More Criticism of How Guidant Handled Flawed Products

The full report has been posted on Guidant's Web site. The crucial issue for the future is how to make such disclosures without causing unnecessary panic. Is the mainstream media capable of reporting the facts but showing restraint?




Brushless dc motor

A brushless dc motor series has a newly designed motor, gearhead, and driver. High-performance speed control for the BLF series is achieved with an increased speed range of 80 to 4000 rpm. The motor driver includes a detachable digital operator unit that serves both as a data input unit and a digital display that can be used up to 16.4 ft away from the installed driver. The user can program eight separate speed levels. Each speed can be set in steps of one revolution per minute with separate acceleration and deceleration values.
Oriental Motor, Torrance, CA

Position transducer

A general-capability position transducer offers a long displacement range, multiple mounting options, and size efficiency for OEM and high-volume applications. The Series M line has a maximum range of 85 in. A reduced displacement cable fleet angle increases repeatability and reduces cable overlap compared with a pervious design. Three options give users flexibility in mounting the units. Choices are available for electrical connectors and signal conditioning.
SpaceAge Control Inc., Palmdale, CA

Rodless actuator

An electric belt-drive actuator features a wide belt for longer strokes at higher speeds than previous models. The B3W offers a patented heavy-duty sealed bearing system at both drive and idle pulleys, a stainless-steel dust band for internal parts protection, and a urethane steel belt. Consistent tracking is maintained for the full life of the actuator, owing to its sturdy construction.
Tol-o-matic, Hamel, MN

Lightweight brake

A spring-applied, electronically released brake fits into small places, making it suitable for a variety of electromechanical applications. The brake works in a defined arc, ±15° from the null position. The unit is 5 in. long, weighs 1.1 lb, and supplies 90 lb-ft of torque. Four inner aluminum clear-anodized disks with friction pucks and five outer aluminum hard-anodized disks are some of the brake’s other features. The steel magnet body and spring-loaded armature plate are fixed to a stationary surface. When the coil is energized, it compresses the spring and attracts the armature plate, allowing the disks to rotate.
Sepac, Elmira, NY

Linear actuators

Linear actuators come enclosed in an aluminum box structure that provides a compact envelope incorporating the linear bearing and drive mechanism. Integrating all components into a single unit that includes the motor mount saves assembly time and eliminates the need to source additional parts, according to the company. The actuators offer straight-line accuracy of less than 2 µm and repeatability of less than 1 µm. They deliver 10 million in. of travel at their full load rating.
Del-Tron Precision, Bethel, CT

Piezo motors

Motors offer linear motion at low power for small portable electronic
products. The SQL-series motors feature a metal and ceramic
construction. The patented ultrasonic motor design has lower power consumption than miniature electromagnetic motors, according to the company, and can hold its position when the power is turned off, further conserving battery life. Standard models are available in 2.4- and 3.4-mm sizes, with customizable shaft lengths and travel ranges.
New Scale Technologies Inc., Victor, NY

Timing belts

Polyurethane timing belts are reinforced with steel, stainless steel, or Kevlar and come in imperial and metric pitches. The timing belts are open-ended, welded, or truly endless, and are used in conveying, driving, indexing, linear drive, and power transmission applications.
Brecoflex, Eatontown, NJ

Dc micromotor

A micromotor has an external motor diameter of 10 mm and a length of 24 mm. The Series 1024…S motor features an ironless rotor and neodymium rare earth magnets to achieve a stall torque of 2.89 mN•M and speeds of up to 14,700 rpm. The precious-metal commutation allows operation at low starting voltages due to inherent low contact resistance. The housing of the motor is black to facilitate optimum heat dissipation.
MicroMo Electronics Inc., Clearwater, FL

Copyright ©2006 Medical Product Manufacturing News

Emergency Monitoring Device in Trial

Patients receive a waist pack with sensors, transmitters, and tracking gear that allow their heart rates, blood oxygen levels, and movements while they wait for treatment. It was developed by the hospital, Harvard Medical School, and the Massachusetts Institute of Technology, and the trial is being funded by the National Institutes of Health. It's also envisioned for use at disaster sites. If the trial is successful, this is something someone in the device industry might want to commercialize.

