More than a year before the COVID-19 pandemic began, John Scrivener, a senior buyer from Nonin Medical, Inc., contacted Diversified Plastics, Inc. (DPI) to learn about the company’s capabilities and capacity as part of a supplier selection process. That was the start of a mutual partnership in the fight against COVID-19.
Nonin Medical’s Onyx® Fingertip Pulse Oximeter
The Nonin supplier selection team was looking for a long-term partner to manufacture components for its Onyx® fingertip pulse oximeters and other potential products. Onyx fingertip oximeters are small and lightweight. They measure and display functional oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of a person. Clipped to a finger or toe, the device is used in hospitals, clinics, long-term care facilities, emergency medical services and home health settings. The first fingertip pulse oximeter on the market, Onyx has a durable hard plastic case designed to withstand vibration, shock, bumps and drops. Manufactured in black, blue and red, it has plastic channels that hold the batteries securely in place. In addition to Onyx fingertip oximeters, Nonin products are sold in 125 countries.
Supplier Selection Process
DPI was one of three plastic-injection molding companies that Nonin considered. Prior to starting the review process, Nonin’s team developed a vendor selection matrix. Key considerations included a robust quality control system and comprehensive validation process as well as a convenient location for easy collaboration. Each candidate company was asked to respond to a formal request for proposal and to provide a tour of their facilities.
“We were transitioning from another plastic injection molder,” says Kristin Finberg, project manager at Nonin. “Searching for a new supplier was a big step for Nonin. We needed to be confident that the chosen vendor could meet our needs today and in the future. We ranked the companies based on the selection matrix criteria. DPI came out on top as a great fit.”
Tooling, Validation and a Rapid Surge in Demand
After many years of use, the tools used to make the plastic-injection mold components for the Onyx fingertip pulse oximeters needed to be replaced. Moreover, there were a few design changes that Nonin wanted to integrate into the product. Alex Cromett, DPI’s engineering manager, along with Aliza Alverson, sales engineer for DPI, developed an action plan and schedule for Nonin. To ensure good communication and a smooth process, the technical teams from both companies held weekly
status meetings.
While Nonin had the product design completed, they relied on DPI’s experienced team for tool design that would deliver maximum manufacturability and consistent, high-quality components. As part of its continuous improvement process, Nonin wanted to raise the bar for validation of the new tool. DPI delivered with an advanced validation protocol. Before the molds were made the teams reviewed the tool design. Once the tool was complete, prototypes were developed, and the first article inspection was successfully completed.
“Just as we were getting close to going into production, COVID-19 happened,” explains Finberg. “That’s when Onyx product sales rapidly accelerated. Fortunately, we were already working with DPI to manufacture, decorate and assemble components of the Onyx fingertip pulse oximeters.”
(Related content: Avoid Pitfalls: Tool Transfer Protocols and Design for Manufacturing Yields Better Profits and Shortens Time to Market and DPI’s Validation Service Program)
Silent Hypoxia
An early warning symptom of COVID-19, silent hypoxia, is a condition in which oxygen levels in the tissue have dropped, but the individual has no signs that something is wrong. A pulse oximeter, or pulse ox, identifies patients with silent hypoxia, alerting physicians early that treatment may be indicated. Early treatment can keep COVID-19 patients off ventilators—and alive. Common and as simple to use as a thermometer, a pulse oximeter is an electronic device that measures pulse rate and the saturation level of oxygen carried in red blood cells.
Meeting Increased Demand
“When we started the review process, we couldn’t have imagined that demand for the product would increase as much as it has. This sales growth was a result of the product’s ability to help diagnose and monitor silent hypoxia in COVID-19 patients, and of our effective marketing strategy,” says Finberg. “The team at DPI was able to quickly assess the surge in volume and develop a plan, including additional tooling, to increase capacity. DPI has done an amazing job meeting our needs for increased production, and DPI was in the right place at the right time. Everything is going well.”
Nonin’s marketing strategy regarding COVID-19, called All Together Now, is focused on serving the health care industry through education, recognition and thought leadership. Press coverage at NPR, in the Star Tribune, New York Times, CBS Morning Show, at Kare11 and others, generated as part of the campaign, contributed to the company’s recent success.
DPI is manufacturing everything that is plastic on the Onyx fingertip pulse oximeters, including the exterior or enclosure and the soft touch material that holds the finger. Some of the parts being manufactured require complex overmolding of different materials, which is one of DPI’s proficiencies. DPI also manages direct sourcing of lens components with one of Nonin’s other vendors. Additionally, the manufacturer is sourcing product decorating and completing some of the assembly. Once completed, the parts go back to Nonin to add the electronics, finish the assembly, and packaging. As a result of the ongoing pandemic, demand will continue globally for Nonin’s pulse oximeters. To maximize capacity, DPI invested in additional presses.
For more information about Diversified Plastics, Inc. or to request a quote visit divplast.com, call +1 763.424.2525 or email [email protected].
About Diversified Plastics, Inc.
Employee-owned Diversified Plastics, Inc. (DPI) is a custom plastic-injection molder and digital manufacturer of high-precision, close-tolerance parts and components for medical device, filtration, aerospace and a variety of other industrial markets. Founded in 1977, the company is a full-service contract manufacturer providing design for manufacturing assistance, additive manufacturing, mold construction and intricate molding, as well as cleanroom assembly. In 2018, DPI purchased Pacific Plastics Injection Molding in Vista, Calif. DPI is ISO 9001:2015 and 13485:2016 certified, FDA registered, ITAR certified and UL registered. www.divplast.com
