Whether you’re developing a medical device, medical technology or combination product, there are three ways you can smooth your path towards a successful conclusion.
1. Define, upfront, the journey you will take from the very start, right the way through the 4 stages every project transits, to getting your product on the market.
2. Set out the big steps for each of the 9 key disciplines involved in development projects.
3. Identify the points along each track, where the disciplines must interact, and ensure these happen.
Scroll down to read more about each of these.
Then keep on scrolling to see how they can be put together on one page.
Every project moves through 4 stages; define; develop; industrialise; launch. Resist temptation to rush through the first stage. Instead, reap the rewards of time spent here. Ensure that you have a clear view of what is needed to navigate the choppy seas of development to reach your product launch.
The vast majority of projects to develop a medical technology involve 9 key disciplines, each with their own must haves, intricacies and dependencies. Regulations and international standards dictate some of the things that must be done in each of these arenas, but there will be others you’ll need. Be clear about what must happen for each discipline, during every project stage. That way you will be able to review your project at appropriate times, with one eye on the detail and the other on the big picture.
How often do projects resemble a collection of silos, without interconnecting tunnels? Establish the points at which these tracks must connect/ The times at which their coming together is essential, for a sound understanding of what’s been done and where you’re going next. Design Reviews are a case in point. These only cease being a millstone around your neck and become really valuable when all disciplines are involved and the review reaches decisions based on hard data and results from each and every one of track.
We’ve experienced what works and what doesn’t, to be in a position to sketch what good looks like. Back in 2013 we crystallised all this into a route-map for medical technology development. Since then, it’s been used in Australia, Asia, Europe and North America. Users have fed back great experiences as a desktop aide mémoire, a teaching aid, through to a planning and design review tool!
Experience doesn’t stand still, and a lot has changed in three years. We’ve incorporated the changes into our evolved model. We call it medical technology development 5.0, though you’re welcome to suggest another name!
You may already see how this picture will be helpful, whether you’re working in medical devices, combination products, pharmaceuticals, aerospace, defence, electronics…
Send me your thoughts on how you can use the route map, because having a straightforward, independent view is always valuable.