A Look at Medical Electronics Design and Assembly Challenges

Estimated reading time: 9 minutes

Tom Reilly: Sure. My name is Tom Reilly, and I’m the director of marketing and sales operations for Vexos. Vexo is a full service, high-mix, low- to mid-volume mid-tier electronics manufacturing services (EMS) provider, operating in focus market sectors such as: medical, industrial, semiconductor, automotive, safety, security and industrial internet of things (IIoT) markets. Vexos has a global manufacturing presence with two manufacturing sites in China, Shenzhen and Dongguan along with its North American sites in Markham, Ontario, and LaGrange, Ohio. All sites are ISO-9001 and ISO 13485 certified. We have more than 25 years’ experience in providing a high-level of electronic manufacturing services, value engineering solutions and global supply chain management services that supports all our sites. We are deeply involved with provisioning highly complex, fine-pitch electronics assemblies, electromechanical assemblies, full turnkey solutions and custom mechanical parts.

The medical and life sciences sector is about 15–20% of our business and we currently specialize in manufacturing a number of difference products such as; visual aid, monitoring systems, diagnostics and connectivity-type products. As we grow in this market sector, we continue to meet the needs of our customers through a range of offerings in manufacturing and engineering services. Apart from our electronic services, which include printed circuit board assembly (PCBA), sub-system assemblies, and full box-build product. Our engineering services include design for supply chain (DFSC), design for fabrication (DFF), design for manufacturability (DFM), design for test (DFT), and complementary development services.

It’s important to mention we work very closely with our customers and partners and some of the companies are world-renowned corporations, who rely on these high-level services. We also worked with smaller, localized companies to help develop and bring their products to market.

As I mentioned, we work very closely with customers and provide them with value engineering support in the early stages of product development, from quick-turn prototyping to new product introduction, right through to full mass production, whether that be localized within one of our North American facilities or one of our China facilities for a more low-cost, high-volume region. These facilities also give our customers the opportunity to launch products into the market as well.

Kaspars Fricbergs: I am the VP of quality for Vexos. I’m based in the Toronto facility, and I’m responsible for the coordination of the quality functions across the various Vexos locations. I’ve been with the organization and its predecessors for about 17 years now. I have a long background in quality in electronics and electromechanical devices, including experience in the medical realm as well. We’re ISO-13485 registered at all our manufacturing facilities, as well as ISO 9001 certified. In China, we are IATF 16949 registered in one of our facilities; and both of our facilities have ISO-14001 and OSHAS 18001 registrations as well.

Las Marias: Earlier on, Despina was telling us about her problems and challenges when it comes to the lab on a PCB. From your perspective as an EMS provider covering the medical electronics industry, what are some of the top challenges you’re seeing in this sector?

Fricbergs: There are a number of challenges associated with the field. I was about to say one of the top ones is the regulatory regime in medical devices. We are an EMS company, so we’re not design responsible, and we don’t do product submissions to the FDA; but there are a whole host of regulations surrounding the manufacture of the products that need to be met. Those are largely covered by the ISO 13485 registration, but there are also the regulatory regimes of the FDA and other local, jurisdictional regulations. In Canada, we would need to deal with Health Canada requirements as well for any products that would be marketed and sold in Canada.

The ISO 13485 certification largely covers the specific requirements that the FDA has outlined in their Quality System Regulation, 21 CFR Part 820, although there are some differences. You also have FDA regulations surrounding the use of software and the compliance of software, that’s 21 CFR Part 11. You have specific requirements for documentation, validation, traceability, validation of process, validation of software, medical device files, and medical device histories. All of that has to be in place to provide the level of assurance to regulatory authorities and to our customers that we produced the product properly according to the processes that have been defined. Some of those requirements go beyond and are different than those of other industries.

Another challenge that we often run into is simply the time to market. Often, customers can come with an immature design. It may not be manufacturable, so Vexos can help in those cases. We offer design for assembly feedback services and design for test feedback services, that can help make the products manufacturable and bring the product to market faster. Sometimes with new product launches, because our customers don’t have a strong view of the manufacturing process, they come with an idea, they may have a design that’s been provided that may not be manufacturable. Or they may not have explored all the regulatory regimes and may not be clear on what requirements they may specifically have for quality.

We’ll work with them on that, but again, a typical challenge is simply the time to market. Usually, when a design and concept have been firmed up and there’s some backing for it, the desire is to quickly get it out to market, or at least get it into the approvals stage from a regulatory point of view.

Those are some of the bigger challenges we have. Of course, we have to have a very strong eye on the product’s quality and make sure we’re complying with all the requirements and regulations in order to avoid any situation that’s going to affect our customers.

To read the full article, which appeared in the November 2018 issue of SMT007 Magazine, click here.

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