In a previous article, we outlined the importance of identifying and documenting user needs when designing a new medical device product. In that article, we looked at the two objectives you must achieve when documenting user needs:
- Defining the intended use of your new medical device product
- Defining the indication for use of your medical device product
This sounds straightforward enough but when you go through it in practice, the process can be quite tricky, not least because documenting it is a regulatory requirement.
So, how do you create the above definitions to complete the process of documenting user needs? An effective approach is to ask and answer a series of questions about your product including how and when it will be used, and who will use it.
Questions to Ask When Documenting User Needs
Here are some examples of the questions you should ask. This is not an exhaustive list, and some may not apply to your product, but they will give you an indication of the process you must go through.
- What does the product do?
- What conditions, symptoms, and diseases is the product designed for?
- Is the product designed to diagnose, prevent, mitigate, treat, or cure?
- Who will benefit from the product? When considering this question, think about the condition, disease, or symptoms the beneficiary suffers from, even if those conditions, diseases, or symptoms are not directly related to the product. Also think about things like age and gender as well as other defining characteristics.
- Who will use your product?
- Is the user of the product different to the person benefiting, i.e. is the user a medical professional or other third-party, or does the patient use the product on themselves? If the user is different from the beneficiary, who will be using your product?
- When will the product be used?
- In what circumstances will the product be used? For example, will it be used under clinical supervision, in a sterile environment, in an emergency situation, etc? Think of the environment, the people who will be involved, other people who might be nearby, etc.
- Will the user use all the product’s features?
- What are the stages the user will go through in order to use the product, i.e. remove packaging, remove safety features, prime the device, etc?
- How will the user interact with the product?
- If the user and the patient are different people, how will the patient interact with the product?
- How long will these interactions last?
- Does the product interact with other devices? What are the implications of that interaction?
- How often will the patient need to use the product?
- Will the patient use the product multiple times, or will they require a new product for each use?
- If the product can be used multiple times, is there a maximum, or recommended maximum, number of uses?
- How will used versions of the product be safely disposed of?
Documenting User Needs
Remember, you shouldn’t just think about the answers to these questions. Instead, you should also document your answers, so you have a record.
Don’t worry about the wording you use or the thoroughness of your answers. The key is to demonstrate and provide proof of the thought process that went into defining the user needs that your new medical device product addresses.
If you have an idea for a new medical device product and would like to speak to one of the product design and development experts on our team, contact us at Arrotek today.