Metal Fabrication

OUTSOURCING OUTLOOK

Metal Fabrication
Ken Marino, president, Orbel Corp., Easton, PA.

Companies seeking ways to achieve competitive advantages in the design and production of next-generation medical devices should consider the benefits of outsourcing precision metal fabrication. Product designs that were previously difficult or impossible to obtain with traditional stamping processes can be quickly and efficiently achieved through photochemical milling, for example. Extremely thin and flexible parts can be made and reproduced in a variety of shapes. Coupling this process with electroplating and passivation capabilities gives design engineers a new way to meet the demanding requirements of the medical device industry.

The cost and learning curve required to bring these technologies in-house can be prohibitive, however. Companies specializing in these advanced processes can help OEMs reduce time to market. Consider some of these points when searching for your next metal fabrication supplier:

  • Confirm whether the company has been exposed to the demands of the medical industry. Does it demonstrate a sufficient level of competency?
  • Establish whether there is a recognized quality system in operation. Is the company certified to the appropriate quality standards required for your applications?
  • Verify that all of the required hazardous materials permits are in place. Are hazardous materials being disposed of properly? Is recycling being practiced?
  • Determine whether prototype turnaround times meet your expectations. Does the company have the capacity to scale up to production?
  • Make sure that there are sufficient capital resources available in the event of a downturn or unexpected cost overruns.

Contract Manufacturer Fabricates Stainless Steel and Titanium

A contract manufacturer specializes in precision machining of stainless-steel and titanium components for medical implantable and surgical device applications. Project managers assist medical device OEMs through all phases of production, including concept, prototyping, design for manufacturing, qualification, validation, and full-scale production. Capabilities include micromachining down to 0.3 mm; 3-, 4-, and 5-axis micromilling; and 5-, 8-, and 10-axis Swiss machining, as well as machining, turning, and milling of miniature features. Parts and features are assessed using advanced inspection systems.
Remmele Engineering, Big Lake, MN
www.remmele.com

Stamped and Drawn Components Are Suitable for Medical Applications

Stamped and drawn parts can be produced from tantalum, exotic-metal alloys, or stainless-steel, and are suitable for such medical applications as catheters, stents, implants, and surgical tools. The deep-drawn and progressive stampings can be up to 3.5 in. long, have ODs up to 6 in., feature wall thicknesses ranging from 0.003 to 0.125 in., and achieve tolerances to ±0.0001 in., according to the company. Component design support is available, and the company provides test results of chemical and mechanical properties.
The Evans Co., East Providence, RI
www.evanstechnology.com

Firm Offers Turning and Milling Services

A company specializes in CNC machining for precision turning and milling of various metals. The firm renders custom parts in stainless steel, aluminum, titanium, and carbon steels. Ancillary operations include grinding, honing, polishing, painting, welding, deburring, plating, anodizing, and heat-treating. Machining services are conducted in a 39,000-sq ft facility.
4 M Industries Inc., Livonia, MI
www.4mindustries.com

Company Machines Light-Gauge Metals

Light-gauge metals suitable for medical device applications can be precisely milled or chemically etched by a metal fabrication provider. Metal can be etched as thin as 0.0002 in., with widths up to 24 in. A selection of materials are available, including stainless steel, brass, copper, beryllium-copper, phosphor bronze, and nickel-silver. OEMs can partner with the company during the metal selection process; a rapid prototyping service is provided. In-house electroplating and passivating services are also offered.
Orbel Corp., Easton, PA
www.orbel.com

Photoetching Process Produces Intricate Parts

Specializing in the manufacture of small, light-gauge parts through photoetching, a company produces intricate components with close tolerances. Parts include encoders, masks, filters, lead frames, springs, strain gauges, laminations, needles, heat sinks, shields, shutter blades, electron grids, fluidic circuit plates, reticles, drive bands, and shims. Metals include nitinol, titanium, tungsten, molybdenum, copper alloys, beryllium-copper, stainless steel, aluminum, and nickel alloys. Thicknesses range from 0.0005 in. and up. Formed parts are manufactured by combining photoetching for blanking with universal tooling for forming.
Tech-Etch Inc., Plymouth, MA
www.tech-etch.com

