Keeping Up With Demand
The adaptive, high-tech world of machining and laser processing continues to innovate.
Designing a medical product is, in some ways, the easiest step of the process. Getting it manufactured and into the marketplace quickly enough to satisfy the customer and beat the competition creates some hefty challenges for the machining and laser processing departments.Time to market is a top concern for medical device companies. “We are seeing continued demand for shorter lead times during the development phases,” said Les Duman, sales manager for Peridot Corp., a precision component and assembly manufacturer in Pleasanton, Calif. “We are frequently being asked to turn prototypes in less than a day. That’s not always possible, but quite often we can turn prototypes in a few days, and on rare occasions even the same day. Calls for rush delivery have increased by at least 20 percent over the last year, and we do not see that softening for 2009.”
Machining and laser processing providers face the daunting task of meeting the challenge of quickly making smaller, more advanced medical components.
Photo courtesy of Metal Craft.
Then, of course, there’s the constant challenge of keeping up with the ongoing miniaturization of medical and electronic devices, a trend that is essentially a standard expectation these days. Devices are becoming smaller and require more functionality within smaller operating windows, which translates into more precise machining and laser processing capability.
“There’s no reason to believe that the focus on miniaturization will not continue,” said Lori Beer, president of Potomac Photonics in Lanham, Md., which specializes in micromanufacturing. “With a history of 26 years in the business, we have yet to see a significant change in the medical device market opportunity. The trend has always been to make things smaller, better and faster.”
Providing More Services
Over the last several years, medical device companies have struggled with the idea of bringing manufacturing equipment and staff in-house to control proprietary processes and simplify the supply chain, versus outsourcing all or part of their product prototype and/or production needs. “In general, there appears to be more of a trend toward outsourcing to satisfy these needs,” said Beer.
This means forward-thinking manu-facturers are doing their best to meet or exceed these growing (and often specialized) needs by providing more services to streamline the production process and shorten the supply chain. Manufacturers want to be viewed by their OEMs as a one-stop solution as much as possible. “We don't engineer or design, but we do help our clients improve the performance of their products by modifying either their design and/or changing the substrate material, with an emphasis on reducing the production unit cost,” said Beer.
Duman agreed. “At Peridot, we are often asked to recommend alternative materials and processes that may improve the product performance and/or reduce costs,” he said. “This is usually relative to an initially specified material’s availability, its cost and how well it meets the application requirements of our client’s device.” For example, Peridot’s expertise in forming wire and hypo-tubing allows it to replace nickel-titanium with stainless steel, saving the client thousands of dollars and utilizing readily available material. “We have also developed quite a few new tricks in our hypo-tube forming as well as processing and joining of tubing to other components,” continued Duman. “We recently completed a turnkey project for a client that included fabrication, assembly, sterilization, packaging and shipments of a spinal implant system.”
“Companies like suppliers who bring technologies to them,” said Beer. “Potomac was asked to help develop a device that could map the heart of a premature baby to determine abnormalities. The ability of our technology to look at the options for not only the 64 electrodes but also the plunger which was used to activate the electrodes, helped us get the contract.”
Everite Machine, Inc. in Philadelphia, Pa., has provided tube-cutoff and other tube-processing equipment for more than 45 years. Its equipment produces a variety of common medical devices from needle tubes to arthroscopic shavers that are processed by the electrochemical grinding process, considered to be the best in the medical tube industry. Everite recently expanded the technology to include sharpening the ends of tubes and wires and specialty parts for the medical products industry with its innovative high-precision form grinding that provides superior wheel life, as compared to conventional and creep-feed grinding.
“The turnkey approach is quickly becoming common among equipment buyers,” said Thomas Travia, director of operations for Everite. “Competitive cost pressures have forced many manufacturers to cut the staff available for tooling design and manufacturing engineering. Everite and other equipment manufacturers have had to step in to fill the void. The days of selling a generic machine are ending. Companies now want the machine, tooling process development, operator training and even automation as a package deal.”
