Materials technology company Lucideon has invested seven-figures in a new US biocompatibility lab designed to accelerate the development of safer medical devices and help manufacturers meet increasingly complex regulatory demands.
Lucideon’s new state-of-the-art facility in South Carolina will work in tandem with its in vitro cell biology lab which opened at the company’s UK headquarters in Stone last year.
The Greenville facility is focused on assessing how medical devices and materials interact with the human body, helping manufacturers reduce the risk of harmful biological responses while speeding up product development and regulatory approval.
Craig Donald, Head of Analysis & Evaluation at Lucideon, said: “With laboratories in the UK and now the US, Lucideon offers a truly global biocompatibility and materials performance solution to drive faster and safer innovation and development of medical devices, so that future developments can move from R&D to market more easily.
“We are in a position to offer a global footprint for the world’s medical device manufacturers to support their innovation and compliance journeys, ultimately improving and protecting patient health and function worldwide.”
Lucideon chose Greenville for the new laboratory, because a significant number of device innovations are taking place there. Its opening created a handful of specialist roles.
Services will include cytotoxicity, extractables and leachables (E&L) testing, toxicological risk assessment, long-term implant performance, advanced material and surface characterisation, and regulatory testing.
Craig added: “Ensuring biocompatibility isn’t only a regulatory hurdle, it’s essential for patient trust, provider reliability, and clinical success.
“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, ensuring that implants or medical devices do not provoke harmful reactions, such as inflammation, toxicity, or rejection.
“However, as medical device design becomes more advanced, utilising a broader set of novel materials systems, such as new polymers, composites, coatings, and surface modifications, the risk of unexpected or adverse reactions increases.
“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.”
By bringing chemical characterisation, extractables and leachables testing, implant performance assessments, and advanced materials analysis together under one roof, Lucideon aims to simplify development for manufacturers, reduce complexity, and speed up turnaround times.
The company believes the broadened services will support innovation across a wide range of medical technologies, including stents and vascular delivery devices, joint replacement implants, tissue scaffolds, wearable devices, and advanced biomaterials.
The new lab strengthens Lucideon’s US presence, which spans three sites.
After an expansion in 2020, the Greenville campus is now the company’s largest US site by area and is also home to metallurgical, machining, mechanical testing, and tribological laboratories.
