Product safety must remain a primary consideration from conception to final production in every industry, though adhering to these standards is more critical in some industries than others.
If a part or circuit fails in a cell phone, the worst consequence is typically that the manufacturer issues a recall (Samsung's Galaxy Note7 debacle notwithstanding). If the device in question is a motor inside an insulin pump or the shielding in an X-ray machine, however, the ramifications can be much greater. In truth, they might be life-threatening.
Functional safety remains the gold standard approach in design and manufacturing. In the North American market, TÜV SÜD's Adam Menzies stands at the forefront of this effort, as our Program Manager for Functional Safety and Audit Team Manager for Active Medical Products. With a B.Eng. (Hons.) in Electronics and Electrical Engineering from the University of Edinburgh, Adam got his start at a medical device manufacturer out of Scottsdale, AZ.
At that firm, he rose to the position of Vice President of Product Development, with overall responsibility for engineering, manufacturing and quality assurance. This background in designing, building and overseeing precisely the kind of devices he now certifies from a functional safety perspective makes him well-placed to expand TÜV SÜD's footprint in the NAFTA region.
"My background is actually on the design side," Adam says. "We designed small X-ray machines, and I started as the fifth or sixth employee of a startup. When I left as a VP, there were 105 or 106 people."
Fundamentals of functional safety
The name gives some indication - but how exactly does functional safety differ from a standard or conventional safety approach?
"Functional safety is well established in the transportation arena, where they have mature standards that have evolved over 20-plus years. It is really an emerging standard in the medical world, where we're talking about how it applies specifically to medical devices," Adam says. "Functional safety is a top-down approach - it focuses on the functions of the device, how hazards arise, taking a more holistic view. If we get involved at an early stage, we are able to ensure that the engineers are designing a safe product up front. We look at the concept of what they're about to design, and ensure that it'll result in a safe design at the end. The second part is the more hands-on, in the lab stuff - before producing the first true prototype, we take the product and test it to ensure the safety features work correctly."
The technical methods involved in functional safety certification may vary from device to device - after all, the specific, functional safety concerns for a pacemaker differ drastically from those for a defibrillator or a dialysis machine. The core concepts, however - top-down evaluation, moving from overall function to specific components, investment in design and the principle of 'fail early, fail cheap' - remain the same.
Implementation in the medical arena
The ever-increasing sophistication of medical devices demands higher and more rigorous standards for manufacturing and operational safety. The International Electrotechnical Commission's 60601 standard and the European Union's Medical Device Directive (MDD), along with collateral rules, demand that certain measures be implemented for any device that isn't inherently safe in its function.
Where potential consequences include severe injury or death, it's necessary to employ a single-fault assessment. Effectively, the complete failure of one safety mechanism, which on its own could imperil the patient or user, must be covered by another failsafe. The functional safety approach looks to implement these measures at the beginning of the design process. They must be fundamental, rather than an afterthought or an add-on in the debugging or prototyping stage.
The relevant approaches differ. In some devices, for example, the control measure might be an automatic shut-off system. However, this approach could be wholly inappropriate for another class of devices, where any interruption in function might imperil the user: for instance, in the case of a heart-lung machine.
Market and regulatory forces incentivizing functional safety
In the first quarter of 2017, the EU is expected to approve its new Medical Device Regulations, replacing the existing MDD that governs the industry within the EU. Included in the new language is a segment regarding device certification in functional safety, compelling both manufacturers within and outside the economic region to seek these standards when marketing devices to Europe.
"TÜV SÜD's kind of blazing the path on this topic," says Adam. "The strategy of our competitors is typically to lean on the general functional safety practices that come from the automotive and rail industry. TÜV SÜD's engineers are working on the specialized medical device side of things."
With a large team of engineers already working in Germany on the global market for functional safety certification, the resources are already in place to deal with these new regulations. Overall, the market for functional safety services tied to the medical device manufacturing industry is projected to grow approximately 7.3 percent from 2017 to 2018.