MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Sitemap


Articles from 2005 In August


COMPANY DESCRIPTIONS

Originally Published MPMN August 2005

COMPANY DESCRIPTIONS

Aerotech

Aerotech has been involved in collaborative design efforts with leading medical device manufacturers for well over 30 years. The company's team-driven approach to solving complex motion control problems in the medical field has produced systems that far outperform component-based nonintegrated approaches. This approach has been successfully deployed in applications such as stent cutting, IOL/contact lens manufacturing, DNA sequencing, hermetic seam welding, catheters and endoscopes, haptic mills and drills, and x-ray/MRI/CT machines. In addition to system-level solutions, Aerotech offers a full line of motion control and positioning components such as multi- and single-axis controllers in stand-alone and PC-based configurations, a full line of linear and rotary motors, and direct-drive or screw-driven linear and rotary positioning tables.

Colder Products

Colder Products Co. is a provider of quick disconnect couplings for medical device applications. The firm's couplings are used anywhere a fluid connection needs to be made - connecting a DVT pad to a pump, attaching a cannula to a coronary artery bypass circuit, connecting a blood pressure cuff to a monitor, or connecting an endoscope to a reprocessor for cleaning and sterilization. The coupling and fitting technologies allow flexible tubing to be quickly and safely connected and disconnected. Special product features include built-in shutoff valves to prevent product spills and an easy-to-use, push-button thumb latch for quick connecting and disconnecting. Founded in St. Paul, MN, in 1978, the company has direct sales and distributor representation in North America, Europe, Latin America, Australia, and Asia.

Donatelle

Donatelle offers component manufacturing through device assembly, packaging, and sterilization management. The company operates under ISO 9001- and ISO 13485-certified systems and is FDA registered. Current capabilities include complete engineering services, quick turn-around prototyping, in-house tooling design and fabrication, expert processing capabilities for the entire range of engineered resins. Molding capabilities include insert molding, overmolding, micromolding, white room molding, and Class 10,000 liquid silicone injection molding. The firm also offers Class 100,000 clean room assembly, Class 10,000 cleanroom molding and assembly, extensive contract manufacturing services, and machined metal component fabrication.

Epson Robots

Epson Robots offers PC-controlled precision factory automation with a product line of hundreds of SCARA, Cartesian, and six-axis robots. The company's EPSON RC+ PC-based software and integrated options, such as vision guide, conveyor tracking, Active X controls, force sensing, DeviceNet, Profibus, and security option help reduce development time, improve system performance, and save money. Building on a 21-year heritage, Epson delivers robots for precision assembly and material handling applications in several industries, including biotechnology, consumer product, electronics, medical devices, pharmaceutical, plastics, semiconductor, and telecommunications.

Filtertek

Filtertek is a filtration and fluid control device manufacturer specializing in the development of innovative devices for the medical marketplace. The company specializes in contract manufacturing for medical device and pharmaceutical customers with high volume or critical requirements for precision molding and advanced automation. The firm is capable of working with every type of filter media in order to meet customer requirements. With its global manufacturing capability and focus on efficient production and continuous improvement, Filtertek provides high quality, cost-effective products to customers worldwide.

Fischer Connectors

Fischer Connectors, an ISO 9001-certified company, engineers and manufactures circular connectors for use in demanding medical applications; offering more than 30 sealed and unsealed body types for cable and panel mounting. Contact configurations include multipole, coaxial, triaxial, mixed, high voltage and thermocouple, in standard or custom designs. Made from precision-machined shells of brass, stainless steel, or aluminum, as well as high-performance plastic, the connectors feature high chemical resistance and high level of EMI/RFI signal shielding. The connectors can withstand operating temperatures of 200° C and are safe for all medical sterilization procedures, including autoclave and liquid germicide. Sealed connectors are rated at IP68. Plugs can be sealed for use in moisture-laden or gaseous environments. A full range of accessories is available, including cable strain reliefs, sealing caps, and crimp contacts.

W. L. Gore & Associates

Gore's fluoropolymer products provide innovative solutions in consumer, industrial, electronic, medical, and surgical markets. Device manufacturers depend on the company's medical industry experience and fluoropolymer innovations to develop products that improve clinical outcomes. The company's portfolio encompasses implant biomaterials, unique cable and tubing products, and membranes for critical venting and filtration applications. Gore partners with companies that share its passion for medical device innovation.

Interpower Corp.

Interpower Corp. is a supplier of power system components for companies that wish to export products overseas. The company carries a full line of hospital-grade power cords, medical power entry modules, isolation step-up and step-down transformers, plugs and sockets, accessory power strips, power distribution units and various other power system components. All power system components are suitable for use both internationally and domestically with all necessary agency approvals. Interpower Corp. has no minimum order quantity and stock items are available for same-day shipment.

Liquid Control

Founded in 1975, Liquid Control designs and manufactures a complete line of precision meter, mix, and dispense equipment for single-component, two-component, and other multiple-component resin systems. Available metering technologies range from piston and rod positive displacement pumps and valves to continuous flow rotary pumps, including gear and progressive cavity designs. On January 1, 2005, Liquid Control and all of its affiliated companies were purchased by Graco Inc. Liquid Control will continue to operate in all existing facilities and retains its name and brands while becoming a wholly owned subsidiary of Graco. Graco, headquartered in Minneapolis, Minnesota, is a world leader in fluid handling systems and components. Graco's products move, measure, control, dispense, and spray a wide range of fluids and viscous materials used in commercial and industrial settings. Founded in 1926, Graco has over 75 years of experience serving more than 40 industries.

