SLOWING DOWN RESEARCH

It’s not just the JDRF that is complaining.

A survey of 150 firms from the National Venture Capital Association, released in October, shows that venture capitalists have been cutting back on their investments in medical-device companies, blaming regulatory hurdles at the FDA.

Investment in medical devices last year fell to $2.38 billion from $2.62 billion in 2009 and $3.52 billion in 2008, according to the survey.

While U.S. researchers have been allowed to test artificial pancreas systems in carefully supervised hospital studies, they need to be tested outside of the clinic in real-world settings to see how well they work. That has forced many to seek research partners abroad.

“We have needed to collaborate offshore and continue to do so just because it was taking us so long to get these regulatory approvals,” said Dr. Howard Zisser of the Sansum Diabetes Research Institute in Santa Barbara.

Zisser and Frank Doyle, a chemical engineer at University of California Santa Barbara, have developed the “brain” portion of an artificial pancreas system - a software program that uses blood sugar readings sent wirelessly from a continuous glucose monitor and tells the pump how much insulin to give.

So far, the software from this team can work with pumps from Insulet Corp and Animas, a unit of Johnson & Johnson. And it works with sensors from Abbott Laboratories, Dexcom Inc and Roche Holding. That allows components from different device makers to become part of one artificial pancreas system, a new approach for medical technology.

In October, Zisser, Doyle and other members of an international consortium won a $4.5 million National Institutes of Health grant to test the technology in challenging settings. The group has run two pilot studies in Italy and in France.

In these trials, study volunteers placed the control of their disease in the hands of the device while they dined in a restaurant and slept overnight in a hotel. Research teams huddled in nearby rooms wirelessly monitoring their progress.

Zisser says it will be challenging for the FDA to feel confident with these kinds of trials. But there has been progress. The agency last month gave the green light for Medtronic to begin an in-home clinical trial of a low glucose suspend system in the United States.

Dr. Francine Kaufman, former president of the American Diabetes Association and chief medical officer for Medtronic’s diabetes business, says the company worked hard with the FDA to reach agreement on the trial design.

It will not be easy. The company must find a group of diabetics who are especially prone to hypoglycemia and they will try to show that the device is not only safe, but that it reduces such episodes.

“We’ve agreed to do it. We’ll start that trial and get our way down the path,” Kaufman said.