The right stuff: Medical device testing can ensure materials are safe for the market

When a medical device breaks down or malfunctions, it reflects poorly on the facility, may affect the treatment patients receive and requires the organization to make repairs or arrange for replacements. These and other unforeseen results of poorly manufactured medical equipment create huge costs for the facility that uses it. Equipment failure is an inevitable part of nearly any business, but when devices stop working unexpectedly, it places an extra burden on the company.

Not only that, expensive and complex machinery is crucial to effectively treat some patients. What happens when that technology doesn’t work and cannot be quickly and easily replaced? How do hospitals provide the care those patients need?

“One of the most avoidable causes of device failure is inadequate materials testing.”

There are several reasons why a medical device might fail, but one of the most avoidable causes is inadequate materials testing. If the materials used to create a device don’t pass through third-party testing, any defects can pass through unnoticed and contribute to an untimely failure.

All in all, there are numerous costs associated with device failure. But why does this equipment fail in the first place?

Unreliable materials lead to failed equipment
Medical Device and Diagnostic Industry estimates 20 to 30 percent of recent device recalls came primarily from inadequate materials. Additionally, in cases where materials were a secondary factor in device failure, that number could be closer to 50 percent.

The research from MDDI indicated that complex materials were undervalued by failure modes and effects analysis. In other words, manufacturers and end users don’t realize just how important reliable materials can be to the prolonged function of a device. This is important to note, because as medical technology advances, so will the materials used to construct these products. Manufacturers must be certain the materials they use can hold up.

In some cases, these new materials are so cutting-edge, few understand how they will react under a variety of circumstances. Products like hydrogels, nanomaterials, bimaterials and conductive polymers were designed to address a specific need. While those materials may successfully fill a void, they are not exempt from rigorous testing.

Medical device testing can save money in the long run.
Medical device testing can save money in the long run.

How to calculate the cost of failed medical devices
If a piece of medical equipment fails, replacement isn’t as simple as grabbing a spare from the basement. These devices are often expensive and complex, plus they may require professional help to install and set up. Any calculation of cost created by equipment failure cannot only look at how expensive the device was – it must also take into account the downtime and labor involved in setting up a new one.

The downtime is a separate set of costs, comprised of time the equipment takes up space in a room, preventing patients from receiving necessary treatments and keeping technicians from accessing the equipment they need. Determining how much money is lost through downtime can be a difficult thing to ascertain precisely, because it will depend on how much the equipment would have been used if it were available.

Failed equipment doesn’t only cost the hospitals and health center where it’s installed – it is also a drain on the medical equipment industry itself. Device recalls, warning letters, warranties, lawsuits and other events cost the industry between $2.5 and $5 billion every year, according to a McKinsey report. These providers can also lose revenue due to bad publicity after a major recall event.

“Failed devices are a drain on the medical equipment industry itself.”

The cost-benefit analysis
If better materials are the only thing keeping medical device manufacturers from saving billions of dollars a year, why haven’t these businesses taken the appropriate response? It is likely a question of upfront costs and perceived outcome. Some of these manufacturers invest heavily in materials research. Learning those materials aren’t quite ready for the market could be a tough pill to swallow.

But these organizations would be better served by examining those materials on the front end, before including them in products to be shipped off to hospitals and other facilities. Fortunately, there are companies whose entire purpose is to guarantee equipment and materials will perform as expected. It might be an investment in thousands of dollars initially. But if any defects are discovered that would cause that product to fail, that could be millions of dollars in cost avoidance in addition to the other negative aspects that come with malfunctioning medical equipment like putting patients in harm’s way.

With all the focus on producing next-generation materials with cutting edge properties, there must be an equal focus on ensuring these materials are able to live up to the necessary safety standards of today’s hospitals and clinics. That means subjecting every piece of equipment – especially those featuring the latest materials – to ample analytical testing. These independent labs have the tools, expertise and experience required to assess how a product will perform under real-life circumstances. That way, the medical products industry and hospitals can eliminate a large chunk of equipment failures, save money and provide a better experience for patients.