company capabilities (dunn industries inc.-hi-tech group).

Dunn Industries Inc. 123 Abby Road Manchester, NH 03103 Phone: (603) 666-4800 Fax: (603) 666-4884 E-mail: info@dunnindustries.com Web: www.dunnindustries.com VITAL STATISTICS Year Founded: 1987 Number of Employees: 15 Number of Facilities: 1 WHO WE ARE [ILLUSTRATION OMITTED] Dunn Industries Inc., a manufacturer of thermoplastic tubing for the medical device industry, offers prototyping through production services.

The company manufactures single or multilumen tubing up to 0.400 in. OD accurately and consistently to customer specifications. Dunn Industries also offers bump tubing, striping, coextrusion, and over-extrusion.
ISO 9001:2000 certified.
MAJOR MARKETS Medical, Pharmaceutical, Aerospace, Marine, Telecommunications, Industrial SERVICES OFFERED Medical grade tubing produced from a wide variety of engineering thermoplastics including: Acetal, Tecoflex[R], Polysulfone, Polyester, Pellethane[R], Lexan[R], Plexiglas[R], C-Flex[R], Texin[R], Polypropylene, Rilsan[R], EVA HDPE, LDPE, LLDPE, PETG, Pebax[R]., Isoplast[R],, Hytrel[R], or YOUR CUSTOM COMPOUND. [ILLUSTRATION OMITTED] Dunn Industries is your custom extrusion specialist capable of a wide variety of applications in tube sizes as small as OD's 0.
010" x ID's 0.
005" and as large as 0.
250".
When size is critical, we have the expertise, backed by our solid reputation to get the job done to your specifications on time and within budget. Your guarantee is Dunn Industries' Quality Policy, which is to exceed the demands and expectations of our customers by the continuous pursuit of unsurpassed quality in our products, service and relationships. Just Minutes from the Manchester, NH airport, Dunn Industries Inc.
's state-of the art extrusion facility allows us to better serve our customers throughout the U.S. and around the world. Our ongoing flexibility and reliability to accommodate the needs of the fast changing medical field, coupled with our experienced staff and superior equipment gives Dunn Industries the critical edge in meeting your exacting demands. For more information, a prompt price quotation and samples, Please contact us today.
www.
dunnindustries.
com [ILLUSTRATION OMITTED] Eagle Stainless Tube & Fabrication Inc. 10 Discovery Way Franklin, MA 02038 Phone: (800) 528-8650 Fax: (508) 520-1954 E-mail: generalsales@eagletube.com Web: www.eagletube.com VITAL STATISTICS Year Founded: 1982 Number of Employees: 70 Number of Facilities: 1 WHO WE ARE [ILLUSTRATION OMITTED] Franklin, Massachusetts based Eagle Stainless Tube & Fabrication, Inc.
is celebrating its 26th year of operation serving customers in medical, aerospace and high tech manufacturing. With a record of on-time delivery, fair pricing, product quality and highly skilled employees dedicated to continuous improvement and training, Eagle has earned its reputation as a supplier of choice of off-the-shelf stainless steel products and fabricated stainless steel components. With Eagle as an ISO 9001:2000, AS 9100:2000 certification and Six Sigma initiative driven manufacturing plant, you can be assured that every member of our staff is concerned with the quality of every product at every step of its journey through our plant.
MAJOR MARKETS * Medical * Aerospace * High tech manufacturing SERVICES OFFERED * Stainless steel tubing shipped from extensive inventory (Tubing, Bar Stock, Hollow Bar, Pipe, Flanges, Fittings, Custom Sizes and Shapes) * Precision cut-to-length tubing * Custom fabricated stainless steel components * Custom shaped and sized tubing * Stainless steel metric tubing * Square and rectangular tubing * Bending, Cutting, CNC Machining, Laser Welding & Cutting, Grinding, Assembly, and more. Eagle specializes in Stainless Steel, High Nickel Alloy and Titanium Components. There is no Voicemail! When you call Eagle expect to talk with a friendly professional who speaks your language and is prepared to respond to your needs.
Whether you need specifics on our capabilities or details on our inventories, you will get answers immediatley! www.eagletube.com [ILLUSTRATION OMITTED] EDGE Medica 1071 Lindenhurst Road, PO Box 1376 Newtown, PA 18940 Phone: (215) 579-5700 Fax: (215) 579-7350 E-mail: info@edge-pdc.com Web: www.edgemedica.com VITAL STATISTICS Year Founded: 1985 Number of Employees: 30 Number of Facilities: 2 Annual Sales: $4 Million WHO WE ARE [ILLUSTRATION OMITTED] EDGE Medica is an ISO 9001-2000 certified design and engineering firm adhering to FDA CFR Title 21, Part 820 Design Controls and Quality Systems Regulations.
EDGE Medica develops electromechanical and oem single use, disposable medical devices for early stage, venture funded stark up companies and industry leaders. EDGE Medica provides a team of experienced professionals to help get your medical product to market--fast. Our approach to innovation is working with strategic partners, early on, and leveraging an experienced, multi-disciplinary team to a development program from the initial concept through production.
MAJOR MARKETS * BIOTECH/LABORATORY EQUIPMENT: Anthrax Detector, Cell Culturing Systems * INTERVENTIONAL CARDIOLOGY: Stent Introducers, Arterial Closure Device, Endoscopic Vessel Harvesting * ONCOLOGY: Biopsy Devices, Thermal Ablation Catheter Systems * NEUROLOGY: Transcranial Magnetic Stimulation * ORTHOPEDICS: Orthopedic Implant Guide, Spinal Disc Fixation Systems * OPHTHALMOLOGY: Ophthalmic Laser Systems * DRUG DELIVERY: Fluid Warmers, Safety Syringes, Dry Powder Inhaler, Needle Free IV Access Device * PATIENT MONITORING AND DIAGNOSTIC DEVICES: Digital Ultrasound Systems, Neonatal Care Equipment, Blood Analyzers SERVICES OFFERED [ILLUSTRATION OMITTED] Engineering * Technology assessment/evaluation and recommendations--Software development and systems integration * T Wireless technology * Mechanical Engineering--Mechanisms--Electromechanical Kinematic studies * Electrical Engineering--Embedded controllers--Analog, Digital, and Opto-electronics--Signal acquisition and processing * CAD modeling and FEA analysis * Fluidics and Optics design * PCB design and layout * Bio-Chem sensor design and Biocompatability * Higher performance materials / Composites * Enhancing device performance * DFM / DFX Design * Market and user research * Product discovery through task analysis and product use scenarios * Human factors engineering and ergonomic studies * Concept generation * Generating attractive, sales driving product aesthetics * Developing a consistent family look and feel for entire product lines * Complex geometry CAD surfacing * Graphical User Interface design Models and Prototypes * Quick breadboard prototypes for "prod of principle" demonstrations * Appearance models to sell device technology to customers and investors * Engineering prototypes for testing * Pre-production prototypes for field evaluation www.edgemedica.com EFD, Inc. 977 Waterman Avenue East Providence, RI 02914 Phone: (800) 556-3484; (401) 434-1680 Fax: (401) 431-0237 E-mail: info@efd-inc.com Web: www.efd-inc.com/pr/mddi-1207.html VITAL STATISTICS Year Founded: 1963 Number of Employees: 280 Number of Facilities: Worldwide WHO WE ARE [ILLUSTRATION OMITTED] For more than 40 years, EFD has been the world's leading manufacturer of precision dispensing systems for applying controlled amounts of adhesives, sealants, lubricants and other assembly fluids.
