DFM & DFA Can Aid the Medical Device Manufacturing Process

I found a recent EMDT article by Bill Welch and Paul Harhen, "A Method to the Moulding," very insightful and wanted to share some of its high points with you. Welch and Harhen -- Chief Technical Officer and Director of Engineering Europe at Phillips-Medisize (Europe) -- discuss the medical device product development and how certain design principals such as design for manufacturing and design for assembly can help the process be effective.


Stephanie Wiseman

The authors point out, "It is estimated that 80% of product cost is determined during the first 20% of the product development timeline." Therefore, design for manufacturing (DFM) and design for assembly (DFA) are "foundational elements of a robust product development process."

The authors define the difference between DFM and DFA:

  • DFM "is focused on process-specific design guidelines at the component level, ensuring the part can be manufactured with the chosen production process."
  • DFA "is focused on integrating components on a system level, ensuring that ideas translate into a functional product and that all industry-critical factors are dealt with in the shortest possible time."

Moulded plastics is the manufacturing process the authors focus in on:

By applying a handful of established DFM guidelines for moulded parts, a majority of design issues can be prevented. The same can be said for DFA, in which planning for manual, semi-automated or automated assembly from the early stages can prevent problems from cropping up during clinical, pilot or manufacturing launch builds, when their mitigation becomes much more costly. To meet targeted cost and quality objectives, as well as other programme goals, designers, engineers and manufacturing representatives should collaborate early and often to develop designs.

Innovation depends on technology
The authors note that, "Innovation in medical devices requires advanced technologies to achieve manufacturable solutions." And they also point out that collaboration with the manufacturing team at concept development can lead to a more robust design and lower costs.

Adding DFM & DFA into your process
Finally, the authors insist, "a sound DFM/DFA philosophy should be deeply ingrained within all phases of development and focused on meeting manufacturing quality, cost and risk objectives." And that "early manufacturing involvement can be used to ensure design engineers and manufacturing representatives collaborate to provide a robust, yet advanced, manufacturing solution."

Do you follow Welch and Harhen's advice and incorporate DFM and DFA principles into your medical device design?

Focused on medical packaging design and technology?

Stephanie Wiseman, Community Editor, UBM

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