Medical Device Development Consultancy
Through our materials expertise we offer product and process development and testing and analysis services to medical device manufacturers and suppliers.
We have extensive knowledge in the field of orthopaedic implants, cardiovascular implants, dental devices, and surgical instruments and can provide medical testing and regulatory support for a wide range of devices and materials. Working to ISO, ASTM and FDA (Food and Drug Administration) standards (and novel methodologies with rationale when the standards aren't available or suitable), we offer a complete solution to mechanical and chemical testing, consultancy support for regulatory submissions, and materials characterisation.
Our analytical interpretation and rationale support makes regulatory submissions more robust as you can clearly demonstrate why you chose your method and show a full understanding of what the results mean for your devices and the end-users.
Informed testing, and years of experience, allows us to study any medical device issues and challenges to troubleshoot problems. We at Lucideon have built our reputation on this approach for supporting the successful submission of medical devices to FDA and other regulatory bodies.
Materials expertise
Our team comes from varied backgrounds and works closely together to cross-fertilise expertise for any given application. As well as medical device specialists with industry experience, we are made up of surface science experts, metallurgists, ceramics & polymer experts, mechanical engineers, materials authorities (e.g., on hydroxyapatite), and many other disciplines.
Your product or material could benefit from the many services we offer, including:
- Biocompatibility - ensure your products are biocompatible and avoid unnecessary in vivo testing
- Quality Control Testing - ensure batch consistency through existing or Lucideon-developed protocols
- Powder Processing Consultancy - troubleshoot and optimise processes to create better yields, stability and overall performance including milling, foaming, and rheology
- Regulatory Submission Support - generate accurate and complete data to submit to FDA and other authorities
- Cleanliness Validation - develop protocols, validate cleanliness, identify contaminants, and understand the significance of changes to your manufacturing process
- Wear and Mechanical Testing - test the durability and robustness of orthopaedic implants and other medical devices
- Failure Analysis - find root causes, solve failures, and prevent re-occurrence
- Method Development - we can develop and validate customised methods for all your testing and analysis requirements where industry standards aren’t available
- Additive Manufacturing Support - understand the limitations of your new process and its impact on your product performance, including achieving cleanliness and understanding failure modes
Lucideon experts sit on several standard development committees including BS and ISO.
Materials development & technology innovation
Lucideon has a range of in-house-developed technologies that could have applications for you. We work with industry partners to develop our technologies into game-changing products for the market.
- Controlled Release Technologies – novel delivery platforms based on glass and ceramic materials to release actives and nutrients in a highly selective and targeted manner
- Bioactive Materials – inorganic ion doping of glasses and ceramics to achieve improved or additional biological responses e.g., antimicrobial
- Toughened Ceramics – a world-first low-energy ceramic processing technology that allows you to control and tailor the microstructure of your ceramics
- Microbead alternatives - Lucideon's microbead alternative technology offers a cost effective and environmentally friendly solution to your microbeads challenge. Our range of materials are free from plastics, entirely biodegradable and adaptable to consumer needs
White Papers
This process involves ensuring cleaning procedures used to clean medical devices and instruments are effective at removing contaminants and microbes
The goal of this white paper is to demonstrate the risk of working with the wrong material, to highlight the upside when the right material is selected
This white paper highlights some of the testing involved in ISO 13356 and discusses how recent and ongoing research into ceramic processing provides opportunities to meet product improvement challenges
Wear simulation for implantable knee, hip and intervertebral spinal disc prostheses have all been well documented and standardised tests methods have been created to assess the performance of these medical device implants
In this white paper we review the key tribology & testing techniques available for orthopaedic implants
In this white paper we look at why the testing of implants is so important. Traditional test methods and their limitations are detailed and adverse event testing is discussed
Case Studies
Characterisation of the surface chemical composition of medical implants
Lucideon has worked with Greatbatch Medical to help them gain FDA approval
Testing and analysis provided by Lucideon
Surface contamination investigation carried out by Lucideon
Lucideon's additive manufacturing expertise helped identify root cause of product failure
We helped our client with discolouration issues after hot isostatic pressing