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Articles from 2005 In July


Not Just Scratching the Surface Anymore

Originally Published MPMN July/August 2005

PRODUCT UPDATE

Not Just Scratching the Surface Anymore

Manufacturers offer new alternatives in laser coding, thermal printing, and surface treating

Corinne Litchfield

Options available to manufacturers for printing and marking on medical devices continue to expand. Thermal printing for labels and packaging can produce two-dimensional bar codes, as well as special characters. The permanent nature of laser coding and marking may prove to thwart possible counterfeiting of parts and goods used in the manufacture of medical devices.

Thermal Printers Are Compact, Versatile

The Thermal Printmaster from About Packaging Robotics (Thornton, CO) can be used on pouches, bags, lidding stock, and preprinted media. Its 300-dpi resolution with near-edge printing capability gives the appearance of preprinted pouches and its flexibility enables on-demand production of text, graphics, and bar codes. Suitable for use with Tyvek and other flexible packaging materials, the unit can print directly on media ranging from 1.5 to 10 in. wide, with a maximum print area width of 8 1/2 in. Media printing and processing rates range from 4 to 10 in./sec. The printer features a rugged steel printing platform and a stepper motor–driven infeed.

A printer from Fujitsu Components America Inc. can output data, graphics, and 2-D bar codes.

A high-capacity thermal printer assembly has been enhanced with more standard features and print capabilities for expanded use in medical and scientific equipment. The FTP-639USL001/002 compact printer unit from Fujitsu Components America Inc. (Sunnyvale, CA) measures 136 × 163 × 107 mm and can print at 200 mm/sec. It comes with an integrated 3-in. thermal print mechanism, an automatic guillotine-type cutter, and either a miniature high-speed serial or USB controller board. Capable of outputting data, graphics, and text characters, the printer can produce 2-D bar codes at speeds of 200 mm/sec with 8-line/mm resolution. The print speed can be decreased to 125, 80, or 40 mm/sec to conserve power. The printer accommodates paper or label stocks ranging from 60 to 120 µm thick and 80 mm wide. Designed to accommodate various mounting schemes, the printer features a partial tilt function. The die-cast metal frame provides durability and mounting stability, as well as ESD protection and heat dissipation or retention.

Laser Coding and Marking Systems Offer Flexibility and Permanence

Laser marking systems are an option for manufacturers looking for printing methods that are durable and cost-effective. The Focus S60 laser coding system from Videojet Technologies Inc. (Wood Dale, IL) can deliver permanent codes on a variety of materials, such as paperboard packaging, plastics, glass, labels, clay-coat, and secondary packaging. Suited for use in high-speed environments, the system provides high-quality print resolution for nearly 100% verification system read rates. Its CO2 laser–based technology ensures clean, low-maintenance operation and eliminates consumable fluids and parts associated with other printing techniques. To meet the needs of nearly any coding requirement, the system can print mixed fonts, logos, special characters, RSS/composite bar codes, and 2-D symbols. An optional graphical user interface offers an intuitive color touch screen with a WYSIWYG display. For applications that require 21 CFR Part 11 compliance, the Focus S60’s software provides built-in, password-protected audit trails of all actions.

A laser coding system from Videojet Technologies Inc. was used to permanently mark the medical device shown here.

Baublys Control Laser (Orlando, FL) has introduced a fiber-pumped 20-W laser marker. The ProWriter F20 laser marker uses an active fiber and patented pumping technique that allows the use of telecom-grade diodes with a projected life expectancy in excess of 100,000 hours of operation. With its high-beam energy density, the laser is capable of marking a variety of stainless steels, titanium, alloys, and other materials. Operating on typical house current, the marker does not require special electrical connections or external cooling. Its compact design allows for quick relocation and easy integration into crowded production lines, making it appropriate for industrial marking applications where space is limited.

Surface Modification Has Its Benefits When Printing on Plastic

In order to decorate or print on plastic parts, manufacturers may need to pretreat the products’ surface to ensure adhesion and durability. Julian Joffe, president of Pad Print Machinery of Vermont (Manchester Village, VT), has several insights on the pretreatment process.

“Substrates such as polypropylene and polyethylene may need to be modified to ensure a good bond for ink,” he says. “These extremely inert materials have a very low surface tension and, now that they need to be decorated or marked, their inert nature provides a challenge.

“Pretreatments modify the bonds of the substrate surface and increase the surface energy, allowing the ink to bond to the substrate,” Joffe states. By adding oxygen molecules to the surface, ionic positions are opened so that chemical bonding can occur.

Pretreated surfaces slowly lose their ionic character over time. Because the ionic charges on the pretreated surface dissipate quickly, Joffe recommends incorporating pretreatment devices on the actual printing equipment. “Pretreatment incorporation not only assures you of a good, highly durable ink bond, it also eliminates double handling, thus saving time and manufacturing costs,” he adds.

Joffe offers a simple test to check materials for insufficient pretreatment. “Trickle water over the substrate and watch what happens. The water will either flatten out onto the surface or form small beads that appear to be suspended over the top of the surface. A well-treated surface becomes ‘wet’ when the water hits it and will begin to dry after 10 seconds or longer.”

This test measures what is referred to as the Dyne level—the angle of the side of the water droplet on a substrate surface. “Both polypropylene and polyethylene usually have a dyne level below 35 when they’re produced. For proper bonding, the dyne level must be increased to 42 or above,” says Joffe.

The type of surface treatment chosen by manufacturers will depend on the characteristics of the substrate. Highly curved or shaped parts can benefit from flaming, which energizes the surface to a point acceptable for bonding by using the oxygen present in an open flame. Corona or plasma treatment uses electrical current to create an ozone layer at the substrate surface. “This method energizes the surface while increasing the Dyne level for good ink bonding. It’s the best method for pretreating sheet-fed material,” Joffe says. Chemical wipes can also be used to pretreat surfaces.

Biocompatible Surface Coating Is Wear- and Corrosion-Resistant

The fiber-pumped laser marker from Baublys Control Laser can operate on typical house current.

