Gemma Budd, business manager of healthcare at Lucideon, explains why understanding materials is essential for all medical device manufacturers and how the company is blazing a trail in developing new materials technology for the future.
Materials lie at the heart of every product and process; understanding how they perform, how they interact with each other and the body, how to optimise them and how they can cause failure is critical for medical device manufacturers. Introducing new materials, coatings, products or even processes is a lengthy and costly business, and with the obligatory hoops of regulatory approval to jump through, understanding the fundamentals of materials helps to expedite introduction and successful realisation.
Lucideon helps manufacturers and suppliers to understand materials using techniques ranging from chemical and physical to mechanical, microstructural and surface analysis, combined with its in-depth, cross-industry knowledge of metals, ceramics, polymers and coatings.
Demonstrating compliance is critical when seeking approval from regulatory authorities. Take the example of synthetic hydroxyapatite (HA), a bone substitute material often used to coat metallic medical devices thanks to its ability to stimulate bone growth: identifying and proving compliance of its mineralogy, chemistry, crystallinity, particle size, solubility, dissolution rate and bioactivity through a comprehensive testing package is an integral part of a successful submission - and Lucideon knows exactly what is required.
One of the techniques used to provide this evidence could be X-ray diffraction, which allows the microstructure of materials to be understood. This technique has also been used to support developments to improve the bioactivity of biomaterials by modifying their crystal chemistry and structure.
As well as understanding your materials it is also vital to understand any materials that may have been introduced into or onto your device during processing, such as during cleaning.
Maintaining a robust and audited cleaning process is necessary not only to avoid failure, but also to ensure that any protocol submitted to regulatory authorities is not compromised. Techniques such as X-ray photoelectron spectroscopy, which can analyse the upper 1-10nm of a device surface for its elemental composition, can be used to check if any elements have been left on the surface after cleaning.
Organic or particulate materials left on a device can also be identified by extracting residual materials using a solvent and then analysing that extract using ion chromatography/inductively coupled plasma for trace elements, gas chromatography/mass spectrometry for organic compounds, and scanning electron microscopy for particle identification and imaging.
Understanding how materials and devices interact with each other and the body is key to ensuring biocompatibility and avoiding failure in vivo. Moving parts, such as hip and knee joints, for example, must be evaluated in terms of friction, wear and lubrication using physiologically relevant simulators.
Mechanical testing, including wear and fatigue testing, provides evidence regarding the integrity and performance of the implant, whereas surface analysis can provide information around wear patterns. This topographical characterisation can be determined from full-scale 3D images generated using the technique of white light interferometry.
Lucideon's platform technology includes: multi-element-substituted hydroxyapatite (mxHA) to enhance bioactivity; low-energy ceramic firing to create materials with improved properties through tight control of the microstructure and at a reduced cost; and inorganic controlled release technology (iCRT), a technique that uses bioactive glasses and bioceramics as carriers for actives or ions over a controlled period. Current work includes applying iCRT for use as a drug delivery mechanism to improve the delivery of poorly soluble drugs. This technology can be used with delivery devices, such as bioresorbable stents, to add antimicrobial properties or stimulate tissue regeneration.
It is an exciting time for materials development, and those manufacturers that commit resources to understanding and developing their materials are sure to be at the forefront of game-changing devices and technology - with Lucideon as their development partner.