Company capabilities (Accellent-Donatelle).

Accellent

100 Fordham Road Wilmington, MA 01887

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

Web: www.accellent.com

VITAL STATISTICS

Number of Employees: Over 3500

Number of Facilities: Accellent is headquartered in Wilmington, MA and has 19 facilities across North America and Europe.

WHO WE ARE

Accellent is proud to support our customers in Helping People Live Better Lives. Our Mission is to be the World's BEST Provider of Comprehensive Supply Chain Solutions to the Medical Device Industry in the Eyes of Our Customers, Employees, Competitors and Communities.

Accellent speeds product realization and maximizes your return on investment by accelerating time-to-market in an industry that demands rapid product innovation and rigorous cost control.

No matter what you require--innovative design, integrated engineering, precision component manufacturing, final device assembly or supply chain management, Accellent delivers it all. With nearly one million square feet of medical device manufacturing space, over 3500 employees and extensive network of technical experts, we have the size, experience, breadth of capabilities and technology to deliver the latest innovations in medical device manufacturing.

MAJOR MARKETS

Accellent is an established leader in the outsourced medical device market. We design, develop, manufacture and assemble implants, devices and instruments for the following markets:

* Cardiology

--Cardiac Rhythm Disease Management (CRDM)

--Interventional Cardiology/Radiology

--Cardiac Surgery

--Peripheral Vascular

* Drug Delivery

* Endoscopy

--Urology

--Gastrointestinal

--Laparoscopy/Gynecology/Less Invasive Surgery

* Neurology

--Neuromodulation

--Neuorvasular

* Orthopaedic

--Reconstructive Implants

--Spinal Implants

--Trauma Implants

--Sports Medicine Devices

--Orthobiologics

--Instruments

* General Medical

--Arthroscopy

--Opthalmology

--Dental Implants

SERVICES OFFERED

Partnering with Accellent means more than just outsourcing. The Accellent Advantage gives you the opportunity to team up with a comprehensive supply chain solution. Accellent Idea Centers are focused on creative concept development and innovative design to accelerate new medical device product launches for our customers. Accellent has the capacity to execute the most aggressive product cycles, the tightest deadlines and the most ambitious product transfers. From design to manufacturing to final delivery, Accellent's broad offering allows you to focus on what you do best. When you partner with Accellent, you have access to a full suite of capabilities.

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* Assembly--including device assembly, subassembly, device testing, sterile barrier packaging, device labeling

* Machining--Swiss, CNC Milling, Electrical Discharge Machining (EDM), Laser Cutting

* Finishing--including heat treating, passivation, electropolishing, laser ablation, laser marking, pad printing and coating (hydrophilic, silicone, PTFE, parylene)

* Forming--Metal tube fabrication, marker band fabrication, deep draw progressive stamping, film cast tube fabrication, wire drawing, wire straightening and cutting, forging, wire forming, grinding, coil winding, plasma welding and stamping

* Molding--Insert molding, plastic injection molding, implantable molding, metal injection molding and polymer extrusion

* Joining--Laser welding, resistance welding, soldering, brazing, UV bonding, adhesive bonding, crimping and swaging

www.accellent.com

Adept Technology, Inc.

3011 Triad Drive Livermore, CA 94551

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

Web: wvw.adept.com

VITAL STATISTICS

Year Founded: 1983

Number of Employees: 150

Number of Facilities: 8

Annual Sales: $65M

WHO WE ARE

Adept is based in Livermore, CA and is a recognized industry leader in the development of intelligent robot systems. The company provides complete training, service, repair and robot remanufacturing services from this location and has offices throughout North America, Europe, and Asia.

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The company offers no-cost feasibility studies to prove applicability and functionality. Such studies include cycle-time reports and video footage. To arrange for your study go to:

https://www.adept.com/support/feasibihty.asp

Adept works with many systems integrators worldwide. We can recommend the right robot for your application and suggest integrators that can design and build an automated assembly system to suit your unique needs.

MAJOR MARKETS

Adept provides cost-effective assembly robots to the Packaging, Medical, Pharmaceutical, Lab Automation, Food/Baking, Disk Drive, Electronics and Semiconductor Markets, as well as to traditional industrial markets including machine tool automation and automotive component assembly.

SERVICES OFFERED

Wide variety of robot systems to meet the flexible automation needs of medical contract manufacturers.

* Robots can be programmed via both PC And Allen-Bradley PLC.

* Quattro Packaging Robot: Fastest Commercially Available Robot in the World.

* Adept machine vision for use with Adept robots: Guidance & Inspection from a single supplier.

* AnyFeeder: Flexible parts feeding system to feed a wide variety of different parts with a single feeder.

* Tool Changers: Easily outfitted for quick functional changeovers, flexible feeder.

* Conveyor Tracking: Track parts for pickup on the fly.

* Compact Design: Adept iCobra is the only SCARA robot with controller built into the base of the robot itself.

* CX Controller can control other non-Adept axes of motion.

* Mix and Match Robots: All Adept robots can be used in concert with each other.

www.adept.com

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Admedes Schuessler GmbH

Rastatter Str. 15 75179 Pforzheim, Germany

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

Web: www.admedes.com

VITAL STATISTICS

Year Founded: 1996

Number of Employees: ~250+

Number of Facilities: 1 Manufacturing facility in Germany 2 Offices in the United States

WHO WE ARE

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Admedes Schuessler GmbH is the largest OEM manufacturer of precision machined Nitinol implants and medical device components serving healthcare markets in the United States and worldwide. We specialize in the manufacturing of stents, filters, coupling devices, orthopedic implants and other miniaturized instrument parts utilizing Nitinol and other medical grade alloys. Admedes offers a wide range of proprietary micro machining capabilities and advanced laser techniques to expand options for device miniaturization.

MAJOR MARKETS

Medical Devices & Implants

SERVICES OFFERED

Admedes provides a full range of capabilities and services:

* Concept generation

* Prototyping

* Tooling

* Production of the finished customized component

Engineering Services:

* Rapid Response Prototyping

* Project Engineering to integrate new products into production

* Manufacturing Engineering Team to support production

Processing Expertise:

* Precision Laser Cutting

* Wire Forming

* Shape Setting

* Heat Treating

* Electropolishing

* Radiopaque Marker Attachment

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Electropolishing:

Electropolished Nitinol has outstanding corrosion resistance and biocompatibility. The Admedes Schuessler polishing process results in a protective surface film that is entirely Nickel free, and is a clear advantage to mechanically polished surfaces.

Micro Joining Technologies:

Admedes Schuessler has developed a new Ultra-Flat Micro-Riveting process technology for Tantalum and Gold markers with superior process features.

Material Testing:

* Corrosion Testing

* Radial & Crush Force Testing

* Physical, Mechanical and Analytical Testing

Quality System:

* Process Design Control Assistance

* Regulatory Support

* DIN EN ISO 9001-2000 and DIN EN ISO 13485-2003

* FDA Registered

* In Compliance with 21 CFR Part 820 Quality System Regulation

US CONTACTS

Mark E. Piper

Phone: [phone] EST

Email: [e-mail]

Eric Veit

Phone: + 1 925 417 0778 PST

Email: [e-mail]

www.admedes.com

Advanced Polymers, Inc.

