STUMBLING BLOCKS

The potential stumbling blocks go beyond the design of clinical trials. Researchers and medical device executives say they still have plenty of work to do to make sure they have a system that functions properly.

While the technology has come a long way from the refrigerator-sized machines developed in the 1970s for hospital use, many of the systems are still using laptops to run the software program instead of more portable devices.

Medtronic Chief Executive Omar Ishrak said the company is committed to developing the technology, but there are many technical and clinical hurdles yet to cross. He says it will take a decade or so before a system is ready.

“It’s early enough for me to not even think about products,” Ishrak said. “We can do demonstrations and we’ve done clinical studies here and there, but we don’t have a product.”

Boston University’s Ed Damiano is part of a team developing an artificial pancreas system that uses both insulin and glucagon, a hormone released by the pancreas to raise blood sugar levels when they drop too low. He says blaming the FDA will not help scientists work out the kinks in the devices.

Damiano, like Brewer and Zimliki, has a personal stake in getting an artificial pancreas approved.

His son David, now in middle school, developed type 1 diabetes when he was 11 months old. Since he was a baby, Damiano has crept into his son’s room several times a night to check on David’s blood sugar.

David’s blood sugar levels have been in the normal range for most of his life. Damiano wants him to have a system that helps ensure his good health when David goes off to college.

“We’ve got seven years,” Damiano said. “It’s important.” (

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By Julie Steenhuysen