|Manufacturer of the Year|
Andrew Thompson, cofounder and CEO of Proteus Digital Health, has an issue with our current healthcare system: It doesn’t exist. At least, it doesn't exist in terms of meeting the health needs of the 21st century.
“We have a brilliant ‘sick care’ system that was built in the 20th century to deal with the issues that were dominate in that time, which were mainly acute,” Thompson says. “We now stand at the beginning of a new century with a new set of problems, and they’re mainly chronic. And what we need is a new healthcare system.”
|The Ingestible Event Marker (shown in pill form) communicates with a bubble patch worn on the body that can in turn send information to a smartphone or other device.|
What Thompson is talking about is a system that puts patient care in the hands of patients, allowing patients to actively work with their doctors and better manage their own well-being. The system for doing so would function on three imperatives. First, it would have to utilize the Internet. “Not plugging into the mobile Internet today is like saying you could run a hospital in the 20th century without electricity,” Thompson says. “The system also has to focus on delivering products that are relevant to the largest group of healthcare workers. . . and that’s not doctors and nurses. That’s you and me, because most healthcare work isn’t done in professional settings; it’s done in community settings by informal [caregivers], who typically outnumber professional [caregivers] by 10 to one.” Finally, medicines have to do their job. “Many medicines in the supply chain are fake, and even when they are real and reliable, as in the United States, they are frequently misused,” Thompson says. “We have this tremendous asset being developed at an enormous cost that, in the real world, doesn’t deliver as much as it could.”
For Proteus, the product that aims to meet all the attributes of the 21st century is a medicine that is also digital product. It combines pharmaceuticals with a platform that can deliver information and also educate and motivate patients to take care of their own health. In short, Proteus thinks of drugs the way Apple thinks of songs, as digital content.
Proteus Digital Health made headlines in July, when its Ingestible Event Marker (IEM) received FDA approval. The IEM is a sensor, about the size of a grain of sand, that when swallowed is capable of relaying information to an external sensor attached to the skin. As part of Proteus’s planned end-to-end personal health management system, the IEM has potential in a variety of healthcare applications—so much so that it has earned both awe and skepticism. But not many medical technologies can boast a satirical shout out on The Colbert Report. “Because nothing is more reassuring to a schizophrenic than a corporation inserting sensors into your body that beam information to all those people watching your every move,” host Stephen Colbert joked of the IEM’s potential for helping the mentally ill.
Minding The Gap
Although certainly mocking, Colbert’s jab is also indicative of the sort of forward-thinking behavior that has driven Proteus from its inception. Thompson and his cofounder George Savage met while attending Stanford University. They formed a partnership, working as entrepreneurs in the medical device industry for 23 years in Silicon Valley. Savage, who serves as chief medical officer, says the two of them where particularly fascinated by microelectromechanical systems (MEMS) technology and how the small electronic sensors could be used for medical applications. It was through this exploration that they met their third cofounder, Mark J. Zdeblick, the current chief technology officer, whose background in MEMS would fill in the final piece of the puzzle.
|Andrew Thompson||George Savage|
The idea for Proteus’s flagship digital health system emerged quite literally from making observations. “The ideas for digital drugs came from making fairly simple observations about the extent to which computing, and information, and customization were affecting the medical device industry but had yet to make any headway into the pharmaceutical industry, at least from a physician or consumer perspective,” Thompson says. Walking the floor of the American Heart Association Scientific Sessions trade show in 2003, Thompson was struck by how sophisticated medical devices were becoming.
“If you walked around the trade shows for medical products, you tended to notice a trend among the medical device companies for their implants, with more software and computers. More and more of the selling effort is aimed at customizing therapy for particular patients, recording their response to therapy, and sending that to therapists,” Savage says.
