Parallel Prototyping And The Engineer's Dilemma

By Craig Sundberg, Heatron, Inc.

Attaining success in the development of medical devices can become extremely difficult, especially when trying to balance critical factors such as the time-to-market, safety, compliance, and cost. When faced with the dilemma of rapidly shrinking development cycles and rising competitive pressures, engineers can use parallel prototyping as a tactical tool that can reduce time-to-market and uncertainty. This white paper describes the parallel prototyping of Aluminum Nitride and Alumina in a heating component design for low-to-medium-volume production, and discusses the verification, validation, form and fit testing relative to the FDA approval process.