Human Factors Engineering and User- centered Design Principles in the Design and Development of Device Combination Products for Special Patients Populations

Abstract: The US Food and Drug Administration (US FDA) is a global leader in the regulation of device combination products and founded the Office of Combination Products (OCP) in December 2002, Combination products range from physical or chemical combinations to products packaged together and separately packaged products that need to be used together. The OCP has developed many policies and guidance, in particular, the US FDA Human Factor Guidance, the regulatory lens for this paper (1, 2). In the Combination Product Human Factors component, the US FDA, similar to other leading agencies, in Europe, China, Japan, and WHO, stresses the importance of usability studies in medical device combination product design to promote patient ease of use and error reduction. This guidance further emphasizes the physical safety features of the device when used by the end-user. Device design flaws can cause injury to the end user and prescription compliance to the patient. End-users refer to healthcare practitioners: pharmacists, nurses, doctors administering the drug to the patient, or the patient administering it to oneself (4, 5). The 2024 US FDA draft and China’s National Medical Products Administration (Final, Oct. 2024) guidance are closely aligned in requiring manufacturers to use user-focused design principles in the design and development of new drug delivery devices and recommend specifications based on rigorous usability research rather than technical properties of device components (6, 7). New pharmaceutical products are generally developed for most of the population and largely exclude the special segments of the population which include pediatrics, geriatrics, and people with debilitating diseases or specific physical impairments. (1) Geriatric Population: Impaired vision, cognitive decline, motor sensory challenges.(2) Pediatric Population: Pediatric drug delivery systems repurposed from adult formulations and devices are difficult to administer, leading to compliance issues. Off-label use, physician- directed and Adult devices are difficult to use in pediatrics, i.e. Nasal, meter-dose, and dry powder inhalers. (3) Patient disabilities such as hand dexterity, and color blindness.(4) Patients with specific illness or disability: Rheumatoid Arthritis - Did you test your device or container closure with an arthritic glove; Schizophrenia - Very sensitive to any change in drug product appearance or design. There is a case for including Human Factor Engineering-led user-centric design principles and usability research in designing and developing device combination products targeting these special patient populations (8, 9, 10, 11).References1. Lauritsen, K. J., & Nguyen, T. (2009). Combination products regulation at the FDA. Clinical Pharmacology & Therapeutics, 85(5), 468-470.2. Tian, J., Song, X., Wang, Y., Cheng, M., Lu, S., Xu, W. & Zhang, X. (2022). Regulatory perspectives of combination products. Bioactive Materials, 10, 492-503.3. Schillinger., D. C. (2004). The office of combination products: its roots, its creation, and its role. 4. Jackson, J. (2022, July 11). FDA “hit list” of highest priority medical device for human factor guidance, Blogarithmic Thinking, Starfish Medical.5. World Health Organization. (2022, July). WHO global model regulatory framework for medical devices including in vitro diagnostic medical devices6. Food and Drug Administration. 2024. , Guidance for Industry and FDA Staff. Purpose and Content of Use: Related Risk Analyses for Drugs, Biological Products, and Combination Products. Rockville: Food and Drug Administration.7. ClariMed. (2024, Aug). New NMPA Human Factors Guidelines for Medical Devices in China: What Manufacturers Need to Know.8. Espinoza, J., Shah, P., Nagendra, G., Bar-Cohen, Y., & Richmond, F. (2022). Pediatric medical device development and regulation: current state, barriers, and opportunities. Pediatrics, 149(5).9. Djukic et al., 2020). Training improves the handling of inhaler devices and reduces the severity of symptoms in geriatric patients suffering from chronic obstructive pulmonary disease.10. Schneider, A., Richard, P., Mueller, P., Jordi, C., Yovanoff, M., & Lange, J. (2021). User-Centric Approach to Specifying Technical Attributes of Drug Delivery Devices: Empirical Study of Autoinjector- Cap Removal Forces. Patient preference and adherence, 159-168.11. Randal McCarthy, R & Li, Z (2024, Feb.). The Role of Human Factors in the Design of Drug Delivery Systems to Optimize Patient and Heath Care Provider Use and Compliance, US Annual Medical Device Human Factors and Usability Engineering Conference, Boston.

Keywords: Device Combination Product, Human Factors Engineering, Special Patient Population

DOI: 10.54941/ahfe1006189

Cite this paper:

​