Based in Las Vegas, NV, American High Voltage manufactures specialized high-voltage power components for extreme temperatures and harsh environments. They produce power solutions for critical applications across various industries, including military, oil wells, semiconductors, and medical equipment, such as defibrillators.
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Defibrillator Component Manufacturers
Last updated: February 2026
This directory lists 105 defibrillator component manufacturers across the United States, from specialists in high-voltage capacitor banks and intricate control board assemblies to expert producers of biocompatible electrode pads and robust enclosure systems.
Buyers in this space aren't just looking for parts; they're solving critical challenges like ensuring consistent energy delivery for successive shocks, achieving precise impedance compensation across varied patient loads, and guaranteeing the long-term reliability of a device subjected to harsh environments. The complexities extend to miniaturization without compromising dielectric strength, managing thermal dissipation in compact designs, and verifying the robustness of lead wires under repeated flex cycles.
The suppliers in this category range from highly specialized component houses focusing on specific technologies like high-energy storage capacitors or custom high-voltage switching circuits, to contract manufacturers offering comprehensive assembly services for entire sub-systems. Others specialize in critical consumables like electrode pads, emphasizing materials science and biocompatibility, while some focus on precision machining or injection molding for the device's external chassis and internal mounting structures, all requiring strict adherence to medical device manufacturing protocols.
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Company Directory
105 companies nationwide
Based in Danbury, CT, Allied Sinterings, Inc. manufactures custom miniature powdered metal components. They produce high-quality, precision metal parts to tight tolerances for OEMs across medical, consumer, industrial, and commercial industries. With over 50 years of experience, the company is ISO 9001:2015 certified.
Based in Minneapolis, MN, Aprios Custom Manufacturing provides precision injection molding, tooling, and additive manufacturing. Specializing in medical and industrial applications, the company offers design for manufacturing, prototyping, and production services. Aprios is ISO 13485 certified, FDA registered, and utilizes clean room facilities for high-quality, complex component fabrication.
Arterex Medical is a global medical device contract manufacturer offering design, development, and manufacturing solutions. They provide vertically integrated capabilities such as injection molding, extrusion, metals processing, and assembly for medical device components. The company serves medical device and life sciences industries, including cardiac markets.
ASH Industries provides engineered injection molding services for plastic, metal, and silicone components. With an ISO 13485 certified ISO Class 7 medical cleanroom and biomedical engineers on staff, they specialize in high-precision medical molding for critical applications, including components for medical devices.
Based in Tyngsboro, MA, Axenics is a medical device component manufacturer. The company provides a full spectrum of services, including prototyping, final production, and delivery. They specialize in producing reliable, high-quality components essential for critical medical equipment, such as defibrillators.
Based in Santa Barbara, CA, Bentec Medical specializes in custom silicone fabrication for medical devices. They provide extensive material science engineering expertise and medical-grade silicone fabrication capabilities to develop optimal solutions for medical device OEMs, with applications spanning cardiology, urology, and oncology.
Based in Fairfield, NJ, Bergen Cable Technology manufactures high-quality wire rope and custom cable assemblies. The company provides tailored solutions for demanding applications across diverse industries including aerospace, marine, electronics, and transportation, offering specialized medical cable assemblies.
Based in South Elgin, IL, BESTProto provides quick-turn PCB assembly services, specializing in prototype and low-volume production. The company delivers fast and reliable printed circuit board assemblies, ensuring high quality with IPC certification for various industrial applications, including critical medical devices.
Biomerics is a contract manufacturing partner offering complete molded plastics solutions and engineered components for the medical industry. With vertical integration, they provide design services, polymer and metal expertise, and custom compounding. They deliver end-to-end solutions for complex interventional medical components and devices.
Based in Colorado Springs, CO, Carrio Cabling is a USA custom manufacturer of medical cable assemblies for OEMs. With ISO 9001:2015 and ISO 13485:2016 certifications, the company provides high-quality components essential for medical devices such as defibrillators, leveraging experience since 1988.
