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Chopra: Regulation, billing and workflow management

By Brian Dolan

Gopal Chopra"You can enable ubiquitous [wireless health] sensing, but without a services and disease management workflow system in place, who is this data going to?" Duke University Adjunct Associate Professor Gopal Chopra explained to Mobihealthnews in a recent interview. "Who will interpret it? If there are algorithms involved with telling users what to do, well, who is overseeing that? There's risk in that. You need a care provider to be overseeing it, which then leads us back to who is going to pay for it? I don't think sensors are the only answer."

Chopra certainly has opinions about the emerging wireless healthcare industry. Besides teaching health data management to Duke University MBA students, Chopra is also building two wireless healthcare start-ups and is one of the lead organizers of Duke University's Medical Innovation and Strategies Conference 2009 on Wireless and Consumer Health.

Read on for highlights from Mobihealthnews' interview with Gopal Chopra.

Can you give us a brief background about your position at Duke University and past experiences?

My quick background is: Neurosurgeon-turned-entrepreneur. Most recently I was an investment banker, but ever since I got my MBA, I have been on the faculty of the health sector management program at Duke University's Fuqua School of Business. I am an associate professor that teaches the elective course in health data management for the full-time MBA students. Outside of that I have been in business development at Boston Scientific, in investment banking, and now I am an entrepreneur.

The event you are producing and your current area of interest is "wireless & consumer." With all that is going on in healthcare right now, why did you choose this focus?

Two reasons -- one is personal. I spent the last 15 plus years in and around medical devices working or advising the likes of Johnson & Johnson, Stryker and others, while watching the market for implants grow. I understood we were supplying implants and technology to a chronic disease market. The health costs just continue to escalate. As a result, we began looking for better solutions and at the stickiness of products that involve medical devices but also services. Then in the last five or six years some companies have come forward and made the services side very interesting.

What are some examples?

One example is the MEMS technologies that Medtronic is using to understand blood pressure and arrhythmia in order to prevent re-admission either in cardiac rhythm management or cardiac failure. Jim Sweeney [founder of CardioNet] is a close friend, and watching him struggle to get CardioNet up and running, has shown it's possible. That company became a huge success because of the reimbursement and the support around data and event capture that Sweeney's team finally proved.

We are all learning very quickly that this is a new segment that is being created -- one that even capital markets have not yet defined. Investors have not yet defined it. Clearly, though, innovators have merged technologies and services and enabled this mobile health with wireless technology. The wireless healthcare term was coined around a lot of these efficiency solutions. I looked at all of that and said that, as did many others, that this is a big opportunity. Hopefully we are the first few to realize that this is a big opportunity. It will have a significant impact on healthcare. So that's the first reason we decided on wireless and consumer as a focus.

Then, the academic side of me wants people to focus on this because wireless technologies companies need healthcare expertise and medical device makers need wireless expertise. We want to bring these two industries together. And as an investor and entrepreneur in this space, I'm interested in helping companies in this space. I'm currently working with a wireless solutions operating room asset management start-up. I'm also interested in building companies -- I'm building [one start-up] for the pediatrics field. There are a lot of verticals and niches where we can create a lot of value, improve outcomes and create mobile remote health.

Can you tell me more about these start-ups that you are involved with? They are wireless-enabled?

Yes, they are wireless health related. One is for managing operating rooms. It's more than scheduling: It's asset management logistics. It's looking at the human resources, the tools, the inventory, and just-in-time event management of what happens in an operating room, which is very complex. To be able to do that you need everyone from an operating room manager all the way through to the lead surgeon, wirelessly connected with real-time information about what is happening on the floor.

The one I am currently building, which I am launching rather shortly, is in pediatrics. Very briefly, it's just taking a primary care problem that is abused both on the consumer and physician side of it. In a highly burdened primary care system with not enough physicians and not enough access, too many things could be intervened in and prevented at an earlier time point. [The problem we are solving is] a classical child situation -- they typically don't tell you or warn you about a medical event. These events often incubate for a little while, and sometimes until it's too late. That's a perfect case for a wireless sensor that can connect the data to a care provider who can analyze the data and prevent a problem well before the emergency care services need to become involved.

Can you highlight any other companies you see as driving innovation in wireless healthcare?

