An army of novel implantable, ingestible wireless medical devices is mobilizing to march medicine into the future. These technologies show potential to improve patient care, reduce medical errors and lower costs.
One example: Researchers at Brigham and Women's Hospital, Boston, are providing a better endoscopy camera capsule. This one is steerable, a big improvement on current capsule endoscopy technologies, which merely tumble uncontrollably through the digestive tract. The BWH design allows radiologists to guide the device during MRI scans and aim the onboard camera to obtain real-time images of specific areas of interest. Ultimately, that may mean less invasive and less costly examinations of digestive tract disorders, particularly in the hard-to-reach small intestine.
The BWH device has a unique propulsion system. "We use both static and radio frequency magnetic fields available in MRIs to generate capsule propulsion," says Nobuhiko Hata, an associate professor in the BWH radiology department.
Another example: A new device wirelessly transmits data from sites of recent orthopedic surgeries. This one, from Rensselaer Polytechnic Institute, Troy, N.Y., promises cost-effective and less invasive post-surgery monitoring.
Usually, surgeons rely on imaging studies to assess orthopedic recovery. Now, once implanted near the surgical site, RPI's sensor transmits data about load, strain, pressure and temperature.
One more: A device developed at the Massachusetts Institute of Technology, now licensed to a Waltham, Mass., company called MicroCHIPS, enables personalized drug delivery. "Each implant can contain multiple drugs that are released at precise times, thereby relieving patients of remembering to take medications," says MicroCHIPS President and Chief Operating Officer Robert Farra. The result, Farra says: better compliance, better outcomes and lower costs.
Transformation of health care
Akram Boutros, M.D., chief medical officer at South Nassau Communities Hospital, Oceanside, N.Y., says medical device innovations will transform health care fundamentally in the next decade, focusing on diagnostics, treatment, prevention and integration.
Wireless devices will morph into self-contained diagnostic laboratories, electronic medical record communicators, and eventually a treatment delivery vehicle. "We're already seeing the promise of molecular and genetic diagnostics, miniaturization of medical devices to deliver targeted therapies, bioengineering of organs, and integration of all these advances to monitor and address physiologic needs of chronic disease," Boutros says.
Device innovations will be key to eliminating the 30 to 40 percent of waste in health care and the 25 percent of preventable hospital admissions, Boutros says. Preventing the hospitalization of even one patient is good, but it also saves the health care system on the order of $10,000.
Regina Herzlinger, a Harvard Business School professor of business administration, says one problem with current therapies is they're too broad-brush. "We don't get the right therapy to the right person at the right time," she says, "the result being unnecessary costs and suboptimal care."
Herzlinger believes personalized, miniaturized instruments, along with genomics, will reverse that. "But, whereas the promise of genomics will take decades to materialize, the devices are ready now," she says.
Aside from the impact on admissions and revenues, hospital executives need to understand that patients soon may be entering hospitals with these implants. A diabetic with an implantable chip that samples the patient's blood and delivers insulin directly into the bloodstream will require different care processes, provider skills and safety mechanisms than the current patient population.
One peril inherent in these new medical devices is an over-reliance on technology by patients. For example, if a device can sense fluid overload in a heart patient and automatically administer the proper dosage of diuretic to combat impending respiratory distress, what's the incentive for that individual to avoid salt-rich foods?
Privacy also can be an issue. When data are transmitted wirelessly, security breaches are possible. "Research teams, clinicians and technology transfer offices are ill-equipped to deal with privacy while engaged in innovation," says Ellis Meng, an associate professor of biomedical engineering at the University of Southern California. Meng says engineers may not be aware of HIPAA, so privacy might be addressed only as a reactionary measure.
There are other barriers to adoption, not the least of which is cultural obstinance. Some clinicians resist change because it threatens professional power, competence and opportunity.
"Far too frequently, providers and hospital executives cling to older, less efficient and less productive processes because the total cost in effort and dollars to change seems too high," Boutros says.
The hospital CEO can start the innovation process by appointing a C-level clinical transformation executive. This person should be a physician executive, experts say, a persuasive, visionary leader with expansive knowledge of health care delivery.
