The Infrastruture for Biosensors in Medicine: Better Mathematics and a Mindset Shift

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An interview with James Levine, Professor of Medicine, Mayo Clinic, Arizona,
Director, Obesity Solutions, Mayo Clinic and Arizona State University
By Claire Topal, Senior Research Consultant, Center for Sustainable Health


CSH: Recent technology advances and explosive growth in sophisticated but inexpensive data capture devices – biosensors – promise to revolutionize our ability to detect, diagnose, and prevent disease. How are you seeing this revolution manifest, particularly for physicians?

James Levine, MD, PhD, is Professor of Medicine, Physiology, and Bioengineering at the Mayo Clinic in Arizona. He is also Director of Obesity Solutions for the Mayo Clinic and ASU. Levine is a Scholar at the University of Cambridge and holds the Mayo Clinic Richard Emslander Chairs in Nutrition and Metabolism. He is a Senior Scientific Advisor to numerous national governments and a designated expert to the United Nations, National Institutes of Health, and National Science Foundation.

James Levine, MD, PhD, is Professor of Medicine, Physiology, and Bioengineering at the Mayo Clinic in Arizona. He is also Director of Obesity Solutions for the Mayo Clinic and ASU. Levine is a Scholar at the University of Cambridge and holds the Mayo Clinic Richard Emslander Chairs in Nutrition and Metabolism. He is a Senior Scientific Advisor to numerous national governments and a designated expert to the United Nations, National Institutes of Health, and National Science Foundation.

JL: Members of the public are now buying low- cost, self-measurement biosensors, and their use and interest is back-filtering into medical space. Why is this starting with the consumer rather than the doctor? Any member of the public can buy a biosensor from the internet and use it today without approval, administration, or bureaucratic systems. The healthcare team, working with patients, cannot simply buy biosensors and give them to patients.

There are many reasons why a healthcare provider cannot liberally give out wearable biosensors: Who will upload and download the data? Who will confirm that the device actually works—in general and for each patient? Who will educate the patient? Who will pay for it? How is all that going to happen? We don’t have these answers. But will biosensors eventually be fully integrated into medical care 10 years from now? Yes. It isn’t surprising that members of the public are moving more quickly than those in the medical space, but it’s inevitable when one thinks about it. Ultimately, every patient is going to be wearing bio-sensors within about 10 years. It’s going to be part of a fundamental change in medicine.

CSH: What is different about uptake and interest in biosensors and medicine today, compared to 10 years ago?

JL: Technology has enabled us to think through a highly scalable, high-volume deployment of biosensors across millions of patients. Ten years ago, that capability didn’t exist. The primary advance has actually been in the biosensor space. The host of new devices, companies, Internet infrastructure, wireless infrastructure, and other infrastructures (such as IC chip production systems) has come into play.  A few years ago we didn’t have the technology to broadly deploy biosensors. Now we do.

CSH: How do you think this will look in 10 years?

JL: When you actually look at how society changes, it is very difficult to pinpoint a day, an hour, a minute, where something actually happened, and I think this will be the same with the use of biosensors in medicine.

In 10 years I think biosensors will be ubiquitous in clinical care. These changes are already happening very quickly, and they will continue to advance rapidly.  Sensor costs are going to plummet, creating compelling opportunities for market leaders.

Are we being ambitious enough? Not yet! You and I could reflect on this conversation 10 years from now and say, “My goodness, we didn’t even think about patients wearing disposable underwear containing multiple sensors that beam and aggregate continuous data to your electronic health record.”

PHB-Chr-SL-BQ1CSH: Are physicians prepared for these changes?

JL: Many physicians have been brought up in a hierarchical system; namely, the master is right and the student must learn at the feet of the master. As a result, I think part of the revolution in medicine that we’re inevitably going to see will begin with nurses, PAs, and other allied health personnel because the uptake will be quicker than with physicians.

While there is certainly a subset of physicians who are going to embrace this technology, by and large the medical community (and physicians in particular) can be slow to adopt new technologies. Part of the reason for this is because their focus must be on the needs of their patients.

CSH: Is the technology a key driver in fundamental changes to modern medicine?

JL: If you look through history, technological developments often drive change. The printing press and steam engines are examples. Urbanization wouldn’t have occurred without the Industrial Revolution. And now we are experiencing a technological medical revolution.
The availability of cheap technologies will necessitate the change in medicine. Technological induction will involves many parties: physicians, nurses, PAs, and students, but also the healthcare industry, including the pharmaceutical industry and health insurance companies.

CSH: Where do you think the impact of this will be on communities, particularly in underserved population communities?

JL: The changes and improvements in healthcare that will occur through these biosensors will be the most significant in underserved populations; this is because healthcare provision is least in poor populations. I have worked in slums in Nairobi and in Mumbai, and I find that effective and inexpensive technologies have the greatest potential impact on all those populations because the current provision of care is lowest.PHB-Chr-SL-BQ1

CSH: Is the infrastructure in very poor communities ready to support biosensor technology in the clinic?