Cornell Dubilier specializes in designing and manufacturing high-quality capacitors, including hermetic aluminum electrolytic, film, and mica types. The company provides critical components for lifesaving medical devices, directly serving defibrillator manufacturers. They offer various capacitor technologies for demanding applications.
Based in Milford, NH, Cirtronics is a contract manufacturing company providing high-reliability electronic and mechanical assemblies. They specialize in manufacturing for demanding industries including medical equipment, printed circuit boards (PCBs), electronics, robotics, and defense, serving industrial B2B clients throughout the United States.
Based in Tustin, CA, ClearPath Medical specializes in the design, development, and manufacturing of custom medical cable assemblies, interconnect solutions, and connector systems. They provide full-service solutions from prototype to qualified production for critical-to-care medical devices, helping clients navigate regulatory environments and bring products to market.
Based in Menlo Park, CA, Control Plastics Inc. provides custom plastic injection molding and metal components, including prototyping and assembly services. Specializing in medical devices, military, and electronics industries, the company holds ISO 9001, ISO 13485, and FDA registration. They deliver quality manufacturing for complex components.
Cretex Medical, based in Elk River, MN, offers end-to-end contract manufacturing solutions for medical devices. They specialize in precision molding, stamping, laser processing, and assembly. With robust quality systems and industry certifications, the company provides expert manufacturing and engineering services for critical medical components.
Based in Auburn, NY, Currier MOS Plastics is an ISO 13485 certified and FDA registered contract manufacturer. The company specializes in custom injection and blow molding, producing quality medical parts for the healthcare market with zero-error QA. They operate facilities in Central NY and Southern California.
Based in San Jose, CA, Digital Power Corporation specializes in providing digital power solutions for the healthcare industry. They manufacture critical power components that enable life-sustaining, life-saving, and quality-of-life improvement medical products, supporting device manufacturers with reliable and efficient power systems.
DINGS' Motion USA is certified with ISO 13485:2016 for quality management systems in medical device manufacturing. The company specializes in motion control components, crucial for various medical equipment. They provide solutions tailored for the healthcare industry, serving medical device manufacturers with their specialized components.
D&M Plastics, LLC offers high-precision plastic injection molding services for the medical and dental industries. Based in Burlington, IL, the company has over 50 years of experience producing tight-tolerance parts with complex geometries. They provide engineering and value-added services, maintaining ISO 13485:2016 certification.
Based in Cincinnati, OH, Elite Biomedical Solutions, LLC is an ISO 13485:2016-certified, FDA-registered US manufacturer. The company provides high-quality, USA-made replacement parts for various clinical equipment, serving healthcare organizations with a focus on safety and reliability through rigorous testing.
Based in Lancaster, PA, ETEMCO provides electronic manufacturing services, specializing in precision PCB assembly. They serve the medical and healthcare industries, offering prototype to production solutions for complex, custom applications. The company is ISO 9001 certified for quality assurance.
Excell Battery specializes in engineering and manufacturing custom battery solutions and smart power systems for critical applications, including medical devices. With over 40 years of experience, the company offers full-lifecycle support from design to manufacturing, ensuring advanced battery packs meet stringent requirements.
Based in Anaheim, CA, Excello Circuits manufactures high-quality printed circuit boards. They specialize in various PCB types, including rigid, flexible, HDI, and heavy copper boards. The company primarily serves the medical, aerospace, automotive, and high-end industrial sectors.
Golden Valley Products specializes in manufacturing components and products for various medical devices. The company provides services tailored for medical equipment manufacturers, offering a range of capabilities for the production of critical medical device parts, including those potentially for defibrillators.
Based in Hayward, CA, Halco USA is an ISO 13485 certified manufacturer of medical device components. They specialize in custom hook and loop solutions, designed to meet the exacting quality and performance needs for various medical applications. Their products are suitable for defibrillator manufacturers.
Based in Lake Forest, CA, HDA Technology specializes in creating and building custom medical devices. The company provides comprehensive manufacturing services for clients nationwide, focusing on intricate components and assemblies for various critical healthcare applications.
