The Computer Age: Simplifying Manufacturing Processes

Information technology is here to stay in orthopedic manufacturing

Jennifer Whitney

The speculation that fueled the Dot Com boom of the mid-1990s had a profound impact on far more than just IPOs and what seemed like a no-limit ceiling for the NASDAQ—it changed what was conceptually possible. Although Web sites, search engines and e-mail all proved invaluable during the information technology (IT) metamorphosis, perhaps the development of ergo-nomic software was the most critical advancement.

Indeed, most workers today are using some form of IT to perform their duties. Product designers for orthopedic devices and equipment no longer have to sketch everything by hand or rely solely on a calculator to develop specifications; instead, they routinely use CAD or other software to gain 3-D perspectives on their designs. And in the era of Sarbanes-Oxley, corporate accounting has been simplified by the advent of integrated software that can help keep documents consistent and stored virtually—not manually.

Orthopedic manufacturers, both large and small, are an intelligent bunch, so it’s no surprise that the industry as a whole is using more sophisticated IT in its daily work. As 2006 nears its end, Orthopedic Design & Technology spoke with contract service providers about some additional IT applications that are making the manufacturing and product delivery process smoother than ever while helping to enhance the quality of products and  manufacturing/distribution operations.

Zooming in on the Manufacturing Floor

With product quality paramount, it is imperative that flaws are virtually non-existent. As engineering processes improve and quality personnel become armed with more resources and knowledge, what’s taking place on the manufacturing floor is a much more streamlined and sophisticated operation than in times past. And where the boundaries of human ability end, software is stepping in.

For example, Olympus, known for its imaging equipment for consumers and industry professionals alike, has developed additional equipment that can supercede the human eye’s ability to spot the most minute problems in manufacturing machinery. Some of the orthopedic industry’s largest OEMs have incorporated Olympus’s micro-imaging equipment to perform inspections and measurements of their hip implants or other types of joint replacement devices.

Microscopy, which uses an optical system to make an image of a small machined portion on an implant larger, for example, can help a manufacturer zoom in and really evaluate the quality of a part.

“The manufacturer wants to know if it’s a smooth finish, because if it’s very rough, that’s not going to be very helpful when you insert the implant in someone’s body. You can determine this by eye just looking through optics, but to make it more professional, allow for better quality control and provide documentation, most companies want to take a digital image and make measurements based on that image,” said Matt Smith, director of micro-imaging business for Olympus Industrial, headquartered in Orangeburg, NY.

The software component of these microscopy systems enables a high-resolution image that allows for precise measurements and offers conversions according to roughness factors—all in a matter of seconds instead of hours. Further, while a microscope usually will allow you to examine a component and determine whether it passes or fails, the type of software being incorporated in this industrial equipment enables you to actually quantify what constitutes a pass or fail designation and document it.

“Since you’re able to easily generate data, you can then use these tools as part of your data gathering and for process control,” said Mario Gislao, an applications specialist for Olympus Soft Imaging Solutions in Eastchester, NY.

Another benefit of this technology is that OEMs and their supplypartners can facilitate better communications by sharing the images captured by the equipment. For example, Gislao noted, consider a manufacturer with offshore operations. “You can share an image that was taken in China and e-mail it back to the United States in a matter of seconds and vice versa,” he explained.

Also taking more guesswork out of problem-solving is remote visual in-spection equipment. Using a fiber optic illumination and imaging pipe, this equipment can be wound down into a lathe or mill and capture images, take measurements and gather data. This technology can be used for tasks such as looking for contamination in machinery, evaluating the sharpness of a cutting wheel or identifying for broken parts in the machinery.
    

Taking Stock of Inventory

Once a product has moved through the manufacturing stage, many companies can be stumped as to how to best maintain inventory. Larger OEMs often have the capital to invest in a solid tracking system while smaller, emerging companies can find this task perplexing, given that they may not have vast resources for storing and tracking their products.

Millstone Medical Outsourcing in Fall River, MA realized several years ago that many of its customers were relying on simple Excel spreadsheets as a form of inventory management. Since many of these clients couldn’t afford to invest in larger tracking or enterprise resource planning systems, the company, which specializes in aftermarket services, startup solutions and contract packaging services, decided to expand its own Web-based tracking system to help other companies better manage inventory.

“Smaller companies need to spend their money on developing new products,” explained Jonathan Tillman, Millstone’s vice president of sales. “We offer a subscription-based inventory tracking system, so they defer a large upfront cost. It has enabled us to provide a full-service, soup-to-nuts process for them. Even with our larger clients, product is sent to us from their manufacturing vendors without [the customer] having even seen the product. With our system, they can see the product as it is received at our dock, moves through the process and then is shipped out the door.”

He added that he believes that as outsourcing continues to grow in orthopedics, going “virtual” will be more a necessity than a desire.

“I just talked with a client who’s worried about distribution because he’ll be traveling to Europe soon. He wants to use our system because it’s Web based. He can be in Heathrow airport and monitor what’s going with his products,” Tillman said.

