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Company capabilities (Popper & Sons, Inc.-Ximedica, LLC).

Popper & Sons, Inc.

300 Denton Avenue New Hyde Park, NY 11040

Phone: (800) 717-7677; (516) 248-0300

Fax: (516) 747-1188




Year Founded: 1922

Number of Employees: 105

Number of Facilities: 2

Annual Sales: $13+ Million



Popper & Sons has been serving the medical device industry since 1922. Popper is ISO 9001:2000/13485 certified and FDA registered OEM manufacturer. Our manufacturing facility is located in Lincoln Rhode Island and our corporate offices in New Hyde Park NY. We proudly employ over 100 dedicated and highly skilled specialists.


Medical devices, Laboratory Automation and Instrumentation


Popper is ISO 9001:2000/13485 OFM manufacturer of device components with unmatched quality and service reputation. Popper's Tubing Services Division features extensive inventory of 304 and 316 stainless steel tubing, tight-tolerance precision cut-offs and point (cannula) grinding. Rapid Prototype Priority Services offer quick 2-4 weeks delivery. Popper's small diameter tubing fabrication services include; Centerless Grinding, Swaging, Bending, Laser Welding, Needle Assemblies, EDM, CNC, Flaring, Tip Reducing, Electro-Polishing, Micro-Polishing, Teflon, Ceramic, Parylene Coating, Grit Blasting, Laser Marking, assembly and packaging.



Peridot Corporation

1072 Serpentine Lane, Suite E Pleasanton, CA 94566

Phone: (925) 461-8830

Fax: (925) 461-8833




Year Founded: 1996

Number of Employees: 42

Number of Facilities: 2 ISO 9001:2000 Certified, ISO 13485:2003 Certified, Class 10K Clean Room



Peridot[TM] Corporation is a next-generation, precision medical component manufacturer and fabricator dedicated to delivering the most efficient manufacturing process innovations available.


Manufacturer of precision components for the medical equipment and healthcare industries.


We are unique among contract assembly companies, combining assembly, testing, and packaging services with in-house, multidisciplinary fabrication capabilities.

Peridot helps clients develop a simpler supply chain resulting in higher quality products and reduced lead times. No other company in the industry offers as many processes under one roof to provide better time-to-market on R&D projects, as well as greater flexibility in production schedule requirements. We support these efforts with in-house tooling and jig/fixture departments to further reduce cycle times.


Our surgical components include cannula; guide wires; blades; formed needles (hypodermic, laboratory, and CE-marked reusable needles, syringes, lauer connectors). Value added services include electronic data interchange; design for manufacture; computer aided drafting; cost reduction engineering; spring design stress analysis.


Phillips Plastics Corporation

1201 Hanley Road Hudson, WI 54016

Phone: (888) 633-6653

Fax: (715) 386-4326




Year Founded: 1964

Number of Employees: 1500

Number of Facilities: 14

Annual Sales: $250 Million


Phillips Plastics Corporation is a custom injection molder of plastic and metal that provides its customers with total solutions from design through production, assembly, sterilization and packaging. Supporting every program are design centers in California and Wisconsin, complemented by an experienced network of 120 engineers, 110 toolmakers, and over 1000 production people.


Medical original equipment manufacturers in the surgical instrumentation, drug delivery, testing equipment, and orthopedics market segments.


With over 110,000 square feet dedicated to class 100,000 clean room molding, decorating, and assembly, including three FDA registered facilities, and an additional 10,000 square feet of flexible incubation and production space, the company has the capacity to meet low to high volume manufacturing needs. Phillips' facilities adhere to ISO 9000 and EN 46000 standards, and have established internal systems to maintain complete traceability and compliance with all regulatory agencies.


Phillips Plastics Corporation has become one of the largest custom injection molders in the nation because of its commitment to investing in state-of-the-art technologies to meet customer demand. The company has 663,000 total square feet and 235 presses ranging in size from 7-750 tons.

As one of only a handful of suppliers in North America to provide not only plastic but also metal injection molding, and magnesium injection molding services, Phillips continues to carve a niche for itself by providing components made of either one or a combination of these materials. Combining the benefits of metal with Phillips' experience in tooling, molding, and decorating has given the marketplace a new source for the design and manufacture of metal parts.


* Industrial and Mechanical Design Refinement

* Product Development

* Fully integrated CAD/CAM, IGES compatible software platforms

* Models

* Stereolithography

* Rapid Prototype Parts

* Market-Entry Tools and Molding

* Tooling for Production and Secondary Operations

* Low and High Volume Manufacturing

* Multi-Shot Molding

* Medical Device Assembly

* Insert Molding

* Decorative Insert Molding

* Clean Room Molding

* Magnesium and Metal Injection Molding

* Micro Molding

* EMI/RFI Shielding

* A complete range of secondary operations including laser etching, in-mold decorating, electroplating, pad printing, hot stamping, painting, and plating.


Pilgrim Software, Inc.

2807 W. Busch Boulevard, #200 Tampa, FL 33618

Phone: (813) 915-1663

Fax: (813) 915-1948




Year Founded: 1993

Number of Employees: 120

Number of Facilities: 1

Annual Sales: Privately Held



Pilgrim Software, Inc. is a world-leading provider of Enterprise Compliance and Quality Management solutions for highly regulated industries. Pilgrim has pioneered effective, integrated software solutions for the Life Science industries. Pilgrim's fully Web-based solutions help businesses centrally manage domestic and international operations to ensure product safety and compliance, reduce manufacturing costs and improve customer satisfaction.


Pilgrim serves a worldwide array of customers in the Medical Device, Biotechnology, Pharmaceutical and Blood Banking industries, as well as other regulated manufacturing industries. More than 300 customers globally, and more than 500,000 end-users, work with Pilgrim every day to meet the diverse challenges of the world's highly competitive marketplace.


Pilgrim Software has been offering Real Solutions for Real Life[TM] since its inception in 1993. As a world-leading provider of Enterprise Compliance and Quality Management (ECQM) software, with its best-in-class solution, Pilgrim provides a comprehensive process automation solution for:

* CAPA Management

* Document control

* SOP enforcement

* Internal and external audit management

* Complaint handling

* Change management

* Employee certification and training management

* Equipment calibration

* Supplier quality management

* and other key quality and compliance management solutions.

Pilgrim offers complete and process-oriented solutions, imbedded with Best Practices and more than a decade of domain expertise. Pilgrim's SmartSolve[R] Suite is highly scalable to meet expanding enterprise quality needs, and is highly configurable to meet specific business requirements. This proven ECQM solution is fully Web-based and designed to easily integrate with cornerstone applications.

As a customer-driven organization, Pilgrim pledges end-to-end commitment to its customers, imparting its knowledge and skill from project management, to system configuration, to validation, to solution deployment. Consultants work side-by-side with customers throughout the entire implementation process, providing accurate, consistent and reliable analysis of the customer's business environment, then aligning with them to follow a comprehensive delivery model to implement a tailored solution that meets their specifications.

Pilgrim's affordable technical support maximizes the availability and productivity of its system, by providing rapid resolution, quick updates and fluid system performance. Ultimately, this allows the customer to maximize the effectiveness of Pilgrim's solutions, yielding greater overall compliance and quality management success.

Plitek, LLC

69 Rawls Road Des Plaines, IL 60018

Phone: (847) 827-6680

Fax: (847) 827-6733




Year Founded: 1968

Number of Employees: 100+

Number of Facilities: 2


PLITEK is a leading manufacturer of custom precision die cut components & converted materials for a range of medical device, diagnostic, and drug delivery applications. We offer a broad set of vertically integrated die cutting and converting capabilities and value added services to support customers from product development through commercialization. Since 1968, PLITEK has built a reputation as one of the most innovative and skilled converters in the industry by continually striving to provide solutions for even the most challenging applications.



