What is a medical device contract manufacturer?

A recent report indicates that the global medical device market was USD 518.46 billion in 2023 and is projected to grow to USD 886.80 billion by 2032^*1. In the rapidly evolving field of medical technology, the role of medical device contract manufacturers is becoming increasingly important. These specialized companies provide a variety of services to ensure that medical device manufacturers can efficiently bring high-quality and compliant medical devices to the market. Join us as we examine the typical roles associated with medical device contract manufacturers and discover some of the tasks that our company engages in later in the article.

Please note that the technical terms mentioned in the text are explained in detail in the endnotes at the end of the page.

Medical device manufacturers are companies that design, produce, fabricate, assemble or process finished devices. Among them, medical device contract manufacturers perform contracted manufacturing activities (such as production, processing, packaging, storage and testing, either partially or fully) according to agreements with manufacturers. Additionally, the contracted tasks may include design improvements necessary for manufacturing. Whether design is included in the contract manufacturing process or not varies by country. In Japan, under the Pharmaceuticals and Medical Devices Law (PMD Act), for instance, manufacturers are categorized by the operations they perform - design, main assembly, storage of final products and sterilization. In contrast, the Food and Drug Administration (FDA) in the United States distinguishes between facilities that develop product specifications, referred to as specification developer, and medical device contract manufacturers.

Design and development

Medical device contract manufacturers take requirement specifications and design plans - created based on market and customer needs and expectations - as inputs to carry out design and development in compliance with regulatory requirements such as risk management^*2, usability engineering^*3, the software life cycle processes^*4, cybersecurity^*5 and safety standards^*6. Verification and validation ensure that the medical devices meet all necessary requirements and are ready for mass production.

Concept diagram of design and development stage for medical device contract manufacturing

Production

Optimal process design and equipment design are conducted according to the type and quantity of medical devices. Through risk management, process validation^*7 and software validation^*8, appropriate manufacturing processes are realized. Additionally, to ensure the quality and safety of medical devices, appropriate production management is conducted from the selection and procurement of suppliers for purchased parts to the assembly, labeling, packaging and storage of final products. Production management includes:

Concept diagram of production stage for medical device contract manufacturing

Product cleanliness and contamination control

Sterile medical devices have specific requirements, but even for regular medical devices, hygiene management such as product cleanliness and contamination control are necessary due to product characteristics. Contamination control has two aspects: managing contamination among workers handling the products and preventing the spread of contamination to the market. It is necessary to conduct production management and servicing activities with these aspects in mind.

Servicing activities

Servicing activities are strategic activities aimed at the support for continuous product use and improving customer satisfaction. In terms of support for continuous product use, medical device contract manufacturers provide installation, returns, repairs and service parts to maintain the quality and safety of medical devices in the market. For medical devices that require maintenance, maintenance services are offered. On the other hand, to improve customer satisfaction, technical advice and user training are provided.

Concept diagram of servicing activities for medical device contract manufacturing

Compliance with regulatory requirements

One of the most crucial functions of medical device contract manufacturers is compliance with regulatory requirements. Various regulatory requirements exist in countries where medical devices are sold, such as the FDA in the United States, the Medical Device Regulation (MDR) in Europe and the PMD Act in Japan. It is necessary to design and manufacture medical devices that comply with these regulatory standards.

Design and development

ASPINA centralizes its design and development departments at its headquarters in Japan, leveraging accumulated experience and knowledge to develop products that meet the needs of customers worldwide. Designers are also stationed at each sales office responding promptly to customer requests.

Production

ASPINA has production bases in Japan, China and Mexico, promoting local procurement of parts based on effective supply chain management. Additionally, ASPINA purchases parts used in other fields such as automation, environment and automotive in bulk, enabling the provision of products with cost-effective parts procurement.

Servicing activities

ASPINA has a proven track record in returns, repairs and service parts provision for medical devices in Japan, and can respond flexibly to consultation requests based on the content of the inquiries.

Compliance with regulatory requirements

ASPINA has registered with the authority for medical device manufacturing (design, main assembly, storage of final products) to manufacture medical devices for the Japanese market. Additionally, ASPINA has obtained the second-class marketing for medical devices and marketing and manufacturing certification of designated controlled medical devices for pocket-type hearing aids to manufacture and sell these devices in Japan. ASPINA has also acquired ISO 13485 certification, an international standard for the quality management system of medical devices, for the design and manufacture of some products in Japan, demonstrating experience in regulatory compliance. Currently, ASPINA is working on establishing systems that comply with FDA regulatory requirements and plans to expand these systems to production bases outside Japan in the future.

Reliable partner in medical device manufacturing - ASPINA

Medical device contract manufacturing companies are indispensable partners in the medical technology industry, offering comprehensive services that support the entire lifecycle of medical devices, from design and development to manufacturing, packaging and servicing. By leveraging ASPINA, medical device manufacturers can focus on technological innovations and deliver cutting-edge medical solutions to the market. ASPINA provides comprehensive support for manufacturers developing innovative, advanced medical devices. Please feel free to contact us if you experience any issues.

Contact ASPINA