There will be an international focus at Medical Design & Manufacturing
'96, the premier West Coast conference and exposition devoted to the design and
manufacture of medical products. Officials of China's Ministry of Health and the
U.S. Department of Commerce will present a detailed review of China's healthcare
system and a look at opportunities for U.S medical device manufacturers in
China. The session entitled, "The Chinese Medical Market: Opportunities for U.S.
Manufacturers," will highlight a number of programs specifically designed for
medical professionals with interests in international markets.
The Chinese market, which is expected to exceed $1 billion this year, is seen as a major growth opportunity for U.S. manufacturers. Officials of the Ministry of Health will present overviews, including "Overview of the Chinese Healthcare System." Paul E. Barry, an international trade specialist at the DOC, will speak on "U.S.-China Government Initiatives."
Attendees of the conference will also benefit from the technical knowledge of the industry's premier associations. Among the highlights will be a daylong session on auditing strategies and techniques, presented by the American Society for Quality, Biomedical Division. The Metal Injection Molding Association, a trade association of the Metal Powder Industries Federation, will introduce the technology of metal injection molding, offer criteria for components suitable for the process, and enumerate properties and applications of its materials.
In a breakfast round table, John Stigi, director of the Small Manufacturers Assistance Division of the Food and Drug Administration, will address the latest FDA requirements for medical design and manufacturing, such as executive responsibilities under the forthcoming new Good Manufacturing Practices regulation, the new design controls, and premarket clearance timeframes.
MD&M West management anticipates 800+ international exhibitors to show off their latest products and services in the medical field. This conference and product exposition is sponsored by Medical Device & Diagnostic Industry magazine, which is published by Cannon Communications Inc.
Seals and gaskets
Precision-cut seals and gaskets are used in various disposable devices such as infusion pumps, specimen vials, and connectors. Products are manufactured and washed in an environmentally controlled clean room, designed to meet the strict cleanliness requirements of the medical industry. The seals are offered from USP Class VI, as well as CFR 21 177.2600 silicones. The outside diameter ranges from 0.020 to 2.500 inches, the inside diameter ranges from 0.010 to 2.200 inches, and the cut thickness ranges from 0.015 to 2500.0 inches.
Parker-Hannifin Corp., JBL Div.
Spartanburg, SC 29302
FAX (803) 583-4299
C10-series miniature seals provide low friction and consistent sealing performance in very small diameters, from 0.020 inch, and cross sections, from 0.015 inch. Fluid seals are made of Teflon(R) PTFE and PTFE compounds for low breakout and running friction. Applications include sealing syringes, pipettes, catheters, diluters, and other dispensing devices. The seals can operate in vacuum to 10,000 psi and temperatures from -420 to 500F. Spring materials include 302 and 316 stainless steel, nickel alloys, and titanium.
Bal Seal Engineering Co. Inc.
620 W. Warner Ave.
Santa Ana, CA 92707
FAX (714) 241-0185
Miniature clamps are for clamping lines (hose, tubing, and cable) as small as 3.3-mm O.D. They are suited for tamper-proof connections for service applications and the medical appliance field. The three styles of miniature clamps available include the basic 2-Ear crimp-on clamp, the 1-Ear Special, and the 1-Ear Stepless(R) for a complete 360-degree seal.
Marlette, MI 48453
FAX (517) 635-2157
Mini-Baraton(R) pressure transducers are used in medical manufacturing and testing applications including thin film deposition, plasma surface modification, filter monitoring/testing, sterilization processes, leak testing, and in-production calibration equipment. MKS 700 Series pressure transducers are available in both gage and absolute full-scale ranges and feature a usable resolution of 1 part in 10,000 so that a single instrument can be used to measure a wide dynamic range.
MKS Instruments Inc.
6 Shattuck Rd.
Andover, MA 01810
FAX (508) 975-0093
A PC family of pressure transducers is available in four package styles, eight ranges, and six porting options. These units provide calibration and temperature compensation in mV outputs and offer up to 0.5% accuracy in eight pressure ranges, from 4-inch WC to 100 psi Absolute; gauge and differential versions are available. All package styles are suitable for PC mounting and several are identical to competitive units for second sourcing, while one is a high performance alternative to DIP packages.
Data Instruments Inc.
100 Discovery Way
Acton, MA 01720
FAX (508) 263-0630
Non-stretch silicone tubing incorporates all the properties found in silicone with the exception of elasticity, thus creating high-strength tensile members. Wire or other conductive or tensile material is co-extruded within the wall of the silicone tubing, eliminating silicone's ability to stretch. By incorporating high- or low-voltage conductive elements, the tubing can be used in electrosurgical instruments. Other applications range from brain pressure to knee ligament devices.
5400 Frankline Dr.
Franklin, WI 53132
Thin-wall (0.001 inch), stainless-steel, and precious-metal tubing can be cut square and burr-free to precise short lengths by a new cutting method. This method uses thin, abrasive wheels and a proprietary support system to make cuts with no burrs on either the ID or OD. Lengths can be held to 0.0001 inch. This method can cut any small diameter (under 1-inch) thin-wall metal tube with no end distortion.