PLITEK manufactures precision die cut components and converted materials for:

* Diagnostics, Microfluidics, & Laboratory

* Ostomy & Incontinence

* Advanced Wound Care

* Surgical/Cardiovascular

* Drug Delivery



PLITEK offers an array of precision die cutting & converting capabilities and value added services to enable our customers from design through commercialization.

Precision Die Cutting

* High speed, multi-station rotary die cutting

* Large format steel-rule die cutting

* Tight tolerance match-metal die cutting

* State-of-the-art laser cutting systems

* Integrated island placement

Material Converting

* Custom engineered film extrusion

* Multiple layer laminating

* Slitting & rewinding

* Specialty adhesive coating

* Printing & marking

* Surface treatment

* Radio frequency identification, RFID

Value Added Services

* Material sourcing assistance

* Design support

* Clean room manufacturing

* Component assembly & packaging


Potomac Photonics

4445 Nicole Drive Lanham, MD 20706

Phone: (301) 459-3031

Fax: (301) 459-3034


Web: www.


Year Founded: 1982

Number of Employees: 22

Number of Facilities: 1

Annual Sales: $4.5 Million


Potomac Photonics (Potomac) has, over the past 20 years, become a leader in miniaturization technology. By continually developing and utilizing the latest technologies, Potomac is able to offer its customers cost-effective solutions for prototyping and production, while providing them with a significant competitive edge. Potomac's Specialty Manufacturing Group has the capability to laser machine feature sizes as small as 1 micron in most materials and has been successful at partnering with many medical device and biotechnology organizations to bring their products to market in the most efficient and cost effective manner possible.



Potomac has successfully partnered with a wide range of industries within the Medical Market to include:

* Medical Device Manufacturers

* Biotechnology

* Pharmaceutical

* Medical Technology

* Medical Electronics

We are committed to helping improve the health and quality of life by providing our clients with the ability to miniaturize their products utilizing cutting edge laser technology.


Specialty Contract Manufacturing:

* Product Development / Prototyping

* Production Manufacturing

* Assembly

* Custom Tooling and Fixturing

* Cleaning

* Supply Chain Management

Potomac is committed to partnering with Medical Device Organizations to help bring their products to market in the most efficient, cost-effective manner possible. Our First-To-Market Program aids our customers with their initial design, prototyping, and qualification phases by offering turnaround times that can be as fast as 24 hours. Once a component or device is ready for production, Potomac Photonics can ramp up quickly to accommodate high volume manufacturing. Examples of Products and applications that Potomac has successfully helped our clients include:

Products / Services:

* Catheter hole drilling

* Stent Manufacturing

* Wire Stripping

* Implantable Glucose Sensors

* Marking / Serialization


* Holes drilling with sizes as small 1 micron

* Metal tube cutting

* Flat patterns in most substrates

* 3D Machining

* Blind holes and channels

* Excision of parts

* Leak Testing

Potomac supports US manufacturing and has implemented practices that allow us to provide our services at or below the costs of overseas contract manufacturing.

We are committed to finding innovative ways to help our clients realize a cost savings of 20% or greater, once projects move to production.

We are ISO 13485, ISO 9001:2000 certified.

Precision Extrusion, Inc.

12 Glens Falls Technical Park Glens Falls, NY 12801

Phone: (518) 792-1199; Toll-Free: (877) 792-1199

Fax: (518) 792-3805


Web: www.


Year Founded: 1991

Number of Employees: 20

Number of Facilities: 1


Precision Extrusion is an ISO 9001:2000 certified manufacturer of high quality, custom extruded, medical grade tubing from thermoplastic materials. We manufacture tubes that are single, multi lumen, co-extruded, striped and braided. Additionally, we manufacture acetal mandrel for manufacturing support of tight-tolerance tubing.

At our Glens Falls, New York Headquarters, highly skilled and experienced technicians manufacture a wide variety of single and multi-lumen, braided, and co-extruded small diameter tubing that meets or exceeds customer requirements.


Approximately 80% of our business is in the medical device industry. The balance is split among automotive, fiber optics and sporting goods. Our products and service are provided worldwide. Over 30% of our businesses are from outside of the United States, European and Asia markets mostly.


Through precise computerized equipment, extruded tubing of PUR, PA, PC, PE, PEEK, FEB PLA, PEBAX, PVC PP and most engineering resins are manufactured to meet your precise specifications. Materials can be compounded with barium, bismuth, or tungsten for radiopacity. Melt temperatures are maintained to within one degree. Screw RPM is held constant. On-line lasers monitor and maintain outside tubing diameters through automatic feedback control loops. Inside diameters and wall thickness are precisely controlled through on-line statistical process-control. PEI can handle the most complex tubing needs. We have state-of-the-art equipment that allows us to make the highest quality reinforced braided tubing in various compounds and configurations. Our high production lines manufacture acetal mandrel for use in the manufacture of tight-tolerance tubes. We manufacture in Liquid Crystal Polymer (LCP) for unequalled strength and temperature profiles. And, finally, we have bump or taper tubing for variable OD's and ID's. High quality, custom-extruded, medical grade tubing. Rapid order turnaround. A company wide commitment to total customer satisfaction. It's the perfect combination. It's what you want and need. And it's the reason Precision Extrusion, Inc. is among the leaders in extruded thermoplastics for the medical device industry.



Putnam Plastics Company

130 Louisa Viens Drive Dayville, CT 06241

Phone: (888) 36-GO PPC

Fax: (860) 774-6439




Year Founded: 1984

Number of Employees: 130

Number of Facilities: 1


Putnam Plastics Company has established itself as an innovative problem solver in responding to critical component challenges in the medical device industry. Our core capabilities include the manufacture of multilumen, multilayer, braided, and extremely thin-walled tubing and profiles formulated from one of the industry's widest selection of radiopaque and non-radiopaque polymers.


* Extruded wire coating (down to .002" wire)

* Co-extruded Polyimide Tubing

* Tri-layer Sheath Tubing

* Braided and Multilumen TIE Tubing

* Lined Multilumen Tubing

* Coating of optical fibers

* High Temperature Materials (PEEK, PS)

* Spiral Wound Tubing

* Narrow Films

* Coextruded Profiles

* RF Tipping

* Hole Punching

* Printing

* Insert molding of connectors


An extensive portfolio derived from two decades of experience in combining different materials and structures has enabled PPC to co-extrude tubing with the enhanced properties desired by the most progressive and innovative device manufacturers. Some of our recent developments include multiple layer micro-tubing with improved co-efficient of friction, polyimide liners with thermo-plastic coatings, and the ability to coat discrete length taper wires. PPC has also realized success in the development and manufacture of fluoropolymer wire coating with walls as low as (.0007"), coating of individual guidewires and catheter shafts, encapsulated wires and optical fibers in the wall of single and multi-lumens, multi-lumen tubing with linings (HDPE, FEP, PTFE) in specific lumens. Our TIE tubing continues to set the industry standard in continuous extrusion variable stiffness tubing.

While specializing in complex medical tubing, PPC also fulfills standard tubing needs in a state-of-the-art manufacturing facility equipped with online statistical quality control and two class 100,000 clean rooms. For development projects, PPC has a complete in-house machine shop and designers who utilize the latest in three-dimensional modeling software.

PPC offers unmatched technical expertise, custom design ability, complete in-house tool-making capabilities, and is a major supplier of complex tubing and sub-assemblies. Our core capabilities include the manufacture of multilumen, multilayer, braided, and extremely thin-walled tubing and profiles formulated from one of the industry's widest selection of radiopaque and non-radiopaque polymers. The PPC culture is one that emphasizes world class quality in our process and our products, an important element in supporting those efforts is adherence to the recently achieved registration/certification to the ISO 13485:2003 Medical Device Quality Management Standard.

