Solving FDA Compliance Challenges with MagConnect® Magnetic Connectors

Val Chepurny / January 30, 2025
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Solving FDA Concerns with MagConnect® for Minimally Invasive Connectors

Overview

Original Equipment Manufacturers (OEMs) in the medical device industry face stringent regulatory requirements from the FDA. These are especially important for minimally invasive devices. These regulations emphasize patient safety, ease of use, and compliance with design guidelines, especially concerning locking connectors. MagConnect, an innovative magnetic connector solution, has emerged as a robust response to these challenges, addressing both engineering and compliance concerns.

The Challenge

Locking connectors are essential in minimally invasive devices to ensure secure connections during procedures. However, they come with specific challenges that often raise concerns for OEMs being compliant with the FDA:

    1. Safety Risks from Unintended Disconnection: Locking mechanisms must provide sufficient retention without risking accidental disconnection during critical operations.
    2. User Error in Assembly: Complex locking mechanisms can lead to misalignment or improper assembly, increasing the risk of device failure.
    3. Cleaning and Sterilization Challenges: Traditional locking connectors can have intricate designs that are difficult to clean, raising the risk of contamination.
    4. Regulatory Compliance: FDA guidelines require locking connectors to be both secure and easily operable by medical professionals without excessive force.
    5. Misconnections: Attaching the correct connector to the correct device is vital to ensure a safe environment.

Onanon’s team has talked to heads of engineering at top OEMs who reported these pain points, emphasizing the need for a solution that balances safety, functionality, and regulatory compliance.

Watch the full video on our Youtube: Onanon Innovates

 

The Solution: MagConnect®

MagConnect® offers a revolutionary approach to connector design, leveraging precision-engineered magnetic locking mechanisms to address these challenges.

1. Secure and Reliable Connection

MagConnect®’s magnetic technology ensures a firm connection by combining magnetic force with mechanical alignment features:

  • Prevents Unintended Disconnection: Magnetic retention provides consistent strength, while custom locking geometry enhances connection reliability.
  • Meets FDA Standards: Rigorous testing demonstrates compliance with force retention and disengagement thresholds required by FDA guidelines.

2. Simplified User Experience

MagConnect® eliminates the complexity of traditional locking connectors:

  • Error-Free Assembly: Intuitive self-aligning features reduce the risk of misalignment.
  • Effortless Operation: Connectors engage and disengage with minimal force, ensuring ease of use for medical professionals even in high-stress scenarios.

3. Enhanced Cleaning and Sterilization

Designed with smooth surfaces and minimal crevices:

  • Easily Sterilizable: Simplifies cleaning processes, meeting FDA and OEM standards for sterility in reusable devices.
  • Durable Under Repeated Cycles: The robust construction withstands repeated cleaning and sterilization without degradation.
  • Onanon also provides disposable options.

Case Study Results: MagConnect®

A leading OEM specializing in minimally invasive surgical devices integrated MagConnect® into their product line. Key outcomes included:

  • FDA Approvals: Devices with MagConnect® experience approvals with the FDA. 
  • Engineer Satisfaction: The engineers we worked with highlighted reduced design complexity and increased confidence in meeting FDA guidelines.
  • Improved Physician Feedback: Clinical trials reported an improvement in procedural efficiency due to MagConnect®’s ease of use compared to traditional locking connectors.

Medical magnetic connector

Why OEMs Choose MagConnect®

MagConnect®’s magnetic connectors provide a compelling alternative for OEMs navigating the complex regulatory landscape of minimally invasive devices. By solving safety, usability, and compliance concerns, MagConnect® empowers OEMs to innovate confidently while adhering to stringent FDA requirements.

Conclusion

As engineering directors at top OEMs continue to voice concerns over traditional locking connectors, MagConnect® is setting a new standard in the industry as a leading magnetic connector. Its combination of advanced engineering and regulatory alignment ensures that OEMs can deliver safe, reliable, and compliant minimally invasive devices to the market.

Interested in learning more? Contact us today to explore how MagConnect® can transform your device design.

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