How design thinking impacts generic drug development? The concept of Quality by Design (QbD) originated in the early 1990s. The early nineties started the generic drug boom. Companies all over the world were trying to get first to file applications submitted to the FDA. The old way of thinking was to get the application filed and continue to work on the drug. Drug developers would then tweak the formula and have answers to anticipated FDA questions. As more and more multinational companies entered the U.S. market, pressure and backlog on the USFDA became apparent.
In a 2020 article in Pharma Manufacturing, the author Dr. Matteo Zacché states that QbD brings a systematic approach to drug development that aims to ensure quality by applying analytical and risk-management methodologies to the design, development, and manufacturing of new medications. At its core, the approach looks to design quality into workflows upfront. A product’s objectives and essential attributes are defined during the initial stages of a program, with risk and data analysis, then used to understand how processes can affect a product’s characteristics. As a result, QbD provides a robust framework for the design and implementation of processes that achieve consistent quality and meet the pre-defined standards.
QbD is a proactive approach to generic pharmaceutical development, incorporating deliberate design effort, and appreciating how processes impact product performance. User experience design thinking is a non-linear, iterative process that teams use to understand users, challenge assumptions, redefine problems, and create innovative solutions to prototype and test. Drug development design thinking focuses on how the process can impact performance. A better design can give you a more effective manufacturing process. UX design thinking aims to understand how users will use their product and anticipates how to make it a better experience to keep users engaged and loyal.
This type of thinking has multiple applications. Having no experience in UX/UI, I did not expect to find common ground in my business. The more I read, the more I could connect the two. Design thinking offers superior solutions, lowered costs, and risks. Three things that are applicable in every type of industry.
Liedtka, J. (2018, August 28). Why Design Thinking Works. Retrieved July 27, 2020, from https://hbr.org/2018/09/why-design-thinking-works
Lowenborg, M. (2018, June 15). QUALITY-BY-DESIGN – Quality-by-Design: The Good, The Bad, The Inevitable. Retrieved July 27, 2020, from https://drug-dev.com/quality-by-design-quality-by-design-the-good-the-bad-the-inevitable/
Zacché, D. (2020, January 06). The advantages of a ‘Quality by Design’ approach in pharma drug development. Retrieved July 27, 2020, from https://www.pharmamanufacturing.com/articles/2019/the-advantages-of-a-quality-by-design-approach-in-clinical-and-commercial-pharma-development/