In June of 2007 PPC added a dedicated business unit devoted to streamlining secondary operation applications. PPC+ is emerging as a critical added value resource for a number of our current customers. The efficiency and focus provided by PPC+ covers a wide range of secondary operation applications and provides our customers a broader range of capabilities within one manufacturing organization.


Memry Corporation

3 Berkshire Boulevard Bethel, CT 06801

Phone: (866) GO MEMRY

Fax: (203) 798-6363




Year Founded: 1983

Number of Employees: 410

Number of Facilities: 4

Annual Sales: $52 Million


A recognized global leader in the field of superelastic shape memory alloy technology, Memry Corproation has leveraged the dynamic material properties of Nitind in the development of a number of products that have enabled our customers to introduce breakthrough technologies and devices to the medical device market.


* Interventional Cardiology, Neurology, Radiology, Vascular Surgery

* Peripheral & AAA Stents

* Guidewires/Microcoils

* Urology, OB/GYN, Gastroenterology

* Endo-Surgery, Flexible Endoscopy

* Orthodontics/Endodontics

* Orthopedics

* Miscellaneous Formed Components

* Miscellaneous Assemblies

* Aerospace/Defense

* Automotive High Pressure Sealing

* Telecommunications Cell Phone Antennae

* Eyeglass Wear

* Intimate Apparel


With twenty-five years of success in supporting a wide variety of platforms in a number of diverse markets and applications, Memry Corporation is a recognized global leader in the field of superelastic shape memory alloy technology. Our customers have come to depend on Memry for superior design engineering consultation, assembly expertise, unique manufacturing processes, quick development, and rapid turnaround time. Memry has leveraged the dynamic material properties of Nitinol in the development of a number of products that have enabled our customers to introduce breakthrough technologies and devices to the medical device market.

In 2004 Memry Corporation completed the acquisition of Putnam Plastics Corporation. This partnership has provided significant enhancements to our vertical capabilities on a number of product platforms. Memry has long recognized that our customers are looking for development partners who can provide extensive added value to design concepts and production. PPC brings over twenty years of experience to Memry in the field of polymer extrusions. This confluence of proprietary cutting edge technologies continues to broaden the platform from which our customers can create and design. While the acquisition of PPC expands our already extensive capabilities, Memry continues to set the standard for superelastic shape memory alloy technologies and other Nitinol associated applications.

Memry has demonstrated worldwide leadership in converting Nitinol wire, strip and tubing into a wide range of components for medical devices and other markets. We provide extensive product development capabilities, including testing and prototyping to assist our customers in developing their product concepts. Recent product announcements include the launching of a Nitinol micro-tubing platform (Memry V2 Tubing), a large diameter Nitinol tubing platform (Memry Hybrid Tubing), and the establishment of PPC+, a dedicated business unit within Putnam Plastics that focuses strictly on secondary value added applications for polymer tubing products.

Memry recently achieved registration/certification to the ISO 13485:2003 Medical Device Quality Management Standard.


Precision Medical Products, Inc.

44 Denver Road Denver, PA 17517

Phone: (717) 335-3700

Fax: (717) 335-0007




Year Founded: 1969

Number of Employees: 98

Number of Facilities: Main facility located in Denver, PA and a molding division located in Shrewsbury, PA



Precision Medical Products, Inc., the preferred choice for medical device outsourcing, represents over 50 years of experience in manufacturing, assembly and packaging of medical devices incorporating a variety of metalworking and plastic molding technologies for the leading pharmaceutical and medical device suppliers worldwide. For more information visit our website


With more than 50 years of experience in the engineering, manufacturing and packaging of OEM medical devices, Precision Medical Products, Inc. (PMP), is uniquely positioned to respond to a wide range of customer needs for medical, surgical, dental, and pharmaceutical product applications, which our clients can take to the market. By integrating many technologies, PMP is able to manufacture medical devices more cost effectively. As a single-source manufacturer, PMP helps to ensure a successful and risk-free product launch.


In the production of your innovative specialty medical device, PMP offers a wide range of unique manufacturing and packaging capabilities. These capabilities include product manufacturing, engineering, component assembly, tool and mold making, as well as an extensive variety of plastic and metalworking manufacturing skills to ensure a medical device that meets your economic targets.


When necessary, Precision Medical Products (PMP) is capable and experienced in developing customized machinery to manufacture your product requirements. PMP's state-of-the-art medical manufacturing facility is idea for high volume, automated processes that blend the most precise requirements with cost-effectiveness and consistent quality.

In the world of health care, how a product is packaged is just as important as how it is designed. PMP can ensure you that your medical device will be manufactured to the highest quality standards, and packaged in certified clean rooms, tailored to your specification requirements.

Precision Medical Products (PMP), is a FDA registered state-of-the-art medical device manufacturing facility that is also certified to current ISO (International Standards Organization) standards.

Additionally, PMP manufactures and distributes CE marked medical devices. Our commitment to advanced quality assurance methods, along with the depth and breadth of our experience and expertise, has made us the preferred choice of leading suppliers throughout the world for medical device outsourcing.



2700 N. First Street San Jose, CA 95134

Phone: (408) 964-3555

Fax: (408) 964-3636




Year Founded: 1980

Number of Employees: 55,000

Number of Facilities: 80+


Sanmina-SCI[R] Corporation is a leading electronics contract manufacturer serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market. Recognized as a technology leader, Sanmina-SCI provides end-to-end manufacturing solutions, delivering unsurpassed quality and support to OEMs primarily in the communications, defense and aerospace, industrial and semiconductor systems, medical instrumentation, multimedia, computer and storage, and automotive technology sectors. Sanmina-SCI has facilities strategically located in key regions throughout the world.


Sanmina-SCI has established fully compliant Medical facilities in the United States, Mexico, Europe and Asia, combining the quality, and compliance of an OEM with the global presence and cost saving of an EMS provider.


Sanmina-SCI provides a comprehensive suite of medical device development services with an extensive offering of integrated manufacturing solutions for the entire product life cycle. These services include:

* Product design

* Engineering

* Testing and verification

* Component and full system assembly

* Documentation and regulatory compliance

* Global order fulfillment

* Warranty and repair


At Sanmina-SCI we believe that quality is the ability to consistently provide service and value that exceeds our customers' expectations. Sanmina-SCI is committed to this challenge and continuously works to improve our day-to-day operations in all our facilities worldwide.



The Medical Division at Sanmina-SCI has a dedicated staff that harmonizes and implements policies and procedures uniformly at all medical plants worldwide. Each medical facility is FDA registered and compliant with CFR Part 11 and 820, Canadian CANCAS and ISO 13485:2003.


* Relentless focus on customer requirements

* Globally focused quality management system

* Data-driven management

* Specialized resources and focused training

* Certification to industry standards

* Measurable management-ready reporting systems

* Lead Six Sigma process

* Operational audit programs

* ISO 9000

* Commitment to customer satisfaction


Proven Process Medical Devices

141 Washington Street East Walpole, MA 02032

Phone: (508) 660-9045; Toll-free: (866) 826-4594

Fax: (508) 660-6946




Year Founded: 1994

Number of Employees: 85

Number of Facilities: 1

Annual Sales: $10 Million to $20 Million


Proven Process Medical Devices is a full service organization that provides exceptional design, development, validation and contract manufacturing services, exclusively for the medical device industry. With a broad range of experience designing, validating and manufacturing novel Class II and Class III medical devices and equipment such as drug delivery systems, monitoring systems, cardiac assist devices, neurological stimulators, therapeutic devices, vascular access ports, catheters, disposables, disposable drug delivery systems and complex multi-functional mechanical/electrical systems, Proven Process is uniquely qualified to assist you from concept to your customer's door and anywhere in between.


