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Articles from 2007 In March


FDA Unhappy with Abbott, Again

Oddly, the plant is one of several about to be transferred to GE, which has agreed to buy Abbott's diagnostics business, and GE recently had two plants shut down by FDA because of quality issues. The letter states that Abbott violated Good Manufacturing Practices, was slow in its Medical Device Reporting process, and failed to follow adequate purchasing procedures. Some of the problems identified on the latest inspection four months ago were the same ones identified in 2003 and 2004. This is the kind of thing that tries FDA's patience. Given Abbott's history with FDA -- it signed a consent decree, paid a $100 million fine, and pulled numerous products off the market in 1999 because of quality problems -- don't be surprised if the agency's patience runs out.

Message to Device Industry: You're Next

It's anticipated that increased enforcement will be seen in areas from off-label promotion of devices to improper payments given to doctors. Companies also need to be aware of the new tactics that the government is using to find evidence. "The government has stepped it up a notch in terms of investigative techniques," said John Bentivoglio, partner at King & Spaulding (Washington, DC). If your company is looking at past settlements --which generally involve conduct that happened a long time ago -- as a model for assessing risk areas, then you're essentially looking in the rearview mirror, said Bentivoglio. As more government offices and prosecutors become involved in investigations, more tactics are being used than in the past. Some examples include taping promotional events, creating a paper trail within a company when dealing with human resource issues, and doctors serving as cooperating witnesses. The government has also been focusing on internal financial documents of a company of interest, because these records (which also detail audits, incentives, etc) can serve as powerful evidence of a company's intent.

Japan Takes Longest to Approve New Devices, Report Finds

It found that approval times in Japan were longer than those in other principal global markets. As the leader in developing and exporting innovative medical technologies, the United States may be disproportionately affected by this. Even though reform was enacted in 2005, significant challenges remain, especially for small and mid-sized businesses, the report states. And if the GHTF chair can't succinctly explain how Japan's approval system works, don't expect them to be overcome any time soon.

MRI Use Could Get Boost from Breast Cancer Reports

Bombshell: Many Angioplasties and Coronary Stents Unnecessary

More stunning is that angioplasty gave only slight and temporary relief from chest pain, which is the main reason the procedure is performed. Drugs are just as effective, and 2/3 of the patients who tried drug therapy first did not need angioplasty or bypass surgery later, the study found. The findings could drastically reduce the number of angioplasties performed -- many of which also result in stents being implanted. The debate may shift from what kind of stent to use to whether stents should be used at all. As expected, many interventional cardiologists and the device companies who supply them with stents, balloons, and catheters are not happy with the study. A Boston Scientific adviser decried it as "rigged to fail." This could be a huge blow for the cardiovascular device industry. In recent years, researchers have found that arterial plaque works differently than assumed. Blockages that are complete or nearly complete are not the ones most likely to cause a heart attack. Instead, it is blockages that contain "vulnerable plaque" that can move unexpectedly. Angioplasty and stenting solve the problem of blockages, but not of vulnerable plaque. Thus, the finding that they did not prevent heart attacks and death was not surprising. The finding that they did not do much to alleviate chest pain was more of a shocker. Michael Drues, PhD, president of Vascular Sciences (Grafton, MA), says that "unfortunately, this is not new. I (and a very small number of others) have been talking about these issues for years. We are using lots of devices today, but we are using them very unintelligently. In the future, we will be using more devices, not fewer, than we use today. The question is, will we be using them more intelligently?"

Abbott DES Performs Strongly in Clinicals

For Boston Scientific's part, it reported that Taxus outperformed brachytherapy in treatment of in-stent restenosis. Xience is likely to get FDA approval in early 2008 and is expected to garner 30% of the market or more. The only reason Abbott has the technology, originally developed by Guidant, is that Boston Scientific had to sell off Guidant's stent business to satisfy antitrust concerns when buying Guidant. Wouldn't it be ironic if the stent technology it sold overtakes the stent technology it kept?

