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When you are presented with a medical device product development project, you do not want to have to ask what the intended use, user needs, design input, design verification, and design validation means.
You will learn about this and many more things in the video below, which is coming from our Design Control for Medical Devices course.
Getting the terminology right is crucial for understanding both your colleagues’ and your company’s quality procedures. This article covers some key terms and should bring you up to speed on them.
One major key term in design control is the intended use. In short, it is the high-level description of the user profile, for what indications is the device intended by the manufacturer, and other relevant conditions of use.
Even if this might look small and insignificant, it is not; it must be selected with great care and documented properly.
The intended use affects risk management, usability engineering, reimbursement, as well as whether your product will or will not need a clinical investigation to get regulatory approvals.
In the US, it may be what determines if the product can be cleared under a 510(k), or requires pre-market approval. This makes a world of difference when it comes to both time and money.
The medical device legal manufacturer does. It is important to remember that the intended use is not only a paragraph in the instruction for use; it includes other communication as well, e.g., advertisements, and what your sales representatives say about your product and its use.
One way to define the intended use is to ask the five questions starting with:
Not all manufacturers would answer all of the above questions in their intended use statement, but, answering them all should give you a rather good idea of the intended use. Oftentimes it will include a medical indication. Bear in mind that you will have to prove that every statement you make about the efficacy or anything else is objectively true.
Remember: intended use is synonymous with the intended purpose. However, indications for use are a narrower concept, as the focus is on the “for WHAT” part.
Intended use can be changed over time; both during development and after the release to market. In all of these cases, you must apply relevant change control to identify the impact on your product documentation and regulatory approvals.
The next important key term is user needs. User needs are just that – what the users need for the product to work as intended by the manufacturer, and they should be based on the intended use.
Who defines user needs, then? The people competent for doing that would often be found in the marketing department, or they work with product management, typically.
The next step is translating the user needs into design input.
The physical and performance requirements of a device that are used as a basis for device design are the design input. As it should be technical, it is established by engineering and should use engineering language.
When the product has been designed, what ought to be done next is to check if it meets the requirements set at the beginning, and this is not merely a suggestion – in the medical industry, this is a regulatory requirement. For design inputs, this is called design verification, and, to quote QSR, it needs to confirm that “design output meets design input requirements”.
Verification is not only testing, contrary to popular belief. Other methods include reviews, demonstrations, inspection, or analysis, all to demonstrate that the requirements have been met.
You must prove that your medical device meets the intended use(s) and satisfy the user needs. This is important because a device may be completely technically correct, yet useless in a real setting.
Design validation is another regulatory requirement, and it is done by validating the device design in a real or simulated environment. This part is not always simple or easy since sometimes you cannot show that intended use and user needs have been met with anything less than a clinical investigation and use on real human subjects.
If you want to look up user needs and design input, you will find them in QSR, which you can easily find on FDA’s website. However, if you look into the ISO 13485, there is no mention of user needs and design inputs; they are jointly referred to as Design and Development inputs.
If you found this article helpful, you can read more of them here.
Get instant access to our online Design Control for Medical Devices course right here. In 6 hours, you can learn more about how to develop new medical devices and maintain them in organisations where design control requirements apply. This course is taken by quality assurance, project management, design engineering or those involved in R&D and product development teams.
Or if you’re looking for a tailored training to align with your company’s specific needs – contact us for inhouse training options.
Peter Sebelius is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that is revising the ISO 13485 and ISO 14971 standards.
He has vast ‘hands on’ experience, having developed, amongst other things, a mechanical chest compression device and an ex vivo perfusion machine for lungs. He has received numerous awards including the Great Design Award and the title “This year’s specialist” by Veckans affärer.
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