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Path Cleared for Tyco Split

Tyco's medical products include pulse oximeters, surgical supplies, wound care products, and safety needles. These would form one of the new companies, Tyco Healthcare. Being part of a smaller corporation should only help those businesses. They'll be more of a focus under the new structure. And focus was one of many things the old Tyco lacked.

Industry Complaint Management Systems Offer Lessons for FDA

A report recently issued by FDA's Center for Devices and Radiological Health (CDRH) criticized the ability of the agency to monitor postmarket medical device safety issues. The report, Ensuring the Safety of Marketed Medical Devices: CDRH's Medical Device Postmarket Safety Program, was the culmination of a year-long internal inventory of the tools used to monitor the postmarket safety of medical devices.

The findings of the report came as little surprise to many in the medtech industry. In fact, many of the current inadequacies cited within FDA's postmarket monitoring program are mirror images of challenges that many manufacturers have already identified and addressed in their own complaints management processes.

According to the report, CDRH doesn't get full information about problems that arise with devices after they are approved and isn't always able to properly analyze the data it does receive. The report states that FDA has a “lack of quality information” about device safety and often doesn't get full reports on device malfunctions.

Despite this lack of quality data, the agency is already incapable of handling the volume that it does receive. According to the report, the volume of information being submitted to the agency “currently exceeds the center's ability to consistently enter or review the data in a routine manner.”

Industry Solutions

In December 2005, research and advisory firm Gartner Inc. (Stamford, CT) published a study evaluating 10 commercially available complaints and adverse-events management systems, including systems combined with professional services. The report, A Survey of Leading Adverse-Event and Complaint Management Solutions for Life Sciences, found that the complaints and adverse-events management systems currently available to medtech manufacturers are quite complete. The systems typically offer the following capabilities.

• Collection of safety data from multiple sources.

• Ability to ensure that data are consistent and complete.

• Automated triage of the issues to the appropriate internal stakeholders.

• Reporting functions.

In some cases, the systems are also able to assess risk associated with the issues at the product level and to facilitate regulatory reporting. Points of differentiation among the systems include their global support and how they integrate with other systems, such as enterprise resource planning and customer relationship management software.

Similarity of Issues

With so many devices hitting the market, it stands to reason that some safety issues will inevitably arise. The key to handling them is to have a consistent yet flexible approach to collecting and evaluating data related to these issues. According to Gartner's research, medtech companies that have implemented best-in-class systems provide multiple points of entry for safety-related data, including input from the Web, phone, and field sales. Despite multiple points of entry, all of the data reside in a single database, providing better visibility and actionability to the company.

Although FDA's report on its postmarket surveillance program cites a “lack of quality information” regarding device safety, medtech manufacturers actually collect significantly more data through their systems than they submit to FDA in the prescribed forms. The additional data help manufacturers address sales, marketing, manufacturing, corrective and preventive actions, and direct-response issues. In short, best-in-class complaints and adverse-events management systems operate under the premise that a company must ask the right questions if it is to properly identify and address a problem. Manufacturers generally collect the data that FDA needs to improve its monitoring, but the agency hasn't yet harnessed this information through its reporting requirements.

Study: Medical Manufacturers Focus on Improved Postsales Service

The report, Industry Traction of Strategic Service Management, is based on surveys and interviews with executives at more than 600 enterprises in the high-tech, discrete and process manufacturing, telecommunications, utilities, and other industries. According to the report, 93% of medical equipment manufacturers surveyed are targeting improved customer satisfaction and retention through strategic service management. Additionally, 86% are looking to service management as a source of increased profits.

“A well-coordinated service program assures customer satisfaction, which will drive customer equity and long-term retention,” says Troy Taylor, vice president for worldwide customer technical services at Ortho-Clinical Diagnostics (Raritan, NJ), a Johnson & Johnson company. “Without the benefit of a well-coordinated program, such companies will struggle to do well. In companies where the capital sale is joined with some form of consumable, the financial outcome of highly effective service is less visible but equally important. In such cases, excellent service offerings and delivery may not drive operating profit as directly, but they certainly support the sale of the all-important consumable for customer lifetime value.”


