Using ‘White Box’ Workstations with Medical Devices Does Not Compute for This IT Company

The practice puzzles IT experts like Edwiges Demello of Momentum Microsystems, a software and hardware systems integrator based in Fremont, CA. “Manufacturers need to take the same consideration when selecting the computer system that they do for making the device,” says Demello, the chief technical officer for Momentum. “They will go to great lengths to find the perfect tube, with the perfect bend and materials, for a medical instrument. Then they put a white box there, and they don’t do the research, while companies like HP do.”

A white box is the term Demello and others use for a non-branded computer that is assembled from a motherboard and other purchased parts. The device manufacturer then either integrates the assembled computer with the actual medical instrument or connects it as a standalone component. Using white boxes can lead to both hardware and software problems, according to Demello. For example, “a lot of software had major issues when hyperthreading was introduced in a CPU. Sometimes, hyperthreading may work well on dual-core and not quad-core processors.” She adds that video images may also suffer “because the graphic cards have different amounts of memory that could impact the display of crucial medical information.”

Momentum Micro launched in 1991and signed its first device client about 10 years ago, Demello says. The company has been working with Hewlett-Packard since 2003 to supply standalone workstations for medical devices made by customers such as Heidelberg Engineering and BD Biosciences.

Stability and Control

Manufacturers have one overriding reason for using a custom-built computer, says Dan Olsen, marketing and business development manager for Hewlett-Packard’s workstation global business unit in Fort Collins, CO. “A lot of healthcare OEMs have historically ‘gone white-box’ because of the desire to keep things stable and to maintain control of their configuration.”

The need for stability is tied to FDA approval. The microelectronics industry and the device industry are world’s apart in terms of product development speed. FDA’s device approval process can take several years, while computer manufacturers and chipmakers introduce new models and faster microprocessors every year or so. “The computer is part of the instrument, and the instrument goes through the FDA process. Everything has to be closely monitored,” Demello says.

Roger Smith, a 21-year veteran of the medical device industry, says that his company had to take into account the contrasting paces of technological change and the regulatory process when designing its blood diagnostics instrument. Given the need for FDA approval, the device manufacturer noted the computer’s “very short lifetime” versus the instrument’s “fairly long lifetime,” says Smith. “We decided that our regulatory process would be easier if the computer was separate from the instrument.” The company simply “didn’t have the staff, the warehouse, the floor space. And it wasn’t our main focus to be doing computer integration,” he notes.

Smith says his company’s chief competitor “made its first desktop instrument, more or less equivalent to ours, with a built-in computer. That was really a big nightmare for them.” As a result, the competitor decided to use a separate workstation and “went the white-box route.” Smith says his company “didn’t want to go that route,” believing it was more cost efficient to find an outside computer supplier.

Real Benefit Is Service

There are advantages to both approaches, according to Smith. “The advantage of having an OEM box is that the customer doesn’t know what’s in it. And in some ways you don’t want the customer to know because it doesn’t make any difference whether it’s the latest and greatest hardware or not.” Having decided to tap an outside supplier, Smith’s device company initially used Apple Macintosh computers, which created problems when rapid technological churn clashed with the diagnostic instrument’s life cycle.

“One of the problems we had with the Mac was the customers wanted the latest and greatest,” Smith says. “It became a selling problem, because we were still selling older computers, which were perfectly fine for the application, but they wanted a newer product.”

Smith’s company had been using a Texas-based systems integrator, but the long-range nature of the business arrangement made it difficult to sustain, he says. Around 2000 the company decided to dispense with the Mac and find a local integrator, “and we came across Momentum. It turned out to be a very good fit for the company. It was local, and we could have weekly meetings with them in person.”

Smith pinpoints one key benefit that device manufacturers derive from using a systems integrator and a brand-name computer vendor. “The real issue is service,” he says.” Post-sales maintenance for white-box computers wasn’t a problem for customers in the United States, he says. “But if you’re selling a computer worldwide like our company is, then service became a real issue. If you were in, say, Czechoslovakia and the box broke, nobody could fix it. We ended up having to ship the box back, or the company had to keep spares.

“So, your service became a hassle,” Smith adds, “and ultimately it cost more in the long to use a white box because of the service hassle than it did for us to use, say, an HP computer.” In fact, he says the company “had really good luck” with the HP workstations. “They’ve been really reliable, the life cycle’s been good, and service has been good. Even in Europe out in the boonies we can get good service from HP. That saved us more money in the long run by going with the name brand.”

HP’s Olsen says the computer manufacturer is aware of the distinctive challenge posed by working with healthcare providers. “Regulatory certification, whether its FDA in the U.S. or agencies in other countries, is one of the biggest issues for the medical device manufacturer, and that flows on down to us, the workstation manufacturer,” he says.

‘Stability of Configuration’

HP addresses that challenge by offering “stability of configuration,” Olsen says. Changes to a workstation that could affect the software image “generally means a recertification with FDA. That’s a lot of pain for the medical device manufacturer. So HP has developed what we call ‘stable and consistent offerings.’ That’s an official program HP has developed.”

Olsen says the company’s Z400, Z600, and Z800 series workstations have three-year life cycles. Introduced in 2009, the line will be for sale into 2012. “But inside of that three years, for instance, Intel will have three different revisions of their processors. So to medical OEMs that now looks like three one-year life cycles, and one year is a pretty short period in their world. The stable-and-consistent program is where HP has chosen a subset of the major components in the workstation that could impact the software images—like the microprocessors—and we basically freeze those and make them available all the way to the end of the workstation’s life.”

As a result, Olsen continues, “a medical OEM can choose a configuration of one of our workstations, and it will now get that same configuration all the way till the end of life.” Manufactured for high-end third-party use, the workstations are designed for 2D and 3D medical imaging and picture archiving and communications systems (PACS) in radiological, surgical, and diagnostic applications.

Jim Niemi, partner business manager for HP, started working with Momentum in 2003, when the computer manufacturer and systems integrator began calling on specific medical device customers. Together, they developed a turnkey solution for Momentum’s first medical device client, which manufactures diagnostic machines for blood analysis. “Momentum was able to work with HP and get the right configured machine, sell and implement it, and have an order track and a turnkey solution within 24 hours,” Niemi says. “HP doesn’t have that kind of speed for a custom-configured machine. That’s why it was a good thing that we work with a company like Momentum, because they have the speed and flexibility to deliver the solution within a 12- or 24-hour time frame. They have it available in their warehouse ready to go.”

As a systems integrator, Momentum specializes in managing a product’s entire life cycle, acting as a single point-of-contact for IT assets. The company installs standard and customized operating systems, including back-up programs and server management software. The company consolidates end-of-life information in one electronic mailbox in order to enable suppliers to notify Momentum of product changes, and its sales team identifies any affected customer orders. Momentum is in the process of adding to its ISO 9001:2008 status to the ISO 13485 certification, Demello says.

“An integrator can help you keep the life cycle of the computer and keep you informed of when components are going out of life and when you might have to go into another development cycle,” Smith says. “That’s a real advantage.”

Having worked with several device companies in the last 10 years, Demello says the company has gained valuable experience that can help manufacturers lower costs and improve their ability  “to take care of the business they’re in, which is medical devices, and not the computer integration business.”