M. James Barrett and his lean team of scientists and engineers are hot on the trail of overcoming a challenge that has stumped medical-device makers for years: developing a fast, accurate blood-sugar monitor small enough to be implanted in diabetics.
Barrett puts the task before him succinctly: "The field is littered with the dead bodies of those who have tried and failed at this."
Nevertheless, the 56-year-old executive is no stranger to the high-wire risk involved in launching a new company to develop breakthrough technologies. Among his recent accomplishments: He started and headed up one of the first companies to test gene therapy in humans, Gaithersburg, Md.-based Genetic Therapy Inc.
In fact, said those who know Barrett well, it's the derring-do involved with the micro-sensor project that may have enticed him out of semi-retirement last year to head up the new company, Germantown-based Sensors for Medicine and Technology, dedicated to developing and commercializing the glucose device.
"Jim has an uncanny ability to look at a new technology and see the future of where it can go, and the importance of getting there," said French Anderson, director of USC's gene therapy laboratories and a former National Institutes of Health researcher.
In 1987, Anderson and Barrett co-founded Genetic Therapy Inc. to capitalize on Anderson's groundbreaking work on gene therapy at a time when many skeptics were predicting that the obstacles were so great that it could take 30 years to get to human testing.
Anderson recalls it was Barrett's vision of how the technology should be developed--and then his focusing all of GTI's resources on achieving that goal--that led to the company and the NIH winning government approval just three years later for the first human test.
Barrett stepped down from GTI in July 1996, a year after the former Sandoz Pharmaceuticals Ltd., now Novartis, bought the company for $295 million. In his latest venture, Barrett, who holds degrees in chemistry, biochemistry and business administration, is focusing on a tiny sensor developed by Arthur "Skip" Colvin, a former research scientist who had worked under him in the mid-1980s at Bethesda Research Laboratories, now Life Technologies Inc.
Said Barrett, "Let's face it, you only go around once in life and you might as well do something that is worthwhile. To me, this technology has enormous potential to make a lasting difference in people's lives and if we make money doing it, that's worthwhile too."
Barrett will need more than altruism to make Sensors for Medicine a success, said analysts of the medical-device industry.
For one, it faces competition. At least three other small U.S. companies are attempting to develop devices to make glucose monitoring easier. They include MiniMed Inc. of Sylmar, SpectRX of New York, and Implanted BioSystems Inc., a subsidiary of Synthetic Blood International, of Kettering, Ohio. All are publicly held.
Also, regulatory and government hurdles still must be overcome. Chief among them is tweaking the design of a molecule to be embedded on a microchip that will monitor blood glucose levels.
If Sensors for Medicine is successful, the glucose monitoring device has huge market potential.
There are an estimated 8 million diagnosed diabetics in the United States, the American Diabetes Assn. says. An estimated 8 million others are either misdiagnosed or undiagnosed. Also, it is one of the fastest growing chronic diseases in the country.
The market for blood glucose monitoring strips and meters is estimated by analysts to be a $2.5-billion global industry.
It's unclear yet whether Sensors for Medicine's device would replace how diabetics monitor their blood sugar levels today or if big medical equipment companies would be interested in licensing it for sale. But the patented technology behind the device has potential applications in industries as diverse as pollution control monitoring and food packaging, said Charles W. Newhall III, of Baltimore-based New Enterprise Associates, the venture capital group backing Sensors for Medicine with $2 million in seed financing.
Meanwhile, there is an enormous need for a simpler way to monitor a diabetic's blood sugar than the way it is commonly done today, diabetes experts say.
Diabetics monitor their blood glucose levels by taking a blood sample up to eight times a day by pricking a finger and swabbing the sample on a small strip treated with an enzyme. The strip is fed into a hand-sized meter, which provides a blood sugar level reading. From that, a diabetic can determine whether an insulin shot is needed.
The process can be painful, particularly for children and the elderly, and requires daily discipline.
As a result, parents of young children anguish over the regimen, and many diabetics don't take regular readings. That can lead to complications and worsening of the disease.
Barrett said he expects in a few months to have a clearer picture of his company's chances for success. That's when Colvin and other researchers should wrap up work on the blood sugar-recognizing molecule, and Barrett wants to pitch investors for more funding.
Engineers at Sensors for Medicine have designed a microchip as small as the eye on a Lincoln penny on which the new molecule will be embedded.
The chip would then be injected into the fatty tissue layer of a diabetic's arm or other area. From there, it would transmit blood glucose readings to a meter worn on the wrist like a watch.
The sensor uses a common light-emitting diode, the same light source found in calculators and other consumer electronics to "excite" the fluorescence of Colvin's indicator molecule. The light from the fluorescence is affected by the presence of glucose molecules. Another diode tracks the weakness or brightness of the fluorescence and sends a signal to a wrist meter.
The sensor would be run by a power source in the wrist device, eliminating the need for a battery implanted in the sensor.
As Newhall puts it, the appeal--and potential pitfall--of Colvin's invention is that it has "literally hundreds of potential applications" in a diverse array of industries.
Where Barrett's skill came to bear early on the technology was in determining which application to target first and then getting everyone, from investors to company engineers, focused on that one goal, said Colvin, the inventor.
Colvin said he started out attempting to design a new sensor for the fermentation industry. But after he approached Barrett for advice on how to market the invention, Barrett suggested a better opportunity may lie in medicine.
"The great thing about Jim is, he not only has sharp business judgment, but he's deep technically," Colvin said. "He doesn't get mired in the details of what an engineer may be working on, but he understands a lot of complex disciplines and can see the broad picture."