It’s a complex business, developing an idea into a medical device. And it’s complicated by the myriad of important things you need to address, to get approval to sell your product in markets around the world.
So, it’s understandable that many people struggle to get to grips with everything they need to take care of, to minimise the risk of failure. To get their product to market sooner, maximising the useful life of patents and seeing a return on investment.
It can be difficult to visualise all that needs to happen, let alone how disciplines interact and depend upon each other.
A while back, I was wrestling with these complexities when inspiration hit, thanks to a trip to London the day before. What I needed was a straightforward way to depict all this, a way that we could relate to, could readily use.
And here it is…
We’ll go into this in more details in future videos, but for now, here’s how to navigate the territory.
The map is made up of the key disciplines, areas of technical capability, that you need to cover:
- Project Management – respecting the 5 key features of successful projects (the subject of another video)
- Quality – including regulatory, verification and validation
- IP – patents, protecting your investment and know-how
- Design Development – turning your idea into something that can be manufactured, assembled and is reliable in use
- Human Factors – understanding who your users are, what they need your product to do for them and ensuring that you fulfill those needs, safely.
- Risk Management – identify and evaluate likely risks, putting in place measures to mitigate them as far as possible
- Market Research – is there actually a market for your product, how do you get to it and maximise the potential
- Clinical – what scientific evidence to you need to demonstrate your device’s clinical benefit and safety
In future episodes, we’re going to look at each of these disciplines in a little more detail, examine the 4 development phases and lift the covers on Design Reviews. Then we’ll look at how you may want to use this route map.