Tube-Cutting Process Yields Long Lengths without Contamination

Burr-free cutting of long-length metal tubing can be accomplished without exposing the components to corrosive chemicals, according to the company. The company’s fabrication process is designed to provide smooth-surfaced tube ends while holding parallelism and squareness. Length tolerances of ±0.002 in. are possible on parts as long as 20 in., with tolerances of ±0.010 in. High-volume production is possible, and the method is environmentally friendly.
Metal Cutting Corp., Cedar Grove, NJ
www.metalcutting.com

Copyright ©2008 Medical Product Manufacturing News

Regulatory Process Criticized in Journal

Transforming FDA LogoAn article published in today's New England Journal of Medicine finds fault in FDA's regulatory system for medical devices, using the recall of Medtronic's ICD lead in 2007 as part of the basis for the criticism. According to author William Maisel, MD, the combination of the number of patients affected, money at stake in the market, and dialogue between doctors and patients about the product's performance "highlight the shortcomings of the regulatory system...and underscore the urgent need for legislation that will ensure adequate protection for the patients receiving them." Part of the problem, he writes, is that the Sprint Fidelis lead was approved based on bench testing, not human clinical data. He also says Medtronic failed to notify the public about the potential product defects and continued to sell the ICDs. From Maisel's perspective, patients have a right to be told about the possible risks of a device that will be implanted to ensure that they can make an informed decision. FDA has the duty to protect the public's health and is "failing to fulfill that mission," he says.

Precision Motion Control

SPOTLIGHT

Precision Motion Control

Ultraminiature ball screw

A company has introduced what it claims is the world’s smallest commercially available stainless-steel ball screw. Featuring a diameter measuring only 3 mm, the product comes in a choice of 1- or 0.5-mm pitch. The supplier also offers a range of miniature stainless-steel screws with diameters ranging from that of the ultraminiature screw up to 16 mm. Offered either with or without preloading, the screws are outfitted with one of four types of ball nuts. Applications include surgical robots and fluid-dispensing pumps, among others.
Steinmeyer Inc., Burlington, MA
www.steinmeyer.com


Lubricant bearings

Employed in such medical applications as infusion pumps, a line of sealed lubricant bearings is available with inside diameters ranging from 1⁄8 to 1 in. Preinstalled oil-filled polymers lubricate the bearings with a film or oil. Because the oil-filled polymers contain approximately twice the amount of oil found in most greases, excess oil is available for lubrication, according to the company. As a result, the product is suited for harsh environments or equipment that requires frequent cleaning. Stainless- and chrome-steel construction is available for most sizes.
Sapporo Precision Bearings USA (SPB-USA), Sarasota, FL
www.spb-usa.com


Hysteresis brakes

Engineered with the manufacturer’s patented Cog-Buster to automatically smooth braking torque, hysteresis brakes can be used in the winding process employed in the manufacture of stents and wire-reinforced medical tubing. Precision wire tension can easily be maintained, even on open-loop systems, according to the company. Torque is smooth—even near zero rpm—owing to the production of frictionless torque via internal magnetic fields, rather than contact between parts. Units are available with torques from 0–11 to 250 oz-in. and heat dissipation to 110 W.
Placid Industries Inc., Lake Placid, NY
www.placidindustries.com


Self-aligning bearings

A coefficient of friction as low as 0.001 enables users of a line of bearings to employ smaller and more cost-effective motors, belts, gears, and ball screws than those used with high-friction bearings, according to the manufacturer. Offered in 16-, 20-, 25-, 30-, 40-, and 50-mm versions, the Super Ball Bushing bearings feature a self-aligning capability of up to 0.5° that automatically compensates for inaccuracies in base flatness or carriage machining. Acceleration rates up to 150 m/sec2 and steady-state travel speeds 3 m/sec can be achieved without the derating factors commonly required with linear guides. Adjustable open and closed configurations are offered. Lightweight wear-resistant polymer retainers and outer sleeves reduce inertia and noise. The company maintains that, when combined with its 60 Case shafting, the bearings can withstand three times the load of conventional bearings and can last 27 times longer.
Danaher Motion, Wood Dale, IL
www.danahermotion.com


Optical encoder

A company’s optical encoder features a 1.2-in. OD, an overall height just exceeding 1 in., and the stability of a bearing encoder design. Configured to potentially replace a modular encoder in an application, the QR12 offers increased versatility and an improved feedback solution, as well as performance upgrades, according to the supplier. It further claims that a flexible member enables greater tail-shaft run-out than can be tolerated by modular encoders; it also provides 30° of rotation for commutation timing. Outputs consist of a quadrature with index pulse and three-phase commutation.
Quantum Devices Inc., Barneveld, WI
www.quantumdev.com


