The Medical Devices Sector is a dynamic and crucial component to the global healthcare industry. Its origins date back to the rudimentary medical instruments used in ancient times. Significant advancements in the 19th and 20th centuries gave us innovations such as the X-ray machine, pacemaker, and insulin pump, just to name a few, that have revolutionised medical treatment. The sector rapidly continues its advancement, with breakthroughs in materials science and technology paving the way for more sophisticated and precise devices. The industry is not without its challenges, such as stringent regulatory requirements, including approval processes, testing and documentation, which extend development times. Ensuring safety and reliability is also paramount, and high-performance materials are essential to meeting these requirements. Outbreaks of new and evolving viruses, pathogens and diseases require rapid development and deployment of diagnostic and therapeutic devices to help combat these emergencies. The Medical Device Sector is in a transformative phase, driven advances in materials science, miniaturisation, integration of smart technologies and enabled by biocompatible materials and nanomaterials. Goodfellow, a trusted global supplier of high-quality advanced materials and expert technical services have already partnered with this industry to provide solutions and develop medical devices.
Medical devices are covered by one of the most complex and stringent regulatory environments to ensure patient safety. Many materials used in the context of medical devices will require additional testing not just for their own toxicity but also as a result of the potential existence of any extractable and leachable chemicals in the solvents.
EN ISO 10993-12:2021-08 governs the testing requirements around the testing of extractables and leachables in medical devices and also outlines the various categories in which medical devices can be used. Devices that will be implanted under the skin for long periods of time must undergo more stringent tests than medical devices that will be in minimal contact with the patient and used for short periods.
When it comes to choosing materials for medical devices and healthcare applications, both their chemical and physical stability and biocompatibility must be considered. Biocompatibility is why many inert and chemically unreactive metals, such as titanium and platinum, are popular choices for medical devices. In chemical terms, the human body can be quite an aggressive environment for medical devices with the non-neutral pH of blood. Therefore, large numbers of chemical species and inert materials are required to prevent any unwanted reactions between the medical device and its surrounding environment.
Polymers for biomaterials are becoming increasingly common as these offer an abundance of possibilities in terms of manufacturing complex shapes and structures that can mimic natural structures in the body. Polymer compositions can also be modified to achieve the right material properties, whether that is tensile strength or flexibility. Some polymers are deliberately designed to be biodegradable; thus, once the treatment is complete, the polymer simply dissolves, meaning an additional procedure to remove materials is unnecessary.
Other materials, like silver, are also used in medical settings and medical devices as a result of their treatment properties. Silver is a proven antimicrobial agent and can be integrated into devices or wound dressings to help prevent infection and promote healing.
Medical devices also require high quality material components, such as sensing wires that have good conductance and are resistant to degradation with time. More often than not, platinum and iridium are the wires of choice for applications involving medical devices.
Goodfellow Materials for Medical Devices
Goodfellow is a specialist in the global sourcing, testing and development of materials for a range of different sectors, including medical devices. Goodfellow's market-leading position as a supplier of small to mid-volume materials has led to a wide portfolio of over 150,000 materials, including a combination of biocompatible polymers and high quality metals.
Goodfellow works with the customer to not only identify and supply the right material for the medical device but also to ensure that the material meets the right quality control standards. For medical devices, where such quality control standards are absolutely crucial for legislative compliance and correct device functioning, Goodfellow can help ease the process of getting new medical devices to market and getting the right performance.
During the COVID-19 pandemic, Goodfellow partnered with Hummingbird Sensing Technology to supply high-quality platinum and iridium wires for gas sensors that were to be integrated into medical devices. Goodfellow supported the manufacturing teams by providing technical advice on the annealing and uses of the alloy wires in the final medical devices. Using their expertise in supplies and logistics, Goodfellow was able to provide the materials needed in a timely fashion to rapidly scale up medical device production at a critical period for public health.
Materials Range suitable for Medical Devices
Biohastalex® is just one of the carbon-based nanocomposite materials that Goodfellow supplies for medical purposes and medical devices. The material is a graphene composite that can be produced as thin films in a number of thicknesses and sheet sizes. Biohastalex® is an incredibly strong and flexible product, and there is hope that it could offer a replacement for many plastic-based materials and provide a mesh-like material that is biodegradable.
The applications of Biohastalex® include surgical meshes and, more widely, are a replacement for materials like GORE-TEX as it is extremely light and flexible. It is also possible to modify the graphene so that it can be used to attract or repel water and its manufacturing scalability makes it a promising alternative to other polymer materials in medical devices and other applications.
Goodfellow now has an exclusive contract for the re-selling of Biohastalex® materials and is also now working with NanoRegMed to help develop a new range of functionalised graphene oxide composites that can be used for medical devices, tissue engineering, 3D scaffolds, nerve generation and patches. The National Physics Laboratory in the UK has recognised the high purity of the products offered by Goodfellow in comparison to other products on the market.
Goodfellow offer over 1000 different polymer options in a variety of different formats, from rods to sheets, depending on the application or what is suitable for the intended medical device. Where the right choice of polymer is not obvious, Goodfellow can support you with technical advice on finding the right material for the target medical device or application.
For medical sensors, Goodfellow has an extensive range of ultrafine wires available in a variety of materials, including gold, titanium and niobium. It is possible to achieve diameters of less than 1 micron, and Goodfellow can also create custom alloys where required. Chemical resistance is often a particular consideration for medical applications as well as avoiding oxidation and similar processes that may lead to issues with the sensor no longer providing accurate readings.
Contact Goodfellow today to find out how its support could help reduce your device-to-market time for medical device development or support in upscaling your manufacture with a reliable and trustworthy source of materials on demand.