BBI Contributing Writer

ANAHEIM, California – What are the three "bet your business" changes coming in the next two years? According to Matt Holleran, vice president of marketing at Datasweep (San Jose, California), the biggest hits/opportunities to medical device manufacturing will be customized manufacturing, short product life cycles, and outsourcing some or all of production. Speaking at the Medical Design & Manufacturing (MD&M) West 2000 meeting here earlier this year, Holleran emphasized, "Web-based software is accelerating these trends at an amazing rate."

Holleran advised manufacturers of medical devices to exploit these trends and shifts in traditional business models through the use of new software programs and the Internet. "Your online customers want to know the same key things about their order. They want to know where it is, when it will ship, what's in it? Just like any other customer – only now, with the Internet, they want to know right now."

Many names have been used – mass customization, build-to-order (BTO) manufacturing, the Dell factor, supply chain automation. Regardless of the words used, Holleran notes that one of the most important economic trends of this decade is the shift from one-size-fits-all to personalized products.

While some medical device manufacturers continue with a build-to-stock (BTS) business model, many others have adopted build-to-configure (BTC) or BTO strategies. The benefits of direct-to-consumer marketing and e-commerce models on the Internet are spurring interest in mass customization. Companies can now extend their reach to the individual consumer at relatively low cost, and the customer can readily interact with even the largest supplier. According to the AMR Research Report on Manufacturing for May 1999, "E-commerce forces manufacturers to build to order ... from telecommunications to tractors, customer focus speeds the personalization of manufactured goods and shrinks product lifetimes."

Holleran noted, "Progress along the customization continuum toward BTO production is driving the demand for more granular, real-time visibility into factory-floor operations."

Medical device manufacturers are increasing the percentage of finished products and components going to outsourcing suppliers-contract manufacturers. This does not relieve the manufacturer of the tracking responsibilities so key to FDA-regulated products. Holleran noted, "With web-based systems, OEMs and contract manufacturers can share production information in three different ways. In one instance, the OEM owns the production tracking system and requires its contract manufacturers to input information into that system via the Internet by accessing the OEM's application via a browser."

Another sharing option is for the contract manufacturer to own the production management system and provide appropriate access to that system to each of its OEM customers. In the third option, the OEM and contract manufacturer both have copies of the unit-level production information and synchronize updates to that information. All these options are web-based.

Unit-level data tracking provides value throughout the product life cycle – during production and long after the individual product leaves the factory floor. Holleran believes unit-level data management can improve customer service.

He noted, "For instance, a manufacturer of custom computers increased on-time delivery through unit-level tracking from 78% to 96%. As computers move through manufacturing, unit-level tracking enables the company to prioritize production according to shipping time. This improves customer satisfaction and reduces final inventory."

Whether a build-to-stock or build-to-order manufacturing facility, most manufacturers want or need to track detailed "as-built" information on quality tests, sub-component serial numbers, and suppliers. This assures the unit is built correctly the first time. Service and warranty requests are simplified. Upgrades are more efficient.

For many companies, the key to BTO quality and productivity is simply eliminating paper-based travelers and manufacturing procedures – replacing them with Internet-accessible electronic shop floor management systems.

By leveraging both real-time factory-floor data and historical information, the OEM can determine short-term actions and design long-term product strategies critical to optimizing the life cycles of its various product lines. Visibility into the assembly floor across the supply chain enables the OEM to monitor trends and make cost-benefit comparisons across product lines, while leveraging the economic benefits of outsourced manufacturing.

Holleran's firm, Datasweep, has designed a technology architecture to embrace these manufacturing trends. The Advantage product line for web-centric supply chain manufacturing is designed to provide detailed visibility into manufacturing operations across the supply chain while supporting sophisticated analysis and reporting tools to support ongoing improvements in those operations. The key to the Advantage product is its web-centric design and browser-based interface, speed of configuration/rollout, and real time production metrics. Advantage is a packaged unit-level production tracking system that installs on PCs located at manufacturing, assembly and test sites throughout the manufacturing supply chain.

Completely web-centered, relying on Java applets and standard browsers, Datasweep's Advantage architecture is written in Java, yet does not require users to have Java skills. The product is full-featured, providing process design tools, view definitions, and reports through browsers. By harnessing web browser technology, Datasweep solves the data distribution problem of providing easy access to information for operators, other departments within the enterprise, customers, and partners.

The company's companion product, Agile Anywhere, manages product content information and allows OEMs and their supply chain partners to collaborate on products in real time over the Internet. According to Don Chamberlain, document control manager at surgical robotics maker Intuitive Surgical (Mountain View, California), "The combination of Agile and Datasweep with the Agile interface helps us manage the entire product life cycle much more effectively."

MD&M West and its companion Pacific Design Engineering show drew more than 11,500 attendees to the new Anaheim Convention Center. The exhibit floor was divided into pavilions, speeding access for the attendees. Pavilions included those for in vitro diagnostics (IVD), medical electronics, medical equipment networking and medical packaging solutions.

Several new and interesting exhibits included those from Ten North Software, SighTech Vision Systems, and Elo TouchSystems.

Ten North's Channel Management System is an outsourced extranet that bridges the information gap between a manufacturer and its third-party sales channel. By doing so, the system allows manufacturers to increase revenue through their channel partners while reducing channel support costs.

With the Ten North system, the manufacturer's sales and marketing information is available in real-time to all channel partners. This shortens sales cycles. Each channel member has unique access rights to Document Libraries within the system. They can only see and access the information intended for their use. Libraries might be business reports, sales information, marketing information, or training information. Discussion forums are virtual meeting rooms where channel partners can discuss customer perceptions and address competitive concerns. Product marketing can then adjust campaigns based on real-time market feedback.

Information posted to the Ten North system is securely stored in digital format, not on web pages where it might be vulnerable to hackers. When channel members request information, it remains encrypted as it travels over the Internet. Unencryption occurs when the information reaches an authorized user's desktop. Channel members have ease of access; manufacturers have ease of mind.

The Eyebot Trainable Inspection Device from SighTech Vision Systems (San Jose, California) learns to inspect medical device products just by looking at them. The robot system can check for variations in positioning, orientation, lighting, and clutter. It trains in minutes and requires no PC or software.

Eyebot can be used wherever automated optical inspection was previously too complicated or too costly. First, some "good" parts are shown to Eyebot and the system learns them. After training, tell the system to run and Eyebot will tell the inspector when it sees anything it wasn't taught. No PC or complicated software is needed. Some factories are using Eyebots for incoming, in-process and outgoing inspection at different locations during the same week.

Elo TouchSystems (Fremont, California) introduced its new medical-grade touch-screen monitor in January. This new 15" CRT touch monitor is outfitted with the AccuTouch 5-wire resistive touch-screen technology. It offers the simplest, most direct way for medical professionals to interact with medical equipment and computers.

The company refers to the monitor as "inherently accurate and durable." It stands up to long-term use, frequent cleaning, and potential liquid spills. Unlike many touch-screen technologies, AccuTouch can be activated with a gloved hand or stylus – another critical capability for medical applications.