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.
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.
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.
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.
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.
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 www.omtecexpo.com. For a meeting at the show, email phil.allen@lowellinc.com.
To register for OMTEC and Lowell’s presentation, visit www.omtecexpo.com. For a meeting at the show, email phil.allen@lowellinc.com.
Great blog on medical device development- Nectarpd
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