Medical Device Outsourcing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Service (Quality Assurance, Regulatory Affairs Services, Product Design and Development Services, Product Testing & Sterilization Services, Product Implementation Services, Product Upgrade Services, Product Maintenance Services, Contract Manufacturing), By Application (Cardiology, Diagnostic Imaging, Orthopedic, IVD, Ophthalmic, General and Plastic Surgery, Drug Delivery, Dental, Endoscopy, Diabetes Care, Others), By Class (Class I, Class II, Class III), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 132.02 Billion
CAGR (2026-2031)	13.11%
Fastest Growing Segment	Cardiology
Largest Market	North America
Market Size (2031)	USD 276.47 Billion

Market Overview

The Global Medical Device Outsourcing Market will grow from USD 132.02 Billion in 2025 to USD 276.47 Billion by 2031 at a 13.11% CAGR. Global Medical Device Outsourcing involves Original Equipment Manufacturers contracting third-party service providers for product design, prototyping, manufacturing, and regulatory compliance. The primary drivers fueling this market include the imperative for cost reduction, the need to accelerate speed to market, and the strategic desire for companies to focus internal resources on core competencies such as research and marketing. This reliance on external support is structurally underpinned by the composition of the industry itself. According to MedTech Europe, in 2025, small and medium enterprises represented approximately 90% of the medical technology sector in Europe. These firms often lack the capital and infrastructure for vertical integration, thereby necessitating partnerships with specialized contract manufacturing organizations to bridge capability gaps and ensure commercial viability.

A significant challenge impeding the expansion of the market is the increasingly stringent regulatory landscape which demands rigorous quality management systems across the entire supply chain. While regulations such as the European Union Medical Device Regulation drive the demand for specialized consulting, they simultaneously impose high liability risks and compliance costs that can strain relationships between manufacturers and suppliers. Consequently, the complexity of maintaining seamless global regulatory adherence stands as a potential hurdle that could slow production cycles and hinder the flexibility that outsourcing typically offers.

Key Market Drivers

Escalating pressure for cost containment and operational efficiency compels original equipment manufacturers to restructure their asset bases and utilize external partners. As healthcare systems demand lower pricing while inflation impacts production, companies pivot from fixed-cost internal manufacturing to variable-cost outsourcing models to preserve margins. This strategic transfer of production volume allows firms to mitigate overheads while maintaining supply chain fluidity. According to Integer Holdings Corporation, October 2024, in the 'Third Quarter 2024 Earnings Release', the company reported that its sales increased 9% year over year to $431 million, a growth trajectory driven by sustained customer demand for specialized manufacturing capabilities. This performance highlights the industry-wide reliance on contract organizations to optimize operational expenditures.

The growing complexity of device design requiring specialized technical expertise further necessitates collaboration with providers possessing niche skills that exceed internal OEM capabilities. Modern medical technologies increasingly integrate advanced electronics and algorithms, creating a knowledge gap that traditional engineering teams cannot bridge alone. This trend forces a reliance on partners adept in digital health integration to ensure functional precision. According to the U.S. Food and Drug Administration, August 2024, in the 'Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices' list, the agency has authorized 950 AI/ML-enabled medical devices, reflecting the surge in sophisticated products requiring expert development support. To support such innovation, the market relies on the immense capital of the leading developers; according to Medical Design & Outsourcing, October 2024, in the '2024 Medtech Big 100' report, the top 100 medical device companies generated $474.8 billion in revenue, providing the financial foundation necessary to fund these intricate external partnerships.

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Key Market Challenges

The increasingly stringent regulatory landscape acts as a substantial structural impediment to the growth of the medical device outsourcing market. As government bodies enforce rigorous quality management standards, the complexity of maintaining compliance across a fragmented supply chain intensifies. This regulatory burden often negates the benefits of speed and flexibility, as manufacturers must dedicate extensive time to auditing third-party partners. Consequently, the administrative friction involved in managing external vendors discourages companies from expanding their outsourcing portfolios, prompting them to retain critical operations in-house to ensure absolute oversight.

Furthermore, the financial implications of this environment create a barrier to market expansion. The high cost of certifying devices and maintaining documentation strains budgets that would otherwise fund external contracts. Liability risks also escalate, leading to more restrictive partnership agreements. This financial strain is evident in recent industry findings. According to MedTech Europe, in 2025, manufacturers reported that certification and maintenance costs under the new regulations had escalated by up to 100 percent compared to previous directives. Such rising expenditures directly reduce the capital available for outsourcing services, thereby dampening overall market growth.

Key Market Trends

The implementation of supply chain resilience and nearshoring strategies has emerged as a paramount trend as manufacturers seek to immunize their operations against global volatility. In response to increasing geopolitical instability and logistical bottlenecks, OEMs are aggressively diversifying their supplier networks and integrating predictive risk monitoring tools to ensure continuity of care. This defensive restructuring is driven by the need to secure component availability rather than solely optimizing for the lowest price, marking a shift from efficiency-centric to resilience-centric models. According to Resilinc, May 2024, in the 'Life Sciences and Healthcare Supply Chain Recap Q1 2024', the healthcare sector experienced 3,850 supply chain disruption alerts during the first quarter of 2024, a 40% increase year-over-year, underscoring the critical urgency for robust mitigation frameworks.

