Deploy an Agile method in the design of digital medical devices
A patient-centered approach to digital medical device design has clinical impact and generates value by empowering the patient to participate in their own care, according to Jennifer Miller, MD, PhD, medical consultant, McKinsey & Co. Miller a spoken in the MD&M BIOMEDigital round table, “Principles of product design and development for connected devices”. During the session, industry experts discussed all aspects of agile product development and highlighted the benefits of involving and considering the needs and limitations of all users in the design process. medical devices.
In this agile method of product design, Miller said the first thing to do is define your problem and design, and identify your user. “You then develop your user journeys to really understand from end to end what the product you are developing will do,” she explains. The next step, she said, is to assemble an agile team to design the initial concept to be prototyped and tested with selected customers, incorporating their feedback to develop an unviable product, which is then presented to a more. large number of clients selected to incorporate their comments. to develop a product program. “Finally, you adapt that to live clients,” she said.
Since defects in medical devices can lead to death, safety is a major concern, she noted. Companies need to create a quality management system early on and throughout the product lifecycle, Miller said. It should also be taken into account that regulatory compliance should be appropriate based on the particular agencies that will dictate a product, and to identify potential cybersecurity risks and build in data privacy protections.
Panelist Alisa Niksch, MD, Pediatric Electrophysiologist and Medical Device Manager, Tufts Medical Center, spoke on the topic of design feedback and user adoption, sharing tips on how to practically use a strategy design to involve patients and clinicians in the device creation process. . Like Miller, Niksch said the first step is choosing a problem to solve, or a population to impact, that will guide regulatory decisions, including the pathways in which the device fits.
“There are a number of predicates, which is good news for many designers in terms of medical devices and biosensors,” she commented, “so definitely use them as a resource on how they’ve got it. conducted their studies and feasibility tests. good.”
She pointed out that clinical trials are an extremely important part of getting your product adopted by clinicians. “Doctors are a difficult audience; nurses are a difficult audience, ”she said. “We are very interested in regulatory channels; we are very interested in the accuracy of your data. We are also very interested in integrating 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 usable in these populations. To get more information on the needs, she suggested spending time with as many patients as possible, for example in a medical center where you can also get information from the doctors, as well as with family members. who might use your product at home.
Amy Bucher, PhD, Vice President, Behavior Change Design, Mad * Pow, shared her take on why behavior scientists are truly part of the digital health development process. “The key thing to think about is what makes [a product’s] significant effectiveness, ”she said, noting that the results, the results of using a digital health product, are the product of both effectiveness and engagement.
Bucher covered some behavioral model frameworks that could be used in behavioral design and experiment strategy, noting that they all have an engagement component. “How are people drawn to the idea of performing a behavior? And what do they need in their situation to maintain this behavior? ” she asked. “As we look at developing digital health products, I would say we similarly need to take that kind of lens and look for opportunities to enable people to exercise those psychological needs.”
Taking a holistic approach and bringing all of these perspectives together, Jaydeo Kinikar, VP, Virtual Care Offerings Management, Best Buy Health, said, “It’s really important to make sure you think holistically about customer needs – clinical, financial, operational, ”Kinikar says. “And not just a specific client audience, think of different clinicians, think of the end user, a patient and a caregiver.”
When Miller asked how to create a device or platform that is both secure and agile, Niksch replied that this is where partnerships with hospitals, medical groups and large healthcare systems can help, especially with telehealth technology. “And we’ve seen this already supported by the federal government with FEC grants that have gone to places like the Mayo Clinic, which has managed COVID patients at home,” she said.
“You really want to make sure that you are clear on [the] type of medical device, ”Kinikar said. Depending on the use case and type of data you collect as well as the information you drive, he said, a device may not need to be a fully Class 2 device.
The second important thing is to test a device early on in a clinical setting, Kinikar said.
“When you just think of that layer of engagement, the coaching, the support, the behavior change that comes with these types of devices, there’s a big benefit to being agile. One of the things we do know is that human behavior is incredibly context-driven, and as the context changes, having an agile software development method in play allows us to be responsive, ”said Bucher. “One of the best examples that I think we all know now is the COVID pandemic, where we suddenly saw a very drastic change in the way people were using telemedicine.
Mentioning the recent implementation of the FDA’s Center for Digital Health, Miller asked the panel what the changing regulatory scene could mean and if it could be an opening for young startups.
“I’ve noticed that small businesses are often reluctant to venture into areas regulated by the FDA because they feel like it’s very complicated,” Bucher said. However, she said understanding digital health has gotten more sophisticated and the process is getting a bit clearer.
“I think we’re going to see more and more ways to work with the FDA,” Kinikar said. “The pandemic has been a big breaking force to really open the doors, not only to the FDA, but to different vendors and payers and different industry players, because the barriers that we once saw as insurmountable, I think, are falling.
Niksch commented that the FDA is quite sophisticated with AI. “They understand the limits of it, but they treat it like any other technology, and they want data and they want a real verification process, much like any other software or medical device,” he said. she declared.
Closing the discussion, Miller asked about the challenges and successful strategies the panelists used to incorporate this user design approach.
Kinikar emphasized that it’s critical to incorporate the right kind of user research into an iterative design process. “And there’s no substitute for being in the field with clients, with patients, with clinicians, for that,” he said.
“We’ll do our formative research to understand the user’s context and what their motivations and goals are,” said Bucher, “and absolutely bring the methodology of design thinking to it. So not just usability testing once we have a prototype, but what we call desirability or utility testing, asking someone to think about us, whether it’s a product they’re interested in, does it fit your lifestyle, ”she concluded.
Niksch said the social determinants of health should be taken into account. “We’ve talked a lot about physical disability, physical limitations, but I also want to talk about the assumptions we make about language barriers, about the ability to understand how data is presented on a digital health platform.” She also said it was important to take note that accessibility to connectivity is not equal everywhere.
Miller summed up by saying that part of the beauty of this iterative work is that it can identify unmet needs and new solutions can be found. “You could develop a whole new strategy or a whole new device to solve a problem that you might never have thought of, and would not have done, if you hadn’t had this kind of research in your hands. disposition, ”she concluded.