"Information in Order," Feature Article, September 2004

information
in
order

Product lifecycle management systems are touted as tools for collaboration, but they're used for much more than that.

by Jean Thilmany, Associate Editor

Don't get the wrong idea, but engineers have their own way of doing things, says Doron Besser, vice president of marketing and strategy for an Israeli medical-device manufacturer. The marketing and design process moves so quickly, particularly in medical equipment manufacture, that engineers' desks are frequently stacked with papers, nearly all of them design changes.

Keeping track of design changes can be difficult at best, though it's especially important in Besser's field because his company, superDimension, makes a device to be implanted in the human body. That means design and manufacture are meticulously regulated.

If you thought keeping track of the past seven years' tax receipts was hard, try working for a company seeking U.S. Food and Drug Administration approval for a brand-new medical device. Engineers are required to keep close track of documents because, when a company seeks FDA approval, agency staffers might ask to see anything and everything associated with design, manufacture, and clinical trials, Besser said.

"We could get an FDA audit and we'd need to be able to show them everything they ask for, right then," Besser said.

Engineers at superDimension manage hundreds of design changes flying around the company by using the manufacturer's product lifecycle management technology. Once touted mainly as a way for engineers to work together over long distances, PLM technology is now finding a wider array of uses.

Medical device makers constantly seek new technologies; some use product lifecycle management systems to smooth the road to FDA approval.

Keeping close track of the overwhelming number of documents that a regulatory agency might ask to see is one of them. The Air Force will soon use the technology for a different purpose—to give personnel wireless access to maintenance records and technical manuals where they service aircraft.

Besser has estimated that his company, based in Herzliya, developed its minimally invasive lung navigation system an estimated 30 percent faster than originally planned, thanks, in great part, to the tracking, organizing, and collaborative PLM software.

"It's shortened transfer from research and development to production," he said. "If you didn't have PLM, it would take you a few years more because it's all paperwork and you'd never find the proper sketches. An engineer has a few hundred sketches on his table. How would he find the right one? The transfer went from what would be a few years to automatic."

The five-year-old company's superDimension Bronchus system won approval earlier this year from the European Union regulatory agency and executives hope to get a nod from the FDA before year's end. The Bronchus device diagnoses lung diseases via a bronchoscope, which the physician can insert more deeply than a traditional bronchoscope because a computerized tomography image acts as a guide. Being guided like this grants access to the hard-to-reach peripheral areas of the lungs in a minimally invasive manner. Besser likens the software that guides the bronchoscope to a global positioning system for the lungs.

Traditionally, when doctors insert a conventional bronchoscope into the patient to examine the lungs, the devices are used in concert with a flat, CT image. In most cases, the bronchoscope does not show up in that image.
The superDimension system shows the movement of the device. The CT reveals masses in the lung. As the bronchoscope reaches one, the physician inserts tools to take samples for biopsy, Besser said.

"But often the masses discovered by the CT are in the periphery of the lung and the bronchoscope can't get in there. It gets stuck a third of the way," he said. "You're inserting the tube and probing in the lung by trial and error, trying to use the CT images to try to get over there."

An engineer who has hundreds of sketches on his desk can find the right one using technology that tracks electronic documents.

To guide the bronchoscope, the system features software that generates the patient's original CT images in three dimensions. The miniaturized, long bronchoscope includes what Besser calls a localization center on its tip. It's this tip that shows up on the 3-D scan, which tracks its movements in the body. The tool is one millimeter in diameter and can be twisted and turned 360 degrees, so it can reach the very deepest areas of the lung.

"It's really a GPS system for the physician," Besser said. "We can know where we are inside the lung via a map—the CT images. When you move the tool deeper inside, the map changes."

If FDA approval goes according to plan, physicians will not only take tissue samples with the device, they'll use it to perform therapeutic procedures like delivering radiation directly to a tumor. One current superDimension trial uses the device to burn small abnormalities from the lung.

STARTING FROM SCRATCH

Device development started in the marketing department about five years ago, at the company's inception, when marketers wrote up a case which described why the bronchoscope is necessary and how the physicians would use it. It broadly outlined the potential device's characteristics, including how it should look and function.

"Then the engineers sat down and said, 'This is what marketing wants. How do we get it?' " Besser said. "They go backward from the marketing requirements."