A biologically compatible, wear-resistant coating is suitable for use with softer substrates. Armoloy of Connecticut Inc. (Bristol, CT) developed BIO-TDC, the biocompatible surface coating, for use with medical, surgical, and diagnostic devices. A thin uniform deposit has a nonreflective finish and can be applied to most metals that are used in communicating and noncommunicating devices. The BIO-TDC coating is also suitable for pharmaceutical-handling machinery. The coating can withstand repeated autoclaving and is designed to reduce friction and eliminate galling. The corrosion-resistant coating can be applied at low temperatures to avoid distorting tolerances. The coating has passed rigorous tests for cytotoxicity, systemic toxicity, intracutaneous irritation, implantation, sensitization, hemolysis human blood–direct contact, and material-mediated pyrogenicity.

Copyright ©2005 Medical Product Manufacturing News

The Future of Medical Devices: 2025 A.D.

Originally Published MPMN July/August 2005

MPMN 20

The Future of Medical Devices: 2025 A.D.

Mark Ettlinger

Twenty years from now, healthcare as we know it will have changed—dramatically. The basic reasons for these changes are in the headlines every day. Indicative influences, such as demographics, government policies, and social needs, will force the healthcare industry, its providers, and our government to rethink how treatment is delivered and who pays for it.

In the future, we may no longer have the luxury of always saving people. Economics will prevail as the principal influence upon the standard and level of care provided. However, with prudent planning, perhaps this dire circumstance can be prevented. Medical device manufacturers have a key role to play in developing devices that can contribute to lowering healthcare costs, as well as providing more effective, faster, safer, and less-invasive treatments for a variety of diseases.

Are all of the technologies of tomorrow in the research labs today? Probably so. After all, 20 years ago the knowledge of today’s cutting-edge techniques were well known in the scientific communities. Research and application testing of such areas as genetics, stem cells, and tissue biology, as well as their implications, required significant resources, technological advances, and time to prove efficacy. Safety issues are still being verified clinically. Now, with the clinical applications and positive indications growing and advancing steadily, the art and science of these fields are likewise transitioning in the technology and engineering phases.

So it makes sense that tomorrow’s technologies are in the works today. Just as we saw shape-memory alloys, plastic materials, and advanced fabrication technologies go from laboratories to manufacturing facilities, genetic treatments, tissue engineering, and nanomachines will be at the core of many leading devices and implants of the future.

One area that we are already seeing advances in is materials development and selection. Materials and their associated processing technologies will play a significant role by reducing side effects of medical devices and enabling the wider use of combination devices. These products incorporate mechanical features and functions as well as biological, pharmaceutical, or active therapeutic material. Testing for near-term solutions and interaction of drugs, chemicals, and materials will enable more and varied application of these devices.

One way new materials can affect healthcare may be in the fight against nosocomial infections in hospitals. Nosocomial infection and the propagation of antibiotic-resistant strains of bacteria have contributed to a problem that the Centers for Disease Control and Prevention estimates costs American hospitals $11 billion a year in treatment.

Hospitals are quickly learning the utility of following standards of practice and procedures analogous to those that industry uses in manufacturing devices and drugs. And the application of new materials and coating technologies to indwelling catheters, surgical devices, and implants, as well as the building materials and the handheld items (from pens to clipboards) will help hospitals meet their goals of reducing infections and the associated costs.

Features of Future Medical Devices

What will medical devices look like in 20 years? Presently medical devices and systems are used for care, diagnosis, and interventional treatment. In the future, pharmaceutical and biotechnology drug treatments will likely reduce the market for certain surgical devices. However they will increase use of the implantable and nanobased targeted drug-delivery devices.

As patents run out on critical drugs, their generic equivalents will reduce the cost of treating certain disease states. Likewise, says Lester Fehr of ArthroSurface (Franklin, MA; www.arthrosurface.com), “…cost stratification will bring more and more generic devices into the market. The newer devices will tend to be wearable, implantable, and portable.”

Percutaneous vascular and endoscopic access devices, which enable minimally invasive procedures, will have to leap new hurdles in an era when noncritical intervention done outside the traditional hospital-based operating room is the preferred mode of treatment. In a cost-conscious world, regulatory allowances will be made for technologies that enable diagnostic procedures and treatments to be performed in a clinic or office ambulatory surgical centers setting.

As the biotechnology of tissue regeneration improves, replacement organs and tissue-engineering advances will provide radical new options for addressing the most serious disease conditions. Tissue engineers are on the verge of breakthroughs that will grow entire organs, including hearts, livers, and kidneys. This builds off of the significant strides made in developing artificial skin for burn patients and bone substitutes that help repair osteoporosis and fractures.

Fully implantable, self-contained artificial hearts will be able to extend the lives of patients whose heart disease is beyond repair. An artificial pancreas, combining skin-based sensors to measure blood-glucose levels, a handheld computer to analyze the information, and an implantable infusion pump that adjusts glucose levels as needed, will provide diabetics with a more accurate and less painful way to monitor and treat their conditions.

Not Just Minimally Invasive

The trend toward minimally invasive medical techniques that we are seeing now will move toward a least-invasive approach. Certainly, the drive for endoluminal procedures (i.e., oral access via the esophagus through the stomach wall into the peritoneal cavity) will enable surgeons to perform abdominal and soon cardiothoracic surgeries with local anesthetic, instead of general.

Further advances in scale and materials will yield similar devices for vascular, cardiac, and neurological surgeries. Integrated laparoscopic and endoscopic procedures will play a transitional role as further advances are made and computer-assisted and image-guided procedures become more prevalent outside of the major teaching hospitals.

The host of sterilized instruments presently provided for surgeries will be gradually replaced by mechanisms of actuating “arms” and articulating cannulae with various detachable end-effectors for multipurpose applications. Everything from cutting through suction and irrigation through stapling will be accomplished by these “smart” instruments that can be handheld or attached to external fixation platforms. These systems will also be integrated for image-guided, remote, and robotic control of surgeries.