Nissha Medical Technologies manufactures critical medical device components, including HeartSync Defib Pads and multifunction electrodes for AEDs and manual defibrillators. The company focuses on advancements in medical device technologies, combining miniaturization with emerging solutions. They also provide ultrasound thermal film.
H&S Manufacturing Co. is a contract manufacturer specializing in expertly fabricated components for the medical community and diverse industries. Based in Rowlett, TX, they offer precision machining, custom sheet metal fabrication, laser cutting, value-added assembly, and precision liquid dispensing services. They focus on on-time delivery and customer satisfaction.
Based in New Braunfels, TX, HVM Technology, Inc. specializes in manufacturing high voltage DC-DC converters, amplifiers, and various high voltage components. These crucial components are essential for medical devices like defibrillators, alongside other measurement devices and accessories for diverse industrial applications.
IMH Products, a US contract manufacturer, specializes in precision metal components and subassemblies. They offer comprehensive metal fabrication, CNC machining, stamping, welding, and assembly services. The company provides low-volume prototype work and large-scale manufacturing for original equipment manufacturers, with capabilities in medical device fabrication.
IPD Power manufactures medical power supplies specifically designed for the stringent requirements of the medical industry. Their products are made in the US and comply with the IEC 60601-1 standard, ensuring safety and performance for critical medical equipment components, including those for defibrillators.
Based in Scotts Valley, CA, JACO Machine Works is an ISO9001:2015 and AS9100D certified manufacturer. They specialize in precision CNC machining (5-axis, screw, vertical milling), laser welding, and citric passivation. The company produces high-quality components and assemblies for various medical devices and implants.
Based in Rollinsford, NH, Janco Electronics is an ISO 13485 certified contract manufacturer specializing in medical device manufacturing and expert medical electronics assembly. They provide PCB assembly, electro-mechanical box builds, and RF testing services, serving industries including defense, medical, and industrial.
Based in Brisbane, CA, LeeMAH Electronics is a custom contract manufacturer specializing in electronic assemblies, including PCBAs, cable assemblies, and box builds. The company serves the medical device industry, providing end-to-end solutions with AS-9100D and ISO:9001-2015 quality certifications.
Based in San Diego, CA, Lighteum Medical manufactures precision nitinol, platinum, and coated medical device components. They offer rapid prototyping and on-time supply for OEMs worldwide, specializing in metal components such as marker bands and ring electrodes for critical medical applications.
Based in Meriden, CT, Lyons specializes in medical device component manufacturing. The company offers services from prototyping through full production runs, ensuring all quality requirements are met. Lyons is ISO 13485 certified, demonstrating its commitment to medical device industry standards.
Based in Stoughton, MA, Marver Med is a contract manufacturer specializing in precision metal and plastic parts for medical devices. They utilize CNC Swiss-Screw machines to produce micro-precision components meeting rigorous tolerances. The company is ISO 13485:2016 certified, focusing on high-quality solutions for the medical industry.
Based in Harrisburg, PA, MCL (Millennium Circuits Limited) specializes in precision medical instrumentation PCB fabrication. The company provides medical-grade PCB options, ensuring high quality for various medical devices. MCL focuses on simplifying PCB procurement, emphasizing speed and offering alternative sourcing solutions outside of China.
Mega Plus PCB is a US-based medical supplier specializing in precision-engineered printed circuit boards. The company delivers crucial PCB components for life-saving medical devices and healthcare applications, serving industrial and commercial B2B customers with advanced manufacturing capabilities.
Based in Livonia, MI, Odyssey Electronics specializes in expert printed circuit board assembly services for medical devices. They offer SMT, testing, and protective coatings, meeting ISO 13485 certification standards for high-quality, precision-built PCBs.
Based in Bridgeville, PA, OKW Enclosures designs and manufactures high-quality electronic enclosures and control knobs. They provide a diverse range of plastic and aluminum housings for handheld, wall-mount, wearable, and instrument electronics, suitable for various medical and industrial applications including defibrillators.
Based in Morgan Hill, CA, O&Y Precision, Inc. specializes in custom machining, assembly, and production for the medical industry. They manufacture high-quality components for implantable devices and other medical applications, handling projects from prototyping to full production runs.