Hill-Rom's Gitt: Containing overall costs.

“An effective aftermarket service program can add incremental service revenue, as well as identify product deficiencies, which in turn may help contain overall costs,” says Warren M. Gitt, executive director of Hill-Rom Biomedical Services (Phoenix). Hill-Rom offers service for its own manufactured and rented products, and also operates as a third-party repair entity for companies that outsource their service functions. “End-users demand that critical medical equipment meet performance expectations, and both lives and financial performance may hang in the balance. All else being equal, customers will buy from those companies that routinely provide dependable service.”

“High-tech manufacturers have notoriously based their branding, sales, and marketing strategies on product functionality,” reads the Aberdeen report, written by Mark W. Vigoroso, vice president of service chain management research at Aberdeen. “Now, with these products under increasing commoditization pressure, the manufacturers are looking for ways to win customers based on service levels. Due to the dynamic nature of the high-tech supply chain, senior-level acumen will be required to successfully integrate service into corporate strategies for growth and profitability.”

According to the report, 38% of high-tech manufacturers, including medical device companies, have service executives at the senior vice president level or higher.

The report finds that one area where leading service organizations are leveraging emerging technology is in the implementation of machine-to-machine systems, which enable companies to remotely monitor the status of equipment and determine when it will need servicing. The systems can also allow companies to conduct remote repairs, deploy technicians, and trigger parts orders. Commonly used among utility firms, machine-to-machine technology is increasingly being implemented by healthcare, life sciences, high-technology, manufacturing, and other sectors to improve postsales service operations, according to the report.

“The level of technological implementation is a function of size and scope, customer expectations, the nature of the market being served, and the sophistication and serviceability of the equipment being serviced,” Gitt says. “Some equipment, such as laboratory equipment used at both the hospital and alternate site, lends itself to remote monitoring. Life-sustaining equipment now includes both onsite service as well as remote monitoring and upgrading.”

Such technological systems, however, can be expensive. “It is true that many of these capabilities involve large, multi-year investments in people and systems that simply aren't financially practical for a small company,” says Stephanie Wells, vice president of marketing for the clinical laboratory division of Ortho-Clinical Diagnostics. “In these cases, the company must rely upon superior individual performances rather than technology. The unfortunate aspect of superior individual performances is that they tend to be less repeatable. With the technology investments available to a larger company, the superior results become more consistent.”

The report identifies key challenges facing the medical equipment manufacturing industry's service performance, including manufacturers' lack of sufficient metrics to monitor service performance, as well as insufficient awareness and support among executives of the impact of aftermarket service. Another challenge identified is disjointed processes and communications across the manufacturing, sales, marketing, and service functions—a challenge shared by all surveyed industries.

In addition to seven overall suggestions for building a strategic service organization in any industry, the report specifically recommends that medical equipment manufacturers focus on forging stronger ties between their service and manufacturing operations. “Nearly three-quarters of polled companies see only ad hoc collaboration at best between their service and manufacturing organizations,” the report reads. “Unfortunately, this has prevented valuable insights—gleaned from the field regarding product performance and serviceability—from making their way back into product design cycles.”

Regardless of industry sector, the report also recommends that companies do the following.

• Leverage existing and new technology to synchronize service information and systems.

• Address process deficiencies before deploying new technology.

• Promote service executives from within the company.

• Define requirements and success criteria before evaluating technology solutions.

• Leverage partnerships with service and logistics providers.

• Involve stakeholders in transformational processes.

• Track both operational and customer-centric metrics to measure aftermarket service efficacy.

© 2006 Canon Communications LLC

Return to MX: Issues Update.

Interconnect Technology Enhances Cable Assembly Performance


Interconnect Technology Enhances Cable Assembly Performance

Shana Leonard

A manufacturer of cables and assemblies has introduced a wire welding and soldering operation aimed at facilitating high data-transmission speeds and mechanical strength in cable assemblies. Direct Attach technology by C&M Corp. (Wauregan, CT) is suited for high speed, high-performance computing applications, test equipment, and automation communications.

