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.

How Medtronic used a stagegate process to bring a new implantable cardiac defibrillator to market. BY NATALIE BAUER

MEDTRONIC, MINNEAPOLIS, MINN., USA, initiated a new product development project in January 1999 to combine the best features of its Sprint family of implantable cardiac defibrillator leads into one model, the Sprint Quattro Secure 6947.

Using a stage-gate process, the team brought the product to market five months ahead of schedule. For its performance, the project team received the Medtronic Star of Excellence in recognition of its “lasting impact by solving root cause problems or addressing fundamental customer-focused issues.”

Here's a visual description of how and why this team's project management methods enabled its success.

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