Tag Archives: industrialise

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.

Base jumper or fell runner?

International standards such as ISO 62366, ISO 14971 compliance gurus and journals all talk about taking a risk based approach to elements of your development project.

As with many things in life, the strategy you choose to achieve this becomes a matter of how much risk you are prepared to live with;

  • How comfortable are you with the risk of meeting a costly surprise if you choose to test late in development?
  • How much risk are you prepared to pass onto your customers, your users?

Lets take a look at two strategies for a medical device development project.

Base Jumping

A high risk strategyThe dare devil approach. It’s a high risk strategy that is often seen as the fast way of getting down the mountain.

For this strategy to succeed, the device manufacturer has to be super confident in their design, either because it is very similar either a design they have already done or it is very similar to what’s already on the market. The design will also use existing production and assembly processes, without modification.

In this scenario most device testing and process validation activity is done at the last possible stage, when the design is frozen and the company is ramping up for launch.
Sometimes, testing is even done after launch when the regulators ask for the documented evidence.

To take on this strategy you have to have a lot of confidence that you know how to repeatably and reliably manufacture your product, your customers (and ultimate users) know how to work your device as well as you do.

After all, “Its not the fall that kills you”.

Fell Running

A more measured approachThis approach is often perceived as slowing down a fast track project. Yet, the strategy includes the right development activities, at the right times throughout the various stages of product development.

It’s the more conventional way of getting down a mountain.

“The sooner [you] get involved, the quicker, cheaper development is” Vicki R Lewis, AAMI/FDA summit 2013.

In reality, adding development activities to a project at the right time should not impact on time-lines, as activities can run in parallel. Indeed, these activities will greatly reduce the likelihood of expensive re-designs or fire-fighting as you get closer to scale-up and launch preparation.

Of course, development activities need to be budgeted for, but;

  • How much expensive is unfreezing a design to start developing new mould tools?
  • How much more expensive is a product recall because of a foreseeable use error?

Taking this approach should not end messily, as you descend your mountain.

Which of these two strikes a chord with you, feels like the usual one for development? Perhaps you can see the differences in likely outcomes from the two strategies.

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?