Industry-Leading Medical Device Company

When a large medical device company needed to make improvements in several of its labs three years ago because an outdated system was still being used to handle testing requests, it chose LabLynx’s laboratory information management system (LIMS).

In the relatively short time since implementing a LabLynx LIMS, the company has seen a significant improvement in testing efficiency, and it has totally eliminated the use of paper at three of its labs in the US, Europe, and South America. It’s also been able to expand its use of LabLynx LIMS into five additional labs.

The company has microbiology, chemistry, physical testing, and pharmaceuticals labs.

One of the most significant advantages of switching to a LabLynx LIMS is that, once initially configured, the LIMS can be easily adapted and integrated into the testing workflows of each of these various labs, regardless of the lab type.

In addition to improving efficiency, LabLynx LIMS has also reduced errors and audit findings; promoted uniformity; supported the Environmental, Health and Safety group by monitoring inventory; and, in labs that tracked everything on paper, reduced the head count in the labs or enabled staff that previously managed paper to segue into other roles to support lab efficiency.

The primary reason this medical device company turned to a LIMS was to ensure that specific regulatory-driven workflows are followed in the lab each time a test has to be performed.

“As a medical device company, we are highly regulated and have to follow specific processes,” said Katie, the company’s LIMS administrator. “The problem is that when you have a new trainee, they may skip a step not knowing they skipped a step. Then the lab has to complete an NCEP, which is a corrective action plan where we have to determine what caused a non-conforming event and provide a plan on how to prevent the non-conforming event from happening in the future. We have to include which pieces of equipment were used and which solutions were used. For example, a piece of equipment might have been out of calibration, or a solution expired.”

Katie was instrumental in choosing LabLynx LIMS three years ago when she began her role as supervisor analyst at one of the company’s US labs. With a background in computer programming, she knew immediately that she wanted to make some improvements. “I raised my hand and said, ‘I want to change this. Let’s get into the new century, so let me see what I can find to replace this archaic system.’”

“We started with three labs that all used the same system, and what happened is that after hearing about what we were trying to do, several more labs came on board. So, word is spreading by kind of a grassroots method. When others hear what LabLynx can do for their labs, they want the LIMS,” she said.

Highlighting the many benefits the company has seen since transitioning the first three of its labs to LabLynx LIMS, Katie identified these as the top four:

1. Lab workflow creation: The LIMS enables the creation of specific testing workflows that ensure each step of a specific test is performed the same way each time a sample is tested. This aids in eliminating human error and the potential for missing test steps.

2. Tracking of lab equipment and solutions: The LIMS makes it easy to go back and quickly identify which piece of equipment or which solution was utilized in a test. For example, if something is wrong with test results, and it turns out that a solution used in testing was expired, the LIMS makes it easy to go back and see which samples were tested using that solution. Then they can be retested.

3. Audit trail: Medical device companies are audited. This results in a burden on labs to prove to auditors that they are providing original data, or if data has been modified, to explain why there were changes made to the data. “LabLynx LIMS has that audit trail, and it doesn’t let you change a test result without providing the reason for changing the result. That is extremely important,” said Katie.

4. Customer portal: For labs that work with outside vendors, the vendors can submit test requests and get results through a secure customer portal, which has eliminated the need to keep a paper trail. “We went from this archaic system that helped us track some things electronically, but we also used paper. Now, we’re able to get rid of all that paper,” Katie said.

When she began her search for a LIMS, Katie began with an internet search and read the reviews on different software solutions. She also talked to various people who had used other systems. “What was interesting was I learned that many of the LIMS companies weren’t very responsive. I heard comments like, ‘We’ve had this problem for three years, and we still have not gotten it resolved.’ When I spoke to people who had used LabLynx, I heard that they were very responsive.”

Another reason she chose LabLynx was that it provided an all-in-one solution, while many competitors sold modules separately, requiring multiple modules to be purchased for a complete LIMS system. “You had to buy a module to do the process through the lab, then you had to buy another module to do the inventory, and another module for the instrumentation,” Katie explained. “When I went to LabLynx, I found it was all one system, and I didn’t have to go out and buy Module A, B, and C.”

Another key reason that LabLynx was chosen was because it can be integrated with instrumentation for all the company’s different types of labs. “Some of the LIMS systems would only work with certain types of instruments or tests, and we wanted a LIMS system that was generic, where I could go in and configure it to allow different workflows for different types of labs. For example, microbiology labs use a schedule that is very regimented, and you have [to] complete it in a specific timeframe. In the chemistry labs, sometimes you have very regimented tests that are to release a product and require multiple levels of review. Then you may have another lab where you have an investigation that requires the data to drive the investigation and how it’s being analyzed.”

“LabLynx worked very, very well because it allowed the different flows in the same database, but I can split the database into three different modules, so that I don’t have to have separate modules for microbiology, chemistry, and pharmaceuticals,” Katie continued. “The way my system has been set up, it can do almost anything. We’re actually looking at it now to do sterilization testing and keep track of that process.”

Since the basic workflow of all the company’s labs is similar, she must only customize each lab’s requirements—such as schedules, tests, test frequency, testing parameters, quality control review levels, and reviewers—in the LIMS. The software also makes it easy to add and remove tests. “It’s not boxing me in, which is what a lot of the other systems did,” she said.

Implementing a LabLynx LIMS into an additional company lab now takes as little as six to nine months, Katie explained. It only takes that long, not because of LabLynx, but because the company has to incorporate and configure each specific test.

Initially, Katie investigated LIMS options where the LIMS system could be on internal company servers and maintained by her IT department, or cloud-based maintained by the provider. Most LIMS providers offered to put the LIMS on an internal server, or they charged high rates to maintain a cloud-based system on an external server. She later learned that her IT department didn’t want to maintain the server. “It worked out nicely that LabLynx LIMS agreed to a cloud-based option which they maintain, and our IT didn’t have to do it,” she said.

Katie said a final critical advantage of LabLynx LIMS was that it was one of the most cost-effective solutions that she found, in addition to LabLynx being transparent about the costs from the start. “For some companies, it was like pulling teeth to understand what it was going to cost. LabLynx was about half the price, and they could start the implementation sooner than the other companies.”

To sum up her experience with LabLynx, Katie said, “Our company has found LabLynx LIMS is not only intuitive and easy-to-use for our company, but LabLynx personnel are fun to work with, very responsive and prompt, and acted as an extension of our team by brainstorming with us to provide the optimal system that meets our multiple needs.”