Monarch Medical: Leading the way in patient-specific insulin dosing recommendation technology
Monarch Medical Technologies is the maker of the EndoTool Glucose Management System, patient-specific insulin dosing technology designed to support clinicians in optimizing inpatient glucose management. The team at Monarch is dedicated to providing easy-to-use clinical decision support solutions for clinicians that improve patient outcomes, reduce insulin dosing errors, and enhance the quality of care for patients requiring insulin therapy during hospitalization.
The path to Vendor of the Year
The Vendor of the Year award at Monarch is a company-wide initiative that seeks to recognize the vendor that has made the biggest impact on the company. Anyone in the organization can nominate a vendor and explain why they think the vendor is deserving of the award.
This year, the winner of Monarch Medical’s Vendor of the Year competition was Greenlight Guru.
Greenlight Guru was nominated by Tara Burnett, Senior Vice President, Regulatory Affairs and Compliance at Monarch Medical.
“Regulatory compliance and quality assurance are really important to us as a Software as a Medical Device manufacturer,” Burnett said. Her decision to nominate Greenlight Guru stemmed from the positive impact on compliance and audit-readiness the team has seen since implementing Greenlight Guru. But it’s also due to the partnership between the two companies and Greenlight Guru’s responsiveness to customer needs.
A nomination driven by clear results
Prior to Greenlight Guru, Monarch Medical had been using a legacy QMS system to meet their regulatory requirements. But the old QMS solution had fundamental problems which led to a lack of internal adoption.
With Greenlight Guru, the team at Monarch found a system that solved their immediate issues and continued to provide value over time.
Improved training compliance
One of the major improvements the team has seen since implementing Greenlight Guru is with training management.
Monarch’s previous training program included more manual steps which created room for error and made it difficult to ensure that everyone was getting the right training at the right time.
With Greenlight Guru, Monarch was able to automate training and gain total visibility into their training program. This year, the team is tracking at 98% on-time training completion.
Increased adoption throughout the company
One of the major issues with the team’s old QMS solution was that it just wasn’t user friendly. It was highly customizable, but that led to struggles with document management—including basic necessities like quickly locating documents within the system.
“With Greenlight Guru, it’s much easier to find documents. The team trusts they’ll be able to find what they’re looking for, and the dashboard lets them log in and see exactly what they need to do,” Burnett said. “Those things were missing in the legacy solution.”
Audit-readiness at an all-time high
Greenlight’s ease of use and high internal adoption have helped improve audit-readiness at Monarch.
“Being able to set up saved views to find specific documents is very helpful. Being able to pull a list or download DHF documents, job descriptions, or the approved supplier list during audits and inspections allows us to be more audit-ready,” said Burnett.
The team at Monarch also appreciates the ability to configure built-in workflows to meet their needs.
“In the complaint handling and CAPA modules, we were able to add workflows that force you to either add information or rationalize why it isn’t needed. We had an FDA inspection, and the inspector was looking at our CAPA and risk management processes. Our old system didn’t explicitly require you to evaluate risk before closing a CAPA. But now we have that built into our workflows with Greenlight Guru,” Burnett said.
“We were able to show them that we had to address risk before closing a CAPA. I don’t know if we would have been able to demonstrate that without the workflow in Greenlight Guru.”
What should medtech companies look for in a QMS?
Burnett has used a number of different QMS solutions in the past, and her biggest piece of advice to medtech companies is to use a QMS that’s tailored to the medical device space.
Her second piece of advice may seem counterintuitive, but Burnett believes companies should find a balance when it comes to customization of their QMS.
“As much as people want things that are really customized, being too customizable makes it really hard to validate,” she said. “We really appreciate the validation packages Greenlight Guru offers because that’s just one less burden on our plate. I have used other software that was just too customizable and then difficult and costly to maintain.”
The final thing Burnett suggests looking for is partnership. The relationship shouldn’t just be transactional.
“The training, the templates package, the quarterly touchpoints we get from Greenlight—I think that really shows an interest in being a partner with industry and with their clients,” Burnett said.
“We don’t have other vendors out there we’ve done that much with. That really highlights why Greenlight Guru was the right choice for vendor of the year.”
What's next for Monarch Medical?
Monarch continues to invest in innovation that advances patient-specific insulin dosing. The team remains committed to building solutions that help clinicians deliver safe, more efficient care while supporting hospitals in achieving their quality goals.
