What keeps a medical device engineer up at night? Last month, I posed that question on LinkedIn and received several responses. Since then, the thread turned into a lively discussion, which hammered home the fact that working in the medical device can be stressful.
Safety. "My greatest fear, over and above everything else, always was that my supervisor would tell me to see our legal counsel because someone died when one of the products I had designed failed," says Michael Lubov. "What terrified me was that the failure had been caused because I took a shortcut in the design."
"I was constantly bringing home technical problems that I was trying to solve," says Paul Maher, who later explains that the stress level of an engineer working in the device space tends to be higher than in equivalent consumer industries. "You have a live or die attitude about every decision you make."
"What you don't know that you don't know is always a danger, no matter what you design," says Jerrold Shapiro. "There's a tendency to partition the knowledge required to develop a useful medical device, and to assign responsibility for knowing the anatomy, physiology and pathophysiology to the physicians associated with the company."
Uncertainty / Inflexibility. "This is an inquiry I've made throughout the industry and though the specific answer may vary, the common theme is uncertainty," says Bill Acevedo. The healthcare landscape is quickly changing while device companies are forced to redefine their business strategy. "My opinion is that the industry was either reluctant to change or concerned that the ability to change is stifled by the regulatory environment," Acevedo says.
Still, the medical device industry in some ways can be characterized by more certainty than pharma, where, as Jerrold Shapiro explains, "perhaps one in one hundred drug candidates becomes a viable product."
He adds: "the bioengineer has fewer variables to deal with and a higher probability that her work will result in something useful and used. While juggling all this knowledge is not easy, neither is it so worrisome as to keep us up at night."
Change Aversion. Acevedo elaborates on the point above, stating that "[f]or a medical device company to thrive, they will need to compete effectively for [...] new customers with better, faster, cheaper products." This goal has become standard operating procedure in most other industries.
Verification and Validation. "Regulation can be frustrating, but it's the poorly written ones keep me up at night (or at least the ones that I can't seem understand," says Patrick Miller. "Regulation is needed, however the current implementation is the debate as it seems to slow innovation."
Conflicting Demands. There can be a balancing act between medical device companies' profit-driven management style, which can entail cost and time pressure, and a medical device engineer's personal motivation drawn from compassion to help patients.
Working in the device as an R/D engineer can mean worrying about everything from design for machinability to IP concerns while trying to live up to the "wild and ambitious ideas that surgeons approach us with," says Ramy Zaki. On top of these disparate demands, engineers must contend with budget constraints and aggressive deadlines that "ensure everybody in the company gets their quarterly bonus for when the product gets to market!"
On a similar note, Tony Green points to the "relentless drive to reduce cost by any means necessary while at the same time maintaining the innovation level needed to support the future medical device requirements of our aging population."
Chuck Vecoli, PMP, has a slightly different take: "it is my opinion that any engineer worth their salt is up at night wondering if they were given the right requirements!" He clarifies, pointing out how vital it is the engineers understand the ultimate standards and regulations involved and all of the user needs for the end user. Not understanding the requirements can lead to recalls, he observes.
Working with end users--or lack thereof. Lee Balaklaw, MD points out that many engineers facing the uncomfortable prospect of having end users, frequently clinicians, critique their work. "Getting end users involved and consulting them often seemed to resolve or fine tune ideas early in the process saving a lot of reengineering time," he says.
"Feature creep was a major issue that super users wanted but the bulk of the end users did not, and always had to be kept in mind under the motto of keeping it simple," Balaklaw adds.
While working with end users can prove challenging, so can lack of access to them. "For example, if I'm designing a new TV/cell-phone/car, I can see the person next to me use their phone and understand what features they use/struggle with," says Patrick Miller. "If I'm designing the next medical device, I am often not even allowed in the same building (hospital/home) to observe my product being used."
Still, the lack of customer access to customers can be treated as an advantage by the medical device industry. "The customer doesn't choose the devices, know their cost or even have an opinion on its need in most cases. This provides the company with a layer of immunity in the public eye if and when things go wrong. In the consumer space a brand can be ruined and dedicating efforts towards quality, safety and value are paramount to survival," says Bill Acevedo.