Wearables have significantly grown in importance in healthcare, whether they’re products directed at consumers like FitBit and Apple Watch or devices used to track patients’ progress in clinical trials. But along with that growth, several important questions about their role in healthcare have arisen as well.
The breakout panel discussion, “Leveraging Wearables for Increased Engagement,” took place Tuesday at the ongoing MedCity ENGAGE conference in San Diego. The discussion, moderated by journalist Josh Baxt, brought together several key wearables experts: Withings Healthcare Vice President Alexis Normand; HonorHealth Chief Academic Officer Dr. Priya Radhakrishnan; and Jonathan Hawkins, senior vice president of business development, sales and marketing for Spry Health.
While the discussion touched on numerous topics, there were also several important takeaways.
Regulations haven’t kept pace with development
“When you have smart devices, you need smart regulations,” Normand said, in response to a question from an audience member about organizations’ experiences working with the Food and Drug Administration.
Most of the experience with the FDA has hinged on the question of whether wearables can measure activity, Hawkins said. But there hasn’t been as much attention paid to the analytics engine side of the equation, he said, adding that the agency doesn’t seem to have the bandwidth to handle such things. Yet, despite that perceived lack of bandwidth, Normand said the FDA is significantly ahead of its European counterpart, the European Medicines Agency. Furthermore, he pointed out, FDA Commissioner Scott Gottlieb has said there is an increasing need to factor in electronic data, not only from devices but from drugs themselves.
Indeed, last November, the agency approved the first ever digital pill, Otsuka Pharmaceutical’s Abilify MyCite, a drug for schizophrenia that includes an ingestible sensor to record that the medication was taken. The drug, which is planned for launch by the end of this year, was developed under a partnership between Otsuka and Proteus Digital Health, which last month said they would expand the partnership to develop more digital medicines.
And in September, the FDA approved the Apple Watch as an ECG device.
Normand also compared the US with his native France, saying Ethat while France’s healthcare system is less innovative and slower at adopting new technology, when it does so it is adopted in a highly centralized fashion.
Adoption skews toward the healthy and wealthy
Radhakrishnan pointed to a term doctors often use: “worried well.” This refers to people who perhaps have one or two chronic conditions or risk factors for them, but are otherwise well. That, she said, seems to be the main audience for wearables, along with patients who have chronic conditions that are otherwise well-managed. “But most of what accounts for cost isn’t there yet,” she said.
It is such people and those who are healthy to whom many wearables are geared, Hawkins said, but the vast majority of healthcare costs are driven by the chronically ill, thus creating a need for wearables that can address their needs.
One thing that needs to happen is that wearables have to be taken out of the mindset of consumer products and designed instead as medical-grade devices, Hawkins said.
User friendliness is crucial
A key consideration is in order to be effective, wearables must be out of sight and mind, Normand said. “If we’re serious about changing behaviors, we need to make them invisible,” he said. There is only a limited number of places from which data can be collected, such as the wrist and inside the shirt, along with sleep sensors on the bed or scales.
But visible or not, what might deter some users – especially the elderly. “If you think about a senior who needs that device, a lot of them can’t even put it on,” Hawkins said. For example, a wearable device may have great ability to deliver value to seniors may nevertheless face the barrier of their not possessing a smartphone or wifi connection that may be required to use it. “These devices that deliver a lot of value miss the mark because they create barriers,” he said. “It needs to work right out of the box – plug it in, put it on.”
Photo: Alaric DeArment, MedCity News