Design and Contract Manufacturing Are at Forefront of Medical Product Innovations
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In an industry that continually raises the bar for product innovation, OEMs are succeeding with sources that skillfully combine the best designs, materials, and processes for their applications.

Engineering and technical Services

By Mark Shortt
Editorial Director, Design-2-Part Magazine

His work has him straddling the boundaries of art and science, form and function, perception and reality. A firm believer in the power of a product's image, David A. White is the founder and president of DesignDesign Inc., a 13-year-old company on a mission to bring the benefits of industrial design to product manufacturers located mainly along the corridor between New York City and the nation's capital. The Kennett Square, Pennsylvania, company operates as a product development service for original equipment manufacturers (OEMs), providing industrial design and mechanical engineering to complement the in-house staffs of clients in industries ranging from medical instruments to sporting goods.

DesignDesign is plying its trade at a time when the contributions of industrial designers are becoming more evident in new products, ranging from the iPhone to iForma™, that have the potential to elevate the OEM's brand and become winners in the marketplace. Organizations like the Industrial Designers Society of America (IDSA) are helping to illuminate the achievements of product designers through awards competitions that recognize excellence, and more OEMs are recognizing the power of industrial design to transform their products and generate increased sales. But the impact of these trends has yet to be fully realized, and White believes that many manufacturers—excluding Fortune 100 companies—are still unaware of how they can benefit from the services of industrial designers, who "blend art and engineering to make products more enjoyable to look at, more intuitive to use, and, as a result, more marketable," he says.

"Clearly, design professions are guided more by art than science, while engineering is more quantifiable," White acknowledges. "So the blending of art and engineering makes for good industrial design. The rule of thumb is well known that early changes cost $100, mid-way changes cost $1,000, and late changes cost $10,000. Any number can be substituted, but no one can deny that using a process that allows for more early options, more collaboration, more visualization, and better facts, will save time and money."

Most requests that DesignDesign receives from OEMs arise from their desire to achieve "smart and sexy custom enclosure designs" that provide improved ergonomic features, according to White. The company's ability to provide both is of interest to OEMs looking to build their brand and boost sales.

"The magic that makes a logo relevant, that makes a picture tell a story, or a product's shape seduce a buyer, is an artistic contribution that we all can recognize, but few can deliver," says White. "DesignDesign delivers product styling, engineering solutions, and graphics that stop people, put information in perspective, and elevate the perceived quality of the product or service."

Designing for a Process Saves Costs

Although medical products are quite diverse in areas such as size, shape, weight, strength, and performance, they share at least a couple of essential requirements, according to White. There's no mistaking the fact that their overall technical performance must be proven. Somewhat less known, but also important, is the "perception" of leading-edge quality that they generate.

"Medical products command a premium price and are expected to look sophisticated and be easy to use, despite having very complex science behind the façade of the enclosure," White says.

DesignDesign's strong relationships with electrical engineering, optics, and chemistry firms bring added flexibility to its on-demand service teams. For OEMs in the medical industry, the company has developed options that are cost-effective for any production quantity. Having worked with contract manufacturers on numerous projects, the firm can assess the relative strengths of various vendors, including how to leverage their processes for an OEM client.

"Materials and manufacturing methods need to be decided before CAD geometry is resolved, because the execution of details is different for each process," says White. "For OEMs, it's a clear benefit to have an adviser like this when making business and design decisions concurrently."

When designing enclosures, the designer must balance a number of variables that include speed of assembly, convenient sub-assembly access and testing, and part costs. Labor costs and the preservation of exterior finishes through final assembly must also be considered. Each OEM's priorities with regard to reducing labor or part costs will be different, "though everyone naturally wants both," says White.

An international manufacturer of medical instrumentation recently asked DesignDesign for its support in styling a new enclosure for its next generation instrument. Shortly after selecting a concept, the OEM needed to understand the tooling and part costs to make business decisions about going forward. DesignDesign loosely defined each of 13 parts to get preliminary vendor estimates. In addition, the OEM encouraged DesignDesign to recommend alternate methods of manufacturing and alternate vendors. Previous enclosure parts had been produced as structural foam parts, but quantities were also appropriate for reaction injection molding (RIM).