29 Northwestern Drive Salem, NH 03079

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

Web: www.advpoly.com

VITAL STATISTICS

Year Founded: 1989

Number of Employees: 95

Number of Facilities: 1

Annual Sales: Confidential

WHO WE ARE

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From the time that Advanced Polymers, Inc. was founded, its mission has been to design and develop innovative polymer products and technologies to improve people's lives. Now in its 18th year, and ISO 9001:2000 registered, Advanced Polymers, Inc. manufactures the world's thinnest, strongest and smallest heat shrink tubing; as well as medical balloons and extruded tubing. The company was co-founded by Mark Saab and Elisia Saab. Mark Saab is well known throughout the medical device industry for his expertise in the development of medical balloons. Advanced Polymers, Inc. has doubled its manufacturing space in its new facility, opened in 2005, which includes a 20,000 square foot class 100,000 controlled environment for the purpose of manufacturing its components.

MAJOR MARKETS

The company sells its components primarily to the medical device industry (95%) as well as to the electronics industry.

SERVICES OFFERED

Advanced Polymers, Inc. has long been recognized for producing the world's thinnest, strongest and smallest PET heat shrink tubing. This tubing is seamless, thin-walled, ultra-high strength, EtO and gamma sterilizable and is available optically clear or pigmented. The tubing can be used as is or heat-shrunk for a variety of applications, with shrinking accomplished at very low temperatures. It is available in diameters as small as 0.006" and as large as 1.25", with walls as thin as 0.0002". This tubing is designed and manufactured for products used in applications which must be minimally invasive, need to be used in smaller passageways or in more torturous anatomy (as in cerebral surgery). With this latest offering, more than 400 stock sizes are available. Colors include optically clear, white, black, and a variety of other colors, with all sizes imprintable.

API is also a recognized market leader for producing the most innovative, high-quality medical balloons in the industry; from non-compliant high-pressure angioplasty balloons to compliant polyurethane balloons. Market demands to solve medical product problems that complements its PET materials problem-solving expertise prompted API to offer angioplasty balloons designed and manufactured from a variety of materials in a variety of shapes and sizes and with added features and benefits required by industry users. Benefits of the medical balloons include: 35+ different stock sizes and shapes for quick evaluations; custom shapes and materials; balloons engineered and designed for maximum performance while maintaining minimum profiles; high-quality sub-assemblies from prototype to high volumes. API manufactures medical balloons made of PET, polyurethane and other thermoplastic elastomers. The balloons range in diameters from 0.5 - 60 mm and as thin as 0.00025" (6 microns), and have high burst pressures up to 400 psi (27 ATM). Further, API also offers patented balloon designs for license.

[ILLUSTRATION OMITTED]

www.advpoly.com

AppTec

2540 Executive Drive

St. Paul, MN 55120

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

Web: wwv.apptec-usa.com

VITAL STATISTICS

Year Founded: 1989

Number of Employees: 400

Number of Facilities: 3

WHO WE ARE

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AppTec is a unique single-source provider of comprehensive GLP/ OMP-compliant testing, contract research and development, and custom cGMP man-ufacturing services for medical devices, tissue-based products, cellular therapeutics and biopharmaceuticals.

The company's three facilities, located in St. Paul, Philadelphia and Atlanta, are all FDA registered. Additional qualifications include ISO certification, FDA registration for HCT/Ps, and AAALAC and AATB accreditation. Our experienced professional and technical staff provides the highest level of cutting-edge science, in-depth regulatory expertise and quality assurance, with a commitment to individualized client service that delivers true customer-based solutions.

MAJOR MARKETS

Services are offered across a wide array of markets, with focus particularly on those products requiring interface or approval from the U.S. FDA or similar regulatory authorities around the world. Markets served include the following:

* Single-Use Devices

* Implantable Devices

* Reusable Devices

* Combination Products

* Tissue-Based Products

* Research Devices/Materials

* Cardiovascular Products

* Orthopedic Products

* Neurological Products

* Blood-Derived Products

* Cellular Therapeutics

* Biopharmaceuticals

SERVICES OFFERED

Testing Services for Medical Devices:

AppTec's services ensure that a medical device is manufactured, packaged, and sterilized in accordance with GMP guidelines. In addition, AppTec offers all the relevant test modalities used to study the biological safety and biocompatibility of medical devices.

Testing services (GLP- and GMP-compliant) include:

* Custom device performance and materials testing

* Complete biocompatibility testing per ISO 10993 and JMHLW (Japan)

* Toxicology discovery and safety studies

* Product validation programs for all commercially available sterilization methods

* Lot release, raw material and vendor qualification testing

* Complete testing services for controlled environments

Testing Services for Tissue-Based Products:

AppTec offers the nation's most comprehensive program for processed tissue and tissue-based products, including safety and lot release testing such as osteoinductivity (in vitro and in viva), as well as custom studies such as process change validations.

Contract Services for Aseptic Processing:

AppTec's single-source platform provides GMP/GTP manufacturing services in environmentally controlled laboratories for specialty device, combination and tissue-based products--from pilot projects to commercial-scale production.

Testing & Manufacturing Services for Biopharmaceuticals:

AppTec serves as a unique single-source provider for cGMP contract manufacturing and GLP/GMP-compliant testing services for biopharmaceuticals and cellular therapeutics.

www.apptec-usa.com

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Assurx, Inc.

18525 Suffer Blvd, Suite 150 Morgan Hill, CA 95037

Phone: [phone]; 888-9-ASSURX

Fax: [phone]

E-mail: [e-mail]

Web: www.assurx.com

VITAL STATISTICS

Year Founded: 1993

WHO WE ARE

AssurX: Focused on Quality Management and Regulatory Compliance

AssurX's success is a result of building on a core belief that our employees and customers share a dedication to quality and innovation. As a privately held corporation that has been profitable every year since we opened our doors 15 years ago, we have fueled our phenomenal growth with a relentless commitment to providing practical, flexible, and secure quality management and regulatory compliance software that enhances operations and boosts your bottom line.

We possess exceptional domain expertise, a motivated and talented workforce, and a clear vision to create the most innovative products on the market today.

Simply put, we define the Best Practices that our competitors follow.

MAJOR MARKETS

AssurX serves the FDA-regulated industry including manufacturers and suppliers of medical devices, medical electronics, packaging, pharmaceutical, biotech, and all related manufacturers and suppliers that cater to this industry.

SERVICES OFFERED

AssurX, Inc., provides FDA-regulated organizations with enterprise-wide global solutions for their quality management and compliance systems needs.

With a choice of OnDemand services or OnPremise (licensed) software delivery options, AssurX offers CATSWeb--a flexible, comprehensive all-in-one solution that automates quality & regulatory compliance related processes so issues can be globally managed-from detection to corrective action to trend analysis. It helps collect, organize, analyze and share information to better manage and improve quality and compliance performance everywhere in your enterprise.

