US Medical Device OEM Outsourcing Market Size to Hit USD 124.48 Billion by 2034

The US medical device OEM (Original Equipment Manufacturer) outsourcing market size surpassed USD 35.18 billion in 2024 and is predicted to reach around USD 124.48 billion by 2034, registering a CAGR of 13.46% from 2025 to 2034.

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

• By service, the quality assurance segment underwent notable growth in the U.S. 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

US Medical device OEM (original equipment manufacturer) outsourcing is a company that manufacturers medical-related equipment or devices, finished or parts. It is a process where a MedTech company that owns the idea outsources manufacturing to another medical device manufacturing firm. The U.S. medical device OEM (original equipment manufacturer) outsourcing market growth is driven by regulatory support, technological advancements, and the increasing prevalence of chronic diseases.

The U.S. medical device OEM (original equipment manufacturer) outsourcing market applications include collaboration with international partners, regulatory compliance, speed to market advantage, risk mitigation, scalability, flexibility, access to specialized expertise, resource optimization, cost efficiency, and focus on core competencies.

What are the Trends in the U.S. Medical Device OEM (Original Equipment Manufacturer) Outsourcing Market?

The market trends in the U.S. medical device OEM (original equipment manufacturer) outsourcing market are guided by the need for the development and production of sophisticated devices and the increasing prevalence of chronic diseases.

• The need for the development and production of sophisticated devices: Sophisticated devices are more advanced or complex than others. The key benefits of sophisticated medical devices include the ability to have idea generation through data collection, better medical device management, improved patient and clinician experience, the ability to monitor chronic diseases, and improved diagnosis and treatment.
• The increasing prevalence of chronic diseases: Wearable medical devices are becoming vital in chronic disease management due to they offer personalized care and real-time monitoring. Wearable technology allows continuous monitoring of vital signs, activity levels, and other health metrics for individuals with chronic conditions, empowering patients to actively participate in their healthcare. Sophisticated medical devices are essential to help monitor and manage chronic diseases like respiratory diseases, chronic obstructive pulmonary disease, and cardiac arrhythmia.

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

The restraints in the U.S. medical device OEM (original equipment manufacturer) outsourcing market include product safety concerns and regulatory hurdles.

• Product safety concerns: Medical device hazards are potential sources of harm that may arise during device use. These hazards span environmental factors, user errors, manufacturing errors, software glitches, and design flaws. According to a report published in March 2025 by the USFDA, the FDA receives over 2 million medical device reports of suspected device-associated deaths, serious injuries, and malfunctions.
• Regulatory hurdles: Regulatory hurdles refer to the difficulties and complexities organizations face when navigating the legal and compliance frameworks set by governing bodies. These issues may arise due to frequent changes in regulations, differing rules across jurisdictions, and the need for constant updates to policies and practices.

What is the Opportunity in the U.S. Medical Device OEM (Original Equipment Manufacturer) Outsourcing Market?

The opportunity in the medical device OEM (original equipment manufacturer) outsourcing market is associated with growing investment in healthcare infrastructure.

• Growing investment in healthcare infrastructure: Infrastructure is a key pillar supporting the fundamental aim of promoting enhanced standards of care and wellbeing for all patients. A developed health infrastructure has many advantages, including improved health outcomes and access to high-quality health services, which can lead to better health outcomes, mortality rates, and reduced morbidity.

Recent Developments in the U.S. Medical Device OEM (Original Equipment Manufacturer) Outsourcing Market

• In January 2025, Gainline Capital Partners purchased M&M International (M&M), a manufacturer of precision-engineered stainless steel tubing primarily for the medical device end market.
• In October 2024, Double-Coated Medical Tape with Hi-Tack Silicone and Acrylate Adhesives on Liner was launched by Solventum.