Issue link: https://iconnect007.uberflip.com/i/1047182
20 SMT007 MAGAZINE I NOVEMBER 2018 tive as an EMS provider cover- ing 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 manufac- ture of the products that need to be met. Those are largely covered by the ISO 13485 registra- tion, but there are also the regulatory regimes of the FDA and other local, jurisdictional regu- lations. 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 differ- ences. You also have FDA regulations surround- ing the use of software and the compliance of software, that's 21 CFR Part 11. You have specific requirements for documentation, vali- dation, traceability, validation of process, vali- dation 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 accord- ing 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, custom- ers 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 feed- back services, that can help make the prod- ucts manufacturable and bring the product to market faster. Sometimes with new product launches, because our customers don't have a strong view of the manufactur- ing 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 chal- lenge 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. Moschou: I agree. Even with the medical devices that I am involved with, FDA approv- als are extremely important and cause most of the delays in achieving commercialization. It's extremely important to have absolute control of the repeatability and reliability of the devices because we are talking about medical appli- cations. Even tolerances that may be tolerated in non-medical applications, in our case, may not be acceptable, especially for the biomed- ical diagnostic devices that I work with. The highest degree of cleanliness is critical. Fricbergs: Yes, and those are all part of the FDA and ISO 13485 regulations. When you're looking at sterlization, cleanliness, control of contamination, those are all aspects from a manufacturer's point of view that we have to have the appropriate controls over. Vexos typi- cally does not deal with invasive or implant- able medical devices. We typically operate for Kaspars Fricbergs