New Age of Imaging

Imaging, like drug delivery, is taking on two modalities—systemic and local. The systemic methods include whole-body computer-aided tomography (CAT), magnetic resonance imaging (MRI), and integrated positron emission tomography (PET) scans. The local imaging is provided by ultrasonic, microoptics, optical coherent tomography (OCT), and other light- or energy-based imaging systems, which use catheters and probes to provide discrete images of tissue and structures.

Certainly, in the future we can imagine micro x-ray and microwave-active and feedback devices. We can also imagine combined or integrated devices, where multiple imaging modalities are incorporated on single catheters, so that diagnoses and treatment can be immediately implemented by the surgeon or specialist.

Combined devices will incorporate not just imaging modalities, but biological, pharmacological, and possibly radioactive ingredients as well. A current-day example is drug-eluting stents. Many other combined devices are on the drawing boards of companies right now. Infusion ports and implants, pacemakers, and future implantable monitoring devices will not only exclusively deliver a chemical or electrical therapeutic treatment, but also monitor and regulate that treatment regimen. They will also be able to communicate that information to external, wearable telemetry systems, which will, where applicable, feed information to clinical databases via mobile cellular telecommunication devices.

With the addition of biologic and genetic microlabs, implants—both passive and active—will be able to monitor physiological conditions, disease states, and enzyme production, while providing potential active functions. Neurological implants may provide key interface mechanisms for those suffering from blindness, Alzheimer’s, dementia, and even amputations where interactive function may be restored by prosthetics that interface with such devices.

Molecular and gene-based diagnostics will detect diseases earlier in their progressions, improving patient outcomes and lowering treatment costs. This will allow physicians to target specific drugs to match the patient’s genetic makeup. Molecular imaging diagnostic tests will be able to detect cancers and other disease conditions at the molecular level before they have spread and caused major damage.

Combinations of current diagnostic technologies such as ultrasound, MRI, and PET, will provide physicians with a more precise picture of how a disease progresses and how it responds to various treatments.

Technologies to Watch

Miniaturization of medical devices will allow for more-targeted delivery of therapies. Their smaller size will enable more minimally invasive and noninvasive procedures, which could move care from hospitals to the outpatient setting. Miniaturization will also benefit younger patients because technologies, such as pacemakers, implantable cardioverter- defibrillators, and brain-stimulation devices, can be placed in younger patients who can’t use today’s adult-sized models. And moving even smaller, nanotechnology breakthroughs will create microscopic devices to deliver treatment to individual cells.

Information technology innovations will allow critical medical data, including images of the operating field, to be processed and transmitted rapidly over great distances, saving both patients and physicians time and speeding delivery of treatment. Information from devices such as pacemakers and blood-glucose test kits will be monitored over the Internet or via wireless connections. Specimen-based tests currently performed at a laboratory or a doctor’s office will be performed using home-based versions and the results immediately transmitted to a physician. Physicians will transmit commands remotely to activate or adjust a patient’s implanted device, for example an implantable defibrillator or brain-stimulation device.

Certain existing treatments, such as acupuncture, homeopathic, and other alternative-care therapies, are poised for growth in the new market. Generic medical devices will play a role here as the cost of manufacturing production will always be driven by the need for increased efficiency.

Conclusion

How will the medical technology industry do its part to fulfill the future needs of healthcare? For those of us who design and develop medical devices, our mission must be to overcome the challenges of cost versus innovation. Our focus must be to create products that reduce cost, while at the same time improve standards of care.

Four New Factors Affecting Development

1. Reduced funding pool for new product development. Many venture groups and corporations will find the performance gains limiting and financial risks increased under cost-conscious regulations and reimbursement structures. This trend started after the dot-com bust with significantly lower venture investments in seed funding
for start-ups.

2. Integration and the streamlining of multifunctional systems. Open architectures in all aspects of medical device development will likely be a forced issue and empowered by FDA.

3. Single-use and reuse: The multiuse of devices will play a more significant role, but only after infection and sterilization issues are addressed on the product design side, as well as enforcement of hospital systems and standards.

4. New marketplaces. Nonprofit buying groups will likely form around or in parallel to the existing for-profit corporations. This will open new channels for smaller manufacturers.

Copyright ©2005 Medical Product Manufacturing News

20 Years of Supplying the Medical Device Industry

Originally Published MPMN July/August 2005

MPMN 20

20 Years of Supplying the Medical Device Industry

This year, MPMN celebrates its 20th year covering medical devices. Not surprisingly, we’ve seen a lot of changes in the industry over the years. To find out how things have evolved, we decided to talk to companies that have been suppliers to the medical device industry for 20 years or more. These companies gave us their takes on the trends— past and present—and also provide a look toward the future.

The firms we talked to are as diverse as the industry itself. Some primarily serve the medical market; others count it as a small sector of their business efforts. They range from equipment manufacturers to components makers to contract services providers. But as different as they are, we found a remarkable number of similarities when we asked their opinions on how the industry has changed since 1985.

All see it as an important and growing market sector that will only get stronger. They are again in agreement that regulatory compliance is a must, and that it is not an easy task. Outsourcing is becoming more and more commonplace. And while a lot of manufacturing is still manual, companies are turning to automation everywhere they can. This fuels another trend—toward smaller, faster, better, and cheaper devices. Last, the world is getting smaller, and these firms know they have to be ready to work with their customers all over the globe.

Read on for an insider look at the past 20 years of supplying the medical device industry and a sneak peek toward the future.

The Health of the Industry

Interface associates has begun to offer balloon development services
to meet the needs of its OEM clients.

This industry isn’t going away any time soon. Regardless of the economy, the medical device sector has always been healthy. Despite recent economic uncertainties, Josef Stupecky, president of Interface Associates (Laguna Niguel, CA; www.interfaceusa.com) says, “This industry has not suffered any downturn.”

