Congratulations! You’ve just come up with a medical implant that’s going to revolutionize knee replacement and earn your company a substantial share of the market. You’ll probably be getting a hefty raise and be invited to speak at countless banquets. Now all that’s left is to have your prototype tested and submitted for approval. Better hurry though—you’re in a race against time and the competition.
Generally speaking, medical device testing can be a lengthy and somewhat expensive procedure. It is therefore recommended that you focus testing on specific areas or types of tests. (If you are unsure about this the test lab should be able to offer suggestions. If not, contact me and I will offer my recommendations.)
MAUDE Reports
Before you launch into a “test everything” mode it’s a good idea to check Maude reports. Manufacturer and User Facility Device Experience (MAUDE) data will let you know of specific adverse events associated with medical devices. Available through the FDA, MAUDE reports will allow you to determine where potential problems are likely to be encountered based on similar implants. The reports contain information (submitted voluntarily) since the early 1990s. While it’s important to note that some information may be excluded via exemptions and variances, MAUDE reports are nonetheless a worthwhile starting point.
Medical Device Reporting Data
Medical Device Reporting (MDR) data contains over 6,000 reports on devices and implants that have failed and resulted in injury, litigation, or death. The FDA web site contains a data base search feature that allows visitors to look up MAUDE reports based on a number of criteria. This is a fantastic repository of useful information and I highly recommend that you become familiar with it. Here is a link to that page.
A Good Starting Point
Again, MAUDE is by no means an end-all solution. Rather I recommend it as a starting point that will give you access to a number of documented issues related to medical implants. As a designer or manufacturer this information can go a long way in helping you to avoid the costly mistakes of others. Armed with this information medical implant manufacturers can identify where to concentrate testing dollars. It goes without saying that these reports are obviously not a substitute for testing. No matter if you have a new designs or a variation on an existing design (even if that design has no issues associated with it) you must have the product tested.
Do you have questions about medical implant testing? If so, contact me. I’m happy to share my experience and perhaps offer some ideas that will help you to maximize your testing dollars.
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John McCloy is Founder and President of Engineered Assurance, LLC (engineeredassurance.com). John can be reached at 513.543.8146 or via e-mail at jmccloy@engineeredassurance.com.