Some medical device companies are asking their contract manufacturers to take on more supply chain management, as well as regulatory work, such as developing MPIs and executing other process control and documentation tasks. “We know that an integral aspect of our business is to stay abreast of developing regulatory issues,” said Duman. “Coordinating with our client’s quality teams to assure that our traceability, metrology and other GMP protocols are mapped perfectly with our clients’ in-house methods is a top priority.”
Technology and Design
“We love the new products that have been coming out of the OEMs,” said Trisha Mowry, vice president of Metal Craft (Elk River, Minn.) and Riverside Machine and Engineering (Chippewa Falls, Wis.), which provide precision machining for the medical device industry. “What’s exciting and challenging are the developments in the instruments and implants revolving around multi-axis machining that must meet very close tolerances. Our niche is primarily instrumentation, complex assemblies and the implants that are extremely complex and require multi-axis functionality in machining and inspection. All of these require the extreme attention to the details through every stage of manufacturing.”
LaVezzi Precision, a contract manufacturer in Glendale Heights, Ill., that works with several industries, including medical devices, has seen increasing demand for components for left ventricular assist devices and laparoscopic surgical components.
“The growth in spinal fixation systems has caused the development of newer, stronger materials and a number of unique methods for the fixing of the rods to the sleeves or brackets, through which a vertebra bone screw passes,” said president Al LaVezzi. “The design of these sleeves, brackets and screws, due to the material as well as the geometry, presents a challenge to the manufacturer. Multiple-axis Swiss-type lathes, with the capability to do internal and external thread whirling, are mandatory.”
Because of the popularity of surgical plates, and their variety of shapes and sizes, manufacturers also must be able to perform simultaneous five-axis machining on the toughest implantable alloys. “As with most implants, this requires the ability to move the designer’s ideas from his file to your CAD program,” said LaVezzi. “A coordinate measuring machine with an articulating probe and scanning capabilities are also needed to deliver parts that meet specification.”
Potomac’s BioFAB 1000MB (multi-beam) product series, which includes up to six lasers in a common frame, gives the company the flexibility to laser-process a variety of polymers, metals, ceramics and even diamonds. “Potomac is currently developing a new system that can both micromachine fine features (down to 7 microns wide and deep), as well as deposit nano-sized conductive materials into these embedded features, all in one tool,” said Beer. “When commercialized, this equipment will be state of the art.” This proprietary technology was developed with Defense Advanced Research Projects Agency funding of $7.8 million through its Mesoscopic Integrated Conformal Electronics program.
Creating Efficient Partnerships
Developing creative, long-term partnerships, both with customers and suppliers who share a similar vision, is one of the best ways to ensure an efficient, cost-competitive production process that can respond quickly to changing market conditions.
“We work closely with OEMs and design firms to accelerate results,” said Harvill. “Time is of the essence, and 80 percent of the ultimate cost of a product is defined in the first 20 percent of the effort, so the sooner we are engaged in the process, the better the outcomes will be.”
Metal Craft works closely with clients during the design phase to ensure manufacturability and efficiencies, including costs and lead times. The company is continuously looking for ways to improve the value of its services, including bringing subcontracted services into its facilities to help control quality, price and delivery. With some clients, Metal Craft partners in the development through production process. “We discuss features during design for manufacturability and maintain constant communication during the process of manufacturing,” said Mowry. “We also have put programs in place that support various risk-management initiatives to ensure quality outcomes.”
New product introduction is most effective when a productive team representing the manufacturer, client, designers and suppliers is in place. Although partnering with a design firm can be useful, manufacturers need to be sure the firm has an appreciation for and an understanding of the manufacturing company’s core strengths. “Some of our experience has been that, at times, both engineering and design firms have a reluctance to bring technologies to their medical device companies, such as miniaturization technologies, and basically only respond in a kneejerk fashion when the company asks them to do something,” said Beer. “In reality, if you don't bring technologies to a company in a proactive way, you will be left behind.”