After all, at least for the foreseeable future, people are always going to get sick. And with the world’s population aging, healthcare is becoming ever more important. There are 78 million baby boomers just in the United States alone. And as unbelievable as it may seem, the youngest group of them turns 41 this year.

Regulatory Requirements

All of the companies mentioned that regulatory requirements were growing ever more strict. The industry was first regulated by FDA in 1976 after the passage of Medical Device Amendments. Over the years, the agency has tightened its control over the medical device manufacturing process. In turn, OEMs want to know that their suppliers are in compliance with all requirements.

Suppliers are feeling the pressure. Tom Muccino, global business developement manager at EFD Inc. (East Providence, RI; www.efd-inc.com), says, “The demand for higher-quality suppliers is much more stringent. Companies are doing audits routinely, which is a huge step up from 20 years ago.”
It is also harder for a new supplier to break into the medical device market than it used to be. Stupecky notes the regulatory changes have altered the industry in that “you need a large staff of quality assurance people to start up a business just to be sure that you are compliant.”

EFD’s Model 2400 dispenser meets global demands by displaying readouts in eight different languages.

The emergence of drug and device combination products has introduced another regulatory burden for some companies. For example, Tapemark (West Saint Paul, MN; www.tapemark.com), a provider of die-cutting, coating, packaging, and printing services, makes wound-care dressings that also transmit drugs.

In order to manufacture this product and others in the future, the company had to become drug compliant with FDA. As challenging as it is to become device compliant, to be in line with drug requirements is much more difficult, according to Steve Larsen, Tapemark’s medical and pharmaceutical business manager.

“It was an eye-opening experience for us to become drug compliant,” says Larsen. “It took Tapemark 2–3 years to completely change quality systems and its daily operations.” These efforts were successful. The company has been inspected by FDA and is drug compliant as of April 2005.

Outsourcing

Another topic that the companies agreed on was outsourcing. OEMs are increasingly turning to contract manufacturing. Over the years, device manufacturers have developed a mind-set that they will contract out production and spend their time and energy on R&D and product design.
As Larsen says, “OEMs have made a switch to sticking to what they do best and leaving the manufacturing to Tapemark.”

Stupecky notes another reason for outsourcing is that his customers want to minimize their engineering time so that they can concentrate on clinical trials.

Smaller, Better, Cheaper, Faster

Ivan Farber, account manager at Oetiker North America (Marlette, MI; www.oetiker.com), says that over the years competition has grown fierce. Back in the 1980s, he found the industry to be more open, but now OEMs are demanding consistent quality at a lower cost.

The drive in industry is toward smaller and cheaper components, produced as quickly as possible.

Tim McMullen of W. L. Gore & Associates (Elkton, MD; www.gore.com) says that he has seen seen the biggest change over the past 20 years in the area of materials selection. “We’re more aware of specific materials for medical devices and components,” he notes.

Using the precise materials for a product is key. One of the biggest reasons for this is because of the changes in methods of sterilization and disinfection methods for the finished device. Due to the emergence of diseases such as AIDS, mad cow, or hepatitis, devices require challenging sterilization processes such as Steris, Sterrad, and autoclave. This means materials are subjected to elevated temperatures and harsh chemicals.

“Another factor affecting materials selection is ergonomics,” McMullen says. For example, he mentions an ultrasound probe cable that W. L. Gore & Associates designed. Sonographers were becoming challenged by the weight of the probe device. Material and packaging reduced the weight, making the probe lighter and easier for the users to handle.

McMullen says that he has seen an evolution in this sector of industry. “Real significant engineering has only been applied to medical electronics over the past 20 years or so,” he says. This means the industry is only just now becoming mature.

Automation

Automation is improving both production speeds and accuracy. Suppliers are also incorporating automation into their products. For example, Muccino says, in EFD’s dispensing equipment, fine-tuning has become more important over the years. Twenty years ago, one of the company’s devices had a knob that could be dialed to determine the amount dispensed.

“Now OEMs require a visual display because they need to document precise and specific amounts,” he says. “This will get even more critical in the next 20 years.”

Global Capabilities

“Everything is pretty much global these days,” say Farber. In fact, his company is headquartered in Switzerland and is Swiss owned, although it has manufacturing facilities in Michigan, Canada, and Germany. Oetiker does a significant amount of manufacturing in Ireland and Puerto Rico, however engineering, specification, and prototyping is done in the United States.

“Device manufacturers are looking to suppliers for a global approach,” agrees Muccino. For example, his company’s Model 2400 dispenser can display readouts in eight different languages. It can also calculate in either metric or U.S. measurement units.

Perhaps the biggest difference now from 20 years ago is China emerging as a market for medical devices. It has the world’s largest population, which is aging just as fast as the rest of the globe.

What Lies Ahead

Sil-Kore interconnects from
W. L. Gore are suitable
for applications that
require repeated exposure
to high temperatures and autoclave cycles.

The future is bright for those who manufacture medical devices. Muccino believes the demand is going to increase dramatically in the next 5 years, and certainly in the next 20 years. The world’s population is aging, and that will drive advances and production in the healthcare market.

Drug-and-device combination products, such as drug-eluting stents and wound-care dressings that transmit transdermally, are a major trend that our panel mentioned for the future.

Other devices that can diagnose and treat a condition virtually simultaneously are in the works. McMullen calls this trend fusion. For example, he describes how ultrasound can be introduced via a catheter, and then a balloon or other device administers treatment.

These and many more medical breakthroughs are on the horizon, and it’s certain the industry is only going to grow.

Stupecky offers this bit of advice for those interested in getting into the medical device industry. “Keep scanning new medical markets, keep in contact with doctors, because there must be a need for a product or procedure and that need is usually discovered by a doctor,” he says. “Doctors don’t know how to make a product, but they come up with ideas. I am always amazed at the excellent ideas physicians come up with.”

