Device sponsor, consultant give insider look at industry
Device trial industry is growing
Just as clinical research sites might market their services to device companies, so might device companies market their trials to CR sites.
"Finding sites is a huge challenge," says Deborah Schenberger, PhD, a research analyst for Nerac based in Tolland, CT. Nerac is a research and advisory firm for biomedical and other new products and technologies.
One recent problem involves federal regulatory attention paid to consulting relationships between orthopedic surgeons and device companies, she notes.
"The orthopedic industry just got slammed for having orthopedic surgeons as consultants where they were given monetary compensation for using the product," she explains. "So now they are under a [regulatory] cloud and have to report all of those kinds of activities to the Food & Drug Administration (FDA)."
Federal officials have alleged that consulting agreements between orthopedic surgeons and medical device companies violated anti-kickback laws because the surgeons often received the funds for the hidden purpose of merely using the company's devices, according to media reports.
This has made orthopedic surgeons less willing to sign clinical trial contracts, Schenberger adds.
Even with this challenge, the medical device research industry is braced for growth over the next few years, Schenberger says.
"All class 2 and 3 devices are now going to require clinical evidence that they're safe and effective," she says. "If you can't do an adequate literature review, then you might be required to do a clinical trial under new regulatory changes."
On the positive side, device trials are easier to conduct than drug trials, says Kathi Durdon, MA, CCRP, clinical operations associate with Welch Allyn Inc., a device company based in Skaneateles Falls, NY.
"Studies with non-significant risk might not last very long, maybe from one day to three weeks," Durdon says. "That makes the infrastructure requirement that much easier to build."
Also, some device studies are validation studies in which the medical device companies brings research physicians the device, trains them how to use it, and then lets them use it for a time while collecting information about their experience, Durdon explains.
"It's a relatively easy thing to do," she adds.
Another difference between device and pharmaceutical trials is there typically are fewer adverse events to report in device trials, Durdon says.
"We only report serious events, and the sponsor makes the determination about how it's reported," he says.
Pharmaceutical companies are moving toward this practice because of the recent trend of IRBs being inundated with adverse event reports that may be unrelated to the drug being studied and that take away from the IRB's work on other tasks, Durdon says.
"The device industry had this process right from the get-go," she adds. "Device regulations are newer, tailored to devices."
For instance, an investigator can test a device to a product that's already on the market and that's functionally equivalent and take a faster path to getting the new product approved by the FDA, she explains.
Another area for investigations involves testing user manuals and making sure a product meets its users' needs, Durdon says.
"For the most part, the best way to test usability and customer preference is through clinical trials," Durdon says.
Simulator facilities are useful for pre-validation testing, but it's important to take the prototype out to health care organizations and test its usability, she adds.
"We have a FlexiPort blood pressure cuff, and we tested that cuff throughout its design process and worked out all of the bugs," Durdon explains. "We asked principal investigators and nurses to tell us what they liked and didn't like."
Welch Allyn officials learned from these usability tests that nurses loved having the port on the cuff because they could quickly deflate the cuff by popping off the connector, Durdon says.
"These are the kinds of things you find out," she adds. "This is a novel technology, and we needed to make sure the cuff wasn't deflating improperly and that it gave us the same measurement as a variety of competitor cuffs."
One study had nurses use the new technology without any instructions in a controlled hospital environment.
"We did several in-house studies to begin with and had nurses and biomedical engineers come in three to four times," Durdon says. "Then we did several small private practice and nursing home studies with about 10 sites."
Just as clinical research sites might market their services to device companies, so might device companies market their trials to CR sites.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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