Joe Smith, M.D., chief medical and science officer, West Wireless Health Institute, San Diego, says health care's future does not hinge on the next gadget, but rather on a new delivery paradigm: technology-enabled coordinated care, in which health care becomes independent of the familiar and wildly inefficient and ineffective infrastructure of hospitals, emergency rooms and physician office visits.
"We need a health care jailbreak," Smith says. "In a world where your car can send you an email about its service needs, and you can monitor and adjust your home's heating, air-conditioning and lighting using your cell phone, how could one not imagine that small sensors will be providing you information about your health, the progression of your chronic disease, drug levels or emerging health needs?"
Smith says the revolution has come not a minute too soon: "The costs and logistical constraints of the current system make it inherently unsustainable."
Douglas Page is a freelance writer in Pine Mountain, Calif.
Innovations on the frontiers of medicine
Researchers at universities around the country are developing an army of amazing devices, some of which race through the body to attack an ailment head on.
Good, good, good vibrations
One new type of miniature medical sensor designed to be implanted in the human body overcomes battery size and life limitations of most existing implant designs. This one is powered by music — specifically, the pounding bass runs of rap.
The new device, a pressure sensor developed at Purdue University, ultimately might help in the treatment of conditions such as an aneurysm or incontinence caused by paralysis.
This device harnesses acoustic waves. University researchers found acoustic waves from specific frequencies are effective at recharging the sensor. These frequencies — 200–500 Hz — happen to be the home of rap. The researchers say when acoustic waves of those frequencies pass through body tissue and reach the sensor they cause a cantilever inside the sensor to vibrate, generating electricity that is stored in a capacitor.
Nanobots as destroyers
A device demonstrated recently by Stanford University used electromagnetic waves to propel itself through the bloodstream without wires or batteries. Electrical engineer Ada Poon says it may one day be used as a platform to deliver drugs, perform analyses and diagnoses, and perhaps even to destroy blood clots or remove plaque from sclerotic arteries.
Poon's propulsion system consists of a radio transmitter outside the body that sends signals inside the body to an antenna. The transmitter and the antenna are magnetically coupled so that any change in current flow in the transmitter induces a voltage. The power is transferred wirelessly and can be used to run electronics on the device and move it through the bloodstream.
Robots made of DNA
Another bloodstream device, this one being developed at Harvard's Wyss Institute for Biologically Inspired Engineering, is a tiny robot made from DNA. It's designed to be injected into the bloodstream to search for specific cells, then deliver molecular instructions, such as telling cancer cells to self-destruct.
The Wyss device is currently at the proof-of-concept stage. Lead researcher Shawn Douglas says the nanobot integrates two tasks that previously only have been demonstrated separately. "First, it is capable of selective targeting of specific cells, while leaving non-target cells alone; and second, of performing a simple computation that allows for the reconfiguration of the shape of the device in order to deliver a payload to the target cell."
One new sensor doesn't have to be swallowed, implanted or injected. This one, from Brown University, may bring relief to the 25 million Americans with diabetes. It can check blood sugar levels by measuring glucose concentrations in saliva instead of from blood draws.
The Brown device leverages nanotechnology and a technique called surface plasmonics, which explores the interaction of electrons and light photons. The researchers etched thousands of plasmonic interferometers onto a fingernail-sized biochip and measured the concentration of glucose molecules in water on the chip. Results showed that the biochip could detect glucose levels similar to the levels found in human saliva. Glucose in human saliva is typically about 100 times less concentrated than in the blood.
The researchers believe the same chip can be used to detect other chemicals or substances, from anthrax to biological compounds, simultaneously.
Q&A with Eric Topol, M.D.
Cardiologist Eric Topol, M.D., chief academic officer of Scripps Health, director of the Scripps Translational Science Institute and co-founder and vice chairman of the West Wireless Health Institute, is a leading voice on the digital revolution in medicine. His most recent book, The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care, was published in January.
How do you see personal wireless medical devices evolving in the next few years?
Topol: These technologies are rebooting medicine. It's a fundamental shift; just like the wireless mobile devices have changed the rest of our lives, we're about to see that type of sea change in medicine.
