Coming up with a design for your medical device that can be manufactured, assembled at a low cost, whilst ensuring it does what users need it to do, safely and repeatedly, is one of the big challenges you’ll need to overcome
If you could see a route through the minefield, what would you do?
In this bite-size video, we’ll continue our exploration of the map of medical device development. We’re taking a look at the Design Development track. It’s an overview of the key stops on the journey from the push to develop a medical device through to the completion of Design Control activities, that prepare you for product approval and launch.
We start our journey with:
Market Research – this is finding out what the unmet medical need actually is, what it is not, constraints and the considerations. All this to make sure you’re developing technology to fit a need, instead of the other way around. This step may well be linked to the first stop of the “Market Research and Access” track, however that often comes once you have identified the unmet need and have concepts that set out to address that.
Concept Design (assuming that you’re free to operate – more about that in an upcoming video where we look at the IP track) – developing a set of creative responses to address the unmet medical need that could be turned into a product
Design Feasibility – looks at the concepts you’ve created, with clear eyes, exploring how or whether they could be developed into practical designs, that can be made, assembled, disposed of and, very importantly, be used by your intended users
Design Review (search for our video “4 w’s of Design Review” to learn more about these)
The Design and Process Risk Analysis stop has you identifying and evaluating risks related to the device design, as well as it’s likely manufacture, assembly, distribution, recycling or disposal processes – identifying ways to mitigate risks. One of the difficult things here is balancing these requirements with the needs of the User. As you might expect, this stop is intimately linked to the Risk Management and Human Factors tracks, both of which we’ll cover in future videos.
Design Iteration – sees your device design evolving to incorporate risk mitigations, firstly because of the risk analysis, then to respond to the results of …
Design Evaluation – bench testing and usability testing of design iterations, to see how well they deliver against specific requirements and risk mitigations. Again, this stop is intimately linked to Risk Management, Human Factors and IP tracks. They all have a part to play. It is usual to go through this loop a number of times, as you learn more about how your design performs, especially in the hands of real users.
Consideration of Manufacturing and Assembly processes should start at the very early stops, however here is where these processes will become concrete, with the knowledge that they can be used to build devices for the upcoming verification and validation stops
Test Methods – it’s no good testing devices without using a documented method, as how else can you have confidence in the results? That’s what this stop is all about, creating, refining and validating test methods – they can be for incoming materials, in-process checks, product release, development tests.
Design Verification – answers the question “have I built my device right”, does it meet the specification
Design Validation – however, answers a different question, “have I built the right device”, by comparing your device with the needs and intended use you set out to fulfill. Checking if these needs can be fulfilled consistently.
Design Transfer – at some point, you’ll take your device design forward to production. That transfer is what this stop is all about. In reality, it starts at an early stage in development, but comes to its conclusion at this point in your journey. It takes your design outputs and turns them them into production specifications.
Design Changes – from the stop on your journey where you decide to start design controls, you’ll be taking care to identify, document, assess and manage changes to the design as you go, usually in line with a procedure or process.
And here’s where it loops back, to respond to the information gathered from your post-market surveillance activities.
As you watched this video, you’ll have started to think about how you can go about addressing each of these stops more effectively, making the best of each step of your journey. You may now want to get some guidance to turn your thoughts into concrete actions.
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