Wednesday, June 7, 2017

Design for manufacturability redefines med device measurement and validation

In medical device development, design for manufacturability (DFM) is ultimately about designing for cost. The process involves every member of the product development team – technical, commercial and regulatory – to successfully deliver a product that’s not only easy to manufacture, but profitable as well.

Every critical feature must be measured and validated as a design moves through production. Streamlining the number of critical features in the initial design, as part of DFM, improves this process for everyone involved.

Experience shows it also increases the likelihood of a successful product launch.

Lowell’s Vice President of Operations, Edward Jaeck, will share more about implementing DFM during OMTEC  this June 13-15 in Chicago. His June 14 session, “Data Driven Design for Manufacturability –From Validation to PPAP,” explores how DFM affects and improves the steps of a product’s development.

DFM starts with the technical team
The technical team includes design and quality engineers, R&D and manufacturing. Success for this team means creating a complete and accurate CAD model and drawing set that can be measured and manufactured.

Reducing the number of critical features is one of the best ways to implement DFM, and critical feature confirmation (CFC) is a leading method to achieve this goal. This approach uses design of experiments to test design requirements against key design inputs, to define which features are critical.

CFC, partnered with profile tolerancing, simplifies a drawing and communicates key data points. It also helps the commercial and regulatory teams in developing costs and inspecting, measuring and validating each feature of a device.

The commercial team’s role in DFM
Commercial team roles include sourcing, commodity, purchasing and planning. For a successful product launch, these team members need to generate an accurate parametric cost model that takes into account “what-if” scenarios.

One series of “what-if” questions centers on critical features and how design changes may impact the bottom line.

Critical features often cost more than non-critical ones, and reducing the critical feature count helps drive down overall production costs. Understanding and examining the cost impact of these features are essential functions for DFM as it strives to balance expenses in production.

How DFM affects the regulatory team
While the FDA and EU establish device requirements, it is up to individual companies to define their approach to meeting these requirements.

Measurement and validation are built into the DFM process. With key data easily accessible, regulatory teams can more quickly review and approve designs against drawings, accelerating this vital step of product development.

To register for OMTEC and Lowell’s presentation, visit For a meeting at the show, email


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