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Why You Should Engage Suppliers in DFMEAs

Successful design and manufacture of an implant requires that everyone involved, including your contract manufacturer, is familiar with the product and its components. Autocam Medical Account Managers Michael Spencer and Morgan Taylor are experiencing more conversations during the design for manufacturing (DFM) phase, and some OEMs are even sharing their Design Failure Mode and Effects Analysis (DFMEA). This early collaboration is desirable, because it allows OEMs to identify manufacturing issues and cost efficiencies earlier in the process.

We asked Spencer and Taylor three questions about working with OEMs.

What trends do you see with OEM customers asking for implant and instrument product development assistance?

Spencer and Taylor: One of the biggest trends from OEMs comes in the form of DFM or Design for Manufacturing input. We see OEMs requesting input well in advance of releasing final prints, not only to seek GD&T (Geometric Dimensioning and Tolerancing) advice, but to help in designing products to be more efficiently manufactured. Some customers are willing to share DFMEAs, which also aids in the development of proper process FMEAs on our end. This practice not only benefits the OEM, but the supplier as well. By partnering in the early stages of development, OEMs can launch a product at a lower risk of encountering manufacturing challenges once released. The side benefit for the OEM is the ability to identify cost drivers at the front end of the project.

What best practice can device companies implement to ensure that outsourced product development and manufacturing are on time and within budget?

Spencer and Taylor: With device companies working to adapt to new validation and PPAP (Production Part Approval Process) requirements, the following are several key items to ensure that the project launches on time and budget:

• Partner with a supplier in the early stage of development
• Establish a well-defined timeline (Establish gate reviews with milestones)
• Clearly communicate all deliverables – validations, capability study, prototypes, etc.
• Conduct regularly scheduled (weekly) team meetings to ensure that communication is aligned and gate reviews are conducted from the concept to launch

What question do you wish your device company partners would ask about the product development process? Why?

Spencer and Taylor: As OEMs start to include suppliers earlier in product development, engage the supplier in the DFMEA process to help everyone understand the product’s (surgical procedure) use and risk assessment rationale. Many times, development teams are looking for input from suppliers, although very little input is being provided from a DFMEA standpoint. If the product development team is transparent with design details and intent, the supplier has a better understanding to properly prepare the PFMEA (Process Failure Mode Effects Analysis). A complete and transparent collaboration will result in a clear and purpose-driven product launch.