Proven Process exclusively services the therapeutic and diagnostic medical device marketplace with product design, development, validation and manufacturing services. The company possesses particular expertise with sophisticated Class II and Class III mechanical and electromechanical systems, including active implantable devices.


The Company's core competencies include mechanical, electrical, software, biomedical, manufacturing and quality engineering. As reflected in its name, Proven Process adheres to a process that has proven successful time and again: combining creative state-of-the-art R&D, with exceptional design, process, and quality controls. All employees have been rigorously trained in the latest design control and quality management principles as well as domestic and international quality standards, and bring that expertise to your project.

Specific capabilities include:

DESIGN: Proven Process assures that your product is designed to meet your needs. The design methodology encompasses requirements analysis and definition, concept development, human factors design, risk analysis and management, concurrent design, design for manufacturing and extensive testing capability.

ENGINEERING: The overall goal is to provide you with the best engineering and manufacturing services available for your medical device development and validation needs. To achieve this Proven Process offers a wide range of engineering services at competitive prices. All engineering activities are focused on your requirements and are carried out under a comprehensive design control system developed to meet all of your quality and regulatory requirements. Our manufacturing facility offers the opportunity to take your product through clinical testing all the way to the marketplace. Our team includes experts in: mechanical engineering, plastics engineering, material science, electrical engineering, software development, manufacturing engineering, quality engineering, biomedical engineering, clinical engineering, fluidics, and rapid prototyping.

VALIDATION: Complying with U.S. FDA QSR and GMP requirements, as well as European medical device and active implantable medical device directives, requires that medical device companies provide a high degree of assurance that their products, and the processes used to manufacture medical products, consistently meet specifies requirements and user needs. Proven Process uses a wide range of verification and validation methods to help you meet that challenge including Product and Process Validation Planning, Product and Process Requirements Analysis, Specification and Verification, Software Verification and Validation, Fault Tree Modeling, Failure Modes and Defects Analysis, Process Design Validation, Vendor Qualification, Defect Tracking, Configuration Management, and Risk Management.

MANUFACTURING: As an ISO 13485:2003 certified and FDA registered contract manufacturer, Proven Process takes your product from concept to reality in our scalable, FDA GMP-compliant manufacturing facility. Our product testing labs help assure device quality while our model and prototype assembly labs complement full scale manufacturing with rapid prototype capabilities.


150-Q Executive Drive

Edgewood, NY 11717-8329

Phone: (631) 242-3000




Year Founded: 1980

Number of Employees: 90

Key Personnel: Stuart Herskovitz, President; Elizabeth Seims, CEO; Peggy Wilson, Director of Sales



Qosina is an international resource for OEM components. The company's comprehensive 5,000+ SKU offering includes clamps, connectors, drip chambers, tubing, stopcocks, filters, checkvalves, spikes, luers, syringes, vials, bags, bottles, test tubes, swabs, testers, applicators, sponges and brushes


* Medical Device Manufacturers

* Kit Manufacturers

* Pharmaceutical Industry

* IVD Industry

* Cleanroom Industry

We support your production requirements with just-in-time delivery from our huge inventory in our ISO 9001:2000, ISO 14001:2004 Registered 50,000 square foot facility.


We are a worldwide supplier of stock and custom-made OEM disposable components providing:

* Comprehensive online catalog

* 5000+ SKUs on-hand inventory

* Kanban inventory management

* Product sourcing

* Low minimums

* ISO 9001:2000

Thousands of stock components can be viewed in Qosina's 568 page 2007 edition catalog or by visiting our searchable online catalog at Custom sourcing service is available by knowledgeable specialists using Qosina's extensive resources.



Rapidwerks Inc.

1257 Quarry Lane #140 Pleasanton, CA 94566

Phone: (925) 417-0124

Fax: (925) 417-0128




Year Founded: 2004

Number of Facilities: 1

Annual Sales: $5 Million


Rapidwerks Inc of Pleasanton, California, is promoting its Precision MicroMdding manufacturing expertise in this specialized area to product designers, OEMs, and processors. In addition to processing virtually all types of plastics, Rapidwerks can prototype designs, fabricate tooling, mold parts, and create complex micro molded component assemblies for medical devices, data networking, and storage. As well as service tele-communications, automotive, and military industries.


Rapidwerks Inc. is generating increased interest world wide among designers and OEMs for its ability to fabricate parts that are almost microscopic in size efficiently and economically. Though definitions of micromolding vary, most experts will agree with Rapidwerks Inc. President Scott Herbert it involves a total shot size of 1 gram or less. Its greatest appeal is in applications where miniaturization is critical to product success. Rapidwerks' target markets for micromolding that reflect this. They include medical devices manufacturers, telecommunications, mobile computing, and automotive components.

Rapidwerks uses proprietary tooling and advanced molding equipment that has been designed specifically for micromolding. This offers a number of advantages over conventional fabrication techniques. The process is faster, more productive, and Jess expensive than machining, and the purpose-built tooling and equipment outperforms conventional injection molding machines that have been adapted for micromolding.


Serving a wide range of industries such as Medical Equipment, Device Manufacturers, Automotive Equipment, Mobile Electronics and Military applications, Our MicroMolding services and value-added services allow us to provide a competitive edge for all industries requiring close-tolerance micro or miniature molded Components. With the demand to miniaturize the need to manufacture micro molded components is increasing yearly. Utilizing our state of the art technology each is able to reach it's goals and meet market demands to reduce component sizes significantly.


Rapidwerks Inc. makes it easy to say "Let's Get Small"! A uniquely positioned Precision MicroMolding company offers it's customers the combination of Precision MicroMolding, Micro-Insert Molding, Over-Molding in addition to tool design, tool fabrication and contract assembly all in one location.

Our MicroMolding Services Include;

* Clean Room--MicroMolding in class 10K clean room environment. Preventing contamination to a micro-molded part and improving quality for the most demanding components or device manufacturers.

* Controlled MicroMolding--Controlling shot weights less than 1gram, sprues and cycle times are reduced significantly, increasing quality and lowering part cost.

* Tray Module--Medical component and device manufacturers "dream" Blister pak or tray packaging inline with micromolding. Inline reel or trays protect the micro-molded part from handling or transportation damage and contamination.

* Vision System--Fully Integrated inspection system, reduce second operations for inspection while reducing part cost.


RTEmd 160 Office Park Way Pittsford, NY 14534

Phone: (585) 383-1290

Fax: (585) 383-1294




Year Founded: 1981

Number of Employees: 50

Number of Facilities: 1



Whether you're launching a new product or upgrading an existing device, you can count on RTEmd software services. We do it right and we do it on time. We deliver outstanding project management, disciplined quality processes, and our easy-to-work-with engineers keep you informed every step of the way. Our ISO 9001-2000 certified quality system helps us ensure the efficacy, safety and compliance of your devices.


At RTEmd, our core focus is the medical device industry. We have a wealth of experience in both clinical diagnostics and imaging diagnostics, experience we are leveraging for our customers as these fields continue to converge. We are at the forefront of creating fully integrated product lines in the increasingly interconnected world of healthcare information technology.


New Product Development: We've been helping major medical device manufacturers and innovators launch successful new products for more than 25 years. Our services cover the complete spectrum of software development, from requirements analysis, architecture, and design, to helping you compile documentation for your Design History File and assisting with your regulatory submission.