Along with traditional inventory tracking functions, the company has used its Web application to enhance an “instrument recycling” program. As certain instruments are used in the field, a surgeon may work with them for a while and then desire the next “hot” item in the market, Tillman said. The older instruments typically are then shipped off to a distributorship warehouse or, even worse, sit in an OEM salesman’s car collecting dust.

“What we’re doing is taking them back to be washed, inspected, inventoried, etc, and then set up a Web site where sales reps can go online and see only their own products available and be able to order an item and have it shipped to a customer,” Tillman said. “It’s allowing us to become a kind of centralized warehouse for these older instruments. Without the IT portion, you don’t have visibility to those instruments, because they aren’t considered valuable, and they don’t get tracked well. This is a way to give them more value.”

In addition to the recycling program, Millstone has helped facilitate a “loaner expediting” system as well. Traditionally, according to Tillman, an OEM will have Millstone send out a loaner kit to be used in a surgical procedure if no appropriate kits are available locally. After the procedure, the kit is returned to Millstone. By creating an expedition program, Millstone has used IT to create a new process that streamlines the use of kits in the field.   The loaner kit program, using IT, actually makes it possible for the kits to be inspected and redeployed in the field without having to come back to Millstone—this skips a step, saving customers time and money.

“With the IT component, you’re extending the inspection functionality to the field operator rather than having it have to come back in house.  When a field operator goes into the hospital after a surgery was done, he or she can see what was shipped and then see what was used. Now that person can view his or her inventory, make sure the kit is good to go and get it ready to ship to the next location rather than send it back to the headquarters.,” Tillman said.

The bottom line, according to Tillman, is that orthopedic companies are looking for flexibility and traceability to ensure maximal utility of their products, and IT can help achieve these goals.

Radio Frequency Identification

For the past few years, a steady buzz about radio frequency identification (RFID) has permeated the industry. Indeed, RFID is a natural extension of the inventory management process and is gaining major ground in orthopedics.

In a nutshell, RFID enables automatic identification of objects by using an electronic chip and antenna that transmit information to a network of “readers” that use the data on the chip. This information can benefit everyone from manufacturers and their supply partners to surgeons and  patients.

“It’s part of the overall strategy to have better control over and more visibility of assets in the supply chain…and from a regulatory standpoint. RFID has some enhanced features [over bar coding technology] that enable you to automate supply chain management,” said Daniel Sands, president and CEO of Fort Wayne, IN-based Solstice Medical, a provider of asset lifecycle management for medical device companies.

In terms of inventory, many surgical items often are routed from a manufacturer to its distributor and then a hospital—and finally, back to the manufacturer. Add to that multiple locations in a hospital or distributorship, and it’s easy to see why an OEM can lose track of a device’s whereabouts. RFID can foster a more streamlined approach to supply chain management and logistics.

In addition, “Proper management of inventory can free up capital to focus on product development,” Sands said. “As reimbursement challenges continue to proliferate in the market, companies need to look at cost-containment strategies. Supply chain management with technology such as RFID can help companies fight profit loss in eroding or maturing markets.”

In the operating room, RFID has utility as well. “If someone goes in for a revision procedure, for example, you can find out when the implant was implanted, who the manufacturer was, the serial number of the actual implant…there’s a lot of information that can be tied to that device,” Sands noted.

From a regulatory standpoint, the capabilities of RFID also hold promise in better tracking devices on the market. As the FDA and others look to strengthen post-market surveillance, RFID has been identified as one way to keep track of devices.
    

Tracking Quality and Regulatory

Of course, no discussion on software in medical device manufacturing would be complete without mentioning the growing use of IT applications for automated quality and regulatory compliance. Since orthopedics is one market sector that tends to have some higher-risk products (given that many are implanted), traceability and documented compliance are essential.                

Nikki Willett, vice president of marketing and regulatory products for Pilgrim Software in Tampa, FL, said that investment in these automation software systems is proliferating as more companies realize the potential of having an integrated “suite” that encompasses features such as CAPA (corrective and preventive action) tracking, complaint handling, document management, standard operating procedure enforcement and employee certification.

“For high-risk products, manufacturers need to make sure they’re capturing all the information regarding any deviations on the production line,” Willett said. “They have to be on top of these issues. A product recall could be detrimental to a company’s brand image, resulting in costly adverse consequences. Therefore, sustaining high quality is paramount for orthopedic manufacturers. A lot of our customers have products that are surgical-configured implantable products—meaning, there’s more risk regarding the components that are being put together. They’re not just intact. It’s even more key for these organizations to focus on deviations and nonconformances.”     

Noting that just about every orthopedic manufacturer has some sort of quality system in place, Willett said some of today’s software solutions can help reduce the steps for implementing a corrective action—thereby, increasing the company’s efficiency and productivity. On top of that, the software solutions available today can feature Web-based dashboards and reports that enable manufacturers to get all the information and data they need in real time.

“In a smaller emerging growth company, your focus needs to be on innovation, not time-intensive labor to go through your quality and regulatory processes. You want to be able to minimize that impact. Automated compliance and quality software helps standardize and makes your own system more efficient,” she added. “You’re minimizing risk and preventing problems down the line—and saving time.”