The vendor recommended by DesignDesign was able to substantially reduce tooling costs, parts costs, and time to market by using RIM. Because the vendor and manufacturing method were pre-qualified, the designs were developed with vendor collaboration to optimize designs. "This reduced time to manufacture and reduced revisions," said White. "The savings were then invested in internal feature development and an expanded scope of work."

An Unconventional Design Strategy

Calypso Medical Technologies, Inc., a startup medical device company in Seattle, worked with two design firms (IDEO, of Palo Alto, Calif., and Ziba, of Portland, Ore.) on the design of its Calypso® 4D Localization System. The 4D Localization System, designed to enable doctors to accurately position cancer patients for radiation therapy treatment and then measure and monitor tumor motion during the delivery of radiation therapy, earned a Gold Award this summer in the International Design Excellence Awards™ (IDEA). Although unconventional, Calypso's strategy allowed it to tap the strengths of both design firms, including focusing on usage scenarios in current practice; defining product requirements; and designing unique engineering solutions to the proprietary product design.

In a statement accepting the award, Calypso Medical's president and CEO, Eric R. Meier, shed some light on the importance of product design, particularly in the medical industry.

"Excellence in product design is at the core of all successful products," said Meier. "Medical devices are continually raising the bar on product design and usability. To get design right means you need to understand and anticipate the customer's needs—a challenge that incorporates both art and science in the process. In our case, this meant listening to and acting on input from physicians, physicists, radiation therapists, and patients."

The Calypso® 4D Localization System utilizes proprietary electromagnetic technology in conjunction with Beacon® electromagnetic transponders that are implanted in a patient's prostate. Continuous knowledge of the tumor location is expected to provide greater confidence to clinicians and patients when they know that the radiation beam is always on target. Because the product platform doesn't require expertise in interpreting x-ray or ultrasound images, it is said to greatly reduce the time needed to perform patient setup, a well-recognized bottleneck in the workflow of a typical radiation department.

The Industrial Designers Society of America (IDSA) and Business Week co-sponsor the International Design Excellence Awards™ (IDEA) in recognition of the best product designs of the year.

Contract Manufacturers Provide Turnkey Service for Innovative Product

ConforMIS, Inc., a Burlington, Massachusetts startup that recently relocated from Foster City, California, develops and commercializes individualized implants for patients with osteoarthritis of the knee. The company employs a novel "image-to-implant" process to create patient-specific implants that are designed, using an advanced computer modeling system, to conform to a patient's unique anatomy. One of the company's products, the ConforMIS iForma™ Knee Interpositional Device, is an FDA-cleared metal implant designed to preserve bone and cartilage in patients with early to moderate osteoarthritis in either the medial or lateral compartment of the knee. The small, lightweight device fits into the affected compartment between the femur (thigh bone) and tibia (shin bone) and helps fill the lost cartilage, restore the knee's proper alignment, and prevent painful rubbing of the bones during ambulation.

The process of designing each iForma begins with a series of standard pre-operative CT or MRI images that provide information about a patient's unique bone, cartilage, and meniscus geometry. Proprietary computer modeling software is then used to create a 3D model of the patient's knee based on this personalized information. This patient-specific 3D model is the key to the ConforMIS iFit™ technology, enabling the company to design and manufacture a precision implant that precisely conforms to the patient's joint surfaces.

Arrhythmia Research Technology, Inc. announced this summer that its wholly owned subsidiary, Micron Products Inc., had entered into a five-year supply agreement with ConforMIS to provide manufacturing services for the ConforMIS iForma™ Knee Interpositional Device. Micron Products will provide manufacturing services for the iForma through its Micron Integrated Technologies (MIT) and Leominster Tool divisions in Fitchburg, Massachusetts.

"This opportunity to augment our manufacturing capabilities to include finished medical devices represents just one success in the continuing efforts of our business development team to expand and diversify our business," said James E. Rouse, president and CEO of Arrhythmia Research Technology, Inc., in a statement released in July. "The agreement calls for the iForma to be the first in a series of ConforMIS products to be manufactured by Micron and its divisions as we expand upon the close working relationship that has developed between our two companies. Micron's expansion into medical device manufacturing for an OEM customer such as ConforMIS complements our proven capability as a high quality manufacturer of components for medical products."

