New Medical Devices Get Smart

by | Aug 24, 2012

From: Wall Street Journal

For amputees like John Redfield, shopping for a new pair of shoes used to be a major hassle. Walking up or down an incline was as awkward as wearing ski boots. And going shoeless required performing a constant balancing act.


To achieve comfort in each instance would require a trip to the prosthetist’s office, where adjustments would be made with a wrench—an impractical option.


But now, the 50-year-old sales professional in Connecticut can adjust the heel height of his prosthesis—an artificial foot and ankle device on his right leg—simply by pressing a button on his smartphone. In some cases, the prosthesis will correct itself automatically.


“It just makes my day-to-day life easier,” said Mr. Redfield, who became an amputee at age 29 as a result of a motorcycle accident and is one of the product’s test patients. “My gait is much more natural now.”


The prosthesis from Oklahoma City start-up Orthocare Innovations LLC is among a growing number of medical devices that aim to help people deal with health conditions in ways that previously required the aid of a medical professional.


Another start-up, Boston-based Rest Devices Inc., is testing a T-shirt with wireless sensors that measure respiration in sleep-apnea patients. Users can wear it at home instead of a hospital or sleep lab to gather information that physicians need to select treatment options.


Such devices could benefit patients who have a tendency to ignore or delay care because of the costs and hassles that come with having to make frequent or overnight visits to health facilities. But it also raises concerns that the products could give patients a false sense of security about their ability to manage their health on their own.


“That’s a danger when you hand somebody a medical device that looks professional and therefore they think they’re just fine using that as a substitute,” said Jason Hwang, a physician in Mountain View, Calif., and co-author of “The Innovator’s Prescription: A Disruptive Solution for Health Care.”


Still, Dr. Hwang said products that can give patients with chronic conditions more control over their health are generally a move in the right direction. “This is a critical trend to disrupting health care that provides greater convenience and access for patients who otherwise wouldn’t get care or would delay treatment,” he said.


The concept of medical devices that patients can use themselves isn’t new, given products like home-pregnancy tests that have long aided in reducing the need for professional medical support. But Dr. Hwang said the category is accelerating because consumers are accustomed to using the Internet to gather information.


“Booking our own travel, doing our own taxes—these are things that are options for convenience,” he said. “We want to make these tools available for consumers who demand them and the same thing apples in health care.”


The cost of sensor technology, a common component of medical devices, has also fallen “exponentially” in recent years, according to Vivek Wadhwa, director of research at Duke University’s Center for Entrepreneurship and Research Commercialization. The advent of modern research-and-development tools, such as 3D printers, has also helped to lower expenses, he adds.


Even so, there are plenty of financial hurdles to bringing a new health product to market. Start-ups have to gain the trust of doctors who prescribe these items and depending on the product, secure Federal Drug Administration approval.


Meanwhile, medical-device makers may also need to convince Medicare and private health insurers to help cover the cost for patients.


“We have an approval and reimbursement system that is expensive, risk-averse and basically hostile to start-ups,” said William A. Sahlman, a professor of business administration at Harvard Business School, and an investor in Rest Devices.


Founded by three Massachusetts Institute of Technology graduates, two-year-old Rest Devices is currently working toward applying for FDA approval for its washable, respiration-tracking T-shirt. The sensors embedded in the fabric measure the user’s breathing, and a small data logger with a USB port—which must be attached to the shirt because it’s not waterproof—records the output from the sensors.


“What we’re producing is a measure of how many abnormal respiratory events you’re having throughout the night,” said founder Carson Darling, adding that the company has so far raised $500,000 from angels and is now working a new funding round.


Orthocare’s Magellan product, in beta testing, is imbedded with wireless technology the user can control with the company’s smartphone app. It also makes certain adjustments on its own, such as when a user switches from flat terrain to an incline.


Orthocare, a 30-employee company founded in 2007, has raised $12 million from Schooner Capital, a family fund in Boston. It has six orthotics and prosthetics products, and last year its revenue exceeded $4 million. Its CEO and co-founder, Doug McCormack,, plus its director of software engineering, Mark McWilliams, are both amputees and Magellan users.


A number of other start-ups are working on products aimed at minimizing patients’ dependency on medical professionals, such as Scanadu Inc., a Moffett Field, Calif., maker of a small, handheld device not yet on the market that interacts with smartphones to identify health conditions such as the flu and strep throat. Parents could use it, for example, to try and determine whether a child’s symptoms warrant a doctors’ visit.


Another start-up, Alignmed Inc., offers high-tech posture correcting shirts for helping chronic back, shoulder and joint pain sufferers avoid orthopedic surgery. The form-fitting shirts, marketed under the trademark name Evidence Based Apparel, are embedded with elastic bands and were designed using a combination of biomechanical technology, neurological research and advanced body-imaging systems.


Consumers can expect more products like these in the near future.


Qualcomm Inc., the San Diego-based chip maker, launched a $10 million contest in January to develop a workable “tricorder”—the handheld diagnostic device used on the science-fiction TV show Star Trek. It aims to bring together advances in artificial intelligence, wireless sensing, imaging diagnostics, lab-on-a-chip, and molecular biology. Some 200 teams have so far pre-registered, according to a Qualcomm spokesman.


The winning device, to be determined in about three years, will use sensors to diagnose a dozen medical ailments, such as heart disease and diabetes, as well as, or better, than a team of doctors.


The whistling sound-effect is optional.


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