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Medical equipment testing in the value-based era

John R. Fischer, Senior Reporter | February 24, 2020
From the January/February issue of HealthCare Business News magazine

But constructing such in-house groups can be costly. For some providers, particularly smaller ones, having the OEMs conduct testing makes more sense. Göran Zelander, senior product manager for RaySafe’s diagnostic X-ray portfolio, says the right choice on who conducts testing has a lot to do with the type and complexity of the device.

“If you look at more expensive X-ray environments, like computed mammography labs or interventional suites, it’s going to be almost entirely service contracts handled by the manufacturer because of the complication level and how complex the equipment is, and the knowledge required to test it,” he said. “Traditional X-ray and mobile machines, which you have more of, can sometimes be serviced more by in-house engineers.”

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Karl Ruiter, president of Pronk Technologies, says the decision to test equipment in-house versus having the manufacturer do it can be based on a wide range of factors.

“Maybe the learning curve on a particular device is just very steep, or there may be expensive specialized tools, or the manufacturer does not supply parts or the necessary information for local service,” he said. “Possibly the biomed shop is just looking to outsource some work so it does not have to grow its team. Also, anytime there is a warranty repair required, it makes sense to look at having the manufacturer take care of it. It’s also true that knowledgeable biomedical engineers, on-site, who are seen as part of the team, can bring a lot to the table.”

Abiding by standards
From hospital specifications to ISO guidelines, testing equipment must adhere to a number of standards. Some are required by law while others are not mandatory but strongly encouraged. These guidelines change as technology becomes more sophisticated, with automation, cybersecurity and AI bringing about new advantages and considerations to entire segments of the equipment market. More broadly, regulation is guided by quality of care, user experience, and the diversity of medical equipment needs worldwide.

“If you look at a global level, there will be a lot of testing needs in developing countries such as Brazil and India,” said Zelander. “China is well developed, but from an X-ray equipment viewpoint, it’s very limited in the number of tests per X-ray machine, compared to the U.S. or Western Europe.”

According to Harkless, cost and efficiency demands will lead to more integrated quality assurance processes. Over the next five or ten years, that means testing equipment will move away from the larger instrument models we see today and toward smaller, less expensive solutions.

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