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SPIE Professional January 2012

Imaging inside the eye

A technology engineer and entrepreneur goes on a mission to save retinas and lives.

By Kathy Sheehan

OPTOS image inside an eye

Douglas Anderson didn't have any specialized knowledge about optics, medical imaging, or ophthalmology when his 5-year-old son lost the sight in his right eye in 1990.

What the design engineer from Scotland did have was a personal and professional challenge, a blank piece of paper on which to devise a solution for his son's problem, a great deal of persistence, and a fair amount of impertinence. His innovative approach to developing a patient-friendly device that would image the whole retina without dilating the pupil helped save the sight in his son's left eye. It has also led to a revolution in the way health-care professionals perform routine eye exams today and diagnose non-eye diseases such as diabetes as well.

His quest resulted in Optos, a successful optics business he founded in 1992 that has since produced some 4000 retinal scanning devices that capture an ultra-widefield image (82%) of the retina without dilating patients' pupils. The device has been used more than 30 million times on patients in 17 countries around the world and earned him the 2008 European Inventor of the Year award.

The story about the design and commercialization of the widefield scanning laser ophthalmoscope provides some lessons for technology engineers and future entrepreneurs.


 Photos courtesy Douglas and Leif Anderson
Standard eye exams primitive

Anderson's motivation was spurred when his son, Leif (above), developed severe myopia at a very young age. People with severe myopia are at high risk of developing retinal detachment, so young Leif had regular eye exams. Despite careful monitoring, however, Leif incurred a spontaneous retinal detachment and lost sight in one eye. Leif's eye exams had missed signs of deterioration.

Soon afterwards, Leif had prophylactic surgery on the left eye to diagnose and repair small perforations in the very far periphery of the retina. He had standard follow-up exams after that. The technique, which is still widely used, consists of dilating the pupil with some drops and shining a bright light so the doctor can manually observe the center of the eye.

The exam is uncomfortable for most patients, especially children, gets at only a tiny fraction of the eye, and doesn't leave a record to compare with future eye exams. To see more, a patient would have to undergo general anesthesia, a risky venture.

Anderson carefully observed Leif's follow-up exams and challenged the doctor who told him that Leif's vision health was fine.

"You can't possibly say that's fine," a cheeky Anderson told the doctor, who later acknowledged that the best he could get was a "glimpse" of the center of Leif's eye.

"A glimpse to me didn't seem to be an appropriate measure of a satisfactory examination," Anderson said. "You cannot properly examine a 5-year-old who's at risk of retinal detachment other than with a general anesthetic."

What other health-care modality works on "that kind of primitive basis," he asked, where regular "wellness" exams are recommended but the exams are done without imaging techniques, baselines, or clear records? "That didn't seem logical to me at all," he said. "That sounds like something that needs to be fixed."

Status quo is challenged

So Anderson, an experienced mountaineer who had been developing products for 20 years, created a team at his consulting business to come up with a patient- and user-friendly detection device and/or method that could visualize the whole retina without dilation or discomfort.

One of the first ideas drew from his experience exploring the Arctic. Climbers who develop frostbite first see signs of the problem in their extremities. It seemed reasonable to Anderson that since eye problems, which are often asymptomatic, also develop in the periphery regions, an examination of the eye should be for the whole eye, not just a glimpse of the central part.

The first two teams assigned to his project came up with all kinds of good ideas, Anderson says, but none addressed all of the problems. Either the imaging didn't extend to the periphery of the eye where many problems do, indeed, first manifest, or you needed a cooperative patient and a very bright light.

New device and modality

Anderson learned from the two teams that engineers can really struggle with a blank piece of paper. A new device that is accurate, comprehensive, and patient-friendly isn't exactly a technical spec that an engineer can run with.

A much easier design proposition is to take a successful process or device and make it bigger, smaller, faster, or cheaper. His engineers came up with ideas that solved individual problems with the standard exam, but they didn't address all the problems and all the key human factors.

But the third team was successful in 1995.


 Optos P200 machine

"What we were really doing here was introducing a completely new imaging modality," he says. By this time, "there were cameras around, but these were used after you had done the manual detection. And you needed the skilled person (to conduct the exam), you needed a cooperative patient, and then you could get in there and do a bit of photography."

In addition, the conventional technique used a bright light. As more and more light filters into the pupil, the pupil contracts, and the area to be examined and imaged gets smaller and smaller. "If you want to scan the entire retina, then you actually have to have a scan point which is internal to the eye" and be able to pivot the light in the pupil plane, Anderson says. How could you possibly do that without being intrusive?

Laser and mirror solution

The engineers found a way using a laser and an ellipsoidal mirror to essentially place a scanner inside the eye.

The virtual scan with "optomap" technology doesn't look at the whole image at any one instant, Anderson says. "We just inject a tiny, tiny little spot - and then we move that spot and just take the reflection of the spot at any instant and plot it on a screen. So it's a kind of raster scan. We measure the spot as it moves across the retina. We have to do that very quickly because you blink. And we also don't wish to cause the iris to react."

The lasers in the optomap device scan the entire retina in 0.2 seconds, taking 30 million measurements. "The patients' retinas never perceive the light to be sufficiently bright to cause that pupil to contract."

 The Optomap® is a versatile instrument which allows the practitioner to use ultra-widefield digital retinal imaging.

The engineering problem was solved with an ellipse, a basic optical component with two foci. If you put light in one of the foci, it will come out the other.

"So we constructed our physical scanner at one point, and we fire a beam out from this point. It's coupled to a second focus point, which is essentially a point in free space. If you place a patient's eye over that second focus point, you'll have effectively placed a scanner internal to the eye."

Pay-per-scan business model

With the engineering challenge solved, Anderson thought he would have an easy time making a prototype and interesting someone into buying and marketing his technology. He did not aspire to go down the entrepreneurial path and establish a leading medical technology company.

