Tag: medical device regulations

The Do’s And Dont’s Of Medical Device Design and Manufacturing

Technological Prosthetic Robot Arm is Tested by Two Professional Development Engineers in a High Tech Research Laboratory with Modern Futuristic Equipment. Man and Female Compare Data on a Personal Computer.

Over the years, the medical device industry has seen a lot of innovative changes. And, with more technological advancements being made, many companies in the industry have been pushing for more intuitive, user-friendly, and attractive consumer-level designs.

The challenge now is for designers and manufacturers to produce these devices in the least amount of time without violating local and international regulations. With the increasing growth rate of this industry, it’s even more crucial now to avoid making errors and missteps, so you don’t fall behind the competition.

Here are the do’s and don’ts of medical device design and manufacturing.

Do Design With Users In Mind

A medical device is meant to help users resolve certain problems or meet specific needs. Thus, you should focus on the target end users and their needs instead of getting caught up in the goal of creating a unique device. From the initial phase and all throughout the design process, you should always consider the human factors that affect your design. Failing to do so may result in defective devices, and it would be expensive and time-consuming to make significant changes in the latter stages.

To ensure that your target market accepts and uses the device, you should consider these factors in the design process: ease of use, user needs, user scenarios, potential risks, and safety issues. It’s also important to identify residual dangers in using the device early on, so you can promptly find ways to eliminate or manage these risks.

The importance of ease of use should also be stressed. The end users should be able to use the device without having to struggle or having to ask for help every time they need to use it. Medical devices are supposed to aid people and improve their lives, not present them with another problem.

Continue Reading