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July 11, 2019 09:00 AM

Connected devices push medical industry

Kyle Brown
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    Kyle Brown, Rubber & Plastics News
    Bill Betten talks about the future of digital health and how it will impact medical devices at the Healthcare Elastomer Conference in Schaumburg, Ill.

    SCHAUMBURG, Ill.—The future of health care means a focus on design for consumers and collection and management of data, said Bill Betten, president of Betten System Solutions.

    He talked about the growth and changes of the medical device market in his presentation "The Evolution of Digital Health" at the Healthcare Elastomer Conference in Schaumburg.

    Betten has an industry background as an engineer and in technology and product development at firms such as 3M, Honeywell and Nonin Medical, but he led into his view on the health care industry from his own recent experience as a patient. Wearing a hat, Betten talked about how he was recovering from a surgical procedure in which a non-malignant, tennis-ball-sized mass had been removed from his head.

    "The surgery went well and I'm here," he said. "As someone who is very knowledgeable in the industry of developing products, one of the things I wanted to mention was the human factor in testing devices."

    Betten looks at digital health as "a convergence of medical devices with connectivity and consumer technology, he said. That covers concepts such as wireless medical devices and mobile medical apps, all the way down to software as a medical device and cybersecurity. He recalled back to his work at 3M about 30 years ago, in which his team was working on technology to be able to beam images off of aircraft carriers with million-dollar machines, rather than fly people in and out of battle areas.

    "Fast forward to my Nonin days, and we're dealing with $300 oximeters and cell phone technology for Bluetooth," Betten said. "So in 25 years, we went from that to that, and who knows where we're going to be in the future."

    According to Betten, 55 million Americans will be age 65 by 2020, and "Baby Boomers here aren't going to age gracefully. We don't want to age in the way that our parents are." He talked about visiting his 87-year-old mother and how he's looking at newer technologies to help her age in place, as well as working with elder-assisted living homes to work on integration of those technologies.

    Chronic diseases also are on the increase, with the top seven of cancer, diabetes, hypertension, stroke, heart disease, pulmonary conditions and mental illness worth an impact of $1.3 trillion annually according to a 2007 study by the Milken Institute. Those diseases make up 75 percent of health care costs, Betten said. That cost will rise to $4.2 trillion in treatment costs and lost economic output by 2023.

    "Things like diabetes, which would've been a death sentence 30 years ago, now you can manage and you can deal with," he said. "In certain instances, things like cancer can become a chronic condition that you fight and you work on and continue to live with. So we're living longer with diseases that previously would've killed us."

    Home care growth

    Providers are starting to be paid based more on outcomes, rather than just the fact that the procedure is done, he said. There's also a shortage of qualified health care professionals as the group that needs care grows.

    Betten shared a graph from Intel Corp. Center for Aging Services Technologies showing that as medical care becomes more acute, cost increases. Home care and residential care cost less and show an improved quality of life, he said.

    "This shows how the cost changes and shift in health care is really helping the people to move out of the really specialty areas and live at home, live independently as they age or as they deal with chronic illness," he said.

    As technology advances, patients benefit from being able to be a more active part of their own health and treatment, he said. For example, diabetes care has changed drastically over time.

    "A few years ago, I had led a study on IP and technology involved in diabetes care, and it's been wonderful to watch where it's come to," he said. "From injecting yourself, measuring and injecting to now, glucose pumps. Perhaps someday, the artificial pancreas."

    There also are more options for real-time support, such as using phone apps to help monitor health, he said. Care providers also benefit from enhanced ability to monitor patients' recovery, taking in an increase of patient health data through multiple devices.

    Medical device manufacturers have greater access to more real-world evidence and responses to care, he said.

    "Design teams at the companies now and the people selling the product are required to track what happens," he said. "How are the devices performing in the field? Where are they? What's going on with them? It speeds development of new products that can gain coverage and pricing for it."

    Medical device trends

    The Internet of Things is a big part of the change in medical technology, he said. With additional sensors and inputs using cloud storage, there's more patient data available and new ways to gather it than before. It also allows for a wider range of users, as opposed to just hospitals. Surrounding family and others can be care providers with new medical technology as well.

