Deploying an Agile Method in Digital Medical Device Design
Such an iterative approach to medical device design could help identify unmet needs and new solutions, shared an MD&M BIOMEDigital speaker.
April 27, 2021
A patient-centric approach to designing digital medical devices delivers clinical impact and drives value by empowering the patient to participate in their own care, according to Jennifer Miller, MD, PhD, physician consultant, McKinsey & Co. Miller spoke in the MD&M BIOMEDigital panel discussion, “Design & Product Development Principles for Connected Devices.” During the session, industry experts discussed all aspects of agile product development and stressed the benefits of involving and considering the needs and limitations of all users into the design process of medical devices.
In this agile method of product design, Miller said the first thing to do is to frame your problem and design, and identify your user. “You then develop out your user journeys to really understand in an end-to-end manner what the product that you are developing is going to be doing,” she explained. The next step, she said, is assembling an agile team to design the initial concept to prototype and test with select customers, incorporating their feedback to develop a minimally viable product, which is then introduced to a wider set of select customers to incorporate their feedback to develop a product program. “Finally, you scale this to the live customers,” she said.
Since defects in medical devices can lead to death, safety is a top concern, she noted. Companies need to create a quality management system early on and throughout the product life cycle, Miller said. Other things to consider are that regulatory compliance should be appropriate based on the particular agencies that will dictate a product, and to identify possible cyber security risks and build in data privacy protections.
Panelist Alisa Niksch, MD, pediatric electrophysiologist and medical device executive, Tufts Medical Center, chimed in on the topic of design feedback and user adoption, sharing tips on how to practically use a design strategy to engage patients and clinicians in the device-building process. Like Miller, Niksch said the first step is choosing a problem to solve, or a population to impact, which will guide regulatory decisions, including what pathways the device fits into.
“There are quite a few predicates out there, which is good news for a lot of designers in terms of medical devices and biosensors,” she commented, “so definitely utilize them as resources of how they conducted their studies, and their feasibility trials as well.”
She stressed that clinical trials are an extremely important part of getting your product adopted by clinicians. “Physicians are a tough audience; nurses are a tough audience,” she said. “We're very interested in regulatory pathways; we are very interested in your data accuracy. We're also very interested in integration into our electronic health records and HL7 standards, ” she explained.
Design goals for patients should also include disability access and physical comfort to make the device versatile and workable in these populations. To get more information about what the needs are, she suggested spending time with as many patients as possible, such as at a medical center where you can also gain insights from physicians, and also with family members who might be using your product at home.
Amy Bucher, PhD, vice president, behavior change design, Mad*Pow, shared her perspective on why behavior scientists really belong in the digital health development process. “The key thing to think about is what makes [a product’s] effectiveness meaningful,” she said, noting that outcomes, the results of using a digital health product, are the product of both effectiveness and engagement.
Bucher covered some frameworks in behavioral models that might be used in behavioral design and experience strategy, pointing out that they all have an engagement component. “How do people become attracted to the idea of performing a behavior? And what do they need to have present in their situation in order to sustain that behavior?” she asked. “So as we look at developing digital health products, I would argue that we need to similarly take that sort of lens and look for opportunities to let people exercise these psychological needs.”
Taking a holistic approach and bringing all these perspectives together, Jaydeo Kinikar, vice president, virtual care offering management, Best Buy Health, said: “It is really important to ensure that you are thinking holistically about customer needs—clinical, financial, operational,” Kinikar said. “And not only about a specific customer audience, think about different clinicians, think about the end-user, a patient, and a caregiver.”
When Miller asked how one would create a device or platform that is both safe and agile, Niksch answered that this is where partnerships with hospitals and medical groups and large healthcare systems can help, especially with telehealth technology. “And we've seen that already supported by the federal government with some FEC grants that went out to places like the Mayo Clinic, who managed COVID patients at home,” she said.
“You really want to ensure that you're clear about [the] type of medical device,” Kinikar said. Depending on the use case and the type of data you are collecting as well as the insight you are driving, he said, a device might not need to be a completely class 2 device.
The second important thing is to test a device early on in a clinical setting, Kinikar said.