How to Design a Medical Device in 10 Easy Steps

In order to produce a medical device that meets the needs of the end user, there is a considerable amount of planning and detail that has to be committed to the project. From identifying a market need, to achieving the many regulatory requirements and passing the testing stage, designing and manufacturing a successful medical device depends on good team work and a clear understanding of the objectives involved throughout. We’ve broken down how to design a medical device in 10 steps to help you get a clearer understanding of what needs to happen during the process. 1. Identify a need In order for any new product to achieve success in its desired market, it ultimately needs to fulfil an existing – or unmet – need, and medical devices are no different in that regard. Whether it’s to be used to monitor and improve a patient’s health, or to make the delivery of treatment more efficient, a new medical device should be able to tick at least one of these boxes in order to be perceived as credible. Not every new medical device needs to be a brand new innovation. In many cases they can simply offer advancements on existing technology or instruments by making them more cost effective, easier to use or improve the performance levels. This removes the need to constantly think outside of the box to identify a medical device that doesn’t yet exist. By focussing on market needs you can still successfully add tangible value to the healthcare industry. 2. Classify the device Now you know what need the device is going to address, fundamentals such as intellectual property (IP) rights and the classification of the device need to be finalised. How the device will be classified depends on the level risk involved when it is put to use and the laws associated with that. By securing the concept you are future-proofing it against any future claims or the development of a similar device by a third party who could prevent your own from ever reaching fruition. At this point it makes sense to check for any pre-existing IP based on the same idea or similar – it could save you a lot of time by revealing that the same technology or mechanism already exists. That is something you’ll want to be aware of before valuable time, money and resources have been wasted on a device that cannot legally be put to use.

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