A New Design Process Intervention to Promote Efficient, Evidenced, and Safe Development of Patient-Specific Implants and Guides

The literature featured necessarily short clinical follow-up, and often reported on design and fabrication methods in very poor detail – to the detriment of reproducibility. Health economics evidence was scarce. In the short to medium term future, new regulatory requirements will compel all institutions, including hospitals, to implement a Quality Management System for the design of medical devices. As such, generalisable procedures, forms, and records for compliance with the BS EN ISO 13485 quality standard were devised, and used as the foundation of the design intervention. The QMS-led design intervention form aimed to: create fully-populated product requirements lists before commencing modelling; introduce project management, identification, traceability, review, verification, and feedback activities; improve the confidence and experience of the designer or acting designer; and prompt record keeping in-line with the requirements of ISO 13485. It achieved all of these aims, at least as far as could be ascertained within the research constraints. Further expansion and verification of the framework is required in future – across different specific surgeries and across more users.