MicroMo

MicroMo and the FAULHABER Group specialize in the design, assembly, and application of high-precision, miniature DC drive systems, components, and controls. This includes everything from highly customized dc motion control systems to versatile, standardized, off-the-shelf products. MicroMo Electronics Inc. is ISO 9001 certified and has CNC machining facilities, a 12,000-sq-ft cleanroom assembly operation, online product acceptance of both finished product and incoming goods, and R&D facilities. All applications work is carried out by an in-house engineering staff that assists more than 3,000 customers in the design, specification, and after-sales support of standard and custom motion control products.

Mitutoyo America Corp.

Mitutoyo America Corp. offers metrology products, software, service, and support. Products include calipers, micrometers, indicators, quality control software, form-inspection instruments, CMMs, digital readout systems, hardness testing instruments, height gages, optics, vision inspection systems, precision-measuring microscopes, profile projectors, toolmakers' microscopes, and more.

Moll Medical

Moll Medical supplies injection molding and logistics solutions. The company is a full-service contract manufacturer of Class 1, 2, and 3 medical devices and components with worldwide locations. Its Class 10,000 and 100,000 cleanrooms run continually optimized production, deliver outstanding quality, and supply all-inclusive program administration. From parts procurement through molding and assemblies, including management of sterilization, overseeing audits, preparing ready-for-final-use packaging and into distribution, the company offers contemporary, turnkey services to meet global healthcare demands. Moll Medical is FDA registered, ISO 9001:2000 and ISO 13485:2003 certified, and QSR compliant.

Pneumadyne Inc.

Pneumadyne Inc., an ISO 9001:2000 registered firm, designs and manufactures a broad range of miniature pneumatic components including manual and solenoid valves, flow controls, needle valves, fittings and manifolds for medical and industrial equipment and instrumentation. With more than 20 years experience in fluid handling and precision machining, the firm specializes in the design and manufacture of custom products.

Precision Concepts Costa Rica

Precision Concepts Costa Rica S.A. is a vertically integrated contract manufacturer of disposable medical devices and electromedical assemblies using Class 100,000 and environmentally controlled cleanrooms. The company produces high-quality, custom-packaged, finished devices produced at a lower cost, offering a competitive market advantage to its medical device customers. Its engineering group and highly skilled work force offer a comprehensive set of manufacturing capabilities, including injection molding, US welding, microgrinding, electropolishing, flow and leak testing, and electrical testing. Precision Concepts is ISO 9001:2000 and ISO 13488:1996 certified and FDA device registered.

Rietschle Thomas

With annual sales of more than two million units into more than 70 countries, Rietschle Thomas is the world leader in the manufacturer of OEM air compressors and vacuum pumps. Its product line of pumps and compressors are used for air, gas, and liquid applications. The company's manufacturing philosophy is to match its product exactly to the requirements of its OEM customers to achieve an optimal design that delivers the best possible product at the lowest possible cost. This is accomplished by using computerized manufacturing cells and dedicated "single product" assembly lines.

Teel Plastics

Teel Plastics specializes in the custom manufacture of close-tolerance plastic tubing and profile products. From plastic cores to medical tubing, the firm's plastic tubing comes in a range of sizes and materials. The company can manufacture plastic tubing from 0.05- to 9.0-in. diam and has experience processing more than 50 types of thermoplastic resins. With more than 50 years of experience, the company has the expertise to continually develop processes and value-added services.

Tripp Lite

Enhanced service and industry-exclusive products have been Tripp Lite trademarks for more than 80 years. Company innovations include the world's first UPS system designed specifically for personal computers, and the Isobar surge suppressor. Tripp Lite maintains a ready-to-ship inventory of more than 1,000 different products, including UPS systems, surge suppressors, line conditioners, power inverters, cables, connectivity products, and network management accessories.




Universal Air Filters

Universal Air filters are custom-designed to exact medical equipment standards for blood analyzers, CT and PET scanners, MRI units, x-ray machines, ultrasound devices, and many other medical products. Each design maximizes air flow and lowers air resistance to extend the life and dependability of medical electronics components. A free, round-the-clock prototype service is available to design engineers worldwide at the company's Web site.



Copyright ©2005 Medical Product Manufacturing News

Products from the MPMN Mailbox

Originally Published MPMN September 2005

PRODUCTS

Products from the MPMN Mailbox

Electrical Test Machine

A high-speed, step–repeat electrical tester can be used for testing high-density double-sided and multilayer circuits. The MR402 electrical tester from Yamaha Fine Technologies Co. Ltd. (Hamamatsu, Japan; www.yamaha.co.jp/finetech/) is designed to improve process control and ensure electrical integrity of circuit boards. Available for flexible circuits and thin rigid boards, the machine’s automatic conveyor systems handles thin laminates without damaging them. The machine can test circuits with 70 μm pitch pads or traces with ± 5 μm accuracy. The MR402 can be configured for both in-process testing and final electrical verification. Simultaneous dual-side testing can be performed with microprobe fixtures. An automatic step–repeat mechanism allows for open–short tests over the entire surface of the boards. The multifunctional software provides autopositioning with correction retry and pressure control.

