However great your device design and technology may be, it still needs to work for the users, answer their needs, accommodate their constraints and expectations
If you had a sense of what you needed to do, to take care of this, what would you then 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 The Human Factors track.
It’s an overview of the steps you need to take to understand:
- Who you’re making the device for,
- What they need of your device,
- When and Where they’ll use it,
- How they will use your device.
And our journey starts with researching the answers to these vital questions
User Research – Kick start your project with a clear understanding of who your users are and what they really need, using a range of research tools
Concept Design – Give your design the best possible chance of success by removing potential use errors at the start. Use errors that you’ve already uncovered
Usability Plan – Turn the complex into a straightforward, achievable plan. A plan that ensures you satisfy the regulatory authorities
Design Review -Confirm you’re on the right track and make sound project decisions based on concrete data” (search for our video “4 w’s of Design Review” to learn more about these)
Use Related Risk Analysis – Reduce project risk by identifying and mitigating Use Related risks before they arise. This stop is intimately linked with Design Development and IP Tracks.
Usability Evaluation – Uncover strengths and errors in your design, with real users, before it becomes fixed – often a series of short usability and readability tests, the results of which are gold dust for the designers
Design Validation – Confirm that User Needs have been met and the device is safe & effective in use. Basically “Have I built the right device”.
Doing all this will yield robust answers to the 5 questions I mentioned earlier.
HF Summary Report – Assures regulatory authorities that you’ve conducted an effective Human Factors programme. It tells the story of how you understood users’ needs and created a device that spoke to them.
Post – market surveillance – feeding back into the next version, changes. Know what to avoid and gain valuable intelligence on competitor products
As you watched this video, you’ll have started to think about how you can go about addressing each of these stops properly, making the best of each step of your journey. You may now want to get some guidance to turn your thoughts into concrete actions.
Here’s two of the ways to find out more, right now:
- We’ve written an book about all this
- We’ve captured all this in a shopping list, a toolkit
Get in touch for your copy of either of these.
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