Devices & Diagnostics

Walk through the med device design process from brainstorming to manufacturing specs

The world of healthcare has sometimes been slow to pick up on forward-thinking medical device design (not just strong science and technology) as central to a product’s success. Cambridge Consultants is a design firm based in the UK with big presence in Boston and a host of big-name pharmaceutical and medical device clients. Matthew D. […]

The world of healthcare has sometimes been slow to pick up on forward-thinking medical device design (not just strong science and technology) as central to a product’s success. Cambridge Consultants is a design firm based in the UK with big presence in Boston and a host of big-name pharmaceutical and medical device clients. Matthew D. Allen is the director of drug delivery there. He said medical design and healthcare design really have one guiding principle: usability.

“You can design a device so that it works great, but if you put it in the hands of patient and they use it wrong and hurt themselves . . . you’ve achieved nothing.”

Even from the idea’s infancy, the design team must adhere to the strict regulatory requirements — the main thing that differentiates it from consumer design. The design process is slower-going because of the required safety testing and so forth, Allen said. The other main difference between device and consumer design is the investment. Although a design firm will bill about the same for either–designers, engineers, etc.–because medical devices must go through millions of dollars worth of trials and be used on humans, it ups the ante. The medical device clients “have behind them huge investments and huge amounts of risk in that investment,” Allen said. A failure isn’t as easily brushed off as in consumer products: “If you fail, your investors are going to know about it.”

Though Allen said experienced design and engineer teams can handle most of the process with a detailed brief from the client, he pointed out “the most successful” projects are collaborations. With that big of an investment into a device, it makes sense for a medical device company to put in the time getting to know the design.

With those pressures in mind, once a client has come to Cambridge with a “user need” (i.e. an idea for a device they need but does not yet exist), the design firm goes straight to the patient population it targets and the caregivers who will be prescribing or implementing the device. “That forms the starting point for the kind of engineering requirements,” he said.

Next comes what Allen calls “the most fun part”: the conceptual phase. “A bunch of people coming up with new ideas to solve tricky problems — everyone loves that.” A team works to come up with many potential concepts for device design; then they establish criteria to judge those concepts, Allen said. Finally, they whittle it down to one or two.

Then comes a system architecture — the step in which the designers figure out how it will do all the things it will do and how all the different working parts and needs will interact with each other. A 3-D version may be brought in. It helps “identify any complexities you might need to solve.”

Finally, the design firm designs specifications for the manufacturer — the most challenging, “stressy” step. “You specify every critical dimension on those components. A relatively small component you could hold in your hand might end up with 40 dimensions that need to be specified. . . . It’s where you spend a lot of money and you have to get things absolutely right.”

Once the medical product has left the design firm’s doors, it will enter its clinical trials phase. Then, the real pressure’s on for the technology to perform.