Medical Device Kitting & Sterilization

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Startup Cost
$40,000-$220,000
Difficulty
Advanced
Time to Profit
15-24 months
Profit Potential
$90,000-$450,000/year

Overview

Medical device kitting services assemble surgical kits, medical procedure trays, and device sets with sterilization for hospitals and medical facilities.

With medical device market at $500B+ and custom kits essential for procedures, medical kitting generates revenue of $150,000-$520,000 with 40-55% margins.

The business requires FDA-registered facility, sterilization equipment or partnerships, cleanroom space, quality systems, and compliance expertise.

Services include custom procedure tray assembly, instrument kitting, sterilization services, inventory management, and compliance documentation.

Pricing varies widely by kit complexity and sterilization.

Success factors include FDA compliance and quality systems, sterilization capabilities or partnerships, understanding medical procedures, hospital contracting expertise, and targeting surgical centers and hospitals.

Marketing focuses on healthcare purchasing, medical device trade shows, and GPO relationships.

With medical procedures constant in 2025, medical kitting offers clinical opportunities requiring regulatory compliance.

Required Skills

  • FDA regulations
  • Medical device knowledge
  • Sterilization processes
  • Quality systems (ISO 13485)
  • Healthcare purchasing
  • Compliance documentation

Pros and Cons

Pros

  • High-value services
  • Essential medical need
  • Recurring hospital contracts
  • Regulatory barriers to entry
  • Growing procedures

Cons

  • Complex regulations
  • Sterilization investment
  • FDA compliance required
  • Long sales cycles
  • Liability concerns

How to Get Started

  1. Get FDA registration
  2. Implement quality systems
  3. Acquire/partner sterilization
  4. Build cleanroom space
  5. Target surgical centers
  6. Understand medical procedures
  7. Build GPO relationships

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