Resources > APICS Magazine > November/December 2004 > Spotlight on the Electronics Industry
The Heart of the Matter
Medical device manufacturer keeps on pumping despite a pending production stoppage
When your company manufactures life-saving technologies such as the CardiAssist 3200 external counterpulsation device, a sudden holdup along the supply chain is a particularly serious situation. So when company leaders at Cardiomedics, Inc., learned that the developer of the CardiAssist monitors could no longer meet their medical certifications requirements, they knew they had to take action or face a stop in production in just a few months.
Tim Hunter, systems engineer at Cardiomedics explains, “Our top priority was to find a partner that would allow us to avoid any interruptions to our production cycle and delivery of products—and meet our stringent quality demands.”
Cardiomedics designs and manufactures the CardiAssist external counterpulsation device and the CardiAssess heart failure management system for use in doctors’ offices in North America and Europe. The CardiAssist, a noninvasive tool, is the company’s leading circulatory-assist device. This therapy does not require any type of anesthesia while it works to improve the heart condition of patients suffering from heart failure, acute myocardial infarction, angina pectoris, or cardiogenic shock.
The monitors are a critical electronic component of the CardiAssist, because they allow doctors and nurses to effectively use the technology to rehabilitate patients suffering from severe heart problems. The monitors require highly accurate touch-screen capabilities and multiple domestic and international medical-grade certifications. Therefore, Cardiomedics needed to choose a solutions provider that could produce a compatible monitor to meet their existing specifications, integrate the technology into a custom system, and deliver an ongoing supply of the monitors—all within only three months.
Willing and able
Cardiomedics turned to Avnet Applied Computing Solutions, a division of global technology distribution company Avnet, Inc., which offers companies engineering, integration, manufacturing, distribution, logistics, and support services. The company markets, distributes, and enhances semiconductors, passive and electromechanical components, enterprise network and computer equipment, and embedded subsystems.
Because Avnet uses customized, off-the-shelf technology from leading suppliers such as NEC, Fujitsu, Intermec, Seagate, Sharp, and Symbol, it is able to quickly develop, configure, and integrate solutions for unique applications in order to help customers meet their time-to-market needs.
Cardiomedics decision makers felt that Avnet was uniquely qualified to deliver certified, custom-manufactured monitors. “The Avnet Applied Computing Solutions team had the proven technical expertise, key relationships, and logistics capabilities to ensure that we would be able to deliver our product without interruption to our customers, which was our number-one criteria for selecting a partner,” Hunter says. “It was the ideal outsourcing partner for us in this situation. It was the only company that was willing and able to meet the deadlines of our abbreviated production cycle,” he adds.
A demanding initiation
As Avnet began to provide design support for the monitors, several engineering challenges arose. First, the LCD screen, which was selected based on the existing Cardiomedics design, did not fit the customized shell. Avnet quickly remedied this by researching the options among its supply of off-the-shelf, name-brand components, and ultimately selected a more suitable LCD screen.
In addition, the integrated monitor did not pass its first round of electromagnetic interference testing. The Avnet team worked closely with Cardiomedics to identify the problem, and solved it by including metal shielding to minimize the interference. Also, Avnet found that the assembled touch screen was breaking. Its engineering team identified the cause as a piece of the Cardiomedics shell that needed to be shaved.
“Technical problems will always arise during a design, and the true test of an engineering support partner is how well and quickly they are able to overcome them,” Hunter says. “Avnet Applied Computing Solutions worked closely with our team to identify and resolve any problems that occurred and was able to find a solution to meet our needs in less than 24 hours. This quick turnaround and responsiveness was particularly important for this project because of our tight deadlines.”
Beyond the technical engineering of the product, Avnet and Cardiomedics also faced a unique regulatory challenge. In order for Cardiomedics to use the monitors in the CardiAssist devices, they needed to receive several domestic and international certifications, including approvals for UL (Underwriter’s Laboratories) 6061 and Federal Communications Commission and CE (European Community) standards, while keeping to the demands of a shortened production cycle.
Because Avnet is part of a multibillion dollar, global organization, the company has solid relationships with organizations such as Underwriters Laboratories. The teams are very familiar with the testing processes and can reduce the potential for failure by knowing what is required to achieve certification in advance. This expertise helped to ensure that the Cardiomedics monitors were certified quickly and accurately, and without production delays.
Substantial advancements
After an abbreviated, three-month production cycle, Cardiomedics received the certified monitors in time to meet its orders without any interruptions to its deliveries. Additionally, Avnet’s technical and logistics expertise enabled Cardiomedics to achieve significant cost savings and reduce production time.
Most interesting, however, was the effect the solution had on the quality of the monitors. Although they had been designed to parallel the previous ones that the company had been using, Cardiomedics actually realized several significant improvements. For instance, the monitors developed by Avnet had much better clarity and touch-screen control. Hunter explains, “Our teams were thrilled when they tested the monitors developed by Avnet because they had improved the features doctors and nurses use and rely on most—the quality of the picture and touch screen.”
Plus, even with these upgrades, Cardiomedics still achieved the significant cost savings of $500 per unit, which is approximately half of the previous total unit cost. “Avnet Applied Computing Solutions met every key criterion we had established for this project—and provided Cardiomedics with additional benefits that allowed us to improve our solution and have the potential to impact our bottom line,” Hunter adds.
In addition to the cost-savings and technical improvements, Cardiomedics increased the efficiency of its supply chain because of Avnet’s life-cycle management capabilities. With this tool, the company was able to reduce its order-to-delivery time for monitors from six weeks to a few days. Avnet also now provides Cardiomedics with end-of-life-cycle support to make certain the company will be able to continue to use its monitors into the future—without substantial changes to the components, and therefore avoiding a considerable recertification process.
“We needed to quickly remedy the situation with our monitors before it caused significant business and customer satisfaction problems,” Hunter says. “Avnet Applied Computing Solutions proved itself to be a committed partner to ensuring that we met our goals.”