Mark Shortt

Many of today’s medical devices carry with them a substantial amount of product development risk. From the beginning of the design through the product’s use in the field, there are pitfalls to avoid and wisdom to follow to ensure a successful product. As a designer of medical devices, how do you know you’re on the right track with your new project? And what are some of the common pitfalls to avoid?

First, it’s best to make sure that your design idea is based on a real clinical need—one that’s acknowledged by many physicians, as opposed to just one or two that you may know. You don’t want to be the guys who believe they’ve come up with a great idea for a device and end up shopping it to anyone who will listen before you’ve listened to what they need most. So yes, basing your work on an unmet clinical need that you’ve uncovered through consistent, studious  interaction with physicians, surgeons, caregivers, and other stakeholders within the medical community is a great idea.

How do you do that?

If you really want to develop a better surgical device, you’ll need to not just communicate, but have a considerable amount of meaningful interaction with the surgeons who will be using the device. That means having face-to-face interactions to learn the nuances of how they work and how they feel about different tools. The opportunity to see their facial expressions when they use an instrument or react to its efficacy in certain situations is valuable, but it’s not something you can generally glean from a phone conversation.

And yes, it’s good to think about who your stakeholders are and invite them into the discussion at the start. In the medical device realm, stakeholders typically include clinicians, patients, rehabilitation and support staff, caregivers, and family members. Payers, engineers, suppliers, and distributors are also part of the mix. A good rule of thumb is that stakeholders include not only the user, but everyone who has some personal connection to the product as it goes from design to manufacturing to use in the medical field.

Leaving out stakeholders is bound to create problems down the road. Many products have been happily designed without inviting everyone to the table, only to end up not making it to market. Others have made it to market but haven’t done nearly as well as they could have if their designers had thought a little bit more about who would be affected by some aspect of the product.

At the BioMEDevice Conference in Boston in May, the message that was heard most loudly and clearly was the necessity for designers to always have the patient in mind throughout the design, development, and manufacturing processes. It’s never a good design if it fails the safety test, or if a misguided decision leads to putting short-term profit over the health and safety of patients and other stakeholders. The best medical products are designed and manufactured with the safety, well-being, and best interests of all stakeholders and, ultimately, the patient, in mind.

A good way to get there is through use of human-centered design. A proponent of the approach who works for a major medical device OEM told D2P  that human-centered design is about keeping the people that you’re designing for at the forefront of your process, and using that as the base from which to look for new opportunities to capture value. It’s an iterative process that starts with building empathy, and that’s done through a variety of different ways to understand what your users’ needs are. He also contrasted it with other approaches, such as market research and basic user-centered design.

Whereas market research is often about quantifying specific areas for opportunity, human- centered design is more about understanding the people that we’re designing for on a very empathic level, so that we can make good decisions when the answer isn’t spelled out in front of us, he said.

By way of analogy, he said that one of the most successful products of the last 100 years is, arguably, the iPhone.  But if someone asked you in 2002, or 2005, what your number one problem for your cell phone was, you wouldn’t have said, “It doesn’t surf the internet.” You would have said, “It doesn’t have a long enough battery; I want the battery to last longer.”

“And so, if you use the current model of thinking as the only lens by which you look to improve, you’re doing evolutionary work,” he said, as opposed to truly innovative work.

And whereas user-centered design typically looks at a workflow, a human-centered design looks at the emotional journey, and the needs in the jobs that a person must satisfy as they go through a given workflow. Instead of using the solution as the framework, the human is the framework. “By putting people at the forefront of the process, it just gives you a little bit more opportunity and flexibility to look for new ideas as they emerge.  It allows for just a wider spectrum of concepts,” he said.

Another way of looking at is that human-centered design takes user-centered design to another level. A basketball coach who knows, technically, what a play should be and what the players should be doing to execute the play might be using a user-centered strategy. But if the strategy takes into account his or her knowledge of the individual people involved in those plays—the nuances of their personalities and their abilities, for instance—the coach might be said to be using more of a human-centered approach.

Finally, a good design strategy today for medical devices will incorporate cybersecurity measures from the very beginning and lasting throughout the lifecycle of the product. The very nature of today’s products demands it.

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