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BEGIN:VEVENT
DTSTAMP:20240325T185835Z
LOCATION:Continental Ballroom\, Lobby Level
DTSTART;TZID=America/Chicago:20240326T103000
DTEND;TZID=America/Chicago:20240326T110000
UID:HFESHCS_2024 International Symposium on Human Factors and Ergonomics i
 n Health Care_sess130_INDLEC306@linklings.com
SUMMARY:The Old Switcheroo: Avoiding Unwelcome Surprises in the Developmen
 t of User Interfaces for Generic Combination Products
DESCRIPTION:Oral Presentations\n\nMichael Lau (Insight by Nemera)\n\nThe d
 evelopment of the user interface of a complex generic drug-device combinat
 ion product is complicated and efforts toward successful ANDA submissions 
 are often delayed or stymied due to many different reasons that can arise 
 unexpectedly at any stage of the development process. To consider specific
 ally the use safety and effectiveness of a drug-device combination product
 , the user interface of the reference listed drug (RLD) must be understood
  in detail. The user interface not only includes that of the device consti
 tuent, but also any controls and displays associated with the product, any
  product labeling, and packaging. This presentation focuses on the develop
 ment of the user interface of the combination product.  \nComplex generic 
 drug-device combination products (DDCP) play a vital role in the drug supp
 ly chain.  As they are neither solely a “drug”, a “device”, or a “biologic
 ”, they are typically difficult to develop and are subject to multiple set
 s of regulatory requirements. Manufacturers must consider safety and effec
 tiveness with both drug and device constituent parts AND the combination o
 f these parts as a whole product.\nSome of the potential pitfalls, such as
  needing to circumvent intellectual property or trade dress constraints, c
 an be mitigated by using platform devices (e.g. reusable pen injector, aut
 oinjector, dry powder inhaler) already developed by device manufacturers. 
 However, a platform device is not always available/preferred, and drug man
 ufacturers might need to undertake the design, development, and/or product
 ion themselves. Because DDCP development is so complex, with new inputs be
 coming available at different times, there can be many challenges along th
 e way when developing the device constituent for the manufacturer to navig
 ate.   \nThis presentation will walk through common pitfalls and/or surpri
 ses that can arise from different sources during device and user interface
  development for a DDCP. Surprises, like the discovery of new IP, a differ
 ing evaluation of a “minor” difference by the FDA, or a rejection that the
  proposed product is not substitutable for the RLD can result in significa
 nt delays or increased costs. \nThese surprises can be better planned for 
 if additional efforts are made at the onset of device development (or inst
 ructions/labeling/packaging design) to assess these risks and to account f
 or them within human factors planning for the project. Having a comprehens
 ive understanding of the presence and purpose of design features on all pa
 rts of the user interface of the RLD that users rely on to realize the saf
 e and effective use of the product is a critical activity that must occur 
 at the onset. Methods for evaluating design concepts generated in early st
 ages of device development will be discussed. \nExamples of potential surp
 rises that might arise during user interface development of DDCPs will be 
 covered and strategies that human factors engineers can use to help avoid 
 surprises and to educate their teams on which could be the impact of decis
 ions that are made will be shared.\n\nTrack: Medical and Drug Delivery Dev
 ices\n\nSession Chair: Rachel Poker (AstraZeneca)
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