By providing a reliable, cost-effective way to apply the same amount of assembly fluid on every part, every time, we have helped thousands of companies in hundreds of industries increase yields and process control, reduce rework and rejects, and lower their production costs. MAJOR MARKETS Medical device manufacturers throughout the world rely on EFD's precision dispensing systems to apply assembly fluids in controlled, repeatable amounts. Our customers find that consistent application of cyanoacrylates, adhesives, epoxies, silicones, coatings and other fluids helps them build catheters, cannulas, stents, test strips, pacemakers and surgical tools better, faster and more costeffectively, with greater process control and less worker fatigue.
SERVICES OFFERED Innovative products, superior quality, experienced technical support and on-time delivery have made EFD the recognized leader in precision fluid dispensing technology. Products include: * Air-powered and positive displacement dispensers for making benchtop assembly processes more consistent. * Reliable, low-maintenance dispense valves that increase yields and reduce downtime on automated production lines.
* XYZ dispensing systems for automated tabletop processes. * Disposable components (syringe barrels, pistons and needles) that bring exceptional quality and consistency to processes ranging from product assembly to flushing catheters with saline to dispensing viscoelastic materials and monomers in ophthalmic applications. * High-quality solder pastes that improve first-pass yields in electronics assembly processes.
[ILLUSTRATION OMITTED] All components are precision molded in EFD's own silicone-free, latex-free US facility. To prevent residual contamination, no mold release agents are used in the manufacturing processes. www.efd-inc.com/pr/mddi-1207.html [ILLUSTRATION OMITTED] Elcam Medical Inc.
2 University Plaza, Suite 620 Hackensack, NJ 07601 Phone: (201) 457-1120 Fax: (201) 457-1125 E-mail: info@elcam-medical.com Web: www.elcam-medical.com VITAL STATISTICS Year Founded: 1970 Number of Employees: 200 with over 20 Engineers Number of Facilities: 3 WHO WE ARE [ILLUSTRATION OMITTED] Elcam Medical is the leading worldwide OEM supplier of fluid management, drug delivery, and vital signs monitoring systems and devices. In providing "Ideas to Solutions", Elcam is an innovative customer-centric, full-service partner with capabilities ranging from design through manufacturing with particular expertise in high volume precision molding, high speed assembly and laser applications.
In addition to our core products and capabilities, Elcam is now offering custom design and subassembly services. Our customers consist of the largest medical device and pharmaceutical companies in the world. For over 30 years, Elcam consistently provides high quality products at competitive prices, all delivered on time.
MAJOR MARKETS Elcam serves the critical care, anesthesia, IV-therapy, interventional cardiology, interventional radiology, and pharmaceutical markets. SERVICES OFFERED [ILLUSTRATION OMITTED] Our Products: * Stopcocks--standard 1, 2, 3, and 4-way, swabbable, large bore, high pressure, anti-microbial, and many custom options available. * Manifolds * Needleless--slit septum and cannulas * Angiographic and PTCA Valve Devices * Disposable Pressure Transducers and Flush Devices * Auto-Injectors for pharmaceuticals * Caps--vented and nonvented Our Capabilities: * High-volume precision injection molding * High-speed automated assembly * Laser drilling * LIM molding * Soldering * Packaging * Hand assembly * Design & development * Ultrasonic welding [ILLUSTRATION OMITTED] Newest capabilities: * Custom designs * Subassembly services Our Commitment: * Consistent quality for over 30 years * Customer satisfaction for superior service and outstanding communication * Strong engineering support * On time delivery * Safety stock programs/consignment * In-house Regulatory support Please visit our website (www.
elcam-medical.
com) for more information on our components, sub-assemblies, and complete turnkey solutions. www.elcam-medical.com Endicott Interconnect Technologies, Inc. 1093 Clark Street Endicott, NY 13760 Phone: (866) 820-4820 Fax: (607) 755-7000 E-mail: ttaro@eitny.
com Web: www.
endicottinterconnect.
com VITAL STATISTICS Year Founded: 2002 Number of Employees: 2,1 O0 Number of Facilities: 2 Annual Sales: $363 Million WHO WE ARE [ILLUSTRATION OMITTED] Effective vertical integration differentiates Endicott Interconnect from any supplier in the electronics packaging industry. We are experts in the fabrication and assembly of complex printed circuit boards, advanced flip chip and wire bond semiconductor packaging and precision equipment manufacturing and integration. We also provide the unique services that complement these offerings; design and layout, thermal, electrical and mechanical modeling, reliability and environmental testing and physical analysis.
These products and services are available at any stage of the product life cycle, from concept through end-of-life and quick turn and prototype capability are embedded within the core manufacturing operations. This offers our customers perfect and seamless extendibility from prototype, preproduction and production phases without the headache of shifting facilities, processes and support personnel. MAJOR MARKETS Military/Defense, aerospace, medical, IT and server, semiconductor, advanced test equipment.
SERVICES OFFERED Our solutions deliver leading edge technology and best-in-class quality, performance and reliability. Products include printed circuit board fabrication, electronic manufacturing assembly services, semiconductor packaging substrate fabrication and integrated circuit assembly services. [ILLUSTRATION OMITTED] While uncommon today, Endicott Interconnect is committed to developing new processes, technologies and techniques that enable progress in the electronics industry.
Our continual investment in R&D serves to advance our technology leadership position and results in a truly visionary roadmap. Since the inception of the company in November 2002, we have applied for over 76 US patents and more than 36 have been awarded to date. Our advanced technology roadmap takes us to the year 2020 and we continue to grow and nurture our consortia relationships with academia to support our long range technology efforts.
El's Advanced Lab Services is a powerful combination of people, equipment and expertise whose mission is to add insight and value to product life designs, qualifications and life extensions. We provide comprehensive support services including mechanical and physical design and applications engineering, advanced laboratory services, world-class turnkey manufacturing and R&D. It's part of our continued commitment to provide our customers with support to complement our products and services.
www.
endicottinterconnect.
com [ILLUSTRATION OMITTED] EPIC Technologies 200 East Bluegrass Drive Norwalk, OH 44857 Phone: (810) 695-1521 Fax: (419) 668-2891 E-mail: todd.baggett@epictech.com Web: www.epictech.com VITAL STATISTICS Year Founded: 1988 Number of Employees: 2350 Number of Facilities: 6 Annual Sales: $281 Million WHO WE ARE [ILLUSTRATION OMITTED] Over the last two decades, EPIC Technologies has built a reputation of providing world class, high quality electronics manufacturing services (EMS) to original equipment manufacturers (OEMs) in the medical, industrial control, automotive, computer and telecommunications industries. During the last five years, we've tailored our lean operations to the medium volume, higher mix segments of our target markets.
By successfully implementing and continuously improving this Synchronous Flow Manufacturing (SFM) process, we provide our customers high quality product, when they want it, where they want it. MAJOR MARKETS EPIC is a top 10 provider of Medical electronics devices globally and we understand the needs of our diversified medical customer base. EPIC facilities are both ISO 13485 certified and FDA registered.
