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Including representative and intended users for a human factors (HF) validation test provides invaluable data for manufacturers because participants’ performance data can demonstrate a product’s expected safety and effectiveness once it is in the market. However, it can also be extremely difficult, or nearly impossible, to recruit exact users for a particular product due to the rarity of a condi..

Understanding pen-injector use errors and their implicationsThe proliferation of pen-injectors used by laypeople for self-administration of medication in their homes has caused regulators, such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to task manufacturers with providing sufficient evidence to demonstrate that all users, especially laypeopl..

Why pilot tests are essential for usability studiesDeveloping a methodology for usability studies can involve uncertainty and introduce questions such as “How long should the test session last?,” “How can I improve my setup?” or “Is this prompt clear enough?” Running pilot test sessions prior to formal testing can help you find answers to these questions and increase the data quality of your upc..

Why a known problems analysis is crucial for NMPA complianceA known problems analysis (KPA) is a human factors engineering (HFE) activity that aims to identify use issues and user interface flaws with devices currently on the market. Regulators require medical device manufacturers to conduct a KPA to investigate use problems associated with devices that are similar to a device under development ..

Both the FDA’s Human Factors Engineering (HFE) guidance and the global HFE standard IEC-62366 list “inherent safety by design” as the most effective method of managing use-related risks associated with medical devices. In this article, we discuss what is meant by safety by design, provide examples of products that demonstrate it and explore how it can be implemented within medical device design...