Journal of SMT Article

IMPROVING MANUFACTURABILITY, REDUCING COST, AND EXTENDING PRODUCT LIFE - PROCESSES AND PITFALLS UNIQUE TO MEDICAL DEVICES

Authors: Chris Rozewski and Walter Thomson
Company: Plexus Technology Group
Date Published: 7/1/2004   Volume: 17-3

Abstract: The development and manufacture of medical devices occur in a highly regulated environment, with a focus on ensuring patient safety and efficacy of the procedure/treatment facilitated by the device. As such, rigorous controls and standards must be followed, including both the verification and validation of the device. Depending on the device type and state of existing technology, lengthy clinical trials may also be required.

As a result, development cycle times (including the time to transition and successfully pass regulatory muster in a volume manufacturing environment) can exceed 18 months. Once a medical device gains acceptance in the marketplace, however, it can often enjoy a long product lifecycle (5+ years). The combination of a long development cycle time and long product life presents particular challenges in sustaining volume manufacturing over time.

This paper looks at the challenges faced by medical device OEMs in addressing such issues as improving manufacturability, reducing product cost, and ensuring component availability over the extended life of a typical medical device. A discussion of the requirements needed for successfully assessing opportunities for extending the life of an existing medical device is included. A process is also described for evaluating the return on the investment made to implement changes that affect the design and manufacture of the device.

Key words: product redesign, manufacturability, return on investment, cost reduction.



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