We also provide services to non-medical instrumentation, automotive, industrial control and telecommunications OEMs. SERVICES OFFERED EPIC specializes in providing comprehensive EMS solutions, from design to manufacturing to direct fulfillment for our customers. Beginning early in the OEM product design cycle, we become an extension of the customer's team.
EPIC assists in the engineering process, from circuit development, component selection, packaging, validation and product testing to maximize functionality, reliability and cost effectiveness. These capabilities allow us to support our customers programs from concept through the full production cycle, while providing the critical mass for economies of scale by leveraging our purchasing power and shared resources. [ILLUSTRATION OMITTED] EPIC's key differentiator is our focus on lean manufacturing to achieve high throughput velocity.
The basic premise is that materials in active transformation to finished goods are cost effective and stockpiles of materials in a "wait state" for transformation are not. Consequently, our SFM processes are focused on: * Minimizing both raw materials and finished goods inventories * Optimizing the speed with which production moves through the factory * Facilitating the ability to make instant changes to a product which minimizes obsolescence and expensive rework. EPIC's full range of services include: * Product Design Support * New Product Introduction * PCB Assembly * Failure Analysis * Direct Fulfillment/Logistics * End-of-Life Support * Component Engineering * Prototype Assembly * Test Development * System Integration/Box Build * Warranty Repair www.
epictech.
com [ILLUSTRATION OMITTED] EtQ, Inc.
399 Conklin Street, Suite 208 Farmingdale, NY 11735 Phone: (516) 293-0949; Toll Free: (800) 354-4476 Fax: (516) 293-0784 E-mail: info@etq.com Web: www.etq.com WHO WE ARE [ILLUSTRATION OMITTED] EtQ is the leading Enterprise Quality and Compliance Management Software for identifying, mitigating and preventing high-risk events through integration, automation and collaboration. EtQ uses the best in class-integrated modules and enterprise application integration to manage and measure quality and compliance processes and execute organizational change.
EtQ's mission is to make compliance management and business communication easy and efficient. Founded in 1992, EtQ has always had a unique knowledge of quality and compliance processes and has always strived to focus on making overall quality operations and quality systems better for businesses. MAJOR MARKETS EtQ Medical Device is an integrated quality and FDA compliance management system that has been pre-configured to specifically address the needs of the Medical Device industry, and exceed 21 CFR Part 11 and GMP requirements.
EtQ's unique modular approach provides unparalleled flexibility and automation. SERVICES OFFERED Streamlined Compliance Process Using Risk Assessment EtQ's unique FDA Compliance Software System is designed to minimize the number of CAPAs using an advanced filtering model; which features: * Automatic segregation and categorization of events at the source * Automatic identification and display of related events * Built-in risk assessment software module * Initial assessment to allow early closure * Risk assessment throughout the process to guide decision making * Full investigation with step-by-step root cause analysis * Automatic lookup and display of related investigations and CAPAs * Comprehensive CAPA action and effectiveness check plan with risk mitigation history. Collaborative, Enterprise Environment Large companies with multiple divisions typically have independent, hybrid systems in place.
Bridging the gap between these systems is inefficient in the long-term and ultimately will require expensive customizations to link the enterprise. Re-routing documents, meeting to discuss integration strategy, and IT man-hours in customizations result in lost time and money. EtQ's FDA Compliance Software is designed to incorporate the whole enterprise in collaborating at the enterprise level, while maintaining each division's independent business workflow.
The result is a unified Quality Management system that allows for each division to collaborate with the enterprise. EValidation EtQ offers an automated validation module that shortens the company's validation time by as much as 400% - a 4 day validation project can be done in less than a day using EtQ's eValidator. Furthermore, the eValidator can be run by a single employee, and can eliminate the extensive resources needed to dedicate to a typical validation project.
Finally, eValidator is able to compile a comprehensive report library of all tests and scripts run on the system. When audited by the FDA or other governing body, the validation reports are immediately available for review. www.etq.com [ILLUSTRATION OMITTED] Everite 501 E.
Erie Avenue Philadelphia, PA 19134-1106 Phone: (215) 425-3750 Fax: (215) 426-7768 E-mail: sales@everite.com Web: www.everite.com VITAL STATISTICS Year Founded: 1950 Number of Employees: 75 Number of Facilities: 3 WHO WE ARE [ILLUSTRATION OMITTED] Everite is the world leader in advanced electrochemical grinding (ECG) and machining technology for medical applications. As a pioneer in this field with over 50 years of experience, ECG is our exclusive focus.
Medical product manufacturers save time, money and produce improved products with ECG Technology. MAJOR MARKETS * Everite provides Medical Implant Manufacturers with grinding solutions to support the manufacturing of products that include Bone Screws, Hip Joints, and Joints. * Medical Device Manufacturers turn to Everite's grinding solutions to produce Biopsy Needles, Cannula, Tube Products and Skives.
* Surgical Tool Manufacturers apply Everite's solutions for Arthroscopic Shavers, Bone Drills, Electro Surgical Instruments, Needles, Phaco Tips, Scalpels, and Trocars. SERVICES OFFERED Everite provides turnkey solutions for electrochemical grinding, offering six lines of standard equipment, including cutoff machines, surface grinders, vertical and horizontal grinders, plunge grinders and tool room grinders. Everite also designs and develops customized electrochemical grinding and machining equipment to address specific customer needs.
[ILLUSTRATION OMITTED] A new system for grinding needle points can be used for points on tubing such as hypodermic needles and also for stylet and trocar points on wire for biopsy and surgical products. Medical device, implant and surgical tool manufacturers must machine exotic materials and fine tubes without leaving burrs or putting undo stress on manufactured parts. Everite's machinery is designed to provide economical and reliable performance for these applications.
ECG easily cuts today's toughest materials, including Stainless Steels, Inconel, Hastelloy, Monel, Cobalt-Chrome, Nitinol, and Tungsten Carbide. Yet it's also perfectly suited for fragile thermosensitive and thin materials. The ECG Technology Advantage * Burr-free cutting can eliminate secondary operations * Very low cutting forces for deep cuts on thin materials * No heat affected zone or recast layer * Significantly faster than EDM * More accurate than laser cutting * No metallurgical damage to the workpiece * Easily cuts hardened workpieces Rc65 and higher www.
everite [ILLUSTRATION OMITTED] Executool Precision Tooling, Inc. 2727 W. 16th Street Erie, PA 16505 Phone: (814) 836-1141 Fax: (814) 836-8301 E-mail: vhaibach@executool.net Web: www.executool.net VITAL STATISTICS Year Founded: 1991 Number of Employees: 55 Number of Facilities: 1 Annual Sales: Under $10 Million WHO WE ARE [ILLUSTRATION OMITTED] Executool is a full-service tool design, tool build and custom injection molding facility, specializing in close tolerance parts, laminated tooling, hot runner manifold systems and multi-cavity tools for the medical industries.
Executool offers close tolerance molded plastic parts for a global customer base in a variety of engineered grade materials. Executool features a full in-house; part and tool design team, an injection mold tooling department, first article inspection department, tool repair department, injection molding department, and a 24-hour quality assurance team. Mission Statement At Executool, our goal is simple: to provide you with superior-quality, closely inspected parts on time, at the lowest possible price.
