Testing is essential before any medical device makes it to the market. And as a medical device manufacturer, you want your products to be thoroughly tested so that they're successful once they reach the market. On the other hand, testing can be a time consuming process. The FDA takes about five months to review a product, and third-party testing, while faster, still takes more than two months. Dental products tend to take a bit longer than average. After all the time and money you've spent researching and developing a quality product, the faster it goes through testing, and the sooner you can start profiting from it, the better off you are. So how can you ensure smooth, speedy testing? Take a look at a few tips that you can use to help testing go more smoothly.
Before Sending the Product For Testing
Ensuring a smooth product testing experience begins before you send the device for testing. If you're sending the product to a third-party lab for testing, start by choosing a lab with the expertise that you need. For example, since you know that dental products take longer to evaluate on average, choosing a lab with a reputation for expertise in dental products may speed the process if your product is a dental device. Be sure that the lab is accredited and the staff is qualified to test the product that you're submitting.
When you send your device for testing, make sure to include clearly defined goals and objectives. If you need the lab to recreate specific damages, be sure that those are listed and explained. The lab needs to know exactly what criteria the device needs to meet before it's accepted.
While the Product Is Being Tested
If at all possible, you or someone you designate should be available to view the testing. If you're sending the product too far away for on-site viewing to be a viable option, look for a lab that offers the option of viewing the test from your facility via a webcam monitor.
By viewing the testing in person or remotely in real time, you'll be able to make on-the-spot decisions and changes in response to test results. This is a terrific timesaver on the path to product acceptance. Otherwise, you may be stuck sending the product back and forth multiple times, which can seriously slow down the testing and eventual approval. Keep detailed documentation of your observations and any changes made during the testing phase of the product so that it can easily be approved by a project manager once the testing is complete.
After Testing Is Complete
Your job isn't finished once the medical device testing has been completed. For one thing, not all products will be ready to go to market after one round of testing. Chances are good that you will be repeating the process at least once before your device is ready to go. To speed things along, make sure that you complete an analysis of the testing report as soon as it's received. The more on top of the results you are, the faster you can make needed changes and authorize additional testing.
Your testing laboratory should help by sending the results in a timely manner, preferably via email. If you've been observing the testing yourself, you may already have a good idea of what the report will say, and you can begin drafting changes right away. Be ready to consider that you may need different tests the next time, as well as changes to the product itself.
Smooth, speedy, and successful testing depends largely on your close involvement before, during, and after the testing process. Choose a lab that encourages and facilitates your participation, and your device will reach the market sooner than you think.