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Turn-key processes such as corrective action management, complaint handling & regulatory reporting, issue tracking, audit management, customer support, and supplier quality are provided with full documentation, validation scripts, eMDRs, template forms, executive dashboards, and everything else needed for rapid deployment. Codeless configurability allows you to point-and-click your way to designing your own forms, workflows, rules, permissions, charts, dashboards, and an unlimited number of processes.

Management Dashboards, KPIs and Metrics: CATSWeb comes with built-in (not added on) comprehensive, configurable reports, charts & dashboards enabling you to monitor key performance indicators and drill down to the underlying data--in real time, all the time without the need to install 3rd party reporting tools.

Reduce problems by tracking trends over time by site, department, product, activity or any other parameter. Manage resources by identifying and working on the largest issues first. Prevent recurring problems by determining root causes and implementing lasting effective solutions.

Increase efficiencies by monitoring cycle times and reduce costs by process and site. Eliminate lost assignments by providing visibility to late tasks by area, department and individual.

Flexible and Robust Integration with Other Information Systems:

CATSWeb provides an open integration interface that enables you to add value by integrating with any of your existing information systems and databases.

PROFESSIONAL SERVICES

AssurX maintains a staff of highly experienced life sciences domain consultants that are available to assist you in identifying operational areas and processes that can be improved, resulting in higher product quality, improved operational efficiencies, and cost savings.

www.assurx.com

ATEK Medical

2600 Niagara Lane N Minneapolis, MN 55447 Grand Rapids, MI San Jose, Costa Rica

Phone: [phone]

Fax: [phone]

Web: www.atekmedical.com

VITAL STATISTICS

Year Founded: 1979

Number of Employees: 250

Number of Facilities: 2

Annual Sales: $65M

Key Personnel: Chris Oleksy, President, ATEK Medical; Christy Bieber Orris, CEO, ATEK Companies; Kay Phillips, President, ATEK Companies

WHO WE ARE

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For more than 60 years, ATEK Companies have formed manufacturing partnerships with OEM customers to provide creative solutions tailored to meet their challenging manufacturing needs. ATEK Companies serve the medical, communications, transportation, consumer, and industrial markets.

ATEK Medical is the preferred total solutions partner serving the medical device and biotechnology markets. The company has developed and launched more than 350 unique products and specializes in product management and full-service manufacturing.

MAJOR MARKETS

Class II and III implantable, disposable, and electro-mechanical medical devices.

SERVICES OFFERED

ATEK Medical is a total solutions partner with capabilities across the value chain from product design and launch to distribution and post-production services:

* Product development and launch

* IP development

* Assembly, production, manufacturing

* Line transfers

* Contract manufacturing

* Supply chain management

* Sterilization services

* Reduced cost, tax favorable manufacturing in Costa Rica

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ATEK Medical distinguishes itself from the competition through:

* Sixty years of manufacturing excellence, with almost half of that in medical device manufacturing expertise

* Breadth of capabilities

* Strategic alliances

* Responsive culture

* Global quality

* Regulatory expertise

Quality & Accreditations:

* ISO 13485:2003 (TUV) and 9001:2000

* IPC-610 certified and UL registered

* Regulatory submission expertise

* Compliant with FDA, QSR, cGMP

* Customer-aligned metrics

* Dedicated and skilled, cross-trained employees

* Lean Principles and SCOR[TM]

* WBENC certified

www.atekmedical.com

ATP Engineered Rubber & Plastics Group

565 East Swedesford Road, Suite 315 Wayne, PA 19087

Phone: [phone] x 1224

Fax: [phone]

E-mail: [e-mail]

Web: www.atperpg.com

VITAL STATISTICS

Year Founded: 1997

Number of Employees: 1000

Number of Facilities: 6

Annual Sales: $135 Million

WHO WE ARE

ATP Engineered Rubber & Plastics Group is one of the nation's premier sources of precision custom molded components and assemblies for a broad range of applications. We are among the few suppliers in the world with experience and expertise in combined applications involving rubber, silicone and plastics, offering fully integrated design, engineering and tool-making operations together with geographically dispersed plant locations in key markets across the U.S. and globally.

MAJOR MARKETS

[ILLUSTRATION OMITTED]

Medical components, healthcare market, electronics market, consumer and industrial products.

SERVICES OFFERED

ATP Engineered Rubber & Plastics Group offers customers the advantages of fully integrated product design, protob, ping, molding and assembly capabilities, including particular expertise in the design and production of tooling and components manufactured through liquid injection molding, two-shot auto-rotate molding, and over-molding of rubber to plastic, titanium and other substrates. Our team of professionals utilizes all of the latest software to interact efficiently with customers' design engineering and product development specialists. To meet evolving needs for supply chain management, we are also equipped to provide inventory control and logistics, thus offering a comprehensive resource to customers seeking total outsourcing solutions.

Meeting increasing demands for particulate-free molding in the medical devices and health care markets, ATP Engineered Rubber & Plastics Group provides clean room molding services in the US and China.

[ILLUSTRATIONS OMITTED]

www.atperpg.com

Aubrey Group, Inc.

6 Cromwell, Suite 100 Irvine, CA 92618

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

Web: www.aubreygroup.com

VITAL STATISTICS

Year Founded: 1994

Number of Employees: 60

Number of Facilities: 1

Annual Sales: $10 Million

WHO WE ARE

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Aubrey Group, Inc. located in Irvine, CA specializes in the design, and manufacture of electromechanical and disposable medical devices. Specialties include disposable cassettes, custom tubing sets, RF generators, wireless communication, patient monitoring, fluidics, implantables, blood processing and cardiovascular assist devices. Services include electronic, software, and mechanical engineering, industrial design, FDA submission, prototypes and flexible contract manufacturing. The company is an FDA-registered manufacturer and ISO 13485 certified. For more information, visit our website at www.aubreygroup.com.

MAJOR MARKETS

We offer broad-based technical skills for medical device design and manufacturing, supporting a range of clients from high-tech start-ups to established Fortune 100 companies. We design both disposable and equipment components in order to provide complete systems for our clients. We employ over 35 engineers and are 100% medical device focused.

SERVICES OFFERED

Located in the Irvine Spectrum in Southern California, Aubrey Group's services include system design, rapid prototyping, compliance testing, certification, full documentation, and contract manufacturing. Engineering services include system and electronic engineering, software and mechanical engineering, industrial design, and validation and verification.

Rapid Development

By leveraging our knowledge, design and fabrication of microprocessor-controlled products can be fast-tracked. Complex medical devices from concept to prototype often follow a system integration approach, leveraging our in-house technology. In addition, Aubrey Group streamlines documentation and data entry from initial services and confidentiality agreements through our ERP system. This approach has proven very successful in our fast-paced environment.

Project Management

Our management philosophy encourages a collaborative environment, where productivity demands and engineering creativity are balanced. The project manager provides weekly progress reports to budget and schedule, and remote, secure client access for project files. Emphasis is placed on client communication with contact across all functional levels of the client's team.

Quality Design

Our designs are safe, effective, and reliable. To meet these requirements, we analyze product risks, thoroughly specify requirements, simulate user interfaces, satisfy EMI thresholds, extensively test designs, and validate performance. Our designs also meet the requirements of the FDA, FCC, IEC and UL and we are an FDA registered medical device manufacturer.

