Top 12 companies providing electronic manufacturing services to the medical device industry

What is EMS in the Medical Device Industry?

Electronic Manufacturing Services (EMS) in the medical device industry refer to the outsourcing of design, development, and manufacturing of electronic components and assemblies used in medical devices. EMS providers offer a wide range of services, including:

• Product design and engineering
• Prototyping and testing
• Printed circuit board (PCB) assembly
• Box build assembly
• Supply chain management
• Quality control and regulatory compliance

EMS companies collaborate closely with medical device manufacturers to ensure that the electronic components and assemblies meet the strict quality and regulatory standards required for medical devices.

The Importance of EMS in the Medical Device Industry

EMS plays a vital role in the medical device industry for several reasons:

1. Expertise and Experience: EMS providers have specialized knowledge and experience in designing and manufacturing electronic components for medical devices. They stay up-to-date with the latest technologies, manufacturing processes, and regulatory requirements specific to the medical industry.

2. Cost-effectiveness: Outsourcing electronic manufacturing to EMS providers allows medical device companies to reduce costs associated with capital investments, labor, and overhead expenses. EMS companies can achieve economies of scale and offer competitive pricing.

3. Focus on Core Competencies: By partnering with EMS providers, medical device manufacturers can focus on their core competencies, such as research and development, marketing, and sales, while leaving the electronic manufacturing to the experts.

4. Regulatory Compliance: EMS providers are well-versed in the regulatory requirements for medical devices, such as FDA regulations and ISO standards. They ensure that the electronic components and assemblies are designed, manufactured, and tested in compliance with these regulations.

5. Scalability and Flexibility: EMS companies can quickly scale up or down production based on the demand for medical devices. They offer flexibility in terms of manufacturing capabilities, allowing medical device companies to respond to market changes and customer needs effectively.

Top 12 EMS Companies Serving the Medical Device Industry

1. Jabil

Jabil is a global EMS provider with extensive experience in serving the medical device industry. The company offers end-to-end manufacturing solutions, from design and engineering to supply chain management and aftermarket services. Jabil’s medical device manufacturing capabilities include:

• Class I, II, and III medical devices
• Diagnostic and therapeutic devices
• Wearable health technology
• Drug delivery systems

Jabil has a global network of ISO 13485-certified facilities dedicated to medical device manufacturing. The company’s expertise in advanced manufacturing technologies, such as 3D printing and automation, enables them to deliver innovative solutions to their medical device customers.

2. Flex

Flex (formerly Flextronics) is a leading EMS provider with a strong presence in the medical device industry. The company offers a comprehensive range of services, including design, manufacturing, and supply chain solutions. Flex’s medical device manufacturing capabilities include:

• Diagnostic equipment
• Patient monitoring systems
• Surgical instruments
• Medical imaging devices

Flex has a global network of ISO 13485-certified facilities and a team of experts dedicated to medical device manufacturing. The company’s focus on innovation and advanced manufacturing technologies, such as robotics and data analytics, helps their customers bring cutting-edge medical devices to market.

3. Sanmina

Sanmina is a global EMS provider with a dedicated medical division that serves the medical device industry. The company offers a full spectrum of services, from design and engineering to manufacturing and logistics. Sanmina’s medical device manufacturing capabilities include:

• Cardiovascular devices
• Diagnostic equipment
• Surgical instruments
• Medical imaging systems

Sanmina has a global network of ISO 13485-certified facilities and a team of experienced engineers and technicians. The company’s expertise in complex medical device manufacturing, combined with their focus on quality and regulatory compliance, makes them a trusted partner for medical device companies.

4. Plexus

Plexus is an EMS provider with a strong focus on the medical device industry. The company offers a full range of services, including product design, manufacturing, and aftermarket support. Plexus’ medical device manufacturing capabilities include:

• Diagnostic equipment
• Therapeutic devices
• Patient monitoring systems
• Surgical instruments

Plexus has a global network of ISO 13485-certified facilities and a team of experienced engineers and manufacturing experts. The company’s commitment to quality, reliability, and regulatory compliance has earned them a reputation as a leading EMS provider in the medical device industry.

5. Celestica

Celestica is a global EMS provider with a dedicated healthcare division that serves the medical device industry. The company offers a comprehensive range of services, from design and engineering to manufacturing and supply chain management. Celestica’s medical device manufacturing capabilities include:

• Diagnostic equipment
• Surgical instruments
• Medical imaging devices
• Drug delivery systems

Celestica has a global network of ISO 13485-certified facilities and a team of experts dedicated to medical device manufacturing. The company’s focus on innovation, quality, and regulatory compliance enables them to deliver advanced medical device solutions to their customers.

6. Benchmark Electronics

Benchmark Electronics is an EMS provider with a strong presence in the medical device industry. The company offers a full spectrum of services, including product design, manufacturing, and supply chain solutions. Benchmark’s medical device manufacturing capabilities include:

• Diagnostic equipment
• Patient monitoring systems
• Surgical instruments
• Medical imaging devices

Benchmark has a global network of ISO 13485-certified facilities and a team of experienced engineers and manufacturing experts. The company’s commitment to quality, reliability, and regulatory compliance, combined with their expertise in advanced manufacturing technologies, makes them a trusted partner for medical device companies.

7. Nortech Systems

Nortech Systems is an EMS provider that specializes in serving the medical device industry. The company offers a comprehensive range of services, from design and engineering to manufacturing and supply chain management. Nortech’s medical device manufacturing capabilities include:

• Diagnostic equipment
• Surgical instruments
• Medical imaging devices
• Drug delivery systems

Nortech has a network of ISO 13485-certified facilities in the United States and a team of experienced engineers and manufacturing experts. The company’s focus on quality, reliability, and customer service has earned them a reputation as a leading EMS provider in the medical device industry.

