Surgical and Medical Instrument Manufacturing
Size Standard: 1,000 employees
NAICS code 339112 covers establishments primarily engaged in manufacturing medical, surgical, ophthalmic, and veterinary instruments and apparatus (except electrotherapeutic, electromedical, and irradiation apparatus). Examples include surgical knives, scissors, forceps, hypodermic needles, syringes, and diagnostic equipment.
Government agencies represent a massive market for surgical and medical instrument manufacturers, with the Department of Veterans Affairs (VA) and Department of Defense (DoD) being the primary purchasers. The VA operates the largest integrated healthcare system in the United States, supporting millions of veterans and requiring substantial quantities of surgical instruments and medical devices.
Defense Health Agency (DHA) and military medical facilities across all service branches procure surgical instruments for combat support hospitals, military treatment facilities, and readiness training. The emphasis on medical readiness and deployable medical capabilities creates sustained demand for high-quality, durable surgical instruments.
Contractors in this NAICS code must comply with FDA regulations, including 21 CFR Part 820 Quality System Regulation (QSR), and often need to meet military specifications (MIL-SPEC) for defense contracts. ISO 13485 certification for medical device quality management systems is virtually required for serious government contractors in this space.
Small businesses can compete effectively, particularly for specialized instruments, niche medical devices, and through the VA's Veteran-Owned Small Business (VOSB) and Service-Disabled Veteran-Owned Small Business (SDVOSB) set-aside programs. The VA has aggressive goals for awarding contracts to veteran-owned businesses.
- Department of Veterans Affairs (VA)
- Defense Health Agency (DHA)
- Food and Drug Administration (FDA)
- Indian Health Service (IHS)
- Federal Bureau of Prisons (BOP)
- Surgical Instrument Sets for VA Medical Centers
- Deployable Medical Equipment for Military
- Diagnostic Instruments for Indian Health Service
- Specialty Surgical Tools Manufacturing
- Medical Instrument Repair Parts Supply
These certifications can help you compete for set-aside contracts under NAICS 339112:
What regulatory requirements apply to NAICS 339112?
Manufacturers must comply with FDA 21 CFR Part 820 Quality System Regulation, ISO 13485 for medical device quality management, and potentially MIL-SPEC requirements for defense contracts. FDA registration and device listing are mandatory.
What is the size standard for NAICS 339112?
The SBA size standard for NAICS 339112 is 1,000 employees, which is relatively high for manufacturing. This allows many established medical device companies to still qualify as small businesses.
Which agencies purchase the most surgical instruments?
The VA is the largest federal buyer, followed by Defense Health Agency (DHA), military medical facilities, Indian Health Service (IHS), and Federal Bureau of Prisons. State and local hospitals also purchase through cooperative agreements.
What certifications help win contracts in this NAICS code?
ISO 13485 is virtually required. SDVOSB/VOSB certification is extremely valuable for VA contracts. 8(a) certification helps with set-asides. FDA establishment registration and device listings are mandatory requirements.
Can small businesses compete in medical instrument manufacturing?
Yes. Small businesses compete effectively in specialized instruments, niche devices, and through set-aside programs. The VA has aggressive SDVOSB goals. Subcontracting to large medical device primes is another entry path.
Businesses below this threshold in average annual receipts qualify as small businesses for set-aside contracts.
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