Contract Manufacturing

As part of our time-to-market commitment in turnkey projects, our development team provides a seamless transition to manufacturing. This close integration means shorter turn-around, better in-process test methods, and quicker time-to- market.

www.aubreygroup.com

Autocam Medical

24 Aldrin Road Plymouth, MA 02360

Phone: [phone]

Fax: [phone]

31069 Genstar Road Hayward, CA 94544

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

Web: www.autocam-medical.com

VITAL STATISTICS

Autocam Corporation

Year Founded: 1988

Number of Employees: 2,900

Number of Facilities: 14

Annual Sales: $375+ Million

ISO 9000:2000/ISO 13485:2003/FDA registration (Plymouth, MA)

WHO WE ARE

Autocam Medical is a single-source provider of complex, highly engineered components. We are a member of the Autocam group of companies, which includes 14 facilities on four continents. Our company was formed to apply Autocam's extensive precision-manufacturing expertise to Medical applications. Autocam Medical combines lean manufacturing, value engineering, and continuous improvement with advanced technology and systems to give our customers a true competitive edge.

MAJOR MARKETS

Precision-machined components for Medical applications:

* Implants for joints; spine; trauma/soft tissue; cardiovascular/vascular

* Instruments

* Handpieces

* Components and subassemblies

SERVICES OFFERED

At Autocam, we've spent the last two decades satisfying many of the world's most exacting companies in the Automotive, Electronics and Medical Device markets. Autocam has a demonstrated track record of executing major projects from concept through delivery. We've earned our stripes (plus lots of quality awards) by focusing on our customers' needs for high-precision, high-quality component solutions. To do this, we've become experts in lean manufacturing, continuous improvement, and waste elimination -looking at how the whole production system impacts the value of any given component.

For 15 years, we've focused on analyzing and satisfying the unique needs of our Medical Device customers. From value-engineering an individual part to totally re-designing the value stream, Autocam Medical's consultative approach makes a difference. Our customers appreciate not just the high precision, cleanliness, close tolerances and superior finish of our parts, but also our entire value-added approach to manufacturing.

Process Capabilities:

* Precision turning

* Ultra-precision turning

* Precision grinding

* Laser machining

* Milling

* Sub-assembly

* Finishing and ultra-precise polishing

* Precision cleaning

Services and Systems:

* Rapid prototyping

* Project management

* Concurrent engineering

* Statistical Process Control (SPC)

* Dock-to-stock shipping

* Enterprise Resource Planning (ERP)

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Autocam machines a wide variety of medical-grade materials including all grades of stainless steel, titanium, cobalt chrome, nitinol and engineered plastics.

www.autocam-medical.com

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B&W Tek, Inc.

19 Shea Way Newark, DE 19713

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

Web: www.bwtek.com

VITAL STATISTICS

Year Founded: 1997

Number of Employees: 100

Number of Facilities: 50,000 sq.ft. of lab, custom manufacturing and office spaces

WHO WE ARE

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B&W Tek, Inc. is leading the way in the development of photonics components and instrumentation. We emphasis on low cost, high performance lasers and spectrometers, we strive for versatility--innovating solutions to analytical, industrial, medical, biophotonic, and diagnostic applications.

Our ISO 9001 & ISO 13485 certified facility and patented technologies ensure high quality products, consistently proven and growing every day.

MAJOR MARKETS

Our emphasis is on low cost, high quality lasers and spectrometers for medical and bio-photonics analytical and diagnostic devices.

SERVICES OFFERED

High performance instrumentation at low cost. B&W Tek's products have been successfully used by major instrument manufacturers and customers worldwide, a testament to expertise in engineering as an OED/OEM provider. With a customer base that has been growing to universities, large and small, research labs, oil and refining facilities, paper production, optical products manufacturers, drug and agricultural, health care, process analysis, gemological R&D; our applications are limited only by your imagination.

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Ubiquitous in global reach, B&W Tek is committed to bring excellence to your applications.

B&W Tek, Inc. is pleased to offer:

* Custom laser and spectrometer system design, development, and low cost quality manufacturing

* OEM custom photonic instrumentation manufacturing

* End User and OEM Spectrometer and Laser products

* UV/Visible and NIR array spectrophotometer systems

* Portable Raman and Fluorescence instruments

* Process Raman, UV, visible and NIR analyzers

* Broadband super luminescence light sources

* High power turn-key diode laser systems

* Low noise lasers from 360-2000 nm

www.bwtek.com

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BC Tech

2100 Delaware Avenue Santa Cruz, CA 95060

Phone: Toll Free [phone]

Fax: [phone]

E-mail: [e-mail]

Web: www.bctech.com

VITAL STATISTICS

Year Founded: 1994

Number of Employees: 70

Number of Facilities: 1

Annual Sales: $10 Million

WHO WE ARE

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Get to market faster with BC Tech's turnkey product launch program. Whether you sell lab automation systems or medical devices, our in-house research, development, contract manufacturing and support groups will give you the resources and infrastructure your medical or biotech product demands. Over the last 15 years, we've completed more than a hundred projects for satisfied customers around the world. Some have won design awards, and many are now used in your local doctor's office, hospital or diagnostics lab. So outsource with BC Tech and relax ... our time-tested four phase process and ISO 13485 certified / FDA compliant QMS deliver quality products with accurate schedule and budget commitments.

MAJOR MARKETS

BC Tech serves medical and biotech companies of all sizes that want to bring new products to market. We have extensive experience developing and manufacturing complex lab automation instruments and Class I, II & III medical products, including therapy delivery devices, diagnostics equipment, catheters, disposables, surgical tools, implants and more.

SERVICES OFFERED

Our Turnkey Product Launch Program will quickly and affordably transform your product concept and technology into a polished, market-ready device or instrument. We've spent years perfecting this four-phase program. Even when it was hard, we stuck with it--because we knew that a strong methodology compliant with the QSR and ISO 13485 Quality Standards would ultimately define our company and our reputation.

Research Phase--Refine your business strategy and product specifications with feasibility testing, market research resources and risk analysis. We take time to understand your business model, product requirements and competitive landscape so our experience is applied efficiently and appropriately.

Development Phase--We use 100% in-house product development resources to eliminate slowdowns and mistakes common when using multiple vendors. Our staff includes large mechanical engineering, electronics, software, human factors, industrial design, and quality teams.

Manufacturing Phase--Seamless in-house design transfer and rapid ramp up saves money, cuts your time-to-market, and ensures your product is built right the first time. We have multiple clean rooms, a production machine shop and skilled technicians for small clinical builds and long-term commercial manufacturing.

Support Phase--We help with the details. Expect assistance with regulatory submissions, order fulfillment, product maintenance, offshore manufacturing transfer, and more.

Please get in touch for a free consultation and proposal.

www.bctech.com

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Battelle Medical Device Solutions

505 King Avenue Columbus, OH 43201

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

Web: www. battelle.org/medical

VITAL STATISTICS

Year Founded: 1929

Number of Employees: 150 medical device professionals; 20,000 across Battelle worldwide

Number of Facilities: 2 dedicated medical device facilities; additional technology centers, offices, and national labs in more than 130 cities worldwide.