Based in Morgan Hill, CA, Pacific Capacitor Co. designs and manufactures high voltage mica capacitors. These reliable components are engineered for defense, aerospace, industrial, and medical applications, including those requiring robust high-voltage capabilities for critical devices. All products are designed and manufactured in the United States.
Based in Addison, IL, American Progressive Circuits, Inc. specializes in the assembly and production of high-quality printed circuit boards (PCBs). The company serves various industries, including medical, energy, security, and electric, providing highly specialized manufacturing solutions for diverse customer needs.
Based in Fremont, CA, Phihong manufactures a range of power supplies, including specialized medical power supplies, for original equipment manufacturers. The company's products encompass open-frame and internal power supply units, suitable for various innovative products and healthcare applications.
Based in Thousand Oaks, CA, Polymation specializes in the production of injection-molded plastic components. The company serves industrial clients across Southern California, providing custom plastic manufacturing solutions for various applications.
Precision Molded Plastics, based in Upland, CA, is a vertically integrated plastic injection molding company. They provide custom molds, tooling, and high-quality plastic component manufacturing for medical, aerospace, and other industries. With over 45 years experience, they offer comprehensive solutions.
Based in Roseville, CA, PRIDE Industries is an ISO 9001 and 13485-registered facility, fully compliant with FDA regulations and ITAR registered. They provide competitive business services, including manufacturing capabilities, making them a suitable partner for producing medical device components like those for defibrillators, while fostering employment for people with disabilities.
Based in Bland, MO, Roberson Machine Company specializes in precision CNC machining, milling, turning, wire EDM, and 3D printing. They manufacture custom machined products and parts from prototype to production. The company serves a range of industries, including medical devices, aerospace, automotive, and electronics.
RRC Power Solutions Inc. provides standardized lithium-ion battery packs and AC/DC power solutions, ideal for industrial and medical applications. Their POWERPAQ & FLATPAQ series offers mobile power components with worldwide approvals, redundant safety features, and ISO 13485 certification for medical device quality.
SEACOMP is an ISO 13485 certified electronics manufacturer with expertise in medical PCBs and Class I and II medical devices. They provide turnkey electronic product design, new product introduction, and manufacturing services, supporting clients from concept to volume production.
Seaway Plastics offers ISO 13485-certified injection molding services, specializing in thermoplastic and Liquid Silicone Rubber (LSR) processes. They provide cleanroom molding and assembly (ISO Class 7 & 8) with in-house tooling capabilities, catering to the medical and other highly regulated industries.
Based in San Mateo, CA, San Francisco Circuits specializes in manufacturing and assembly of medical-grade Printed Circuit Boards (PCBs). They provide critical board components for various medical devices and equipment, including those used in defibrillators, with experience dating back to 2005.
Based in Miramar, FL, SIMTEC Silicone Parts specializes in high-quality liquid silicone rubber (LSR) and LSR multi-shot molded components. The company provides custom solutions for the medical and healthcare industries, utilizing ISO-certified class 8 clean rooms and ISO 13485 quality systems.
Based in Anaheim, CA, SMX Power engineers and supplies a diverse selection of DC/DC and AC/DC medical power supplies. These power solutions are meticulously designed to meet stringent requirements for healthcare environments, making them suitable components for medical devices like defibrillators.
Spartronics is a U.S.-based electronics contract manufacturer specializing in complex, mission-critical products. They provide contract manufacturing services and assembly for medical devices, life sciences, commercial aerospace, and defense. Capabilities include printed circuit board assemblies (PCBAs), subsystem integration, and full-box builds.
Springboard Manufacturing specializes in custom plastic injection molding for medical devices and equipment. They provide ISO 13485:2016 certified services, including overmolding and insert molding, producing components for surgical instruments, stents, implants, and other medical devices.
Based in Cincinnati, OH, Strand Products, Inc. specializes in custom, high-tolerance mechanical wire, wire rope, and cable assemblies for the medical device market. They work with diverse materials like exotic alloys and polymers, offering design assistance, cleanroom assembly, laser welding, crimping, and comprehensive testing.
