Originally Published EMDM November 2005
SPECIAL REPORT
The Companies and Products of the Year
As the year winds to a close, EMDM is proud to present a selection of companies and products that have made a notable contribution helping medical device OEMs to design, manufacture, or market their products in 2005.
The product and service descriptions reprised here were selected based on requests for information through our reader service programme.
The companies highlighted in this section were chosen by the readers and editors of EMDM. Given the range of industries and technologies that we cover in this magazine, exhaustivity is an impossible goal. The firms featured here were brought to our attention because of their commitment to innovation; they are by no means the only ones deserving of recognition. With that in mind, we would like to take this opportunity to remind readers that we will soon begin accepting nominations for the 2006 companies of the year. Stay tuned.
Biocompatible Bearing Is Suited for Implants
Available from a motion control specialist that is a member of the Faulhaber Group is a four-point contact bearing that features a biocompatible design for implant applications. Derived from watchmaking technology invented by MPS Micro Precision Systems AG (Biel-Bienne, Switzerland), the ball bearing structure differs from radial ball bearings in that the raceway consists of four inclined planes. For biocompatibility, the rings and ball separator are made from a titanium alloy and the ceramic balls from a zirconium oxide called myrox.
This lubrication-free, space-saving contact bearing is suitable for miniaturization projects and offers the additional technical advantages of high efficiency and stable performance over time. It is designed to minimize play and ensure good behaviour in radial and axial loads. Each reliability-tested bearing is custom designed for the function it is to fulfill and in respect of mechanical and physical application constraints.
US FDA QSR Guide Published
A booklet on the US FDA quality system regulation (QSR) is offered free of charge to interested non-US medical device companies by a firm that acts as a US agent for such companies. Azary Technologies LLC (Huntington, CT, USA) assists in matters of FDA compliance as well, and helps clients prepare 510(k) device submissions.
Working with very large companies and with small start-ups, the firm has experience with cardiovascular, orthopaedic, neurological, gynaecological, surgical, imaging, radiological, x-ray, ultrasound, and sterile disposable devices, as well as software and other types of devices.
Water Jet–Guided Laser Cutting Improves Stent Fabrication
Cleanroom-compatible water jet–guided laser cutting reportedly eliminates many of the problems associated with conventional stent-cutting techniques. Manufactured by Synova S.A. (Ecublens, Switzerland), the LCS 300 laser cutting system minimizes heat damage and the amount of debris, facilitates the deposition process, and can streamline secondary processes.
Cut out from planar sheets or tubes, stents have to meet stringent manufacturing standards due to safety and compatibility requirements. “The surface quality and tube strength are critical, as stents are to be placed inside vessels for a long time,” says CEO Bernold Richerzhagen. “Therefore, the potential causes of material damage during stent cutting must be minimized.
“Minimizing thermal damage is particularly important,” stresses Richerzhagen. Moreover, the stents’ intricate structure and complex curvature require a fast, clean cut. Biocompatibility is also crucial, and an appropriate surface finish makes it easy to apply drug-eluting coatings.
Conventional laser cutting processes tend to leave debris. They also may cause material damage incurred by heating, as shown in the accompanying photo (on page 37), necessitating substantial postprocessing, often involving sandblasting and chemical etching. It is more productive to obtain the prerequisite quality during the initial cutting step, according to Synova, or at least to minimize the need for electropolishing to round off the edges.
The LCS 300 is based on Laser-Microjet technology, a hybrid of laser cutting and water-jet techniques that results in clean cuts. A high-power pulsed laser beam is coupled into a hair-thin low-pressure water jet. Within the water jet, the beam is guided by the total internal reflection at the water-air interface. The jet ensures a consistent spot diameter and consequently enables a single centimetre-long focus. The water jet guides the laser beam as it cuts the metal, cooling the edges and producing clean kerfs.
Single-Chip Wireless Platform Designed for Use in Medical Technology Products
Control and communications radio architecture developed by an engineering and consulting firm is suited for use with implants and other medical products. Introduced by Cambridge Consultants (Cambridge, UK), SubQore is designed for system-on-chip integration. It operates on the Medical Implant Communications Service (MICS) frequency, which is emerging as the global medical band standard.
