Thomas Painter was lounging on his daughter’s sun-drenched patio in Garden Grove one recent morning when his world suddenly went dark.
Within an hour, Painter, 82, a retired machinist from England with a history of heart problems, was rushed to the cardiology ward at UC Irvine Medical Center in Orange.
Not only did Painter unexpectedly become part of the clinical trials for a new computerized heartbeat regulator, but he became involved in an experiment of sorts in how to get a medical device through the Food and Drug Administration as quickly as possible.
At a time when most medical device companies are complaining about a slow FDA approval process, Cardiac Science Inc., which invented the machine, may be setting out a blueprint for dealing with the federal regulator.
“We’ve had no problem with the FDA at all,” said Chairman Howard K. Cooper. “I’ve heard the (horror) stories, but for me it’s been very progressive.”
Here is how the process usually works, with frustrating consequences for everyone:
Device makers with an untested product first go to the FDA for an investigational device exemption (IDE), which allows doctors to test patients. Procuring the IDE takes about 30 days, and does not require companies to show precisely how they will test products or how long clinical trials will take.
The application process starts only after the clinical trials are completed and the data is gathered. For many companies, trouble begins when FDA reviewers find fault in the tests and force them to schedule more trials. The extra testing is time-consuming and costly.
Following an approach now advocated by FDA Commissioner David A. Kessler, Cardiac Science met with the FDA before receiving its IDE to discuss how clinical trials should be performed. As a result, the company said it expects few, if any, problems when it submits its application this year.
“It is much easier to approve an application that is designed well,” Kessler said. “Unless we collectively approach each other with questions up front and understand the advantages, we’re not going to make the kinds of inroads necessary for change.”
David Anast, publisher of the Costa Mesa-based Biomedical Market Newsletter, said such a system would save the industry millions of dollars in research and development funds each year. “It would make an immediate impact,” he said. “Just think of the opportunities.”
The exemption that Cardiac Science received has allowed the company to go to UC Irvine Medical Center and launch the first of three clinical trial phases.
As part of the first phase, which began a month ago, cardiologists taped electrodes to Painter’s heart and recorded his irregular heartbeat. In later tests, the machine’s computer will deliver a shock to the patient, causing the heartbeat to return to normal.
Eventually, the tests on Thomas Painter’s heart will become part of Cardiac Science’s FDA application.
“I think it’s nice,” Painter said softly as doctors adjusted the electrodes on his bare chest. “But it’ll be nicer when I go home.”