PTI Engineered Plastics, Inc. specializes in full-service plastic injection molding for medical device manufacturers. They offer high-quality tooling and scientific molding processes, supporting product development from concept to production. Utilizing an expanded Class 8 cleanroom, they produce robust plastic components for medical, defense, and consumer devices.
Based in Anaheim, CA, Technotronix provides comprehensive electronics manufacturing services, including PCB assembly, prototyping, and box-build solutions. They specialize in surface mount and multi-layer PCBs, alongside electro-mechanical assembly. Offering value-added services like conformal coating and testing, they serve diverse industries, notably the medical sector.
Based in St. Paul, MN, Tempco Manufacturing Company, Inc. specializes in custom metal stampings and sheet metal fabrication. With over 80 years of experience, they manufacture high-quality custom components for medical devices, utilizing precision manufacturing methods for a wide range of industries.
Based in Santa Ana, CA, TTM Technologies is a global manufacturer specializing in medical PCB manufacturing, assembly, and design for medical devices. The company provides advanced printed circuit boards and RF components, offering essential technology solutions for various critical medical applications, including defibrillators.
TDK-Lambda Americas, based in Santa Clara, CA, designs and manufactures certified power supplies for medical applications. The company ensures UL and CB safety standards through its own testing facilities, providing essential power components for integration into medical devices like defibrillators.
Based in Manchester, NH, Proterial Cable America, Inc. manufactures innovative materials and components for diverse medical applications. They specialize in high-strength alloys and medical cable assemblies, providing solutions for life-saving medical equipment and serving OEMs.
Based in Huntington Beach, CA, Vanguard Electronics designs and manufactures custom magnetic components for medical devices. They offer RF & microwave components, power magnetics, and transformers, including high-voltage flyback transformers. Vanguard provides custom solutions for unique power and RF requirements, supporting critical medical device functionality.
ZOLL Medical, based in Spanish Fork, UT, specializes in providing technologically advanced products and services for saving lives. The company manufactures a wide variety of electrodes for defibrillation, monitoring, and multi-function use, empowering healthcare professionals across the continuum of care.
Based in Warminster, PA, Acrotec Medtech is a contract manufacturer for medical device components. The company produces efficient, innovative medical components, including parts for pacemakers, implanted cardioverter defibrillators (ICDs), batteries, circuit boards, connections, electrodes, and leads, offering competitive advantage to clients.
Paragon Medical provides collaborative engineering and custom manufacturing of cable assemblies and interconnect solutions for medical devices. Serving sectors like electrophysiology and cardiac rhythm management, they manufacture components using materials such as Nitinol, PEEK, stainless steel, and silicone.
Abbott Cardiovascular develops and manufactures advanced medical device technologies and solutions for various cardiovascular conditions. The company specializes in creating life-changing leadless and transvenous pacemakers, along with algorithm-rich implantable cardioverter defibrillators.
Loctite AM specializes in advanced manufacturing solutions, holding ISO 13485 certification, which validates their quality management system for medical device components. With a lab in Concord and a production facility in Dixon, California, they are well-equipped to serve manufacturers of defibrillator components and other medical devices.
Medtronic manufactures a wide range of medical devices, including cardiovascular products such as pacemakers, defibrillators, stents, and catheters. The company provides innovative technology solutions for healthcare professionals globally.
Based in Tualatin, OR, TZ Medical, Inc. provides innovative medical devices, specializing in cardiac monitoring solutions. They design and produce defibrillation electrodes, interventional cardiac monitors, and electrophysiology products for healthcare. The company also offers patient positioning, radial and femoral access devices to enhance patient care.
Based in San Antonio, TX, Vishay is a global leader in manufacturing a wide range of semiconductors and passive electronic components. They supply critical components such as capacitors for medical applications, including those used by defibrillator component manufacturers, supporting the production of vital medical devices.
Based in Aurora, CO, AdvancedPCB manufactures and assembles precision-engineered multilayer and rigid-flex printed circuit boards. The company provides PCB solutions for critical medical electronics, aerospace, defense, and industrial applications, adhering to stringent IPC Class 3 and AS9100 quality standards.
