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This article was originally written for and published by MD+DI.
MicroLumen, Inc. high-performance medical tubing is used in a wide range of minimally invasive, critical original equipment manufacturer (OEM) applications such as cardiovascular catheters, stent delivery systems, urological retrieval devices, and drug delivery.
MicroLumen partners with OEMs worldwide to custom engineer high-performance medical products that meet specific needs. The company’s diversified product line also includes secondary operations, such as custom laser machining, composite constructions, assembly, and braid/coil reinforced shafts that solve specific challenges.
AT A GLANCE
– CAPA response compliance jumps from 60% to 98% in six months using Propel's streamlined process management.
– Centralized platform automates quality processes, ensuring consistency and reducing non-compliance risks.
Business imperative: clear data visibility
To successfully support business growth, MicroLumen identified efficiency shortfalls within its business processes. Manual, paper-based record-keeping for quality operations became extremely difficult to sustain as the company expanded its customer base to over 1,000 OEMs worldwide. To support current and future business initiatives, MicroLumen needed a digital system of record to support quality initiatives and communicate those changes throughout the organization.
It needed to track and document training, changes, workflows, and provide robust reporting capabilities. It was seeking a unified source of product truth to replace manual processes and inefficiencies. With a quality management system (QMS) in place, the company could automate tasks and drastically improve the overall efficiency of the organization.
Propel Software: Intelligent QMS for maintaining compliance
With Propel, MicroLumen has automated and modernized its quality processes. Propel enables cross-functional teams to collaborate more effectively by providing real-time access to product information and updates, reducing company silos, and improving internal communication.
Propel’s tracking and reporting capabilities enhance traceability throughout the product lifecycle, making it easy to monitor changes, identify trends, and execute data-driven business decisions.
Propel’s cloud-based solution scales with MicroLumen’s business, allowing it to adapt to ever-changing regulatory requirements. Propel’s customized workflows provide clear visibility to corrective and preventive actions (CAPAs), complaints, deviations, and training, ensuring consistency and reducing the risk of non-compliance.
Delivering measurable business impact in days
Before Propel, MicroLumen faced inefficiencies in maintaining compliance, particularly with training and CAPA processes. Everything was completed on paper – a cumbersome and error-prone system for processes like document change notices that required employees to manually sign off on updated training. When employees were absent during changes, those signatures were often overlooked due to a lack of visibility and monitoring, hence leading to deficiencies in training evidence and compliance.
Within 14 days of Propel going live, MicroLumen increased training compliance from 45% to 100%. Now, when a document change notice is issued, employees are immediately notified via mobile device, ensuring they are aware of and complete the necessary training on time. Propel also sends automated follow-ups and generates detailed reports for managers, highlighting which employees have yet to complete their training within the allotted time frame.
MicroLumen’s CAPA response compliance increased from 60% to 98% in just six months with Propel’s streamlined process management and automated reminders.
In addition, deviations for products and processes are now consistently completed on a timely basis with approvals from all necessary parties, even when team members are away from the office.
“Incorporating Propel into MicroLumen’s quality operations has had a significant impact on our business,” said Eli Javier, MicroLumen’s Continuous Improvement Program Manager. “Propel helped us streamline quality records, ensuring that documentation is complete, up to date, and easily accessible during audits and managerial reporting.”
MicroLumen now has a centralized platform to automate CAPAs, calibrations, complaints, audits, and document control, deviations, and training, ensuring consistency and reducing the risk of non-compliance. Based on the success it has achieved thus far, the company is expanding with additional processes, such as change management, to further enhance its quality system processes.
