Dawn A. Lissy, president of Empirical Testing Corp., was a part of the staff written article, “It Begins and Ends with Testing.” She took time to present a full array of responses that were not able to be included in the article, so they are presented here.
Q: What benefits does the UDI rule offer as far as the testing of medical devices?
Lissy: Unique Device Identification really does not affect the testing of medical devices. It’s designed to make items more easily identifiable in a hospital setting; it does not influence the outcome of mechanical testing.
Q: What’s the most common error OEMs make when it comes to establishing a testing regimen for a device?
Lissy: The most common mistakes I see seem to come back to a lack of experience on the part of the testing company. Yes, there are standards we all follow, but those standards are followed based on subjective interpretation, which can leave a lot of room for error. So even if two testing labs are following the same standard, they may not be testing in the same manner (variances in environment, frequency, materials of test fixtures, etc.), and that will affect your results. There’s also some latitude in the standards that allow test labs to take in their setups, which again means your results may vary from test to test and lab to lab.
For example, one type of device may call for three different static tests and three dynamic tests. Someone with less experience may not know which standard static tests are best suited for that particular device, so they may not be testing appropriately (i.e. testing more than is needed for regulatory approval based on that type of device). That means the client is not getting the most for his or her time and money, and it may lead to setbacks as well.
The best way to avoid these potential pitfalls is to ask for references and be sure you’re working with a lab with a proven track record of consistency, integrity and customer service.
Q: How does device testing in the design phase alleviate problems discovered further into development or manufacturing?
Lissy: Feasibility testing is frequently used to make sure you’re going to hit the minimum criteria before you pay for and wait on a full battery of tests. It lets you know if a device is on the right track and can save you significant time and money if you uncover an issue early that you can correct before a full battery of tests. The full range of testing may require as many as 50 devices, 8-12 weeks of work and $20,000 -$50,000. For feasibility testing, you can often test 8-12 specimens over a shorter period of time for a lower cost and gut-check acceptance criteria. It’s like a preview of the full range of tests. Yes, it’s an additional commitment of time and money, but it’s often well worth it because it can save a company considerable time and money (manufacturing more test specimens than are needed, extra unnecessary testing, etc).
Q: How can device manufacturers realize cost savings through efficient testing?
Lissy: If a manufacturer is working with an experienced, reputable testing lab, that lab will stop the testing process as soon as it’s clear there’s an issue that requires further work from the manufacturers. Some labs will continue to run a full battery of tests even if an early test reveals a fault or problem that will prevent approval. At ETC, we consider that a waste of time and money for our clients. We stop the process early on if it’s clear the device isn’t ready. This usually occurs in the event that the manufacturer skips feasibility testing and goes straight to the full battery of tests.
Q: How do you respond to the questions over the safety of medical devices and the lack of testing of them?
Lissy: I am not sure there is a place where there exists the “lack of testing medical devices”. All Class II and Class III devices have to go through some level of mechanical testing as a measure of safety. The level of testing varies based on the device. The FDA has the strictest requirements in the world, ensuring that the US population is safe with the medical devices that are on the market. Class I devices are basically “over-the-counter” devices like orthotics and wheel chairs. Conscientious engineers will run tests to make sure their products are safe and efficient for the sake of staying competitive in the market place.
Q: Any additional thoughts or comments on testing that you’d like to share with the medical device design/manufacturing industry?
Lissy: I’m very excited and proud to be a part of the FDA’s Entrepreneurs-in-Residence Tactical Team. I’m working with seven other medical industry experts and FDA staff to develop new tools and policies to improve the FDA approval process, with regard to clinical trials. The goal is to maintain the integrity of the process while decreasing its complexity and the time it takes to get innovative devices into the marketplace. I look forward to working with professionals from all points of the process to get their feedback on how we can improve this critical process.