Medical Device and Pharmaceutical Biocompatibility Testing
Biocompatibility refers to the ability of a material or device to perform its intended function while interacting with the body without causing harm or rejection. This is crucial for medical devices and implants to ensure they are safe and effective for patient use.
Biocompatibility testing is the process of evaluating whether medical devices and pharmaceuticals that come into direct contact with patients, such as implants, surgical instruments, needles etc, interact safely with the body to ensure they won't cause harmful side effects in use. During product development, these devices must undergo stringent biocompatibility testing as part of the regulatory pathway (e.g., FDA, PMDA, MDR).
Lucideon, powered by decades of extensive materials expertise, offers end-to-end biocompatibility support for an extensive range of medical devices and pharmaceutical products. Utilising our in-house analytical capabilities coupled with our strong partnership network of industry experts, we help device and materials manufacturers meet stringent regulatory and safety standards for their products as well as solve complex development challenges to accelerate and optimise the route to market.
Our materials solutions can support the development of medical devices for a range of regulatory bodies, including but not limited to the FDA, PMDA, and EU bodies such as DEKRA, TÜV SÜD, etc.
Types of healthcare products we support:
- Orthopaedic implants
- Surgical tools
- Tubes and catheters
- Bone cement
- Dental devices (implantables and tools)
- Combination devices e.g. injectables, inhalation devices, filled IV bags, etc
- External devices e.g. prosthetics, hearing aids
- and more
Our biocompatibility testing solutions:
Chemical characterisation
Lucideon's team of experts offer comprehensive in-house chemical characterisation for biocompatibility assessment (ISO 10993-18).
This process involves the assessment of substances released from medical devices that fall into 2 categories:
- Extractables - substances released from the device under exaggerated conditions e.g. high temperature or in the presence of a strong solvent
- Leachables - substances released from the device under normal conditions as to be expected during use
Our orthopaedic wear and fatigue Centre of Excellence (CoE) is designed to offer support to Original Equipment Manufacturers (OEMs) and Contract Development and Manufacturing Organisations (CDMOs) alike.
Our CoE is equipped with the full suite of testing rigs and analytical instruments needed to produce the data our clients need. Our solutions include but are not limited to:
- Wear testing
- Fatigue testing
- Static testing
Lucideon's depth and breadth of analytical capabilities extend to particulate analysis for medical devices and pharmaceutical products. Applications of our expertise include:
- Analysing particle shedding from additively manufactured devices
- Rapid contamination evaluation in devices and pharmaceutical products
- Particle analysis for vascular devices
Lucideon's state-of-the-art surface science facilities are equipped with cutting-edge technologies to provide accurate and detailed surface analysis of healthcare products and devices. Our services help you:
- Investigate material properties throughout the product lifecycle, from raw materials to finished products
- Rapidly identify manufacturing defects, changes in material surfaces, and degradation over time
- Perform in-depth analysis using advanced techniques like microscopy, microanalysis, and depth profiling to study surface structures at the nano and micro scale
Our in-house cell biology lab offers in vitro cytotoxicity testing in line with ISO 10993-5 to assess the potential of materials, devices, and formulations to cause harmful effects on living cells. This test is a key requirement for demonstrating biocompatibility and regulatory compliance in the development of medical devices and healthcare products. Our experts deliver clear and reliable data to help you progress products safely and efficiently to market.
We are official partners with Bibra, the toxicology advice and consultancy experts. Our partnership means we provide a complete service offerings to ISO 10993-17, spanning the expertise of Lucideon and Bibra, with the convenience and visibility of just one program operator. Our strong collaboration also means we can supply toxicology hazard and risk assessments for our clients.
Cleaning & Sterilisation validation
Lucideon's in-house microbiology and chemistry capabilities extend to developing and validating cleaning and sterilisation processes for both single-use and reusable medical devices. Our analysis ensures your processes and Instructions for Use (IFUs) are effective at cleaning your devices whilst being repeatably reliable. Products we validate include:
- Single use: Orthopaedic implants, syringes, catheters, dental implants, etc
- Re-usable: Surgical tools and instruments for general, orthopaedic, dental applications, and more
Why choose Lucideon?
Our biocompatibility solutions ensure your medical devices meet stringent regulatory requirements to make the route to market easier. Key benefits of working with Lucideon include:
- Partnership: At Lucideon we don’t simply provide you with analytical results, we work with you to truly understand the challenge and navigate the complex regulatory pathway
- Compliance and accuracy: With analytical expertise in commonly used methodologies, Lucideon delivers trusted results recognised by the FDA, MDR, PMDA, and more
- End-to-end solutions: Lucideon can support the biocompatibility assessment of your product from start to end, making your route to market as easy as possible
Contact us today to learn more about how our biocompatibility testing solutions can support your product development.