In So Many Words is a timely chat with an ophthalmic industry thought leader.

As president and CEO of Diopsys since 2000, Joseph Fontanetta has strived to change how ophthalmologists view their patients. With the company’s ARGOS and NOVA vision testing systems, Mr. Fontanetta and the Diopsys team have brought objective retinal testing from the hospital to the clinic. Diopsys started by offering visual evoked potential (VEP) testing to gauge visual pathway functionality, then introduced new modules to test the retina using pattern and flash electroretinography (ERG). Mr. Fontanetta sees this technology as both a help to patients and a way to reduce the financial burden on the health-care system.

Ophthalmology Management: What was the origin of Diopsys’ vision testing systems?

Joseph Fontanetta: Visual electrophysiology has always been an accepted diagnostic testing method for subclinical disorders of the visual pathway. The product that eventually became Diopsys’ visual evoked potential (VEP) test was originally developed by scientists at Rockefeller University in New York, and developed with a governmental grant. The mandate from the government was to make an objective ophthalmic test that could be used on people with disabilities — individuals who might have trouble taking more traditional and subjective ophthalmic exams. The device they developed was called the Venus system and was marketed by a company called Neuroscientific. The founders of Diopsys saw the value in providing to ophthalmologists objective testing like the Venus and acquired the technology in 1998. In 2005, Diopsys introduced its VEP series for use in physician practices.

OM: What is the value of this kind of objective data?

JF: The earliest stages of ophthalmic disorders often affect the ganglion cells in the retina. That’s the stage when the disease is most receptive to treatment. These diseases tend to occur in older patients, who have a harder time with eye exams. Servicing those patients was an important motivation for Diopsys.

As the company was getting off the ground, we met with a well-known glaucoma specialist who said that when he has patients with testing difficulties, he sends them to an electrophysiology lab in New York; the specialist said it would be nice to have something like that in the office instead. A number of companies had previously been providing electrophysiology tests, but their targets were mostly major hospital centers. Diopsys was the first to take that technology, pair it with fast personal computers and make a product user-friendly enough for both patients and physicians so that it could be used in a clinic or private practice.

OM: What retinal issues have Diopsys’ electrophysiology tests been the most useful in diagnosing?

JF: Our vision system accomplishes two things: It helps detect disease and also helps evaluate the effectiveness of treatment. Our main focuses are glaucoma, diabetic retinopathy, maculopathy, media opacities and central retinal vein occlusion.

By objectively testing retinal function, doctors have a clearer picture of a disease. In addition to the clinical benefits for patients, earlier and appropriate treatment can help lessen the economic burden on the health-care system. For example, in the United States glaucoma costs $5.8 billion annually. These costs will continue to grow if we don’t catch the disease early.

In the case of people with elevated intraocular pressure, some studies say 90% of people with this glaucoma risk factor never convert to glaucoma. So, those 90% are a huge economic burden on the health-care system; while their IOP appears high, it’s actually normal for their body. Since our device looks at the function of the retina, we can let the doctor see that patient’s eyes’ function is normal, and thereby avoid unnecessary treatment.

OM: Has demand for this technology changed since its introduction?

JF: It has increased as the years have gone by. We now have more than 2,000 physicians utilizing our products in the U.S. We recently started selling internationally. What has helped us over the years is the support of many physicians who are well-recognized in their specialty. As they have used our products, they write articles and present case studies discussing how effective they are. The AAO also includes the use of electroretinography in its Basic and Clinical Science Course for Glaucoma.

OM: Can you give us any anecdotes about how the testing has made a difference in diagnosis?

JF: We have several stories. Early on in the company’s history, our test found a retinoblastoma in a small child. The child went from the pediatrician’s office to treatment at Yale in 24 hours. There were able to keep the cancer from spreading and save her vision thanks to the early detection.

More recently, a physician who spoke at a medical conference said he had been a doctor for 30 years and that prior to using our system, he was only able to diagnose patients when they had already lost part of their vision. Now, with the ability to detect injured or damaged ganglion cells, he can help restore vision.

OM: Has it been difficult to communicate what it accomplishes for a clinic?

JF: Traditionally in medicine, anything that comes to the market as a new product gets questioned on its capabilities and advantages. The additional difficulty we had to overcome was visual electrophysiology’s reputation among doctors. All doctors receive courses in electrophysiology in school, but the devices used to introduce treatment have been difficult to operate and didn’t have the fast, easy-to-use computer technology available today. So, last year we established the Diopsys University training program to educate people on our devices. It has made people much more receptive; I wish we had started the program earlier.

OM: As you have said, Diopsys has emphasized making these objective tests accessible to clinics. What is the next step in extending that accessibility?

JF: The goal of any medical device company should be better detection, to help improve patient outcomes and ease the burden on the health-care system. We need to take care of people and do it more efficiently. The reason you want a vision system like Diopsys’ in the clinical setting is to have it where the patient goes the most. The more testing you can put in the clinic, the greater your chance at succeeding at both of those goals.

OM: Has your background as chief operating officer at two hospitals given you special insight into the medical device field?

JF: When you spend your life working side by side with physicians, you learn a lot about what motivates them. One reason I came to Diopsys was that I had watched how new technologies were advancing particular specialties in the hospital environment. When the opportunity to lead Diopsys came, I looked at ophthalmology and saw it was not moving at the same pace. Doctors want to focus on the functions of the body’s organs, and this was a huge opportunity to help with that. Our goal is to continue to positively affect the health-care system, for patients and doctors, and to help reduce the economic burden all of us share as taxpayers. OM