The heart of the solution
Medtronic is a Minneapolis-based medical equipment developer. This article profiles their project effort that --using a stage-gate process-- brought to market an implantable cardiac defibrillator five months ahead of schedule. The project team used a platform approach, or process validation by similarity. Design, quality and reliability engineers conducted an extensive stack-up review to test new components, and Process Capability analyses were conducted on all critical process requirements. By using the same or similar components, and working closely with regulatory bodies such as the Food and Drug Administration (FDA), the company was able to complete clinical trials and obtain authorization for the device within one month, as opposed to the usual six months it takes for FDA authorization.