The firm's interconnect method centers around the welding or soldering of signal wires directly to the connector contact. "It's a welded joint, so what you get is a molecular transfer of material from the wire to the connector," says Hal Mueller, director of sales and marketing for C&M. "It's the difference between gluing two things and having them dissolve together."

Fusing the two components together renders printed circuit boards (PCBs) unnecessary, according to the company. Noise and impedance often associated with PCBs can cause delays in signals at higher data rates, a hazardous chance to take in the medical industry, Mueller says.

However, the company recognizes that some customers may want or require a PCB. In this case, the company claims that Direct Attach creates a better termination than traditional soldering. Furthermore, the impedance-diminishing advantages of the technology will be applied to the assembly, despite the presence of a PCB, according to Mueller.

The strong connection and automated indexing ensure repeatability and consistency, according to the firm.

Copyright ©2006 Medical Product Manufacturing News




Rich Nazarian is the president and CEO of  Minnetronix Inc., a medical device design and manufacturing firm in St. Paul, MN. Nazarian has more than 20 years experience in the medical device development field.  Prior to cofounding Minnetronix in 1996, he led product development efforts for implantable artificial heart electronic systems, cardiopulmonary - bypass systems, laser - imaging systems, and other medical and industrial devices for 3M. Nazarian is principal inventor on eight patents ranging from telemetry systems for implantable devices to networked bypass systems, and he is the principal author of numerous papers ranging from artificial heart control systems to medical device development methods. At Minnetronix, he continues to be a leader in the development of new and innovative medical devices. Nazarian earned his BS and MS in e lectrical e ngineering at Stanford University.

MPMN: How has the RoHS directive impacted the medical electronics industry?

Nazarian: As you are aware, the European Commission (EC) issued two directives in 2002-2003 with the goal of reducing toxic waste material. The legislation targets the use of lead, in particular the use of lead-bearing solder, in electrical and electronic equipment. These directives are identified as Directive 2002/96/EC of the European Parliament and of the Council of 27 January 2003 on Waste Electrical and Electronic Equipment (WEEE) and Directive 2002/95/EC on Restriction of Hazardous Substances (RoHS). Although categories 8 [medical devices] and 9 [monitoring and control instruments] are not covered, thus exempting medical device manufacturers from compliance with these directives, WEEE and RoHS do have a profound impact on medical products.

The impact that the RoHS directive has on the medical electronics business takes three principal forms:

1. Availability of components : The primary effect of RoHS on electronics manufacturers is the removal of lead from their assembly processes. Because of this, the industry is experiencing a wholesale migration to lead-free components and OEM assemblies, including single-board computers and electronics modules. In addition, significant numbers of legacy parts, which contain lead, may become obsolete if they are not sold in numbers large enough to justify migration. The combination of these factors is driving part obsolescence and revision on an unprecedented scale. The fact that medical devices are exempt from the directive does not protect manufacturers from the issues of parts modification, obsolescence, and replacement.

2. Appropriateness of processes : Many PCB assembly houses are migrating to lead-free processes. It is important that the appropriate process be used with the appropriate parts, and that these processes are properly qualified. Due primarily to process temperature constraints, leaded (non-RoHS) parts should not be used in lead-free (RoHS) assembly processes. With some notable exceptions, lead-free parts may be used in leaded processes. These process considerations may call for changes in the supply chain and requalification of designs.

3. Reliability of technologies : Leaded component and soldering processes have well-established reliability that has been demonstrated over decades of use. Lead-free components do not have a comparable track record, and the creation of reliable and repeatable processes, for both component manufacturing and PCA's, is still evolving. Known problems in lead-free assemblies include tin whisker growth, components that may age more rapidly, and soldering that is more difficult to rework and that has greater brittleness. These issues may or may not impact an individual medical device depending on the particular design and the intended use.

OEM customers and suppliers need to develop a thorough understanding of issues related to RoHS in their specific environment, and then develop an appropriate and proactive strategy to deal with them.

MPMN: What is spurring the demand for electronic implantable devices? What benefit do they have for patients?