“Advances in electronics technology are [driv-ing] a host of new implantable applications,” says Richard Traherne, head of Cambridge Consultants wireless business unit. SubQore’s design, he adds, draws on three of those trends: very low power consumption, smarter performance, and miniaturization. “Combined with the opportunities offered by the MICS frequency, we see great demand for a single-chip wireless platform [suited] for mass-volume medical products.”
Low power consumption was a key factor in the design of SubQore. It consumes an average current of less than 1 µA (1.7 mA peak) for a 0.05% duty cycle and 400 Kb/sec bidirectional communications rate. In a typical pacemaker, the unit would deliver more than 10 years of activity from a lithium cell, notes the consultancy, yet the device is equally capable of transmitting high volumes of data in short bursts. When it is implanted under the skin, it has a 2-m communications range.
Applications envisaged by Cambridge Communications include implantable pacemakers, defibrillators, remote telemonitors, orthopaedic devices, pump controllers, nerve stimulators, and swallowable diagnostic products. The firm plans to fine-tune the integrated chip core for individual applications.
Technique for Joining Nitinol and Stainless Steel Reduces Guidewire Production Costs
Because of its flexibility, nitinol is routinely used to fabricate guidewires and related devices. The material, however, carries a hefty price tag. Engineering organization EWI (Columbus, OH, USA) has developed a patent-pending technique to join nitinol with stainless steel, and thus reduce the amount of nitinol needed in certain products.
By using nitinol only at the very end of a guidewire where it is most beneficial, device manufacturers can achieve cost savings, according to EWI. The joining technology, which was developed internally, paves the way for the design of more-reliable and economical devices, adds the organization.
The device industry is often more reluctant than other sectors to partner with outside groups, says Dale Robinson, director of commercial sales and marketing. “But market growth is spurring a need to expand R&D,” he says, “and outsourcing can be a good solution for many firms.” EWI’s expertise in metallurgy and materials joining makes it an attractive research partner for international product developers, adds principal engineer Peter Hall.
A paper authored by Hall on the topic, titled “Microjoining Technologies for Scale Up to Automated Manufacturing,” is available from EWI for reference.
Biosensor Platform Offers Contact-Free Monitoring of Vital Signs
In the healthcare industry, determining what medical needs exist is just as critical as creating technology to address those needs. Nexense (New York, NY, USA) has developed a platform that can be integrated into cost-efficient sensors and sensor-based systems to extract and report vital-signs data in real time. The recently patented technology provides precise, noncontact measurement of predetermined parameters, such as temperature and pressure.
The technology is based on the internal propagation of a cyclically repeating energy wave from a primary location that is received at a secondary location. The sensor detects a preset reference point in the energy wave and continuously changes the frequency of an exciter until the number of waves equals an integer. The change in frequency enables measurement of the parameter of interest.
The technology offers high accuracy and sensitivity in a platform that is amenable to incorporation in an external sensing instrument. It includes an alert function and can be equipped with a memory chip to store readings of vital functions. A recently developed example of one such device is the PartnerCare Nexaver, which monitors a couple’s vital signs as they sleep, notifying one person whenever it detects abnormal signs in the other.
Executives at Nexense acknowledge that high levels of accuracy and sensitivity often correlate to escalating costs. However, they emphasize that one of the PartnerCare’s advantages is its cost-effectiveness, made possible by the design of the core technology platform.
“Nexense’s applications use the same core technology platform as a building block, so no development starts from scratch. We can provide simple to extremely complex solutions within a quick-to-market time frame, and this translates directly into cost savings,” says vice president Asialee Huang. “Nexense also has the ability to provide sensor-less sensing. This means that the materials we use are low cost and often the element to be sensed acts as the sensor itself.”
CD-ROM Features Rubber Compound Selection Tool
Unlike metals and plastics, rubber does not have straightforward universal design criteria, according to a firm that specializes in rubber compounding and moulding services. To assist manufacturers in materials selection, Rubber Industries Inc. (Shakopee, MN, USA) has published a free selection guide on CD-ROM.
The disk presents a brief description of the most popular base polymers along with their durometers and useful temperature ranges, properties, typical applications, and cost. The CD-ROM includes a selection tool that allows users to focus on a material’s hardness, fluid resistance, temperature resistance, abrasion resistance, shrinkage, elongation, modulus, or cost. Compounds suitable for fluid applications are also covered in the guide.
