Designing devices centered around patients is a goal espoused by nearly all device companies nowadays, as they aim to make products that people want to use and can incorporate into their everyday lives. Underscoring those products is often years of research and some in the industry have begun to think about how a patient’s needs can be incorporated into the R&D process.
This is especially true for companies working to design solutions for people with chronic diseases, according to a panel of diabetes industry members at T1D Exchange’s annual meeting.
“One of the big challenges with the current therapies for treating diabetes, insulin-requiring diabetes, Type I diabetes, is that they’re not designed for sustainable use from the actual real-world user,” said Jeffrey Brewer, president & CEO of Bigfoot Biomedical.
“How do I make it fit into a person’s life? How do I make it more compatible with all their other problems which they don’t want to be diabetes, with just their family, or their friends or their job. That perspective I think is really lacking,” Brewer said. “And it requires that you really think about things from the, every day I’m going to do it for the rest of my life. That’s a very different kind of thing from, ‘Just do this for the next two weeks and you’ll be all better.'”
The panel included Brewer; Anne Busk, global HEOR lead at Novo Nordisk (NYSE:NVO); Magaly Perez-Nieves, research scientist at Eli Lilly (NYSE:LLY); and Soren Skovlund, who leads Aalborg University’s patient-reported outcomes program and is chief patient officer at DrugStars.
Skovlund pointed out that industry and the regulatory landscape are changing, as both groups realize that patients can play a central role in designing and optimizing devices.
“We have a healthcare industry and healthcare technology development environment that is opening up more and more to partnering with the patient, if you will, people with diabetes and other conditions as well,” he said.
Many of the panelists noted that a patient’s ability to access medication is something companies need to consider when they’re bringing a product to the market.
“If it’s not affordable to the patients, then it’s not worth it anyway,” Busk said.
“Obviously we can get great medications approved, but if we don’t have access to those medications,” Perez-Nieves added. “If they are not accessible and affordable, we will not be able to use it.”
Regulators need to understand that it’s not always all about clinical outcomes, she said, noting that patient preferences should help determine a device’s or drug’s availability.
“Regulators are starting to acknowledge that all these preference meanings, satisfaction, perspectives of the patients actually also mean a lot,” Busk added.
Brewer pointed out that patient-reported outcomes can help device and drug companies understand how diverse a patient population is.
“We treat all patients of a given chronic disease category as if they’re the same. They should use the same tool, the same drugs, be treated by the same kind of doctor, and use the same therapy, and the world just doesn’t work like that. We’re all different,” he said. “Different things are important to different people, in different respects, and that includes chronic disease. There are some people that are willing to put it at the forefront of their lives and give a lot to it, in order to optimize their health. And then there are people who just simply refuse to do that. They are going to prioritize other things in their lives, and I think we should have solutions that meet the needs of both of these kinds of patients.”
As an example, Brewer pointed to the ongoing internal debate in the diabetes community over how to deliver data to people. Some people want a constant stream of data, as well as alerts when they aren’t doing well, Brewer said. Others don’t want the reminder of their disease and for those people, a constant stream of data isn’t ideal.
“We need to let people have what they need to be successful, because at the end of the day, the only measure of success is if a person uses it. If they’re not using it, it’s kind of like what I say about diets and exercise now. What’s the best diet or exercise regimen? The one you’ll do,” he added.
Patient-reported outcomes can be a useful tool in accelerating and guiding a company’s development and clinical research efforts, Skovlund noted.
“That patient report outcomes provide that research foundation through the clinical trials, that allows us to have a much clearer picture, even a prediction of the real world usage, and the real world applications, the real world acceptability of the treatments,” he said.
If regulatory bodies, industry members and payers choose not to reach out to patients as partners, they risk losing out on “all the understanding of how the specific medicine or the technology interacts with its surroundings,” Skovlund added.
Brewer said that while companies should strive to record patient-reported outcomes, they also need patient-observed outcomes.
“We need to be capturing all the data, and not just listening to what people say, but what they do,” he said.
“You can actually see that if you have the data, and you can design ways for them to be more successful. All these systems should be connected, all these systems should be gathering all this data and using it in a very quantitative way in order to drive the design future generations. If people aren’t using it, it should change.”