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AAMI, FDA Focus on Merits of Simulation Testing

Simulation testing allows designers and clinicians to explore controlled situations without putting patients at risk, according to Jeff Cooper.

Although usability testing isn’t a replacement for clinical testing, it is gaining interest from industry designers as well as from FDA. Usability testing simulates the real world in a controlled environment, and among its advantages is its ability to keep patients out of harm’s way.

One of the key questions surrounding usability testing is whether it is possible to bring people into a simulated environment in a manner that makes the designer confident about a device’s performance in a clinical environment. When conducting usability testing, representative users perform representative tasks. These tasks enable companies to explore high-risk scenarios that wouldn’t be safe to perform in a real-world clinical setting.

Michael Wiklund says FDA may soon adopt a standard that addresses usability testing guidelines for medical devices.

It is also part of the human factors design process. Human factors isn’t just ergonomics; it’s the interaction process with products on an intellectual level, said Michael Wiklund, president of Wiklund Research & Design (Concord, MA), at the 20th Annual AAMI/FDA International Conference on Medical Device Standards and Regulation in March. He indicated that it looks like FDA is moving toward recognizing IEC 62366:2007, a standard that addresses usability engineering for medical devices. European nations currently recognize this standard.

Isaac Chang, PhD, deputy director of CDRH’s Office of Science and Engineering Laboratories, also spoke at the meeting. He said that FDA finds the use of usability testing and simulation “intriguing.” However, agency staff is currently dealing with the testing method on a case-by-case basis, along with relying on the expertise of industry to help them.

“Human factors is state of the art,” said Wiklund. “A company would be negligent if it didn’t conduct usability testing.” He added that usability testing isn’t a replacement for clinical testing but rather a supplement. Another benefit to simulation testing is that it doesn’t need to be performed by a human factors expert, and behaviors can be recorded without a patient’s consent.

Simulation testing enables education, training, and product testing. It enhances patient care and facilitates R&D, said Jeff Cooper, PhD, executive director of the Center for Medical Simulation at Harvard Medical School (Cambridge, MA). With the advances occurring in technologies such as mannequin simulators, full virtual reality isn’t that far away, he said. The panelists agreed that although simulation testing isn’t a substitute for clinical trials, its benefits in identifying product risks as well as potential new device uses make it an important part of the design process.

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