Rochester-area health care startups are eager to bring new medical technologies and devices to market. The young companies, however, face an uphill climb.
“The climate overall for medical device startups—the one word I would use is ‘challenging,’” says Michael Riedlinger, manager of the Rochester BioVenture Center at High Tech Rochester, a technology firm incubator.
The hurdles are many—and high. After creating a new medical device, startups have to obtain the U.S. Food and Drug Administration’s approval for its use with patients. They may also have to meet insurers’ guidelines to demonstrate the device’s value as a means of maintaining or improving health, as well as convince them to reimburse patients for its purchase.
Finally, they have to market their product to the medical community and patients. As a result, the process of developing and marketing a new medical device is often both lengthy and expensive.
“To successfully bring it to market requires millions of dollars and many years of sustained effort,” Riedlinger says.
Despite such hurdles, some local startups are developing, testing and even manufacturing new medical devices.
Ovitz Corp. CEO and founder Felix Kim came up with an idea for the EyeProfiler in 2013 while doing undergraduate research toward his optics degree at the University of Rochester’s Flaum Eye Institute. The portable, battery-operated device allows an optometrist to measure a patient’s vision when it is held before the person’s eyes.
“(It) can give you a prescription for your eyeglasses,” explains Kim, who graduated this year with a degree in optics. “Just one click, and that’s it.”
EyeProfiler is about half the size of a phone book and has a pistol grip. Because it does not need the bulky, expensive equipment and boxes of lenses now found in optometrists’ offices, the device could be used to bring better eye care to those in rural areas and Third World countries.
“Many people (are) going effectively blind, just because of their uncorrected vision errors,” Kim says.
Ovitz, which opened its doors at the Lennox Tech Enterprise Center in West Henrietta in 2013, has tested the prototype EyeProfiler with a small group of subjects. Kim says the device is provisionally patented, and his firm is preparing to conduct more extensive tests.
Pittsford startup PharmAdva LLC also has a new device in the works, called Dosemgr. If all goes as planned, older adults will have a new means of keeping track of their medications within a few years.
“It stores and sorts pills and prepares doses,” says Jonathan Sacks, CEO, chairman and co-founder of PharmAdva. “Those doses are dispensed automatically to patients.”
Dosemgr—short for dose manager—is geared toward patients over the age of 65 who need to take multiple medications, but have trouble remembering to take them, Sacks says.
Shaped like a 10-inch cube, the device can be loaded with 90-day supplies of up to 16 medications, each of which is kept in its own bin. Dosemgr can read the bar codes from pill bottles and open the appropriate bins for loading.
Once Dosemgr is loaded, the patient or a caregiver can use its touchscreen to program it to dispense the drugs as scheduled. At the appropriate time, the device issues a pre-recorded verbal message reminding the patient to take the medication and dispenses it.
When a patient does not take drugs as scheduled, the Dosemgr notifies the patient, caregiver or both via text message, phone call or email, depending upon its programming. The machine also can be set to notify medical professionals caring for the patient of the missed medication.
Michel Berg M.D., associate professor at the University of Rochester and PharmAdva’s co-founder and chief medical officer, developed the technology used in the Dosemgr, Sacks says. The startup has licensed the technology from UR.
PharmAdva began testing prototype Dosemgrs in March 2013, Sacks says, and has already obtained FDA approval for the device. It plans to produce the first 50 units by December.
Thirty are on order to private individuals, and the remainder will be tested with University of Rochester Medical Center patients who have difficulty taking their medications as scheduled. The pilot program is intended to show health insurance companies the value of reimbursing patients for the purchase of Dosemgrs.
“We need to collect data to show the device reduces medical claims costs,” Sacks says.
PharmAdva expects to sell its first 1,000 Dosemgrs by October 2015, Sacks says, though the market for the devices is much larger than that.
“Our initial target is 4 million patients over the age of 65,” Sacks says.
Another UR licensed technology is helping cancer patients. Raland Therapetics, Inc.’s CytoComm Living Biosensor System helps doctors give their patients the right amounts of drugs during chemotherapy.
“What we’re able to do with this … is actually determine the body’s response biologically and allow the caregiver to adjust the chemotherapy lower or higher to make sure that it’s fully effective,” says Bill Rader, Raland’s president and CEO, who founded the firm in 2011.
Physicians currently use blood tests to estimate the amount of cancer-fighting drugs given to patients. The problem, according to Rader, is that the drugs are toxic by nature, and physicians can only estimate the proper dosage.
“Too much chemo … is toxic,” he explains. “Not enough, and it’s not really effective.”
The CytoComm is designed to give physicians a clearer picture of the effects of chemotherapy in real time, according to Rader. The system consists of a biosensor smaller than a dime and a cellphone-sized transmitter-receiver.
Live cells drawn from the patient are genetically altered to make them respond to the biological changes wrought in the body by chemotherapy. They are placed in the biosensor, which is then implanted in the patient.
“It is slipped subcutaneously into the patient,” Rader explains.
The biosensor detects the cells’ responses to the effects of chemotherapy and transmits the information to the exterior transmitter-receiver outside the body. That device wirelessly transmits the information to a private network that is accessible to physicians. Rader says the data CytoComm provides is as accurate as that found by blood tests, and it is continuously updated.
Raland’s chief medical officer, Spencer Rosero M.D., developed the CytoComm system’s technology, Rader says. Rosero is associate professor of medicine at UR.
Raland has tested CytoComm prototypes with animals; the company plans to market it for the experimental use of breast cancer chemotherapy drugs in animals in about two years. The firm plans to start testing the system with humans at about the same time. Both markets could prove lucrative.
“In humans, we’re talking a billion dollars,” Rader says.
While the markets for new health care devices and technologies appear huge, the odds of overcoming all the hurdles to them can be slim, especially for the uninformed.
“The naive person that starts off on a design—I would say just the raw odds are probably one in a 100 that they will be successful,” Riedlinger says. “The ones that understand what they are getting into, that do their homework and pay attention, it’s probably close to 50-50.”
Mike Costanza is a Rochester-area freelance writer.
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