But eye doctors and technology companies didn't believe such a device was needed or would really work. Consumers seemed perfectly content with the standard exam when they had no symptoms, he says. And practitioners at small- and medium-sized eye clinics weren't willing to replace $10,000 worth of standard examining equipment for a new device that would cost about $100,000.

Venture capitalists weren't interested in investing in the company he eventually founded, Optos, because none saw the market potential either. Besides, Anderson wasn't even a laser engineer.

"I didn't have any credentials other than observation to justify my position," he says. "No one understood a word of what I was saying."

During some of his presentations about his new technology, an eye doctor would look at the widefield image of the retina and ask, "What's that?" Anderson says. "You should know. I'm just an engineer," he wanted to say. "It reinforced the fact that they don't often see very much."

In some ways, the solution to the problem wasn't even a technological one. "It was all about the human factors," Anderson says.

Anderson persisted, though, eventually launching his product in 2000 and creating the initial market for approximately 4000 ultra-widefield retinal-imaging devices by essentially giving them away. In exchange for having no capital cost for the equipment, eye clinics pay Optos about $20 each time an optomap exam is administered.

That innovative business model figured heavily into the growth of the company, which now employs about 400 people. Anderson served as CEO for 10 years and is now vice president of global advocacy at Optos.

Without giving the machines away, "we would have been stymied," he says. "We would have had only 100 systems," no recurring revenue model, and little peer acceptance for a totally new modality.

Business venture "just had to be"

Optos went public on the London Stock Exchange in 2006, raising £;50m at that time partly to fund continued growth and partly for equity release from the individuals who invested in the company when VC firms wouldn't.

Douglas Anderson, OPTOS founderBefore the company went public, Optos turned to angel investors for funding about 20 times. "We rarely had enough money to see us through the next three to six months," he says. The company eventually sank about $150 million into product development, manufacturing, and marketing before it got close to a positive cash flow, Anderson says. Optos sales for 2011, which include other medical devices, are estimated at U.S. $143 million. And various pricing plans provide for the outright sale of devices to some customers. "We're not as pure to price as we once were," he says, preferring to offer "whatever suits the commercial environment."

Looking back, Anderson says he is pleasantly surprised and proud at what he accomplished. "I never intended to commercialize it. It was not my intention ever to build it, and certainly never to market it, sell it, support, it, and have a 400-person organization."

Anderson says he "just had to" create the device and the company "because no one else would believe in the product."

Panoramic retinal imaging has become an important tool for the screening and diagnosis of non-eye diseases, such as diabetes, hypertension, and certain cancers, as well.

The technology was also responsible for saving Leif's sight a second time, when he suddenly lost vision in his left eye at age 21. Fortunately, he was taken to a hospital that had an optomap device. Although there was no one there who could operate it, Leif had done it many times at the Optos factory, so he took images of his own eye. It was immediately obvious that most of his retina had detached.

The severity of the problem was quickly appreciated, and a surgery this time restored his sight.

"It has saved a lot of retinas, and eyesight, and some lives," Anderson says, "and most of the time we've had pretty good fun doing it."

 


Inventor's bio: Douglas Anderson 

Douglas Anderson, OPTOS founderDouglas Crombie Anderson founded Optos in 1992 and has been its vice president of global advocacy since 2009. He served as CEO of Optos until 2002.

He holds a Higher National diploma in Industrial Design from Napier University in Edinburgh (Scotland) and an honorary doctorate of Engineering from Heriot-Watt University in Edinburgh. He is a fellow of the Royal Society of Arts and the Royal Society of Edinburgh and an Officer of the Order of the British Empire (OBE).

The European Commission and European Patent Office named him the 2008 European Inventor of the Year in the SME and research category to recognize his scanning laser technology.

A self-described obsessive winter mountaineer, he and his family have made Arctic expeditions every year for some 30 years.


 Douglas Anderson's family on an Arctic trek.

 


Eyes reveal many diseases

 

Panoramic retinal imaging has become an important tool for the screening and diagnosis of retinal detachment, glaucoma, cataracts, age-related macular degeneration, and other eye problems.

The imaging modality can also indicate evidence of non-eye diseases, such as diabetes, hypertension, and some cancers.

Before optomap, advanced practitioners could sometimes diagnose diabetes through eye exams, but the prevailing thinking was "if there isn't any indication of diabetic retinopathy in the little bit that we can see, it won't be there at all," says Optos founder Douglas Anderson.

"Of course, that's proven not to be the case. We have demonstrated that diabetic retinopathy always starts in the periphery first and in many cases can be clinically significant before showing in the center."

Similarly, Anderson says, age-related macular degeneration (AMD) was presumed to be purely a macular disease. "But nobody had ever looked for indicators anywhere else."

Within the last couple of years, Anderson says, evidence is mounting that AMD may actually be age-related retinal degeneration, with early indicators seen across the entire retina.

 


Future device may be OCT capable

 

Optos plans to launch its next generation optomap device in the first quarter of 2012. The desktop device will be smaller and lighter, weighing about 27 kg (60 lbs.) in contrast to the 150 kg weight of the original device.

The U.S. Food and Drug Administration approved its use in August 2011.

Optos also recently purchased the instrumentation division of Opko Health, which develops, manufactures, and sells optical coherence tomography (OCT) diagnostic devices and optical ultrasound scanners.

CEO Roy Davis says Optos plans to integrate its widefield retinal imaging technology with a widefield OCT capability to bring a new depth of imaging to the periphery of the eye, "creating the ultimate retinal diagnostic tool.

Have a question or comment about this article? Write to us at spieprofessional@spie.org.

DOI: 10.1117/2.4201201.03

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