Lucideon has announced the launch of its new, dedicated biocompatibility laboratory in the United States, complementing existing UK capabilities, significantly advancing its global testing infrastructure for materials and medical devices
The laboratory will enable Lucideon to offer more rapid and robust assessments of medical materials' interactions with human biological systems, ensuring patient safety and helping device manufacturers meet strict regulatory requirements.
Biocompatibility refers to the ability of a material or device to perform its intended function in contact with living tissue without producing adverse local or systemic effects. In practice, this means that implants or medical devices must not provoke harmful reactions, such as inflammation, toxicity, or rejection, and must elicit a proper host response. Lucideon is equipped to carry out the full range of these assessments.
What the new lab offers
- Comprehensive testing: The facility enhances Lucideon’s existing capabilities of direct toxicity, but also more complex interactions such as effects on surrounding tissues, potential for immune response, and performance over time.
- Faster turnaround: Locally based in the U.S., the lab removes delays related to overseas shipping of materials for testing, enabling quicker feedback to manufacturers.
- Regulatory alignment: The laboratory’s protocols are designed to conform with U.S. FDA requirements and international standards, a critical factor for devices seeking approval in multiple markets.
Why it matters
As medical device design becomes more advanced, utilising new polymers, composites, coatings and surface modifications, the risk of unexpected or adverse reactions increases. Ensuring biocompatibility isn’t only a regulatory hurdle; it’s essential for patient trust and clinical success. With this dedicated U.S. lab, Lucideon strengthens its ability to help companies identify and mitigate risks earlier in the development process.
“Having a dedicated U.S. biocompatibility laboratory means Lucideon can deliver our world-class materials testing closer to where many device innovations are happening,” said Tom Archer, Product Marketing Specialist – Healthcare for Lucideon. “Our goal is to enable device makers to move faster and more confidently, knowing that their materials can safely interact with biological systems in the way they intend.”
Impact across the medical device lifecycle
From prototyping through to regulatory submission and post-market surveillance, biocompatibility assessments are integral. Lucideon supports test programmes for:
- Implants and prosthetics
- Coated devices (e.g. stents, catheters)
- Wearables with skin contact
- Tissue engineering scaffolds and biomaterials
Lucideon expects the expanded U.S. capability to reduce lead times, lower costs associated with re-working or redesigning materials, and assist in bringing safer medical devices to patients more quickly.
October 2025