Nazarian: Increased demand for implantable devices is being driven by a number of converging forces. These include demand-side factors such as an aging population, as well as supply-side factors such as technological advancements. More specifically, some of the leading influences motivating the increased push for implantable devices include:

1. Historical cost-effectiveness of implantable devices : Over the past 30 years, implantable devices have proven to be extremely cost-effective alternatives to hospitalization or drug therapies for the treatment of various chronic illnesses. Studies such as "The cost-effectiveness of automatic implantable cardiac defibrillators: results from MADIT. Multicenter Automatic Defibrillator Implantation Trial." (Mushlin, AI, et. al.) PMID: 9626173 [PubMed - indexed for MEDLINE] and others have demonstrated that implantable devices compare quite favorably with other therapies when measured on a cost-per-year-of-life-saved basis. In addition, this index has steadily fallen as technology has reduced implant costs and increased years of life saved.

2. Demand for new treatments : While implantable electronic technology was once largely confined to the cardiac arena with rhythm management devices, there is now a much broader array of therapies that rely on these types of products. These therapies range from drug delivery, to pain management, to hypertension treatment, to cochlear implants, to treatment of neurological disorders such as Parkinson's disease and many others. As medicine gains a greater understanding of the mechanisms and morphologies of disease processes, devices are being designed to perform very specific functions in the treatment of those diseases. This provides new ways for implantable devices to provide benefits for patients.

3. Advances in microelectronics miniaturization and technology : As microelectronics technology advances, functionality that was only dreamed of 10 or 15 years ago is quite realistic in implantable designs today. Ultralow power DSP technology, for example, allows for biological signal processing and stimulation in ways that were previously impractical. MEMS and nanotechnology are just now starting to push their way into biological interfacing, and integrated packaging, battery, and wireless technology is allowing for devices that do more in less space with less power than ever before.

4. Advances in device-tissue interfaces : Technology is enabling devices to be integrated directly into biological subsystems such as the cochlea, vascular aneurysms, and stents, and even complex structures such as the optic nerve. Some of these advanced applications serve both therapeutic and monitoring functions and may be part of a drug-device interaction that provides optimized treatment benefits. Drug delivery, for example, has traditionally been an open-loop process, limited to symptomatic feedback control. Implantable sensors monitoring specific physiologic or biochemical responses can integrate with delivery devices to tune the dosing levels to provide superior therapy with fewer side effects. These types of drug-sensor-actuator interactions will continue to drive implantable electronics development for the foreseeable future.

MPMN: Consumer electronics has spawned a craze for wireless devices. Is it inevitable that many medical devices that have traditionally operated from a power supply source will soon be wireless? What are some examples of wireless products emerging in the medical device field? What are the obstacles?

Nazarian: A number of medical technologies, both external and implantable, are migrating to wireless implementations. From wireless ECG systems to implantable pressure monitors and pulse generators, the applications and demands for wireless devices continue to grow. Device interaction with wireless in-hospital networks is increasing, particularly for limited risk diagnostic equipment such as monitors, as is acceptance of the integration of general consumer electronics standards such as Wi-Fi. Body-worn wireless technology for patient data monitoring is another field that is generating a great deal of interest. Products incorporating mini-personal-networks allow pressure, oxygen saturation, pulse, temperature and other types of data to be collected continuously for both in-patient and out-patient use.

The obstacles to wireless device adoption come in several forms, including robustness, safety and regulatory concerns, evolving technology, and international considerations. Although numerous standards exist for wireless communications, unlike consumer devices, interoperability is quite rare in wireless medical devices. For perspective, if you were to picture a world in which your PDA only talked to a certain computer brand, its wireless capabilities would be far less attractive. This level of limited interoperability is common among today's wireless medical devices. In addition, there are drawbacks related to batteries and power management for wireless devices. For low-power devices, adding wireless capability can add significantly to the power and battery requirements for a device. While power can be managed and tradeoffs explored between device size, transmission bandwidth and distance, battery impact must be considered. For higher-powered active medical devices that perform significant amounts of physical work and are in continuous use, the power required to go fully wireless can be prohibitive. Unlike consumer devices, regular battery recharging for many medical devices, such as blood pumps and temperature controllers, is often awkward and impractical. This combination of factors brings battery technology to the forefront for wireless device applications. Despite the advances in lithium chemistry, batteries are often the primary impediment to true wireless medical technology. This is not to say that tremendous progress hasn't been made, it only goes to highlight that in a world where devices are still too big, too power hungry, and not long-enough lasting, there is ample room for technology-driven improvement.

