Tag Archives: launch

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?

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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