Interview With Dr. Stephen Oesterle, Medtronic Senior Vice President
By Jaymin Patel
Stephen N. Oesterle, M.D., joined Medtronic in 2002 as its Senior Vice President for Medicine and Technology, overseeing the company’s scientific research, formation of technological strategies and continued development of strong cooperative relationships with the world's medical communities, such as technical universities, financial institutions, and emerging medical device companies. Previously, Dr. Oesterle served as an Associate Professor of Medicine at the Harvard University Medical School and as the Director of Invasive Cardiology Services at Massachusetts General Hospital, Boston. He has also developed and directed interventional cardiology programs at Good Samaritan Hospital, Los Angeles; at Georgetown University; and at Stanford University. Dr. Oesterle received his medical doctorate from Yale University in 1977.
Medtronic recently released the results of its deep brain stimulation therapy for epilepsy, in which a device was surgically implanted into the brain to electrically stimulate certain targets. Will such treatments become commonplace?
Well, first of all, this technology isn’t specific to just epilepsy. For instance, we’ve already developed a Deep Brain Stimulation process for treating a neuropsychiatric disorder called obsessive compulsive disorder in which we target certain structures in the brain to ameliorate if not abolish the symptoms, which can be crippling for some people. We’re also in the middle of doing a study in which we will try to stimulate patients into a mood altering situation in order to erase profound symptoms of drug-resistant depression. We also have similar targets for drug addiction and Deep Brain Stimulation is an approved approach and a standard of care for advanced Parkinson’s disease. So the epilepsy story is just a continuing application for a technology that we’ve been developing over 20 years.
You mention obsessive compulsion and depression. Some would argue that this is going beyond treating more traditional illnesses and is instead altering mood and personality – how people think and feel. Do you receive any resistance from bioethics groups for this?
I think your premise here is wrong. Depression is a profound illness; it’s no different than hypothyroidism or diabetes. These are chemical imbalances causing abnormalities in neurotransmitter release that we are trying to fix. In terms of treatment for these types of illnesses, this is one of the major differences between devices and pharmaceuticals. Most pharmaceuticals are small molecules that are taken by mouth and systemically distributed and you hope that you get enough into the area of interest so that something good will happen. On the other hand, most devices, either mechanical or electrical, are targeted, controlled local delivery systems. As a result of this local treatment, they generally have very few side effects as opposed to drugs – take Vioxx for example. We also treat with biologics, including protein and siRNA. However, you cannot ingest these the way you ingest pills; if you ingest biologics, you will digest them. Most often, they need to be delivered through a device acting as an infusion system. Thus, we see devices catalyzing the realization of such biotechnology, which ultimately will replace pills.
Medtronic generally works with the device side of medication. Will it expand into developing the biogenics that you’ve just mentioned?
We’re not a discovery operation. We generally don’t discover new proteins as a rule, but we have all sorts of collaborations with biotechnology companies. For example, the leading company in the world in siRNA is in Cambridge, MA – a company called Alnylam. We have a very active collaboration with them to try to silence the abnormal proteins that are associated with Huntington’s chorea. We also have all sorts of collaborations with pharmaceutical companies to package their drugs into our pumps and devices. We have these collaborations because, as you say, Medtronic is largely an engineering company and we generally don’t do biology or drug discovery, but we recognize that there are many interesting drugs that could be given locally and would be much more effective in smaller doses and with less side effects.
As more of these devices and products are developed, do you think costs, in terms of the devices themselves and the procedures to implant them, will become excessive and thus prohibitive for most patients?
We’re not in the business of adding costs. If we can’t prove that our products are cost effective, we’ll never get reimbursements for them, so we don’t think we’re actually going to add costs to the system. For example, right now, the single greatest consumption of healthcare dollars in the United States is tied up in hospitalized patients with heart failure – we spend about $35-$40 billion a year on these patients. We think we can keep 20-30% of these people out of the hospital using an implanted pressure sensor that we’re working on that monitors their pulmonary pressure. These sensors would speak to a handheld device such as a Blackberry, which would then use broadband networks to communicate with distant data storage facilities that would keep track of patients. So that’s 20-30% of $40 billion saved. We’re just trying to use technology, whether it’s information technology, communications technology, biotechnology, genomics, you name it, to ultimately take money out of the system and provide better healthcare. Another example would be patients with high blood pressure. Generally, you would go to the doctor every 2 weeks or every month and have you blood pressure checked to have your medications adjusted. There’s no reason we couldn’t remotely manage hypertension in a much more efficient way through a combination of wearable sensor technology and broadband communication. This would mean more efficient care and better care which translates to less money wasted.