MPMN: What would you identify as the most significant trend in the medical electronics market? Why?

Nazarian: Many areas are transforming the way medical electronics are developed and perceived. Among these are demand for implantable devices, interactions between devices and drug-based therapies, demand for wireless technologies, and the increasing integration of embedded microcontrollers and software into safety critical functions for the creation of 'smart' systems. Medical electronics are currently being heavily influenced by rapidly advancing electronics technology, and by constantly expanding knowledge and advancements in all areas of medicine. As these technology areas continually expand and grow, their convergence in medical electronics implies more technically complex devices in new and expanded medical treatment areas. Along with this expansion comes increasing need for understanding and diligence in risk management and safety in medical electronics, in areas ranging from usability, to electrical safety, to electromagnetic compatibility.

MPMN: How do EMI and ESD affect electronics manufacturing? What are some ways to avoid them?

Nazarian: ESD in manufacturing has long been identified as a threat to device performance and reliability. EMI, both conducted and radiated, has grown in recent years, particularly in production environments that have heavy machinery or equipment that doesn't comply with the same standards that devices might be subjected to in use. In addition, components and subassemblies that might be extremely robust when installed in completed products may be highly susceptible in process. Most manufacturers have well-established approaches to managing these threats, a few of which are listed here.

1. Separation : Short of building EMI screen rooms, physical distance and dedicated power are the next best approaches to managing conducted and radiated emissions.

2. ESD coatings, paints, and work surfaces : Many facilities use conductive paints and coatings for flooring and work surfaces. These can be expensive and must be monitored, maintained, and managed, but can have a significant widespread impact on reducing ESD.

3. Clearly identified ESD safety zones and susceptible components : Labeling work areas and parts can substantially reduce their tendency to be exposed to ESD. It is not a good idea to label everything in this way, as it then loses its effectiveness.

4. ESD-related training : Perhaps the most important factor is proper training of personnel with respect to ESD issues. Employees must know how to use and check wrist straps, grounding pads, test equipment, and material packaging in order for any protection plan to be effective.

5. EMI and ESD mitigation monitoring : All mitigation methods must be tested on a regular basis as appropriate. Inadequate ground connections are common causes of loss of ESD protection even in well-planned environments. Additions or changes in equipment placement or power routing can have a subtle impact with respect to EMI, necessitating field testing, and power quality measurements in sensitive environments.

As with most failure mode threats, awareness and understanding of EMI and ESD in specific environments is the key to their management and mitigation.

Copyright ©2006 Medical Product Manufacturing News

Metal Fabrication


Metal Fabrication

Joshua Jablons, PhD, is the Executive Vice President of Metal Cutting Corp., a specialty metal fabrication company in Cedar Grove, NJ. Jablons has worked in the metals business since 1987. During his career in the industry, he has specialized in three areas: the manufacture and metrology of tight tolerance parts, burr-free production techniques, and refractory metals. He earned his BA at Wesleyan University and his MA and PhD at New York University.

MPMN: How has the trend of miniaturization impacted the metal fabrication industry? Do you view this as a negative or positive trend for the field?

Jablons: Miniaturization has been an excellent trend so far for the metal fabrication industry. It has provided value-added challenges that producers have mostly met. Of course, not every part can be made- there is a saying amongst fabricators that "if you can draw it to scale, we can make it." However, when compared with the traditional smokestack approach to making railroad ties, creating value by proprietary techniques geared towards ever smaller parts, that additionally have a far more limited impact on the environment and also consume less energy during manufacturing, is a good thing.

MPMN: What changes may be necessary to accommodate the increasing demand for micromachining?

