Why medical device development takes time

Device testing laboratory coordinator at Team Consulting says: Because of the complicated design and development process of medical devices, it is not unusual for them to take years to finalise. Working at Team Consulting, I have come to appreciate the time it takes more than ever, but I once questioned the need for it.

medical device testing

As a device testing laboratory coordinator, part of my role is to set up laboratories and equipment ready for use by our developers so that they can focus on their core work. I ensure there is minimal unnecessary distraction for lab activities to occur and to provide an effective way of working.

One crucial stage that must be given enough development time is the device testing stage. Four testing stages; proof of concept testing, proof of principle testing, pre-design verification testing and design verification are all required to ensure a device functions correctly. Even when these test processes are carried out seamlessly, this can still take years to finalise.

The importance of medical device testing

I have always had an appreciation for medical devices, having previously relied on one myself. As a child, I used to experience regular asthma attacks, however luckily I grew out of it before my early teens. The attacks were terrifying to me and nothing else frightened me more than the feeling of one coming on.  My parents knew how much I hated the attacks and would always come running with the inhaler and what can only be described as an American football-sized adapter. This adapter supported the air flow of the drug to my lungs more effectively than using the device directly to the mouth. A device that may have taken years to develop was able to give me instant relief and save me from a potential life-threatening issue.

medical device testing

When thinking back to my asthma attacks it makes me feel grateful for the design and development that was put into both the inhaler and the adaptor. The time taken to test these products ensured that they could be effectively used in emergencies to allow people like me to breathe when the need arises.

I can now appreciate this more than ever working with medical devices. The more our device developers spend ensuring a product is reliable, easy to use and meets the rigorous regulatory requirements means more time gifted to patients. Although medical devices may take years to finalise, the time taken is worth it to create these lifesaving products.



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