In addition, in the last 10 years, we’ve seen the unraveling of the human genome. As sequencing gets faster, we think genomics is going to play a major role in so called “personalized medicine”. We’ll be able to decide, for example, who should and who shouldn’t take Lipitor, or who should get an implantable defibrillator, or who would benefit from cardiac resynchronization. I think we’re going to be able to sort all that stuff out.
How are you working with companies like Google, Research in Motion, or Microsoft to develop these remote monitoring systems?
We talk to all of these companies. We talked to IBM, for example, because if we want to remotely manage millions of people, we need supercomputer capability. It also takes a new web architecture to handle the data. In terms of telecommunication, Qualcomm, Apple, they are all are interested in handheld devices and we’ve talked to broadband networks ranging from Verizon in the US to Docomo in Japan. We also have Microsoft in our lives all the time; we’re trying to figure out how we can use interactive databases so that, for instance, patients who are being operated on in India can have their pacemakers remotely programmed from Minneapolis. If you think about it – if you were Apple and you had a choice between sending iTunes over the internet and sending vital physiologic data, which one do you think could be more valuable to them ultimately? Accordingly, the Apple iPhone is perfectly set up for healthcare management. In fact there are already applications if you go the Apple Store. Nike, for example, has over a million people running around with sensor in their shoes speaking to their iPods; that gives you a little glimpse of where companies like Apple are going. I think everybody’s going to part of this trend in healthcare management.
You say devices are part of the key to reducing costs in the system. Nonetheless, the Healthcare bill that just passed incorporates a multi-billion dollar tax on medical device manufacturers. Why do you think your industry has been targeted and what will be the implications of this tax?
Well, Congress has been gotten money from many areas in healthcare. The logic behind it is that if more people are insured, those are more customers for companies like us. But that isn’t necessarily true since most of the patients we treat are elderly Medicare patients already, so the uninsured have not been that big of an issue for us. The real windfall in this is going to be for pharmaceutical companies and in hospitals where patients will have access to medications and hospitalizations in a way they haven’t before. What you’re saying is basically right. The tax is basically a tax on innovation because the more tax we pay the less money we have available to put back in the company in terms of R&D. We support the healthcare bill, but do we want to be taxed for it – no. It will hurt innovation and it becomes another challenge for us.
Another exciting area in Medtronic research is diabetes management – you mentioned wearable pumps and such. What challenges are there in developing these sorts of devices?
For years the Juvenile Diabetes Research Foundation had a basic goal of curing diabetes, but in the last few years there’s been a sort of cultural change; they’ve realized that maybe what they want instead is to perfect a closed-loop artificial pancreas. And that’s where we’ve positioned our business. We have a pump that pumps insulin into the body and communicates with a wearable sensor, essentially mimicking what your pancreas does – sensing ambient blood glucose and responding with the release of insulin. The challenge is that it’s never as good as nature makes it. There’s a certain lag time between what the sensor senses in the subcutaneous tissue and how the pump reacts. The goal is to get more accurate and timelier. We’ve already released a product that has the pump accelerate as blood sugar goes up. But the challenge is to do that safely because if you accelerate the pump and the blood sugar goes too low, it quickly becomes a problem. The other challenge is in proving to people that pumping insulin is better than injections. A lot of people just prefer to take their one or two injections per day. Thus, we’re doing clinical trials now to prove that a continuous flow of insulin is a more efficient and better way to deliver insulin in terms of minimizing organ damage.
As you develop into the international market, do you find that there are different demands there than in the US?
We are a global company – we operate in 120 countries. Some of our biggest growth markets are in places like China, India, Russia, and Brazil. But there are many things different in these emerging markets. In China, though there is health insurance, most people pay out of pocket and the average person there makes $300 a year. It changes the marketplace dramatically. Of the 1.3 billion people in China, there are probably only 200-300 million who can easily afford healthcare. We must therefore adapt different distribution models everywhere we go. Right now the US spends 16-17% of its GDP on healthcare whereas the UK spends half of that, and it’s even less in other places. Thus, we face issues of reimbursement and affordability that are different in every country.
Our other major issue in places like China is really around training. Unlike pharmaceuticals, which are not very hard to administer, you can’t just hand over a neurostimulator to a physician. If a trained technician isn’t available on the spot, you need remote communication capability to allow someone to remotely program the devices and such.
Historically, Medtronic has been strong on health-related technologies. Will that be the trend in the future?
We think the most interesting challenge in the next 20 years is in the neuro field. There’s going to be a dramatic increase in neuro-degeneration incidence with the baby boomers – things like Alzheimer’s disease and Parkinson’s. So it’s the one area where we see the greatest need for work.