Guide Presents Overview of IEC 60601-1
An introduction to the international safety standard for medical equipment, IEC 60601-1, has been published by a manufacturer of biomedical testing instruments. Available free of charge from Rigel Medical (Peterlee, Co. Durham, UK), the 24-page booklet deals specifically with the section of the standard related to medical equipment that is used in patient monitoring and treatment.
The standard’s requirements are explained in easy-to-follow terms, and commonly used definitions and symbols, various leakage measurements, pass/fail limits, and single fault conditions are also profiled. Although IEC 60601-1 is a manufacturing safety standard, its test specifications and limits are also used to ensure that equipment remains safe once it has been put into use in a medical environment.
Carbon Coatings Achieve Diamond-Like Properties
Diamond-like carbon coatings provide chemical resistance, low friction, electrical insulation, and biocompatibility. Morgan Advanced Ceramics (Munich, Germany) uses plasma or ion-beam chemical vapour deposition technologies to create the coatings, which exhibit chemical and physical properties similar to those of diamond.
Suited for catheters, surgical instruments, implantable joints, medical instrumentation, and packaging, the coatings are applied at near-ambient temperatures, thereby maintaining dimensional tolerances. They can be supplied in either electrically insulating or charge-dissipating forms and can be engineered to meet the specific performance requirements of each application.
Microfluidic Manifolds Are Free of Solvents and Adhesives
Diffusion bonding is used to produce complex manifold assemblies without the use of solvents or adhesives. Carville Ltd. (Dorking, Surrey, UK) produces the acrylic manifolds with internal tracks down to 0.006 in. The tracks can be machined in various lengths and patterns to create precise fluid volumes with mixing chambers and reservoirs. Valves, pumps, seals, and fittings are used to enhance chips. Both single-unit prototypes and high-volume production quantities can be accommodated at the company’s manufacturing facility.
Double-Coated Films Suited for Composite Devices
Designed for use in medical devices where skin contact is possible though not intentional, a polyester film double-coated with hypoallergenic medical-grade adhesive provides medical designers with a means to assemble composite devices such as diagnostic sensors, surgical drapes, and dental dams.
The TM9720 film offered by MACtac Europe S.A. (Soignies, Belgium) is constructed of MP-597 skin-friendly adhesive, a 0.5-mil clear polyester film carrier, and a 70-lb densified semibleached kraft release liner. It can be used to assemble products made from such base materials as plastic film and sheet, thin-gauge foils and metals, and woven and nonwoven fabrics and foams. Manufactured in compliance with ISO 10993, the adhesive has passed cytotoxicity studies, primary skin irritation studies, and repeat-insult patch tests.
Quick-Disconnect Coupling Simplifies Tubing Assembly
A miniature plastic quick-disconnect fitting is designed to simplify tubing connection during assembly of fluid-control systems. The patented F-4150-series 10-32 UNF male-threaded coupling is available from Air Logic (Racine, WI, USA) in straight, elbow, and tee barb configurations. Depressing the latching push button enables the barb to be removed, while simply reinserting the barb locks it into position.
Barbs can be provided for tubing with inner diameters of 1¼16, 1¼8, and 0.170 in. The unit’s design allows the fitting to swivel 360°.
Mass-Produced Metal-Injection-Moulded Parts Feature Uniform Microstructures
Industrial volumes of complex-shaped metallic components weighing 0.5 to 100 g can be manufactured by means of metal-injection moulding (MIM) by an ISO 9001:2000–certified specialty company.
Offering development expertise, value-added customer service, and process-oriented quality management, Parmaco Metal Injection Molding AG (Fischingen, Switzerland) produces smooth high-density, high-tolerance parts from iron-nickel alloys, stainless steels, soft magnetic alloys, Kovar, low-alloy steels, and tool steels for medical device, electronics, and other manufacturers. The MIM process results in components with a uniform microstructure, good precision and shape retention, precise reproduction of structural details, and good unpolished surface quality. Tolerance without rework is +0.3% of blueprint dimensions, and density of a moulded part is between 96% and 100% of theoretical.
Foot Switches Designed for Medical OEMs
Single- and multipedal foot switches are designed on a custom basis for medical device manufacturers. Herga Electric Ltd. (Bury St. Edmunds, Suffolk, UK) offers customers a wide choice of plugs, sockets, and electrical ratings; the products can be distinguished by corporate colours and logos. Switches are manufactured to comply with the standards of IEC 60601 for medical equipment.
Copyright ©2005 European Medical Device Manufacturer