Fiber Optic Medical Probes

A company has expanded its offering of probes for use in the medical industry. Luxtron (Santa Clara, CA; www.luxtron.com) has released additional RF and MR-compatible probes and fiber optic instruments for medical research applications. One of the firm’s products, the I652 industrial monitor, provides a simple fiber optic monitor that requires initial calibration, with no recalibration needed. The company’s temperature sensors are suitable for medical treatments and research involving MR, RF, microwave, and electrical biases. The probes are nonmetallic and electrically nonconductive, and are immune to electromagnetic interference. As a result, the probes can accurately measure temperatures in environments where conventional electrical sensors may be ineffective.

Pump Head

A pump head features automatic tubing retention for quick setup or changeover. The Masterflex L/S Easy-Load 3 pump head from The Barnant Co. (Barrington, IL; www.barnant.com) includes a “twist-lock” mounting feature to mount single- or multiple-stacked heads without tools or hardware. Up to four pump heads can be stacked for increased flow capacity or multiple-channel applications, and a mounting plate adapts the new head to all Masterflex L/S drives. The pump heads are suitable for applications that require quick tubing changes. A spring-loaded lever on the unit opens the occlusion bed and simultaneously retracts the tubing retainers so tubing slips right in. when the pump head is closed, the retainers automatically grip, securely holding the tubing in place. The occlusion bed applies optimal occlusion force to all accepted tubing sizes, and the head’s wide occlusion angle prevents fluid backflow. A precision tubing model and a high-performance precision tubing model are available, offering flow ranges of 0.06 to 2300 mL/min and 1.7 to 2900 mL/min, respectively.

Connector System

The performance of a fiber optic connection is combined with the versatility of a rugged industrial connector in a duplex connector system. The Optical Industrial LC Duplex connector system from Molex Inc. (Lisle, IL; www.molex.com) features assemblies with push–pull insertion and a bayonet-style mechanical latch to ensure an environmentally sealed optical connection in just one step. Its bulkhead adapter is designed with a sealed panel feed-through design for easy installation into enclosures. The removable connector provides sealing between both the adapter mating surface, as well as the cable exiting the connector. The system works with any standard fiber type and is available in both single and multimode styles. It offers moisture and dust protection, along with a temperature range of –40 to +85° C.

Compressed Gas Adapter

A compressed gas adapter can detect the microbial content of compressed gases in an area. Biotest Diagnostics Corp. (Denville, NJ; www.biotestusa.com) offers its RCS compressed gas adapter for use in areas where specific microbial counts must not be exceeded. Used in conjunction with the validated RCS Plus, RCS High Flow, or RCS Isolator microbial air samplers, the adapter provides a measurement of high and low concentrations of microbes in isolators and laminar flow environments, as well as in sterile and aseptic production lines. The adapter is part of the Hycon system, a line of products used for environmental monitoring which includes air samplers, particle counters, and contact slides for surface sampling.


Copyright ©2005 Medical Product Manufacturing News

Products from the MPMN Mailbox

Originally Published MPMN March 2005

PRODUCTS

Products from the MPMN Mailbox

LED Arrays

A supplier of custom infrared and visible LEDs has developed a 60 die LED array product line. The arrays from Opto Diode Corp. (Newbury Park, CA; www.optodiode.com) have a 40˚ radiation beam angle with much higher intensity in the center of the working beam, compared to other LED arrays. The extremely bright arrays feature excellent thermal conductivity and a range of wavelengths from 405 to 870 nm. Storage and operating temperatures range from –55˚ to 100˚ C with a maximum junction temperature of 100˚ C and a thermal resistance J-C parameter of 3˚ C/W, typical. Customized, higher temperature versions of the arrays are available upon request.

Surface Mount Fuses

A high-powered surface mount fuse is RoHS compliant. The UMT 250 surface mount fuse from Schurter Inc. (Santa Rosa, CA; www.schurter.com) has a breaking capacity of 200 A at 250 V ac, 277 V ac, or 100 A at 125 V dc over a current range of 315 mA to 4 A. Measuring 10×3×3 mm, the fuse maximizes circuit protection while enabling significant advances in miniaturization. It is suitable for replacement of axial or radial lead through-hole fuses. The fuse provides similar performance, yet occupies 80% less volume than a typical microfuse or 5×20 mm cartridge fuse. The UMT 250 is solder-immersion compatible, according to IEC 60068-2-58. Its markings are clear and visual identification of rated currents is easy for pick and place.

Power Connectors

A new line of power connectors is designed to provide safe and dependable power interconnects in portable equipment of any type. Amphenol Corp. (Sidney, NY; www.amphenol-industrial.com) offers its Neptune connectors for use in modular power generation equipment and modular manufacturing plants. The line of connectors includes plugs and receptacles from 30 to 400 A at 600 V, featuring the company’s patented Radsok contact system, which allows for more amperage and voltage through a smaller connector. Its lightweight, rugged aluminum hardware is precision-machined from high-tensile-strength bar stock and finished with a hard coating. Conductors are readily terminated to easily accessible pressure wire terminals. The contact inserts are interchangeable and reversible to suit specific needs.

