Tag Archives: process

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

4 steps to (device) heaven

After I wrote about the MDA’s approach to device development (here’s the post), several people emailed me to find out more. Perhaps, like them, you’re curious about it?

Feed your curiosity by reading this brief summary of the four steps; Define – Develop – Industrialise – Launch


When it comes to medical device design getting it right is crucial. Unsafe and ineffective devices often result from informal development that did not establishment real design requirements or did not assess device performance adequately.

To combat this, follow a User Centred Design Process to understand the whole user experience before you start designing. Identify who your users are and how they are likely to use your product. This provides a solid basis on which a device development project can be built.

At this stage you need to capture the project activities in a plan. A plan that describes the process you are going to follow, taking care to ensure design activities (such as product design, risk and usability) and quality requirements (e.g. design reviews, design control procedures, supplier audits) are included.


Now, you refine concepts that will address the needs you’ve already identified. This iterative process irons out design flaws and risks to reveal the design which best meets the needs of both your users and your business.

You can choose from a variety of ways to do this, such as; creative techniques, brainstorming, visualisation, prototyping, testing and scenarios. Evaluate your design concepts’ feasibility from usability, risk and mechanical perspectives, feeding the results into the next design iteration. Subsequent testing of iterations ensures that you have successfully controlled the use-related hazards and that new risks have not been introduced.

Depending upon the device you’re developing, you may want to consider a clinical evaluation. This assesses and analyses clinical data concerning safety or performance of your device (or similar devices or therapies) and determines the need for clinical trials.

Take care to document changes as you go along; to device, instructions, labelling and user training, as their control is crucial to device quality.


You’ll now scale-up the product manufacturing and assembly processes in readiness for launch. This involves transfer of the design to manufacturing, handover of the design history to the production team, supporting scale-up activities such as supplier management and process design. A key factor in the success of this stage is the qualification and validation of both manufacturing and assembly of your product.


Preparing for a smooth launch of your product means having a clear strategy for compliance to international regulations. This will likely includes your activities to gain CE marking or conformity to associated international standards. Product launches are exciting and also resource hungry activities, so make sure you’re addressing supplier quality, manufacturing volume and expansion capabilities, and resolving of supply issues.

If you have identified the need for a clinical evaluation, launch preparation will include a risk benefit analysis and associated risk management report, both of which are required for releasing a medical device to market.

Next time…

You may be curious to find out what it was about Medical Device Development that recently got people nodding and smiling, before asking if they could have a copy?  My next post should satisfy your curiosity.  You might wish to be alerted when it’s published,  just sign up below (we will treat your email address with care, and won’t share it).

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