November 2016

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Tuesday, November 1st, 2016

Design for Manufacturability and FDA Approval

by Michael Kanis, National Sales Manager

Designing a new medical device for ultimate FDA approval requires a great deal of planning. That plan must balance technology development and product efficacy vs. the engineering design cost, future product cost constraints and time-to-market demands. Proven Process Medical Devices has an extensive portfolio of successful medical product development programs derived from 24 years of medical device development experience. Those successes begin with our experienced project engineering managers understanding how to develop and allocate resources for a product development program. That program is structured to confirm early on that the technology performs, that it can be designed for manufacturability, and that it can be tested and validated to pass global regulatory requirements.

PPMD conducts initial technology concept and feasibility tasks quickly. "Program Review Tasks" are added into the program schedule to allow all stakeholders a chance to step back and learn of any design or process risks. This is particularly crucial as engineering time is allocated for designers to consider issues that may affect eventual manufacturability. These reviews can uncover design and process concerns which are collated into a Design for Manufacturing (DFM) matrix. Identified issues are researched early in the development phases so the design path can be altered and navigated efficiently to alleviate any DFM risks. Read the full article...

To learn more about our firm's capabilities or to discuss a specific project, contact Mike Kanis, National Sales Manager at 508-261-0849 or email Mike at

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