Yet Thompson observed the pharmaceutical industry had none of this. There was a gap, one with a lot of ramifications for the global health industry. It wasn’t long before Thompson was on the phone with Savage, brainstorming an idea for designing a product to function in this space. “Andy’s challenge to me, which I remember quite clearly, was, ‘Isn’t there something we could do with the kind of sensing technology we’re developing to do for ingestible drugs (which are 85–90% of all therapy) what the rest of the medical device industry is doing for implantable therapy?’” Savage recalls. After suspending his disbelief, Savage posited that such a product would have to be both incredibly safe and incredibly inexpensive. “And that means we’d use what we believe is a parts list of things that were in your diet anyway,” Savage says.
The Battery is You
Proteus’ engineering team was given the challenge to build a computing system out of the ingredients you’d find in a multivitamin. The result—the IEM—is an ingestible sensor composed of a tiny piece of silicon (with a surface area of about 1 mm2) and sand-particle-sized traces of copper and magnesium, both being minerals most of people ingest daily in their diet.
The sensor works on the same principle as the potato or lemon batteries seen at middle school science fairs—generating power using an electrochemical reaction. The sensor is an 800 × 300-µm silicon wafer with a tiny circuit with a bit of magnesium on one side and copper on the other. When swallowed, the device gets wet, powers up, and the chip becomes a battery. The circuitry on the board then begins to modulate the current. “The concept was first explored for implantable medical devices and indeed ingestible medical devices back in the 1960s," Savage explains. "A pH-sensing capsule that was first marketed in 1969 that’s still sold today operates on the same principle using zinc and silver." Modulating that current creates a voltage fluctuation on the skin, which is recorded by an external sensor. The IEM doesn’t communicate via medical body area network or wireless. It’s not a radio or miniature antenna—it’s a power source made of the ingestible chip and you, the patient. “We aren’t the innovators in terms of coming up with the idea; we are in terms of miniaturizing it to the scale that we have and making it practical to include in dose forms,” Savage says.
A World of Digital Health
Although Proteus is excited by the recent FDA approval, Thompson stresses that the IEM is only the first step on an ambitious path. Once complete the system will offer options for patient care and monitoring and also for drug safety and delivery. By implementing the sensor directly into pharmaceuticals, for example, caregivers can remotely monitor how much and often a patient takes a drug. And, on the supply chain, chips with serial numbers can help ensure integrity down to the individual pill—a particularly valuable asset in the developing world, where a significant number of pharmaceuticals sold are counterfeit or fake.
But before all this, the next step is beginning the regulatory process for the rest of Proteus’s personal health management system. Thompson says Proteus doesn’t see this as an obstacle or challenge, merely the requirement of doing respectable business in uncharted waters. “New ideas are always things that are relatively challenging, Typically you have to displace something that is already out there.”
Proteus is proposing not only a new type of product, but a whole new way of doing things. Global medical expenditures are poised to triple over the next decade, as more people in the developing world gain access to affordable healthcare. At the same time, in the developed world there is a related challenge in that healthcare expenses are rising and an increasing number of patients are dealing with chronic disease over acute. “We have to improve the productivity equation,” Savage says. “Not just give more people access to health insurance and care. The challenges we face are common to any start-up when you’re trying to change the standard of care. The competition is the existing way of doing things.”
Thompson agrees. "Digital medicine is around where digital commerce was in say 1997 or ‘98," he says. "Everyone can see it’s coming. There’s lots of noise, lots of new things out there, but no one is quite sure what it’s going to look like. Some people are excited about it, some people are nervous about it, some people are dismissive."
"Three to five years from now there will be an ecosystem of between three and 10 companies that are significant players in this new digital health world. Some of them will be established players who have adapted and some will be very new companies that have built very large business.”
Thompson operates on the principle that perhaps the most important thing that can be done in U.S. and European healthcare in particular is to figure out how to deliver health services for less money. “It’s the beginning, not the end of the journey," he says "We now have some permissions to begin what we think will be a very important mission over the next several decades, but over the next few years there will be big changes."
Digital platforms have fundamentally changed nearly every major industry. They've given us computer-augmented cars. They've taken us from vinyl records to downloadable MP3s. They've put movie theaters in our living rooms. And they've taken us out of malls and put every consumer good just a mouse click away. Isn’t it time they did the same thing for healthcare?
- Chris Wiltz is assistant editor of MD+DI.