STARTING A MEDICAL DEVICE PROJECT

Any project which starts has end point timeline financial objective (we are discussing medical device project) Both are important as if we do not meet them, we may be out.
Medical device project, however, does not dwell on above two things though they are business goals but not the means to achieve them.
It starts with User needs. The ultimate user who is going to use it who may be doctor or doctor and patient both together. Let us take common example of pacemaker. Doctor’s user need is that it regulate heart but doe that mean that you can device machine which is so big that patient must carry it externally like backpack. Does this work? So, User need of patient is not met. It is so critical device that it goes inside of patient’s body yet monitored. Now you will realise that to meet main objective many sub objectives need to be met.
With that comes regulations because you are dealing with human so that also becomes user need.
All above needs must be captured in design plan to start with. Now your project objective is to make product meeting user needs as described above. If you do them successfully your aim of timeline and financial goal will be achieved.
Remember Rightfully capture all user needs and then make design plan. Once you do this all steps are defined well in various regulatory guidance documents like US FDA and MDR. Design control is the approach till you get product and validation of the process and product.
Some questions for you to think about when capturing User Needs should include:
1. Who is going to use the medical device?
2. How user will visualise the product think with their mind and interact more with them if needed.
3. What sort of clinical procedures are involved? Will regulation permit that?
4. what is the environment where it will be used?
5. Are other product or medical device is going to interact with this device if so, then consider all those aspects.
As Iziel we suggest below diagram in short as approach to product.