Sustaining Engineering: RTEmd's Sustaining Engineering services provide a turnkey solution that lengthens the value cycle of your current products, both for you and your customers, and enhances your competitive advantage. We offer a range of capabilities, including:

* New feature design and implementation

* Bug fixes

* Component obsolescence solutions

* Manufacturing cost reductions

Verification & Validation: RTEmd offers testing, verification, and validation services to ensure that your software fulfills the stated requirements, complies with FDA regulations, and protects the safety of operators and patients. We help manufacturers verify product design and test software at virtually every stage of the development cycle. From analyzing requirements and developing comprehensive test plans to code reviews, testing, compliance audits, and documentation, we can help you meet FDA requirements.


Schutte TGM, LLC

4055 Morrill Road Jackson, MI 49201

Phone: (517) 782-3600

Fax: (517) 782-3363




Year Founded: 1880

Number of Employees: 800

Number of Facilities: 5



As a privately held company located in Cologne, Germany, Alfred H. Schutte GmbH manufacturers Multi Spindle Automatic Machines and CNC Tool & Production Grinding Systems. The company owned facility in Jackson, Michigan supports the North American market. With the largest selection of both CAM and CNC Multi Spindle machines, Schutte is continually developing tooling and machines for the high production of parts required for this competitive market. With the ability to automatically change grinding wheels, the WU305 Linear machine offers a number of capabilities not offered by any other machine in the world.


Schutte Grinders can be found in both job shop and high production applications, including medical, automotive, aerospace and wood working industries.



A full service, applications parts, soft-ware and sales staff are located at the Jackson, Michigan facility. Customers are invited to send samples and prints for testing and sample grinding or turning on both styles of machines.

Schutte WU305 Linear Grinder is the first machine to offer the capability to mill, grind, belt sand, and polish in one setup. The combining of all 4 operations in a single machine is quickly revolutionizing the "just in time" requirements of US industry.

For the regrinding market, the WU305 TREND features automatic wheel changing and auto parts loading. When combined with the Schutte SIGS software, customers are able to regrind different shank size and styles of tools in an automatic mode.

Schutte Multi Spindle machines offer the latest in digital and linear technology providing the finest resolution and accuracy in the industry.


S.S. WHITE[R] Medical

151 Old New Brunswick Road Piscataway, NJ 08854

Phone: (732) 752-8300

Fax: (732) 752-8315




Year Founded: 1999

Number of Employees: 200

Number of Facilities: 3

Annual Sales: $25 Million


S.S. WHITE[R] Medical, a wholly owned subsidiary of S.S WHITE[R] Technologies, was founded in July 1999 when S.S WHITE[R] Technologies acquired Snap-On Medical Products. S.S. WHITE[R] quickly pioneered its way into becoming a world-class manufacturer of custom medical instrumentation. Today, it services virtually every Orthopaedic OEM worldwide.


S.S. WHITE[R] Medical is dedicated in meeting the needs of the medical industry by providing world class service. Experienced engineers, a full service production facility and years of experience have earned us the trust and respect of the largest surgical Orthopaedic implant and instrumentation companies worldwide for their contract manufacturing needs. It is because of these very principles, with which S.S. WHITE[R] Medical prides itself that has made us a manufacturer the Orthopaedic Industry relies on. Today, S.S. WHITE[R] Medical services OEM's in market segments such as reconstructive devices, fracture fixation and spinal implants and instrumentation.



At S.S. WHITE[R] Medical, our experienced engineering and production staff know that in order to produce the highest quality medical instruments; every stage of the process must be controlled. Our dedication and manufacturing capabilities allow us to do just that. In house engineers are available from prototype to production to ensure that your specifications are met.


Our 85,000 sq. ft. in-house facility is fully equipped with state of the art equipment, allowing us to have the technical superiority and capabilities we need to get your products produced to your specifications.

Quality Assurance & Control

* FDA Certified Medical Device Facility

* ISO 9001:2000

* FAA FAR21 Subpart K Certified

* Optical Comparators

* QSI Quality Management Software System

* Comprehensive gage system test & reliability equipment

* cGMP Facility

* QS 9000 Certified

* Life Cycle Testing

* Autoclave units

Production Equipment & Support Turning

* Tsugami NP 20 mm twin spindle Swiss turn

* Tsugami NP 32 mm twin spindle Swiss turn

* Okuma LB 15

* Okuma LB15, 8" swing

* Okuma ES6 7" swing

* CMS GTS micro turning centers with live tooling

CNC Grinding

* Huffman HS 155 R 5 axis grinding cell

* Surface grinding

* Universal grinding

Water Jet Cutting

* Flow Bengal, 42,000 PSI


Okuma VR 40s with Haas 4th axis, Okuma VR 40s with Haas 4th axis, Kira Hz KN40HBs with index able pallet, Kira VTC 40Bs with Haas 4th axis


* Sodick A230 5 Axis wire EDM

* Sodick Moldmaker sinker EDM

Other Capabilities

* Laser Engraving

* Electropdishing

* Laser Welding

* Gundrilling

* Heat Treating

* Passivation

* Anodizing


SMC Ltd. Molding and Manufacturing

330 SMC Drive Somerset, WI 54025

Phone: (715) 247-3500

Fax: (715) 247-3611




Year Founded: 1988

Number of Employees: Over 500

Number of Facilities: 11


SMC Ltd. Molding and Manufacturing is a global supplier offering full service contract manufacturing for healthcare companies around the world. Since its inception in 1988, SMC has been known as an industry leader in technical engineering expertise. Based on a core competency of injection molding, SMC today provides full engineering design services and finished devices. Globally competitive options exist with multiple production facilities in North America and India.



Finished Devices, Full Product Design, and Molding Services for medical device and drug delivery device manufacturers. Healthcare is 90% of SMC's work.


Product Design & Development

SMC has a team of specialized dedicated engineers ready to address the challenges specific to your product. Our extensive experience in complete product development not only allows strength in product design but also the ability to recognize challenges down the road in manufacturability. The collaboration of our project team can ensure that your product will be first to the market at the lowest over-all cost.

Injection Molding

Since the birth of SMC, complex molding has been our core competency.

* Silicone (LIM)

* 2-Shot

* Gas Assist

* Miniature

* Insert

* Over-Molding

* Bioabsorbable

* Clean Room


Finished Devices

SMC offers full device manufacturing. Regulatory requirements are fulfilled through dedicated product validation processes. Just some of the services that our engineering team can offer are:

* Full Engineered Product Design

* Design and Manufacturing Consultation

* Tool Design and Layout

* IQ/OQ/PQ Validation Protocols

* Detailed Process Work Instructions

* Documented Process Control Parameters


Southmedic Inc.

50 Alliance Boulevard Barrie, Ontario L4M 5K3

Phone: (705) 726-9383

Fax: (705) 728-9537 or

(800) 463-7146 in the U.S. and Canada

Fax: (705) 728-9537




Year Founded: 1983

Number of Employees: 100

Number of Facilities: 1



Southmedic: A fully integrated manufacturer, specializing in certified clean room injection molding, and assembly.

As your Silent Strategic partner, Southmedic is your one stop solution for your aspirations, from concept to design, prototyping, tooling, production, assembly, and distribution.

We understand program life cycles. From conception to Maturity we maintain the program in house as if it where our own. Our 60,000 square foot GMP compliant facility is certified to ISO 13485 2003.