Custom Core Pins

A full range of custom core pins with precision-ground and EDM forms is available for use in molding medical products. The core pins from Ezell Precision Tool Company (Clearwater, FL; www.ezellprecision.com) can be manufactured with tip diameters as small as 0.002 in. and lengths to 14 in., with ±0.00005-in. tolerances and details, such as tapers, rings, vents, ribs, and spirals. Materials include tool- and powdered steel, stainless steel, and copper alloys. Molding area can be polished or plated and coated. The pins can be produced for use in molding disposable syringes, needle sheaths, closures, nipples, pipettes, IV connectors, and electronic components.

Ac Inductive Sensors

Two-wire ac inductive sensors provide a less expensive alternative to ac/dc sensors. Balluff Inc. (Florence, KY; www.balluff.com) offers the new family of sensors with a current load capacity of 500 mA. The tubular-style sensors are featured in M12 through M30 sizes, in shielded and unshielded configurations. Multiple cable lengths are available. The sensors are suitable for noncontact presence sensing of metal objects in virtually any industry application for positioning, automation, discrete control, or process monitoring.


Copyright ©2005 Medical Product Manufacturing News

Sneak Peek: Hotline

Originally Published MPMN September 2005

Product Update

Sneak Peek: Hotline

Small Modem Uses Low Power, Yet Offers High Performance

A modem that consumes little power is available for small footprint devices to communicate data. The Half-Inch Modem from Radicom Research Inc. (San Jose, CA) is a self-contained TTL interface voice/data/fax modem module. It provides medical device designers the flexibility to include modem functionality in system products with minimal engineering resources.

The modem is suitable for such applications as instrumentation for patient monitoring. For example, a device can measure the blood sugar level in a diabetic patient, and then transmit the data using the modem from the patient’s home to his or her doctor’s office.

The unit has a built-in data pump and modem controller. Measuring 1 ´ 1 ´0.3 in., with a –40° to 85°C operating temperature, it is controlled by standard AT commands. Handset interrupt and connection detection features allow the modem to share a phone line with other equipment, eliminating the cost of a dedicated phone line.

“The Half-Inch Modem’s small footprint and ease of use enables designers to provide connectivity to their applications in a very small space, adding value to products with its advanced communications features,” says Alex Tsau, the company’s vice president of operations.—Susan Shepard



Copyright ©2005 Medical Product Manufacturing News

SUD Reprocessing: Growth Amid Controversy

ssue Update

August 2005

Tucker Tucker: Legislating reprocessed devices.

In spite of its widespread use and growing application in a variety of markets, the reprocessing of medical products designated as single-use devices (SUDs) continues to be a controversial subject. The objectivity of reports regarding the safety, efficacy, and cost savings of the practice is frequently compromised by the agenda of the organization behind the particular study. In general, medical device manufacturers have tended to resist third-party SUD reprocessing since it is seen as having an adverse impact on their sales. Hospitals tend to be supporters, since purchasing such devices lowers their operational costs.

And now a new wrinkle may be emerging. Massachusetts State Senator Susan Tucker (D-Andover) has introduced a bill that would require doctors, hospitals, and other healthcare providers

to notify patients if any reprocessed devices will be used in the course of their treatment. Countering, hospitals and reprocessors say that such a requirement would drive up medical costs. [ More ]

Frist Calls for Restrictions on Pharma DTC Advertising

In early July, U.S. Senate majority leader Bill Frist, (R-TN) called for a two-year moratorium on direct-to-consumer (DTC) advertising of new pharmaceuticals. In making his case, Frist contended that such advertising "can lead to inappropriate prescribing and fuel prescription drug spending" and that the ads "oversell benefits and undersell risks."

The pharmaceutical industry has been quick to respond to Frist's statements, and, although Frist currently has not extended his calls for a moratorium to the device market, the medtech industry is keeping abreast of the situation's developments. Although medtech's

 Frist
Frist: Targeting DTC drug advertising.

expenditures for DTC advertising are currently infinitesimal compared with those in the pharmaceutical industry, industry consultants say that the current debate could set a new standard for all to follow. [ More ]

Cleveland Clinic Turns Spotlight on Orthopedics

The 2005 Cleveland Clinic Medical Innovation Summit: Bench to Bedside and Back, being held October 24-26, will immerse industry professionals in three days of discussion and analysis of the latest trends and developments in the orthopedic sector.

CCF logoThe summit comes eight months after the Cleveland Clinic's announcement that it had formed a 10-year alliance with Stryker Corp. (Kalamazoo, MI) under which the medical device company will support the clinic in the advancement and testing of image-guided surgery systems and other sophisticated orthopedic surgical technologies, with the ultimate goal of developing "the orthopedic operating rooms of the future." [ More ]

Guidant's Good News Month

McCoy
Guidant's McCoy: Upward momentum.

