Following the positive response to the Rebus Medical poster presented at HFES Healthcare Symposium 2024, Charlie Irving and Ian Culverhouse have published a peer-reviewed journal article on the subject of Human Factors Integration with Clinical Investigations; recently published in the Journal of Medical Engineering & Technology, Volume 47 Issue 8 (https://doi.org/10.1080/03091902.2024.2355322)
- The article goes into more detail on topics such as:
- What are the current regulatory guidelines for HF study design before clinical trials/studies?
- How should HF studies be designed before clinical trials/studies?
- How can HF data be gathered from clinical trials/studies?
If the abstract for the article below is of interest, this can be accessed for free by filling in the form below.
Abstract
The human factors engineering (HFE) process supports the design and development of medical devices, including that of novel devices requiring clinical investigation. The typical culmination of the HFE process leading up to pre-market approval is a human factors (HF) validation study, with specific requirements of participants, environment and task representation that carry a financial and temporal burden for medical device manufacturers. Whilst thorough HF evaluation is strongly recommended ahead of clinical investigations by regulators (and the authors), the scale of HF evaluation prior to a clinical investigation may be scaled accordingly during the development process. This paper provides recommendations in what to consider when determining what type of HF study to conduct ahead of each clinical investigation phase as well as insights into the symbiotic benefits of HFE and clinical investigations.
The Version of Record of this manuscript has been published and is available in http://www.tandfonline.com/.
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