One example is iVisit: They enable PDAs and a variety of other cellular mobile tools with software that enables people to do wound management, home care, workflow tools for people with Alzheimer's. Companies like iVisit are trying to build platforms and applications.

Then you have all the wireless sensor companies who are going after the consumer market. It might be weight loss, exercise, calorie counting and things like that. Healthcare is really a very inefficient chronic disease management engine that requires the sophistication of these technologies, but it really needs much more focus on workflow solutions for disease management. The successes [in wireless remote monitoring] so far are related to cardiac failure and cardiac rhythm, but there is an "umpteem" number of conditions that we could be doing this for. We can see the beginnings of this even in sleep apnea. Look at what ResNet is doing: They have provided a ventilator and a monitor capability, but they don't know how to take the service to the home without going cellular or wireless. For providing an appropriate physician to monitor it, they need to figure out the billing side of it. That is the roadblock and one of the challenges we need to figure out as a group. We need to start scratching that service and beating the drum on, which I think you are already doing well.

You had mentioned wireless sensors before. Many believe that wireless sensors are really a critical enabling technology for this emerging wireless healthcare industry. Do you agree?

I agree that they are critical for getting timely, accurate information to caregivers, but I don't think that is the only hurdle. You can enable ubiquitous sensing, but without a services and disease management workflow system in place, who is this data going to? Who will interpret it? If there are algorithms involved with telling users what to do, well, who is overseeing that? There's risk in that. You need a care provider to be overseeing it, which then leads us back to who is going to pay for it? I don't think sensors are the only answer.

How do you see the larger federal healthcare reform discussion effecting the wireless health opportunity?

I think [everyone in this emerging industry] is in favor of healthcare change because it will bring the attention to "efficiency, efficiency, efficiency," which, obviously for reform, is a significant issue. Efficiency does not just mean "efficiency that the costs associated with communicating with a physician," it is also the efficiency of the patient understanding what their problem is. I think this industry is in favor of the heightened awareness and the talk of reform, but at the same time, when government talks about change, regulators get into the mix, too. The regulatory burden on the device world in the last two or three years has been extremely painful. It's only going to get worse, unfortunately. That regulatory issue is one we need to manage and explain to the government and explain to them where we need assistance.

Why is regulation going to get worse? In what sense?

Worse in the sense that there are various complexities. How do we discern safety and efficacy? How much efficacy do we need to show against cost benefits? For safety, of course, everyone realizes -- absolutely: We do not want to put anything out there that is not safe. The complexity of understanding efficacy and cost benefit, however, won't come from a double-blind trial as we do in pharmaceuticals. What are the benchmarks that we are setting as our regulatory hurdle? This is where we need to begin communicating with the government, otherwise we will be regulating the cell phone as well as the potential tool that we are putting out there. That will only increase the cost burden and defeat the purpose of efficiency.

Any closing thoughts?

Yes, I think another purpose for our event is to increase awareness and clarity of the potential investment in wireless healthcare from several groups -- the venture capital, institutional investors, corporate investors and government private equity. The pools of capital that really going to fuel innovation here have yet to get clarity on the model. I really want people to explain the model in terms of how these are revenue generating and sustainable opportunities. Some of that explanation only comes from creation, but there are many companies experimenting with this and we'd like to know how they are doing it. Explaining that there are various ways that this is going to work will help both entrepreneurs and investors understand that appropriately. Start-ups don't all have to be as capital intensive as a CardioNet, for example.

And all of this will be covered at the event you are producing at Duke University?

Yes, we were very fortunate to get such a stellar line-up. Attendees will speak highly of all of our speakers because they are all thought leaders and successful operators of various private and public entities. The commentary that comes out of it will be very meaningful. We will present to both policy makers and investors something that is both extremely important and exciting.

We thought it was high time to produce an event related to the medical device sector, and so we are starting with Wireless & Consumer. This event is more of an industry institutional investor-facing event that includes speakers who are setting the stage for the next stage of healthcare. This is really going to be a platform for leaders in wireless and consumer healthcare to discuss the issues and successes they have had in maneuvering around particular hurdles.

This will be the inaugural event and we hope that Wireless & Consumer will be an annual event.