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Medical device and equipment flaws caused by poorly researched design, mishandling, user error, and malfunction are common causes of medical errors. Many of these errors can be attributed to lack of standardization, poor design, poor maintenance, differences between devices from different manufacturers, and more.<\/p>\n
Devices recalled nationwide are typically taken to task for usability issues that could have been prevented with proper usability testing throughout a product\u2019s development lifecycle. This means there\u2019s a significant opportunity to reduce the potential for harm by conducting quality usability testing early and often.<\/p>\n
Digging further into causes of those medical device recalls, the top four, according to industry statistics, are:<\/p>\n
By testing early enough in the product design lifecycle, life-threatening medical device errors can be prevented by the appropriate design changes. Unfortunately, testing is often done too late in the process when the design has already been \u201cfrozen.\u201d Once you get to this point, use errors are often forced into mitigation by changing the label or altering the instructions-for-use (IFU). As the statistics show, these measures are frequently insufficient.<\/p>\n
So how can you prevent this by proactively starting a user-centered design process?<\/p>\n
First, draft a strategic Human-Factors Engineering (HFE) and Usability Engineering (UE) Plan. Putting your users at the center of your product design process may seem intuitive, but once you get into the weeds of development, these user needs can get lost.<\/p>\n
It\u2019s helpful to keep three questions in mind: Who are the users? What are the product\u2019s intended uses? In what use environment is the product being deployed?<\/p>\n
From there, dive deeper:<\/p>\n
From a regulatory standpoint, the FDA will be looking to see that all elements of the users, uses, and use environments have been researched and incorporated into the plan for conducting proper usability testing in the relevant simulated-use environment with the intended users and uses.<\/p>\n
The ideal process might include multiple rounds of formative usability testing, which can be used to inform a Use Failure Mode and Effects Analysis (uFMEA). As you go through the cyclical design process \u2014 adding design inputs, testing them, refining, then adding more design inputs \u2014 you\u2019ll eventually reach a point where you\u2019re comfortable with the product you\u2019ve created.<\/p>\n
A final production-equivalent medical device should be put through validation, or summative, testing, to assess whether or not the product can be deemed safe and effective to use.<\/p>\n
2. Assess: Create a Use Failure Mode and Effects Analysis (uFMEA)<\/strong><\/p>\n A uFMEA assessment is meant to identify components of the user interface and the impact of task failures. What are the possible failures that could occur? Why would these failures occur? What are the consequences of the failure and what\u2019s the associated harm?<\/p>\n Start by creating a step-by-step list of all tasks, required to accomplish the device\u2019s end goals. (Tasks are defined as the action or set of actions performed by a user to achieve a specific goal.)<\/p>\n The uFMEA also notes what could go wrong if any of these tasks are not completed correctly. To help determine this, go through a\u00a0PCA (perception, cognition, action) analysis process<\/a>. As your team goes about defining tasks, determining failure modes, and assigning levels of severity of harm, you may next want begin to categorize your tasks as critical versus non-critical.\u00a0Critical tasks are those which, if performed incorrectly or not performed at all, could cause serious harm to the patient or user where harm is defined to include compromised medical care. User tasks are often tied to product requirements, and usability testing (formative and validation) will be needed to prove these user needs have been met.<\/p>\n Finally, when developing your product\u2019s uFMEA, make sure your team has thought through the level of mitigation that will, ultimately, be required by the IFU and labeling within the context of intended use. During this process, you may also come to a point where you recognize whether or not your product will require some level of training.<\/p>\n Be diligent about identifying all potential use errors and outcomes before getting into validation or even pre-validation testing. Be as clear as possible about what could go wrong and what needs to go right to merit a task has been completed successfully. These success criteria will feed into a task analysis table that will define what needs to be tested from a usability standpoint.<\/p>\n And finally, keep in mind that a uFMEA should be treated as a living, breathing document that evolves as the product progresses through the design process. Expect it to change as the device goes through rounds of formative usability testing, is put in the hands of users, and as the design team gains a better understanding of how the product can and should be used.