Copyright ©2005 Medical Product Manufacturing News

OutsourcingOutlook

Originally Published MPMN July/August 2005

Outsourcing Outlook

Prototyping and Rapid Prototyping


Digital Converting Technology Requires No Hard Tooling


Single- and multilayer substrates for the IVD and microfluidics market can be prototyped using digital converting technology. The Precision Medical Converting Group of LasX Industries uses LaserSharp to prototype with no hard tooling required. This allows for a noncontact process without die constraints. The technique is used throughout the design stage. As a result, the manufacturability of the device remains constant, resulting in decreased time to market. Through-cutting, kiss cutting, scoring, and perforating are preformed for feature sizes down to 100 µm with tolerances in the ±50-µm range. LasX Industries, White Bear Lake, MN www.lasxindustries.com


Functional Prototyping Speeds Time to Market

A thermoplastic injection molder and full-service supplier offers short-run through production components. More than 30 highly skilled mold makers provide functional prototyping. The company’s toolroom offers 36 toolmakers and is equipped with 13 CNC machines. The most complex parts can be prototyped in production resins and made available in 5 days. PTI Engineered Plastics Inc., Clinton Township, MI www.teampti.com


Company Installs a Controlled Environment Manufacturing Area

A company has devoted 2000 sq ft of its facilities to controlled environment assembly and final packaging. Design, development, and manufacturing services are available to medical device companies. Services range from brainstorming through concept and prototype development to the delivery of clinical, pilot, and market-release sterile products. Complex handheld devices are a specialty. TDC Medical Inc., Marlborough, MA www.tdcmedical.com


Laser Sintering Now Available for Rapid Prototyping

A company has purchased a laser sintering system and can provide its customers with accurate sintered nylon parts directly from their CAD data. The EOS machine enables the company to offer real nylon parts, suitable for direct manufacturing and prototyping applications, in a 2-day time frame in most cases. The firm specializes in high-quality stereolithography models, RTV molded urethane, and silicone castings. Protogenic Inc., Westminster, CO www.protogenic.com


Streamlined Organization Offers Product Development

A mechanical design engineering company uses engineer and designer teams and a network of diverse fabrication associates to reportedly minimize time to market and the cost of product development. Services include concept, design for manufacturing, and rapid prototyping of assemblies. Special machines and processes are offered for the manufacturing and assembly of the finished products. Device Development LLC, Buffalo, MN www.devicedevelopment.com


Quotes Available in 24 Hours

A company has set up a rapid prototyping center to accommodate quick turnarounds for prototyping needs. The firm uses its clients’ electronic files to eliminate errors and minimize time to market. Quotes are returned within 24 hours, and sheet-metal prototypes are shipped within 72 hours of the time the order is placed. All that is needed is a sheet-metal CAD model and all associated feature and component files. Materials must be readily available and the prototype cannot require outside services. Dayton Rogers, Minneapolis, MN www.daytonrogers.com


Company Offers High-Tolerance Plastic Part Prototypes

Working with aluminum tooling, a company can produce aesthetic and high-tolerance plastic parts. Threads, undercuts, and side actions can be accommodated by its prototype tooling program. Capabilities range from micromolded parts that weigh a fraction of a gram to larger 2-kg parts.
Customers can choose the exact plastic or elastomer needed for a specific application. A choice of colors is also available. Other services include insert molding, overmolding, and encapsulation. Deliveries arrive within days, according to the company. Mold Threads Inc., Branford, CT www.moldthreads.com


Rapid Tooling for Medical Devices Enabled Company to Jump-Start Testing

A company has developed an advancement in prototype tooling that has allowed its clients to get specified material parts quickly. This tooling application enabled St. Jude Medical to get a jump start on its testing and certification. The pictured parts were created using a family of tools designed to keep costs and lead times to a minimum. Custom color and laser marking were also applied to simulate production quality.

All the parts have undercut features, which are captured using manual slides and hand pick-outs. The first parts off the tools were shot in 2 to 3 weeks. The tools were modified to meet the required changes once the fit-ups were tested in assembly. Injection-molded parts from prototype tooling are often used to expedite testing before production tooling is released. Production tooling lead times can typically run 8 to 14 weeks. Vista Technologies, Vadnais Heights, MN www.vistatek.com

Copyright ©2005 Medical Product Manufacturing News

Packaging

Originally Published MPMN July/August 2005

SPOTLIGHT

Packaging

Contract packaging services

A manufacturer is FDA-registered for packaging and labeling medical devices and bulk pharmaceutical products. Products can be packaged in standard or custom glass or plastic bottles, pouches, tubes, canisters, or flamed, sealed ampules. Capabilities also include the handling and packaging of powders, gels, high- and low-viscosity liquids, creams, and sterile products from 1 to 2,800 g. Products are packaged in a Class 100 cleanroom. Polysciences Inc., Warrington, PA www.polysciences.com


Component packaging products

Packaging products are designed specifically for safe shipping and handling of medical devices. The product line is based on an ISO 9001:2000–certified manufacturer’s proprietary elastomer gel material, which provides a tacky, nonadhesive surface to securely hold small parts in place during transport. The material’s design eliminates the need for pockets or custom-molded packaging. One product is an integrated box system suited for handling medical components that are easily removed manually with tweezers or forceps, or by hand. The carriers are compatible with EtO and gamma sterilization methods, and can accommodate an array of device sizes and shapes. Gel-Pak, Hayward, CA www.gelpak.com


Plastic liners and containers

A manufacturer uses patented melting technology to produce plastic liners and containers. The Melt-Phase process uses precut billets cut on close centers, allowing for efficient use of plastic and minimized waste. Products feature thin wall thicknesses, deep draw qualities, seamless design, and flexibility. The company’s offerings include traditional and engineered thermoplastics that are heat and chemical resistant. The conception-to-production process can be completed in 3 to 5 weeks. pbm plastics, Newport News, VA www.pbmplastics.com


Inventory repackaging services

Inventory management services are designed to repackage and redeploy unused medical equipment.
A company cleans, sorts, inspects, repackages, and redeploys tens of thousands of opened but unused orthopedic devices, eliminating the cost associated with manufacturing new replacement parts. Commonly repackaged products include spinal, external fixation, and orthopedic trauma implants, and a range of surgical instruments. Millstone Medical Outsourcing, Fall River, MA www.millstonemedical.com