Concurrently, there is a rising trajectory in the outsourcing of connected and wearable medical device development, fueled by the demand for sophisticated electronics and Internet of Medical Things (IoMT) integration. As these devices require complex assembly and advanced engineering that often exceed internal capacities, OEMs are increasingly awarding large-scale contracts to specialized electronic manufacturing services providers. This reliance on external expertise allows medical companies to scale production of digital health solutions rapidly while navigating the technical intricacies of modern connectivity. According to Plexus Corp, July 2024, in the 'Fiscal Third Quarter Financial Results', the company secured $279 million in new manufacturing program wins, driven by a record contribution from the Healthcare and Life Sciences sector, reflecting the accelerating market appetite for high-tech manufacturing partnerships.

Segmental Insights

The cardiology segment represents the fastest-growing category in the global medical device outsourcing market due to the rising prevalence of cardiovascular conditions requiring immediate intervention. Manufacturers are increasingly partnering with contract organizations to manage the complex engineering required for devices such as pacemakers and heart valves. This strategic reliance assists companies in meeting rigorous safety standards established by regulatory bodies like the U.S. Food and Drug Administration. Furthermore, outsourcing these intricate manufacturing processes allows firms to optimize production costs while ensuring high-quality compliance in a highly regulated environment.

Regional Insights

North America maintains a leading position in the global medical device outsourcing market due to the high concentration of major original equipment manufacturers within the United States. These companies utilize contract services to reduce production costs and streamline supply chains while focusing on core competencies. Additionally, stringent compliance requirements enforced by the U.S. Food and Drug Administration drive manufacturers toward specialized partners who possess established quality management systems. The strong healthcare infrastructure and consistent demand for diagnostic and therapeutic devices further reinforce the regional reliance on external engineering and manufacturing services.

Recent Developments

• In September 2025, Resonetics announced the acquisition of Eden Holdings, a precision manufacturer known for its expertise in injection molding and micro-machining solutions. This transaction added critical micro-molding and insert-molding capabilities to the company’s existing portfolio of advanced engineering and manufacturing services. The integration of these technologies was designed to complement the firm’s established metal processing strengths and support the production of complex medical devices for high-growth sectors such as robotic surgery and rapid diagnostics. The acquisition reinforced the organization’s position as a leading contract development and manufacturing partner by providing a more integrated and comprehensive set of solutions to medical device companies.
• In April 2025, Cirtec Medical announced a significant expansion of its operations in Costa Rica, planning to more than double its footprint in the region. The company revealed it would add a new facility exceeding 50,000 square feet to support growing industry demand for its end-to-end design and manufacturing services. This strategic move was intended to enhance capabilities in key therapeutic areas such as neuromodulation, electrophysiology, and structural heart markets. The expansion in the Coyol Free Zone allowed the firm to offer increased capacity for processes including assembly and packaging, thereby optimizing costs and shortening product development timelines for its global partners.
• In February 2025, Jabil Inc. entered into a strategic collaboration with Midwest Interventional Systems (MIS) to advance the design and development of catheters and other minimally invasive medical devices. This partnership aimed to leverage the company’s extensive global manufacturing footprint alongside the specialized expertise of MIS in catheter technologies, including extrusion and balloon forming. By combining their capabilities, the organizations sought to provide medical device original equipment manufacturers with enhanced solutions for high-performance catheter systems. The collaboration was established to accelerate time-to-market for complex medical products and improve patient care outcomes through innovation in the critical sector of minimally invasive surgery.
• In January 2025, Integer Holdings Corporation completed the acquisition of substantially all assets of Precision Coating, a manufacturer specializing in surface coating technology for medical devices. This strategic transaction, valued at approximately $152 million, enhanced the company's service offerings by adding differentiated capabilities in fluoropolymer and anodic coatings, as well as laser processing and ion treatment solutions. The integration of these proprietary technologies was designed to position the company to better meet the evolving needs of its customers in the medtech industry. The acquisition aligned with the organization's strategy to expand its portfolio and deliver comprehensive end-to-end solutions for complex medical device development and manufacturing.

Key Market Players

• Laboratory Corporation of America Holdings
• Pace Analytical Services, Inc.
• Intertek Group plc
• PAREXEL International Corporation
• Accell Clinical Research, LLC
• Criterium, Inc.
• ICON plc.
• IQVIA Inc.
• Integer Holdings Corporation

By Service	By Application	By Class	By Region
Quality Assurance Regulatory Affairs Services Product Design and Development Services Product Testing & Sterilization Services Product Implementation Services Product Upgrade Services Product Maintenance Services Contract Manufacturing	Cardiology Diagnostic Imaging Orthopedic IVD Ophthalmic General and Plastic Surgery Drug Delivery Dental Endoscopy Diabetes Care Others	Class I Class II Class III	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Medical Device Outsourcing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Medical Device Outsourcing Market, By Service:

• Quality Assurance
• Regulatory Affairs Services
• Product Design and Development Services
• Product Testing & Sterilization Services
• Product Implementation Services
• Product Upgrade Services
• Product Maintenance Services
• Contract Manufacturing

• Medical Device Outsourcing Market, By Application:

• Cardiology
• Diagnostic Imaging
• Orthopedic
• IVD
• Ophthalmic
• General and Plastic Surgery
• Drug Delivery
• Dental
• Endoscopy
• Diabetes Care
• Others

• Medical Device Outsourcing Market, By Class:

• Class I
• Class II
• Class III

• Medical Device Outsourcing Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE