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Navigating the Challenges of Generic Device Design Using an "Outside-in" and "Inside-out" Approach

Gupta SP.

RDD Asia 2018. Volume , 2018: 27-36.

Abstract:

The global generic product market is expected to grow significantly in the coming years, driven by the opportunities presented by expiration of many blockbuster drug product patents. Other factors driving the growth include the low cost of development compared to new drugs, profitability, and encouragement by regulatory bodies such as the Food and Drug Administration (FDA) in terms of market exclusivity and shorter market approval routes. However, there are many challenges ahead. A generic drug must demonstrate therapeutic equivalence to a branded or reference listed drug (RLD) product. A generic drug-device combination product must also demonstrate substitutability (interchangeability) with the RLD with respect to the user interface. This means that the generic product must “look and work” like the RLD so that it can be substituted for the RLD without the intervention of a healthcare provider or a need for additional patient training.

Exactly replicating the RLD may not be possible in view of intellectual property (IP) infringement issues, thereby compelling the design of the generic product to be different. Technical, clinical, or regulatory requirements may also necessitate that the design be different, e.g., a new formulation containing a different inactive ingredient may require a different deagglomeration engine. The generic manufacturer may also be motivated to improve the value proposition by, for example, changing the design to improve the manufacturability or reduce the cost of goods. However, in all cases, the external operating principles (i.e., the user interaction with the device to accomplish the intended use) and user interface of the generic product must be similar to the RLD to claim substitutability and receive market authorization via the ANDA/505(j) route. This is a huge challenge as the external operating principles and user interface may have interdependency with other aspects of the design, e.g., the internal mechanism and functions.

This paper discusses a novel approach to designing a generic product to fulfill the FDA’s requirements, while navigating the challenges. It will also highlight areas for innovation and improvement in design.