The Next Big Thing


The Next Big Thing

The revolutionary potential of nanotechnology drives development

"It is true that the lab, at some point, will be the new manufacturing floor."
–Christine Peterson, founder and vice president,
public policy for the Foresight Nanotech Institute
Although there is a lot of buzz around nanotechnology, there are currently few concrete examples, and theories as to its potential effects abound. In this roundtable discussion, MPMN editors spoke with experts about this cutting-edge technology. This session’s participants included Mansoor Amiji, PhD, associate professor and codirector of the Nanomedicine Education and Research Consortium at Northeastern University; Christine Peterson, founder and vice president, public policy for the Foresight Nanotech Institute; and Chris Phoenix, director of research for the Center for Responsible Nanotechnology.

How will nanotechnology and molecular manufacturing alter the way in which we currently develop products? Will the lab be the new manufacturing floor?

Phoenix: Molecular manufacturing is expected to use fully automated encapsulated manufacturing tools. They would have to be automated, because to achieve the productivity of nanosystems, they cannot be controlled individually by direct human intervention. Once you automate a device, then you won’t have professionals controlling it, but users. You do not have to be a professional to operate an ink-jet printer or even a printing press nowadays. I would say that not the lab, but the tabletop will be the manufacturing floor.

Peterson: It is true that the lab, at some point, will be the new manufacturing floor. But the goal, as Chris points out, is in the longer term: to bring these things out to the consumer in order to actually manufacture items on-site where they are going to be used. This will eliminate huge transportation costs and the accompanying environmental damage. It will still be engineers developing products, but the people building them, once manufacturing is fully automated, will presumably be the consumers.

Phoenix: There are different kinds of product development. For example, a lot of software is developed under practices that simply would not fly in most other kinds of engineering. You do not ship an alpha version of a highway overpass and if it collapses, rebuild it. For products that are easy to rebuild if the current one is not satisfactory, their design could be more like software engineering than like any kind of mechanical or hardware engineering that we are familiar with today. We could see a much more rapid development of such products similar to the way that Web applications flowered as soon as the World Wide Web came along. Again, that does not apply to all products. It does not apply to safety-critical products, such as cars and medical devices. Those would require more traditional engineering. But I would think that lightweight consumer products could be developed very fast and very experimentally once we get programmable general-purpose nano-based rapid prototyping.

"When you have programmable molecular shapes, you can use one material–probably carbon lattice–to build sensors, motors, and computational systems."
Chris Phoenix, director of research for the Center for Responsible Nanotechnology.

Will nanotechnology require different materials than traditional manufacturing? If so, what materials will be in demand?

Amiji: I will begin with the health perspective, specifically focusing on biomedical nanotechnology. We clearly will have to have different materials. There will be some issues specifically about materials– biological interfaces–and what kind of interactions such materials will induce or not induce. There are some efforts already on the way to design materials specifically for biomedical applications based on combinatorial synthesis approach and high throughput testing.

Peterson: Nanotechnology will require new and different materials. In some cases, over the longer term, we will see a continuation of the transition that we have already begun, moving away from using so much metal. We can expect that change to continue because we are finding that carbon-based materials in nanotechnology are very strong and very lightweight. This hopefully will mean that we will have to mine less metal, which should, in theory, help the environment. In the very long term, we would hope to get the carbon that we need from the excess carbon dioxide in the atmosphere, so we could combine taking carbon from the atmosphere with cleaning up the CO2. So it is a win-win there; it could be a very different world.

Phoenix: Looking in the post-productive-nanosystems time frame, it will be possible to build nanostructures that are engineered to perform all kinds of functions. When you have programmable molecular shapes, you can use one material–probably carbon lattice–to build sensors, motors, and computational systems. There will be less need for exotic materials when you can design functionality rather than having to use material properties. But when we can build engineered structures that perform engineering functions, programmable function coming from programmable structure coming from flexible manufacturing of carbon lattice, then we will be able to do a whole bunch of things with just one material in many shapes.