Based in Torrington, CT, Altek Electronics, Inc. provides electronic contract manufacturing and turnkey PCB assembly services. They specialize in manufacturing PCB assemblies for the medical industry, offering circuit card assembly and box build solutions for various medical applications.
Astrodyne TDI specializes in manufacturing medical power supplies that adhere to the IEC 60601-1 safety standard. These essential components deliver continuous and reliable power to diverse medical equipment, including those requiring critical functionality like defibrillators. Based in Hackettstown, NJ, the company supports the medical device industry.
BMP Medical specializes in custom plastic injection molding, injection blow molding, and precision manufacturing for medical device OEMs. They co-develop scalable, high-quality components and assemblies, offering over 45 years of experience. BMP Medical serves as a long-term partner for medical device parts and IVD components.
Boston Scientific is a global medical technology company dedicated to advancing science for life through innovative solutions. The company develops and manufactures a wide range of medical devices, including those for treating vascular system blockages and cutting-edge cancer therapies, with a strong focus on product and patient safety.
Based in Farmingdale, NY, EB Industries provides specialized electron beam and laser welding services, including laser hermetic sealing. They expertly join common and exotic, difficult-to-weld materials. Certified to ISO 13485:2016, the company serves the medical device industry, offering precision fabrication vital for components like those found in defibrillators.
EVCO Plastics operates ISO Class 8 clean room facilities, specializing in manufacturing high-quality plastic injection molded components for medical devices and packaging. The company offers collaborative project development through the entire lifecycle, leveraging global manufacturing capabilities, including multiple locations across the United States.
Based in Fremont, CA, Evolve Manufacturing specializes in producing complex medical and life sciences devices and instruments. The company operates a 75,000 sq ft facility in Silicon Valley, offering manufacturing services crucial for intricate components. They directly support the needs of the medical device industry, including advanced defibrillator components.
Based in Hartland, WI, Fathom MFG is a contract manufacturer for medical OEMs, providing high-quality parts for diagnostic and surgical tools, prosthetics, and other medical devices. They apply advanced engineering and stringent quality controls for regulated environments, moving projects efficiently from concept to production with deep industry expertise.
Based in Waco, TX, Foamtec Medical specializes in providing high-quality open-cell medical-grade polyurethane foam solutions for the medical device manufacturing industry. They offer contract and custom manufacturing, R&D, fabrication, and kitting, producing precise and compliant foam components for healthcare products and devices.
Gilero partners with global healthcare companies, providing plastic injection molding and development services for innovative medical devices and drug delivery systems. They manage projects from concept to commercialization, delivering high-quality, compliant healthcare products.
Based in Lombard, IL, iCONN Systems, LLC specializes in custom-engineered interconnect solutions, including electrical and electronic connectors. The company designs and manufactures overmolded and discrete cable assemblies. They provide critical components for medical devices, supporting life-saving treatments within the healthcare industry.
Based in Camarillo, CA, Johanson Dielectrics manufactures high-power capacitors. These components are engineered for medical applications such as MRI, CT scanners, and ultrasound systems, offering stable, compact, and noise-suppressing performance crucial for sensitive medical equipment.
Based in Jasper, IN, Kimball Electronics provides comprehensive Electronics Manufacturing Services (EMS), Contract Manufacturing Organization (CMO), and Engineering & Design. They specialize in creating solutions for the medical, industrial, and automotive markets, contributing to health, safety, and productivity.
Based in Louisville, KY, LINAK specializes in electric linear actuation solutions and control systems for medical devices. They provide Li-Ion batteries with advanced venting systems to prevent thermal runaway, ensuring enhanced safety and reliability. These critical components are essential for manufacturers producing advanced medical equipment, including defibrillators.
Based in Grand Rapids, MI, Medbio, LLC specializes in precision injection molding using medical-grade plastics. The company partners with clients in the critical cardiovascular medical device industry, providing essential components for various applications including defibrillators.
