Powering Safe Innovation in Surgical Robotics

July 25, 2025

Biocompatible Magnetics

What good is your breakthrough surgical robot if your magnetic component fails a biocompatibility test, and sets your entire project back six months?

In the world of surgical robotic devices, the line between innovation and regulatory failure often comes down to a single overlooked factor: material safety. And for magnetic assemblies, that means biocompatibility isn’t just a checkbox, it’s a design imperative.

Whether you’re designing a torque sensor, a retention mechanism, or a robotic actuation module, your magnets must do more than deliver force, they must survive sterilization, withstand stressors, and meet regulatory scrutiny. This is where we steps in, with materials, coatings, and engineering expertise designed to keep your devices safe, compliant, and launch-ready.

 

Safety First: Why Biocompatibility is Non-Negotiable

Implantable, biocompatible, powering safe innovation.

In the high-stakes world of medical device engineering, especially within surgical robotics and diagnostic systems, material safety is not optional, it’s foundational. The magnetic materials embedded in your device’s actuation, retention, or sensing systems must perform at high levels, and comply with the rigorous biocompatibility standards set by ISO 10993 and ISO 13485.

Understanding Magnetic Materials for Medical Use

Magnetic components in medical systems must be carefully selected for both performance and safety. Here are the most commonly used magnet types:

Samarium Cobalt (SmCo)

  • Excellent thermal stability and corrosion resistance
  • Naturally more biocompatible than many other magnet types
  • Ideal for high-temperature, high-reliability applications

 Neodymium Iron Boron (NdFeB)

  • Highest magnetic strength among rare-earth magnets
  • Requires protective coatings due to porosity and corrosion risk
  • Often used in actuation or sensor-driven robotic modules

 

Dexter specializes in transforming these materials into medical-ready components through advanced coating, sealing, and packaging solutions.

 

The Role of BarrierMax™ Parylene C Coating

 Dexter’s BarrierMax™ process applies a Parylene C coating to NdFeB magnets, creating a pinhole-free, ultra-thin, and conformal barrier that:

  • Prevents corrosion and oxidation
  • Ensures long-term biocompatibility
  • Provides a chemically inert, lubricious surface
  • Meets ISO 10993-5 cytotoxicity testing requirements

The process includes vapor-phase deposition at room temperature, making it safe for even the most sensitive components. Because the coating is uniform and non-porous, it protects even small or complex geometries.

Hermetic Sealing for Longevity and Compliance

 For applications requiring extreme protection, Dexter also offers hermetic sealing technologies:

  • Titanium and glass enclosures that isolate the magnetic material from biological exposure
  • Laser welding techniques that prevent heat-induced demagnetization
  • Hermetic housings that maintain magnetic performance and field strength over the life of the device

These seals are ideal for devices that may be exposed to fluid ingress, sterilization cycles, or extreme thermal conditions.

Testing and Compliance: What OEMs Can Expect

Dexter supports its medical OEM partners by aligning with stringent validation workflows:

  • ISO 10993 Biocompatibility Testing: including cytotoxicity, sensitization, and irritation
  • Accelerated Life Testing: for salt spray, thermal cycling, and saline immersion
  • Helium Leak Testing: for hermetic assemblies

Documentation and traceability are built into our production workflows, supporting your DHF and FDA submission packages.

Why It Matters for OEMs

You, as a design engineer, know the cost of delays, recalls, or noncompliance.

Partnering with a magnetics supplier who understands medical regulations, design constraints, and quality systems reduces development risk and shortens your timeline to market.

Dexter is ISO 13485 certified and has supported Class III device launches, giving your team a proven partner for magnetics that meet the highest standards.

Ready to Build Biocompatible Confidence Into Your Design?

With Dexter, you get more than just magnets. You get a trusted engineering partner who understands the intersection of performance, compliance, and safety in magnetic design.

Speak with a medical device sales specialist

Additional Resources

  1. The Parlene Family: https://www.dextermag.com/wp-content/uploads/2023/07/Parylene-Family-7.18.23.pdf
  2. Dexter BarrierMaxTM Parylene C coating for NdFeB Magnets: https://www.dextermag.com/wp-content/uploads/2024/12/Dexter-BarrierMax-1-Parylene-Coating-Revised-6-2-2023-Copy-2-Copy-2.pdf
  3. Hermetic Sealing of Magnets in Implantable Medical Devices: https://www.dextermag.com/wp-content/uploads/2023/10/Hermetic-Sealing-of-Magnets-in-Implantable-Medical-Devices.pdf
  4. Hermetic Seals: https://www.dextermag.com/wp-content/uploads/2023/07/Hermetic-Seals-7.18.23-Updated.pdf