Align Sources Early
Medical device manufacturing today requires OEMs to think ahead. It is important to consider the complete product lifecycle and use the upfront design process to identify and mitigate risks later in the product lifecycle that may impact the patient experience. Therefore, addressing sourcing and other supply chain management considerations as a product moves through alpha and beta builds to volume builds is a must. That said, it can be difficult to answer the question, ‘Where are we going to get our parts from?’ due to the sheer volume of sourcing options and wide variances in lead times and pricing. That’s why supply chain partners or sourcing engineers should be engaged early in the design process before functional architecture and block diagrams are completed. The right sourcing strategy takes into account availability, lead times, cost, and quality, and is top priority when it comes to securing parts.
“Before 2020, many engineering teams viewed the supply chain as part of manufacturing transfer on the back-end of development. Now, product development teams are driving more supply chain awareness early in the design phase, thinking more about multi-sourcing and how to have redundancy. The ultimate goal is ensuring healthcare providers around the world have the medical devices they need to deliver the highest level of patient care.”
— Kevin McFarlin, Design Engineering Director of HealthTech, Celestica
Manufacturers need to know where critical supply chain vulnerabilities exist within the design. These include components like power supplies and multiprocessors that are core to the function of the device. Critical parts also include elements that differentiate the product. As soon as the critical components are known, the right suppliers must be chosen carefully.
Consideration must also be given to passive components. Although considered commodity items, they could pose a struggle if they became scarce, delayed, or unobtainable. When sourcing such supplies, designers should have not just two alternates, but five or six to prevent the production line from shutting down due to the lack of a small component such as a capacitor or a resistor.
For optimal effectiveness, the design team should include the sourcing engineer and suppliers. Suppliers can contribute in a positive way to design by guiding engineers towards materials and components that are more stable than others. With such upfront awareness, designers can consider options such as incorporating dual footprints or using a series of processors of the same core but different variants.