No industrial manufacturer is perfect. For medical device manufacturers, there are many pitfalls surrounding product developments. There are many common mistakes medical device manufacturers make. We’ve outlined four of the most common ones for you to look out for.
Forgetting About The User
One of the most common mistakes that medical device manufacturers make is forgetting the main reason why they’re creating this product: they fail to keep the user in mind. This often happens at the beginning of the product development, and unfortunately, can make for a complete failure.
Oftentimes, manufacturers assume their users will be smart enough to understand how to work this device. But once the product is furthering development, the users have no idea what they’re looking at. An ideal practice would be to have a user involved at the very beginning stages. This can prevent problems like this from arising, and with the constant feedback, you may end up creating a highly marketable product.
Designing For a Specific Person
While this may sound contradictory to the first pitfall, you still need to avoid designing products for a specific individual. The biggest issue is that by focusing on one individual, you are keeping out a population of people from which your device may benefit. To circumvent this, broaden your user needs across your population. Sometimes designing for a specific person in need may work, but the chances of it being successful are slim.
Delaying Your Quality Management System
A quality management system is required for every medical device. The FDA will examine it eventually. Waiting on implementing a QMS is a terrible idea, as you need a great process and core procedures outlined from the very beginning.
Rushing Human Trials
Many manufacturers want to get a human study done as fast as they can. However, rushed human testing can be incredibly disadvantageous. Manufacturers need to ensure they have done a thorough job with their products. First and foremost, you are creating a product for human use, so it needs to be proven that it is safe. A rushed human trial can be detrimental to the outcome of your product, and you may even encounter issues with its safety.
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