Why User Needs Matter During Medical Device Development
To market any type of product successfully, it’s important to identify how people will use it and what difference it will make in their lives. Put simply: You must understand your end users’ needs. If you don’t consider user needs during product development, your product is unlikely to appeal to the very audience you created it for.
Understanding user needs is especially key when it comes to medical device design and development. Why? Because the right design choices — choices derived from user needs — can make all the difference in both regulatory compliance as well as the device’s effectiveness in treatment.
Defining User Needs for Medical Devices
Making appropriate design choices based on user needs starts by understanding what user needs are — and aren’t.
User needs describe what a product should do and how it should function by specifying why it’s important to the end user. It’s crucial to note that user needs are not design specifications (aka design inputs) in and of themselves.
As mentioned, user needs should dictate design inputs. That way, the final product meets users’ expectations. But again, a user need on its own is not a design input/spec. You’ll need to translate the user needs for your medical device into actionable design inputs your team can leverage to inform a user-centric design.
User Needs and Regulation
We stated that allowing user needs to inform your design choices can affect your product’s regulatory compliance. But what does that mean? And why does it matter? Let’s examine the relationship between user needs and regulatory compliance.
The FDA Guidance Elevating User Needs
As laid out in a guidance document issued in March 1997, the U.S. Food and Drug Administration (FDA) takes user needs into account when applying quality system requirements for design controls.
This set of quality practices and procedures focuses on whether a device meets standards for design inputs and human factors. Remember, design inputs are the physical and performance characteristics that influence design. They’re design specifications. Human factors refers to practices that ensure end users can interact safely and effectively with final products.
These controls apply to all Class II and Class III medical devices, as well as several Class I products, such as:
Automated devices that rely on computer software
Tracheobronchial suction catheters
Manual radionuclide applicator systems
Radionuclide teletherapy sources
The FDA’s CFR 820.30, which was updated in early 2022, relates to and supports the 1997 design control guidance, thus reinforcing the FDA’s commitment to user needs. The Association for the Advancement of Medical Instrumentation (AAMI) has yet another supporting document regarding design controls and usability: AAMI TIR59:2017.
Why the FDA Emphasizes User Needs
To summarize the above section in simpler terms, the FDA calls out user needs in a piece of its cornerstone guidance. The regulatory body is commanding you to explicitly define how a new device will be employed, demonstrate that it is built to fulfill its purpose, and stay vigilant for possible issues with design controls.
Safety and efficacy problems were the leading reason for recalls between 2003 and 2012, according to a report from the FDA’s Center for Devices and Radiological Health. Hence the regulatory body’s continued focus on user needs.
The FDA acknowledges that since medical products have a wide array of applications, design requirements — and the user needs behind them — simply cannot be universal. For every product, manufacturers must consider how it will be put to work and make engineering choices accordingly.
The FDA also emphasized that setting clear requirements is the most crucial part of design control. It allows managers to address any problems early in the process, which saves an organization a great deal of money in the long run. And once again ensures the all-important safety and efficacy of products from the beginning of a development project.
Implications for Your Medical Device
The FDA’s commitment to user needs should compel your commitment to user needs.
Ultimately, you will need the FDA on your side as your medical device goes through summative usability testing as well as other regulatory compliance milestones. Not to mention creating a safe and effective product that meets or exceeds users’ needs is vital in and of itself.
The Benefits of Allowing User Needs to Inform Device Requirements
It’s clear user needs matter from a regulatory compliance perspective. But the positive impact user needs can have on your medical device go well beyond meeting the FDA’s standards.
Keeping user needs at the forefront requires you to set up stringent approaches to design and create extensive documentation to direct these processes. The benefit? These documents outline the user needs and intended uses for your device, detailing verifiable design inputs and providing a checklist for easier usability testing.
Having verifiable design inputs provides everyone on your team with measurable, specific goals to work toward. And everyone is focused on the same priorities — meeting those design inputs and the preceding user needs that informed them. No more pulling design specs out of thin air.
What’s more, the design inputs (based on user needs) give your team something to evaluate your product against. That’s why user needs provide an automatic checklist for usability testing purposes.
Meanwhile, human factors engineering (HFE) professionals are able to concentrate on reducing the likelihood of errors or failures. Thanks to user needs guiding the HFE team, your device will be as safe and effective as possible, which we’ve already established to be of the utmost importance.
Keep in mind that everything from medical user interface design to packaging can have implications for the people who rely on a product — your end users. The nature of the requirements differs based on the type of product, so it’s vital to make the appropriate adjustments according to the complexity of a device and the risk it presents to patients.
For instance, if user needs call for a blood glucose sensor that is portable, then designers must think carefully about what parameters are acceptable for the product’s weight and size. Fortunately, focusing on user needs means you won’t miss an important requirement like product portability, which is yet another benefit of paying close attention to user needs.
The Basics of Discovering User Needs
The importance and benefits of user needs are (hopefully) evident. But how do you come up with an appropriate list of user needs for your medical device?
Gathering user needs starts with early research in the beginning stages of your development journey. You might undertake interviews or focus groups with representative end users and/or perform contextual inquiries wherein you observe the use environment for your product. Early marketing research and activities can also provide insight into what the market needs.
From your research, you can start to form an idea of what the people who will eventually use your medical device require and want out of a product.
User Needs Make for Better Medical Devices
User needs are a key concern throughout the medical device product development process. Thoughtful healthcare usability design principles and a robust strategy for applying them to every device result in better outcomes for life sciences organizations when bringing new products to market.