Analyzing Current FDA Human Factors IFU Guidance Through the Lens of a Rapidly Changing Medical Drug Delivery Device Landscape

Abstract

The medical drug delivery device landscape is changing at a rapid rate: Administration by lay users (non-healthcare professionals; patients or caregivers) for delivery of medication to themselves or a person in their care is becoming more common. Patients self-administering may have clinical manifestations based on their disease state that impact their physical and cognitive ability to utilize a drug delivery device safely and effectively. In general, our population is aging, leading to decreased physical and cognitive capabilities, both for lay users and healthcare professionals (HCPs). Moreover, pharmaceutical companies are increasingly developing larger molecule, higher viscosity, higher volume drugs that are more difficult to inject based on level and duration of force required for full dose delivery. Our research team has been analyzing the progression of these factors, as well as the increase in FDA complaints for drug delivery devices that passed FDA approval but exhibit failures in the marketplace. Based on our extensive experience in drug delivery device testing and understanding of the issues at play, we have determined that solely following FDA guidance may be insufficient for user success in the marketplace given the changing drug delivery device landscape. Moreover, solely following FDA human factors (HF) guidance in drug delivery device development may only become more insufficient as the above mentioned trends continue to progress. In this paper, we discuss current shortcomings of the general FDA HF guidance, as well as guidance related specifically to drug delivery device instructions for use (IFU), within the context of this changing landscape. The paper concludes with high-level recommendations that could help resolve the core problems with current FDA guidance. In developing our recommendations, we understand that some may increase cost for manufacturers to bring a drug delivery device to market; however, such costs pale in comparison to costs and consequences associated with a drug delivery device failing once in the marketplace.

Keywords: medical device design, drug delivery device design, human factors engineering, instructions for use design, design criteria, user percentile design, product design, HFE design criteria, FDA HFE testing, FDA human factors testing guidance, FDA guidance, AAMI/ANSI HE75