With that, the engineering, and research and development departments began designing. The kicked-up pace of design could have caused chaos. To organize the flow and head off chaos, superDimension implemented its PLM software from the very beginning. The manufacturer uses SmarTeam from the vendor of the same name.

The company engineered its PLM technology to suit its particular needs.

"You're speaking about thousands of documents generated along the way," Besser said. "When we have to transfer this massive info from engineering sketches and into production, well, the only way we could provide the production department with up-to-date sketches was with a technology like the PLM system."

Israeli company superDimension used PLM technology to track the progress of its bronchoscope (above). The scope's tip (below) guides doctors as they insert it into the lung.

Engineers particularly rely on what Besser calls the family tree within the system. The original document acts as the trunk and each change to that document is noted as a branch. A change to the branch document would be tracked off the branch, like a stem.

"We can always know the core documents, which may be stuff I did in 2000, and see exactly how, when, and where they've been changed," Besser said. "I need a family tree to know where I've been. I can always know who changed it, when it was changed last time, and the final document.

"In the past, you only had folders and papers," he added. "Engineers, if I may say so, have their own way of working. They put papers on the side and then perhaps can't find them. With this system, you put the sketches in there, and you always know where to find them and who's been looking at them."

Other documents, like pictures and JPEGs, can be attached during the changes. SuperDimension relies on the PLM family tree in updating clinical and marketing documents. Besser calls those records the bible from which engineers develop the entire system.

Doctors insert the bronchoscope into the lung using a CT scan as a map.

Another important PLM feature is the capability to sign off on changes. That way, the system tracks the person who authorized each change. This record, coupled with the family tree, is required for FDA approval.

"We can see who authorized it and when," Besser said. "That would be something the FDA would look at it. They might do an audit, and we'd have to show that we're working in a proper manner, that production got the most up-to-date sketch, and that everyone signed off on producing the tool."

The medical device maker must document each step of its validation process—the process by which it tests and proves the tool can be sterilized and is safe to use within the human body. This, of course, means even more information tracked in the PLM system.

"All this takes a long, long time with hundreds of documents inserted constantly," Besser said.

The payoff, of course, is FDA approval. SuperDimension executives are preparing for a U.S. product launch in October.

A COMPUTER IN THE FIELD

Most of superDimension's 47 employees have access to the PLM system. The U.S. Air Force, mean- while, is developing a mobile system that will make a vast record archive available to almost 2,000 people.

At Tinker Air Force Base in Oklahoma City, service people repair and maintain large aircraft. Each year, about 75 large military aircraft like B-1 and B-52 bombers and C-135 transports make their way to the base for repair, said Edwin Kincaid, National Center for Manufacturing Sciences manager at the base.

Each aircraft and its engines are completely dismantled, inspected, serviced, and reassembled, in a process that usually takes about six months, he said. Currently, staff members fill out paper forms to track the maintenance they've done. But they were spending too much time searching for paper files, filling out paper forms, and looking through maintenance manuals, Kincaid said.

The Department of Defense wanted to make records-keeping electronic so that staff could access orders, parts, and aircraft information by computer. The trick is that staff members work in the field, not in front of computers on desks. They need a portable electronic PLM system they can carry with them, Kincaid said.

To that end, the Air Force is working with technology vendors to develop a wireless tablet system so Tinker staff can locate and update aircraft maintenance and order information on computerized tables while they're in the aircraft hangar. The developers are UGS of Plano, Texas, which makes PLM software, and Intel Corp. of Santa Clara, Calif., along with the National Center for Manufacturing Sciences. The center is a collaborative research and development consortium.

In the first phase of the system, which ended in June, about 20 Tinker staffers had access to the technology, called the Integrated Point-of-Maintenance Execution System. By the end of the year, the developers hope to roll it out to all 1,800 users.

The system lets Tinker personnel use their hands to work on the planes, rather than to handle papers, Kincaid said. They will see each item that needs repair on their tablet computer, and the repairs are marked on an image, or 3-D CAD model. The technician can also search the system for historic data on similar problems or to get recommendations on how to fix a problem.

Software developers expect engineers to push the boundaries of PLM use, and the developers themselves are quick, of course, to suggest new uses. Only a few years ago, the collaborative technology was said to be in its infancy. Now it may be a teenager looking to grow.