As leaders in the field, we are committed to offering high-tech, cutting-edge processes, materials, equipment and tooling that meets--and exceeds--each customer's specific demands. MAJOR MARKETS Executool designs and builds custom thermoplastic injection tooling molds for the medical, pharmaceutical, aerospace, defense, electrical housing, connector, and other leading OEM industries. SERVICES OFFERED Executool manufactures Class-A high-production tooling: multicavity hot manifold molds to single-cavity prototype tooling.
Our world-class tooling facility--is IS09001:2000 certified, staffed by highly skilled craftsmen who build quality metal components with precision and attention to detail. Our toolmakers can hold tolerances of up to .00002 per inch in laminated tooling. [ILLUSTRATION OMITTED] Executool offers lower cost over-seas tooling with approved partnership tooling facilities in several low cost regions around the world.
Executool is a world-class custom injection molder, specializing in tight tolerance of engineering-grade resin polymers. Our injection molding department quality management team is ISO 9001:2000 certified and continues to build upon our reputation for exceptional quality and attention to detail. Executool operates in a clean environment, with a climate-controlled atmosphere, our 2006 Quality Rating--99.
64% and 2006 Delivery Rating--99.
76% [ILLUSTRATION OMITTED] Executool's Engineering Division is proud of their established track record of meeting customers' individualized requirements and accelerated time-to-market expectations. Our design team generates precise molds from conventional prototypes, single-and multi-cavity, slide-action, standard two-plate, three-plate, two-shot, and hot runner molds. We can also work with you directly to generate solid models of your products.
www.
executool.
net ExtruMed, LLC 1941 Petra Lane Placentia, CA 92870 Phone: (714) 993-4100 Fax: (714)993-4141 41984 Rio Nedo, Suite 300 Temecula, CA 92590 Phone: (951) 296-0233 Fax: (951) 293-0235 E-mail: sales@extrumed.com Web: www.extrumed.com VITAL STATISTICS Year Founded: 1990 Number of Employees: 65+ Number of Facilities: 2 WHO WE ARE [ILLUSTRATION OMITTED] ExtruMed LLC is an ISO-registered extrusion company that serves the medical device industry. Our precision tubing solutions include catheter, lead and device tubing manufactured to exacting tolerances from virtually any thermoplastic and available in configurations such as co-extrusions, multi-lumens and tapers.
ExtruMed also offers irradiated balloon tubing and ultra-thin walled polyolefin heat-shrink tubing. Our Extrusioneering by ExtruMed[TM] approach to the extrusion process marries engineering discipline and principles with the "black art" of extrusion to enable us to manufacture the most complex designs. Our strict process and quality control ensures that every product we make has been thoroughly designed, manufactured, inspected and documented--because precision matters.
Whether you require a "quick-turn" prototype run or a high volume production run, single or multi-lumen, heat-shrink or co-extrusion, ExtruMed is your source for quality tubing and exceptional service. MAJOR MARKETS ExtruMed is focused 100% on the medical device market. The major markets that our tubing is utilized in include: Cardiac Rhythm Management, Neurostimulation, Interventional, Endosurgery and Vascular Surgery.
SERVICES OFFERED Our range of precision tubing solutions includes catheter, lead and device tubing manufactured to exacting tolerances from virtually any thermoplastic. OUR PRODUCTS: * Balloon Tubing ExtruMed's Balloon Tubing possess excellent concentricity, tight tolerance and repeatable mechanical characteristics. * Co-extrusion (striping, dual-layer and tri-layer) --Multi-lumen and bump co-extrusions with wall thickness as thin as 0.
0005" * Custom Extrusion --ExtruMed specializes in the full range of thermoplastic materials and cross-section designs between 0.005"- 0.450" (0.13 mm-11.4 mm) diameters. * Heat-Shrink Tubing --ExtruMed manufactures polyolefin heat-shrink tubing with ultra-thin walls and high-shrink ratios of 10:1 with wall thicknesses as thin as 0.00025" for a variety of medical device applications.
* Lead Tubing --ExtruMed has been manufacturing lead tubing for active electrode applications for more than a decade. * Multi-Lumen Tubing --ExtruMed's experienced technical staff utilizes advanced process technology coupled with expert die design to tackle the most challenging multi-lumen configurations. OUR SERVICES: * Material Consultation Our extensive industry experience enables us to provide consultation in the material selection and processing of thermoplastics for extrusion.
To ensure fast turnaround of customers' tubing needs and to assist them in the selection of the right material for prototype or production, ExtruMed maintains an extensive inventory of commonly used thermoplastics. * Inventory Management ExtruMed's service team will accommodate the different procurement needs of its customers. Our inventory management can meet your Kanban, Just-in-time, Dock-to-Stock or other inventory requirements.
* Product Engineering ExtruMed's technical staff works hand-in-hand with customers to design configurations that meet the functional, manufacturing and budgetary requirements of the customer. Whether your requirement is for a quickturn prototype or high-volume production, our technical staff has the experience to meet your needs. FactorsNY LLC 29 Broadway, 16th Floor New York, NY 10006 Phone: (212) 943-1600 Fax: (212) 943-1636 E-mail: paul@factorsny.
com Web: www.
factorsny.
com Year Founded: 1974 Formerly known as: Human Factors / Industrial Design WHO WE ARE "The ultimate success of a product is determined by the extent to which it exceeds customer expectations." Our experiences in product development and design are extensive and wide ranging. Over 30+ years, we have created hundreds of successful products and brands.
We bring together all the factors from the aesthetic and emotive to the human and technological to create exceptional products. We merge the disciplines of applied human factors, engineering and industrial design with an FDA compliant process that quickly identifies opportunities. We use a vast array of tools, both traditional and technologically advanced, to generate concepts, develop designs, resolve details, and implement results.
Our process challenges and validates evolving design decisions through feasibility testing, physical modeling, and prototype assessment. We have the energy and commitment to see programs through the entire product lifecycle from inception through production implementation and product launch to following market performance. We work closely with our clients to align objectives, providing turnkey services or specifically applying our expertise to compliment and support other team resources.
FactorsNY thrives on challenges.
We would welcome your call to discuss our complete capabilities further and to demonstrate how FactorsNY can contribute to your success. MAJOR MARKETS Life sciences 454 Life Sciences [ILLUSTRATIONS OMITTED] surgical Richard-Allan (ConMed) [ILLUSTRATION OMITTED] respiratory Ventaira [ILLUSTRATION OMITTED] dental Dentsply [ILLUSTRATION OMITTED] diagnostic OraSure Technologies [ILLUSTRATION OMITTED] cardiovascular St. Jude Medical [ILLUSTRATION OMITTED] home health care Antares Pharma [ILLUSTRATION OMITTED] therapeutic VasoMedical [ILLUSTRATION OMITTED] Filtertek Inc.
11411 Price Road Hebron, IL 60034 Phone: (815) 648-2416; (800) 648-0791 Fax: (815) 648-2929 Web: www.filtertek.com VITAL STATISTICS Year Founded: 1965 Number of Employees: 908 Number of Facilities: 6 Annual Sales: >$100 Million WHO WE ARE [ILLUSTRATION OMITTED] Filtertek is a high-volume, OE manufacturer of custom developed filters, valves, and critical molded components for the medical, laboratory, and blood markets. Custom developed medical products are brought from conception to finished product at an ISO certified facility under GMP regulations and manufactured in a clean room environment.