Together, Micron's MIT and Leominster Tool divisions have the necessary capabilities to provide the OEM with a finished medical device, and are already delivering complete manufacturing services ranging from machining to polishing.

"We're basically a turnkey operation for them, which includes securing the bar [material], says Daniel White, director of new business development, Micron Integrated Technologies. "We're [Micron Products] doing machining on 3- and 5-axis machining centers for the IPDs (Interpositional Devices) and the UNIs (Uni-Compartmental Resurfacing Devices). "We're also providing part marking, passivation, sterilization, and polishing. We supply a complete part that's ready to go into the patient."

Leominster Tool, Micron Products' mold-making and machining division, provides all of the tooling, fixturing, and machining for the iForma. By providing all manufacturing services in-house, Micron is able to control the process tightly from a quality standpoint. This, coupled with process efficiencies that have greatly reduced the time required to go from art to part, represents a big advantage for ConforMIS.

"Once we receive the CAD file, it's downloaded to our CNC machines, the program runs, and we cut the parts," says White. "It's a 5-day process for us. The former supplier needed four weeks, but we've been able to reduce it to 5 days. Our goal is to get it down to 3."

Patrick Hess, Ph.D., CEO of ConforMIS commented, "Micron provides us with the manufacturing and service excellence to continue building our unique value proposition to our customers. We evaluated a number of manufacturers and found Micron's flexible manufacturing operations and commitment to helping us scale over time to be unique. Given our rapid growth and patient-specific manufacturing process, we were pleased to find a manufacturer who demonstrated a willingness to work with us as partners."

Innovative Approach to Part Design Brings Maximum Performance to Gene Chip Product

Plastics Reaction Injection Molding

An ISO 9001:2000-certified manufacturer in East Syracuse, N.Y., Armstrong Rapid Manufacturing specializes in the production of metal and plastic parts in prototype through mid-range quantities. Services provided by Armstrong include plaster and precision sand mold aluminum casting, CNC machining and hog-outs, reaction injection molding (RIM), and plastic injection molding. Among the company's biggest strengths—and reasons why customers choose Armstrong—are its strong DFM support and fast turnaround, according to Armstrong's Dan O'Brien, the company's resident "RIM guru." Along these lines, Armstrong provides multiple processes that can be utilized at different points in the transition from prototype to production.

For OEMs in the medical industry, Armstrong Rapid Manufacturing produces short runs (1-2000 per year) of machined aluminum castings and reaction injection molded (RIM) components. "Aluminum cast parts can be used for housings, chassis, and consolidation of CNC parts," says O'Brien. "Foamed polyurethane RIM parts provide covers, bases, and housings that can provide thermal and acoustic insulation, as well as encapsulation of other parts."

The company's work for customers reflects 40 years of innovation and problem solving experience, according to O'Brien. "We have strong engineering expertise internally and as well as from our material suppliers," he says. For one customer in the medical industry, Armstrong Rapid Manufacturing was able to solve an engineering challenge by combining a housing and insulation into one integral RIM part.

Affymetrix, Inc., the Santa Clara, California company that invented the first micro-array and scanner, won an R&D 100 Award in 2004 for designing and producing the GeneChip® Scanner 3000 with AutoLoader. Judged by R&D magazine to be "one of the 100 most technologically significant products" of 2004, the product is a laser-scanning, fluorescent confocal microscope scanner that reads Affymetrix GeneChip arrays containing up to 2.5 million biological features. Its design has laid the foundation for continued evolution of the GeneChip platform as an integrated genetic analysis system, according to the manufacturer.

The compact bench-top scanner provides rapid scanning—it's about twice as fast as other systems—and an auto-loading capability that enables automated, unattended (walk-away) operation. It is reportedly able to scan 48 catalog GeneChip arrays, each containing as many 2.5 million features, in 4.5 hours or less, depending on the array type. Because the scanner can read extremely small features, the GeneChip arrays can provide entire genomes on one array. Researchers can use the scanner in conjunction with these arrays to perform thousands of simultaneous experiments to determine the genetic makeup of the sample.