Jablons: The key here is the design of tooling. As the part dimensions shrink, the problem is not necessarily the metallurgy of the part. It is the ability to make a tool that can remove such a small amount of metal - that is machining after all - and also the tooling or fixture to hold the part that is to remain. Alternatives to traditional turning and grinding have their own challenges, so if you use chemical machining, you've still got to hold the tiny part and control the chemical reaction to the desired tolerances. Not that these and other methods can't do the job - in fact, they often can - but they all have their challenges, and the proprietary value consists of figuring out the changes needed to make your particular approach work.

MPMN: Which metals are most difficult to work with? Why?

Jablons: Again, the key here is tooling. Everyone knows about the hard metals that immediately dull a seemingly hard tool, but in terms of being difficult, if you use a self-dressing tool to work soft material, that tool will "load" and will be rendered as useless as the prior example. With the correct tools, all metals can be worked -- although the point is well taken if posed as cost. Harder metals typically require more expensive tools. For example, carbides, which require diamond tools to be worked, are therefore amongst the most difficult to work in financial terms.

MPMN: What role does the threat of corrosion play in metal fabrication processes?

Jablons: It plays a significant role in two ways. First, metal parts that are subject to a corrosive or oxidizing chemical reaction must be protected both during manufacturing and in transit to the customer. This protection can be simple (but messy) such as a coat of oil used in the low carbon steel industry. This example is to illustrate the issue, although the medical device industry doesn't usually work with such metals and almost never accepts parts coated in oil. Other protective techniques such as anodizing are obviously difficult to remove. The other problem posed by corrosion is to the manufacturing equipment itself. It is difficult to hold tight tolerances on parts if the components of the machine producing the parts are not correctly aligned due to a corrosive reaction. On the other hand, the threat of corrosion is a terrific opportunity for those manufacturers of metals that resist the particular corrosion problem encountered.

MPMN: Metal fabrication is known for generating a lot of waste. What are the most common waste-reduction or recycling methods for medical metal fabrication? Are they effective?

Jablons: I recall that when I began in the industry "tri-chlor" was being phased out for cleaning parts "spot-free" and chemical coolants were often still used. The former is famously bad for the ozone layer and the latter is harmful to both human operators and is also a disposal hazard. Now there are many spotless cleaners that are environmentally benign. The trend towards greater precision has also meant that important parts of machines are often made from carbides and therefore using plain water as a coolant is not a problem. Another benefit of miniaturization is that the parts are getting smaller, so when compared with the environmental impact and energy consumed making structural metal, medical device metal fabricators produce far less waste and the waste is far easier to manage and clean.

MPMN: The rise of biocompatible ceramic components and the exploration of nanotechnology indicate that other materials may replace metal in many medical applications. How might this affect the metal fabrication industry?

Jablons: Metal fabrication means two different activities. First the metal itself is fabricated. Second the part is fabricated from the metal. In the first sense, as the fabrication of ceramics is essentially similar to powder metallurgy, that relatively small group of metal fabricators who use powder metallurgy technology - and this includes refractory metal producers - can benefit from any market share shift from metals to ceramics. In the second sense, metal fabricators who have the ability to machine ceramics - and it is not a simple transition - can also be protected as the market shifts. However, when customers replace a metal part with a ceramic or plastic one, it is generally not good for either type of metal fabricator.

Nanotechnology is a paradigm shift from removing a substance that reveals the shape of a part to the building of the part at the molecular level. While metal injection molding and certain deposition techniques may be considered remotely similar in concept, there is no meaningful overlap between nanotechnology and current metal fabrication. For example, an SEM image of a metal part showing dimensions in nanometers is not nanotechnology. Even if the dimensional tolerances of the part are repeatable at a nanometer scale - which is achievable in only a limited set of dimensional circumstances - the methods of fabrication to make that part has nothing to do with the molecular assembly of nano structured materials. Ultimately, as miniaturization reaches the nanometer scale, metal fabrication as is now practiced will lose market share.

Copyright ©2006 Medical Product Manufacturing News

Interconnect Enables Effective Use of Disposable Electronic Probes


Interconnect Enables Effective Use of Disposable Electronic Probes

Shana Leonard

A manufacturer specializing in connectors has debuted its custom interconnects for medical disposable electronic probes. The Hypertronics Corp. (Hudson, MA) interconnect is suited for such electronic probe applications as electrophysiology catheters, endoscopes, and intravascular ultrasound.