3-D modeling system

A rapid prototype machine is used to help customers build models of packaging products in hours. Part of a company’s line of CNC machines, solids software, and prototyping equipment, the machine can build small to medium-sized parts and models directly from 3-D drawings. The manufacturer can facilitate a sampling of packaging products and support a trial of the actual product concepts with the assistance of a sister company. Tray-Pak Corp., Reading, PA www.traypak.com


Pharmaceutical and medical bottles

A line of high- and low-density polyethylene narrow-mouth round bottles is available for pharmaceutical and medical applications. The series includes HD modern rounds (4–32 oz), HD/LD Boston rounds (0.5–16 oz), and HD/LD cylinder rounds (0.5–32 oz). Suitable for cough syrups, nutritional liquids, and powders, the bottles feature a variety of closure options, including child-resistant and continuous threaded systems. A range of liner materials is also available. Healthcare Packaging Group, O.BERK Co., Union, NJ www.oberk.com


Pouches, bags, and covers

Bags for oxygen bottles, pulse oximeters, and pacemaker monitors are among a company’s line of customizable medical packaging. Capabilities range from pouches for wearable devices such as pain pumps, epilepsy monitors, and ECG recorders to large covers for hospital carts and sick-bed mattresses. Products can be designed to include the customer’s logo or customized graphics. The company’s quality management system is compliant with the ISO 9001:2001 standard. SeamCraft Inc., Chicago, IL www.seamcraft.com


Automated package testing

A machine tests seal strength on medical device packaging and conforms to ASTM 1140-00 standards. The 2600 seal-strength tester performs burst and creep tests on a range of open or closed and porous or nonporous packages without complex parameter adjustments. Optional restraining plates meet ASTM 2054 standards. An integrity tester offered by the same firm facilitates visual verification of leaks in nonporous packages according to ASTM D-3078-94 standards. A vacuum pump and several test chamber sizes are available. Test-A-Pack Systems, Orchard Park, NY www.testapack.com

Copyright ©2005 Medical Product Manufacturing News

Motors and Motion Control

Originally Published MPMN July/August 2005

SPOTLIGHT

Motors and Motion Control

Step motors

A line of IP65-rated motors includes sizes 17 and 23. The series is suited for use in potentially damaging environments. The motors are totally protected against dust and are guaranteed to withstand low-pressure jets of water sprayed from all directions from a distance of 3 m. The coating on the motors is FDA approved. Lin Engineering, Santa Clara, CA www.linengineering.com


Cleanroom robot

A cleanroom robot has a cleanliness rating of Class 100. The LR Mate 200iB/5C is suitable for material handling for optical and magnetic media, flat-panel displays, clean injection molding, and other applications where particle emissions must be tightly controlled. Fanuc Robotics, Rochester Hills, MI www.fanucrobotics.com


Ceramic servomotors

Ceramic servomotors are available for precision motion control applications. The motors are suited for operation in standard, vacuum, and UHV environments. The design is offered in complete nonmagnetic versions with no intrinsic magnetic field, or in magnetic materials for use in such applications as MRI, E-beam, and ion beam. The direct-drive technology supports linear and rotary motion and positioning, minimizing parts and simplifying system design. Nanomotion, Ronkonkoma, NY www.shelley.com


Gearmotor with encoder

A miniature integrated dc motor, gear train, and encoder assembly measures 0.63 in. outer diameter by 2.46 in. long. The HG16-series dc gearmotor is available in 12 models with voltages at 6, 12, and 24 V, in combination with four gear ratios of 30:1, 60:1, 120:1, and 240:1. The rated torque varies from 3.47 to 6.94 oz-in. An optional miniature encoder enables the user to accurately position the gearmotor in increments of 75, 150, 160, and 200 positions per revolution. Gearmotor no-load speeds range from 390 rpm in the 30:1 model down to 60 rpm in the 240:1 model. Nidec Copal USA Inc., Torrance, CA www.copal-usa.com


Brushless torque motors

A series of brushless torque motors is intended for direct-drive applications in large-inertia load systems, such as diagnostic scanning and radiation therapy equipment. Megaflux motors are also suitable for small handheld medical devices. The units deliver stall torque ranging from 7mN•m up to 2020 N•m. Diameter sizes range from 19.3 to 792 mm. Custom sizes are available by special order. Emoteq Corp., an Allied Motion Co., Englewood, CO www.alliedmotion.com


Servo motor feedback system

A multiturn rotary encoder tracks absolute position over 4096 turns and features a minimum number of components to allow miniature and subminiature motor manufacturers to shorten the overall length of their products. The design of the gearbox includes only three stages of operation. The SKM 36 features technology that includes a track radius of 2 mm. This permits full scanning of the entire code disc that compensates for such errors common to conventional systems. Sick Stegmann Inc., Dayton, OH www.stegmann.com


Brush servo driver

A fully programmable dc servo driver and controller requires little or no tuning when used with most motors measuring less than 1.5 in. in diameter. The EZSV10 measures 0.95 ¥ 1.4 ¥ 0.6 in. A single four-wire bus can daisy-chain up to 16 dc motors simultaneously. The driver and controller accept high-level commands from a serial port to control motors at 1.5 A continuous, from 12 to 40 V. All Motion Inc., San Jose, CA www.allmotion.com


Integrated stepper motor

An integrated stepper motor and drive package is based on a NEMA size-23 motor. According to the company, the SMD23 is approximately half the cost of a conventional stepper motor and driver configuration. Unlike separate stepper motors and drives that are built independently of each other using parts and labor unique to each assembly process, the unit uses processors and engineering to reduce manufacturing time. Advanced Micro Circuits Inc., Terryville, CT www.amci.com

Copyright ©2005 Medical Product Manufacturing News

Metal Fabricator Gains CompetitiveAdvantage through Automation

Originally Published MPMN July/August 2005

PROFILE

Metal Fabricator Gains Competitive Advantage through Automation

An automated microabrasive-blasting and grinding system helps to meet growing demand for large batches of custom products

Integrating microabrasive blasting as a secondary step in the machining process requires precise positioning of the nozzles and the fixtures that hold the workpiece.