The GeneChip Autoloader, designed as an add-on to the existing Scanner 3000, consists of four unique RIM polyurethane parts: the main housing, a door, and two internal and non-visual functional parts. It provides a temperature-controlled environment that can maintain long-term stability and integrity of the samples for up to 16 hours. Temperature is held constant at 15°C for all arrays (pre-scan and post-scan) in the 48-sample carousel.

Affymetrix's need for low-temperature insulation, along with structural needs and cosmetic appeal, led Armstrong Rapid Manufacturing to consider a combination of materials and specific processing opportunities made possible by Armstrong's RIM process. Requirements of the main housing included the need to provide structure for mounted internal and external components, and a surface to allow a paint coating for outside visual appeal. For function, it needed to provide the required thermal insulation. The door was required to provide all of the above and have additional visual quality and toughness to the exposed insulation layer.

The specific properties of the RIM process and the properties of the Bayer materials combined to allow technically sound performance and attractive economics. Bayer Prism CM-2000 was chosen as the material for the structural shell of the main housing and internal parts, each having the need for a 1/8-inch wall and 94VO rating. Bayer Baydur 726, with its nominal ¼-inch wall and UL flammabilty rating, was chosen as the structural skin of the door. Each of these skins has a second layer of Baydur 9000 low density rigid foam.

For the door, Armstrong Rapid Manufacturing came up with an innovative solution for the exposed insulation by molding the Baydur 9000 low-density foam to a thermoformed Kydex skin and then assembling this structure to the molded 726 door after the painting operation is finished. The carousel cover completes the assembly with Baydur 9000 being molded to a Kydex skin.

One-stop Custom Fabrication

Engineering and Technical Services As the global economy has evolved in recent years, the extensive loss of contract manufacturing work to overseas suppliers has forced American contract manufacturing companies to find creative ways to survive and, in many cases, thrive. One Schiller Park, Illinois firm has beaten the odds by transitioning to what it does best-manufacture highly-engineered parts with tight tolerances. Although it has moved to a more labor-intensive manufacturing process, Craftsman Custom Metals (CCM) "We have to be much more effective and productive, since so much work is going to low-cost producing areas overseas," says Gesklin. "My way of going about it is creating mini-businesses called cells. For example, we have one customer that is a medical instrumentation company. We have a dedicated team, with equipment, that are the sole owners of that business; they run the business for that customer. They come in every morning and they know exactly what to do, they know what their quality processes are, and they know their customer's needs very intimately. There is one manager in each cell that has direct contact with the customer. Everything is a single point of contact, so we cut out all the people in between."

Craftsman Custom Metals is a growing company that employs approximately 90 people and registered $13 million in sales last year. Because of its cellular approach, CCM has the flexibility to handle high-mix, low-volume parts as well as high-volume, low-mix projects. Operating as a one-stop shop for custom contract manufacturing, the company provides sheet metal fabrication services, stampings, CNC machined parts, and mechanical and electro-mechanical assemblies. Its capabilities also include Level 4 integration, UL-certified testing, and the design and building of tools and dies for high-volume stamping.

"We can hold stampings and fabrication to +/- 0.005-inch," says Gesklin. "In machining operations, we hold features to +/- 0.001-inch." Medical parts manufactured by the company are installed in state-of-the-art blood analyzing machines that require tight tolerances and a pristine operating environment. The company also makes complete systems for sterilizing machines that require very sophisticated materials and processes.

Craftsman Custom Metals gets involved early with its clients' design engineers to provide assistance in design for manufacturability. The company's early supplier involvement with its customers is a strength that reflects the company's plant-wide emphasis on customer satisfaction. "All team metrics are geared towards satisfying the customer," says Gesklin. "If you walk through the manufacturing facility, you'll see that each cell has a production scoreboard that measures on-time delivery and quality of the finished product, as well as safety/health of the work environment, productivity, and satisfaction level of the customer."

A New Product Introduction (NPI) cell is dedicated to design and development, producing production-grade prototypes and pilot builds. The cell forms the centerpiece of the Start-Point CCM program to assist customers in proving product design and ensure manufacturability in a compressed timeframe.