The complete interconnect system consists of a single-use connector that joins the disposable electronic probe to a sterilizable cable that is configured for multiple mating cycles. Embedded electronics can be integrated into the connector or cable as well. Features of the interconnect systems include customization, a single vendor source, high reliability, design for sterilization, complete cable assemblies, and the use of disposables.

"By applying this high-reliability interconnect to the electronic probe system, Hypertronics facilitates the medical trends toward less invasive procedures, disposable probes, embedded electronics, high cycle life, and sterilizations," says Tom Kannally, the firm's industry manager of medical invasive probes.

The system's generator end can withstand up to 100,000 mating cycles and employs the company's Hypertac contact system, which exhibits a low contact resistance of less than 8 m W for small signal contacts.

Designed with wires situated at an angle to the socket's axis, the contact sleeve contorts in response to the insertion of the pin. The wires stretch around the pin, creating multiple linear contact paths. Favorable properties of the contact system include high current-carrying capability, low insertion force, shock and vibration immunity, and good wiping action.

Copyright ©2006 Medical Product Manufacturing News

Products from the MPMN Mailbox


Products from the MPMN Mailbox

Drill Unit

A drill unit is capable of precision end-milling and face-machining operations. The Varimec Selfeeder SSV-4 drill unit from Sugino Corp. (Itasca, IL; is available with chuck capacities from 0.07 to 0.787 in. The unit comes in two models. The low-speed, high-torque unit offers no-load spindle speeds ranging between 250–1750 rpm and torque is rated between 5.24 and 9.07 ft·lbf. The high-speed model has a no-load spindle speed between 1000–7000 rpm; torque is rated between 1.33 and 2.29 ft·lbf. Total stroke length is 9.83 in. and the adjustment length for the rapid advance is variable. Maximum cutting speed is 0.656 in./sec. Internal linear slides are used to guide the moving Z-axis quill. The controller for the unit can store up to 99 individual programs. There are 13 preprogrammed drill modes, including standard, step, dwell, skip, spot-face, and inverse spot-face. It can be equipped with multispindle and off-set drill heads. The drill unit can be mounted directly to a machine base or to adjusted columns for drilling or machining at any required angle.

Green Laser Diode Modules

Green laser diode modules are suitable for use in positioning applications. The modules are offered by BEA Lasers Inc. (Elk Grove Village, IL; and can be used for spectroscopy, particle measurement, medical tissue analysis, interferometry, holography, robotic control, and flow visualization. Both the 2501 and 2503 models feature a fixed-focus, CW diode-pumped laser diode module. The 2501 module is 11 mm diam and has a beam divergence of <1.2 mrad. It has been designed with threads at the front so that additional optics can be added. The 2503 module has a beam divergence of <0.8 mrad, with a 12-mm diam housing. Both units require 3 V dc, with operating current around 300 mA.

Vertical Injection Press

A vertical injection press is engineered for rubber and silicone molding. The Maxi-Jet press from Technical Machine Products (TMP; Cleveland, OH; is offered in standard models from 50 to 400 tons, with shot sizes up to 6000 cm 3. The press is part of the company’s Asian-sourced Maxim series line of hydraulic presses. The line includes rubber injection systems, hydraulic compression presses, and vacuum presses. Custom designs are also available.

High-Speed Camera Systems

A line of camera systems offers short shutter speeds for sharp images. The Silicon Video 642M and 642C camera systems from Epix Inc. (Buffalo Grove, IL; have 640 pixels by 480 lines at 240 frames/sec and up to 19600 frames/sec at 640 pixels by 4 lines. Shutter speeds as short as 20 μs provide sharp images of high-speed motion. The systems include a plug-and-capture camera, PIXCI SI PCI bus frame grabber, cable, and XCAP-Lite imaging software. Applications include high-speed inspection, particle tracking, kinematics, and biological image analysis.

