“A medical device is anything that is neither a drug nor a biologic product,” Karen Rosales, details in her report entitled “Medical Device Clinical Trials: What We Should Know.”

“Medical devices usually work physically,” she continues, “while pharmaceutical products usually work chemically or biologically.” Getting such a device approved takes lots of time, work and commitment. With proper guidance, though, it is attainable.

Getting approved

Medical device approval starts with a premarket approval application process and a study confirming the device’s effectiveness. “You do all this testing until you’re satisfied that all the risks you can think of are mitigated,” explains Michael Otlewski, M.S. and clinical program scientist at MED Institute. “You have to think, ‘Do the benefits outweigh the risks?’”

Many manufacturers consider the “Grandmother Test,” asking whether they’d allow the device to be used on their own grandmother.

“'You do all this testing until you’re satisfied that all the risks you can think of are mitigated.'”

Pharmaceutical vs. device

While pharmaceutical clinical studies can have up to four phases, many medical devices don’t require any clinical studies. Still, medical devices are classified into Class I, II and III, with Class III devices being highest risk and considered “life-sustaining devices,” such as a pacemaker.

During device clinical trials, three things are evaluated: safety; whether the device is effective and performs as expected; and does it provide a better outcome than the current standard of care, such as products already approved. Studies are overseen and approved by an institutional review board.

Shoring up safety and ethics

Safety matters. The priority? “Making sure patients are protected,” answers Sandy Maddock, R.N. and the president of IMARC Research, Inc.

To do that, she continues, the review board ensures “that no one’s getting enrolled that shouldn’t be enrolled and that data that will eventually be submitted to the FDA has integrity.”

Investigators must provide accurate data to regulatory authorities and consumers, too. “Patients want to get better,” says William D. Voorhees III, vice president and chief science officer of MED Institute. To him, the benefits are mutual: “They certainly want to hope your device is the one to help them get better.”