Clinical diagnostic laboratories may have business goals that include increasing profits, reducing costs, or accelerating innovation. Continuous improvement is an organized approach to identifying opportunities to achieve these types of goals.
What is a continuous improvement pipeline?
In our work with clinical labs, we recommend building a continuous improvement pipeline—a repeatable mechanism (often called a “recipe”) for planning and deploying improvements to your laboratory software and processes. Improvements generally involve a process of iteration and refinement over time. The simplest way to begin the process is to ask how your lab usually addresses a deficiency or non-conformance event. From there, the goal is to make this cycle of identifying an issue and resolving it as short as possible, and scalable.
While some labs might be intimidated by the idea of iteration, there’s really no need to be. In fact, it’s a concept that’s entirely familiar to software engineers who work within the Agile+Scrum methodology. Iteration is an integral part of complex software development and it’s generally accepted that understanding iteration is key to accelerating and improving product development.
That said, iteration introduces positive and negative effects, and therefore it needs to be managed properly.
Three common continuous improvement approaches
The following three approaches to continuous improvement are all based on the scientific method. To some extent, they each align across four distinct phases.
The OODA Loop was originally used by the military to plan strategic decisions. Now it’s an important tool in the business world.
|1. Observe||Gather information.|
|2. Orient||Evaluate the information you’ve gathered.|
|3. Decide||Decide on the outcome you want to achieve.|
|4. Act||Act on the decision.|
Deming PDSA Cycle
The Deming PDSA Cycle was introduced by Walter Shewhart of Bell Laboratories.
|1. Plan||Identify the problems, gather information, develop a plan for improvement.|
|2. Do||Implement the plan.|
|3. Study||Monitor and assess the effectiveness of the actions taken.|
|4. Act||Adopt or abandon the change. Begin again with planning to continue the improvements.|
FDA Critical Path
The FDA Critical Path from Laboratory Concept to Commercial Product applies to the development of new drugs or medical devices. It has continuous improvement at its core.
|1. Characterize||Establish and characterize a safety profile for the new product.|
|2. Standardize||Create standards that must be met.|
|3. Control||Control for quality.|
|4. Mass Produce||Scale for production.|
Speeding up the laboratory continuous improvement pipeline
Whichever of the approaches you adopt, even if it’s not listed above, we recommend optimizing your continuous improvement process:
- Automate (as much as possible). The more you can automate, the faster the process will go and the fewer errors you’ll make. This includes automating software testing. Current-state LIMS are configurable pieces of software, which means they require validation. If you choose to use manual software testing and validation, you have few, if any, opportunities to speed up the continuous improvement pipeline. Instead, you’re committing yourself to significant human effort for every software iteration, something that directly affects the total time of a continuous improvement cycle. Automating takes time upfront, but it pays dividends on each iteration, accumulating significant value over time.
- Develop competency in continuous improvement methods. While labs don’t necessarily need an internal software capability (this can be handled by software consultants who have expertise in the domain), they do need competency in continuous improvement to ensure that every lab workflow and piece of software is evaluated. We highly recommend that labs map out their continuous improvement process and share that with their consulting partners so that everyone is on the same page.
- Set aside time for lab staff to interact with analysts responsible for lab software infrastructure for improving the system, including LIMS, software system, and business analysts. Some of the best feedback is bound to come from employees—the staff working directly on the day-to-day will have valuable ideas about how to improve processes.
- Consider how your software systems support continuous improvement. Can they be easily tested, integrated, and automated? Are they ready for validation or accreditation review? Can they handle deficiencies and iterative changes? Can processes be updated to accommodate improvement? These are all important questions to ask to understand how your systems support your business needs.
Continuous improvement is an invaluable part of a lab’s business strategy. It’s the best way to ensure you’re meeting your goals and it’s absolutely key if you’re considering growing the business. Remember, a seemingly small issue now can have widespread implications at scale. The faster you can address an issue, the faster you can return your focus to creating innovative new products that will make a difference in patients’ lives.