Annual Sales: $4 billion globally; $30 million in medical devices

WHO WE ARE

For the past 15 years, Battelle Medical Device Solutions has served more than 250 customers with multidisciplinary teams that apply expertise in engineering and life science areas. Battelle generates innovative solutions for today's most complex medical device development challenges.

MAJOR MARKETS

We deliver comprehensive research, development, and product support services to medical device, biotechnology, and pharmaceutical firms representing a wide range of therapeutic and diagnostic markets.

SERVICES OFFERED

Applied Research

Through a systematic understanding of the requirements and targeted feasibility experiments, our applied research service makes device development more predictable in scope, time, and cost.

Device Development

Our disciplined approach to systems engineering, programmatic risk management, and detailed design reduces development risk and minimizes cost and time to market.

Clinical Research

By integrating device developers and clinical researchers through out the development process, our clients better manage their risk and increase their chances of a successful clinical trial.

Sustaining Engineering

Battelle Medical Device Solutions offers technical services required to enhance a marketed device, reduce cost, or address CAPA related issues rapidly and effectively.

www.battelle.org/medical

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B. Braun OEM Division

824 12th Avenue Bethlehem, PA 18018

Phone: Toll-free (866) 8-BBRAUN; [phone]

Fax: [phone]

E-mail: [e-mail]

Web: www.bbraunoem.com

VITAL STATISTICS

Year Founded: 1957

Number of Employees: 34,000+

Number of Facilities: 27

WHO WE ARE

The B. Braun OEM Division of B. Braun Medical Inc. delivers complete contract manufacturing capabilities, focusing on Class II and Class III medical devices. The company manufactures thousands of standard and specialty items from components to custom trays to solutions to serve a variety of markets: pharmaceutical, biotech, interventional, laparoscopic, arthroscopic, endoscopic, urologic, ophthalmologic and cardiovascular, as well as the medical device market.

B. Braun OEM Division is a part of B. Braun Medical Inc., a medical company with over 160 years of experience and more than two dozen worldwide FDA registered and ISO 9001 and 13485 certified production sites.

With three global divisions (Europe, Asia-Pacific and North America), the B. Braun OEM Division offers diverse and complementary capabilities resulting in new products, expanded production, cost efficiencies, and country-specific knowledge. And through our Sharing Expertise[TM] initiative, you have immediate access to B. Braun's renowned manufacturing and engineering capabilities.

MAJOR MARKETS

Pharmaceutical, Biotech, Interventional, Laparoscopic, Arthroscopic, Endoscopic, Urologic, Cardiovascular and Ophthalmic.

SERVICES OFFERED

Complete contract manufacturing services

As a contract manufacturer, the B. Braun OEM Division offers complete project management services, including:

* Design and prototyping

* Tooling and molding

* Product and process validation

* Manufacturing

* Packaging

* Sterilization

* Quality control

* Private labeling

* Regulatory affairs

Quality components

With over 35 check valves, the B. Braun OEM Division is an industry leader in valve design and production. But valves are only the beginning. Our product line covers the entire spectrum from adapters to clamping, piercing and capping devices to chamber assemblies and stopcocks. And for pharmaceutical applications, we offer the MINI-SPIKE[R] Dispensing Pin, filter needles, vented needles, double ended transfer needles, air venting filters and filter hubs in a variety of configurations.

Custom kits and trays

Hundreds of companies work with the B. Braun OEM Division to produce custom, private-labeled trays and kits featuring a variety of components. Experienced design engineers will work with you to develop disposable procedure kits that enhance your existing product line.

www.bbraunoem.com

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Beahm Designs, Inc.

Campbell, CA 95008

Phone: [phone]

E-mail: [e-mail]

Web: www.beahmdesigns.com

VITAL STATISTICS

Year Founded: 1990

Number of Facilities: 1

WHO WE ARE

[ILLUSTRATION OMITTED]

We provide first-class thermal mechanical solutions for an array of intricate process and device design challenges for the disposable and implantable medical device industry. Our equipment is hailed as "the best equipment of its class". Satisfied customers throughout the world attest to our optimum cost/quality tube processing solutions including Shrinking, Bonding, Tipping, Necking and Flaring equipment.

Our engineering customers rely on our ongoing research efforts, and value our drive to continually provide the best mechanical solutions available for their work.

MAJOR MARKETS

Beahm Designs customers include medical device manufacturers, local to global, from start up companies to the biggest names in the industry.

SERVICES OFFERED

Eliminate operator dependency with our MICRO-AUTOMATION[TM] Beahm machines. This technology combines delicate machine interfacing and material handling in order to achieve the exact and repeatable process results you need. Beahm Designs' Micro Machines address the need to reduce catheter "real-estate" and profiles.

Thermal Shrinking System Solutions

These systems provide exact delivery of uniform heat and traverse speed control with superior shrink/lamination results.

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Whether it's short or exceptionally long shrink lengths, Beahm Designs has the technology to support your shrinking application and production needs. As a pioneer in the design and manufacture of tube shrinking systems, and with thousands of machines in the field you can rely on our extensive knowledge for your shrinking applications.

Catheter Balloon & Shaft Bonders

Innovators of the Axial Compression Bonding systems, featuring MICRO-AUTOMATION, Beahm machines offer strict control for your bonding process. These systems repeatably perform high quality heat welds and balloon bonds on thermoplastic catheter tubings of various sizes, durometers and lumen configurations. These handy bench-top systems create strong, flexible bonds for challenging applications such as short balloon bonds, ultra-smooth lap and butt welds, single to multi-lumen braided shaft or thin wall balloons to catheter shafts.

System Selection Service:

Our team of experienced engineers and customer service representatives work with you to ensure complete process/ equipment compatibility and optimal results. Building on hundreds of satisfied customers, our application knowledge can be the difference between the success and failure of your project. Call today for selection assistance.

www.beahmdesigns.com

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Bodycote Testing Group

2395 Speakman Drive Mississauga, Ontario, Canada L5K 1B3

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

Web: www. bodycotetesting.com

VITAL STATISTICS

Year Founded: Various labs date back to the 1920's

Number of Employees: Over 1500 in North America

Number of Facilities: Over 30 in North America

Annual Sales: Over $200 M in North America

WHO WE ARE

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Bodycote Testing Group (BTG) has over 100 laboratories worldwide offering broadly based research, development, analysis and testing services on a contract basis to essentially all industrial sectors. We are part of Bodycote International PLC which has annual revenues well in excess of $1 billion. BTG labs all conform to ISO/IEC 17025. Our Medical Device and Pharmaceutical activities are cGMP compliant, and FDA and/or Health Canada inspected.

MAJOR MARKETS

Bodycote Testing Group services essentially all market sectors with materials, component and product-based testing, failure and development activities. Sectors served include: Medical Device, Pharmaceuticals, Food, Aerospace, Transportation, Automotive, Environmental, Textiles, Construction and others.