There is a lot of talk about various nanodevices that will perform tasks inside the body to improve health. How do we know that they are biocompatible, safe, and nontoxic?

Amiji: The issue of biocompatibility or safety of a product is really one of the most important challenges that we will have to address in developing nanotechnology for health applications and other areas where not only the consumers, but also the workers in this area, will be exposed. You will start to see a lot of effort in this area from various toxicologists who are looking at the safety issues of nanoparticles, whether it is with carbon nanoparticles or some other type of nanoparticle. The scientific data are really what will determine how these materials are performing. One of the ways to at least partially address some concern is something that we are doing in my lab, which is to focus on some of the biocompatible materials as starting points and look at what is already known about the safety issues of these materials. Then, we will investigate how we can develop and exploit the nanostructures made out of these materials for biomedical applications.

“The issue of biocompatibilty or safety of a product is really one of the most important challenges we will have to address”
Mansoor Amiji, PhD, associate professor and codirector
of the Nanomedicine Education and Research Consortium at Northeastern University

Peterson: In terms of how we will know that various medical nanodevices will be safe for the patient, all of these things are going to obviously have to go through the same old standard procedures that we have been using for medical devices and pharmaceuticals now for quite a while. The procedures that we have in place, although not perfect, work pretty well for the patients over time. As Mansoor mentioned, in this case we also have to look at the workers who are producing these products and make sure that they also are safe. The whole regulatory community that deals with worker safety is starting to have to grapple with this question of how you regulate nanoparticles that may have potential issues. That is an area of active debate and is gaining a lot of attention right now. On the upside, at least it is getting that attention. The consumer can feel relatively happy that, compared to previous innovations, we are getting an earlier start on this issue.

Besides dealing with materials invisible to the naked eye, what are the biggest obstacles when working with nanotechnology?

Amiji: Our obstacles mainly come from not knowing what the interactions will be between the biological environment and these nanostructures. Sometimes it is the fear of the unknown that drives decisions, or just the lack of measurements of these interactions because we are dealing with a scale for which we do not yet have the tools to address some of the fundamental questions. Safety is going to be one particular challenge that we will have to address early on and also as we move towards developing more sophisticated nanostructures. We will have to continuously ask the proper questions to make sure that what we are doing and what we are working with is safe.

Peterson: I will address this issue on a different level, perhaps a more societal level, and identify at least two challenges. One is that nanotechnology is a multidisciplinary area. What that means is you need to get people from different academic departments, perhaps even different schools, to work together, and they are not used to doing that. This is a challenge and it is making people who are trying to do nanotechnology have to come up with new forms of organization, new centers where we can try to bring these folks together. The second big challenge is funding. This is not two guys and a PC in a garage, the way the software industry got started. The equipment is expensive, and projects take a larger team than many software projects do. It is good that we have the level of funding that we see now, but we could use even greater funding. Certainly in the medical area, it would be very easy to justify increased spending.

Phoenix: From my point of view, the biggest problem is that nanotechnology is not one field; it is not even a bunch of fields that have to work together. It is so broad that it is a bunch of fields that really have very little contact with each other. The problem is that there is only one word that covers all of this. One of the big problems is that when you say nanotechnology, are you talking about nanoparticles or nanobots or nanofactories?

View the full text of the nanotechnology roundtable.

Copyright ©2006 Medical Product Manufacturing News

Laser Sintering Benefits Design and Manufacture of Blood-Separation Device


Laser Sintering Benefits Design and Manufacture of Blood-Separation Device

By replacing injection molding with laser sintering technology, a maker of centrifuges was able to streamline product design while reducing tooling and assembly costs

Corinne Litchfield

Laser sintering enabled the integration of fixtures into boxes that are part of the Rotomat device, thus avoiding additional tooling and assembly costs.
A manufacturer of laboratory centrifuges has developed a device that sediments and separates blood. The Rotomat incorporates a drum motor and six boxes and drip trays. The boxes have a complicated geometry and must withstand rotational speeds of 2000 rpm and acceleration forces of 1200 g. Andreas Hettich GmbH (Tuttlingen, Germany) determined that the use of conventional manufacturing technologies to make the device would require complex tooling and time-consuming assembly work. The firm decided to investigate other options. One that showed promise was laser sintering, offered as part of its e-Manufacturing technology by EOS GmbH (Krailling, Germany).