Why should hospital executives care about these developments?
Topol: Because there may not be hospitals as we know them in the future. Ultimately, hospitals will be needed only for intensive care, procedures and surgeries. There will be no need for regular hospital beds, because that will be done less expensively at home. Same with clinics. Why would we have such a load of in-person visits when we can do electronic house calls efficiently without inconveniencing the patient with commutes and waits? With these digital devices, we can get vital signs in real time. We can take histories and do evaluations using FaceTime, Skype or video chat. What we're talking about is an overhaul of the way medicine is provided through the digital infrastructure. It already exists in every other walk of life, except health care.
What are the drivers?
Topol: Efficiency. In medicine today, everything is done on a population level. Everyone gets the same inoculation, the same screening, the same tests. It's remarkably wasteful and imprecise, and it doesn't account for any individuality. Now, we can capture data about each individual that we never could before. That will change everything radically going forward.
Patient benefits are apparent. What are the perils?
Topol: All these new technologies have to be validated that they are not just accurate, but that they make a difference — that they prevent illness or provide better outcomes. There's also the issues of reimbursement and of getting regulatory approval from a Food and Drug Administration that's risk-averse. The biggest issue, though, is a physician community that is historically and remarkably resistant to change, especially when reimbursement is under siege by some of these technologies.
What can hospital executives do to help drive physician adoption?
Topol: They can develop a vision for where this can go. Think what's happened in the last decade in the rest of their lives, how radically it has changed with smart phones, tablets and social networks, with broadband everywhere and now cloud computing and supercomputing. Play that out in health care, where a person's entire genome of 6 billion DNA letters will be done in 15 minutes by year end. The technology is all in place. Hospital executives need to be aware of that, because it doesn't take a wild imagination to see where this can go.
Beam me up, Scotty!
In January, the X Prize Foundation announced its intent to launch health care into the 23rd century by posting a $10 million award for the first team to invent a handheld device capable of diagnosing disease simply be scanning the human body.
The prize is called the Qualcomm Tricorder X Prize. Qualcomm is a wireless technology company and a tricorder is a medical scanner from Star Trek.
In this competition, teams will use a range of technologies, from artificial intelligence and wireless sensing to lab-on-a-chip and molecular biology. The top prize will be awarded to the team that develops a handheld platform that most accurately diagnoses a set of 15 diseases across 30 patients in three days.
Real-time vital signs such as blood pressure, respiratory rate and temperature must be captured. The device must weigh no more than 5 pounds, and systems must include a way for consumers to store and share their information via the Internet.
The X Prize Foundation creates competitions in four areas, one of which is life sciences. The goal of the Life Sciences Prize Group is to stimulate breakthroughs in medicine and health care that enable consumers to make better choices of when and why to seek care and, in the process, make health care more convenient, affordable and accessible.
"The $10 million Qualcomm Tricorder X Prize aims to help achieve these goals by spurring the development of solutions that put health care in the palm of your hand," says X Prize Vice President Eileen Bartholomew.
The winning solutions must enable consumers anywhere to assess personal health conditions quickly, determine if they need to seek professional help and answer the question, "What do I do next?"
More than 140 groups have filed forms stating their intent to compete. The qualifying round will take place in about two years, organizers say, with the final round about 26 months later. — Douglas Page
The paradigm is shifting.
Personalized, wireless medical devices, designed to continuously monitor, diagnose and treat diseases in noninvasive ways, are changing the way medical care is delivered.
These patients are different.
Patients admitted with implants will require different hospital care processes, provider skills and safety mechanisms than those of current patients.
Incorporate creative thinking.
Inflexible management strategies are barriers to change. Create a mechanism to train managers in innovation adoption and process engineering. Provide time for innovation and creative thinking.
Appoint a transformation chief.
Hospital CEOs can meet the digital device revolution by appointing a C-level executive to serve as innovation and clinical transformation chief. Ideally, this person should be a visionary physician — a persuasive leader who can capture an audience, sway others' opinions and convert opponents' opinions. — Douglas Page