8. Kimball Electronics

Kimball Electronics is an EMS provider with a dedicated medical solutions division that serves the medical device industry. The company offers a full range of services, including product design, manufacturing, and supply chain management. Kimball’s medical device manufacturing capabilities include:

• Diagnostic equipment
• Patient monitoring systems
• Surgical instruments
• Medical imaging devices

Kimball has a global network of ISO 13485-certified facilities and a team of experienced engineers and manufacturing experts. The company’s commitment to quality, reliability, and regulatory compliance, combined with their expertise in advanced manufacturing technologies, enables them to deliver innovative solutions to their medical device customers.

9. Integer Holdings Corporation

Integer Holdings Corporation (formerly Greatbatch) is an EMS provider that specializes in serving the medical device industry. The company offers a comprehensive range of services, from design and engineering to manufacturing and supply chain management. Integer’s medical device manufacturing capabilities include:

• Cardiovascular devices
• Neuromodulation devices
• Orthopedic devices
• Portable medical devices

Integer has a global network of ISO 13485-certified facilities and a team of experienced engineers and manufacturing experts. The company’s focus on innovation, quality, and regulatory compliance has earned them a reputation as a leading EMS provider in the medical device industry.

10. Nypro (a Jabil Company)

Nypro, a subsidiary of Jabil, is an EMS provider with a strong focus on the medical device industry. The company offers a full spectrum of services, including product design, manufacturing, and supply chain solutions. Nypro’s medical device manufacturing capabilities include:

• Diagnostic equipment
• Drug delivery systems
• Surgical instruments
• Medical consumables

Nypro has a global network of ISO 13485-certified facilities and a team of experienced engineers and manufacturing experts. The company’s commitment to quality, innovation, and customer service, combined with the resources and expertise of Jabil, makes them a trusted partner for medical device companies.

11. Viant Medical

Viant Medical is an EMS provider that specializes in serving the medical device industry. The company offers a comprehensive range of services, from design and engineering to manufacturing and supply chain management. Viant’s medical device manufacturing capabilities include:

• Surgical instruments
• Orthopedic implants
• Diagnostic equipment
• Medical disposables

Viant has a network of ISO 13485-certified facilities in the United States and a team of experienced engineers and manufacturing experts. The company’s focus on quality, reliability, and customer service has earned them a reputation as a leading EMS provider in the medical device industry.

12. Sparton Corporation

Sparton Corporation is an EMS provider with a dedicated medical division that serves the medical device industry. The company offers a full range of services, including product design, manufacturing, and supply chain solutions. Sparton’s medical device manufacturing capabilities include:

• Diagnostic equipment
• Therapeutic devices
• Patient monitoring systems
• Medical imaging devices

Sparton has a network of ISO 13485-certified facilities in the United States and a team of experienced engineers and manufacturing experts. The company’s commitment to quality, reliability, and regulatory compliance, combined with their expertise in advanced manufacturing technologies, enables them to deliver innovative solutions to their medical device customers.

Frequently Asked Questions (FAQ)

1. What is the role of EMS providers in the medical device industry?

EMS providers play a crucial role in the medical device industry by offering design, development, and manufacturing services for electronic components and assemblies used in medical devices. They collaborate with medical device companies to ensure that the electronic components meet the strict quality and regulatory standards required for medical devices.

2. What are the benefits of outsourcing electronic manufacturing to EMS providers?

Outsourcing electronic manufacturing to EMS providers offers several benefits, including access to specialized expertise and experience, cost-effectiveness, the ability to focus on core competencies, ensured regulatory compliance, and scalability and flexibility in manufacturing.

3. What certifications should EMS providers have to serve the medical device industry?

EMS providers serving the medical device industry should have ISO 13485 certification, which is an international standard that specifies requirements for a quality management system specific to the medical device industry. This certification demonstrates the EMS provider’s commitment to meeting the strict quality and regulatory requirements for medical devices.

4. How do EMS providers ensure regulatory compliance for medical devices?

EMS providers ensure regulatory compliance for medical devices by staying up-to-date with the latest FDA regulations, ISO standards, and other relevant guidelines. They implement rigorous quality control processes, maintain detailed documentation, and conduct regular audits to ensure that the electronic components and assemblies they manufacture meet the required standards.

5. What should medical device companies consider when selecting an EMS partner?

When selecting an EMS partner, medical device companies should consider factors such as the provider’s experience and expertise in the medical device industry, their range of services, global footprint, quality management systems, regulatory compliance, and ability to scale production. It is also essential to evaluate the EMS provider’s financial stability, reputation, and customer references to ensure a successful long-term partnership.

Conclusion

Electronic Manufacturing Services (EMS) providers play a vital role in the medical device industry by offering specialized expertise, cost-effectiveness, and regulatory compliance in the design, development, and manufacturing of electronic components and assemblies. The top 12 EMS companies serving the medical device industry, as highlighted in this article, have demonstrated their commitment to quality, innovation, and customer service.

Medical device companies can benefit greatly from partnering with these EMS providers, as they can leverage their expertise, global footprint, and advanced manufacturing capabilities to bring innovative and compliant products to market quickly and efficiently. When selecting an EMS partner, it is crucial to consider factors such as experience, range of services, quality management systems, and regulatory compliance to ensure a successful long-term collaboration.

As the medical device industry continues to evolve and demand more complex and sophisticated electronic components, the role of EMS providers will become increasingly important. By staying at the forefront of technological advancements and regulatory requirements, these top EMS companies will continue to support the growth and success of the medical device industry, ultimately contributing to improved patient outcomes and healthcare innovations.