Laser Pattern Cutting System

A company has built a high-speed laser cutting system. Developed by Orca Photonic Systems Inc. (Redmond, WA;, the system can cut repetitive patterns in large, roll-fed textiles. The machine is the first in the company’s line of high-speed pattern cutters. The cutters are based on a hybrid architecture that combines the large-area coverage of the firm’s X-Y and roll-fed machines with the agility and spatial resolution of galvanometer-based laser etching and marking machines. The resulting systems can cut patterns with submillimeter feature sizes while processing material widths in excess of 6 ft and nearly unlimited lengths.

Copyright ©2006 Medical Product Manufacturing News

Tool Company Supports Educating Skilled Workers


Tool Company Supports Educating Skilled Workers

Shana Leonard

On the heels of a rewarding experience in 2005, Sandvik Coromant (Fair Lawn, NJ; will once again contribute to educating the nation's skilled workforce. The company has announced its return as a supporting organization for the 2006 SkillsUSA Championship in the field of precision machining technology.

The competition is comprised of state contest winners who have the opportunity to showcase their talents in their respective trades. Each contest assesses a contestant's grasp of necessary skills for an entry-level job in his or her field. Last year, 4600 students competed in 80 occupational and leadership areas that ran the gamut from culinary arts to firefighting to precision machining technology. The event is hosted by SkillsUSA, a nonprofit organization that prepares students and professionals for trade, technical, and skilled-service occupations.

"This competition is an opportunity for focused individuals to be recognized for their achievements," says Paul Leming, training specialist for Sandvik Coromant. "In the area of precision machining, it is an opportunity to educate participants about efficiency, productivity and profitability, which are all crucial to improving one's manufacturing process."

Sandvik Coromat provided tool packages for the precision machining contest, which required contenders to demonstrate adeptness in the operation of manual milling machines, lathes, drill presses, and surface grinders. In addition to the successful completion of these tasks according to National Institute for Metalworking Skills standards, proficiency in industry-related math and vocabulary were also evaluated. Sandvik donated tools to the top two competitors' schools.

The 2006 SkillsUSA Championships will be held June 21-22 in Kansas City, MO.

Copyright ©2006 Medical Product Manufacturing News

Companies Cooperate to Optimize Precision Cleaning System


Companies Cooperate to Optimize Precision Cleaning System

Corinne Litchfield

The F-500 bisolvent cleaning system uses materials that are in compliance with air quality regulations.

Two companies have joined forces to optimize a precision cleaning process. 3M Electronics (St. Paul; and Forward Technology (Minneapolis; have worked together to develop a cleaning system that uses 3M’s Novec 7200 engineered fluid. The fluid is clean air solvent certified by the South Coast Air Quality Management District of California. As a result of their work, Forward Technology has introduced the F-500 Series bisolvent cleaning system.

The F-500 system is an all-in-one, wash-rinse-dry model. It uses industrial-grade methyl soyate in addition to Novec 7200. The unit works with standard equipment and minimizes energy, floor space, and process time. The system removes oils, heavy waxes, grease, and particulates, leaving parts residue-free.

The process begins when parts are immersed in methyl soyate, which serves as the primary cleaning agent. The parts are then sonicated to remove the bulk of the contaminants. In the next step, they are rinsed in distilled Novec 7200 to yield clean and spot-free parts. Contaminants are automatically purged from the cleaning cycle, minimizing the cost of cleaning chemistry.

The system uses Novec 7200 in place of ozone-depleting materials. As a result, the F-500 series offers parts makers a way to comply with many strict air quality regulations. The fluid also has low global warming potential and is low in toxicity. It is compatible with a range of metals, plastics, and elastomers. With a higher boiling point than most CFCs, HCFCs, and HFCs, the fluid can reduce evaporation in vapor degreasing applications.

“To meet the customer’s needs for a system that limits VOC emissions without compromising performance, 3M drew upon its broad technology base of segregated, nonflammable hydrofluoroethers,” says David Hesselroth, the company’s product development specialist. “Novec 7200 was an ideal fit for the cleaning system, because the fluid is based on a sustainable technology that balances environmental concerns with performance and safety.”

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