Above is a quick map of the phases of Medical Device Development from Understanding the 5 Phases of Medical Device Development. Below I’ve outlined a brief summary:
Phase 1 – Planning, Research and Funding
In Phase 1, after formulating the initial idea, it is crucial to perform more research to understand the market; i.e does this product already exist, are there previous clinical studies you can use, do you need to patent the idea etc. These will be vital when it comes to applying for funding and in determining bodies to apply to..
You will also need to set up a QMS (Quality Management System), this will be the foundation on which your company proceeds with, it allows you to keep track of your development.
Phase 2 – Proving Feasibility
This phase is all about proving that as a concept your device/ idea works. This phase only begins once you have shown your idea has viability in the market and is financially feasible. At this point, you start prototyping and taking feedback. It’s crucial to keep the voice of the customer in mind and keep adapting your product accordingly. Make sure to keep note of the changes as you proceed.
Phase 3 – Validation
Passing regulatory standards is a key part of Phase 3 and is crucial to putting your device on the market. The main regulatory body involved in this for products to be used in the UK is the MHRA (Medicines and Health products Regulatory Agency). You need to pass their criteria so your product can be placed on the market. You can find their main website and everything else you may need with regards to them here: Medicines and Healthcare products Regulatory Agency – GOV.UK
The main things to consider for this stage would be to make sure customer requirements are still being met, the product is safe and clinical trials are performed if needed.
Phase 4 – Launch Preparation
This is about the final touches; completing documentation, making sure all your product claims are backed with evidence and ensuring you can deliver the product on a larger scale. Ensure you have plans in place for post launch i.e how will you take feedback and deal with complaints.
Phase 5 – Launch and post launch assessment
At this stage your device is being used. You need to monitor it’s usage; are there any problems, can anything be improved etc. If so, you will need to update documentation and notify the relevant authorities.
If you need any added help navigating through these phases here is a list of bodies you can go to for advice.
NHSX is also a good resource to use for maintaining good quality products if you are planning to introduce them into the NHS.