Medical Device OEM Outsourcing Market Drives Quality Assurance Innovation

The global medical device OEM (Original Equipment Manufacturer) outsourcing market size was calculated at USD 149.29 billion in 2024 and is predicted to attain around USD 528.93 billion by 2034, expanding at a CAGR of 13.48% from 2025 to 2034.

Highlights of the Medical Device OEM (Original Equipment Manufacturer) Outsourcing Market

• Asia Pacific dominated the global medical device OEM (original equipment manufacturer) outsourcing market in 2024.
• North America is projected to host the fastest-growing market in the coming years.
• By service, the quality assurance segment underwent notable growth in the medical device OEM (original equipment manufacturer) outsourcing market during 2024.
• By service, the regulatory affairs services segment will gain a significant share of the market over the studied period of 2025 to 2034.
• By application, the cardiology segment enjoyed a prominent position in the market during 2024.
• By application, the general and plastic surgery device segment is predicted to witness significant growth in the market over the forecast period.

Industry Valuation and Growth Rate Projection

A medical device OEM (original equipment manufacturer) is a company that manufactures medical-related equipment or devices, finished or component parts. In the business world, this means a company that makes a product to be sold by another under its name. Most consumers are familiar with the OEM model, where an outsourcing company submits all specifications, design, and development processes to the OEM. The medical device OEM (original equipment manufacturer) outsourcing market growth is driven by government initiatives concerning reported adverse events, worldwide growing awareness regarding medical devices, and the increasing number of adverse events.

Medical Device OEM (Original Equipment Manufacturer) Outsourcing: Stats and Figures

• According to a report published in April 2025 by Arterex Medical, the medical device industry supports 2 million jobs globally. The United States employs more than 300,000 professionals in research and development, manufacturing, and distribution fields.

How has AI Benefited the Medical Device OEM (Original Equipment Manufacturer) Outsourcing Market?

One of the most significant benefits of AI in manufacturing is that it can allow more visibility. Medical device manufacturers use AI to improve patient care and promote sustainable growth in this rapidly transforming industry by finding a balance between workforce development, innovation, and strong risk management. AI-based devices can offer real-time outputs that may help to inform the medical provider's decisions. AI in medical device manufacturing improves operational efficiency while reducing manufacturing processes. AI can enhance translation accuracy, which is critical in highly regulated industries like medical devices.

Industry Leader Announcements

• Jason Allen, Technical Innovations Manager at Intertek

Jason Allen, Technical Innovations Manager at Intertek, said, “Our clients demand precision and efficiency in testing to stay ahead in a competitive landscape.” “The ABMS, paired with Intertek’s expertise in global standards and regulatory consultation, will empower manufacturers to develop high-performance RPDs with confidence, delivering safer solutions to end-users.”

• Dr. Steve Yang, Co-CEO of WuXi AppTec and Chairman of WuXi AppTec’s ESG Committee

Dr. Steve Yang, CoCEO of WuXi AppTec and Chairman of WuXi AppTec’s ESG Committee, said, “SBTi validation of WuXi AppTec’s near-term targets marks an important milestone in our Company’s sustainability journey.” “This recognition underscores our commitment to corporate social responsibility, scientific rigor, and transparency of greenhouse gas emission reduction efforts. WuXi AppTec is dedicated to supporting our customers in delivering innovative therapies to patients worldwide, working together toward a healthier and more sustainable future.”

Geographical Insights

Asia Pacific dominated the global medical device OEM (original equipment manufacturer) outsourcing market in 2024. Governing initiatives concerning adverse events, worldwide growing awareness regarding medical device vigilance, and an increasing number of adverse events reported are driving the growth of the market in the Asia Pacific region.

North America is projected to host the fastest-growing market in the coming years. Regulatory support, increasing demand, technological advancements, and increasing prevalence of chronic diseases are contributing to the growth of the medical device OEM (original equipment manufacturer) outsourcing market in the North American region.

What are the Recent Developments in the Medical Device OEM (Original Equipment Manufacturer) Outsourcing Market?

• In February 2025, the AW Stepper Motors, featuring an IP65-rated design that ensures reliable operation in harsh environments, were launched by Applied Motion Products. These motors are engineered for a higher level of protection; these motors effectively shield internal components from external contaminants such as grease, moisture, dirt, and dust.
• In September 2024, Tablet-based Venue Sprint, a new POC ultrasound device that the company designed for maximum portability, was launched by GE Healthcare.

Competitive Landscape

• Company Name: Intertek Group PLC
• Year of Incorporation: 1996
• Headquarters: London, United Kingdom

Over 100 countries where it operates. It operates in the Industry & Assurance, Chemicals & Pharmaceuticals, Commodities, Commercial & Electrical, and consumer goods sectors, around the world.

• Company Name: Wuxi Apptec
• Year of Incorporation: 2000
• Headquarters: Shanghai, China

It operates in over 30 countries. It operates in the medical device, biopharmaceutical, and pharmaceutical sectors around the world.