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
Nov 4, 2025 - Tariff Dispute Reaches US Supreme Court
- The US Supreme Court is hearing arguments in early November on whether tariffs imposed by the Trump administration are legal. Medical device manufacturers are likely to benefit if the cost of goods imported from countries that were hit with tariffs decrease. The US Court of Appeals for the Federal Circuit ruled earlier that President Trump overstepped his authority when he declared national emergencies to justify tariffs on many countries. US law "bestows significant authority on the president to undertake a number of actions in response to a declared national emergency, but none of these actions explicitly include the power to impose tariffs, duties, or the like, or the power to tax", the court said in the 7-4 ruling. Many of President Trump’s steep tariffs are "unbounded in scope, amount and duration", the ruling added, and "assert an expansive authority that is beyond the express limitations" of the law his administration has cited.
- Medical device manufactures are beginning to consider measures needed to protect medical data and connected devices from quantum-enabled security threats, according to Medical Design and Outsourcing. Today’s cryptography is considered secure because it would take a very long time for traditional binary computers to solve the complex mathematical equations used to encrypt information. The processing power of nascent quantum computers will perform these operations much faster to break current cryptography. The device industry has long development cycles due in part to strong regulatory oversight, so the transition to quantum-resistant post-quantum cryptography (PQC) must start now, according to Medical Design and Outsourcing. This means devices developed today should be PQC-ready by implementing approved post-quantum algorithms or by providing crypto-agility and allowing for future upgrades.
- Medical technology companies are expanding their US manufacturing presence, according to Modern Healthcare. Firms are investing millions — and in one case, billions — of dollars to boost capacity by adding facilities and expanding existing ones. Medical device maker Autocam Medical, for example, plans to build a $70 million assembly plant in Indiana. The company hopes to break ground on the 100,000-square-foot factory in August or September of 2025, with construction expected to take 18 to 25 months. The plant is expected to create up to 300 new jobs within three to four years.
- Medical device manufacturing industry employment was unchanged and averages wages for nonsupervisory employees increased slightly during the first seven months of 2025, according to the US Bureau of Labor Statistics (BLS). Miscellaneous durable goods inventories, which include medical devices, remain significantly above pre-pandemic levels in early 2025. The Producer Price Index for medical equipment & supplies manufacturers increased 1. 77% year over year in August, according to the BLS.
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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