Medical Device Manufacturers NAICS 339112, 339113
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Industry Summary
The 8,260 medical device manufacturers in the US produce a range of products designed to diagnose and treat patients. Medical devices range in nature and complexity from simple tongue depressors and bandages to complex programmable pacemakers and sophisticated imaging systems. The key products include surgical appliances and supplies, surgical and medical instruments, electro-medical equipment, in-vitro diagnostic substances, irradiation apparatuses, dental-related products, and ophthalmic goods.
Challenges of Complex Regulations
Medical devices are subject to extensive regulation in the US by the FDA, and by comparable government agencies in other countries.
Developing New Hybrid Technologies
New hybrid technologies that incorporate pharmaceutical products with traditional medical device products are becoming popular.
Recent Developments
Jun 3, 2025 - Agentic AI may Improve Device Maintenance
- Agentic AI can reduce medical device malfunctions and improve patient care by enhancing predictive maintenance for medical devices, according to Medical Product Outsourcing Magazine. Agentic AI continuously monitors device performance, sensing issues in real-time to recommend maintenance strategies. It can act autonomously, setting goals and completing tasks through machine learning, deep learning, reinforcement learning, and natural learning processing. Agentic AI also offers immediate awareness of device failures as well as data-driven insight into repair strategies. These capabilities may reduce failure rates, minimizing downtime while increasing patient safety, operational efficiency, and cost optimization.
- Medical device makers, hospitals, and other healthcare stakeholders are seeking exemptions from tariffs imposed by the Trump administration in April. About $303 billion of imported drug, biotech, and device industry goods entered the US in 2024, $294 billion of which entered duty-free, according to professional services firm PwC. Healthcare's heavy reliance on foreign countries for raw materials and manufacturing means new levies could result in supply chain disruptions and higher prices for providers and consumers, according to PwC.
- Medicare payments to Medicare Advantage plans are expected to increase an average of 3.7%, or over $16 billion in 2025, according to the Centers for Medicare & Medicaid Services. Medical device manufacturers are likely to benefit from the increase in expenditures. The finalized the Calendar Year 2025 Rate Announcement for Medicare Advantage is projected to result in payments of between $500 and $600 billion in Medicare Advantage payments to private health plans in 2025.
- Medical device manufacturing industry employment was unchanged and averages wages for nonsupervisory employees increased slightly during the first three months of 2025, according to the US Bureau of Labor Statistics (BLS). Medical device manufacturers increased their prices only slightly during 2024, according to the BLS. Miscellaneous durable goods inventories, which include medical devices, remain significantly above pre-pandemic levels in early 2025.
Industry Revenue
Medical Device Manufacturers
Industry Structure
Industry size & Structure
A typical medical device manufacturer generates $11 million in annual revenue and has fewer than 10 employees.
- The overall medical device manufacturing industry consists of about 8,260 companies with $92 billion in sales and 334,200 employees.
- The two largest segments of the industry, surgical and medical instruments and surgical appliances and supplies, consist of about 2,760 companies with about $76 billion in sales and 248,700 employees. These segments are the primary focus of this profile.
- The states with the highest number of medical device companies include California, Florida, New York, Texas, Illinois, Indiana, Pennsylvania, Ohio, North Carolina and Minnesota.
- Major US medical device companies include Medtronic, GE Healthcare Technologies, Johnson & Johnson, Boston Scientific, Baxter, Becton Dickinson, Beckman Coulter, Abbott Labs, and Stryker Corporation.
Industry Forecast
Industry Forecast
Medical Device Manufacturers Industry Growth
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