Hello readers, we’re back with another topic in the series of Usability Engineering for Medical Device. The last blog described The Use Specifications, a starting point for applying usability engineering for your products. But what is the starting point for writing Use Specifications? That’s what this blog is all about.
If you are a regular reader of our blogs, you know that Use Specifications is an elaborated version of the device’s intended use. So, if you don’t get the intended use right, there’s a chance of going wrong with use specifications as well. Not only that, you might also classify your device wrong and end up choosing an incorrect regulatory pathway.
That sounds like a lot of re-work! Let’s save you the trouble of re-work by extending your understanding of ‘a very important statement – Intended Use’.
In simple words, intended use must tell the user what your device is used for..!
That’s it? Is it always this simple? Not really. The intended use statement must be more accurate, more specific, and more detailed. Let’s re-write:
Do you find any difference in the above examples? The second set of statements give more instructions to the user for the device’s specific use, intended users, user profile, and other characteristics of the device such as its sterile and single-use nature.
This difference explains to us that little words matter. Not all surgical blades or K-wires are always supplied sterile; one manufacturer may claim the use of their surgical blade for general surgery while another may claim it for specialized surgery. Depending on the claims you make, the level of risks differ which ultimately differs the regulatory pathway for one device from another.
Depending on what you’re trying to offer in your device, the details in the intended use statement may vary. But in general, you may answer the following questions to eventually get the statement right:
[Figure 1: Characteristics of intended use]
Other than the questions above, you can also refer to elements of use specifications that we described in our previous blog to prepare a statement for intended use.
You may know a lot of things about your device but what contents to include within the intended use is also very important. Let’s see what that means:
Okay, that sounds good. Now let’s see how your statement reads when you add all the details you know about your device.
See how the above statement loses its essence for accurately telling the user what their glucometer does.
Remember that the intended use statement is not a place to put marketing claims or device features!
We love facts. So more for you too!
- Intended use is different than indications for use. Indications for use focus on a medical condition that the device diagnoses, treats, or prevents.
- Intended use must be defined at the design stage because it serves as the foundation for many of the design tests.
If you’re struggling with writing an intended use, or any contents from instructions for use, we are here to serve you. Alceon Medtech Consulting can help you prepare instructions for use, use specifications, usability engineering files, or any piece of document that may be a challenge for your regulatory compliance. We can also help you train your staff with customized training materials and provide annual maintenance services for your regulatory needs. Inquire today at contact@alceonconsulting.com
Because we are passionate about what we do, we would love to offer a FREE one-time consultancy on the intended use statement for the device of your choice. Avail today!
Author: Alceon MedTech Consulting
Alceon MedTech Consulting (AMC) is founded with a mission to help our clients in the medical device and invitro diagnostic device sectors to navigate the complex regulatory landscape and obtain the necessary approvals to bring their products to the market. We offer a range of services to our clients, including regulatory strategy development, risk management, clinical trial design and management, post-market surveillance, trainings and more.