Saint-Gobain Medical designs, develops, and manufactures custom medical components and engineered systems for diverse medical devices. They specialize in providing critical parts and solutions for various healthcare applications, ensuring high-quality and reliable performance in medical technology.
Based in East Aurora, NY, Moog provides advanced motion control hardware and software solutions for medical OEM design. They supply reliable components for diverse medical equipment, including CT scanners, MRI, and diagnostic devices. Moog supports manufacturers requiring precision parts for critical medical applications.
Based in Bristol, CT, Novo Precision offers comprehensive precision manufacturing and assembly solutions for diverse industries. They specialize in CNC machining, stamping, plastic injection molding, and producing custom cable assemblies. The company explicitly provides medical cable assemblies and precision components, serving demanding applications within the medical sector from concept to finished product.
Pexco manufactures advanced plastic components for medical devices, offering lightweight, durable, and biocompatible solutions for healthcare applications. Based in Philadelphia, PA, the company specializes in cost-effective plastic solutions tailored for critical medical equipment, including defibrillator components, enhancing product performance and reliability.
Power-Sonic collaborates with medical OEMs to develop custom batteries, including advanced lithium chemistry solutions, specifically tailored to device specifications and performance requirements. They provide critical power components for various medical applications, supporting innovation within the medical device manufacturing sector.
Sierra Circuits provides American-made PCB prototypes and assemblies from its Silicon Valley location. Since 1986, the company has offered high-quality, high-speed, and precise circuit board manufacturing services, specializing in rapid turnaround times for critical electronic components.
Resolution Medical, based in Fridley, MN, specializes in the development and manufacture of complex medical devices, including active implantable devices and catheter delivery systems. They offer end-to-end component manufacturing, from concept and product development to commercial production, serving various medical device OEMs and innovators.
Spectrum Plastics Group provides custom plastic injection molding and advanced components for medical devices. They offer specialized extruded tubing, catheter technologies, and medical balloons, serving diverse healthcare applications. The company partners with clients from concept to final product, applying medical device expertise to foster innovation.
Based in Plymouth, MN, Teleflex Medical OEM supports medical device industry leaders. They provide expertise in the design and development of various medical devices, including components crucial for life-saving equipment like defibrillators. Their services encompass specialized manufacturing capabilities for complex medical applications, improving development speed and efficiency.
Based in Livermore, CA, Westec Plastics is an ISO 13485:2016 certified plastic injection molding organization. They specialize in manufacturing custom plastic components for the medical device industry. Capabilities include mold building, clean rooms, and secondary operations, ensuring high-quality parts for various medical applications.
AlphaEMS specializes in complete medical PCB and product manufacturing services. The company supports both high-volume production and prototype development for the medical industry. Located in Silicon Valley, it offers essential manufacturing capabilities for critical medical devices, including components for defibrillators.
CONMED is a global medical equipment manufacturer that designs, builds, and distributes clinical products and surgical technologies. They cater to orthopedic and general surgical specialties, alongside patient monitoring needs. Their offerings include adult electrodes designed for continuous pacing, patient monitoring, and capable of delivering up to 50 shocks, serving as defibrillator components.
Resonetics designs and manufactures electro-chemistries and medical lithium-ion batteries for implantable MedTech applications. They provide advanced manufacturing, rapid prototyping, and product development services for bioelectronics and other medical devices. Expertise includes Nitinol solutions, sensor technology, and custom laser systems.
Spellman High Voltage Electronics Corporation supplies high voltage power supplies, X-Ray generators, and X-Ray sources for medical imaging and therapy applications. They provide essential high voltage components used in devices for security screening and sensitive measurement, serving manufacturers in various industrial and medical sectors.
Viant Medical designs and manufactures advanced cardiac and interventional devices for medical OEMs. The company offers extensive design and manufacturing capabilities, supporting the development of high-performance medical technology solutions for various clinical markets.
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How to Choose a Company
- Verify a manufacturer's proven track record with FDA 21 CFR Part 820 Quality System Regulation (QSR) and ISO 13485 certification, specifically asking for evidence of their approach to design controls, risk management, and post-market surveillance support relevant to your Class II or Class III medical device.