Because Filtertek isn't vertically integrated, customers get the advantage of a vast selection of filtration and molding materials ensuring that quality and performance requirements are satisfied every time. Design, tooling, prototyping, testing, and automated manufacturing are provided. MAJOR MARKETS * Drug Delivery * Laboratory * Respiratory * Pharmaceutical * Blood * OEM, Custom SERVICES OFFERED Pinpoint precision and strict attention to details keep Filtertek medical filters, valves, and critical components in line with leading edge medical technology and the needs of its customers.
Filtertek develops and manufactures a full range of products for use in the medical industry including products for drug delivery, respiratory therapies, surgical preparation, pharmaceutical processing, and equipment protection. [ILLUSTRATION OMITTED] Additionally, Filtertek is committed to proactive, solution-driven product development to help its customers achieve optimal results. With its wide range of product application expertise, medical clean rooms, and strategic manufacturing locations, Filtertek is uniquely positioned as a global partner in the development of advanced products for growing medical markets.
Customers' growing desire for "turn-key" projects affords Filtertek the opportunity to quickly and efficiently offer finished products tailored to the most widely used drug applications. Custom Development Services include: * 3-D Product Design * Tool Design and Build * Automated Manufacturing * Cleanroom Manufacturing * Materials Selection * Rapid Prototyping * Product Testing * System Assembly For more information on Filtertek's custom development capabilities visit us at www.filtertek.com or contact us today at 815-648.2416. www.filtertek.com [ILLUSTRATION OMITTED] Filtrona Extrusion, Inc.
PO Box 370, 764 South Athol Road Athol, MA 01331 Phone: (800) 755-7528; (978) 249-5343 Fax: (978) 249-5727 E-mail: MassSales@Filtrona.com Web: www.FiltronaExtrusion.com WHO WE ARE [ILLUSTRATION OMITTED] Filtrona Extrusion, Inc. has been servicing the Medical OEM market as PEXCO[R] Medical Products for over 45 years.
Our manufacturing facility in Massachusetts alone totals 140,000 square feet, employs more than 200 people and contains 27 extrusion lines. A Class 100,000 Medical Clean Room for extrusion and sub-assembly is now operating in our new 100,000 square foot Monterrey, Mexico facility. CAPABILITIES Filtrona manufactures thermoplastic medical tubing and extrusions in Class 100,000 clean room environments.
ISO 9001-2000 and ISO 14001 certified, Filtrona's capabilities include: SPC documentation, on-line measurement controls, in-house Wire EDM Cad/Cam system, single and multi-lumen tubing, reinforced high-pressure tubing, co-extrusions, tri-extrusions, custom profiles, printing, bar-coding, sub-assembly and packaging. Specializing in medical grade flexible tubing, rigid tubing and custom profiles, Filtrona's USP Class VI materials include: PVC, Non-DEHP, PE, PP, PU, PC, Nylon, HIS, TPE, TPR, Radiopaque and PVC alternatives. Filtrona's in-house contract manufacturing and general-assembly operations include: specialty tube cutting, coiling and banding, solvent bonding of components to tubing, thermo-bonded tube coiling, champhering and special packaging.
Kanban or JIT inventory and shipping programs are available. GLOBAL PRESENCE Filtrona Extrusion's U.S. corporate headquarters, located in Alpharetta, GA, oversees multiple plastic extrusion facilities in the U.
S.
and Mexico.
Together, Filtrona offers a complete source for custom thermoplastic tubing, profile and sheet extrusions, with over 150 extruders and over 800,000 square feet of production facilities. End markets serviced include: Medical, Automotive, Aerospace, Lighting, POP & Display, Fence, Refrigeration, Home & Office, Recreation and Traffic Control. The Filtrona Extrusion companies are part of the billion dollar international corporation, Filtrona plc--based in Milton Keynes, England--which operates in five major international niche business groups: * Custom plastic extruded tubing, profiles and sheet * Custom plastic injection molded caps and plugs * Bonded fiber components for medical devices, writing instruments, printing systems and household products * Self adhesive tear tapes and coated plastic films * Innovative (low tar/low risk) specialty cigarette filters The global reach of Filtrona plc spans 40 manufacturing facilities, 32 distribution outlets and sales offices and three research centers spread across 22 countries in the Americas, Europe and Asia.
Over 5,200 employees are working hard to provide quality products with efficient service to business customers worldwide [ILLUSTRATION OMITTED] www.FiltronaExtrusion.com Fischer Connectors, Inc. 1735 Founders Parkway, Suite #100 Alpharetta, GA 30004 Phone: (678) 393-5400 Fax: (678) 393-5401 E-mail: sales@fischerconnectors.com Web: www.fischerconnectors.com VITAL STATISTICS Year Founded: 1954 Number of Employees: 60 Number of Facilities: 6 Subsidiaries, 1 Corporate Headquarters Annual Sales: Privately Held-Confidential WHO WE ARE [ILLUSTRATION OMITTED] Since 1954, Fischer Connectors[R] has developed and produced innovative electronic connectors ideally suited for use in automotive and instrumentation applications.
Fischer uses state-of-the-art computer-aided design and manufacturing systems and works closely with the customer engineering team to create efficient and customized solutions: Products that not only meet demanding performance and quality standards, but also do it in a cost-effective and timely manner. Automated production equipment enables precision manufacturing of a wide range of products, made up of an array of high-performance materials fully suited for medical application. [ILLUSTRATION OMITTED] Fischer Connectors, Inc.
--the North American headquarters of the globally operating and ISO 9001 certified Fischer Connectors Holding SA--designs, manufactures, sells, and distributes high-precision electrical, fiber-optic, and hybrid connectors. Primary design and manufacturing facilities are located in Switzerland, with other design, manufacturing, and distribution centers located worldwide. MAJOR MARKETS Connector & Cables Assemblies for the Medical, Broadcast, Military, and Testing and Instrumentation SERVICES OFFERED * Cable Assemblies * Harness Assemblies * Over-molded Assemblies * Flex Assemblies * Custom Connectors * Engineering Design Services www.
fischerconnectors.
com [ILLUSTRATION OMITTED] FloMet LLC 810 Flightline Boulevard DeLand, FL 32724 Phone: (386) 736-4890 Fax: (386) 736-6063 E-mail: dtasseff@flomet.com Web: www.flomet.com VITAL STATISTICS Year Founded: 1991 Number of Employees: 150 Number of Facilities: 1 WHO WE ARE [ILLUSTRATION OMITTED] The ability to formulate metal powder with a binder system into a feedstock that can be injection molded and then processed by sintering to form high density metal with exacting tolerances was conceived in the late 1970's in Southern California. During the 1980's, the process was refined in DeLand Florida, emerging in 1991 as FloMet.
This is what separates FloMet from the rest of the MIT industry. FloMet's staff developed the technology and is continuously improving it. We blend our own feedstocks and design and build our own sintering furnaces, specifically for corrosion resistant alloys.
Our tool designers built the original metal injection tools for the orthodontic industry in the 1980's. FloMet was the first with multicavity tooling, incorporating 16 cavity tooling into production in the early 1990's, and by the end of the decade FloMet was running advanced 32 cavity tooling. MAJOR MARKETS Medical, Orthodontic, Communications, Electronic SERVICES OFFERED [ILLUSTRATIONS OMITTED] Achieve Real Cost Savings and Out of this World Performance from the Pioneer and World Leader in Metal Injection Technology[TM] Replace outdated and expensive processes with MIT[TM]- * Kovar, Invar, HiMu80, FeNi and Stainless Steels * Net shape "Chipless" forming * CTE tailored by chemistry * Superior hermeticity * Precision tolerances * Tooling from 1 cavity up to 32 cavities * State of the art, ISO 9000/2000 certified facility * Production of highly complex parts with tolerances of less than 0.
