Safety and quality are two hallmarks for any manufacturer, but they become non-negotiable when it comes to the production of medical devices. Medical device manufacturers bear the responsibility of producing secure products through individual part testing and assembly—and they come under intense scrutiny if an incorrect part is used or if any piece of the finished good malfunctions.
Phase 2, a contract manufacturer of single-use medical devices, continually seeks out new technologies to enhance the security of its production lines in order to provide top-quality products and services. The company handles all aspects of the production process—from assembly to testing to packaging—for customers from two facilities located in New Hampshire and Mexico. Each facility is equipped with a modern, environmentally controlled ISO Class 8 cleanroom. (Phase 2 will be exhibiting at Booth # 2491 the upcoming MD&M West show in Anaheim February 9-11.)
“We receive an influx of orders on a daily basis, and many projects have short lead times,” said Adam Prime, president of Phase 2. “So it’s essential for us to have a scalable, fluid system in place to move projects through the production process in a controlled and efficient way. That system has to be as visual as possible so every single employee can understand the status of a project or where a particular part or component came from or is supposed to go.”
The visual inventory management system that Phase 2 relies on for all active projects is called kanban. Under this system, labels are used on all components as well as each bin and rack in the warehouse, where parts are stored until they are sent to the cleanroom for assembly. Once parts arrive in the cleanroom, different labels are applied as part of a point-of-view system. Under this system, each line has a dedicated label color to distinguish it from other lines in the facility.
This controlled inventory process is also a critical component when it comes to traceability. Phase 2 tracks the lot numbers of all components, assemblers, and equipment in the event they need to trace back any aspect of a medical device that does not perform as intended.
Clearing the Hurdles
While Phase 2’s labeling strategy worked from a practical perspective, the execution of it was cumbersome and interfered with the very efficiency the kanban system was supposed to provide. Each label had to be created individually in an Excel template. Employees would then take a picture of the template, upload it to a computer, manually enter required information, and print out labels one at a time. In addition to taking up a significant amount of time and manpower that could be better used elsewhere, the process also increased the risk of mislabeled parts or components.
Image Caption: The “before” labels, when Phase 2 relied on simple black and white labels for work-in-progress tagging. Producing these labels proved inefficient and increased the risk of mislabeled parts or components.
Image Caption: The “after” labels. Epson’s ColorWorks C3500 printer allows Phase 2 to color code its parts to match the manufacturing line it will be sent to in the clean room, producing crisper, easier-to-read text and facilitates data updates on the fly.
Another aspect of Phase 2’s labeling process that needed to be improved was its use of color. “Color is a huge advantage when it comes to kanban and finished goods in general,” commented Prime. “For example, in our cleanroom environment, we have several different manufacturing lines. It’s not uncommon for them to be producing devices of a similar shape and size or to use similar components, making it difficult to know what is supposed to go where. Color coding offers a simple, reliable solution.”
Unfortunately, Phase 2’s method of generating color labels was far from ideal. “It was really inefficient, and costly, to have to stock 15 different preprinted labels with different colors,” said Prime. He tried different routes to solve the problem, including investing in two-color and three-color printers, but soon realized the systems were not flexible enough to keep up with ever-evolving production requirements. Prime ultimately settled for producing labels in black and white as a short-term solution. Multiple labels were printed on 8.5 x 11-in. sheets, which were then cut into individual labels for application either in the warehouse or the cleanroom.
Color Makes Everything Better
To identify a color labeling solution that would support the principles of kanban, Prime headed to the Pharma Expo trade show. It was there that he discovered Epson’s ColorWorks printers with Just in Time Color labeling.
Based on Phase 2’s needs and requirements, Epson recommended its ColorWorks C3500 model, a four-color ink-jet printer with high print speeds and exceptional image quality. Epson’s patented ink-jet technology, combined with the high quality of its pigment inks, produces labels with vibrant images and sharp, easy-to-read text. The ColorWorks C3500 had the flexible capabilities that Phase 2 was looking for, while also offering the ability to seamlessly scale up production as needed.
After consulting with New England Programming Services Inc. (NEPS), its partner for ink, media, and technical support with 20-plus years of experience in the healthcare industry, Phase 2 proceeded with the ColorWorks C3500. Overall, printer installation went smoothly, and Epson representatives spent time on-site to help set up proper formatting for the labels.
Image caption: An example of how color labels are used by Phase 2 to indicate where components will be directed to once they enter the cleanroom for assembly.
While Phase 2 experienced some key successes with the kanban process, installing the ColorWorks C3500 led to even greater benefits.
“Epson’s technology was the perfect fit, particularly considering that we produce a high variety of products at low volumes, ” explained Prime. “On-demand color labeling allows us to produce the precise number of labels we need, precisely when we need them. We can make on the fly changes to inventory information on the label, and no longer have to invest in purchasing pre-prints that end up being stored for months at a time or get outdated because critical details on the label need to be updated. All we need is a single type of blank label stock. Integrating color in this fashion has helped us get closer to the core principles of kanban and see the results that stem from running a truly efficient operation.”
Since installing the ColorWorks C3500, Phase 2 has been able to print the color labels it requires in about half the time it used to take to produce black and white ones.
Color has also solved the challenge seen in the cleanroom environment with multiple manufacturing lines producing similar products with similar parts. Robert Wickham, Senior Vice President of NEPS, said that, “Every manufacturing line in Phase 2’s facility is represented by a distinct color, so staff can make sure the parts coming from the warehouse or assembly room have labels with the same color as on the equipment. Along with being practical, it provides an important extra layer of safety and keeps operations running smoothly.”
With the ColorWorks C3500, Phase 2 has also seen a drastic improvement in the clarity of graphics used to depict product components, reducing chances that employees will pull the wrong item from the warehouse.
Building on Success
Given the strong results seen to date, Phase 2 plans to invest in additional ColorWorks printers and will eventually integrate Epson’s on demand color labeling technology to produce labels for finished goods.
“With such a tightly controlled warehouse and manual production line, labels play an integral role in how our company communicates and operates,” stated Prime. “Epson’s on demand color labeling technology brought about a huge, positive change in our production lines right out of the gate.”
Epson manufactures point-of-service technology, including printers, precision printing mechanisms, digital image scanners, and mobile printing solutions. Epson America Inc. is the U.S. affiliate of Japan-based Seiko Epson Corporation, a global manufacturer and supplier of high-quality technology products. To learn more, visit: http://pos.epson.com. You may also connect with Epson America Business Systems Division on Facebook (http://tinyurl.com/EpsonFacebook-BizSys), Twitter (http://twitter.com/EpsonB2B_PR) and YouTube (http://tinyURL.com/EpsonYouTube).
Phase 2 Medical specializes in medical device development, medical device engineering, and medical device assembly including medical packaging for companies seeking medical product outsourcing. For more information, visit www.phase2medical.com. Visit Phase 2 at Booth # 2491 the upcoming MD&M West show in Anaheim February 9-11.
New England Programming Services Inc. (NEPS) is an affiliate of Taylor Corporation and offers solutions in vertical markets including insurance, finance, and healthcare. It has helped companies with document processes and provided communication management services. For details, visit http://neps.com.