JL: There are tremendous challenges.  Many impoverished areas don’t have electricity, very few have broadband Internet, many don’t have cell towers, and in many regions people cannot read or write. Also, there are major infrastructural and political challenges; namely, roads, legitimacy, transparency of funding, access to individuals, literacy, and so on. Rather than  only seeing the limitations, however, I think we need to focus on the potential impact and the opportunities.

CSH: Many biosensor innovators are currently targeting comparably much wealthier consumers and communities. How do underserved communities in developing countries connect?

JL: Underserved populations can become great commercial opportunities; in the slums where I work, cell phones are commonplace. The data suggest that as populations become healthier, the economy improves and stabilizes. That is where these technologies can fit in, because they are part of a sustainable, economic solution package.

CSH: You have explained how biosensors and related technology can be part of the global healthcare revolution in the future, but is there a place for these technologies in underserved communities today?

women with laptopJL: I was involved in a project in Mumbai delivering diabetes care. These programs were delivered out of wheelbarrow for less than $ 10 per person (U.S. diabetes care costs 700 times more!).  In Mumbai, even though much of the patient population could not read or write, we still used electronic records; here a thumb print was the identifier. A thumbprint is a good way of having a de-identified medical record and addressing confidentiality issues. Interestingly, opportunities and innovations that arose in Mumbai were germane to the U.S. market.

CSH: Let’s talk about the U.S. health system. How can we be more creative and entrepreneurial here?

JL: Diabetes care in the United States is about $ 7,000 per year per person; meaning the health care system pays that much. Wouldn’t we have a better health impact and be more cost effective if we could prevent diabetes?

For the most part we can do that; we can identify people with early diabetes (pre-diabetes), and we know how to prevent pre-diabetes from becoming diabetes in most cases. But the trouble is the healthcare system doesn’t reward that.  The math is simple: for every person who does not get diabetes, we save $ 70,000 each decade.

CSH: Can technology help us address this misalignment between prevention and reward?
JL: Technology is only part of the solution.  Technology goes hand in hand with programs and access to the healthcare team.  As noted, the U.S. reimbursement system doesn’t reward prevention, and yet prevention is so obviously financially wise.

Part of the technological revolution is a different way of thinking about health.

CSH: Who needs to be at the table to work out a systemic shift towards health promotion and disease prevention in the U.S.?

JL: The generic answer is: policymakers, industry, healthcare, medical people, healthcare insurers, and the list goes on.   However, to affect change the specific responses must match the specific challenge.  Let’s say, I want to launch a diabetes prevention program in an underserved Hispanic population in Arizona. Talking to the stakeholders and key informants in Arizona makes most sense. I need to speak to the local healthcare professionals who provide the specific care to those individuals. I need to speak to the healthcare payers. Most importantly, I need to speak to the people with pre-diabetes I want to reach.PHB-Chr-JL-BQ3

If you compare deploying a pre-diabetes program in Mumbai versus Arizona, you will realize that the programs have similar content. But the way the programs are deployed is completely different. The more focused you can be, the better the solution becomes.

CSH: Speaking of targeted, please tell me about the 1,500 patient cohort study you are doing with Mayo that focuses on the nexus between biosensor technology and prevention.

JL: Rather than saying, “Let’s take a series of technologies and deploy them to patients,” what we’re doing at Mayo and ASU is trying to build the infrastructure for using biosensors in clinical medicine.

We have identified six very different groups of patients who have agreed to work with us: patients with congestive heart failure who can barely walk because their hearts are failing; patients with depression who need to be active to help improve their most; patients going through transplantation who have very specific guidelines for physical activity and are at risk for gaining weight, particularly if they’re on Prednisone; patients with pre-diabetes who have specific issues regarding their ability to be active; and patients with cancer who are going through chemotherapy.

CSH: How do biosensors fit in?

JL: We have given each patient a sensor that tracks certain kinds of activity that is appropriate for their situation. Our core question is: what are the best recommendations for each of these patients? To find those answers, we are focusing on targeted populations with very specific needs and designing the solutions around those needs. We are not designing technologies around our needs as caregivers.
patient dr - smallInstead of saying “The technology is amazing, it’s going cure everything,” our perspective is, “We’re going to put the patient in the middle of the question and find out what technology helps them.” That’s the Mayo-ASU Biodesign approach.

CSH: Your team at Mayo has already begun collaborating with Project HoneyBee. Can you give us a glimpse of what’s possible through this partnership?

JL: As long as we always remember that the needs of the patient come first, I see Project HoneyBee growing into something very special.

If you look around the country you have people who are trying out sensors, but in many cases the technology comes first, and the patient has to fit into the schema. The Mayo-ASU team is taking the opposite approach. We’re putting the patient in the middle and working out how we can best help them. I think if we keep doing that, Project HoneyBee will help change modern medicine and improve the outcomes for my patient.


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