After months when it seemed as though every announcement went from bad to worse, August turned out to be a good news month for executives at Guidant Corp. (Indianapolis). During August, the company received a handful of critical approvals: approval to move its implantable cardiac defibrillators (ICDs) back on the market, approval to expand its U.S. drug-eluting coronary stent trials, approval of a next-generation heart synchronization device with wireless programming, and European approval of its acquisition by Johnson & Johnson Inc. (New Brunswick, NJ).

By all accounts, the market return of Guidant's recalled ICDs came much sooner than expected, and such a quick turnaround is considered likely to minimize any

loss of market share. "Our progress toward full inventory availability is ahead of schedule," said Fred McCoy, president of Guidant's cardiac rhythm management division. "Already we have achieved an inventory position to meet all current implant demand and to replenish customer inventory." [ More ]

AdvaMed Report Promotes Value of Diagnostics

A recently released report, The Value of Diagnostics: Innovation, Adoption, and Diffusion into Healthcare, from industry association AdvaMed (Washington, DC) seeks to raise the visibility of diagnostics and document their importance and contribution to patient care. The report also points out that diagnostics are significantly underutilized—as much as 51% of the time—and that their adoption, full utilization, and ongoing development and innovation are all adversely affected by inadequate coding, coverage, and reimbursement.

Henry L. Nordhoff, chairman, president, and CEO of Gen-Probe Inc. (San Diego), said the report provided

Nordhoff
Nordhoff: Hopeful of change for diagnostics.

"compelling information and will likely emerge as a standard reference tool for the subject of diagnostics." Nordhoff, who is also chair of AdvaMed's diagnostics sector, reinforced the findings of the report, stating, "Coding and reimbursement have not kept pace with the realities of the science of diagnostics" or the healthcare marketplace. With the steady advance of diagnostics developments and the rapidly emerging era of molecular diagnosis and the promise of personalized medicine, we're a totally different industry than we were when these coding and coverage policies were established. I'm hopeful that Congress and CMS will recognize these realities and implement the recommendations of the report. [ More ]

Healthpoint Capital Report Highlights Opportunities
in Sports Medicine

A new report produced by Healthpoint Capital (New York City) details the "orthopedic opportunity" that the growing sports medicine market holds for manufacturers. The report, 2005 Orthopedic Market Report: Sports Medicine, projects a $1.36 billion market value in 2005 for the products used in orthopedic arthroscopy, including surgical instruments and equipment ($850 million) and implants ($510 million)—a 39% increase over 2001 market value of $0.98 billion. In addition, it estimates the 2005 nonsurgical product market at $622 million, a 26% increase since 2001. [ More ]

Devices Lead Medtech Deals in Second Quarter

The device sector accounted for the greatest number of medical technology deals in the second quarter of 2005, according to The Medical Technology Acquisition Record, published by Irving Levin Associates Inc. (Norwalk, CT). The 38 transactions represented a gain of 9% over the 35 deals reported in the year-ago quarter, but were down 12% from the 43 deals in the first quarter of 2005. The number of second-quarter 2005 transactions represents approximately 27% of the 143 medical device deals announced during the past four quarters. [ More ]


MX: Issues Update is a monthly e-supplement prepared by the editors of MX: Business Strategies for Medical Technology Executives and sent to you as a benefit of your online registration with Canon Communications. To become a regular subscriber to this monthly medtech business update, click here.

The editors welcome your suggestions for future content in MX: Issues Update. Please feel free to contact us with your comments and ideas.Steve Halasey, Editor in Chief, MX

MX: Issues Update is a monthly e-supplement prepared by the editors of MX: Business Strategies for Medical Technology Executives and sent to you as a benefit of your online registration with Canon Communications. To become a regular subscriber to this monthly medtech business update, click here.

Avail.com

AVAIL The world's largest and most trusted outsource provider of design and manufacturing services for finished, disposable medical devices.

www.availmed.com


CAMSTAR

Reduce risk, improve yield and product quality, and reach volumes quickly with Rapid eDHR for medical device manufacturers.

info.camstar.com


IBM

Streamline the creation, review, and approval of clinical trials documentation; support best practices in controlled assembly, approval, tracking, and publishing; and facilitate earlier regulatory agency review. Click here to see how IBM can help.

 

Senate Confirms Crawford, At Last

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published MDDI August 2005

NEWSTRENDS

After a prolonged delay, the Senate in July confirmed Lester M. Crawford as FDA commissioner. His nomination passed by a vote of 78–16.

Crawford has served four tenures at FDA. He has twice been acting commissioner, the second time starting in March 2004. He is the first commissioner to come from FDA's internal ranks since 1954.

President Bush nominated him in February, but the vote had been delayed because of a controversy over review of a morning-after contraceptive pill, among other reasons.

Industry welcomed the news. Both AdvaMed and the Medical Device Manufacturers Association issued statements applauding the vote and praising Crawford.

Copyright ©2005 Medical Device & Diagnostic Industry

Protomold Expands Operations In UK and at Home

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published MDDI August 2005

OUTSOURCING NEWS

Protomold Expands Operations In UK and at Home

Rapid injection molder Protomold Company, Inc. is expanding its North American manufacturing plant in Maple Plain, MN, to a 20,000-sq ft facility. In addition, the company will open an additional facility that is 25,000 sq ft in the West Midlands area in the UK by the end of 2005. The UK facility will employ a staff of 40 and offer prototyping and low-volume production to the U.K. and Germany. The company plans to offer services to other western European nations as well. This marks the company's first international expansion. Protomold was recently ranked number 48 on the Deloitte Technology Fast 500 as one of the fastest growing companies in North America.