Specializing in clean room manufacturing requiring high precision and rapid delivery, we are the supplier of choice for many providers in the following sectors:

Health Care

Medical devices


Sterile & non sterile

Disposable, Consumables, Reusable


Explosive and narcotic detection

Insert molding

Consumer packaged goods

Feminine hygiene

Cosmetic delivery systems


Design engineering

Solid Works

Pro E




Clean roam Injection molding

Clean rooms certified to 209 E

Insert molding

Scientific Molding

From 35 ton to 300 ton injection molding machines


2 -5000 square foot Clean rooms certified to 209 E currently

White room assembly


Sonic welding

Pad printing



Sterility management

Quality Assurance/Control

Regulatory affaires


Specialized Medical Devices, LLC

300 Running Pump Road Lancaster, PA 17603

Phone: (717) 392-8570

Fax: (717) 392-8578




Year Founded: 1962

Number of Employees: 155

Number of Facilities: 1

Annual Sales: Confidential

Certifications: FDA Registered and ISO 13485:2003



Implants--instruments--class 10,000 cleanroom packaging. SMD specializes in complete spinal implant systems, small bone implant systems as well as custom orthopedic instrumentation. SMD is a full service manufacturer of medical implants and instruments from prototype runs to full production.


* Cardio Vascular

* Dental Implant

* Neuro

* Ophthalmic

* Orthopedic

* Otolaryngology

* Spine



SMD's expansive in-house capabilities include ultra-precise CNC-Swiss screw machining, 5-axis vertical milling, wire EDM, titanium anodization, a validated implant cleaning process, vacuum heat treating, laser marking, electropolishing and passivation. Materials: titanium, stainless steel, cobalt chrome, PEEK and exotic metals & plastics. FDA registered and ISO 13485:2003 certified.


Sunlite Plastics, Inc.

W194 N11340 McCormick Drive Germantown, WI 53022

Phone: (262) 253-0600

Fax: (262) 253-0601




Year Founded: 1946

Number of Employees: 75

Number of Facilities: 2

ISO 13485 Certified



Sunlite Plastics has been a quality custom, medical extruder since 1946. Sunlite manufactures in a Class 100,000 clean room and we extrude most thermoplastic materials. Our capabilities include producing everything from standard, high volume PVC tubing to highly engineered extrusions. In-house PVC compounding gives us a unique advantage in the PVC markets (including Non-DEHP PVC). It is our technologies, however; which have truly set us apart.


Medical Market Worldwide



Sunlite Plastics manufactures custom medical tubing in a Class 100,000 clean room. The company's technologies include single-lumen, multi-lumen, paratubing, coextruded, striped, heat seals, cut to length tubing, neck-down tubing, funnel tubing, thermal bonded tubing and custom compounding. Sunlite Plastics offers a wide range of FDA and Class VI approved materials including PVC, Non-DEHP PVC, EVA, Polyethylene, Polypropylene, Polyurethane, Butyrate and filled material, to name a few.


Syncro Corporation

PO Box 890, 1030 Sundow n Dr. NW Arab, AL 35016

Phone: (256) 931-7802

Fax: (256) 931-7920




Year Founded: 1947

Number of Employees: 130

Number of Facilities: 1



Syncro Corporation has been providing product development and manufacturing support to contract manufacturing customers requiring electronic and/or electromechanical subsystems and products for over half a century. Our combination of vertical integration and depth of expertise in supporting complete product life cycles from development through depot repair enables us to closely align our project support with whatever mix of capabilities our customers require.


We serve customers in the medical, automotive, industrial controls, telecommunications, utilities and instrumentation markets.


At Syncro, our business model provides superior support for low-to-medium volume, variable demand, box build projects through:

* Access to a low turnover, skilled workforce in a competitively priced labor cost region

* Access to a vertically integrated manufacturing facility whose resources include:

--Product development engineering

--RF design and test development


--Plastics injection molding

--Metal forming/stamping

--Coil winding


--PC board assembly and test

--Electromechanical assembly and test

--Post-manufacturing support including fulfillment, repair and refurbishment


Our project management team is focused on meeting customer goals for:

* Rapid project launches

* Fast response to schedule change requests

* Cost reductions through a focus on continuous improvement in supply base management and production processes

* Superior product quality and alignment with quality reporting methodology

* Minimized finished goods inventory.

We specialize in listening to our customers' needs in developing a complete solution for complex, variable demand production projects. The end result is that your "hard to fit" outsourcing projects become easy to manage in an environment that is truly an extension of your production strategy.


STERIS Isomedix Services

5960 Heisley Road Mentor, OH 44060

Phone: (877) 783-7479

Fax: (440) 392-7914




Year Founded: 1972

Number of Employees: 750

Number of Facilities: 21



STERIS Isomedix Services provides expertise in contract sterilization and microbial reduction to Customers in the medical and pharmaceutical industries. Through a North American network of 21 facilities, we offer the most comprehensive array of sterilization services, using Gamma Irradiation, 100% Ethylene Oxide (EO), and Electron Beam (E-beam) technologies. State-of-the-art sterilization capabilities are just part of a complete managed program that emphasizes exceptional process quality, efficient turnaround, and optimum cost containment.


Contract sterilization services provided to a wide range of industries within the medical device market, including:

* Medical devices

* Pharmaceuticals

* Labware

* Surgical kits


Gamma, EO, E-beam. STERIS Isomedix Services has been committed to providing the most comprehensive contract sterilization services to the medical device community for more than 30 years. Blending industry-advanced technology with a team approach to Customer service, STERIS Isomedix Services offers the industry's most competitive advantage encompassing Gamma, EO, and E-beam sterilization.

Technical Consultation. Our TechTeam[R] professionals provide vital technical support in all phases of the sterilization design process including product development, materials testing, protocol generation, and sterility validation. Going beyond contract sterilization, our TechTeam presents insightful alternatives, choices, specialty solutions, and total project management to address complex sterilization issues.

Locations. Through our network of 21 North American facilities we deliver leading technology to meet our Customers' needs. With customized programs built around client satisfaction, Customers receive can-do solutions at every possible touch point, maximizing return on investment. All facilities are FDA registered, ISO 13485 Certified, and AAMI/ANSI/ISO 11135, AAMI/ANSI/ISO 11137, EN 550, and EN 552 compliant for product acceptance in U.S. and international markets.

Supply Chain. Our dedication to providing cost-effective, quality service extends beyond the scientific reaches of our work. STERIS Isomedix Services is committed to minimizing transportation costs and streamlining response time. Our supply chain focus also includes SteriLink[R], the interactive online service providing complete, real-time visibility into STERIS Isomedix processing facilities.

Customer Satisfaction. STERIS Isomedix Services offers an unmatched combination of technologies, services, and employees with the dedication and passion to help our Customers succeed. Our continual investment in facilities, technology, and our people ensures our Customers have the best possible resources for continued success.

STERIS Isomedix Services is a subsidiary of STERIS Corporation (NYSE: STE).


Symmetry Medical Inc.

3724 North SR15 Warsaw, IN 46582

Telephone: (574) 268-2252

Fax: (574) 267-4551




Year Founded: 1976

Number of Employees: 1,938 (as of August 2007)

Annual Sales: $254 Million (2006)

Key Personnel & Job Titles: Brian Moore, President and Chief Executive Officer; Fred Hite, Senior Vice President and Chief Financial Officer; D. Darin Martin, Senior Vice President, Quality Assurance and Regulatory Affairs; Michael Curtis, Senior Vice President and General Manager, Medical Products Division; John Hynes, Chief Operating Officer, Europe.


Symmetry Medical is a leading independent provider of implants and related instruments and cases to the global orthopedic device industry. Symmetry designs, develops and produces these products for companies in other segments of the medical device market, including dental, osteobiologic and endoscopy sectors, and provides limited specialized products and services to non-healthcare markets. Through its Total Solutions[R] approach, Symmetry offers customers a broad range of products, as well as comprehensive services and production capabilities to help them bring their implant systems to market quickly and efficiently.



Symmetry Medical offers a broad range of products in the following categories:

* Implants, including forged, cast and machined products for the global orthopedic device market;

* Instruments used in the placement and removal of orthopedic implants and in other surgical procedures;

* Cases, including plastic, metal and hybrid cases, used to organize, secure and transport medical devices for orthopedic and other surgical procedures;

* Other specialized products and services for non-healthcare markets.


