MicroVention is a Tustin, CA-based medical device company and wholly owned subsidiary of Terumo Corp. MicroVention is a leading global developer, manufacturer and marketer of neuroendovascular technologies such as intraluminal stents, occlusion balloons and polymer coils. It operates facilities in California, Costa Rica and China. The company is experiencing rapid growth, fueled by product demand and expanded distribution in key international markets.
To date, MicroVention leveraged a barcode label design solution called LABELVIEW, from TEKLYNX, to design and print labels. However, the recent growth caused MicroVention to re-evaluate its labeling operations in favor of gaining efficiencies across all facilities.
“We reached a point in our growth where we needed a labeling solution that was available over our network, not stored on each individual computer,” explains Frank Carranza, MicroVention Associate Label Engineer. “I immediately thought of TEKLYNX, given my past experience with TEKLYNX’ enterprise-level barcode labeling solution, TEKLYNX CENTRAL CFR, at a previous employer.”
For MicroVention, the upgrade to enterprise-level labeling—that integrates with its Enterprise Recourse Planning (ERP) System—positions the company to streamline labeling operations globally while addressing the need to:
• Adequately support a global and secure, multi-user environment with more than 50 different employees in four different facilities requiring access and print desired labels.
• Efficiently support a leanly staffed label design environment, with employees responsible for designing and managing labels for at least 2,000 different SKUs.
• Provide bandwidth for future growth since operating in a rapidly growing industry means MicroVention must have a labeling solution that grows with them over time.
• Comply with medical device manufacturer labeling regulations such as those required by the FDA’s Unique Device Identification (UDI) requirements.
Security and access
In addition to these unique labeling challenges, MicroVention’s global presence required it to be mindful of security and accessibility issues related to the company’s data center. “We have thousands of global installations and know that security and access is top of mind for companies,” says Cory Catterall, TEKLYNX Enterprise Sales Executive. “We were confident our enterprise-level barcode labeling could meet MicroVention’s labeling requirements while providing secure access and sophisticated user profile control.”
The TEKLYNX Enterprise Team collaborated with MicroVention to determine that the browser-based, integrated enterprise label management system, TEKLYNX CENTRAL CFR, was scalable and efficient for managing the different facilities, including those outside of the U.S., while providing the bandwidth for future growth.
“We were excited to work with MicroVention on its upgrade from LABELVIEW to an enterprise-level barcode label solution. As companies grow and business requirements change, so do labeling requirements,” explains Catterall. “Upgrading to TEKLYNX CENTRAL CFR was an opportunity for MicroVention to streamline labeling operations globally.”
Label creation versatility
MicroVention and TEKLYNX worked closely throughout the implementation, providing MicroVention with significant advanced label creation services that proved invaluable. These include extensive logical date stamp formulas to ensure accurate printing of expiration/manufacturing dates on MicroVention products.
These formulas allowed MicroVention the flexibility to manually override dates when special circumstances required MicroVention to do so (i.e., a product label reprint from a previous production day). This intelligent label design reduced the chance of manual error globally while allowing for granular date control when necessary.
MicroVention also relied on TEKLYNX to develop a Structured Query Language (SQL) script that synchronizes work orders, products, labels, and variables from more than 50 tables in MicroVention's database. Developing the SQL script eliminated manual processes, allowing MicroVention to create thousands of printable products with the single press of a button while improving the company’s database speed and efficiency—a move that made it easier for network users in Costa Rica and China to utilize the system.
TEKLYNX also created interface patches to further customize and simplify MicroVention’s user interface, allowing for ease of use and faster network speed.
MicroVention’s implementation of the enterprise-level system also positions it to integrate labeling operations with the company’s existing JD Edwards ERP system. Integrating the two systems meant that all label files could now be created using database-driven templates, minimizing potential human error.
A crucial benefit of the system is the ability for MicroVention to comply with medical device manufacturing industry regulations. Because TEKLYNX CENTRAL CFR was specifically designed to help manufacturers align with FDA compliance standards such as 21 CFR Part 11 and UDI, MicroVention is in the best position possible to meet these requirements.
“The TEKLYNX team’s guidance throughout the implementation process was remarkable,” says Carranza. “They were knowledgeable, responsive and successfully guided us through our internal issues as they arose.”
Carranza, and the MicroVention team set out to improve labeling efficiency, control and support for its global, multi-user labeling environment. “From design to approval, production, and print, our goal was to make our labeling process leaner overall,” says Carranza. “By implementing TEKLYNX CENTRAL CFR, we were able to streamline our entire labeling process on a global level, resulting in a 50% improvement in total production efficiency.”
MicroVention’s successful implementation of the labeling system led to the following labeling environment enhancements:
• Improved ability to support its global multi-user, multi-facility environment. Access to true internet printing allows MicroVention to print labels from anywhere in the world. The ability to print labels to a virtually unlimited number of printers provides the necessary bandwidth to support future growth.
• Improved ability to support its lean staffed labeling environment. The automated network printing module can manage hundreds of printers in multiple locations from a single server. The regulatory compliance software ensures that electronic signatures are linked to relevant electronic records by requiring user ID and password sign-in to perform all functions.
• Provided the desired level of data center security throughout its global network. User privileges are controlled with customizable user groups so only authorized individuals can use its system and/or electronically sign a record. The system records audit trails throughout label life cycles, making MicroVention audit ready.
• Improved ability to comply with medical device manufacturer labeling regulations so that the company can:
—Easily create complex bar codes, such as HIBC or GS1 Databar, to meet FDA compliance and healthcare industry standards.
—Access a label approval module that allows for electronic approval while providing the required security and traceability in accordance with FDA 21 CFR Part 11.
—Use a single regulatory compliance software Command Center that coordinates its enterprise labeling process while providing secure access and sophisticated user profile control.
Beyond addressing all of MicroVention’s immediate labeling challenges, the TEKLYNX CENTRAL CFR implementation also positions MicroVention to address future labeling challenges in a highly competitive, fast-growing and ever-changing industry.