SERVICES OFFERED

Bodycote has been involved in contract research, development and consulting to the Medical Device industry for over three decades. Our breadth of capabilities and experience allows us to offer comprehensive materials-based product and process development, based on broad technical knowledge, supported by comprehensive analytical & testing capabilities, using well equipped materials processing laboratories and clean rooms.

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Pharmaceutical, Diagnostic, Medical Device and related development capabilities include materials development (polymers, metals, coatings, adhesives, textiles, pharmaceuticals, etc) comprehensive analytical testing, engineering, product and process development, prototyping and pilot manufacturing. Services are tailored to meet client needs and range from concept development and prototyping through cGMP compliant testing, validation and clean room pilot production.

Other materials testing capabilities include: Analytical Chemistry, Microbiology, Mechanical Testing, Fatigue, Vibration, Metallurgical, Thermal Analysis, Environmental Exposure. Bodycote also provides services to other industries

We also offer comprehensive failure analysis, contaminant identification, deformulation support, forensic expertise, and consulting services.

www.bodycotetesting.com

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BSI Product Services, Healthcare

12110 Sunset Hills Road, Suite 200 Reston, VA 20190-5902

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

Web: www.bsiamericas.com

WHO WE ARE

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BSI Product Services, Healthcare contributes to our clients' success in the global medical device industry by accelerating access to international markets. As a world class Notified Body, BSI provides rigorous quality system reviews and product certification, delivering confidence to regulators, manufacturers and consumers. Our responsive team includes product specialists, engineers, microbiologists, regulatory affairs and quality experts. We understand your business, as well as the challenges of the global marketplace.

MAJOR MARKETS

BSI has been doing business in more than 100 countries for over 100 years with offices around the world. Our experienced team works with Medical Device Manufacturers needing verification of regulatory and quality requirements and we specialize in:

* High-risk * Invasive Medical Devices

* Combination Products * Implantable Medical Devices

SERVICES OFFERED

Our one-stop shop approach offers proven programs and services that help get your medical devices to global markets swiftly:

Regulatory and Quality Management

* ISO 13485 Quality Management System

* CE Marking for the European Market

* Health Canada CMDCAS

* Japan PAL

* ISO 14971 Risk Management Certification

* FDA 51 OK Third-Party Review Program

* FDA Accredited Persons Inspection Programs

* Hong Kong Conformity Assessment Body (CAB)

* China State Food and Drug Association (SFDA)

* Australian EU Conformity Assessment Body under EU/Australian MRA

* Additional services available

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Speed-to-Market Programs--We continue to develop Speed-to-Market programs to meet the challenging demands of the medical device industry. Our CE-90 Program has been specially developed for products needing design dossier reviews. Most reviews can be completed within 90 working days from submission.

Medical Device Free Email Update Service--Take advantage of this free service to keep you updated on what's happening in the industry and changes in regulatory and quality requirements. Sign up at www.bsiamericas.com/MDupdates

Informational Webinars--We offer a wide variety of interactive multimedia presentations allowing convenient participation via a web-based interface. Our one-hour Medical Device overviews are free of charge.

Guidance Documents--MedDevs Guidance Documents, issued by the European Commission, provide assistance in understanding the requirements of the medical devices directives.

To download these free documents, visit www.bsiamericas.com/ MEDDEVs

Medical Device Training--BSI's range of course offerings is among the most comprehensive available and addresses the needs of quality and regulatory professionals. We offer public, onsite, e-learning and Webinar training courses.

Standards--BSI British Standards deliver leading-edge best practice solutions through the development and publication of more than 20,000 standards and related products.

raising standards worldwide[TM]

Coeur, Inc.

704 Cadet Court Lebanon, TN 37087

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

Web: www.coeurinc.com

VITAL STATISTICS

Year Founded: 1999

Number of Employees: 140

Number of Facilities: 3

Annual Sales: $275 Million+

WHO WE ARE

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Coeur OEM is a state-of-the-art designer and contract manufacturer for the medical and commercial marketplace. In addition to manufacturing and assembling its own proprietary line, the company offers a full complement of services ranging from design, molding, extrusion, assembly and packaging of medical devices. Coeur OEM also provides regulatory support including 510(k) submissions and sterilization services to the medical marketplace.

MAJOR MARKETS

Contract Manufacturer for the Medical and Commercial Marketplace.

SERVICES OFFERED

Injection Molding / Assembly / Packaging

At their Washington, NC facility, Coeur OEM offers full contract injection molding and insert molding for most thermoplastic engineering resins including polycarbonate, ABS, nylons, PVC, PET and SAN, as well as filled polypropylenes and other engineering resins.

The facility in Washington is also the site of one of their controlled environment manufacturing areas (CEMA), controlling 0.5 micron and larger particles for the assembly and packaging of Class I and Class II Medical devices. A wide range of secondary, post-molding services including sonic welding, pad printing, heat staking, foil transfer printing and solvent bonding is also offered. This is a registered FDA facility and is ISO 13485/ FM77132 certified and QSR (cGMP) compliant. In addition, the company also maintains its listing with Underwriter's Laboratories (UL) as a manufacturer of fabricated plastic parts.

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Extrusion

In their Sheboygan, WI facility, Caeur OEM offers custom extrusion, including HDPE, LDPE, MDPE, PP, TPE, Urethane, FPVC, RPVC, EVA and PVC/ABS alloy materials. Additionally, Coeur WI provides assembly and heat forming services.

Quality and Regulatory Support

Coeur OEM can provide regulatory support (including 510(k) submissions and sterilization) to the medical marketplace. Coeur can also coordinate material testing for biocompatibility or physical properties.

Coeur OEM provides a full range of inspection and testing capabilities including:

* Dimensional inspection using calipers, micrometers, an optical comparator, and other measuring equipment.

* Custom designed and built go / no go gauges for improved inspection consistency.

* A laminar flow station that allows component and product inspection without contamination

* Custom built test equipment that allows for functional product testing and data collection for statistical analysis, including trending and product capability

* "Real time" SPC / SQC process monitoring

Project Management

Coeur OEM offers a full complement of services ranging from engineering and design, injection molding, extrusion, assembly and packaging of medical devices. Coeur OEM also provides regulatory support including 510(k) submissions and sterilization services providing companies with the ability to turn entire projects over to Coeur from concept to finished product.

www.coeurinc.com

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Camstar Systems, Inc.

2815 Coliseum Centre Drive, Suite 600 Charlotte, NC 28217

Phone: [phone]

E-mail: [e-mail]

Web: www.camstar.com

VITAL STATISTICS

Year Founded: 1984

Number of Employees: 165

Number of Facilities: 5 Worldwide

WHO WE ARE

Camstar is a leading global provider of Enterprise Manufacturing Execution and Quality solutions that help manufacturers rapidly boost the performance of their distributed and outsourced manufacturing operations by delivering complete visibility and by providing the flexibility required for rapid growth and change. Camstar's unparalleled solutions monitor, control and synchronize global manufacturing, delivering process interoperability and best practices throughout the entire supply chain--resulting in maximum agility, the highest quality products, and leaner, more efficient operations.

