Human factors and usability engineering are inherent in FDA design control requirements, but are receiving increased emphasis and required for certain submissions. By outlining a usability program that defines both patient and user requirements prior to product design, manufacturers can improve efficacy, increase customer satisfaction, mitigate risk and decrease costs.
Rob Ngungu is head of Regulatory, Clinical and Product Development at Austen BioInnovation Institute in Akron. He has more than 30 years of drug and device development experience leading to global registrations, approvals and post-market surveillance programs. His area of specialty is product development, including reliability/human factors, regulatory strategies and compliance, clinical trial design and risk mitigation in quality systems for drugs, biologics and devices.
Mr. Ngungu has served on various industry and FDA taskforces and delivers lectures on drug and device development topics. He also holds an adjunct faculty appointment at North East Ohio Medical University (NEOMED).
Mr. Ngungu has led global development teams from small companies to Fortune 500 companies. He started his career at Johnson & Johnson, and has held vice president positions in regulatory, compliance and clinical development at Inamed, OraSure Technologies and Zila Biotechnology.
He holds mechanical engineering and applied health sciences degrees from London, UK.