Symmetry Medical's Total Solutions[R] approach presents customers with a broad range of products, as well as comprehensive design, engineering, project management services and production capabilities to help them bring their implant systems to market quickly and efficiently. Symmetry's Total Solutions[R] is based on the following elements.

* Comprehensive services

* Single source for complete systems

* Proprietary Symmetry instruments and cases

* Precision manufacturing expertise

* Quality and regulatory compliance

* Global reach


These elements can provide the following benefits to customers.

* Shorter time to market

* Reduced total product acquisition costs

* Increased focus on marketing and research and development efforts

* Rationalized and reliable supply chain

* Enhanced product consistency on a global basis


Synovis Interventional Solutions, Inc.

475 Apollo Drive Lino Lakes, MN 55014

415 Road 693 Dorado, PR 00646

Phone: (651) 792-8500

Fax: (651) 792-8600




Year Founded: 1979

Number of Employees: Minnesota--170

Puerto Rico--45



Synovis Interventional Solutions is a division of Synovis Life Tech-nologies, inc. (NASDAQ: SYNO), a diversified medical device company engaged in developing, manufacturing and bringing to market medical devices for the surgical and interventional treatment of disease.


* Cardiac Rhythm Management

* Neurology

* Urology/Gynecology

* Vascular intervention

* Orthopedics

* Gastroenterology


* Contract manufacturing--Working in controlled environments, our trained technicians use the industry's latest technology and automation to deliver components, assemblies and devices that conform to your exacting specifications--on time and on budget. Our experience in the medical device industry strengthens our contract manufacturing capabilities.

* New product development--Throughout development, we customize our processes to meet your specific needs. Our engineers work closely with your development staff to reach milestones and achieve goals. Along the way, we help you find opportunities to improve product quality, reduce time to market, and lower costs.

* Wire Coiling--Synovis Interventional Solutions, Inc., winds micro coils for leads for cardiac rhythm management and neuro-stimulation markets, for guidewires in the vascular intervention market, and for delivery devices in multiple markets. Synovis winds a range of configurations, from the simplest, straight, single-strand coils to the most complex, multiple-pitch, multi-filar coils.

* Wire straightening, forming and grinding--Synovis offers wire straightening, grinding and forming services that ensure your end-using physician is favorably impressed. Synovis has its own proprietary straightening processes that produce torque, flex, stiffness, and shaping characteristics that match the handling features doctors demand.

* Precision machining, including Swiss, CNC milling and turning, EDM--Synovis offers its customers a one-stop-shop solution for the production of Swiss and CNC machined metals and plastic components. From assisting with design to making prototypes to the machining of parts, yours will be a qualified process-controlled production run.

* Plastic injection molding, including micro molding--Synovis is your best choice for fulfilling your need for thermoplastic components. We apply our many years experience engineering tight-tolerance medical components to offer you a full range of plastic injection molding services.

* Laser processing and welding--Synovis offers a variety of laser processes to complete your wire, metal and plastic products including welding, ablation, forming, end cutting, etching and engraving.

* Joining and assembly--In addition to laser welding, Synovis has an array of joining processes and the experience and knowledge to make sure you choose the best method for your sub-assembly or device. Synovis has a variety of clean environment areas and ISO 13485:2003 certification of our quality systems. With assembly and packaging services, we can ship components, subassemblies, and finished devices to our customers in dock-to-stock condition.

Partnerships work best when they are built on trust and transparency. This approach describes the way we work. Upholding confidentiality, we welcome you to our facilities to work side-by-side with our engineers. Feel free to ask questions, offer suggestions or make alterations. We are convinced that a flexible, responsive collaboration will result in a product that works better for you and your customers.

For more than 20 years, Synovis Interventional Solutions has been supplying components, assemblies and devices to the medical industry. We are committed to manufacturing medical innovation--and devoted to securing your success.

Call or visit us today.

TechDevice Corporation

650 Pleasant Street Watertown, MA 02472

Phone: 888-TECHDEV (832-4338)

Fax: 617-972-5815





TechDevice specializes in the design, development and contract manufacturing/assembly of a broad range of guidewires, balloons and balloon catheter assemblies. This includes 510(k) approved products for OEMs that prefer total outsourcing solutions. TechDevice offers superior quality systems, competitive pricing and the resources necessary to execute jobs in a timely fashion--from front end new product development through contract manufacturing to back-end value-added services.


Medical--vascular, urology, endoscopy and products for many other applications.


Guidewires--To customer specifications or from our 510(k) approved matrix of products.

TechDevice will contract manufacture guidewires to customer specifications using a variety of core materials, coil types, coatings, markers, tip configurations and packaging requirements.


Go to to view a matrix of TechDevice's 510(k) approved guidewire portfolio.


Balloons--Manufactured to customer specifications.

TechDevice specializes in the development and contract manufacturing of a wide range of high-quality medical balloons. TechDevice balloons feature exceptional quality and consistancy as a result of the high grade of materials used and the expertise exhibited by our skilled technicians.

Materials include: New Yulex[R] all-natural latex, Hevea latex, compliant, semi-compliant and non-compliant types.


Balloon Catheters--Standard product with 510(k) approvals or made to customer specifications.

TechDevice offers a full range of finished 510(k) approved balloon catheters including latex occlusion balloons for temporary intravascular occlusion.

TechDevice custom manufactures a wide variety of balloon catheters for occlusion, esophageal, biliary and vascular indications. Balloon catheters can require a variety of options that include shafts with multiple lumens, specific unique material types, end forming, molded hubs, markers, pad printing and packaging. Allow us to work with you through the design process to find the right combination of components.

Quality & Regulatory

* ISO 13485:2003 and CMDCS Certification

* FDA Registered

* Design control system compliant with FDA & European regulations

* Experience with the FDA 510(k) approval process


The Tech Group

14677 N. 74th Street Scottsdale, AZ 85260

Phone: (480) 281-4500

Fax: (480) 281-4503



Year Founded: 1967

Number of Employees: 1900

Number of Facilities: 12


The Tech Group has established a reputation as a global leader in partnering with the world's largest OEM's and providing them with on-time development and commercialization of their medical and drug delivery devices. With 12 facilities throughout the United States, Mexico and Europe, we offer custom molding and contract manufacturing solutions for the medical and pharmaceutical industries worldwide. Facilities are FDA registered, ISO certified (9001:2000) and cGMP compliant. The Tech Group is a Class II and Class III medical device manufacturer committed to producing the highest quality injection molded components and devices. Contract manufacturing projects range from product design refinement and development, tool design and fabrication, process designs, validation and production. The company also offers OEM's value-added services such as multi-component molding, class 10K and 100K clean room molding device assembly and packaging solutions..



* Medical Device

* Drug Delivery

* Pharmaceutical

* Diagnostics

* Hospital Products



* Program Management

* Product design/development engineering

* Internal mold design and construction

* Qualification and validation * Prototyping

* Manufacturing excellence--including Six Sigma and Lean manufacturing processes

* Well defined quality systems and regulatory compliance through class III devices

* Contract manufacturing and assembly solutions

* Process development and monitoring

* Global support for new product introductions

* Turnkey, high-speed, high-volume automated assembly solutions and specialized precision applications including:

--High speed stack molding

--Insert molding

--Over molding

--Optical molding

--Thin wall molding

--Two-shot molding

At The Tech Group, the products we make are just as important as the way we make them. Our employees are committed to understanding and meeting customers' evolving needs. Tech Group facilities operate to ISO 14001, 13485, 9001:2000 and FDA quality standards. Our focus on continuous improvement, operational excellence and quality assurance facilitates innovative products and quality solutions.