Flexibility, Specs Facilitate Successful Assembly Outsourcing

OUTSOURCING OUTLOOK: ASSEMBLY

Flexibility, Specs Facilitate Successful Assembly Outsourcing
Robert F. Houghland, president, HPC Medx, Hanover, PA


There are many good reasons to outsource the assembly of medical devices. When you decide to do so watch out for these pitfalls:

  1. Know that FDA requires a contract between the two companies that outlines their respective responsibilities, not just a purchase order.
  2. Be sure to specify the format for lot numbering and how you account for lot numbers on the individual components incorporated into the final assembly in order to maintain traceability.
  3. Be sure to specify tolerances for the final assembly. However, do not specify more precise tolerances for the assembly than are specified for each of the component parts.
  4. Do not specify tight tolerances when less precision will suffice, e.g., imprint size and location versus machined metal components.
  5. Avoid sole-source components whenever possible. Sole sources can dictate production scheduling.
  6. Be open to suggestions for ease of assembly, such as the design for the assembly. Small changes can often reduce cost and expedite production.
  7. Allow enough time, especially for new products. Premature marketing of a product is the leading cause of failure.
  8. Be comfortable with the company you are dealing with. Open, honest dialogue between the two parties is the best assurance for success.


Flexible Assembly Capabilities Offered by Contractor

A contract manufacturer of medical devices offers a full range of services, including manual, semiautomated, and fully automatic assembly, as well as subassembly. Stamped, cast, machined, and fabricated sheet-metal parts and injection-molded, extruded, cast, and fabricated sheet-plastic parts are assembled into prototypes, sample devices for clinical testing, or final devices by a variety of techniques. Hot-melt and cyanoacrylate adhesives, ultrasonic welding, microspot welding, temperature and UV curing techniques, press fitting, snap fitting, and mechanical fastening are among the methods employed. Wire harnessing and automatic wire cutting and stripping also are capabilities. The flexible service provider has an in-house machine shop capable of building everything from simple fixtures to high-speed automatic assembly machines.
HPC MEDX, Hanover, PA
www.hpcmedx.com


IVD Die-Cutter Offers Automated and Manual Subassembly

Automated and manual subassembly services offered to manufacturers of in vitro diagnostic devices include the laminating and narrow slitting of microcellulose, absorbents, conjugates, and other sensitive IVD materials. End products are semifinished or finished cards and finished test strips. The company maintains a dry-room manufacturing environment that supports lamination of active membranes and papers at a controlled temperature and at humidity levels as low as 14% RH. In addition to assembly, the service provider performs tight-tolerance and high-speed rotary die-cutting, multilayer lamination, flatbed die-cutting, laser cutting, punch pressing, narrow-web slitting and converting, and flexographic printing for a variety of medical device as well as IVD applications. Design and materials assistance is available.
G&L Precision Die Cutting Inc., San Jose, CA
www.glprecision.com


Line Includes Surface-Mount Equipment

A contract medical device manufacturer has added surface-mount equipment to its expanding assembly line, enhancing its ability to produce circuit-board assemblies for both in-house finished-goods assembly and subassembly box builds. Company capabilities now include a full range of printed board assemblies that are manufactured with the assistance of software design teams consisting of staff employed by the customer and the contractor. Aiming to provide a comprehensive outsourcing service characterized by added value and minimal risk for the client, the manufacturer offers assembly competence in flexible and rigid PCBs; automated and manual through-hole technology; full-system integration; programmable and manual conformal coating; in-circuit, flying-probe, functional, and environmental testing; and cable and harness assembly. Its assemblies are WEEE and RoHS compliant.
Providence Enterprise Ltd., Shenzhen, China
www.providence.com.hk


Electrical and Mechanical Assembly Available from One Company

An FDA-registered and ISO 9001:2000–certified contract medical device manufacturer produces Class I, II, and III devices ranging from simple cables through printed-circuit-card assemblies to large-scale systems that incorporate many complex units. Its capabilities include electrical and mechanical assembly. Both manual through-hole and automated surface-mount techniques are applied with high precision in soldering components to printed wiring boards. The company can perform complete panel and chassis wiring and cable harness fabrication. Its assemblers are appropriately trained and certified for the type of projects they undertake, and fully equipped individual workstations help ensure optimum productivity. Finished products are reliability tested via MIL-STD burn-in methods.
Tricor Systems Inc., Elgin, IL
www.tricor-systems.com


