Last month (March 2024) Charlie Irving attended HFES Healthcare Symposium 2024 in Chicago and presented a poster on approaches to integrating human factors activities with clinical investigations. The poster draws on over a decade of experience developing novel medical device technologies and drug delivery systems in and around clinical investigations, identifying the symbiotic benefits from interwoven human factors and clinical investigation efforts. Regulations are clear that HF validation studies are a requirement and a fundamental prerequisite to pre-market approval for devices that are intended for commercial launch. However, when working on investigational devices which are intended to facilitate clinical investigations, a strong human factors development program has an equally valuable role to play in evaluating and reducing the potential risk to study subjects, users and investors.
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