Why Usability Testing Matters in Medical Device and IVD Product Development
One of the simplest yet most important elements of human-centered usability design is right there in the name: humans. Developing a valuable understanding of the people that will actually use the product—and, importantly, how they will use it—is critical to the product’s conception and development. However, it’s surprisingly easy to lose sight of this in light of impersonal specifications and ambitious timelines. Product development teams tend to focus on meeting user and market requirements and sometimes, important elements (such as the actual experience of using the product) are lost in the shuffle.
The fact is, usability testing can be an important tool that helps you effectively anticipate problems with your point-of-care diagnostic or medical device before they even occur and ultimately optimize your chances for success in the market.
Proven Expertise, From Concept to Market
Usability Testing: An Important Part of the Medical Device and Diagnostic Development Lifecycle
Product development is an iterative process, and usability testing should be a key component. The basic process works like this: after generating an initial product design for a diagnostic or medical device, the engineering team will consult with key stakeholders, marketing, senior management, the Scientific Advisory Board, and possibly even investors or board members. Based on the feedback it receives, the engineering team may revise the product design and develop a prototype. With a prototype, the engineering team can conduct internal testing of its durability, reliability, and overall performance. Any deficits discovered at this stage can be addressed rapidly and retested until the development team is satisfied. At this point, usability testing can be effectively leveraged.
Usability testing can answer several important questions related to diagnostic test kits and medical devices, such as:
- Is the design right? Does using the product feel intuitive to the user? If there are multiple designs which one works best?
- Does the product work in the contexts in which it will be used? For example, physician offices, hospital bedsides, patient homes, and CLIA lab settings all differ from one another.. A design that’s versatile enough to be used in various sites reduces operational costs, enables faster market uptake, and may expand the total market.
- How will usage of the product affect the customer’s work space? Does it have a large footprint? Does it require special storage conditions?
- Does the product work for users of different skill levels or experience? It may be possible to predict the user if the product is replacing an existing one; however, it’s safest to not assume any prior knowledge when introducing a new option.
- Does the medical device work for all patients in a category (e.g. age, handedness, disabilities such as blindness or color-blindness deafness, limited dexterity)? It’s easy to make assumptions or overlook special cases, but the feasibility use for each target audience should be tested.
- Does the product work for all anticipated specimen types?
- Does the user feel confident using the device or test kit? Are they satisfied with the overall experience?
- Can the product be used with the anticipated speed (e.g., time to test result) and efficiency (e.g., number of tests that can realistically be performed in parallel)?
- What type of instructions should be provided to guide the user through the use of the product?
- When should instruction be provided during product use? Which instructions should be repeated in the course of using the product? Should visual cues be provided in written language or graphical symbols? What languages should be considered at initial launch, and how should the ideas be phrased?
- Are there any aesthetic concerns about the product from the user’s perspective? How will it look, feel, sound, and even smell in the specific settings in which it will be used?
Ultimately, medical device and IVD usability testing is a preview of the real-world experience. It provides an opportunity to address product deficits before customers even see them, and to capitalize on opportunities to delight customers with product performance.
As in any type of market research, the earlier in the process you learn about a problem or an opportunity, the faster you bring a successful product to market. Unlike typical market research, however, usability testing offers the opportunity to assess the functionality of your product in a structured and methodical way. This allows for an unbiased preview of your product’s performance in “real life” and provides robust performance and feedback data with which to develop an action plan.
Creating a More Competitive Medical Device or IVD Through Usability Testing
Once a prototype is in hand and has completed its initial review within the company, usability testing is a logical next step to improve both product quality and time-to-market with a competitive offering. Evaluating your product through usability testing can supplement your market research, helping you simplify user interfaces or clarify directions. Assessing your product through usability studies can also show you whether insights from the Scientific Advisory Board have led to meaningful benefits.
Incorporating usability testing early and frequently in the development process can help to address issues quickly and easily, allowing key decisions to be made before too much time and money have been invested in an irreversible path. For example, early usability testing will allow you the option to either narrow your target user base and be more selective about a use case, or realize the need to modify your product to serve all users. When product modification is the best choice, it can be directed by the specificity of early usability testing.
Establishing a usability testing framework early on will also help to make the process of iterative testing and development cycles easier, with faster turnaround and better ability to track the improvement of your product over time, as your product design approaches its optimal form.
Conclusion
The development of a medical device or diagnostic product is a multi-faceted process. It must take into consideration many aspects of regulation, functionality, and design limitations, in addition to the needs and expectations of the people who will use the product in the “real world.”
Amidst these competing considerations, it’s important to maintain awareness of the product’s end-users and their ability to actually use your product. Human-centered design—and usability testing in particular—can help you place the user at the forefront of this process by articulating and considering user needs.
When leveraged correctly, these techniques can help ensure your design is on the right path to great user satisfaction and successful market uptake.