Laser sintering systems melt and solidify powders, which are deposited in successive layers to build a product. Plastic, metal, or sand powders can be used. The process has evolved over the years from a rapid prototyping and rapid tooling technology to a flexible batch-quantity manufacturing technique. Laser sintering is the core technology behind EOS GmbH’s e-Manufacturing platform, which allows companies to go directly from electronic data to fast, flexible, and cost-effective production.

Laser Sintering Versus Injection Molding

When it first evaluated laser sintering as an alternative production method, Hettich set as a baseline that it be at least as economical as injection molding. The evaluation included intensive testing of the laser-sintered boxes under production conditions. The results showed that the boxes, made of a polyamide 12 material, behaved similarly to those that were injection molded.

The boxes and trays inside the centrifuge must withstand rotational speeds of 2000 rpm and acceleration forces of 1200 g.

In other aspects, laser-sintered parts did more than simply match the performance of their injection-molded counterparts. In particular, the technology affords considerable design freedom. For example, internal structures can be easily realized, a capability that was used to its full advantage by design engineers at Hettich.

Conventional production methods require that box fixtures be molded separately. Consequently, additional tooling would have to designed and built, and the systems would need to be assembled. Laser sintering allowed the company to integrate fixtures into the box design. While the modified part was minimally more expensive to produce, the elimination of a new set of tooling and a reduction in assembly work more than made up for it. In addition, the new design improved functionality and added value to the product.

Laser sintering also enables parts production to be performed on demand. Design changes and product variations can be implemented quickly and at minimal cost. For example, the technology allows Hettich to offer different versions of the Rotomat to accommodate various blood bags.

By adapting its production methods to laser sintering technology, Hettich was able to design and manufacture a product with increased functionality without increasing costs, notes EOS GmbH.

Copyright ©2006 Medical Product Manufacturing News

Thinking Outside of the Box


Thinking Outside of the Box

Corinne Litchfield

Medical OEMs can reduce waste and eliminate the converting process by bringing packaging in-house. One of the easiest ways to add packaging capabilities is by using automated equipment. This article highlights several machines for use in packaging finished products. Also featured are new packaging materials that offer reduced moisture and increased peel performance.

Automated Systems Offer a Variety of Packaging Solutions


The PalletWorld palletizing system from Motoman can be customized through the use of add-on modules.

A fully integrated, modular system is designed for high-throughput palletizing. The PalletWorld from Motoman Inc. (West Carrollton, OH) features an EPL-series robot and an NX100 controller with menu-driven application software. Preengineered modules are integrated with the robot to achieve desired performance. Modules include package grippers, valve packs, and in-feed conveyors. Pallet locators, racks, and out-feed conveyors are also offered. The system can be customized using the flexible add-on modules. The system has an average mean time between failure of more than 62,000 hours for both the robot and controller. Standard palletizing grippers can handle a range of bags or cases. The unit is protected from power loss with special power-failure-recovery processing. Its absolute encoders require no homing operation after a loss of power.

The company also offers PC-based tools for its line of robots. Its MotoPallet PC-based simulation software works with its MotoSim EG off-line programming and simulation software. MotoPallet software uses a process programming approach. It allows the user to think in terms of boxes, pallets, and pallet patterns, rather than robot, cycle times, and payloads. Both software programs can optimize operations based on box size, shape, and orientation requirements.

Sealed Packaging

Circle Packaging’s Integri-Seal form-fill-seal machine comes in single- and dual-lane configurations.

Four-side-seal packages can be made using a horizontal form-fill-seal machine. The Integri-Seal from Circle Packaging Machinery Inc. (De Pere, WI) can make packages with secure, sterile seals. Applications include wound dressings, sterile field swab sticks, catheters, syringes, and sutures. Each unit features a seal-validation system and a color touch screen display. During normal operation and at process setup, the display monitors speed, single-point temperature, and single-point pressure. All electronics are made by Allen-Bradley. The Integri-Seal is offered in single- and dual-lane configurations. Each type features quick hot changeover, single-point temperature, and pressure control. A long-dwell traveling cross-seal with touch screen temperature controls is also included. The unit can also print out operation parameters that include date and time stamps.

