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.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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]
