Over one-third of all Class II devices now have “Special Controls” designations from FDA. The rate of such classifications in the last seven years has increased by over 240 percent (Desjardins 2010). What is driving this trend?
Why should you care about completing human factors engineering (HFE) in relation to your supply chain? Simple: humans are involved. At every stage of your medical device’s lifecycle, there are people participating in assembly, handling, packing, and so on. Particularly during manufacturing, your team wants to focus on HFE exercises to help control risks that could arise in later lifecycle stages. But what manufacturing steps should be evaluated with human factors in mind?
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As the year begins to wrap up, FDA is finalizing several pieces of guidance and initiatives as it heads into FY 2018. Here are some previews and highlights for October: National Cybersecurity Month.
In your product development cycle, your teams get heavily involved in usability engineering—particularly during risk management. This process is meant to be intensive: the more exhaustive your team’s efforts in identifying as many user interactions as possible, the greater benefits they yield. FDA is then satisfied you have applied their “Inherent Safety by Design” principle, and there is less overall risk to the user.
With the growing risks of potentially fatal hacks of interconnected medical devices, FDA is more concerned than ever that product development teams are incorporating robust cybersecurity measures into their device design. No matter what measures teams decide to implement, FDA’s main concern is for maximizing user safety while mitigating risk as much as possible.
The short answer is: it’s complicated. Design processes can be standardized, but workflow can change based on the project. A Class III medical device requires more evidence of reviewing design-related risks and subsequent risk controls than a Class I device. Connected devices can require reviews that ensure the proper implementation of cybersecurity in each stage of software design.
When we talk about risk in regard to usability, we usually center the conversation around the physical interaction with the device. User capabilities or disabilities, tactile functionality, device setup—all of these have a tangible impact on how the device is handled and used. However, multiple perceptive and cognitive forces behind usability can also have an effect. One that can get easily overlooked is color.
Why are people having trouble with medication at home?
Risk scoring has been, historically, a significant part of many risk management activities. It is a method for evaluating which risks are the most critical to control. Successive scoring of risk controls allows teams to see how the level of risk on the evaluated design, process, function, operation, etc. may improve over time. Within risk exercises such as failure modes effects analysis (FMEA), risk scoring is a multiplicative process involving three factors: severity of harm (S), probability of occurrence (O), and detectability (D). These will yield a risk priority number (RPN) that, depending on the guidelines a business has in place, will determine whether a risk is acceptable or requires risk control measures. Because these scores are often expressed on scales between 1 and 10 (least to greatest), the RPN for FMEAs has a potential scoring range between 1 and 1,000.