The market for laboratory information management systems is growing quickly
By Gordon Feller
The demands for deeper data capabilities for healthcare are only going to increase as the 21st century progresses, and a modern laboratory information management system (LIMS) increasingly needs to be flexible enough to balance the needs for data accessibility with the requirements for data integrity and cybersecurity. The days when clinical diagnostic labs—and healthcare in general—depended on paper orders and results reporting are fast disappearing, and today’s LIMS integrates information flow by connecting all of the instrumentation and systems inside the lab.
A LIMS is a computer program or information management system designed to handle the workflow and data tracking of laboratory information. (Although there are subtle differences, the term LIMS is often used interchangeably with laboratory information system, or LIS.) A modern LIMS has numerous components, including computerized provider order entry, rules-making ability, barcoding, direct interfaces with laboratory instrumentation and the electronic health records, patient portals, and so on, with potential for adding rich content and patient-oriented data interpretation.
These capabilities, of course, are only the beginning: LIMS have to be adaptable to meet the varying needs of more than a quarter-million different laboratories, including multiple lab types, and the LIMS needs to handle multiple complicated connections between all the moving parts, including physicians, hospitals, clinics, insurers, and patients. The US government has been advocating for the development of LIMS. National legislation such as the Patient Protection and Affordable Care Act and the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 both provide incentives for healthcare providers, including laboratories, to adopt electronic health information technology that is both interoperable and accessible. Consequently, the market for LIMS is expected to grow by $705.85 million between 2020 and 2024, which represents a compound annual growth rate of 9% over that period, according to a market research report published by Technavio in February 2020. The Technavio report also suggests that 39% of that growth will originate in North America.
One factor that is driving the growth in this market is the increasing demand for biobanks, repositories for the collection of biological materials such as serum, blood, tissue, and DNA. Biobanks play a critical role in research, and they require a LIMS solution to effectively manage and track data quality, bio-species location, security, compliances, end-user billing, and patient demographics. A LIMS also helps improve the sampling of data that involves different laboratories, FDA, and partner organizations and aids in integrating research information. It also helps in easy access of data for analysis. LIMS deployment enables dependable transmission of information among different biobanks. “Factors such as the integration of LIMS with hospital information systems and increased adoption of analytics in the healthcare industry will have a positive impact on the growth of the LIMS market value during the forecast period,” says one senior analyst at Technavio.
LIMS in Practice
One route many laboratories are taking is to install software as a service (SaaS)-based LIMS, in which software is installed on a centralized server and access to it is licensed by client companies. This solution is economical because it enables laboratories to remotely access data through a web browser without having to install and manage separate application software. SaaS-based services reduce implementation costs and improve efficiencies.
SaaS-based systems are just one step in the evolution of LIMS. “When LIMS were first introduced, they began as simple sample tracking solutions but evolved over time to manage all aspects of the laboratory,” says Richard Milne, vice president and general manager of digital science for Thermo Fisher Scientific, Waltham, Mass. “LIMS provide an effective way to manage resources and balance workload while enabling regulatory compliance and enforcing good scientific practices. Today, LIMS have become the informatics backbone for laboratory operations managing and connecting the scientific workflow across people, samples, instruments, consumables, tests, and results. Our customers utilize LIMS to connect instrumentation, manage assets, and plug into service arrangements. Effectively, LIMS help laboratories optimize utilization to derive maximum value from hardware, software, and the resulting data.”
Still, Milne and his team believe that “this is only the beginning,” he says. “As the laboratory continues to evolve, LIMS will act as a digital operating system, effectively providing a software environment that enables organizations to maximize the value of all parts of laboratory processes, including collaboration, with internal and external laboratories and departments. The role of LIMS as an informatics platform is evolving to enable true digital transformation at the laboratory and, ultimately, enterprise scale. We are at an exciting time, where technology has evolved to where we can help our customers create a connected ecosystem that accelerates science and enables laboratory productivity.”
SciCord, Cary, NC, offers an electronic lab notebook (ELN)/LIMS solution created by the company’s current CEO, David Strauss. ELNs are digital replacements for paper notebooks, and according to SciCord, their product is credited with a 30% increase in productivity. Over the past 15 years, the SciCord ELN has grown to serve more than 6,000 scientists. “The devil is in the details,” says Strauss, in describing the challenge of selecting a LIMS that can adapt to the specific needs of an individual lab, and often it’s not until the implementation process begins that all of the “details” emerge which cause costs to soar and eventually derail the LIMS. Strauss advises prospective buyers of any LIMS to “require a prospective vendor to ‘pilot’ several of your work processes before the purchase.” The vendor should provide such a ‘pilot’ at reasonable cost in order to obtain your business, he adds.
A fully functional pilot process identifies potential gaps, reveals how a vendor will work through issues, and forecasts the real cost of a vendor solution. A minimal expenditure for a “pilot” can avoid the most common LIMS selection pitfall. One big challenge is developing the proper plan to implement and integrate a LIMS project across the enterprise. “The pharmaceutical industry has historically identified ‘the best’ ELN/LIMS vendor and then force-fit that solution across all organization functions,” says Strauss, who adds that at one point there were practical reasons for this practice, such as data integration; using a single system to implement, manage, and validate; leveraging the relationship with a single software vendor; and relying on only one organizational data source to facilitate data mining.
However, Strauss says that “common standards and SaaS delivery eliminate many of the barriers to ELN/LIMS implementation that drive the need for a single vendor solution.” For example, he says, selecting an ELN/LIMS that can “speak” the language of the specific community group—with targeted structure, calculations, and reports—is much better than a generic system that the users must redefine themselves to use.
Rising demand for ELNs is one indicator of the future direction for LIMS. Apart from the obvious “now I don’t have to try to read my own handwriting on a daily basis,” ELNs offer lab personnel and managers two major advantages over paper notebooks:
• Integration. While specialized digital analyzers are becoming commonplace, nearly every piece of equipment in the modern lab is being digitized to create an “Internet of Things.” Vendors are eager to create digital “ecosystems” within lab environments that will ultimately integrate with, and be controlled by, the LIMS. ELNs will have an important role to play in these ecosystems—as the primary “gateways” people will use to interact with their digital labs.
• Compliance. Complying with regulations is a major concern in any lab. ELNs have audit trail functionality built in, so lab workers can easily keep track of their data. Also, the organization that owns the lab can regulate access to ELNs in a way that cannot be done with paper notebooks. With these barriers in place, there can be no question of data manipulation in lab records. l
Gordon Feller is a freelance writer whose insights about advanced science/technology research have been published for more than 40 years by leading organizations including MIT, the World Economic Forum, the United Nations, The Financial Times of London, the World Bank, and dozens of other organizations.