Facility Equipped for Turnkey and Consignment PCB Assembly

A contract provider of electronic manufacturing services offers capabilities in PCB design and layout, fabrication, and assembly, as well as box build, repair, and testing, all in one facility. Boards can be processed in prototype or production quantities. Operating as a member of the client’s project team, the company can take on PCB assembly tasks on a consignment basis or provide turnkey assembly. Assembly and related services include materials procurement, surface-mount or through-hole technology, mixed technologies, box-build assembly, and rework. The fully equipped assembly department includes installations for solder-paste inspection, microscopic inspection, reflow profiling, and electrostatic-discharge monitoring. PCBs and PCB assemblies are RoHS compliant.
Printed Circuits Corp., Norcross, GA
www.pcc-i.com


Expanded Operations Include Disposables Assembly

Twelve years ago, a company that had specialized in the manual assembly of cables and sensors expanded its operation by beginning to assemble medical disposable devices in a Class 10,000 clean area. This controlled environment has subsequently been enlarged to two rooms occupying a total of 300 m2 of floorspace. Most of the products manually assembled in the cleanroom are customer-specific. These include sampling lines for anesthesia-gas and CO2 measurement, spirometry tubes and kits, nasal sampling lines, exhaust lines, and suction tubes, among others. In addition to assemblies, the ISO 9001– and ISO 14001–certified company produces medical profile extrusions in a dedicated cleanroom facility.
A&G Ltd., Tallinn, Estonia
www.ag.ee

Copyright ©2007 Medical Product Manufacturing News

Motors and Motion Control Products

SPOTLIGHT

Motors and Motion Control Products

Actuators with built-in controllers

A line of computer-controlled linear actuators, linear slides, rotary stages, mirror mounts, and other motion control devices offer flexibility in automating submicron positioning applications. Because the devices have built-in controllers, they need only be connected to a computer’s serial or USB port to be ready for use. Additional devices can be daisy-chained to the first and controlled via the same port. Linear actuators to suit a wide range of application requirements are available, offering capabilities that can be matched with needs for thrust, resolution, range, or vacuum compatibility.
Zaber Technologies Inc., Richmond, BC, Canada
www.zaber.com


Electromagnetic brakes

Easy-to-install spring-set electromagnetic power-off brakes with a built-in quiet feature are designed to provide safe and energy-efficient braking in such applications as medical equipment, robotics, actuators, motor systems, and packaging equipment. The Thomson-Deltran AKB–series brakes come in diameters of 1.83–5.00 in. and provide static engagement with torque of 12.5–470 lb-in. The brakes’ field assembly is fixed and unable to rotate, while the rotor assembly is secured to the shaft; the shaft rotates freely when the coil is energized. But when power is off, the fixed and rotating components engage, stopping or holding the load.
Danaher Motion, Wood Dale, IL
www.danahermotion.com


Air cylinders

Air cylinders with a twin-rod design are offered as a means of achieving precise, nonrotating linear motion while producing twice the force of conventional cylinders of their size. Exhibiting less than 1/3° of rotation, the design ensures precise rod alignment and essentially eliminates end play. The rectangular cylinder body simplifies mounting, saves space, and facilitates the achievement of precise angles. The rod end plate accepts other pneumatic devices. Available in single- and double-acting models, the cylinders come with finely adjustable 1/2- to 4-in. strokes and in six bore sizes ranging from 1/4 to 1 1/4 in.
Humphrey Products Co., Kalamazoo, MI
www.humphrey-products.com


