The road from physician to physician-entrepreneur has spanned nearly two decades for podiatrist Dr. Todd O’Brien. But he’s now applying his life’s work to an updated and improved digital diagnostic device to help doctors — and eventually patients — check for early signs of nerve damage caused by diabetes.
O’Brien got his first taste of inventing when he completed his residency and took a job developing products for a startup medical device company. That was when he discovered his taste for inventing and got “bit by the entrepreneurship bug,” he said.
While he returned to the full-time practice of podiatry a few years later, he continued to develop simple, niche device solutions that he occasionally licensed out through a company he founded in 1999, O’Brien Medical LLC.
A few years ago, he decided he wanted to take the company a step further, from designing the products to actually making them. “As an inventor, it’s been somewhat of a mixed bag creating these things and trying to license them out,” he said. “I partially wanted more control over the process — they may not make it or market it the way you want to.”
The first device O’Brien’s company will make is less niche and more scalable than previous products. It’s based off a 128-Hz tuning fork, a long-trusted tool used by doctors to measure sensation in the feet of diabetics. Along with other sensation tests, the tuning fork helps them detect signs of diabetic neuropathy, a condition developed by about half of all diabetics in which high blood sugar levels cause damage to the nerves in the body. It’s a precursor to foot ulcers, infections and amputations, O’Brien said.
So the tuning fork test is used in prevention and early detection efforts. The problem is that every doctor administers this test differently and it requires patients to report when they can no longer feel the vibrations the fork produces, which causes a lot of variability in results. To make the test more quantifiable and reproducible, O’Brien has created an electronic device based on the fundamental features of the tuning fork by using vibrations sent through the foot and a digital timer.
A proof-of-concept prototype of NeuroCheck has been developed and used in a small clinical trial comparing the digital device to other neuropathy screening exams, he said. A paper is pending publication and an oral abstract from that paper won O’Brien the top prize at the 2012 American Podiatric Medical Association’s annual meeting.
Over the next few months, O’Brien will work with a design team and engineers to convert that beta version into one that can be mass-produced. He anticipates a 510(k) filing later this winter.
While he estimates the initial market at 250,000 to 300,000 doctors who take care of diabetics on a daily basis, he envisions an at-home application of the technology in the near future. It’s part of a trend he said he’s observed in the consumer world that’s trickling into healthcare: standardizing and updating existing, proven technology for mass use by consumers.
“We could make a wireless device that could communicate with their phone,” O’Brien said. His business plan calls for a consumer version of the device that would cost between $50 and $150, two to three years down the line.
“The main hurdle is interoperability with EMRs and getting all that information back to the doctor with all of the HIPAA regulation,” he said. “The standards haven’t been finalized in terms of how to get this information into the doctor’s systems, but we think they will figure it out by then. There are a lot of device makers that are looking to do this.”
He’s on to something; just look at the blood glucose meter, which revolutionized diabetes care when it moved out of doctors’ offices and into patients’ homes, pockets and purses. O’Brien said he envisions a device that uses the existing technology on a smartphone such as AliveCor and CellScope have done with their consumer diagnostic devices.
Meanwhile, detecting diabetic foot ulcers is already being turned into an at-home effort by Canadian company Orpyx Medical Technologies and Boston-based Rock Health graduate Podimetrics, which are both developing early warning systems.
“It’s going to be a nice leap forward to patient care,” O’Brien said.
[Screen cap from University of Maine video]
One "home diagnostic instrument" I would like to see concerns the assessment of retinal microvascular dysfunction that correlates with brain microvascular dysfunction and, in turn, with risk of stroke:
Retinal microvascular dysfunction can be measured by the microvascular response to flickering light. This reponse could conceivably be measured by a digital camera modified to admnister flickering light to the non-dilated pupil and record the response of the microvasculature to that flickering light. A normal resonse is vasodilitation of a certain magnitude over a certain time to the flickering light.
For people with diabetic peripheral neuropathy identified by Dr. O'Briens techniques there could also be identification of endothelial dysfunction as a contributor to the neurovascular component of diabetic peripheral neuropathy using a laptop computer, attached toe temperature probe and delineation of temperature curves in Wolfram's Mathematica upon application of a thigh cuff for five minutes with a pressure over systolic AND the recording of the temperature curve in the laptop computer before, during and after application of the cuffed pressure. If endothelial dysfunction is thereby identified in the microvasculature of the toe, one could then "self-care" with over-the-counter Benfotiamine for treatment of the pain of diabetic peripheral neuropathy. One could also advise this in patients who have diabetes and have pain on the bottom of the foot without Dr. OBrien's or this endothelial dysfunction measurement.
@Charles Beauchamp MD Interesting ideas. Do you think a digital camera could really measure retinal vasodilitation/constriction?
@Todd OBrien No a digital camera alone could not really measure retinal vasodil / vasoconstriction; There would have to be optics integrated with a database but potentiall if a light flickering capability could be integrated with a digital camera and then a retiana video taken before, during, after the flickering light AND the video loaded into an analysis program like Wolfram's Mathematica it could be done. That is my dream at least.