Presentation
The Old Switcheroo: Avoiding Unwelcome Surprises in the Development of User Interfaces for Generic Combination Products
DescriptionThe development of the user interface of a complex generic drug-device combination 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 specifically 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 constituent, but also any controls and displays associated with the product, any product labeling, and packaging. This presentation focuses on the development of the user interface of the combination product.
Complex generic drug-device combination products (DDCP) play a vital role in the drug supply chain. As they are neither solely a “drug”, a “device”, or a “biologic”, they are typically difficult to develop and are subject to multiple sets of regulatory requirements. Manufacturers must consider safety and effectiveness with both drug and device constituent parts AND the combination of these parts as a whole product.
Some of the potential pitfalls, such as needing to circumvent intellectual property or trade dress constraints, can be mitigated by using platform devices (e.g. reusable pen injector, autoinjector, dry powder inhaler) already developed by device manufacturers. However, a platform device is not always available/preferred, and drug manufacturers might need to undertake the design, development, and/or production themselves. Because DDCP development is so complex, with new inputs becoming available at different times, there can be many challenges along the way when developing the device constituent for the manufacturer to navigate.
This presentation will walk through common pitfalls and/or surprises that can arise from different sources during device and user interface development for a DDCP. Surprises, like the discovery of new IP, a differing evaluation of a “minor” difference by the FDA, or a rejection that the proposed product is not substitutable for the RLD can result in significant delays or increased costs.
These surprises can be better planned for if additional efforts are made at the onset of device development (or instructions/labeling/packaging design) to assess these risks and to account for them within human factors planning for the project. Having a comprehensive understanding of the presence and purpose of design features on all parts of the user interface of the RLD that users rely on to realize the safe and effective use of the product is a critical activity that must occur at the onset. Methods for evaluating design concepts generated in early stages of device development will be discussed.
Examples of potential surprises 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 decisions that are made will be shared.
Complex generic drug-device combination products (DDCP) play a vital role in the drug supply chain. As they are neither solely a “drug”, a “device”, or a “biologic”, they are typically difficult to develop and are subject to multiple sets of regulatory requirements. Manufacturers must consider safety and effectiveness with both drug and device constituent parts AND the combination of these parts as a whole product.
Some of the potential pitfalls, such as needing to circumvent intellectual property or trade dress constraints, can be mitigated by using platform devices (e.g. reusable pen injector, autoinjector, dry powder inhaler) already developed by device manufacturers. However, a platform device is not always available/preferred, and drug manufacturers might need to undertake the design, development, and/or production themselves. Because DDCP development is so complex, with new inputs becoming available at different times, there can be many challenges along the way when developing the device constituent for the manufacturer to navigate.
This presentation will walk through common pitfalls and/or surprises that can arise from different sources during device and user interface development for a DDCP. Surprises, like the discovery of new IP, a differing evaluation of a “minor” difference by the FDA, or a rejection that the proposed product is not substitutable for the RLD can result in significant delays or increased costs.
These surprises can be better planned for if additional efforts are made at the onset of device development (or instructions/labeling/packaging design) to assess these risks and to account for them within human factors planning for the project. Having a comprehensive understanding of the presence and purpose of design features on all parts of the user interface of the RLD that users rely on to realize the safe and effective use of the product is a critical activity that must occur at the onset. Methods for evaluating design concepts generated in early stages of device development will be discussed.
Examples of potential surprises 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 decisions that are made will be shared.
Event Type
Oral Presentations
TimeTuesday, March 2610:30am - 11:00am CDT
LocationContinental Ballroom, Lobby Level
Medical and Drug Delivery Devices