Metal Cutting Corp.
59 Village Park Rd.
Cedar Grove, NJ 07009
FAX (201) 239-6651
APC-1000 portable airborne-particle counter is for the detection of particulate contamination. It is a hand-held, battery-operated unit with a clearly labeled front panel for easy operation. The APC-1000 simultaneously measures total particles or particles per cubic feet at 0.3, 0.5, 1.0, and 5.0 microns, while also measuring temperature and humidity. Battery operation provides up to eight hours of continuous use between recharges. Up to 200 measurements are automatically stored in memory with the date, time, and sample count, for later onscreen review or downloading to a PC.
Biotest Diagnostic Corp.
66 Ford Rd., Suite 131
Denville, NJ 07843
FAX (201) 625-5882
Model N86 diaphragm vacuum pump provides 6.5 liters/min flow and 27-inches Hg end vacuum in a compact, oil-free package. It features a patented, FEA-designed structure molded into the diaphragm that controls flexibility; and a multi-port valve system that increases flow, gas-tightness, and reliability. Some models are available to 29.8-inch Hg vacuum, for use wherever deep vacuum in a compact, oil-free package is required.
KNF Neuberger Inc.
Two Black Forest Rd.
Trenton, NJ 08961
SPRINT four-channel concurrent tester can test four products--or four parts of the same product--at the same time using independent test circuits contained in one small enclosure. It can be used for bench or automation applications to increase testing throughput. The tester can detect a pressure loss of 0.02 inches of water in a pressure range of 1 to 60 psi, it can alsomeasure mass flow in 0.01 increments up to 200 sccm. Flow rates as high as 20,000 sccm are possible with the tester.
Industrial Data Systems
2370 S. 2700 West
Salt Lake City, UT 84119
INTEGRA Peel PLP-019 is a cost-effective material for lidding. This 70-lb reinforced paper provides breathability and strength with an air-knife, heat-seal coating. PLP-019 seals both rigid and flexible bottom webs on either platen or rotary equipment.
Rexam Medical Packaging
175 E. Hawthorne Pkwy., Suite 102
Vernon Hills, IL 60061
FAX (708) 918-4668
Model 1500XL-15 dispenser uses a timed air pulse to apply precise, repeatable amounts of cyanoacrylate to catheter marker bands, for significant improvements in process control and product quality. The unit features a 0 to 15 psi regulator, for accurately controlling air pressure at the lower settings needed to dispense thin fluids. Dispensing times as brief as 0.001 seconds are easily set and repeated with the microprocessor-controlled timer. This combination of consistent, repeatable air pulses and exact dispensing times eliminates variations in deposit size that can interfere with product performance and reliability.
977 Waterman Ave.
E. Providence, RI 02914
FAX (401) 431-0237
Pouch sealing machines
The MED PAC is an impulse pouch sealer that gives precise hermetic seals. Control alarms for time, temperature, and pressure parameters are standard on the machine. These controls can be calibrated and validated in medical packaging applications. Model 522 and 555 are continuous bandsealers with built-in control parameters, such as heat bar temperature, conveyor and sealing belt speed, and pressure roller readouts. Many options are available for both machines, and custom machinery for unique applications can manufactured.
Packaging Aids Corp.
San Rafael, CA 94912
FAX (415) 454-6853
Clear, thermoformed packaging reduces sterilization residence time by withstanding heat up to 270F without deformation or degradation. The packages are made of Makrofol PCEE 400 polycarbonate film with a tensile stress break that of 10,500 psi, and a flexural modulus is 330,000 psi. The clear film provides optical transmittance of 89%, with haze of less than 1%.
Pittsburgh, PA 15205
Model CT16 programmable temperature controller can perform as a simple indicating temperature alarm, as well as an autotune PID control with dual setpoints. Optional fuzzy logic software draws on artificial intelligence techniques to improve control responsiveness in unpredictable or unstable systems. The CT16 accepts input from three RTD or ten thermocouple types, all field selectable, with outputs via a 3.5-A solid-state or mechanical relay. It can control pressure, flow, pH, or other variables by means of 4 to 20 mA transmitter output. Other standard features include 100 to 240V ac supply power, non-volatile memory, C/F display, and multi-level security.
Minco Products Inc.
7300 Commerce Lane
Minneapolis, MN 55432
0816 Series motors are available in 3-, 6-, and 8V dc versions and are capable of output power up to 0.18W and stall torques of up to 0.06 oz-in. Mating planetary gearheads with ratios from 4:1 up to 4,096:1 affords maximum output torques to 8.5 oz-in continuous, and up to 120 oz-in intermittent with gearhead efficiencies of up to 90%. Six different ratios are available. Both the motors and gearheads come standard with sintered bearings and optionally with ball bearings. No-load motor speeds range from 15,800 to 17,800 RPM depending on coil version.
MicroMo Electronics Inc.
14881 Evergreen Ave.
Clearwater, FL 34622
FAX (813) 573-5918