Copyright ©2005 Medical Device & Diagnostic Industry

No More Excuses for Medical Errors

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published MDDI August 2005

EDITOR'S PAGE

No More Excuses for Medical Errors

The still-too-high rate of medical errors could be cut if more device companies used human factors research early on in product design.

Despite all the publicity about medical errors since the 1999 release of a landmark Institute of Medicine (IOM) report, the healthcare industry has not made a whole lot of progress toward stamping them out. The report set a goal to reduce errors by 50% by 2004. According to the Commonwealth Fund, not only was the goal missed by a wide margin, but also the effect on error reduction has been negligible. Not only have healthcare professionals been unable to show progress, but they also have achieved little consensus on how to approach the problem and on what to measure. This means the IOM report's estimate of 44,000–98,000 deaths per year due to medical errors has likely not changed much.

This is simply unacceptable.

Why has almost no progress been made? There are several reasons, according to Marilyn Sue Bogner, PhD, president and chief scientist of the Institute for Study of Medical Error LLC (Bethesda, MD). One is that efforts have relied too much on error reports, which perpetuate a “blame culture” that ends up encouraging secrecy instead of working to solve the problem. Another is that no one seems to know what to do with the reports once they are filed. Perhaps even more problematic, she says, is a “resistant medical culture in which doctors still balk at efforts to record errors and participate in systematic steps to solve them.”

Device companies, then, need to take matters into their own hands.

How can they do that? By incorporating human factors research into the design process from the very start. Not all future errors can be designed out, of course. But if device design conforms to what makes sense for the users, instead of vice versa, perhaps use-related medical errors could be drastically reduced.

There are many ways to bring human factors expertise to bear early in a design project. Several models were shared at AAMI's Human Factors, Ergonomics, and Patient Safety for Medical Devices conference, held in June in Washington, DC.

Abbott (Abbott Park, IL) uses a “broker model.” It has a three-person human factors internal staff that is a “critical and visible” part of the organization, said Edmond Israelski, program manager of human factors.

GE Healthcare (Waukesha, WI) uses an “internal core competency group model.” It's an internal team that gets involved in almost all design projects, said John Bowie, GE's user experience leader. It is based on, among other things, “observing actions of the user; understanding customer workflow, roles, and responsibilities; and measuring the extent to which our customers are able to accomplish key tasks by using our products and services,” he said.

Even small companies can have human factors programs. Angel Medical Systems Inc. (Tinton Falls, NJ) hired a human factors expert, Mary Carol Day, EdD, after discussions with FDA about the company's heart monitor turned up human factors concerns. “There are two overarching roles of the human factors team member,” she said. “First is involvement throughout the entire process: planning, design, implementation, and testing. Second, focus on both user needs and project goals. Someone needs to keep both in mind.”

For many companies, an outsourcing model may be most appropriate. There are several ways to approach this, said Tim Reeves, PhD, managing director of Human Factors MD Inc. (Brampton, ON, Canada). A consultant can design and evaluate a client's human-device interfaces or can provide guidance on safety, usability, standards, and regulatory requirements.”

With all the options available, there is no excuse for eschewing human factors research early on in product design. And, as Michael Wiklund points out in this issue, cost is no reason to justify cutting corners. (See “Return on Investment in Human Factors,” p. 48.) If use-related medical errors are to be reduced, it is up to the device industry to be proactive. Anything less is letting down your customers and their patients.

Erik Swain for The Editors

Copyright ©2005 Medical Device & Diagnostic Industry

Central Mexico Holds Allure for GW Plastics

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published MDDI August 2005

OUTSOURCING NEWS


A new plant in Querétaro, Mexico, could help GW Plastics Inc. (Bethel, VT) serve its Latin America–based customers with growing industrial needs. GW provides injection molding for precision tooling, components, and assemblies.

“We already supply to Northern Mexico customers from our plants in San Antonio, TX, or Tucson, AZ,” says Ben Bouchard, vice president of marketing. “This will let us better serve customers in Central Mexico.”

The facility is ISO 9001:2000 certified. Querétaro, a city of 1.5 million people, lies northwest of Mexico City. The plant was built in a new industrial park with state-of-the-art infrastructure, transportation logistics, and aesthetics.

Initial operations will have 25 conventional and insert molding machines. It also has room for value-added assembly operations and the expansion capacity to accommodate 40 machines.

The facility has space for a Class 100,000 cleanroom that will serve the growing medical industry in that region of Mexico.

“We believe this plant is an excellent place to support our customers in Mexico City, Toluca, and Guadalajara,” says Bouchard.

GW also has molding facilities in Bethel and Royalton, VT, San Antonio, and Tucson.

Copyright ©2005 Medical Device & Diagnostic Industry

Finding a Fit with Rapid Injection Molding

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published MDDI August 2005

Cover Story: Molding

Rapid injection molding may be a good fit for design engineers looking for quality first-run parts. But they should first know the basics.