001" * Custom sintering process perfect for non-corrosives and stainless steel alloys * Custom blended feed stock * Total process repeatability * Secondary processes including coining, straightening, bending, tunneling and heat treating * Critical components supplier to leading edge manufacturers * Eliminates high priced scrap and pollution www.flomet.com [ILLUSTRATION OMITTED] Fresenius Kabi Product Partnering Fresenius Kabi AG Else Kroner Str. 1 D-61352 Bad Homburg v.d.H, Germany Phone: +49 (0) 6172 686 1240 E-mail: customer.
services@fresenius-pp.
com Web: www.
fresenius-productpartnering.
com VITAL STATISTICS Year Founded: About 40 Years Ago Number of Employees: > 10,000 Number of Facilities: 21 Annual Sales: ~ 2 Billion [euro] WHO WE ARE [ILLUSTRATIONS OMITTED] Fresenius Kabi Product Partnering is a Fresenius Kabi unit dedicated to Third Party Manufacturing providing contract development and manufacturing services of medical devices and sterile dosage forms. We offer our customers access to the expertise of more than 20 manufacturing facilities and innovation centers worldwide which are operated in strict conformity with international quality standards. As a flexible outsourcing partner we understand all aspects of pharmaceutical projects from bench to product.
We balance the need for a rapid time to market with stringent quality and regulatory compliance. MAJOR MARKETS Fresenius Kabi Product Partnering is the supplier of choice of an impressive number of pharmaceutical companies. Our products are exported to more than 30 countries worldwide.
SERVICES OFFERED We are one of the leading manufacturers of sterile disposable products for the application of medicines. Through the use of validated manufacturing methods, we produce high-quality, sterile and latex-free infusion and transfusion sets, products for insulin therapy, pumps and sets for enteral nutrition as well as a comprehensive range of accessories for the respective application. [ILLUSTRATIONS OMITTED] The business approach of Fresenius Kabi Product Partnering is to provide our customers integral support throughout the life cycle of their products: starting at the early stages through full commercial scale, covering development and production.
Fresenius Kabi Product Partnering is besides a global leader in the contract development of sterile injectable products. We provide the full range of assistance in the development and filling & finishing of solutions, powders and emulsions, including a broad variety of different containers such as IV bags, ampoules, vials and bottles. www.fresenius-productpartnering.com [ILLUSTRATION OMITTED] Fotofab 3758 W.
Belmont Chicago, IL 60618 Phone: (773) 463-6211 Fax: (773) 463-3387 Email: sales@fotofab.com Web: www.fotofab.com VITAL STATISTICS Year Founded: 1967 Number of Employees: 50 ISO 9001: 2000 Certified WHO WE ARE [ILLUSTRATION OMITTED] A leading supplier of precision metal parts, Fotofab uses its process of chemical machining (also known as etching or milling) to produce quality metal parts with faster lead times and lower prices than traditional methods. Standard delivery is 2 weeks with 5-day, 3-day, and same day options available.
The Fotofab process is flexible: low tooling prices make Fotofab a cost effective solution for prototype and production qualities and complex geometries can be produced without increased cost. A wide variety of metals can be used including Titanium, Nitinol, Zirconium, Stainless Steel, and Copper. Visit wvvw.fotofab.com to learn more and receive a free "Design Guide to Photochemical Machining.
" MAJOR MARKETS Medical, high tech electronics, aerospace, defense, and telecommunications [ILLUSTRATION OMITTED] SERVICES OFFERED * Photochemical Machining * Laser Cutting * Stamping * Forming * Plating * Passivation * Electropolishing * Tumbling * Heat Treating * Soldering * Tape & Reel [ILLUSTRATION OMITTED] www.fotofab.com G&L Precision Die Cutting, Inc. 1766 Junction Avenue San Jose, CA 95112 Phone: (800) 327-4553; (408) 453-9400 Fax: (408) 451-1199 Email: sales@glprecision.com Web: wuw.glprecision.com VITAL STATISTICS Year Founded: 1978 Number of Employees: 45 Number of Facilities: San Jose, California and The Netherlands Annual Sales: Privately Held WHO WE ARE G&L Precision Die Cutting, Inc.
is a worldwide converter, specializing in the medical, diagnostic (IVD) and electronic markets. Converting and contract manufacturing services include tight tolerance and high-speed rotary die cutting, multi-layer laminating, flat-bed die cutting, laser cutting, narrow web slitting and converting, Flexographic printing, subassembly and finished device assembly services, and design and material assistance. G&L serves customers in more than 35 countries, manufacturing to exacting customer specifications and schedules--on time and on budget.
[ILLUSTRATIONS OMITTED] SERVICES OFFERED GL-187[TM]--DIAGNOSTIC ADHESIVE SYSTEM G&L Precision Die Cutting is internationally recognized for its proprietary GL-187[TM] acrylic pressure sensitive adhesive used by leading diagnostic companies. GL-187[TM] is an industry standard for diagnostic test strips and lateral flow devices. Since its introduction, more than 6 billion test strips have used GL-187[TM]--enough test strips to reach the moon.
Custom IVD backing material with GL-187[TM] is available in card (sheet) form or in roll form. [ILLUSTRATION OMITTED] PRODUCTS/SERVICES [ILLUSTRATION OMITTED] G&L works with an extensive material base for diagnostic, wound-care and medical device applications, including pressure sensitive adhesives, films, foils and foams. Specific to the IVD market they offer: * Plastic backing cards * Custom laminations * Backing rolls * Slitting of delicate membranes * GL-187[TM] adhesive * Hydrophobic coating * Custom printed cover tapes * Biosensor components [ILLUSTRATION OMITTED] SUBASSEMBLY SERVICES Meeting the growing need to get to market faster and save costs, G&L offers complete diagnostic subassembly services.
They are widely experienced in laying down backed and un-backed nitrocellulose, laminating active membranes, slitting and laminating absorbents, and laminating multi-layer films or other materials to provide finished or semi-finished cards or test strips. Dry room manufacturing is available for handling active membranes. FACILITIES AND CAPABILITIES [ILLUSTRATION OMITTED] Corporate offices are located in San Jose, California with over 50,000 square feet of manufacturing and warehouse space.
ISO 9001:2000 certified and GMP compliant to CFR 21 section 820. Class 10,000 Cleanroom and dry room manufacturing is available. Additional capabilities include CAD services, in-house design and fabrication, a modern machine shop, complete privacy of customer proprietary designs, and computerized job tracking.
For more information, please contact G&L Precision Die Cutting at 408.453.9400 or visit www.glprecision.com. www.glprecision.com [ILLUSTRATION OMITTED] Genesis Electronics Manufacturing, Inc. 14201 McCormick Drive Tampa, FL 33626 Phone: (813) 854-1661 Fax: (813) 854-6182 E-mail: medical@genesismfg.
com Web: www.