Recently, CCM was able to help a large manufacturer of medical instrumentation that needed to reduce its vendor base. The OEM was looking to partner with a supplier capable of managing a very complex product line with more than 765 part numbers. According to Gesklin, CCM provided a dedicated manufacturing cell geared to producing minimum runs based on production requirements; it also introduced a Kan Ban system to reduce inventory levels. Because the CCM system made it possible to produce a high mix of products with drastically reduced lead-times, the customer was able to win additional business, increase throughput, and minimize its end-of-life material risk.

"The fact that our work is highly-engineered, high-precision, and highly-cosmetic are advantages that CCM offers to medical device manufacturers," said Gesklin. "We make parts for one piece of equipment for a medical manufacturer that costs hundreds of thousands of dollars. It's going to be used in a hospital, so our work has to look good. Most of our medical work is highly-engineered with a lot of components attached. And parts have to be high-precision because everything has to fit just right."

Earlier this year, Craftsman Custom Metals (CCM) was named one of the top 100 minority businesses in the United States by Diversity Business. The ISO 9001:2000-certified, UL-approved company ranked 30th in the Hispanic-American category based on size.

Medical Composites for Minimally Invasive Surgery

Polygon Company, an engineered materials company that calls itself the world's largest supplier of composite cannulae, is known for producing Continuous Fiber Thermoplastic (CFT®) tubing that satisfies the chemical resistance, high strength, and non-conductivity requirements of medical surgical devices. The company's PolyMed™ composite material replaces stainless steel tubing in minimally invasive endoscopic surgical instrumentation, and is used extensively in heart surgeries, gall bladder procedures, and surgeries performed by the DaVinci™ Surgical System from Intuitive Surgical. In addition to being non-conductive, PolyMed materials are USP Class VI-rated, ISO 10993-compliant, and stable across a number of autoclave cycles.

"POLYMED composites are ideal candidates for replacing thin-walled tubing where radiolucence, better strength-to-weight ratio, and improved durability are desired," says Angie Yates, marketing coordinator for the Walkerton, Indiana-based company. Medical product applications for the composites typically consist of two primary areas, one being replacement of extruded thermoplastic materials that don't meet the mechanical requirements of the application environment. The other main area includes applications where metallic extrusions aren't suitable because they corrode, are too heavy, or aren't radiolucent.

The company's PolyMed composite tubing is available in two constructions: CW (circ-wound) or UD (unidirectional) per application. Both the CW and UD materials are available in outside diameters (OD) from 3 to 20mm and can be autoclave sterilized. Polygon offers high-strength multi-lumen tubing, which can also be autoclave sterilized and is available in ODs from 3 to 20mm. Some restrictions on lumen size and orientation exist, however. Braided tubing, incorporating a high composite material used in disposable strength, thin-walled (0.015-inch) applications, is typically used for sizes ranging in from 5 to 20mm, but is not well-suited for autoclaving or other sterilization techniques.

"This material is designed explicitly for endoscopic and laparoscopic instrumentation sheaths," says Yates. "It can be used where reusability is a primary concern; water absorption is naturally minimized by the nature of the materials as well as the processing characteristics. The minimization of water absorption also serves to maximize the dielectric value of this material. Potential additional application areas where stiffened CFT extrusions can be used include hospital beds, a variety of hospital furniture systems, medical devices, orthotic inserts, prosthetics, fixators for orthopedic and other skeletal procedures, and imaging system structural components."

The company offers dedicated product development resources, including full laboratory capabilities, for working with purely conceptual products that may not yet exist. "Our product development activities range from transitioning batch processes to continuous processes, to taking well-known traditional metal applications and proving, through extensive design validation, that a composite can do the job as well, or better, than any metal," says Yates. "We are more than just a tubing supplier."

Through its product development group, Polygon provides engineering support with a high degree of design flexibility. The company uses an Applied Composite Engineering (ACE) approach to analyze the inherent value—such as reducing costs by eliminating part of an assembly—of using a composite for a specific application. Such an analysis pinpoints how a custom-designed composite material can increase design flexibility for the engineer and reduce costs of the complete design.

