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10 Things You need to know about Human Factors Validation

10 Things You need to know about Human Factors Validation

As medical devices become more complex, the FDA will continue to place greater emphasis on ways to improve safety and effectiveness before products are commercialized. One relatively recent method is Human Factors Engineering, also known as Usability Engineering, which is used to identify and mitigate use errors. Of course, this can place additional burdens on manufacturers to justify that their device has accounted for as many of these potential risks as possible. The list below, which is by no means exhaustive, is intended to point you in the right direction as you prepare for meeting FDA requirements for Human Factors Validation Testing. Human Factors should be considered throughout the design and development process, not just when you’re ready to go to market. Formative evaluations, such as focus groups and expert interviews, can and should be conducted throughout the design and development process. These studies usually consist of 5-8 people and can be conducted somewhat informally. Valuable information can be gleaned from formative evaluations, such as design improvements and identification of potential use errors that could be mitigated by making adjustments to the device interface. Additionally, the FDA and other notified bodies often want to see how your design has been influenced based on the results of these studies. Summative evaluations are the formal validation studies conducted for the final version of the device. These studies are your Human Factors Validation Testing that must follow the requirements of the FDA guidance, Applying Human Factors and Usability Engineering to Medical Devices, and the EU standard, IEC 62366-1: Medical devices – Part 1: Application of usability engineering to medical devices. These studies...
Human Factors Engineering for Medical Devices

Human Factors Engineering for Medical Devices

In February 2016, the FDA released a guidance entitled, “Applying Human Factors and Usability Engineering to Medical Devices.” The intention of this document, in combination with IEC 62366-1:2015 Part 1: Application of usability engineering to medical devices, is to maximize the safety and effectiveness of devices for intended users, use and use environments. Its purpose is to direct manufacturers to ensure their device user interface has been designed in a manner that will either eliminate or reduce use errors to the greatest extent possible by taking the user, user interface and use environment into consideration during design and development. Human Factors Engineering applies the knowledge of human behaviors, abilities and limitations to the design of the medical device interface. To get a handle on Human Factors Engineering, which you might also hear referred to as Usability Engineering, there are a few terms you should be aware of: User Interface: includes all parts of the device a user will see, hear and touch, including packaging, labeling, training, physical controls and display elements Use Error: a user action – or lack of action – that was different from what the manufacturer expected and could result in harm Critical Task: a task that, if performed incorrectly or not at all, could cause harm to the patient or user The FDA is now requiring several types of device manufacturers (as described in the FDA draft guidance, “List of Highest Priority Devices for Human Factors Review”) to conduct Human Factors Validation Testing. As an industry, we will see an increasing number of manufacturers required to conduct these studies, especially as more devices are available...

IEC 60601-1

Organize your Risk Management Program For those who design or manufacture electromedical equipment, IEC 60601-1 3rd Edition A1 is one of the most important safety and performance standards to meet. The standard addresses critical safety issues, including the risk of electrical shock, fire hazards and mechanical hazards, such as entrapment risks. Devices that must meet current IEC 60601-1 requirements include those which: Diagnose, treat, or monitor the patient under medical supervision Make physical or electrical contact with the patient Transfer energy to or from the patient; and/or Detect such energy transfer to or from the patient. IEC 60601-1 Management Solutions Meeting the requirements of 60601-1 3rd Edition documentation requirements can be extensive and difficult to interpret. We use InfoStrength’s solutions (our regulatory software) and our expertise to provide structure to your product documentation for easier compliance, faster validation, and better process management– so you can meet your commercialization goals sooner. If you are currently in the very early design stages, now is the time to talk about the implications of IEC 60601. At this stage, we’ll work with you to provide IEC 60601-1 training for your engineering team. This training will guide the engineers in a way that allows them to: Think through  – well in advance of being ready to submit the product for testing – the impact of the standard on their design ideas Engage in more cost effective redesign early on Keep project milestones and plans on track by avoiding redesigns due to safety testing failures Our goal is to help you achieve easier compliance, more efficient validation and improved process management. Be prepared for your next FDA inspection...