Genesismfg.
com VITAL STATISTICS Year Founded: 1993 Number of Employees: 100 Number of Facilities: 1 Annual Sales: $20,000,000+ WHO WE ARE [ILLUSTRATION OMITTED] Genesis Electronics Manufacturing, Inc. (GEM) is an ISO 13485 & 9001 certified Electronics Manufacturing Services (EMS) company. GEM provides a full range of premier manufacturing and supply chain solutions to medical device OEM clients.
GEM specializes in the electronic assembly, integration and lifecycle support of medical devices. From turnkey component sourcing, through the state of the art manufacturing process and extending into the post assembly repair & service, GEM delivers yours product with uncompromising quality. Source IT, Build IT, Service IT--"Consider IT Done!!" MAJOR MARKETS * Medical Diagnostics & Instrumentation * Industrial Controls * Defense & Aerospace * Warranty & Repair Depot * CRT & LCD Displays * Wi-Fi & Bluetooth Wireless Equipment * Commercial Electronics * Telecommunication SERVICES OFFERED Genesis Electronics Manufacturing, Inc.
(GEM) provides manufacturing and service solutions for your critical electronic products. GEM meets the special needs of the medical device industry with our Source IT, Build IT, Service IT, Consider IT Done strategy. SOURCE IT: GEM provides total turnkey supply chain solutions.
Our seasoned procurement teams work daily with a global supply network to provide you with best price, and best delivery material options. Our years of experience in the industry have allowed us to build a database of world-class suppliers. Confidence and Trust--GEM's internal systems for ordering material provides traceability needed for critical medical products.
BUILD IT: GEM provides state of the art production capabilities that match the complexity and volume requirements of the medical electronic device market. Our technology spans the range from very small 0201 components and high I/O micro-BGA's to complex system integration. Our test engineering team can help you find the right Analog, Digital or RF test solution for your medical device.
From the New Product Introduction (NPI) phase through on-going production our customer focused teams will work with you to develop the necessary plan to assure success. GEM employs a extremely low turn-over work force, that stability along with our proven processes equates to a consistent high quality result. GEM provides both standard and RoHS compliant manufacturing solutions.
SERVICE IT: At GEM we understand that electronic medical devices have long product lifecycles. Issues such as part obsolesce or "last-time buy" requirements can unexpectedly erode profitability. GEM can help you manage that risk by providing expert refurbishment / rebuild service.
The award-winning Service and Repair Logistics Depot will continue to support your device throughout its serviceable life. The depot will do component level repair, refurbishment to "like new" condition and provide detailed failure analysis back to your quality and product development team. If your requirements include Whole Unit, PCB Assembly, CRT, LCD or even third party manufactured products our repair our Service and Repair Logistics Depot is available to controls costs.
In or Out of Warranty our advance exchange programs are available to enhance your level of customer service. CONSIDER IT DONE: Our mission statement is simple, "Consider It Done". When you need it RIGHT, and you need it ON TIME then place it in the hands of a company you can trust, Genesis Electronics Manufacturing, Inc.
www.
genesismfg.
com Glebar Company, Inc 527 Commerce Street Franklin Lakes, NJ 07417 Phone: (201) 337-1500 Fax: (201) 337-6848 E-mail: info@glebar.com Web: www.glebar.com VITAL STATISTICS Year Founded: 1952 Number of Employees: 50 Number of Facilities: 2 WHO WE ARE [ILLUSTRATION OMITTED] Glebar Co., Inc. has been manufacturing precision machine tools and gauging equipment and providing contract grinding services in Franklin Lakes New Jersey since 1952.
Glebar was the first company to grind tapered guide wires for the medical cardiovascular industry in 1964 and since have developed precision grinding equipment and gauges specific to that market. We are ISO 9001:2001 Certified company and all business and production processes are documented with emphasis on continuous improvement. Our machines are also available with CE certification.
Glebar develops turnkey precision grinding equipment for a wide variety of industries such as medical, aerospace, automotive among others. We have representation in Europe, Asia and South America. MAJOR MARKETS Glebar provides precision grinding systems for forming medical devices used in Neurological, Dental, Cardiovascular and other Minimal invasive procedures.
SERVICES OFFERED Glebar manufactures precision grinding and gauging equipment Glebar primarily builds precision grinding machines used in the forming of medical devices. These machines produce the majority of guide wires in the world. The CAM.2 CNC Grinding system can produce wires with tapers, flats, hexes, and virtually any shape required and can grind wire down to 0.
0203mm in diameter.
Glebar also manufactures conventional centerless grinders with full automation to produce multi tapered guide wires. To support the machines we manufacture, we produce gauging equipment to measure the product produced on the Glebar grinding systems. [ILLUSTRATION OMITTED] Process & Product Development Some customers have new products they wish to launch in the marketplace but need to have their production process streamlined and optimized.
Glebar stocks hundreds of grades of vitrified and diamond abrasive wheels, and have over 50 years of experience in product development. The Glebar R&D Center will extensively run their product to produce the highest yields at the best possible quality. At that point the customer can take in the equipment into their facility with proven production performance statistics.
Prototyping Glebar machines have been used for over 50 years to introduce new products to the market. Glebar has worked closely with startup companies and OEMs to develop prototypes and new products for the medical industry. This has kept this company on the cutting edge of grinding technology and has allowed us to improve our equipment to suite the market's changing needs.
One example of this, was a company that was looking to produce a neurological part with extreme tight tolerances and small dimensions down to 0.0005" diameter. They searched for several years but were unable to find the expertise or the equipment to produce it. Glebar was able to produce a prototype within minutes, and then proceeded to run production for them until their turnkey equipment was built.
Contract Grinding The R&D center is equipped with the latest in precision grinding machines and gauging systems. We offer Contract grinding using Glebar technology to deliver high quality product from guide wires to other medical devices requiring high precision forming. Glebar has extensive grinding experience with metals, plastics, ceramics, glass and composites.
www.
glebar.
com Halkey-Roberts Corporation 2700 Halkey-Roberts Place North St. Petersburg, FL 33716 Phone: (727) 577-1300; (800) 303-4384 Fax: (727) 578-0450 E-mail: sales@halkeyroberts.com Web: www.halkeyroberts.com VITAL STATISTICS Year Founded: 1941 Number of Employees: 200 Number of Facilities: 1 WHO WE ARE [ILLUSTRATION OMITTED] Halkey-Roberts has provided the medical OEM industry with innovative products for over 60 years.
We manufacture plastic components and subassemblies used in disposable medical devices including flow devices, medical valves, needlefree valves, catheter and tracheal tube valves, tubing clamps, closures, and hand pumps. Products are available in a variety of colors and materials. Our one-way valve technology also delivers outstanding flow rates over a variety of pressures.
We pioneered the use of plastics for fluid flow and gas applications and continue to create new and innovative products. Halkey-Roberts' primary mission is to supply our proprietary valve products and technology to meet our customers' needs by being a vertically integrated manufacturer. We mold, assemble and test virtually all of our own products in our facility.
We have manufacturing expertise in molding (thermoset/thermoplastic), high speed automated assembly and automated testing as well as extensive product development experience. We can also custom design a valve for your particular application. Halkey-Roberts is ISO 9001 and ISO 13485 certified and manufactures to the standards of GMP.
MAJOR MARKETS Halkey-Roberts supplies medical OEM's and manufacturers worldwide. Our components are used in cardiovascular, urology, oncology, anesthesia, respiratory, IV/drug delivery and surgical devices as well as biotech applications. SERVICES OFFERED [ILLUSTRATIONS OMITTED] Our latest products utilize patented needlefree and swabable technologies to deliver outstanding value and performance.