Brushless dc motors

A family of brushless dc motors is offered for space- and cost-restricted applications such as pumps, fans, and medical devices, and especially for uses where long life, high power density, high starting torque, and controllability are required. With a 1-in. outside diameter and lengths ranging from 0.5 to 1 in., the BLDC25-OR-series three-phase motors include three Hall-effect sensors for exact positioning and smooth running. Their 12-pole design makes positioning feedback of 36 pulses per revolution available without an additional encoder. The motors can produce continuous maximum power of 3 W and efficiency values above 70%.
Hansen Corp., Princeton, IN
www.hansen-motor.com


Linear actuator

Incorporating an optical linear encoder and linear motor, a rigid, compact positioning actuator that features patented curved-cage technology is designed for high speed, high accuracy, and long-term maintenance-free operation. Its direct-drive design and fully closed control give the Type KLM actuator a positioning accuracy of 10 µm/500 mm and positioning repeatability of ±0.3 µm. The actuator operates at speeds to 2.0 m/sec and with accelerations reaching 4.7 g. The Caged Ball linear motion guide that gives the device its speed and accuracy capabilities provides lubrication, smooth movement, low noise, and low dust generation.
THK America Inc., Schaumburg, IL
www.thk.com


Digital servo amplifier

A high-voltage, all-digital brushless servo amplifier uses a digital-signal-processor-based architecture and provides software-selectable torque-, velocity-, or position-mode operation. Sine-wave commutation enables the compact ACE500 motor controller to deliver smooth torque at low speeds for demanding motion control requirements in robotic, direct-drive, and linear-motor applications. The amplifier uses an ac flux vector control algorithm to provide high dynamic response and very good noise immunity; its low current harmonics ensure smooth, efficient motor control. The 6.9 × 5.2 × 1.95-in. device handles power inputs of 90–254 V ac, single-phase, and 120–360 V dc.
Automotion Inc., Ann Arbor, MI
www.automotioninc.com

Copyright ©2007 Medical Product Manufacturing News

Tubing

SPOTLIGHT

Tubing

Stainless-steel IV tubes

Citric acid passivation using multistage ultrasonic technology is applied to the stainless-steel tubes that a specialty company cuts precisely and without burrs. Suited for IV applications, the cut tubes display the same clean result whether they are coated or uncoated; processing does not damage the outside coating, and the inner diameter remains completely clean. The tubing processed can have thin walls, a small inner diameter, or both, and can be cut at specified angels and in short to long lengths. In addition to stainless steel, all types of metal tubing can be cut and passivated without heat-affected zones and without concentricity being compromised.
Metal Cutting Corp., Cedar Grove, NJ
www.metalcutting.com


Custom plastic tubes

An ISO 90001–certified, GMP-compliant extruder of custom plastic tubing for critical applications offers medical device manufacturers complete two-way traceability and can supply product certification with shipments. It manufactures tubing in diameters of 0.058 to 1 in. from a variety of rigid and semirigid materials and custom compounds, including polypropylene, LDPE, HDPE, Pebax, and other plastics. A company specialty is single-lumen tubes with walls as thin as 0.004 in. As a single-source provider of custom extrusion services, the firm can supply coiled and cut-to-length tubing that is extruded and packaged to specification. Coextrusion and various value-added services are available.
Medical Precision Plastics Inc., Warminster, PA
www.dropstirs.com


Paratubing

Thermally bonded extruded paratubing whose manufacture involves no solvents is designed to eliminate the possibility of tangling in operating-room (OR) applications and the need for removing chemical solvent residue from the tubes. PEXbond paratubing additionally makes expenditures on solvent or UV bonding assembly operations unnecessary. The various lines in a thermobonded paratube can be distinguished by diameter, color, or striping. While the bonded design enables the physician to hold multiple OR tubing lines in one hand, the tubes can be split apart easily, if required, without leaving residue or ridges.
Filtrona Extrusion Inc./PEXCO Medical Products, Athol, MA
www.filtronaextrusion.com