Kit Packaging

A line of thermoform-fill-seal (TFFS) systems helps medical kit packagers simplify production and sterilization processes. The TFFS systems from Multivac Inc. (Kansas City, MO) enable companies to decrease material costs, as well as create compact, user-friendly packaging.

The machines create kits by custom forming the bottom web of material into sections. This allows the package to hold several medical devices at once. The items are then top-loaded into the sections. Finally, the top web of material securely seals the package. Printing capabilities can also be added to the process.

Since several medical products are housed in one kit, the sterilization process is streamlined. In addition, the machines can group related items. As a result, less material is used and production is more efficient.

“Kit packaging is gaining popularity among medical companies,” says Michel Defenbau, Multivac’s president. “It aids the entire supply chain, from production and sterilization through warehousing and distribution.”


Technik Packaging Machinery offers a cartoning system that packages products at rates up to 60 pieces per minute.

A cartoning machine processes smaller products at rates up to 60 pieces per minute in a footprint as small as 40 ¥ 38 in. The Carton King from Technik Packaging Machinery (Covington, GA) was created for the company by a German manufacturer.

Using a rotating turret and a modular design, the machine has room for a range of carton blank sizes. The unit offers several options for printing, embossing, and labeling. It can also provide hot-melt or tuck-in closures. Bar code verification and other quality control capabilities can be easily added. Automation options range from semiautomatic hand feeding to fully automatic product feeding. Leaflet insertion and discharge handling of completed cartons can also be automated. Both vertical and horizontal models are available.

Packaging Materials Focus on Moisture Reduction and Peel Performance

Medical device suppliers are offering products that reduce moisture in packaged medical devices. A moisture-scavenging sealant lamination from Alcan Packaging (Chicago) eliminates the need for automated equipment. Available as a preformed desiccating pouch, the unit can be used to package moisture-sensitive devices. Applications include diagnostic instruments, transdermals, and wound-care products. The scavenger is built into the heat-seal layer of the lamination, so there is no need to add desiccants or salts. This reduces the risk of moisture release-back. The pouch helps protect against foil fracture, pinholes, and package-edge moisture penetration. It is made from FDA-approved resins and additives. No surface contaminants or residuals are used.

Foil header pouches from Amcor Flexibles are compatible for use during EtO sterilization processes.

Another company offers a peelable, moisture-resistant pouch for use in EtO sterilization processes. The foil header pouch is available from Amcor Flexibles (Mundelein, IL). The pouch provides a high-barrier, peelable package for medical devices. After EtO sterilization, the Tyvek header can be removed. This allows the product to be sealed within the pouch. The uncoated Tyvek header has a high level of porosity, which can minimize EtO sterilization cycle times. In order to reduce the risk of contamination, the company produces the units in a white room that is dedicated exclusively to making pouches and header bags.

Packaging used in form-fill-seal machines needs to display certain qualities, such as peelability. A medical film manufacturer has introduced a peelable top web that is suitable for use in high-speed applications. Offered by Perfecseal (Oshkosh, WI), HP-EZ Peel is a fully coextruded nylon-core top web film. The film is designed for use in critical medical device packaging applications. Advanced process control systems are used to reduce variations in film thickness. The film delivers consistent peel performance, mechanical strength, and processing efficiency.

Copyright ©2006 Medical Product Manufacturing News

How Safe Is Laparoscopy?

Rather, it is that the hazards have apparently gone underreported, and that the technology to alleviate the problem exists but is underused. Scanning devices to test the wands for insulation cracks, the usual source of current leaks, are available. And some wands have monitoring systems that shut them off if power is leaking. Yet fewer than 25% of hospitals use these safeguards, probably because personnel are not aware of the extent of the problem. Let's hope they are now, and that they make the appropriate investment in safety technology.

Assembly Services


Assembly Services

Richard P. Bodine Jr.

