Most see design for manufacturing (DFM) as an iterative process between revisions rather than an active practice of aligning the design and manufacturing ends of board production. As board designs become more intricate and costs rise, it’s becoming more apparent that product development needs optimization from the get-go to meet tight time-to-market deadlines. Compounding this further is industry requirements, of which medical device contract manufacturing is among the most stringent. Working alongside an experienced contract manufacturer (CM) can give designers a leg-up on pre-production design work that segues seamlessly into a finished PCBA.
Medical Device Contract Manufacturing: Attributes to Weigh
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Medical Device Contract Manufacturing As a Cost-Saver
Medical device contract manufacturing has to adhere to higher standards due to the inherent danger to users who rely on the devices’ regular operation. The difficulty of manufacturing medical devices that balance industry requirements against cutting-edge designs can boil down to the differences in DFM. As with any third-party contract, communication is vital: at an early process, designers and manufacturers will want to set a meeting to determine the scope of the project and the impact on the design rules. Deciding when to contact a CM will also be essential in the design process, as the needs (and expectations) differ considerably between prototyping and production-level builds. While the general expectation is that most companies will perform the engineering work in-house, a CM can offer additional engineering acumen emphasizing DFM.
New product introductions (NPIs) require even greater design scrutiny, and there is a tendency for those in the industry to view contract manufacturing solely through the lens of cost instead of quality. Design teams need to understand the full weight of NPI manufacturing: it’s exceedingly rare for designs to pass from designer to manufacturer without needing some DFM adjustments. Furthermore, it’s much easier to adjust designs to accommodate changes during the prototyping phase (when volume commitment is low) rather than after production has scaled up. If anything, it’s far more valuable for designers to work with a quality CM at the early stages of design (where engineering and manufacturing knowledge is crucial) than during mass production.
The CM ultimately provides field expertise that frees product development teams to focus solely on the design parameters that draw out the best performance from the device. In addition, because manufacturers are experts in DFM, they can tweak designs to meet the necessary attributes. While most designs will coalesce into a product with high manufacturability and cost-efficiency out of necessity, interim designs over the lifetime of development can instead gravitate towards testing, assembly, or other significant benchmarks in the manufacturing process. Production ramp-up proceeds smoothly as all aspects of the realized design have been thoroughly “tested” before deciding upon the final revision.
Evaluating a Medical Device CM
Turning to a CM has many benefits, including the ability to lean on a partner with an established history of quality. In manufacturing, quality has a deeper meaning than the ability to match design specifications: compliance of devices after leaving the manufacturing floor must adhere to several standardized indicators to ensure manufactured products meet minimum requirements. This constraint can be a double-whammy for design-focused teams that wish to handle manufacturing in-house, as there is an additional cost beyond the considerable expenses of equipment, maintenance, and staffing, resulting in an ongoing drain on resources if production volume is low.
Communication reigns above all else when working with medical device manufacturing. This axiom is valid for the relationship between the manufacturers and designers and the CM’s quality standards as outlined by directives like ISO 13485. Partnering with a CM requires a thorough vetting for suitability to the goals of the project; designers should frame their investigation around a few key considerations:
- Engineering and manufacturing capabilities – While these factors often go hand-in-hand, a CM may not necessarily possess the requisite engineering knowledge to noticeably impact the design outside DFM. Designers may desire an additional engineering resource to check the circuit parameters or better understand the translation between design intent and DFM realities.
- Quality management system (QMS) – ISO 9001 is an interesting standard in that it doesn’t always stipulate how manufacturers need to meet certain quality requirements, providing CMs with ample leeway for implementation. More germane to medical device manufacturing is ISO 13485, which outlines critical topics such as material/component traceability for auditing purposes. Together, these two standards comprise the bulk of a CM’s QMS, providing the scope of manufacturing precision and repeatability.
- Original equipment manufacturer (OEM) – Working alongside a CM at the outset of design prevents frustrating cases where a producible design is unoptimized, causing issues during a scale-up to wider production. Not every device will need high volume lots, yet a late-stage revision to a design to improve manufacturability can imperil project deadlines and budgeting.
Design teams new to the process will want to consider all their possible avenues before partnering with a CM. Begin research with a service-quality-cost focus; ranking different CMs in this manner can yield a semi-quantitative score denoting appropriateness for the current project. However, always follow a bid from desired CMs with an in-person tour to assess compatibility (both in design specifications and generally).
Your CM Can Diagnose and Treat Manufacturability Issues
Medical device contract manufacturing is similar to general contract manufacturing: designers will still want to collaborate early and often with their CM to reduce development time and cost while streamlining the process. However, the additional strain of adhering to rigorous industry requirements exclusive to medical devices can further complicate product development, especially for design teams less familiar with DFM production. Here at VSE, we’re a team of engineers committed to building electronics for our customers while adhering to the high standards set by the industry and our tireless work ethic. Along with our valued manufacturing partners, we’ve been bringing life-changing and life-saving innovations to the market for over forty years.
