Medical DeviceQualified Supplier Directory

  • Adhesives and Adhesive Products

    Used to create bonds, adhesives are employed in various aspects of medical device manufacturing. Primary functions of adhesives include use in assembly tasks to join components of an end device or as a means of attaching a wound-care or other product to a patient. For skin-contact applications, critical factors to consider may be biocompatibility, fluid resistance, shelf life, adhesion, tack, and shear of the adhesive. Adhesives can be manufactured from such materials as acrylics, polyesters, silicones, and urethanes, and may be set using light-, moisture-, and UV-curing methods, among others.

  • Cleanrooms and Environmental Control

    Cleanrooms are highly purified and regulated areas reserved for the manufacture of contaminant-free medical products. Typically rated from Class 100,000 down to Class 10, cleanrooms designated for the manufacture of Class I, II, or III devices require strict temperature, humidity, and other environmental controls. Mechanisms such as sensors, exhaust systems, and particle-control equipment assist in maintaining a clean environment. Special garments and gloves are also required for employees working in a cleanroom environment in order to avoid contamination.

  • Components

    Hardware and accessories serve a wide variety of functions in medical applications. Couplings and fasteners, for example, assist in forming necessary connections while handles and knobs allow for user interaction and casters help to make a piece of equipment mobile. Many such products are offered in stock or standard versions; however, some suppliers can customize components to accommodate application-specific requirements.

  • Computing and Software

    Computers and associated hardware, including power systems, input devices, data-storage devices, and monitors, contribute to smooth plant operations. They can also be incorporated into medical equipment as part of a larger system. Medical device software enables manufacturers to efficiently manage their operations and develop medical products. Computer-aided design (CAD) and computer-aided manufacturing (CAM) software are essential elements in the product development cycle. Process-control, QA/QC, validation, and verification software allow OEMs to ensure that safe, effective medical devices are produced in compliance with FDA and other regulatory standards.

  • Consultants

    Medical device manufacturers can’t be expected to know everything; sometimes they can benefit from the niche expertise of a medical device consultant. Medical device consultants specialize in topics ranging from reimbursement to licensing and medical device–related legal issues. Consultants for medical device companies can also perform audits and inspections or issue ISO certification. Risk-management consultants and market research specialists can assess whether a device is viable in the marketplace and worth the cost and effort while translation consultants can assist with global expansion of a company or product.

  • Contract Manufacturing Services

    Depending on the company, a contract manufacturer can custom fabricate one component of an end product or take an entire medical device from concept through to distribution. Companies may specialize in one service area, such as molding, machining, or assembly, or may provide full-contract manufacturing services that can encompass R&D, design, and engineering assistance; prototyping; and full-scale production. Criteria to consider when selecting a contract manufacturer may include ISO 13485 certification, CGMP compliance, and cleanroom capabilities.

  • Electronic Components

    Medical electronics are the components responsible for an end product’s functionality. Printed circuit boards (PCBs), sensors, and embedded systems are at the core of advancing medical technologies. Many electronic components continue to accommodate the shrinking sizes of medical devices through lower power consumption coupled with increased functionality in a smaller package size. Common electronic components also include cables, connectors, switches, and power supplies.

  • Filters and IV Products

    In the medical device industry, filtration eliminates unwanted substances in air, gasses, or fluids from coming in contact with a patient. Filters are commonly associated with intravenous (IV) components and are engineered from a variety of materials, including plastics and ceramics. Because many medical devices and medications are delivered intravenously, catheters are fabricated from a variety of materials for applications ranging from angioplasty to urology. Connectors, couplings, cannulae, luers, and stopcocks are also critical components employed in delivery systems.

  • IVD

    IVD companies need access not only to the latest developments in biochemistry and genomics but also to the latest products in electronics and robotics, software and telecommunications, plastics molding and packaging, and a great many other fields. They also are not afraid to think about their businesses as global enterprises, to explore the potential of their intellectual properties in extraclinical applications, or to enter into strategic relationships that can help advance company goals. For all of the hard-pressed innovators in the IVD industry, there is a wide variety of supplier companies that can help. Various IVD supplier companies have specialized interests in providing the products and services that IVD manufacturers need to get their products to market in a timely fashion, including biochemicals and chemical reagents, filters, membranes, and bioseparation equipment, assay system components, tools for molecular diagnostics, electronic and mechanical components and software, packaging and labeling materials and components, manufacturing equipment and supplies, contract manufacturing, and consulting services.

  • Manufacturing Equipment

    A diverse array of equipment is necessary to process metal, plastic, and ceramic medical parts. Various manufacturing systems are needed to heat, cool, laminate, cure, drill, grind, cut, machine, or weld the materials, components, or completed medical devices according to specification. Sensors, meters, and calibration equipment, on the other hand, aid in process control to ensure products are manufactured to exact standards. Automated equipment such as robots, conveyors, dispensers, and assembly systems can reduce time and remove operator variability from the manufacturing process.