    The medical market growth and digital health market are expected to grow from $41 billion in 2017 to $158 billion by 2022, according to research by the Deloitte Center for Health Solutions, he said. Expansion is expected across medical devices, systems and software, technology and services.

    "This is an opportunity for the medical device guys, people that I kind of represent and work with and help develop. Systems and software will be almost as big in terms of growth of technology and services," Betten said.

    Medical device service category trends show that 65 percent of those devices will go into monitoring services, according to PricewaterhouseCoopers analysis. Another 15 percent will go to diagnosis and 10 percent to treatment, Betten said. Of the amount dedicated to monitoring, 71 percent will cover independent aging, and 29 percent will go to chronic disease management and post-acute care.

    One of the biggest impacts on the medical device design business for the last four decades has been the evolution of who is providing care, Betten said. New products have to look at the potential of change in who the clients are. Modern device users aren't just hospitals or even patients, but sometimes also surrounding family and others.

    "It used to be that our devices were used by professionals. Doctors and nurses, and you built devices that stayed the same year after year because if you touch them, they'll not know where the buttons are anymore or where to look for them," Betten said. "Now we've got parents, we've got kids, we've got other people starting to use that technology. These are just some of the things that impact med device development differently than consumer (devices)."

    Devices in a consumer space also move more quickly than in the medical segment, he said. While two years is an old age for a consumer device, medical devices can take 3-5 years to develop from scratch before they even reach the market. A medical device's product longevity also can reach between 7-15 years with support going even longer, compared to the shorter lifespan of a consumer device. Medical devices require a more specialized user interface.

    "Medical devices are one of the few areas that you can build a product, and the building materials' cost has very little relationship to the price of the device for a bunch of reasons, not the least of which are regulatory and legal issues," Betten said.

    Reliability of a medical device also is vital, as compared to standard consumer devices, he said.

    "In med devices, it's one of the few things that has to show that it has to work. There's no way around that," he said. "Show here's what it's supposed to do, here's what has to happen, so we have to show that it actually works."

    While consumer devices can run millions of units, medical device volume is more along the lines of thousands to a million. Betten said in his work with pulse oximeters, if the firm moved more than 50,000 devices in a year, that was a lot.

    Dealing with data

    As devices become more advanced, more design considerations will come into play for medical devices that are more connected. For example, he said, while the devices are creating data, are the sources of data medically relevant, and can they be normalized? Is the data secure, and who owns it?

    "As a patient, you might think you own it," he said. "The health care provider thinks they own it. And the guys paying the bills think they own it. That's one of the big battlegrounds. Who's going to make money off of your data? What's it going to be used for? Who pays for it? And, one of the key things is, how do you transform data into information into action?"

    One promise of the integration of the Internet of Things into medical devices in the future is the capability to harness data for projects like large population analytics, modeling disease and epidemics, Betten said. The data will help develop costs and outcomes on a global level, and provide consumer insight and valuable measurements.

    A challenge for traditional medical device developers is to find ways to take the collected information from devices and put it together into a usable format for consumers, he said.

    "I can pull together information on how well I'm sleeping, how well I'm eating, how well I'm doing all these things and put it together to create a new package of information," Betten said. "There's very few physicians who know how to understand and interpret this general stuff anymore. It means we'll see an interesting dynamic perhaps for the generalist or as the Mayo Clinic does, a team of specialists who work together to deal with all that information."

    Using that collected information can be a part of developing personalized medicine based on a person's genome, he said. That approach could inform everything from cancer care to how the patient's children might grow up.

    The Internet also can encourage a stronger adherence to treatment, saving paying for additional care in the process, he said.

    "Medication and therapy compliance will be used, those two areas by themselves can save hundreds of billions of dollars in health care," he said. "If you get people to take their meds and do their exercises for their recovery, that's huge. You can see a number of products coming out in that space."

    The market already has seen a camera that can be kept in a pill to take images inside the body, and by using stomach acid readings, another pill is able to record when a patient took it, Betten said. Eventually, medical devices could be small robots swimming in the bloodstream.

    "I've seen interesting devices there using magnetic fields to kill cancer cells and do things like that," he said. "It's coming, and it'll be here before we know it."

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