Design for Manufacturability & FDA Approval

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 (PPMD) 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. Once feasibility is confirmed, a hard program pivot occurs, and R+D and manufacturing engineers begin work, concurrently, to determine the best methods for manufacture --using that early risk matrix as a guideline.

Experienced PPMD engineers do a great job of choosing methods of manufacture for piece parts early in development, with a goal of reducing the cost and supply chain complexity. For those instances when the design requires engineers to choose a manufacturing process that pushes the limits of known process operating parameters, PPMD leverages a system of fast failure testing. This fast failure methodology is a PPMD expertise that leverages computational dynamics and an ever-increasing array of rapid prototype techniques to help the engineers hone in on the best customized processes quickly.

Understanding the customer's need to meet manufacturing cost targets and time-to-market demand drives the DFM process. At Proven Process, we work diligently with our customers to plan and build the process that will match the scale of manufacturing, and we begin that work at the inception of a device design program. Having a flexible project model allows us to accommodate changes in the design to meet DFM program and budget constraints. Expert DFM techniques used during medical device development programs give our customers great benefits as their patients’ needs are served with an appropriately priced device that operates with great effectiveness.