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.
In the waterfall model, each step is completed before the next one can begin. One consequence of this model is a more protracted development timeline. Delays with individual steps compound over the entire development process, since each step has to be finished prior to the next one beginning. Additionally, each step is somewhat isolated from the others in the overall process, so it is possible that the final product diverges from the initial intent of the designer.
The concurrent model differs from the waterfall method by using a team approach to development. This offers several potential advantages, such as improved communication between groups, reduced production costs and time to product completion because issues that arise can be addressed more quickly. But this model has drawbacks, too, including the potential for components of the product entering the manufacturing phase before they have been adequately validated and verified.
The stage-gate model draws on the best characteristics of the waterfall and concurrent models. At each “stage,” a deliverable that meets specific criteria is required (the “gate”) before continuing the development process. Importantly, the stage-gate model’s phases roughly coincide with design control phases of product development, making it a natural model to use for IVD development. For example, Phase I might entail market analyses, pre-design research, and exploring regulatory strategies. Before moving on to Phase II, when product formulation starts, deliverables such as a solid business plan, market analyses, and reports or white papers on the unmet need, patient care cycle, and clinical workflow would be presented to stakeholders and approved. The stage-gate model is iterative and doesn’t end with the product’s launch. This is an essential part of the continuous measurement/improvement mindset that Six Sigma and other strategies employ. Reassessment of the device throughout the product’s planned lifecycle provides opportunities to address any customer feedback, regulatory and technological changes, and/or market pressures.
Within the crowded IVD landscape, following the stage-gate model as part of design controls can be a competitive advantage. Companies are able to minimize the number of late-stage (read: expensive) changes to product design because they will have been thoroughly vetted by all stakeholders early in the development timeline. Predetermined deliverables keep the process moving along efficiently by serving as a roadmap to production. The end result? A well-designed, thoroughly vetted product that meets users’ needs, any regulatory requirements, and is re-evaluated periodically to adapt to an evolving market—the goal of any IVD developer.