Bradley Cleveland

Suture clamps, like these pictured still in the mold, can be made in small batches for prototyping. At right, a high-speed CNC milling machine is linked to the 3-D CAD file used to generate tool paths for the mold design.

Rapid injection molding is changing the way designers think about prototyping and low-volume production of parts in industries such as medical devices, aerospace, appliances, and electronics. For medical device manufacturers in particular, laborious testing cycles and rigorous product evaluations are needed to submit a product for clinical trials and to bring it to market. Rapid injection molding can help minimize time to market by reducing time spent on the testing and certification processes.

Technological advancements are changing the medical industry. The product design process, for example, uses increasingly powerful 3-D CAD programs that enable more-complex product designs. But these design advances in turn drive demand for more-complex prototypes. Fast-moving competitive markets require frequent design changes, short lead times, and tight budgets. In sum, today's high-tech world means prototyping must be faster, better, and less expensive than ever before.

While traditional molding methods are still widely used, a growing number of design engineers are turning to rapid injection molding. The technique offers designers the ability to create prototypes with high-quality materials. Designers can create inexpensive first-run parts suitable for testing. Rapid injection molding also gives manufacturers the flexibility to create parts that can be used for marketing studies or low-volume production needs.

This article discusses rapid injection molding and related mold-making processes. Understanding these options, their capabilities, and their limits can help designers make better-informed decisions about which processes to employ.

Rapid Injection Molding for Design, Testing, and Production

Table 1. Mold-making technique comparison chart (click to enlarge).

Rapid injection molding can economically deliver from 25 to 10,000 molded prototypes in 3–15 days. Using a CNC-machined aluminum mold that produces the same geometry as subsequent steel production tooling, rapid injection molding can replicate the intended design shape. The resulting prototypes enable engineers to submit parts to the extreme and rigorous testing procedures needed to validate functional properties. The dimensional accuracy of the parts is comparable to that of injection-molded parts made using steel tooling.

Both mechanical properties (e.g., strength, temperature resistance, etc.) and future production costs should be considered when obtaining prototypes.

Because the rapid injection molding process produces functional parts, it can be used in several steps of the new product development cycle. At the earliest stages of product development, an engineer may only need 25 pieces for initial evaluation. During market testing, as many as 250 parts may need to be put into the hands of end-users. And at the bridge tooling stage, a few thousand parts may be created to meet production requirements until steel tooling is ready for full-scale production. In cases where only a few thousand parts per year are required, rapid injection molding can easily perform the necessary machining for all stages.

How Rapid Injection Molding Works

Rapid injection molding is a highly automated method of producing injection-molded parts from a 3-D CAD part model. The core technology of the process involves a software application that automatically converts digital part models into tool paths for CNC milling machines. The CNC milling machines produce metal mold components that are assembled and mounted on an injection molding press. Heated thermoplastic resin is then injected into the mold, where it solidifies to produce the desired part.
Although there are process differences among suppliers, most employ the same basic steps. Understanding the process does not just involve the end product. The path to the end is just as important.

CNC-milled mold components are assembled and mounted on a press. Heated thermoplastic is injected into the mold where it solidifies.

First, the design engineer submits a 3-D CAD part design. Depending on the supplier, the design file can be submitted in any commonly shared file format, including IGES, STEP, native SolidWorks, Parasolids, and ACIS. (IGES is initial graphics exchange specification; STEP stands for standard for the exchange of product model data; and ACIS is Andy, Charles, and Ian's system, owned by Spatial Technologies.)

After a design file is submitted, software typically analyzes the 3-D CAD model, exploring potential changes that might improve the molding process. A quote is sent to the engineer, usually within one business day. If the quote is Web-based, it should provide pricing as well as suggestions for improving design parameters that better fit with the rapid injection molding process. Items that are frequently subject to change include the number of cavities, A- and B-side finish levels, and resin used. The desired delivery schedule may also shift if changes are substantial or complex. Keep in mind that each change may alter the price quote. While software is rapidly evolving to ensure precision, it's always a good idea to double-check the analysis to make certain the part will be manufactured as desired.

Besides offering general geometry improvements, the software may also provide a compatibility review. A compatibility review suggests changes that will improve moldability or reduce tooling costs using the rapid injection molding process. The review should also identify undercuts, wall thicknesses that could cause fill or sink problems, and areas where draft is required. Indications of radii or wall-thickness limitations resulting from the mold-milling process should also be provided.

Although a vast array of geometries can be produced using rapid injection molding, the process does have some limitations. Both part size and part complexities are restricted, largely due to the highly automated nature of the mold-making process. For example, because CNC milling results in rounded external part corners, some part features may not be possible using rapid injection molding. The process is also limited in its ability to produce undercut part-geometry features, which require mold pieces to pull out sideways, perpendicular to the direction of pull. Most problems, however, can be worked around. Design engineers should consult an online design guide or contact the supplier's engineering specialists for more-detailed assistance.