"By working with Polygon's design and product development engineers, it is possible to outline what you need from not only the unit, but more importantly, the assembled product, and determine how designing a custom composite will allow a variety of value-added features for your product," said Yates.

Design Engineering and Contract Electronics Manufacturing

The ability to integrate design engineering with high levels of customer service and supply chain management is a major "value-add" provided by SenDEC Corporation (subsidiary of API Technologies Corp.), a Fairport, N.Y., provider of contract electronic manufacturing services and digital hour meters. Led by president and CEO, Kenton Fiske, SenDEC was recently named to the Inc. 5000 list of the fastest-growing private companies in the United States.

SenDEC operates two independent business units: a Contract Electronics Manufacturing (CEM) Group and a Products Group. Its CEM Group provides printed circuit board (PCB) assemblies and manufactures entire electronic sub-assemblies (also known as box builds), including electronic control panels for medical sterilizers, digital camera and power-supply assemblies for medical imaging, and locking mechanisms for mobile pharmaceutical carts. The business unit also manufactures power supplies for bedside electronic equipment. SenDEC's Products Group manufactures its own proprietary line of digital hour meters, which are integrated by medical OEMs into oxygen concentrators and other devices that require monitoring for maintenance reasons. It also manufactures tachometers and other monitoring devices used worldwide.

Design engineering is a core strength of the CEM Group, which provides PCB design and layout, as well as rapid prototyping services. To streamline the manufacturing of an assembly when it moves into production, the company incorporates design for manufacturability, assembly, and test (DFM/DFA/DFT) into every product design, layout, and prototype.

"SenDEC has provided DFM/DFA/DFT seminars to entire engineering departments of certain customers, so they're able to understand the manufacturing process and are better able to understand the downstream ramifications of design decisions," says Mike Fiske, SenDEC marketing manager. Attendees are provided with reference guidelines, which they can refer to on future designs, in order to improve the manufacturing process.

Within its PCB layout service, SenDEC utilizes software platforms to shorten design cycles, increase time to market, and save costs for its customers. Design rule checks and SenDEC's DFM/DFA/DFT rules are incorporated into the software applications. According to Fiske, this helps ensure that the design is solid from the beginning, before output files are created and delivered to the bare board manufacturer. It also significantly reduces the number of build cycles required to solidify the design.

SenDEC also utilizes Automatic Optical Inspection (AOI) systems that provide superior fault coverage and can automatically inspect circuit boards optically in seconds for the presence or absence of components, polarity, value, misalignment, insufficient solder, and solder bridging. The system compares current PCB assembly images to those stored in memory of a known good assembly.

According to Fiske, SenDEC combines the use of late-model automated SMT placement equipment with supply chain management expertise and the skills of highly trained employees. Its experience in supply chain management enables SenDEC to identify, source, and purchase components on behalf of its customers in less time and at a lower cost than they could typically manage by themselves.

"We have also established KanBan relationships with customers to streamline their supply chain dynamics," says Fiske. "SenDEC also provides valuable rework services to customers and, through its X-ray and automated rework stations, is able to accommodate BGA and micro-BGA projects."

But the real strength of SenDEC's CEM Group, according to Fiske, lies in its ability to serve as a manufacturing extension of its customers. "We are extremely flexible in meeting our customers' needs—even as they change—and we provide them high-quality products with a superior level of customer service," he says.

Because SenDEC offers design services through its CEM Group and develops its own devices through its Products Group, the company is always interested in new products and product developments. The company carefully weighs these developments for their applicability to customer assemblies and new product development opportunities.

In 1984, SenDEC designed a medical sterilizer control panel for a customer, reportedly saving the customer $500,000 and reducing development time by 6 months. Now, 23 years later, SenDEC is still producing this same assembly for them. "This is a testament to a good design, but has also involved a number of component sourcing challenges throughout the years, involving several end-of-life issues that we have helped the customer mitigate," says Fiske. "This customer is now in the process of having SenDEC update its original design to take advantage of more modern SMT component packages."