- Assess their capability to handle, test, and manufacture components for high-voltage energy delivery systems (typically 1-5 kV). This includes validating their equipment for dielectric strength testing, insulation resistance, and their understanding of creepage and clearance requirements for PCB layouts.
- For components directly influencing shock delivery (e.g., capacitor banks, switching circuits), confirm their testing protocols for maintaining precise biphasic waveform characteristics and energy output stability over the device's lifespan and varying load conditions.
- Demand comprehensive material traceability from raw material to finished component, especially for electrode pads or anything with patient contact. Require specific certifications for biocompatibility (e.g., ISO 10993 compliance) and documented change control processes for critical materials.
- Evaluate their Design for Manufacturability (DFM) and Design for Assembly (DFA) expertise tailored for medical device reliability, not just cost-cutting. A red flag is a supplier pushing generic cost-saving suggestions without considering the impact on device ruggedness, long-term performance, or regulatory re-submission risks.
- Inquire about their multi-sourcing strategies for critical sub-components (e.g., specific capacitor dielectrics, unique semiconductor chips) and their contingency plans for supply chain disruptions, especially given recent global challenges affecting electronic component availability.
Supplier Types at a Glance
| Type | Best For | Typical MOQ |
|---|---|---|
| High-Voltage Component Specialists | R&D teams requiring custom capacitor banks, high-voltage switching circuits, or power management modules with specific energy delivery profiles. | Mid-to-high, depending on customization. |
| Integrated Medical Device Contract Manufacturers | Established companies needing full sub-assembly (e.g., control boards, charging systems) with rigorous regulatory oversight and extensive testing. | Higher volume production runs. |
| Electrode & Cable Assembly Specialists | Manufacturers needing high-volume, cost-effective, and biocompatible electrode pads, lead wires, and patient monitoring cables. | High-volume. |
Frequently Asked Questions
How do manufacturers validate the long-term energy delivery consistency of their defibrillator capacitor banks?
Validation goes beyond initial capacitance measurements. Reputable manufacturers perform extensive cycle testing under varying temperature and humidity, stress testing at maximum voltage, and accelerated life testing to simulate years of standby and discharge cycles. They also track Equivalent Series Resistance (ESR) and leakage current drift over time to predict performance degradation and ensure the specified biphasic waveform can be maintained.
What are the critical regulatory documents a defibrillator component supplier must provide for our FDA submission?
Beyond standard quality system certifications (ISO 13485, 21 CFR Part 820), expect comprehensive Design History File (DHF) contributions, material declarations (including RoHS/REACH compliance or exemptions), biocompatibility reports (ISO 10993 for patient-contacting parts), full test reports (e.g., IEC 60601 safety, EMC), and detailed traceability records down to raw materials for critical components.
We're designing a compact AED. What questions should I ask about component miniaturization and thermal management?
Inquire about their experience with high-density component placement on PCBs, specialized thermal interface materials, and any proprietary techniques for minimizing footprint while maintaining dielectric strength and managing heat dissipation from high-power components. Ask for case studies on designs that achieved specific power densities or thermal profiles, and their DFM insights for compact enclosures.
What's the biggest red flag when a supplier quotes a significantly lower price for high-voltage components?
A significantly lower price can be a red flag for compromised quality controls, use of unverified or lower-grade materials, or insufficient testing protocols. It often indicates a lack of full understanding of the medical device regulatory burden, under-invested R&D in specialized high-voltage techniques, or a reliance on generic industrial component specifications rather than the stringent requirements for patient safety and device reliability in a defibrillator.
How does a supplier demonstrate competence in ensuring signal integrity for control boards and patient monitoring circuits in a defibrillator?
They should detail their expertise in electromagnetic compatibility (EMC) and electromagnetic interference (EMI) design principles, including board layout reviews for noise reduction, shielding techniques, and component selection for robust signal processing. Ask about their in-house testing capabilities for conducted and radiated emissions (e.g., IEC 60601-1-2 standards) and their process for verifying signal chain accuracy under various environmental conditions.