Richard P. Bodine Jr., BCA Contract Assembly and Manufacturing,
Bridgeport, CT
Outsourcing, particularly in the area of contract assembly, continues to be a steadily expanding part of the U.S. manufacturing economy. While significant resources are dedicated to new product development and design, many OEMs are still reluctant to commit the capital for equipment and personnel needed to produce and assemble parts in-house. This tendency is often seen in the medical device and medical disposable industries, where delivery time frames are tight and product life cycles tend to be short or unknown. Contract assembly can offer the best solution to these challenges.

Medical OEMs must be diligent in selecting a contract assembler. They should look for companies that can provide the highest quality assemblies and on-time deliveries. They should also look for a variety of solutions to their requirements. The best contract assemblers can offer their customers a full range of assembly options, from low-volume manual or semiautomated lean cell production to fully automated assembly systems with little or no capital requirements. Contract assemblers must also be fully capable of complete supply chain management.

Manufacturing and Assembly Offered in Costa Rican Facility

An ISO-13485 certified, FDA-registered contract manufacturer offers low-cost manufacturing and assembly to medical device OEMs. The vertically integrated company maintains complete manufacturing and process validation capabilities to support the manufacture and packaging of disposable devices as well as reusable electromechanical assemblies. With Class 100,000 and environmentally controlled cleanrooms, the company’s capabilities include injection overmolding, electropolishing, microgrinding, soldering, UV curing, and ultrasonic welding, all supported by an in-house engineering team.
Precision Concepts Costa Rica, SA, Alajuela, Costa Rica

Medical Device Assembly Can Be Performed in Mexico

A contract assembler and manufacturer of medical devices has a 32,000-sq ft facility in Tijuana, Mexico. The company is U.S. owned and man-aged, and its operations are ISO 13485 as well as ISO 9001:2000 certified. Its manufactur-ing expertise includes a variety of medical devices, such as surgical clip guns used in the operating room, breast pump kits and collection devices, and battery packs for integration in monitoring devices. Its additional services include PC board and electronics assembly. Specialties are labor-intensive medical device assembly and cleanroom assembly operations. Most contracts involve using customer-supplied materials and returning the final assemblies on a piece-price basis.
Roberson & Associates, Corona, CA

Flexible Manufacturing Methods Allow for Small and Irregular Batches

A company offers medi-cal device subcontract manufacturing, as-sembly, and packaging from its Class 10,000 cleanroom in the United Kingdom. Its flexible manufacturing methods enable small and ir-regular batches to be handled, along with high-volume runs. Full sourcing of all com-ponents can be provided, with EtO gas, gamma, steam, and Sterrad sterilization options. Other services include soldering, ultrasonic cleaning, electronic assembly, and injection molding.
Wesley Coe (Cambridge) Ltd.,Cambridge, Cambs, UK

Company Offers Chinese Factory to Fulfill Outsourcing Needs

A U.S. company with a Chinese manufacturing plant is a contract manufacturer of medical devices and box builds, electromechanical assem-blies and subassemblies, PCB assemblies, custom medical cables, and plastic-molded components. With an experienced staff of medical product design engineers, the firm offers medical product fulfillment from initial design to prototyping and on to economical full-scale production. The company is ISO 13485:2003 and ISO 9001:2000 certified and FDA registered.
Sanbor Medical, Allentown, PA

High-Speed Assembly Systems are Fully Automated

From initial product engineering support to finished product packaging and distribution, a company provides turnkey contract assembly and manufacturing services. Product engineering support, supply chain management, metal and plastic forming, automated assembly, automated inspection and testing, automated packaging, third-party logistics, and worldwide distribution services are offered. High-speed fully automated assembly systems are used, as well as flexible semiautomated assembly cells. Typical medical applications include safety syringes, IV sets and subassemblies, dosage dispensers, inhalers, valves, and diagnostic kits. The firm’s facility operates a Class 10,000 cleanroom and is FDA registered and ISO 9002 certified.
BCA Contract Assembly and Manufacturing, Bridgeport, CT

Copyright ©2006 Medical Product Manufacturing News

MDMA Asks for Federal Intervention on GPOs

The hearing was the fourth on the subject since 2002.