Custom Micro-molded Thermoplastic Components

Medical manufacturers have called for increasingly smaller parts in recent years to meet requirements for shrinking electronic devices and minimally invasive surgical instruments. It's a trend that will only accelerate if new technologies create the types of impacts that are widely anticipated in areas like drug delivery, microfluidics, sensors, and a variety of implantable devices. One company that's been at the forefront of this trend for many years is Accumold, an ISO 9001:2000-certified manufacturer of precision injection-molded components for various industries. The Ankeny, Iowa, custom molder has long focused on micro-molding thermoplastic parts that are difficult to manufacture or beyond the capabilities of most molders. For the medical industry, Accumold produces critical plastic components that are used in its customers' surgical, diagnostic, or disposable tools. Because the performance expectations for these parts are very high, their tolerances are, naturally, extremely tight.

"Our biggest strength is our 21 years of experience in micro-molding the very difficult components," says Aaron Johnson, the firm's marketing coordinator. "We produce components that often require micron-level tolerances, exotic materials, and/or tough geometric shapes. We achieve, comfortably, plus or minus 5 microns everyday, and have an optical part that's even tighter than that."

The company attributes these capabilities to its extensive experience in working with thermoplastics (Accumold has several plastics engineers on staff) and an engineering team that works with customers' design engineers to ensure design for manufacturability. Its team approach to problem solving includes the input of experienced mold builders, process engineers, and automation engineers, among others.

"We hire experts with great experience solving problems," says Johnson. "Because each project comes as a challenge, it takes the entire team to solve each opportunity."

One of Accumold's projects involved molding a thermoplastic door that encloses a hearing aid battery. A number of challenges presented themselves, including choice of material. The battery door utilizes a stainless steel hinge pin that snaps into a 0.018-inch groove. Accumold chose GE Lexan® material for molding the part. "We needed a material that could withstand that type of tension and force," said Johnson. "The part has to tightly fit on a post, and it had to fill out and be precise for the snap feature to actually work."

Accumold also molds a programming strip for a hearing aid. The job involves overmolding two plastic parts onto a flex circuit, consisting of a soft-durometer material measuring approximately 2.5 centimeters long.

Communication is Key for Custom Injection Molder

Integrity Plastics, a custom injection molder in Denver, Pennsylvania, offers 100K clean room molding and assembly for the medical marketplace. Custom components produced by Integrity are used in eye surgery, cranial implants, pharmaceutical delivery systems, and heart bypass surgery. Many of these parts are subjected to heat and radiation in sterilization, and need to be very precise in their dimensions to ensure fit and function.

According to Ralph Cook, the company's president, Integrity Plastics is staffed to take a concept through design and manufacturing. An internal design engineering staff helps ensure that customers receive the right combination of "manufacturing economics and efficiency" in the production of components that provide peak performance and functionality. Tapping into considerable experience in design, tooling, and processing, the company is able to collect information that can be used to the customer's best advantage. High competencies in the human arts of communication and collaboration are essential from design through production, and are sandwiched around key software capabilities.

"We feature Solid Works® design software along with Moldflow process analysis," says Cook. "Other software packages allow us to communicate with customer engineers to refine a product design as it is coming together. We employ Mattec process monitoring to oversee our processes and to monitor our plant.

"Communication is a major component of our daily success," he continues. "Our quality manager, engineering manager, and our production management all team up to solve problems and expedite solutions. Where we may need additional help, we are partnered with Penn State University's Behrend campus. We call on their knowledge whenever it may be helpful."

For more information on DesignDesign, visit www.designdesignonline.com

For more information on IDEO, visit www.ideo.com

For more information on Ziba, visit www.ziba.com

For more information on Micron Products, Inc., visit www.micronproducts.com

For more on Micron Integrated Technologies, visit www.micronintegrated.com

For more on Leominster Tool, visit www.leominstertool.com

For more information on Armstrong Rapid Manufacturing, visit www.armstrongmold.com

For more information on Craftsman Custom Metals, visit www.ccm.com

For more information on Polygon Company, visit www.polygoncompany.com

For more information on SenDEC Corporation, visit www.sendec.com

For more information on Accumold LLC, visit www.accu-mold.com

For more information on Integrity Plastics, visit www.integrityplastics.com

This article includes information provided by wire services.

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