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What’s THE Key to efficient IVD development?

In the quest to cut costs and optimize operations, healthcare organizations are increasingly turning to business and engineering strategies such as Six Sigma, Lean, and the Toyota Production System. Though each approach differs in method of execution and area of focus, at their basis is the idea of continuous measurement to drive process improvement and standardization for more efficient business operations. These methods can be similarly adopted by the in vitro diagnostics (IVD) industry and incorporated into product development.

IVD development is extraordinarily complex and involves a variety of staff, each with specialized knowledge, working on multidisciplinary teams. Scientific, technical, regulatory, and marketing roles are just a few that can be involved in the development process. Each department (or individual) will be working on their specific contribution to the overall project. This is one reason I recommend a skilled project manager be involved in the process from the beginning so that IVD development moves smoothly.

In the U.S., IVDs and other FDA-regulated products, such as drugs, biologics, and other devices,  must be manufactured according to good manufacturing practices and design controls as part of the Federal Food, Drug, and Cosmetic Act (21 CFR part 820). Design controls are not a rigid set of prescribed rules that manufacturers follow. Instead, they are a generic framework that ensures the final product meets users’ needs. Two basic engineering models are used for device development — waterfall and concurrent, but the framework is meant to serve as a model for devices for a wide variety of purposes, so customization is expected.


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Sorry for the redirection, but since it is being published I want to make sure I point everyone in the right direction. If you do like the piece, please let me know here and I can write more on this topic or similar topics.