Makers of wireless health devices bemoan slow FDA approval process

Low reimbursement rates from insurance companies also an issue

SAN DIEGO -- Makers of wireless electronic health devices bemoaned the federal product approval process and stingy insurance reimbursements for life-saving technology that they argued could reduce overall national health-care costs.

Despite a federal priority on health care reform, the U.S. Food and Drug Administration is not doing all it should to boost approval of wireless e-health devices for monitoring patients, said Eric Collins, CEO of Montage Systems, during a panel discussion at the International CTIA Wireless I.T. and Entertainment conference.

"With the FDA recently saying too many [medical] devices are getting approved too easily and some other things they are articulating, it's frustrating," Collins said. His company has developed a prototype device called the Wireless Healthphone for sending patient data wirelessly to doctors and other caregivers.

The wireless e-health industry "has a huge opportunity to improve the health care system and reduce costs, but Washington is clearly not paying attention to technology at this level, " Collins added during Thursday's panel presentation.

Collins spoke on a panel with representatives of four companies deploying wireless technology for remote health care. The panel also included Qualcomm Inc., which has work underway with 30 smaller companies deploying software and hardware that will depend on radio communications to provide continual feedback on body systems or to monitor diseases such as diabetes and a variety of cardiac ailments.

Aaron Goldmuntz, director of business development for CardioNet, said his company began offering wireless cardio monitoring technology nearly a decade ago and described FDA approvals of the technology as having generally gone smoothly. However, his company recently faced a reduction in insurance reimbursements for which CardioNet patients are eligible.

Lower insurance reimbursements are also problem for providers of telemedicine applications, said Charlie Huiner, vice president of business development for InTouch. "Broadly speaking, telemedicine is not broadly reimbursable," Huiner said. "You are not necessarily able to charge and get reimbursed."

Huiner said his company has installed 250 robot-like devices in medical centers that allow hospital patients lying in a bed to talk remotely over a live video connection to a doctor, giving them the ability to speak to a personal physician instead of a hospital attending physician whom they have never met. But insurance won't cover the cost of a robot consultation unless the patient is in a rural or narrowly defined area, Huiner said.

Collins said he is trying to get FDA approval for the Healthphone, a handheld device about the size of a pager that gathers data wirelessly from a patient's body and forwards it over a network to a computer monitored by doctors or other caregivers.

The Healthphone could be used to gather data on blood glucose for diabetics to be forwarded to doctors' offices.

A related function calls for using the device to monitor an orthotic device inserted in a diabetic patient's shoe which would notify the patient wirelessly if a pebble or other foreign object entered the shoe that could cause a sore.

Diabetics frequently lose nerve sensation on the bottoms of their feet, so dangerous sores can develop without their knowledge, sometimes leading to foot amputations, Collins said. An early warning system could prevent expensive and painful surgery, he noted.

Collins said that part of the problem is that "the medical world and wireless world really don't have a lot of commonalities, and bringing wireless into these health devices is still something the FDA is trying to understand themselves." The FDA's reviews are more rigorous than reviews for standard wireless products, he noted.

Ultimately, the Healthphone could be used to monitor pills packaged with RFID transmitters to track the medication as it travels through the body, noting the locations where the medication disperses. In turn, such information could be transmitted wirelessly to a doctor or a drug researcher, Collins said. "There's tremendous value in getting that information on the Internet," he added.

Collins said he is in the early stages of proposing an industry syndicate to help mobile e-health technology designers create an open source of hardware and software, related documentation and testing standards, that can simplify the complexity of building the products and getting them approved by government regulators. Ideally, it would also win easier acceptance by insurance companies.

"It's difficult for any single product company to do all that's needed" for designing and bringing a product to market, Collins said. A typical wireless gateway like the Healthphone could have five different radios inside, each with its own hardware and software, but some commonly shared approach for open source technology could help, he added.

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