The use of project templates in medical device development
Micro-Rel is an integrated supplier of hardware and software components and final products. Project templates are repeatable formats enabling the uniform description of processes, plans, and other documentation that result in reliable products with a defined development trail. This article describes some of the benefits of project templates, offering as an example the Micro Circuit Development Protocol, a new product development (NPD) template designed to guide the NPD process and ensure compliance with FDA requirements for heart pacemakers. To support NPD, the company reoriented its organizational structure around dedicated project teams, and gradually saw development cycle time shrink from years to 14 months. In order to prevent creative stagnation and process obsolescence, the NPD template has built-in flexibilities, and is periodically reviewed to encourage continual improvement.