The Laboratory Information Management Systems (LIMS) Tranformation: Think Optimus Prime.
By Drew Barrows
Laboratory Information Management Systems (LIMS) have been around for more than a decade. Basic sample management systems developed on home-grown solutions along with the use of spreadsheets have evolved into more sophisticated systems now known as LIMS. Traditional LIM systems sprouted from university labs and then were commercialized by applying software standards. The idea behind LIMS was to create a system that manage mission critical applications and assists labs in not only tracking samples, but in automating data exchange with equipment, tracking lab procedures and ensuring compliance with GLP standards and FDA regulations.
Many of the original systems that are the market leaders today were created from university labs which were later commercialized based software standards and software design methods to enhance flexibility. Unfortunately what has happened is that systems are not currently as flexible as they need to be and as one LIMs vendor put it, “built and then retrofitted to fit the labs’ dynamic vs. what LIMS vendor has done in that it’s platform is completely open architected to configure the application based on the lab’s criteria. It the difference between a “canned” approach that open forces a set of rules or has fixed dependencies or an “open” architecture that can rapidly model the lab environment at hand.
One key stipulation that goes for both the canned or open approach is that users are demanding more out of their lab automation systems to increase lab efficiency and minimize errors. According to Strategic Directions International, Inc., “laboratory information management systems (LIMS) have evolved to become a necessity for both small and large companies to allow its users to obtain, store, manage, retrieve and record laboratory data. The LIMS market was valued at over $500 million in 2009. Technological advances continue to impact the LIMS market, as well as change the needs and requirements of each Laboratory.”
Several LIMs vendors today provide a next generation LIMS that intersects numerous business and laboratory boundaries to meet the needs of being easily scaleable and has the ability to adapt to a constantly changing environment. This intersection is seen especially as scientific innovation and instrumentation systems continue to progress. Often LIMS are specifically coupled to an expansion in data processing, knowledge management and IT technology activity outside the lab practice, complicating how LIMS adapt to dynamic environments. It is actually not unusual to have the LIMS reporting system be the only interface that non-lab management may have to the lab and in part is why LIMS is considered such a key management tool.
Strategic Directions Internationals cites that there are about 90 LIMS suppliers and given that the entire market size estimates varying from $250M to $450M per year, the number of players is high. What this boils down to is that for every LIMS vendors, there are at least two companies willing to provide implementation and validation services. This also means that there are a lot of different principals and methodologies being applied in the market and companies are having a difficult time sorting through the landslide of LIMS offerings. “First and foremost, it is important to define what you want the new LIMS system to do and write that into a user requirements specification. Expect it to take some time to create because the process of thinking through what is needed is critical to the success of any LIM installation, says Siri Segalstad, Principal of Segalstad Consulting AS and the author of International IT Regulations and Compliance (Wiley-VCH, 2008).”
Building on Segalstad Consulting’s thought, several LIMS providers advocate that any new LIMS implementation should also provide versatility in being able to change workflows to include additional users beyond the usual lab persons. Often lab staff will receive raw materials and testing it out as samples should log that information into their LIMS rather than sending the sample out with a piece of paper detailing the sample. Simplifying the approach further could involve integrating the in-process analysis to the new LIMS. In support of a greater need for LIMS to be more flexible, many LIMS vendors developed a highly intuitive abstracted platform that can support new and existing LIM users with custom-built LIMS applications.
“Today many of the questions being asked often involve whether the Lab is getting the value for money for their LIMS investment and even more importantly whether they are able to provide value to their customers,” said Simon Wood, Ph.D., Senior Consultant at Labformatics Ltd.. “The questions seem simple enough questions and are on lab manager’s mind when they are performing their lab operations. Unfortunately many lab managers often admit that they don’t feel that they harness the full power of their LIMS.”
When Strategic Directions did a perception study, they found that the business challenges in regards to estimation of return on investment (ROI), return on capital employed (ROCE) or invested capital (ROIC) are often difficult to measure when valuing a LIMS installation’s success. It is even more complicated to measure a LIMS on-going future value. Total Cost of Ownership (TCO) is one areas being looked at to provide a more financial quantitative measure for LIMS implementations.
“TCO occurs faster with LIMS that can rapidly self-extend or scale to the labs requirements today and also can handle the lab’s future requirements,” continued Wood. In addressing how to control of the project and the process, most LIMS vendors work with labs whose laboratory practices and systems are in control and alter little as well as those that whose lab practices change constantly. The important factor for serving all types of lab environments is to use a highly configurable LIMS platform that can be equipped for small or start-up organizations as well as more established companies. The use of a hosted LIMS solution can provide a formidable alternative to force fitting traditional enterprise LIMS software. Hosted LIMS can take the edge off the SMBs by offloading all of the support, maintenance, backup and recovery for all of the system hardware and software, which minimizes any need for IT staff to support the system.
For more established labs, vendors provide an Enterprise-wide LIMS data management system that focuses on creating seamless integration with laboratory workflows and instrumentation. According to Dr. Martin Goffman, a LIMS consultant who possesses more than 25 years of relevant experiences in the design and use of LIMS for the management of laboratory data, laboratory information management systems (LIMS) are no longer merely convenient optional tools to be used in labs. LIMS is mandated today. LIMS are now a necessary component of all modern laboratories that desire the combination of processing efficiency, quality assurance, and data validation that are required to be competitive. Pharmaceutical team members today are often responsible for the upgrade and purchase of LIMS in order to meet regulatory requirements and keeping up with new rules, validation, R&D, 21CFR Part 11, and implementation.”
Mangers find operations fast-moving with high data churn, less control and large upfront informatics outlays in labs where new technology and science is being used. The trend today is to use the LIMS as a data and business management control tool. LIM systems have progressively evolved and now can be configured with no programming in hours. This is a big change from working with static applications and databases including complex customization tools that require expensive consultants as well as months or years of work. It has become more important to have customers to take a lot more time thinking about the changes they want to make then it would to actually implement them within a LIMS. Lab managers need to evaluate up front how their LIMS will be able handle anything that comes down the pike at any time in the future. It will ensure investment protection not only on your LIMS but for all of your existing IT infrastructure.
This Kalorama Information report recently showed that there is increasing interest by LIMS users in an easy to use - Enterprise LIMS which can be implemented, without external LIMS-consulting. Users want an Enterprise LIMS that can be configured within days instead of months. Reducing the costs of consulting will decrease greatly the overall cost of a LIMS implementation. The trend in 2011 is one where we will see the reduction of consulting services and coding, which is becoming more and more a growing requirement. One trend that hasn’t changed and won’t be changing any time soon is one where LIMS continues to be a complex business but there is certainly no reason why it should entail difficult tools to use.