Roller pinion system

Enabling engineers to incorporate accurate linear and rotary motion control functions with zero backlash and speeds up to 11 m/sec, a roller pinion system (RPS) can be used in such large medical equipment as MRI, PET, and tomography units. In applications requiring high speed, accuracy, and low noise, the RPS can be used in lieu of typical rack and pinions, linear motors, spur gears, chain and belt drives, and ball screws. The system consists of a drive pinion with bearing-supported rollers that move along the face of the rack or gear-tooth profile, producing low noise, vibration, and wear.
Nexen Group Inc., Vadnais Heights, MN
www.nexengroup.com


Piezoelectric actuators

Designed for applications requiring a small footprint, ultracompact piezoelectric actuators are suited for numerous motion control applications, including miniature valves, optical switching and scanning, and nanopositioning and nanoprobing. The flexure-guided components enable backlash- and friction-free motion. Measuring 8 × 10 × 17 mm, the FPA-80E model features a stainless-steel construction that mechanically amplifies the motion of the internal piezoelectric ceramic, yielding 80 µm of displacement range. Providing 180 µm of displacement range, the FPA-180E is offered in a titanium package measuring less than 8 × 9 × 26 mm.
Dynamic Structures and Materials LLC, Franklin, TN
www.dynamic-structures.com

Copyright ©2008 Medical Product Manufacturing News

Risk Avoidance Writing: A Necessary Tool for Device Personnel

And that can not only get a firm in trouble with FDA, but also expose it to product-liability lawsuits. With that in mind, Nancy Singer, president of Compliance-Alliance Inc. and a member of MD&DI's Editorial Advisory Board, has recently been offering a course on risk avoidance writing. The premise is that writing your documents properly -- and yes, that includes emails -- can help you avoid unnecessary consequences. A memo that seems insignificant can hold just as much weight in court or during an FDA inspection as a whole series of process validation documents. "Documents are like diamonds," Singer said. "They are very precious, and they last forever." Proper writing is one key to showing outsiders that you are doing the right thing. For example, certain "dangerous words" must be avoided. In memos, it is best to just state facts and not editorialize negatively; this can be seized upon by an FDA inspector, a plaintiff lawyer, or a jury. Words to be avoided include "illegal," "attack," "excuse," "shortcut," "wrongful," "catastrophic," and "misleading." There are ways to convey concern without using words that imply that someone at the firm has done something malicious or indicate that the firm has placed profits ahead of patients. Equally bad are words that obfuscate instead of clarify; those may make it seem like a firm has something to hide. Singer has given this presentation for several companies and at a few events, and will be giving it again in a preconference workshop at the Medical Device Regulatory, Reimbursement, and Compliance Congress at Harvard University on March 26.

Harvard Conference to Focus on Information Issues

A number of firms have gotten in trouble for getting this answer wrong. And yet, the landscape may be changing, as a new FDA draft guidance contains a provision that would allow, for the first time, device companies to disseminate peer-reviewed studies of off-label uses.   The agenda for the track covers everything from what physicians want to hear to what device companies want to say (especially concerning off-label claims) to what the role of FDA should be for dissemination issues. After all the issues are aired, three lawyers with life sciences-oriented practices will advise attendees on how to put in place processes and controls for dissemination of information. MD&DI is one of the publication sponsors of the event, which will be held March 26-28 on the Harvard campus in Cambridge, MA.

Cochlear Implant Firm Rebounds from Stock Hit

The firm is working with a Taipei-based charity to sell 15,000 of the devices to patients in China. But the effort has suffered from a lack of properly-trained healthcare workers, and less than 600 have been sold so far. Sales otherwise grew about 18% for the first half of the firm's fiscal year. So Alexander Smith, a healthcare analyst at JP Morgan Chase's Sydney office, deemed the stock undervalued and raised his rating on it.

