Designing A Medical Device? 3 Mistakes Your Start-Up Will Want To Avoid

9 February 2016
 Categories: , Blog


So, you've decided that you want to design a medical device for mass production and consumption? Once you have an idea, you need to get that idea approved by the FDA. Until then, it cannot reach the consumer market. Because this process can be tedious and complex, mistakes are often made by start-ups in the medical device industry. Here are three mistakes that you will want to make sure you avoid at all costs to increase your chances of success:

Mistake #1: Expecting the First Product Will Be Perfect.

As a start-up, it makes sense that you will want the first product that you produce to be 100 percent perfect. You want it to contain every single feature that you want the final product that goes to market to have. However, this isn't necessary. Those bells and whistles can be added to the device later as an improvement or an upgrade. After all, when they're included from the get-go, you're looking at a longer timeline, more money and more scrutiny from the FDA. So, focus primarily on the core functions and the must-haves of the device. This contains cost, reduces the timeline, increases safety and efficiency and improves the chance of obtaining a successful FDA submission.

Mistake #2: Not Planning for Issues.

When you are designing a brand new medical device, you can expect for there to be problems. Unfortunately, most start-ups don't plan for these problems. They aren't anticipated from the start. This can lead to budget issues that could result in tabling the device for months or longer. So, when developing a budget and plan, make sure that you account for any issues that may arise that could cut into your budget and extend your timeline.

Mistake #3: Miscalculating the Work the FDA Requires of You.

When it comes to the FDA, they are focused on ensuring that the medical device that you are designing and presenting to them (and eventually consumers) is safe and effective. Therefore, they will require a significant amount of documentation and research that proves such. Make sure you understand the requirements of the submission package, all items have been checked off the list and that all your t's and i's have been crossed and dotted before you submit the packet to the FDA.

Part of the process of designing a medical device and getting it approved by the FDA is thorough medical device testing. This type of testing is designed to determine whether a product is safe for consumer use, which is crucial information that must be included when presenting it to the FDA. Contact a professional medical device testing company like Nelson Laboratories for more information.