Product engineering and development (PED) platform used by the authors to develop a portfolio of products. The purpose of the paper is to analyse the effectiveness of the platform to create medical devices. A retrospective review of the development cycle and post-market clinical performance was the method used. Usability and end-user interaction was also a focus of this study. The company's quality management system (QMS) records were used as source material. The results of this study showed that the PED platform was suitable to develop FDA, CE and/or India Regulatory compliant medical devices. The different types of products created using this platform indicates its suitability across medical device types.