  • Materials

    Metals, plastics, ceramics, textiles, and other materials are the building blocks of medical products, and are selected for an application based on their properties and performance characteristics. Polyethylenes, polystyrenes, and polypropylenes are commodity thermoplastics, while polycarbonates, acrylics, PET, ABS, and PEEK are considered engineered thermoplastics. Elastomers are synthetic rubber-like polymers featuring viscoelastic properties. Thermosets, such as silicone or rubber, offer similar elasticity and properties, but are composed of organic compounds and cannot be reshaped after the curing process. Metals and alloys often offer strength, durability, conductivity, and heat resistance.

  • Molding Services and Equipment

    Single- and multishot molding operations, enabled by custom tooling, can yield both simple and complex medical device components from a range of materials. Molds vary from single to multicavity, and are specially made to handle materials such as thermoplastics, rubber, and metals. Contract molders can typically assist with every step of the process, from mold design through to production and shipping. Some molders may specialize in a particular molding operation, such as micromolding, injection molding, rotomolding, insert molding, overmolding, or blow molding; however, others have core competencies in multiple molding processes. Related molding equipment is also available for OEMs that mold products in-house.

  • Motors and Motion Control

    Motors and motion control components of various shapes and sizes enable precise movements of medical products. Various ac, brush and brushless dc, gear, servo, and stepper motors are incorporated into applications ranging from handheld surgical tools to full-scale imaging systems. Factors such as torque, efficiency, speed, and power consumption often influence motor selection. Assisting in precision motion control are actuators, brakes, drive systems, encoders, positioning systems, and vibration-isolation components.

  • Packaging and Sterilization

    Packaging and sterilization are instrumental in the production of a safe, effective, and regulatory-compliant end device. Sterilization methods include ethylene oxide (EtO), autoclave, gamma irradiation, or electron beam (E-beam). Proper packaging is critical in maintaining product integrity. Facilitating this goal is the use of packaging equipment and services for bagging, blister packaging, form-fill-sealing, thermoforming, sealing, vacuum forming, and wrapping. Clamshells, moisture-barrier packaging, cases, films and foils, pouches, trays, and other packaging materials and products are also supplied for medical use.

  • Printing, Labeling, and Bar Coding

    Whether printing information on a medical device or its packaging, proper equipment, services, and supplies suitable for medical use are required. Hot-stamping, laser marking, pad-printing, screen-printing, and ink-jet printing can contribute to completion of this step. Labeling equipment can apply the correct date, inspection, or verification information onto the products. Tamper-evident, self-adhesive, laminated, and sequentially numbered labels help to achieve this goal as well. Bar coding equipment and supplies, including scanners, printers, encoders, and labels, facilitate delivery and traceability.

  • Pumps and Valves

    Offered in either custom or standard versions, pumps and valves used in medical devices regulate dispensing and flow rates of air, liquids, and gases. Some medical devices use vacuum pumps, centrifugal pumps, and compressor pumps to help deliver air and fluids by displacing volume using physical or mechanical action. Diaphragm pumps, metering pumps, and peristaltic pumps are also common flow-control components used in medical device applications. Check valves, solenoid valves, ball valves, and control valves open, close, or partially obstruct passageways.

  • R&D and Design Services

    Research and development (R&D) and design services play an essential role in the medical device development cycle. Contract R&D and design services may encompass market and voice-of-customer research, industrial and mechanical design, prototyping, design for manufacturability, and process design and development to optimize operations. Engineering firms, on the other hand, can provide expert assistance with mechanical and electrical engineering, especially in regards to electrical assemblies and subassemblies.

  • Surface Treatment

    Medical devices are made from a variety of materials that offer specific properties; however, modifications to a device’s surface are often required to alter or enhance the functionality of the product for a particular application. Surface-treatment equipment is used to coat, etch, polish, deburr, or clean parts, as well as to prepare or activate a product’s surface for the addition of a coating. Coatings are frequently employed to protect end use devices or components, as is the case with antimicrobial and chemical-resistant versions. They can also provide properties to make a medical device lubricious, hydrophobic, hydrophilic, or antithrombogenic. Many of these services and treatments can also be outsourced.

  • Testing, Metrology, and Inspection

    Rigorous testing, metrology, and inspection processes must be conducted to ensure the safety and efficacy of a medical product, as well as to comply with stringent regulatory standards. Contract laboratories can perform such services as sterility, product safety, package, microbiological, EMC, materials, and biocompatibility testing, in addition to providing validation, surface analysis, and clinical trials. Instead of outsourcing, OEMs can also verify product or part integrity in-house using various measurement instruments, inspection and vision systems, and testing equipment to evaluate torque, thickness, impact resistance, and seal strength.

  • Tubing and Extrusion

    Suitable for use in catheter, anesthesia, and IV applications, among others, medical-grade tubing is fabricated from a range of materials that include such plastics as PEEK, polyimides, fluoroplastics, and silicones, and metals such as stainless steel, for example. Metal tubing is formed through a drawing process while the more-prevalent plastic tubing is typically extruded. Tubing can be offered in single- and multilumen designs; be braided or reinforced; feature thin walls and tight tolerances; and contain additives that enhance properties such as radiopacity. Coiling, crimping, cutting, extruding, and tipping systems can assist in tube processing.