The medical device sector seems to be holding steady so far, with many manufacturers expanding their operations to meet increased demand.
“Our medical and surgical device sector is growing successfully,” said Duman. “We are fortunate that we have been able to add new equipment, square footage and additional personnel during the last two years. We expect 2009 to be our best year ever. We attribute this to both the recession-proof nature of the medical device industry and our own corporate culture of taking on challenging projects and encouraging our clients to allow us to become an integral part of their development teams.”
Everite, with its machining technologies, sells to the medical OEMs as well as their sub-tier suppliers. “So far, we have not seen a significant downturn in our machinery business,” said Travia. “Capital equipment-buying tends to be a long-term decision process with budgets often established well before the actual purchases. As we modernize our machines and increase the capabilities, progressive manufacturers are seeing the advantage of upgrading to the latest equipment, even in tough economic times. Increases in productivity or process capability help to justify the capital expenditures.”
“Things seem to be going strong right now,” agreed LaVezzi. “We have entered into 12-month stocking arrangements with a number of companies, which certainly helps keep our production flow steady and consistent.”
Beer reports that Potomac’s two largest clients have increased their business with the company by 50 percent. “There are two things we have done that have truly helped us maintain our longevity,” said Beer. “The first is pursuing work in the electronics/semiconductor industry, because the crossover of these technologies really benefits the medical device market. The second is maintaining both precision contract manufacturing and laser system manufacturing operations, because one feeds the other.”
Metal Craft also is experiencing significant growth and is in the process of building a new facility nearly three times its current size. Personnel will be added at every level of the organization, as well as new equipment that will enable the company to utilize new technologies and provide more services—all under one roof. “We have also hired quality engineers to better handle the medical device demands of the quality planning production part approval process and process failure mode effects analysis requirements,” said Mowry.
The Near Future
Duman expects to see new process technologies introduced over the next few years that will help the company provide even more specialized services. “We look forward to the suppliers of manufacturing equipment presenting their new machinery and processes to us that will help us provide our clients with smaller, tighter tolerances and lower cost components and assemblies.”
Peridot also is moving into the contract manufacturing arena, with a goal of having at least 50 percent of its annual production be committed to contract manufacturing of complete devices or substantial subassembly. “This is another example of the partnering that we see as critical for this year and moving forward,” said Duman. “We want to be able to provide complete device assembly. As a result, we have greatly expanded our facility, with a much larger clean room area. Most of our current assembly work is for clients for whom we already provide components and sub-assemblies. It’s an important part of our growth to provide turnkey device assembly to those same clients.”
LaVezzi believes the larger device manufacturers will be asking their suppliers to enter into more long-term stocking agreements, which will keep inventory down and ensure a steady flow of product. “We have also taken in-house the capability to electropolish, passivate and laser-mark products,” added LaVezzi. The company continues to invest in new equipment, having just installed another Zeiss CMM with scanning capability and a fourth five-axis Willemin Mill.
Potomac predicts an increased use of electronics/semiconductor technologies within the medical device market, specifically, the ability to implement high-density interconnects in devices. (High density interconnects are substrates or boards with a higher wiring density per unit area than conventional printed circuit boards that are used to reduce size and weight, as well as enhance electrical performance.)
On a cautious note, Beer advises medical device companies to be ready for a sudden push by a number of companies from other markets. “They see business as stable in the medical device market, whereas it’s going downhill in the traditional markets, such as automotive and semiconductor,” said Beer. “This could lead to a lack of experience in medical device manufacturing, and therefore, potential for poor quality.”
Medical device manufacturers are working hard to provide more value to their OEM customers by implementing more services and improving the functional performance of the components they cut and assemble. “We are driven to provide the quality and performance that is obvious to the surgeon and patient in the operating room,” said Harvill. “New capabilities and/or services are certainly beneficial, but not as important to our customers as the results. Said another way, new product development teams are looking for specific performance enhancements and are not very interested in the make and model number of the laser or machining center that we use to generate the results.”