Family owned and operated since 1922, Popper Precision Instruments Inc. (New Hyde Park, NY; www.popperandsons.com) supplies OEM instruments, specialty probes for liquid-handling devices, and custom procedural needles, among other products. It has more than 1000 items in stock. Demand for custom products has surged over the years, to the point where individual products are now produced in batches of thousands at a time. This evolution has led the company to adapt its production processes.

“In an increasingly competitive market, efficiency is the key to survival,” says engineering manager John Perry. “Our goal has been to achieve this efficiency through automation.” One of the company’s recent projects in this regard combines single-step microabrasive blasting and grinding into fully automated process.

“Many of our products require custom cutting, grinding, end forming, and surface treatment,” says Perry. “Microabrasive blasting has become an integral step in our manufacturing process.”

Abrasive methods

Automation systems developed by Popper Precision Instruments can process 9- to 11-in. needle strips.

A refined form of sandblasting for precision manufacturing applications, manual microabrasive blasting has been used in needle manufacturing for decades. The process involves the use of high-pressure compressed air to force micron-sized abrasive media through a nozzle to affect a product’s surface. Various effects can be achieved by altering the pressure or the media. Surfaces can be deburred or textured without causing dimensional changes to the part, making microabrasive blasting an ideal tool for use on cannulae and other specialty needles, according to Perry.

Popper uses the technique to deburr the inner and outer diameters of cannulae, texture the blunt ends of needles to improve bond strength, improve the surface appearance of instruments, and impart echogenic properties to devices. Regarding the last application, Perry explains that customers increasingly request products that are compatible with ultrasound visualization. “Because modern ultrasound equipment is unable to easily pick up shiny surfaces, giving the needle or probe a matte surface allows the doctor to follow it on screen while it travels through the body,” he notes.

Microblasting typically has been conducted at manual workstations. “With the increased quantity and variety of products moving through the facility, it was in our best interest to automate,” says Perry. “When we are running small lots of approximately 250 pieces, a manual station is still the most cost-effective approach. But with production requirements growing to 500, 1000, or 10,000 pieces per run,” he adds, “manual blasting is just too slow and operator intensive.”

Trial and error

Popper initially identified the main factors of automation as uniform coverage, controlled blast time, and proper nozzle angle. Theories were tested by integrating the microabrasive blasting equipment into a cabinet equipped with tooling to hold the parts at the correct angle and location for complete coverage. The operator only needed to load and unload the needles.

“Based on initial test runs, we found that our blasting system was not robust enough for the demands that we were placing on it,” says Perry. “We worked with the equipment manufacturer to select an appropriate system for our needs. Selecting a system that has been engineered to operate in an automated environment is critical.”

Once the blasting unit was installed, company engineers began to customize the system to suit the application. “Initially, we had selected polyurethane abrasive hose for this system. It was the same material that we were using on our manual stations. Several bends were needed in the hose, and it quickly became apparent that the bends posed a weak link in our system,” explains Perry. The firm experimented with several materials before settling on stainless steel. While this meant that the lines would be limited to fixed positions, the stainless-steel lines last 10 times longer than their polyurethane counterparts, Perry adds.

Finding an angle

Automated deburring of needles using microabrasive blasting techniques requires two nozzles: one nozzle projects glass beads to kick out the burrs while a second one pushes them away.

To remove a burr from the heel area of a needle, the abrasive stream must strike at an exact location and angle. An experienced operator has an intuitive feel for this process. On an automated system, however, the nozzle must be held at the proper angle and distance from the grind to remove the burr. The nozzle angle controls how the stream of abrasive will strike the burr. If the nozzle is angled correctly, it will carefully lift the burr away from the needle and round the edge of the heel at the same time.

Proper nozzle distance also must be determined. As the nozzle is moved away from the part, the spray diameter increases. The nozzle must be placed so that the beads are focused on the burr, not the point.

In addition, nozzle shape must be considered. Microabrasive-blasting nozzles are available in many different sizes and shapes, from small round units to large rectangular ones. Rectangular nozzles increase the spray diameter in one direction without increasing the overall blast diameter.

“These variables were combined with pressure, abrasive flow rate, and blast duration to create the proper profile for our needles,” says Perry. “The complexity of integrating all of the variables was challenging.” In particular, automating operations that previously relied on the manipulations of a skilled operator was not as easy as it might seem. “We had to go back to the drawing board several times, studying masking and tooling to maximize production throughput,” says Perry.

The finished system uses two nozzles to deburr the needles. One nozzle projects glass beads to kick out the burrs, while the other one forces the burrs away from the needles. Pressure and bead flow are carefully controlled to avoid destroying the heel areas by creating a serrated edge.

“Our efforts in automation have led to a new level of production capabilities,” says Perry. “In needle applications, an operator now simply loads the tool, shuts the door, and hits the button. The fixture flips up and grinds out the primary angle on about 125 needles at a time. Then the grinding gear moves out of the way, and the fixture rotates the needles into position for blasting,” he explains. The blaster nozzles are programmed to slide down into position. One nozzle blasts at an angle, causing the burrs to lift up, and the other nozzle blasts straight down, separating the burrs from the grind. The grind mechanism then moves back in to cut the secondary angles for a sharp tip. The entire cycle takes only 2 1¼2 minutes.

Popper documents every job setup, from the size of the blast media to nozzle positions and distances. These data allow the firm to accelerate setup for new jobs. “We are able to review our notes and quickly determine the best parameters for a new product,” says Perry. “This formula is now part of our competitive advantage, and a valuable resource to our customers.”

