Tag Archives: straightforward

Three ways to smooth your path for device development

Medical Device Development routemap v5.0 narrow viewSpring of 2013 still seems recent, so I was surprised to realise that the route map for medical device development will shortly be 3 years old. If it were a child in the UK, we would be able to get 15 hours free childcare a week from this September.

Children learn and grow at an alarming rate, especially when you’re looking back over what seems like a very short time and realise that the baby you remember holding in your arms “yesterday” is now a teenager.

The route map too is growing up fast. It’s being used across the world, from Australia, through Asia to Europe and on to North America. Users have fed back great experiences. Uses ranging from a desktop aide mémoire, a teaching aid, through to a planning and design review tool!

There comes a time when a child learns new skills, and naturally integrates them into their daily lives and toolkit.

We’re proud to announce the launch of the route map for medical device development 5.0 today. Numerous user suggestions have been incorporated in this new version, along with two new tracks; Intellectual Property and Market Research.

The route map continues to help you in three ways, it;

  1. Describes the journey you’ll embark upon, from a device idea through to launch.
  2. Sets out the main activities for each of 9 disciplines, through four stages of product development.
  3. Identifies the points where there are major interactions between disciplines.

And here it is…

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.

Is herding cats easier than Design Controls?

With increasing pressures on healthcare businesses to get to market quicker and pressure to lower development costs, managing your design controls activities effectively has never been more important. However, regulatory expectations for medical technology development are continuously evolving. IMG_20150917_121626071There’s a natural tension between these two aims that is further complicated by the interactions and interdependencies of the major strands of product development. Following a process that is focused on doing the right things, at the right times, ensures the balance is maintained, shortens your time to market and reduces development costs.

This may all sound difficult to balance, managing to cope with these strands going off in sometimes wildly different directions.  If you’ve ever even thought about herding cats, you’ll appreciate the challenges involved.  However, in the latest of our programme of professional development training courses, in collaboration with Medilink West Midlands, we had the pleasure of focusing on how to manage control these strands,.Getting to grips with Design Controls

“Excellent, interactive aspect of the course was a brilliant idea”



Our goal was to provide attendees with an understanding of the crucial steps that need to be taken to ensure successful project completion. We outlined common pitfalls and how to avoid them as well as providing strategies to apply to existing and new projects.
Typical of the training events we deliver, the day was intensive and action packed, no time for delegates to switch off!

“Excellent, very well paced, good practical sessions”

Talking issues through
As usual, there were several full immersion workshops, interspersed with “classroom” sessions, as you can see from these photos. Delegates experienced first hand the key stages of defining and managing a project though to completion.

Delegates left the event full of enthusiasm and keen to implement what they’d learned.

“I wish we’d looked at this course 18 months ago”

They left better equipped for their next (or current) device project and perhaps more capable at herding cats too.

All of our professional development sessions can be run in-house and tailored to fit your specific needs. Some of our recent sessions include project management, medical device development, design controls, Human Factors and risk management.

If you don’t have time to do it right…

“…when will you have time to do it over?”

beautiful pebble stackMost of us will agree that there is an ever increasing pressure to deliver immediate results from our projects. As organisations in many sectors tighten their belts, there is an expectation of doing more with less, in shorter time. But, in the rush to get on with doing, are we throwing out the baby along with the bath water? Are project time-lines and costs actually increasing as a result of skipping over or rushing through the scoping or planning activities?

There are many pressures on projects within the modern organisation. Some of these are cultural, such as the belief that “productivity = doing something”.

Can we kick back against this pressure, to identify or check that we are “doing the right something”?

Or, do we usually get swept along by the drive to “get on with it” while no one is quite sure what “it” is. Other pressures are related to project management capabilities and leadership.
Taking sufficient time (you can spend too much time on this, as well as too little) over these initiation activities delivers several benefits ; Continue reading

The train at platform 9 and 3/4

We’ve been on a road trip recently, sharing a way of encapsulating the key steps of device development that has been attracting “rave reviews”.

I’d been working for a while (with our team’s input) to turn initial concept sketches into something eye catching, simple and well formed.  Fruits of those labours were unveiled during the road trip, with people grasping the concept very quickly.  Nodding heads and smiling faces were common responses, followed by requests for copies to keep and use.

Last time, I promised to share with you the whole picture.  The picture that knits together the key disciplines of device development.  You might find this familiar and easy to grasp: MDD route map for DeviceUsability

The route-map does three things, it;

1. Describes the journey you’ll embark upon, from a device idea (left) through to launch (right).

2. Sets out the main activities for each of 7 disciplines, through four stages of product development.

3. Identifies the points where there are major interactions between disciplines.

Seven “lines” integral to effective device development are featured;

  • Clinical,
  • Design Development,
  • Human Factors,
  • Project Management,
  • Qualification & Validation,
  • Quality,
  • Risk Management.

You may already see how this picture will be helpful, irrespective of the industry or sector you’re in.

I’d love to hear your thoughts on how you might use it.

If you’re working outside medical devices, how could this route-map be tweaked for your requirements?

Would printed copies (perhaps A2 or larger) be useful?