Medtronic employs their DRM program (Design for Reliability and Manufacturing), which trains engineers and personnel in the R&D, product development and design quality departments. Through the program, engineers create prototypes to confirm whether a design can be manufactured in a capable process that adheres to budgets and timelines.
“We created a product development center, and once we have a draft, we try to make it here first,” says German Candia, Manager for Design Quality Engineering at Medtronic. “We try to catch issues around tolerancing and manufacturability early instead of later, before we transfer that to the supplier. That’s a new initiative this year.”
The tools within the DRM program allow engineers to account for feature size and inspection by performing MSA (measurement system analysis) and SPC (statistical process control) from the supplier to ensure that they are capable of performing the manufacturing processes.
“We don’t know how hard the design is to measure until we perform MSA, also known as a gauge R&R, typically,” Candia says. “Once we are able to measure [the features in the design], we will proceed to see how capable the process is in manufacturing.”
Input on the manufacturing considerations mentioned above can come from a variety of places, whether internally from colleagues within your organization, or externally from your manufacturing partners.
Ask your manufacturing partners the right questions before the design is frozen, like what manufacturing processes they employ, and how they manufacture similar products.
“It’d be very good to know what their typical process flow is for a similar product, because if you can leverage what they have, that’s typically your best way to drive cost down,” says Ken Trimmer, Senior Director - Chief Engineer, Knee at Stryker Orthopaedics.
Candia also emphasizes the importance of ensuring early on that your supplier is capable of meeting your manufacturing requirements.
“One challenge with the supplier is, yes they may be qualified, because they have a quality system, but the capability is not always there,” he says. “There is a lot to do before they even get the manufacturing transfer; they need to qualify the processes or the machine process for us. Suppliers are sometimes behind our requirements. When you start working with a supplier and realize that they may not be able to meet these requirements for MSA or capability, or sometimes quality, that’s when things get hard.”
Ultimately, you have to know what you want your product to do, Trimmer says.