Copyright ©2005 Medical Product Manufacturing News

High-Voltage Lithium Battery Powers Up Portable Devices

Originally Published MPMN July/August 2005

HOTLINE

High-Voltage Lithium Battery Powers Up Portable Devices

Corinne Litchfield

High-voltage AA-sized lithium batteries are suitable for use in portable medical devices.

A high-voltage, high-rate lithium battery is designed for use in portable medical devices. Tadiran Batteries (Port Washington, NY) has developed the TLM-1550HP to pack 2 Wh of energy at 4 V into an AA-sized cell. Its power capacity and small size makes it suitable for use in devices that require high power, long life, and extended storage, such as automatic external defibrillators, cauteries, resuscitation equipment, bone healers, and handheld surgical power tools.

The battery can handle pulses up to 15 A, with 5 A maximum continuous load. It offers long life in extreme environmental conditions, including a self-discharge rate of less than 3% per year at room temperature, and a temperature range of –40° to 85° C. The company also offers models that can withstand sterilization temperatures up to 125° C.

Solvents used in the battery are nontoxic and nonpressurized, and its anode material is less reactive than that found in other lithium cells, according to the company. Its safe design allows the battery to be shipped as a nonhazardous product. The unit also features a glass-to-metal hermetical seal, instead of a crimped elastomer gasket.

The battery has performed well in a variety of safety tests, including nail penetration, crust tests, high-temperature chambers, short circuits, and charge tests.

Tadiran Batteries

2 Seaview Blvd.
Port Washington, NY 11050
Phone: 516-621-4980
Fax: 516-621-4517
E-mail: sales@tadiranbat.com
URL: http://www.tadiranbat.com

Copyright ©2005 Medical Product Manufacturing News

RFID and Bar Code Reader Helps Increase Patient Safety

Originally Published MPMN July/August 2005

HOTLINE

RFID and Bar Code Reader Helps Increase Patient Safety

Susan Wallace

RFID wristbands for use in patient identification are produced using a RFID and bar code read and write unit.

A radio-frequency identification (RFID) and bar code reader is designed to improve the accuracy of patient identification and safety. The DR 1000 Dual Reader from Precision Dynamics Corp. (San Fernando, CA) can read or write to RFID wristbands and scan 1-D or 2-D bar codes. The tethered unit combines an RFID reader and writer and an imaging bar code scanner.

The device can reduce common manual data-entry errors, eliminate repetitive data entry during medical treatment, and parse data automatically to fill in appropriate fields on a form.

“In recognizing the need to facilitate the interoperability between RFID and bar codes, we developed a device that can read and write to an RFID wristband and read a bar code,” says Irwin Thall, the company’s manager for healthcare. “The DR 1000 will easily connect to point-of-care mobile carts and devices such as ECG machines, pulse oximeters, and infusion pumps—allowing for seamless and efficient patient administration, tracking, and care.”

Precision Dynamics Corp.

13880 Del Sur St.
San Fernando, CA 91340
Phone: 818/897-1111
Fax: 818/899-4045
E-mail: info@pdcorp.com
URL: www.pdcorp.com

Copyright ©2005 Medical Product Manufacturing News

Machine Spins Nanofibers in Industrial Quantities

Originally Published MPMN July/August 2005

HOTLINE

Machine Spins Nanofibers in Industrial Quantities

Norbert Sparrow

A rotating cylinder, in lieu of nozzles, enables the industrial-scale electrospinning of nanofibers.

A young company from the Czech Republic generated a great deal of electricity in Geneva, Switzerland, in April. Exhibiting at Index, the world’s largest nonwovens show, Elmarco (Liberec) demonstrated Nanospider technology, a variation on the electrospinning process. This decades-old technique extracts nanoscale polymer fibers from a charged jet of polymer melt. What drew the crowds to Elmarco’s stand was the unveiling of a machine that could do this on an industrial scale. The resulting materials have a range of applications. On the medical side, filtration and wound-care products are especially promising, according to the firm.

“Traditional systems use a nozzle-shaped spinning head to produce nanofibers,” explains marketing and sales manager Petr Kuzel. An electrostatic field competes with the polymer solution’s surface tension to form a Taylor cone. The fiber jet is drawn from the cone to a grounded plate, where the material collects in the form of a nonwoven mat composed of fibers with diameters between 50 nm and 10 µm.

The system’s architecture makes it “impossible to position several nozzles next to each other,” says Kuzel. “That limits the production quantities that can be achieved using the traditional method.” Researchers at the Technical University of Liberec (TUL) found a way to overcome this limitation.

“Nanospider technology produces Taylor cones in close proximity to each other on a cylinder,” says Kuzel. The cylinder is partly immersed in a polymer solution. A controlled amount of the polymer solution creates a thin film on the cylinder’s surface, where a number of Taylor cones are formed. The machine can produce nanofibers weighing between 0.1 and 10 g m2 in diameters ranging from 50 to 500 nm. Nanospider technology can produce 0.1 to 1g of material in less than 1 minute. By comparison, it would take as much as 1 hour to achieve the same result using traditional electrospinning techniques, says Kuzel.

Elmarco entered into a cooperative agreement with TUL in 2004 to refine the technology. The company holds the exclusive license for its development, production, and commercialization.

Although Elmarco is eyeing high-yield industrial applications, the resulting material’s unique properties make the technology of interest to medical partners as well. For example, nanofibers feature exceptionally small pore sizes and a large functional area combined with low weight. This makes them suitable for advanced filtration applications in medical equipment.

“Wound dressings are another area we are investigating,” says Kuzel. “We have completed some very promising tests on the use of biodegradable polymers to fabricate dressings and other healing materials.”

Elmarco’s primary objective is to sell equipment incorporating Nanospider technology. “But for some low-quantity applications where material properties are paramount, such as biomedical products, we may opt to keep production in-house,” says Kuzel.

Elmarco

V Horkach 76/18
Liberec
460 07 Czech Republic
Phone: +420 482 777031
Fax: +420 485 151997
E-mail: info@elmarco.cz
URL: www.elmarco.cz

Copyright ©2005 Medical Product Manufacturing News