Fluoropolymer tubing

Straight, thin-wall, coiled, corrugated, convoluted, and stainless-steel-overbraided fluoropolymer tubing is stocked to satisfy a variety of fluid-transfer application challenges. The PTFE, FEP, and PFA tubing offers heat and chemical resistance, nonstick properties, and tolerance of extremely cold temperatures. The fairly rigid straight tubing is suitable for transfer and sampling applications. Coiled FEP tubing can be expanded and retracted repeatedly, while corrugated FEP allows a near-zero bend radius. Thin-wall PTFE tubing serves for wire insulation and protective covering. Convoluted PTFE handles higher pressures, especially when overbraided with stainless-steel wire that enables it to accommodate working pressures to 3000 psi.
NewAge Industries Inc., Southampton, PA
www.newageindustries.com


Polyethylene tubing

Soft polyethylene tubing for medical device applications features ultralow extractables and meets USP Class VI requirements. The very high clarity of the SFX tubing provides good flow visibility, allowing even clear liquids to be inspected. The tubing is manufactured without the use of plasticizers. It is resistant to a wide range of chemicals. Available in standard sizes up to 3¼8 in. OD, the tubing can be supplied with an inner diameter as large as 1 in.
if requested.
Eldon James Corp., Loveland, CO
www.eldonjames.com


Metal tubes

A line of high-grade semifinished products, components, and actuators for medical and industrial applications is offered by an ISO 9001– and ISO 13485:2003–certified specialty custom manufacturer. Besides round wire, flat and profiled wire, sheet materials, and special components, the supplier also provides tubes of nitinol, titanium alloy, cobalt alloy, stainless steel, or specialty alloys that have an oxidized or ground surface. Manufactured according to customer specifications and available with a diverse range of special properties, the tubes can have diameters of 0.13–15.00 mm and a wall thickness of 0.03–1.20 mm. Fabrication lengths to 3000 mm are offered.
Euroflex GmbH, Pforzheim, Germany
www.euroflex-gmbh.de


Custom silicone tubing

A cleanroom manufacturer of specialty medical devices designs and produces custom medical-grade silicone tubing and profiles, including microtubing. Single- and multilumen tubes can be extruded to tolerances as close as ±0.005 in.; these and coextrusions can be supplied with a variety of properties and diameters. The company uses specially formulated materials that provide an ultrasmooth tube surface that minimizes surface tension and thus maximizes flow. The FDA-registered and ISO-certified extrusion company can provide a turnkey design and manufacturing service that includes rapid prototyping and low- or high-volume production. It will manufacture products from customer designs.
Axiom Medical, Torrance, CA
www.axiommedical.com


Copyright ©2007 Medical Product Manufacturing News

U.S. Firms Not Interested in Joint Inspections with Canada

Transforming FDA LogoIn the fall, FDA and Health Canada launched a pilot program allowing authorized third-party inspectors to cover US and Canadian requirements in a single inspection. It was viewed as a step toward eventually having a single authority inspect for worldwide requirements, which industry has said it wants. So how many U.S. firms have expressed interest in taking advantage of the program so far? One. This was reported by Larry Kessler, director of CDRH's Office of Science and Engineering Laboratories and chair of the Global Harmonization Task Force, at this week's AAMI/FDA International Conference on Medical Device Standards and Regulation. Kessler said that CRDH obtained a list from Health Canada of all U.S. plants it plans to inspect in 2007, and sent a note offering the joint inspection to all firms whose plants are also on the list for an FDA inspection this year, a total of about 150. Almost all Canadian inspections are done by third parties, so these firms would have to hire an outside inspector anyway. He offered two possible explanations for the lack of interest. One, firms may already be under contract for 2007 with a Canadian third-party inspector who is not authorized to do simultaneous U.S. inspections, and don't want to break their contracts and go through the process of finding someone else. Two, and more foreboding, there may be a perception that "if you do badly [on a multi-nation inspection], you won't be able to market your product anywhere in the world. That's not the way it should work. Yet, it's a legitimate fear." There is a disconnect between what industry says it wants and what it seems willing to do. Industry needs to drop the pretense of wanting a single inspection covering multiple authorities if firms aren't willing to participate in pilot programs.