At Luminex, a biological testing technology manufacturer, digital platforms help field service engineers resolve customer issues quickly and maintain compliance in the heavily-regulated medical device industry.
Recently, the company took the latest step in its digital journey to solve tracking and verifying that service work performed on Luminex’s equipment at customer sites, and even the tools that Luminex’s engineers use, is compliant with regulations set by the U.S. Food and Drug Administration (FDA) and other agencies. Luminex chose TrueContext to simplify complex digital reporting.
“As a technology company, we have to be early adopters of technology—and always look for the latest and greatest solutions for our service engineers,” says Jason Pena, Area Service Director at Luminex.
Managing Compliance in a Highly Regulated Industry
Accurate (and error-free) record-keeping is critical for Luminex’s Field Service Organization, which complies with industry regulations when maintaining medical devices. Precise record-keeping is an essential part of nearly every job. Luminex’s engineers document specific details about each customer appointment, including the service checklists, and create reports to pass along to customers and archive.
“Before… TrueContext, engineers relied on manual, paper-based processes to document these details,” says Michael Queen, Area Service Director at Luminex. It was an inefficient process, further complicated by acquisitions that added new product lines with additional service checklists and documentation requirements. When Luminex acquired Nanosphere (2016) and the Flow Cytometry division of Millipore (2019), the company jumped from four key product platforms to ten.
“Documenting visits for the purposes of an audit trail was a bulky process,” Queen says of the post-acquisition complexity. The engineers weren’t using consistent formats for recording compliance data, making it harder for service leaders to review checklists and reports for accuracy.
“TrueContext is able to do the data sorting we need, based on criteria that the service engineers choose. We used it out of the box…”JASON PENA
AREA SERVICE DIRECTOR
Creating a Standard Workflow
Following its acquisition of Nanosphere, Luminex wanted to streamline and standardize processes to accurately collect and deliver compliant reports across multiple products.
“We wanted to make it as easy as possible to document a service visit,” Pena says, while bringing uniformity to what had been a patchy reporting process.
The logical solution? Field intelligence built for regulated industries. TrueContext’s app development platform checked all the boxes for a better compliance record-keeping system.
“TrueContext is able to do the data ingesting we need, based on criteria that the service engineers choose,” Pena says. “Its low-code platform also means we are able to easily build checklist apps… It’s a smooth experience and, for the most part, we’ve used it out of the box.”
As Luminex’s engineers go through a service call on the TrueContext platform, they complete customizable fields as part of the pre-built workflow. TrueContext then displays the correct checklist and even pre-fills fields with contextual information. The in-app guided workflows prevent engineers from choosing the wrong service checklist. “That has helped us fix a lot of issues in quality review, since we can minimize errors,” Queen says.
Easy to Create Custom Checklists as The Companys
As Luminex continues to grow organically and through acquisitions, TrueContext’s field intelligence platform helps manage compliance-related documentation. If engineers are working offline during service calls, TrueContext syncs automatically with back end systems and queues the reports for quality checks. The service leadership team is now able to incorporate new checklists and workflows within 30 days. That bodes well for future acquisitions and company growth, Queen says.
“The quality review process is much faster now,” Pena says. “The errors have decreased and there’s much less rework for the engineers.” While the compliance review workload has doubled in the past few years, Pena says he can review the reports in the same amount of time. TrueContext’s certified compliance with SOC2 and HIPAA regulations reinforce the quality and compliance process.
With TrueContext, Luminex has improved service efficiency and execution, and also removed the administrative burdens of compliance. But the digital field service tools haven’t just been good for growth and compliance. Luminex’s service engineers like the new toolkit, too.
“It helps the techs feel more agile about their ability to help us improve first-time fix rates and manage compliance,” Queen says. And that means there’s a higher chance the service work will get done correctly the first time.
“It’s much easier to train new people on TrueContext. The workflow is the same no matter which product they’re working on. That’s helped us fix a lot of issues in quality review.”MICHAEL QUEEN
AREA SERVICE DIRECTOR