MAJOR MARKETS

Camstar is committed to deep industry-focus. Our Enterprise Manufacturing Execution and Quality systems are designed to meet the special needs of Medical Device and Diagnostics, Biotechndogy, Semiconductor, Solar, Electronics and Metals manufacturers--whether their plants are company-owned or outsourced. Camstar's industry-specific solutions are comprehensive with rich out-of-the-box functionality, plus:

* Best practices for your industry

* Maximum flexibility to meet your specific needs

* Rapid deployment and time to value

SERVICES OFFERED

Designed for ultimate configurability and utilizing a services-oriented architecture, Camstar's tightly integrated solution set encompasses a Manufacturing Execution System (MES), Quality Management System (QMS), Business Process Interoperability (BPI) and Manufacturing Business Intelligence (MBI).

Industry-specific, out-of-the-box applications and a proven implementation methodology ensure successful deployment and rapid time to benefit.

Camstar's world class Professional Services organization and Partners are renowned for effective project methodology, industry expertise, professionalism and business acumen which lead to highly successful implementations. Camstar is proud to have achieved outstanding customer referenceability.

Strategic partners include IBM, HP, Technology Resources Group, Mizuho, Logica CMG, SAP and Oracle, among others.

www.camstar.com

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Command Medical Products, Inc.

15 Signal Avenue Ormond Beach, FL 32174

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

Web: www.commandmedical.com

VITAL STATISTICS

Year Founded: 1987

Number of Employees: Around 100

Number of Facilities: 2 (Ormond Beach and Managua, Nicaragua)

Annual Sales: Undisclosed as the company is privately held

WHO WE ARE

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Command Medical is a disposable device manufacturer that supports medical outsourced product lines from subassemblies to finished sterile devices. Core competencies include RF Welding, tube extrusion, assembly, packaging and sterilization management. With facilities in the US and in Nicaragua, Command offers cost effective manufacturing options for products of at all stages of the product lifecycle.

MAJOR MARKETS

Command serves many markets with manufacturing of Class I and Class II devices:

* Dialysis

* Blood/Tissue Storage

* Wound Management

* Fluid Collection and Storage

* Infusion Therapy

* Incontinence

* Surgical Supply

SERVICES OFFERED

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Along with our core competencies, Command Medical Products, Inc. offers a variety/of value added services and offerings including:

* Product Design Assistance: Design for manufacturing / alternate parts sourcing

* Prototyping: sample runs / feasibility testing

* Process Development: Validation and cost reduction programs

* Tooling Management: Tool design, management & maintenance

* Supply Chain Management: vendor consolidations / customized inventory solutions

* Dock to Stock Product Delivery

Our Management Team is comprised of an experienced staff knowledgeable in all aspects of medical device manufacturing. Our Team Leaders have over 100 years combined experience.

www.commandmedical.com

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Covidien

15 Hampshire Street Mansfield, MA 02048

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

Web: www.covidien.com

VITAL STATISTICS

Number of Employees: 43,000

Number of Facilities: 67 Facilities Located in 17 Countries

WHO WE ARE

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The Covidien OEM and Custom Product Solutions Division is dedicated to delivering high quality medical and custom engineered products to the Medical Device, Pharmaceutical, Consumer, Rehabilitation, and Industrial Markets.

Drawing from the diverse manufacturing capabilities of 67 manufacturing facilities worldwide, Covidien OEM offers our customers and partners a single source for custom product design and development, and one of the broadest standard product offerings in the medical device industry today.

MAJOR MARKETS

Medical Device, Pharmaceutical, Biotech, Consumer, Rehabilitation, Industrial

SERVICES OFFERED

Products Offered

* Needles and Syringes

* Hydrogels

* Stimulating and Specialty Electrodes

* Sutures

* Urology

* Chart and Thermal Papers

* Soft Tissue Wound Closure

* Skin Care

* Hot and Cold Therapy

* Wound Care

* Bioabsorbable Polymers

* Thermometry

* Enteral Feeding

* Blood Collection

* Suction and GI

* Sharps Disposal

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Manufacturing Capabilities

* Injection Molding

* Hydrogel Mixing and Formulation

* Bottle/Syringe Filling

* Suture Braiding and Monofilaments

* Absorbable and Non-Absorbable Polymers

* Custom Converting

* Rigid and Flexible Packaging

* Ultrasonic Welding

* Die Cutting

* Textile Converting

* Extrusion

* RF Welding

* Electronic PCB Assembly

* Laminating

* Kit Manufacturing

* Electrode Assembly

www.covidien.com

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Conductive Technologies Inc.

935 Borom Road York, PA 17404

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

Web: www.conductivetech.com

VITAL STATISTICS

Year Founded: 1948

Number of Employees: 180

Number of Facilities: 1

WHO WE ARE

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Because of its unique heritage and resources, CTI has been incorporated to explore and exploit the emerging requirements for conductive and interactive analytical diagnostics and sensing componentry.

In 1973, in order to serve the demands of a growing electronic industry for reliable control interface systems, CTI was created with a handful of employees. Since 1974, CTI has grown to over 180 employees and is widely recognized as a global leader in the manufacture of membrane switches, graphic overlays, RFI Shielding, disposable bio-sensors and electrochemical sensors with international affiliates in 10 nations on five continents.

CTI was "present at the creation" of the membrane revolution in interface technology and has been in the forefront of the development of vital innovative and imaginative ideas for designers across the electronic spectrum.

CTI is one of the most advanced creators of circuit-based bio and electrochemical sensors made possible by a wealth of specialized technologies, exceptionally precise printing and processing, proprietary adhesive formulations, abilities to define and convert a wide choice of conductive and dielectric engineered materials, expertise in the properties and exact methodologies if inks, reagents, catalysts and adhesives.

CTI's recently expanded state-of-the-art design and production facilities are located in New York, Pennsylvania and are ISO-13485 and ISO-9001 Certified to assure the most precise and most accurate design and preparation.

MAJOR MARKETS

Medical Electronics, Electrochemical Biosensors, Single Use Test Strips, Membrane Switches, RFI/ESD Shielding

SERVICES OFFERED

* Electromechanical Biosensors

* Custom Membrane Switches & Integrated Control Panels

* Graphic Overlays

* RFI Shielding

* "Just One" Digital Laser Prototyping

* Membrane Technology: Tactile & Nontactile, Flat Panel, Low Profile Design

* Double Pole 4 Wire

* 4 Pole 8 Wire

* Extreme Temperature Sealed

* Nema 4 Custom Components

* EL Lamps

* Embedded LEDs

* Resistors-printed and embedded

* Capacitors

* Slide Switches

www.conductivetech.com

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Creganna

Parkmore West

Galway, Ireland

Phone: [phone]

Fax: [phone]

450 Donald Lynch Boulevard

Marlborough, MA 01752

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

Web: www.creganna.com

VITAL STATISTICS

Year Founded: 1980

Number of Employees: 500

Number of Facilities: 5 Including Sales Facilities

Annual Sales: $65M

WHO WE ARE

[ILLUSTRATION OMITTED]

Creganna create, design and build products and technologies for medical device manufacturers and life science companies. We specialize in solutions for catheter and specialty needle applications.