We currently have incorporated this unique technology into our swabable valve products. Swabable Luer Valves Halkey-Roberts swabable luer valves were developed as substitutes for needle ports in IV applications. These additions to our needlefree valve line allow multiple usage, require no cap, have exceptional flow and low priming volume, all at an economical price.
Valve stems and bodies will mate securely with all standard luer syringes and luer connectors. All materials are Gamma resistant, USP class VI, DEHP-free and latex-free. Available in straight, 'Y' port, vial adapter (13-mm and 20-mm), tube end (available 2mm, 2.
5mm, 2.
8mm, 3.
7mm, and 4.
0mm), bag, break-off, T-port and stopcock valve configurations. Bodies are available in polycarbonate or in copolyester for easy bonding. www.halkeyroberts.com Harmac Medical Products, Inc. 2201 Bailey Avenue Buffalo, NY 14211 Phone: (888) 898-3061 Fax: (716) 897-0016 E-mail: info@harmac.
com Web: www.
harmac.
com VITAL STATISTICS Year Founded: 1981 Number of Employees: 700+ Number of Facilities: 3 * Buffalo, New York, USA * Castlerea, Co., Roscommon, Ireland * Tijuana, Mexico WHO WE ARE Harmac Medical Products, Inc. is an OEM outsource manufacturer that designs, engineers and produces custom single-use medical devices worldwide, building partnerships for the long-term, one successful solution at a time.
FDA Registered, cGMP compliant.
ISO 9001:2000 ISO 13485:2003 MAJOR MARKETS With over 200,000 square feet of manufacturing space Harmac Medical Products, Inc. serves the global outsource marketplace with class 100 capable clean room manufacturing locations in the USA, Ireland, and Mexico. SERVICES OFFERED Harmac is continually evolving, demonstrating to our customers superior end-to-end, lean-manufacturing solutions based on team-based problem solving, cutting-edge engineering, waste-free supply chain logistics, and disciplined quality-control systems.
This strong portfolio continues to win Harmac the opportunity to expand its manufacturing role with our long-term customers. For more information on how Harmac can help you meet your design and manufacturing needs call 716-897-4500 or e-mail info@harmac.com [ILLUSTRATION OMITTED] ENGINEERING * Integrated product design and development * On site CAD / CAM tool design and fabrication * Modular manufacturing system development * Process, package, and sterilization validation * Proprietary processing methods * Rapid response tooling and sampling OPERATIONS * Lean manufacturing capable with single piece flow for flexibility and rapid response.
* Evolutionary automation * Lean Six Sigma process with internal certification program focused on the customer's needs * 24 hour lead-time capable * Single-source disaster planning CUSTOMER SATISFACTION * Zero defects * Proprietary online quality system * On-time delivery * Dock to stock * Kanban driven supply chain management * Technical project management from first contact www.harmac.com Helix Medical, LLC 1110 Mark Avenue Carpinteria, CA 93013 Phone: (800) 266-4421 Fax: (805) 684-1934 E-mail: sales@helixmedical.com Web: www.helixmedical.com VITAL STATISTICS Year Founded: 1984 Number of Employees: 160 Number of Facilities: 3 Annual Sales: Privately held, Freudenberg--NOK parent company WHO WE ARE Helix Medical, LLC is a leading global participant in the medical and healthcare industries.
With the addition of Jenline Industries, Helix Medical has expanded its capacity and service portfolio to new levels. With operations on both the east and west coasts of the United States, Helix Medical offers a product portfolio including an array of custom manufacturing services, proprietary medical devices, and proprietary tubing, stoppers, and gaskets. Helix manufactures silicone components as a contract fabricator for domestic and international medical device manufacturers.
Its products are used in such areas as general surgery, bariatric surgery, plastic surgery, opthamology, orthopedics, cardiology, oncology, general surgery and ear, nose and throat applications. Its proprietary line of platinum-cured silicone tubing, stoppers, and gaskets for pharmaceutical companies is marketed under the HelixMark[R] brand name. Newer applications for the company's silicone products can be found in the genetic engineering and biotech fields.
The company's medical device division markets products under the InHealth[R] brand name. The division is a result of the 1989 acquisition of the Blom-Singer voice restoration line. InHealth[R] manufactures a complete line of voice restoration products for people who have lost their voice due to cancer of the larynx.
MAJOR MARKETS Platinum-cured silicone components and products for the pharmaceutical, cosmeceuticals, medical device, genetic engineering, and biotech industries. [ILLUSTRATION OMITTED] SERVICES OFFERED Molding * LIM (Liquid Injection Molding) * Compression Molding * Transfer Molding * Insert Molding * Micro Molding * Plastic Injection Extrusion * Close Tolerance * Single Lumen * Multi Lumen * Co Extrusion * Radiopaque * Profiles * Cut to Length * Pad Printing * Proprietary Striping * Parylene Coating Assembly * Insert Molding * Bonding/Gluing * Reinforcing * Pad Printing * Skiving Other * Trimming * Cryogenic Deflashing * Punching Packaging * Tyvek Pouch * Form/Fill/Seal * Lot Serialized Labeling * Package Inserts (PIDS) * Translations Sterilization * External Capabilities--E.O. (Etyhlene Oxide)--Gamma Radiation www.helixmedical.com Hi-Tech Group (HTG) 3191 East La Palma Avenue Anaheim, CA 92806 USA Phone: (800) 924-4832 Fax: (714) 632-5647 E-mail: techsales@hitech1 .
com Web: www.
hi-tech-group.
com VITAL STATISTICS Year Founded: 2004--Hi-Tech Group Companies 1982--Hi-Tech Rubber 1964--A.C. Hoffman Engineering 1992--Inland Technologies 1997--Infinity 1994--Ventrex 1991--Accusil Number of Employees: 800+ Number of Facilities: 7 WHO WE ARE Consisting of HI-TECH RUBBER, A. C. HOFFMAN, INLAND TECHNOLOGIES, VENTREX, INFINITY and ACCUSIL, the HI-TECH GROUP (HTG) is a single source contract manufacturer of injection molded plastic components, silicone-rubber components, medical grade silicone tubing, surgical instruments, and single- & multiple-use medical devices.
MAJOR MARKETS The Hi-Tech Group serves Medical Device OEMs along with diagnostic, health-safety equipment, instrumentation, data processing and fluid handling companies. SERVICES OFFERED The Hi-Tech Group provides OEMs prototype to high-volume contract-manufacturing with: * Silicone/Organic Injection & Flash-less Molding * Liquid Silicone Injection Molding * Thermo-plastic Injection Molding * Medical Grade Silicone Extrusions * Wire-reinforced & Multi-lumen Tubing * Medical Device Fabrication & Assembly * Electro-Medical Instrument Design & Assembly * Customized Material Solutions * Rapid In-house Prototyping & Production Tooling * FDA Registered plants with 800+ Employees [ILLUSTRATIONS OMITTED] The Hi-Tech Group offers start-up and full-scale production in its FDA Registered, ISO 9001:2000 & ISO 13485 certified facilities with Class 10,000 and 100,000 clean-rooms. HTG's Quality-control and Process-engineering personnel ensure that all products and services are produced in conjunction with the customers' Quality-control and engineering teams' specifications.
This transparent method assures total quality assurance from the starting