4 steps to (device) heaven

Jun 5, 2013 | Human Factors, Qualification & Validation, Quality + Regulatory

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). [jetpack_subscription_form]