Teleflex Medical OEM

5307 95th Avenue Kenosha, WI 53144

Phone: (262) 657-2800

Fax: (262) 657-2801




Year Founded: 1943

Number of Employees: 10,000

Number of Facilities: Operations in 20 Countries

Annual Sales: $1.4 Billion


Teleflex Medical OEM brings you TFX OEM[TM] Dekantel[R], Beere Medical[R], Kmedic[R] and Specialized Medical Devices brands. We provide custom extrusions, catheters, introducers, dilators, sutures, fibers, resins, orthopedic instruments and implants with the unique performance characteristics you require. We offer dedicated technical services to ensure the successful transition from concept to development, manufacturing, and product packaging.



Custom extrusions made from PTFE and FEP as well as other high performance resins. We provide heat-shrink, standard extrusion, etched liners and other precision products which incorporates ultra-thin walls, profiles, multi-lumen and braided-reinforced tubing to the world's top medical device manufacturers. In addition, we provide customized devices such as catheters, introducers, dilators, and OTNs.



Full-line of high quality absorbable and nonabsorbable surgical sutures and devices, including our propriety Force Fiber[R] product. We have the capabilities to provide you everything from raw materials to final, private labeled and sterilized devices.


Beere Medical

Custom, innovative spinal and orthopedic instrumentation such as ergonomic silicone handles, torque and ratchets instruments. We are your exclusive source for the Evolution[TM] line of spinal implant revision kits and the new Centaur[TM] product line that combines an ultra-smooth ratchet with the precise torque-limiting action you depend upon.



Highest quality German-forged instruments with a standard offering of over 3,000 products. We are a partner who consistently demonstrates the ability to design, develop and manufacture a wide array of custom and standard instrumentation. Our latest addition is the KMedic Kolors product line which is a standard line of curettes, punches and rongeurs that uses color for easy and rapid identification.


Specialized Medical Devices

For over 40 years, orthopedic and spine companies have turned to SMD for their most demanding implants and instruments. We specialize in titanium, stainless steel, cobalt chrome, and PEEK, as well as exotic metals.


TOLAS Healthcare Packaging

905 Pennsylvania Boulevard Feasterville, PA 19053

Phone: (215) 322-7900

Fax: (215) 322-9034




Year Founded: 1987

Number of Employees: 180

Number of Facilities: 2

Annual Sales: >$30 Million



TOLAS Healthcare Packaging, an Oracle Packaging Company, is an ISO 9001:2000 certified converter serving healthcare markets worldwide.

Our business focus is the conversion of high quality packaging materials. We are a solutions-oriented company with solid technological capability and leadership products.

We have integrated coating and converting operations, with heavy emphasis on product development.


TOLAS serves the medical device and pharmaceutical markets.


TOLAS provides Tyvek, paper, film and foil as printed pouches, lidding and rollstock. Materials are available overall or zone-coated for easy peeling after EtO, radiation, plasma, or steam sterilization. The primary function provided by TOLAS' sterilizable packaging is maintenance of sterility throughout manufacture, sterilization, shipping, and storage of your product. We have a broad product line ranging from all-purpose packaging, such as peelable pouches and rollstock, to specialty products designed to solve specific packaging challenges such as the Dispos-A-Vent pouch, barrier packaging for ETO sterilization.


TOLAS has the capability to produce various types of pouches including chevron, corner peel, tear-open or rounded corner pouches, Pouches On A Roll and barrier pouches for EtO sterilization. Pouches are available with puncture resistance and light, oxygen and moisture barrier properties.

TOLAS offers heat-seal coated lidding for rigid tray and Form Fill Seal applications. Our heat seal coatings are engineered to seal at lower temperatures than standard coatings or sealants thus expanding the seal window and virtually eliminating the possibility of tray flange distortion.

Rollstock is available as Tyvek, paper, film or foil coated or uncoated, printed or unprinted.


Web Industries, Inc.

1700 West Park Dr. Westborough, MA 01581

Phone: (508) 898-2988

Fax: (508) 898-3329




Year Founded: 1969

Number of Employees: 500

Number of Facilities: 6


Web Industries is an industry leader in providing contract manufacturing services for flexible materials--from slitting, spooling, printing, laminating, assembly and packaging to complete supply chain management solutions.

As an industry leader in contract manufacturing services for nearly 40 years, we have a long history of applying our expertise, innovative thinking and creative problem solving to help speed time to market, drive costs down and continually improve processes to maximize your success.

Listen. Create. Deliver.

From listening to your challenges, to creating a solution and delivering the results you need, Web Industries can take the worry and the wait out of your manufacturing processes.


Whether you need us to design a manufacturing process for a component, a sub-assembly or a complete turnkey product, or manage your entire supply chain, we will work diligently every day to earn and keep your trust.

From wound care applications through in vitro diagnostic devices and consumables, we are a trusted, behind the scenes partner for some of the most recognizable names in the industry. We work diligently and in a very collaborative fashion with you to assure the integrity of your products as well as your reputation in the industry. We do not manufacture any of our own products and never have, so there is never an issue of competing priorities. We are focused on serving you.


Web Industries offers state-of-art converting services. We offer an array of value-added services such as automated assembly and packaging, specialty film extrusion, electronic document control and complete supply chain management solutions.


Ximedica, LLC

55 Dupont Drive Providence, RI 02907

Phone: (401) 330-3163

Fax: (401) 626-3356




Year Founded: Ximedica is a wholly-owned subsidiary of Item Group which was founded in 1985

Number of Employees: 50+

Number of Facilities: USA and Hong Kong


Ximedica, is a contract design, engineering, development and manufacturing company specializing in capital and disposable medical devices and instruments. Ximedica participates in the entire development process from initial design exploration to supply of finished goods. Its core competencies include fluid management, mechanical and electrical design as well as firmware and software implementation. In addition, Ximedica offers design control, compliance related documentation tracking, and offshore sourcing of components and subassemblies.



* Capital and disposable medical devices and instruments

* Mechanical and electrical engineering and design

* Firmware and software design and implementation

* Compliance related documentation tracking

* Offshore sourcing of components and subassemblies


Our 80,000 square foot ISO certified facility includes: Class 7 Clean CEMA (controlled environmental manufacturing area) rooms, 5000 square feet of R&D and testing facilities, 30,000 square feet of white floor manufacturing space, electric static discharge space, a full metrology lab, and an electro analysis lab.


Top Level Capabilities

* Market & User Research

* Product Strategy Development

* Concept Generation & Feasibility Study

* Design Generation, Verification & Validation

* Industrial Design & Human Factors

* User Interface & User Experience Optimization

* Product Development & Design Engineering

* Prototype Construction & Design Verification

* Design Control Maintenance

* Manufacturing Turnover

* Supply Chain Management

* Production

* Service and Life Cycle Support

Regulatory Services & QSR compliant processes

* Submission preparation (510(k), dossier, etc)

* Supporting testing and reporting

* QSR design, installation & auditing

* ISO 13485 installation

* Post market surveillance

Manufacturing Services

* Capital, Electromechanical Assembly

* Disposable Assembly

* Packaging and Sterilization

* Clean Assembly

* Fixture Development

* Engineering and Pilot Production Runs

Supply Chain Management

* Domestic and Overseas Suppliers

* Molding, Machining, PCB Fabrication

* Repair and Warranty, Services

* Warehousing and Distribution

* Customer Relationship Management (CRM)
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Title Annotation:2008 Company Capabilities & Outsourcing Directory
Publication:Medical Product Outsourcing
Article Type:Directory
Date:Dec 15, 2007
Previous Article:Company capabilities (The MedTech Group, Inc.-Pacific Plastics & Engineering).
Next Article:Medical device categories (Adhesives-Molding, Rubber).

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