Over the past decade, in our experience working with Life Sciences companies, we have seen many companies fail to achieve their laboratory automation goals because the long, expensive systems LIMS implementations did not achieve the expected return on investment. Though most Life Sciences and Consumer Healthcare companies are in a position to reap significant benefits through process improvements coupled with automation of their laboratories, the cost, resource requirements, and limited flexibility of their systems have remained largely unreachable and therefore, perceived as failures.
Our perspective remains that cost reductions, efficiency gains, and increased compliance position should not be so unattainable as to call to mind an unreachable achievement. As Life Sciences and Consumer Healthcare companies embrace the concepts of laboratory automation they can reap benefits including:
- Efficiency gains in sample throughput time
- Reduction in calculation and transcription errors
- Reduced costs to staff and manage the laboratories
- Limited reliance on paper and record retention
- Increased overall compliance position
- Increased capability to perform data analytics
- Enabled review by exception
Over the past several years, changes in the Quality System technology landscape are driving convergence of tools and capabilities. Now more than ever, firms are in a position to leverage their existing system landscape and achieve this vision with significantly less investment.
In less than a decade, the industry has shifted significantly regarding spend on Compliance and Quality System technologies. Gone are the days of ‘compliance at any cost’, as firms have experienced a significant increase in scrutiny related to technology spend. Risk-based approaches to solving compliance and quality needs coupled with an increased focus on return on investment (ROI) and total cost of ownership (TCO) have severely impacted funding requests and project support.
Through this new lens, the technology that has seen the most significant scrutiny is traditional Laboratory Information Management Systems (LIMS). Starting off as a way to capture results and perform calculations, LIMS gained significant momentum in the early part of the last decade due to substantial improvements in their Quality Assurance (QA) and Quality Control (QC) work flow functions. In recent years LIMS providers have taken integration to the next level, allowing for data capture directly from laboratory instruments.
While this was a significant step forward for management and control within the laboratories, it came at quite a price. Excessive customization was required, resulting in exorbitantly high implementation and support costs. Further, these systems were often created with management in mind, rather than lab analysts. The functionality needed to automate the laboratory existed within LIMS; however, it was more of a forced fit, prohibiting full-utilization within the lab.
Over time, both Quality and IT leadership began to see traditional LIMS as a costly tool that did not deliver true value for their money. It did little in terms of truly creating opportunities to reduce work and proved very costly to implement and support.
The appetite for lengthy LIMS implementations, which require significant investments of time, capital, customization, and validation, has virtually disappeared for some segments of the Life Sciences and Consumer Healthcare markets. Additionally, companies have realized the TCO for traditional LIMS, including maintenance and required support headcount, is much higher than anticipated, which has further decreased an already hard to justify ROI.
The result is simply that many companies with stalled or slowgoing LIMS implementations are choosing to stop or re-scope their projects short of realizing the benefits that would come from a true laboratory automation solution. The future of laboratory automation is shifting away from traditional LIMS solutions.