<\/p>\n There are three usability testing approaches to consider:<\/p>\n Rapid Insight Testing<\/strong> may be appropriate if all that\u2019s needed is a quick touch-base to keep the design grounded in user needs. Roughly five to six participants are recommended, but it\u2019s possible to test fewer in certain situations. This type of testing typically occurs prior to entering design control.<\/p>\n We recommend conducting Rapid Insight Testing on all elements of the product, including human factors. Sample questions are: How did it feel to use or handle the product? Is the grip intuitive or did someone need to show me how to grip it? Are we testing all of the possible users of the product or are there others that could be seen as a potential user? This is your opportunity to evaluate all tasks, not just the critical ones. Additionally, this is your chance to get as much subjective feedback on the product as possible! What are their preferences? What are they used to seeing and what would they like to see changed?<\/p>\n Formative Testing<\/strong> begins to inform the design process. Anywhere from five to ten representative users per user group are recommended and aim to simulate the use of the product in the simulated use environment with a high-fidelity prototype. We suggest conducting a minimum of two to three rounds of formative testing during a product development cycle. This is what\u2019s going to lead to product design change mitigations, which is ideal \u2014 better now than later! Design changes are hugely preferable to changing labeling or instructions-for-use (IFU) late in the game.<\/p>\n Validation Testing<\/strong> is required by regulatory bodies in the U.S. and Europe, and elsewhere around the world. At this stage, testing with a production-equivalent product is expected, and when dealing with FDA, 15 representative users per user group is required, as is representative simulated use in the simulated environment.<\/p>\n It\u2019s important to note that once you\u2019ve reached validation testing, only critical user tasks should be evaluated, so it is important to evaluate all non-essential user tasks earlier in the process via rapid insight and formative testing.<\/p>\n A long discussion could be had when it comes to regulatory compliance, but here are a few resources, tips, and misconceptions to keep in mind.<\/p>\n The Association for the Advancement of Medical Instrumentation\u2019s (AAMI) standard HE75:2009<\/a> provides general considerations and principles to help manage the overall risk of use error with best practice design elements and integrated solutions. This document acts as a comprehensive reference for how to incorporate human factors engineering into the medical device design process.<\/p>\n As far as IEC 62366<\/a> goes, it guides the entire usability engineering process, including the elements of accompanying documentation and training. The main purpose of this document is to help define the human factors engineering and usability process as it pertains to medical device design, including consideration of risk management.<\/p>\n The FDA guidance \u2014 2016’s \u201cApplying Human Factors and Usability Engineering to Medical Devices<\/a>\u201d \u2014 lays out the needs and expectations for your Human Factors\/Usability Engineering Report.<\/p>\n The FDA developed this guidance to \u201cassist industry in following appropriate human factors and engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses, and use environments.\u201d The Center for Devices and Radiological Health (CDRH) considers human factors testing a valuable component of product development for medical devices, so it is very important to be mindful of usability throughout the design process.<\/p>\n It\u2019s good to know some of the key differences in expectations between the FDA (Food and Drug Administration \u2014 U.S.) and the IEC (International Electrotechnical Commission):<\/p>\n We know this is a lot to take in. If you need a development partner, Bresslergroup is always up for a good challenge. With our design strategists, mechanical and electrical engineers, and industrial and interaction designers, we\u2019re well-equipped to assist in making a better product. (Read about our medical product design experience and expertise<\/a>.)<\/p>\n In addition to providing design and process recommendations and collaborating on system enhancements, we can plan, conduct, and report on all elements of your usability testing needs \u2014 from rapid insight testing all the way through validation.<\/p>\n3. Research: Use These Three Approaches To Usability Testing<\/h3>\n
4. Comply: Resources and Tips for Regulatory Consistency<\/h2>\n
Resources for Regulatory Compliance<\/strong><\/h3>\n
You Say FDA, I Say IEC<\/strong><\/h3>\n
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Don\u2019t Go It Alone!<\/h2>\n