Catheter solutions include metal, polymer and composite tubing, complex micro molding, subassembly and design of delivery shafts.

We provide a complete range of technologies from 'handle to tip' for specialty needle design & manufacture.

MAJOR MARKETS

A leading supplier to the industry's largest medical manufacturers, Creganna has a worldwide manufacturing reach. Creganna has a leading position in its market and is ranked among the Top 10 global outsourcing providers to the medical device industry. Creganna supplies medical device and lifescience companies serving MI, Cardiology, Vascular, Neurology, Gastroenterology, Endoscopic and Orthopaedic markets.

SERVICES OFFERED

Create

Creganna creates innovative products, materials and technologies for medical device applications. Creganna operates a dedicated Innovation Centre, staffed by industry experienced device design engineers, polymer scientists and metallurgists. The team's pioneering innovations enable customers to develop new and innovative catheter and specialty needle solutions.

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Design

Creganna provides a contract design and development service for less invasive delivery devices. Experienced design engineers and project managers can support a design project from initial contact to market release. State of the art equipment and facilities including scientific laboratories and manufacturing facilities support the design service. The team has a proven track record with market leading medical device companies as well as small early stage start-up companies.

Build

Creganna builds solutions for catheter shaft delivery devices and specialty needle applications. Metal, polymer and composite catheter tubing is available and can be provided as a component or subassembly. Complex micro molding and insert molding services are also available. Creganna is established as a leading supplier of hypotube based delivery devices and related designs and components.

RECENT AWARDS

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DuPont Medical Packaging

4417 Lancaster Pike CRP728/3105 Wilmington, DE 19805

Phone: (800) 44-TYVEK

Fax: [phone]

E-mail: [e-mail]

Web: www.medicalpackaging.dupont.com

VITAL STATISTICS

Year Founded: 1802

Number of Facilities: Operating in more than 70 Countries

WHO WE ARE

Founded in 1802, DuPont puts science to work by creating sustainable solutions essential to a better, safer, healthier life for people everywhere. Operating in more than 70 countries, DuPont offers a wide range of innovative products and services for markets including agriculture, nutrition, electronics, communications, safety and protection, home and construction, transportation and apparel.

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Since its introduction to the industry more than 30 years ago, DuPont[TM] Tyvek[R] brand protective material has been recognized as a standard of excellence for sterile packaging. Tyvek[R] earned this distinction because it provides a higher degree of protection for medical devices and supplies than any other porous material used for sterile packaging applications. Tyvek[R] is used for sterile medical packaging including pouches, lidstock, breather patches and headers. Tyvek[R] delivers resistance to bacterial penetration, strength and compatibility with various sterilization methods. DuPont also markets identif overt and covert authentication technologies for anti-counterfeiting benefiting patients and consumers of health care services and products.

DuPont Engineering Polymers provides high-quality, carefully controlled, chemically stable and sterilizable plastic materials for safer drug delivery systems, advanced non-implantable medical devices and surgical instruments. Special Control (SC) grade materials undergo increased inspection and certification, including USP Class VI testing and FDA 21CFR 177. Premium Control (PC) grade materials are tested for bio-reactivity and are certified by extractables, spectrometric and other material data.

MAJOR MARKETS

* Diagnostic and Non-Implantable Medical Devices

* Health Care & Medical

* Manufacturing

* Medical Devices

* Packaging & Graphic Arts

* Pharmaceutical

SERVICES OFFERED

The DuPont Medical Packaging Team, backed by the vast resources of DuPont, is committed to developing unique and effective solutions and to providing the support medical device manufacturers need to ensure that end-users receive the highest quality medical packaging available. As leaders in the industry, we are dedicated to sharing information and expertise on topics ranging from industry standards and regulatory compliance to technical issues and quality. We developed a seminar series to help the industry stay on top of standards, regulations and new technologies. The series is divided into five different modules, most of which are approximately one hour in length. You can select which module or modules you are interested in and DuPont technical experts will provide instruction at your site.

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Members of our team also regularly participate on American Society for Testing and Materials (ASTM-International), International Organization for Standardization (ISO), European Committee for Standardization (CEN) and Association for the Advancement of Medical Instrumentation (AAMI) committees, as well as in industry activities, such as the Sterile Barrier Association (SBA), formerly the European Sterilization Packaging Association (ESPA), Association of periOperative Registered Nurses (AORN) Congress, Institute of Packaging Professionals (IoPP), and International Safe Transit Association (ISTA). And, because we want to help future packaging engineers, we established a scholarship program at some of the top packaging science schools.

www.medicalpackaging.dupont.com

Donatelle

501 County Road E2 Extension New Brighton, MN 55112

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

Web: www.donatelle.net

VITAL STATISTICS

Year Founded: 1967

Number of Employees: 400+

Number of Facilities: 1

Annual Sales: $65 Million

WHO WE ARE

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Founded in 1967, Donatelle provides medical component manufacturing through device assembly, packaging, and sterilization management to manufacturers worldwide. Donatelle is ISO-9001:2000 and ISO-13485:2003 certified and FDA compliant, which assures full compliance within GMP requirements.

MAJOR MARKETS

Donatelle serves many facets of the medical industry, including the implantable component market. Some of the markets we serve include cardiac rhythm management, vascular, neurological, cardiac surgery, drug delivery, urinary, diagnostics, implantable dental, and orthopedic.

SERVICES OFFERED

Donatelle offers single source expertise from concept through production. We offer historical leadership and expert processing capabilities for the entire range of engineered resins. Our production floor operates 24 hours a day, 7 days a week, and houses over 40 molding machines that range from 5 to 300 ton capacity. Molding is performed in controlled environments and cleanrooms, and is monitored by our ERP System, which has direct interface with primary processing equipment, for optimum throughput.

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Reduced component size is the future of medical components. To address the needs of our customers, Donatelle added micro molding to its list of capabilities in 2003. Our expertise provides our customers with ultra-high precision micro parts with superior process control at shot sizes of 0.001 grams.

Donatelle has dedicated rapid tooling resources in place to help our customers get their product to market quicker. With our in-house resources of engineers, mold designers, and tool makers, Donatelle can assess a design's ability to meet specification long before it goes into production. Near net shape parts with typical tolerances of [+ or -] 0.005" are what you can expect.

To support a variety of contract manufacturing needs, Donatelle also offers machined metal component fabrication. We specialize in close tolerance components, and are experienced in working with a wide variety of materials. Process available in-house at Donatelle include: Swiss CNC including 5- to 12-axis Swiss machining centers; Wire EDM work cells that are robotically controlled for full 24/7 unattended operation; Vertical machining with full 5-axis simultaneous machining; and Micro machining with CNC milling, turning, and EDM.

Donatelle partners with our customers and provides them with a project team approach. Every project has a designated Project Team Leader who is supported by a team of engineering experts in the materials and processing, design, automation, tooling, post-molding, research and development, prototyping, quality assurance, medical device assembly, and six sigma areas. Meeting your expectations is routine at Donatelle; exceeding your expectations is our measure of success.

www.donatelle.net