Joining Technologies

SPOTLIGHT

Joining Technologies

Microwelding capabilities

Specializing in laser energy and automation, a service provider has advanced its laser welding operations to address miniaturization and precision. On disparate materials, the company’s microwelding process can achieve spot welds on disparate metals smaller than 0.004 in. It enables attachment of platinum coils and electrodes, and machine components to copper, nickel, and nitinol conductors and core wires with diameters as small as 0.003 in. In addition to laser welding, the company also can support OEM design with prototyping.
Avicenna Technology Inc., Montevideo, MN
www.avicennatech.com


Laser welding services

Laser welding services are available from a contract manufacturer serving medical device OEMs primarily in the surgical tool and implant markets. Specializing in joining both similar and dissimilar materials, the company welds platinum, tantalum, gold, and stainless steel in a variety of sizes for a range of medical applications. Microjoining capabilities are also offered. The company is ISO 9001:2000 certified.
Pulse Systems, Concord, CA
www.pulsesystems.com


Contract laser welding processes

A service provider maintains that laser welding offers significant advantages over conventional gas tungsten arc and electron-beam welding methods for a number of critical applications, including medical device manufacturing. The 6 kW of peak power and tightly focused laser beam can yield aesthetic weld beads with a smaller heat-affected zone and a higher depth-to-width ratio than other welding techniques, according to the company. Process automation for diverse geometries is enhanced through the computer control of four axes of motion and the flexibility of a fiber-optically coupled welding head. Welding operations can be performed at high speeds in order to reduce lead times.
Fluid Automation Inc., Nottingham, PA
www.laser-weld.fluid-automation.com


Conductive adhesives

A line of electrically conductive adhesives and potting compounds is designed to form paths where hot soldering operations would be ineffective or impractical. Suited for bonding or sealing electrical components or wires that require heat dissipation, Syon products also mix and pour easily, fill voids, and cure with minimal air entrapment. The Tru-Bond 206A conductive adhesive solder is a pourable silver-filled liquid epoxide; the Tru-Bond 214 silver-filled epoxy adhesive is a nonsagging paste that creates conductive paths on circuit boards and prepares electrodes for capacitance and loss measurements; the electrically and thermally conductive Tru-Bond 215 copper-filled epoxy adhesive is suited for preparing and repairing conductive paths on circuit boards and for RF-shielding and heat-sink applications; and the Tru-Cast 111 high-density potting and casting resin is an aluminum-filled epoxide resin featuring thermal conductivity and a low coefficient of thermal expansion.
Devcon, Danvers, MA
www.devcon.com


UV adhesive and potting compound

Suited for medical device assembly, a one-component UV-curable adhesive and electronic potting compound is clear in color and low in viscosity. Unlike most traditional UV systems, the UV Cure 60-7155 is unaffected by oxygen, dark cures after UV exposure, and is low in odor and toxicity. It also exhibits low shrinkage, which enables secure adhesion to metal, plastic, wood, paper, or ceramic, according to the company. Additional properties of the product include the ability to cure shadow areas and fast cure times. The adhesive is awaiting Class VI approval.
Epoxies Etc., Cranston, RI
www.epoxies.com

Copyright ©2008 Medical Product Manufacturing News

Cardinal Health to Buy Infection-Control Firm

Its products fit in with other Cardinal properties geared toward infection prevention, such as surgical apparel.

In Brief

NEED TO KNOW

In Brief

Connector systems provider ODU-USA (Camarillo, CA; www.odu-usa.com) has redesigned its Web site, streamlining its navigation tools to help users find connectors to suit their application needs. The site features detailed images of product lines and a technical library of product specifications. . . . The Polymer Technology Group Inc. (Berkeley, CA; www.polymertech.com), a biomaterials company, has earned ISO 13485:2003 certification from BSI Management Systems (Reston, VA; www.bsiamericas.com). The company has also received ISO 9001:2000 recertification from BSI. . . . Components provider Tyco Electronics (Harrisburg, PA; www.tycoelectronics.com) has added a 5640-sq ft Class 8 cleanroom to its facility in Greensboro, NC, for particulate-free molding of plastic parts. The company will use the cleanroom to manufacture medical-grade parts such as surgical disposables, invasive devices, and surgical filter housings. . . . Saint-Gobain Performance Plastics (Aurora, OH; www.saint-gobain.com) has acquired IFK Isofluor GmbH (Nuess, Germany; www.isofluor.de), a manufacturer of fluoropolymer tubing.

Copyright ©2008 Medical Product Manufacturing News

Vasogen Trial Stymied by FDA Reversal

The company says it will respond to the agency soon. Vasogen was named one of MD&DI's 50 Companies to Watch in 2006. What this means is that the watch will last longer than expected before it's known whether the firm will have success. UPDATE: On April 14, 2008, Vasogen said it would cease funding studies for Celacade and shift focus to a different field. It also said it would cut 85% of its work force.