The Top 7 Reasons Why Medical Devices FailDec 06, 2018
Medical device failures are typically the result of deficiencies in safety check procedures or a lack of attention to potential risks in the design process. Often displaying an eagerness to expedite a device's introduction to the market, device manufacturers may pay scant attention to the need for testing, robust components, and rigorous quality control procedures. Below is a look at the top seven reasons why medical devices fail along with some tips for avoiding those pitfalls.
1) Medical device startup owners fail to assemble competent teams
Research indicates that approximately 75% of medical device companies fail or never make it to market. In many cases, startup owners have a brilliant vision but are unable to assemble a team of professionals to build, test, and market their devices. As a result, many devices are poorly constructed and fail to perform consistently.
2) Failure to properly test the device
"Over 90% of electrical medical devices that Intertek has tested have failed to comply with the required standards on the first submission."
Rigorous testing is the cornerstone of a successful medical device launch. Unfortunately, medical device startups often ignore the importance of testing in their rush to introduce their devices to the marketplace. Testing should occur throughout the manufacturing process and prior to introducing the device to the market. Ideally, testing should be undertaken by an established, independent, and approved testing company with decades of expertise in medical device compliance.
3) Use of poor quality components and materials
There is no substitute for high-quality components when manufacturing medical devices. Some manufacturers attempt to reduce costs by using low-grade stainless steel, flimsy tubing, or poor-quality fittings and connectors. Substandard parts can limit a device's reliability and longevity. Manufacturers can avoid this pitfall by carefully researching vendors and scheduling a site visit before committing to suppliers of critical components.
Learn more about mitigating risk in our white paper MedTech Supply Chain Strategies: How to grow faster with less risk by leveraging your manufacturing partners
4) A lack of quality control procedures
The quality control (QC) process is vital to ensuring that medical devices are intact and function according to set manufacturer specifications. Failure to devote proper attention to this phase of the manufacturing process can result in an abnormally high number of out of box device failures. Manufacturers can help
5) Use of accessories other than those fabricated by the manufacturer
This problem usually arises once a device is in the hands of a user. Typically in an effort to save money, device users will often attempt to use accessories or components that were not specifically designed for use with that device. While this strategy will sometimes work, users run the risk of damaging devices by trying to use generic accessories or replacement components. Manufacturers can help prevent this problem by clearly instructing operators to use proprietary cables or accessories.
6) Insufficient maintenance
Most medical devices require maintenance on an annual or semi-annual basis. Through proper testing and analysis, manufacturers should be able to pinpoint specific maintenance needs and outline a preventive maintenance schedule for devices. Failure to undertake this step by creating a service manual can result in device failures and uncertainty about the proper way to address them.
7) Reusing single-use devices and accessories
"The trend toward single-use devices has been matched by the trend to reprocess single-use devices. In part, this was the result of healthcare organizations seeking cost savings by reprocessing instead of using a single-use device once and then discarding."
- Joint Commission International
The practice of reusing single-use devices is on the rise. In fact, the problem has become so pronounced that it has attracted the attention of Joint Commission International and other prominent agencies. Fortunately, this pitfall can often be corrected by highlighting the nature of single-use devices and the consequences of reusing them.
Medical device failures can result from a wide array of errors during and after the product development cycle. The first step in reducing the number of device failures is to recognize the pitfalls outlined above and introduce the proper safety checks to prevent them. In particular, medical device startup owners should be educated about these production flaws and receive guidance on proper testing and quality control procedures.
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- The Evolution of US Medical Device Regulation
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