Monthly Archives: May 2016

Take these 3 steps to smooth your medical device development path

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!

Click to open a pdf version you can download

Click to open a pdf version you can download

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.

Have you taken these steps to make your medical device safe?

Pressures to get to market quicker haven’t eased up any over the past year. Everyone’s looking for an advantage to press home. Developing medical devices that really meet users’ needs will give you that competitive advantage.98000

And, given how many people die in hospitals each year due to human error (98,000 in the US and nearly 12,000 in England alone), there is an ethical imperative to get it right.

Against this backdrop, the Medical Device School is held in London twice a year, attracting regulators and development organisations from across the EU, and further afield.

Medical device human factors

Following a very successful maiden seminar at the school last November, I recently had the pleasure of returning to present and lead sessions covering the theory and regulatory expectations of Human Factors and, very importantly, its practical application.

Across several “full-on” hours, delegates to the School learned how to deliver a more effective process for product development, incorporating ISO 62366:2015 alongside US and EU regulatory requirements. Delegates took away a tool-kit that enabled them to understand their product’s target user group(s), identify and mitigate risks effectively.

Experiencing User Needs first hand – human factors in action

Exercise photoAs you may have come to expect from us, students experienced three full immersion workshops during our all-too brief time together. These workshops are an integral feature of our training events. Delegates experienced first hand some of the key steps in satisfying Human Factors requirements, from identifying User Needs through to identifying and evaluating use related risks!

“A great way to get inside the heads of our users and understand things from their point of view”

The conversation over lunch was full of enthusiasm and eagerness to implement what they’d learned.

Pick up the phone or email us right now about your training needs, because it is never too early.