Upon receipt of the final 3-D CAD design and order, the software uses the published shrink coefficient of the selected resin and automatically determines the geometry of the mold components that are required to produce the part shape. During this process, the software calculates factors such as core and cavity geometries, shutoff surface generation, gate-design layout, and ejector-pin placement. The software then outputs tool paths for three-axis CNC machine cells to manufacture required mold components for subsequent assembly into a functional mold. Mold technicians produce the final parts using injection molding presses that typically range in size from 30 to 300 tn. This range of presses can support parts with a projected area of up to 75 sq in.

Small parts, like these suture clamps, are especially well-suited to the rapid injection molding process.

If changes to part geometry are needed after an initial run of samples, design engineers must submit a revised 3-D CAD model. The supplier determines whether the change requires a new mold or whether the initial mold can be modified via additional processing. Typically, molds can be modified relatively easily even if the mold material needs to be removed to support required changes. If additional mold material is required, a new mold may need to be machined. What makes rapid molding convenient is that even when a new mold needs to be created, it can be done quickly and cost-effectively. Creating additional iterations is generally a feasible method for rechecking a design before full production.

Working within Rapid Injection Molding's Capabilities

The rapid injection molding process is best for smaller parts. Although it varies by supplier, a typical limit for a part envelope is approximately 7.5 ¥ 14 ¥ 3 in. deep and is subject to an overall limitation of 75 sq in. of projected part area. Also, because the mold is produced by high-speed three-axis CNC milling technology, rapid injection molding is best for parts that require simple, straight-pull molds or simple mold side actions. A straight-pull mold enables the two mold halves to pull straight away from each other without mold metal passing through the plastic part. Side actions require mold pieces to pull out sideways (perpendicular) to the direction of pull. Rapid injection molding can support up to four mold side actions for undercuts if the undercuts are on the outside of the part geometry, at the parting line, and within certain size requirements. There are several considerations to keep in mind for designing within the limits of the rapid injection molding process:

• Avoid placing detailed features adjacent to deep walls, where it can be difficult to maintain accurate milling control.
• Pay attention to corner design. Some part corners may end up with a radius rather than a sharp edge; reshaping a corner may not require a mold change, but it's a design element to consider.
• Steer clear of deep, thin ribs. They tend to increase the mold-milling time and make hand polishing difficult and time-consuming.

Whether the process involves conventional molding or rapid injection molding, parts should have consistent wall thicknesses to minimize the potential for warped or distorted parts. Also, engineers should design a part using the appropriate draft and reinforcing fillets. Doing so will ensure proper ejection, add rigidity to part ribs, and strengthen the mold.

Additionally, if more than 10,000 parts are needed, high-volume steel tooling in a conventional manner may be a better choice, economically.

Evaluating Available Rapid Mold-Making Technologies

Submitting 3-D CAD part designs via the Web can make it easier to provide feedback and explore mold changes.

As with any selection process, it's important to evaluate mold-making options before making a decision. While milling mold parts speeds the time to market for some medical device manufacturers, it's not a one-size-fits-all solution for every prototype and low-volume-production need. Table I compares other options.

Depending on the definition of rapid, design engineers can also work with vendors who use the electrical discharge machining (EDM) method to manufacture their injection molds. EDM technology has fewer geometrical constraints but tends to be a slower process than three-axis CNC milling, so there may be a trade-off to consider. EDM works by eroding material in the path of electrical discharges. It can create both simple and complex geometries.

There are also some relatively new mold-making technologies for quick-turnaround requirements. These are based on additive rapid-tooling techniques. Such techniques include selective laser sintering (SLS) and ultrasonic welding. In SLS, a laser is used to sinter metal powder into the desired shape of the mold. For complex mold geometries, SLS can be significantly faster than using EDM. SLS is useful for a 1- or 2-day turnaround when testing a part's form or fit. This is especially true if the part is highly complex in shape, and the material characteristics of the prototype do not need to match those required for production. But it may not be a good fit for projects requiring duplication of fine detail or testing in extreme conditions. The final SLS surface finish is powdery and porous unless a sealant is used, and the material is difficult to control in extreme temperatures.

Ultrasonic welding uses high-frequency oscillations to weld together thin strips of metal to form the desired mold geometry. The process has been shown to produce high-quality molds from both aluminum and steel, in competitive time frames.

The key advantage to any additive technique is the ability to create nonmachinable features. Nonmachinable features are the geometric shapes within the mold or on the surface that cannot be created by cutting away metal. Conformal cooling channels in the mold geometry, for example, can effectively reduce injection molding cycle times during production.

Conclusion

Rapid injection molding is a convenient way to quickly obtain real parts for prototyping, initial runs, and low-volume production. The medical device industry uses rapid injection molding to get parts that can be accurately tested at a fraction of the cost of full-scale production materials. However, engineers must understand the possibilities and constraints of rapid injection molding to use the technology successfully.

Following simple rules can help engineers choose the best process technique for individual needs. It's important to understand the technical details and compare geometric requirements, such as size and dimensional accuracy, for mold making. Engineers need to know the business constraints and choose the process that best fits their budget and schedule limitations. And they need to select a qualified provider. It is imperative to research the supplier's ability to meet basic requirements and solve the unpredictable but inevitable technical problems that arise during any prototyping project.

Bradley Cleveland is the president and CEO of Protomold Company, Inc. (Maple Plain, MN).

Copyright ©2005 Medical Device & Diagnostic Industry