Arjun Luthra, commercial director, BioInteractions, explains the importance of coatings in driving surface treatment innovations.
BioInteractions
The importance of using coatings for the prevention and protection of medical devices against infections is growing as the number of healthcare-associated infections (HCAI’s) rises. While researchers have been able to pinpoint some causes of hospital-acquired infections, there is still a need to protect complex surfaces including implants from device-related infections as well as surgical equipment and other invasive instruments to be protected from germs and microbes. The protection of all surfaces in healthcare is critical to evolving the infection prevention infrastructure for patients, professionals as well as visitors. The specific need for medical device coatings is almost universal, with increasing demand for implantable devices to be included within the evolving infection prevention infrastructure. Medical implants protected with a non-leaching antimicrobial coating reduces the risk of device related infections to patients, improves the longevity of the implanted device in turn improving the well-being for patients.
New developments are now bringing to light state-of-the-art antimicrobial coatings, such as TridAnt, which offers a new way to combat infections more effectively, efficiently and for longer periods of time. These coatings are proven to provide monoclonal protection, which kills a broad spectrum of gram-positive and gram-negative bacteria as well as enveloped and non-enveloped viruses, including E.Coli, MRSA, Influenza, Norovirus and SARS-Cov-2. TridAnt, for example, is being utilised for enhanced skin protection as well as to prevent pathogens on most surfaces including woven and non-woven fabrics, hard materials such as metals (stainless steel and nitinol) and polymers (polyamides, polycarbonates and polyurethanes).
The new antimicrobial technology is non-leaching and therefore completely safe to use in all environments and even for class 3 implants which are implanted inside chronic areas of the human body. Its active components target microbes (prokaryotic cells) and have reduced risk to human cells unlike other technologies. The coating is able to kill enveloped and non-enveloped viruses and gram-positive as well as gram-negative bacteria which prevents the formation of biofilms for long-periods of time of up to 365 days (as well as safe enough to protect skin for up to 48 hours) without any noticeable reduction in efficacy. As a result, antimicrobial-coated medical devices are protected consistently with a highly effective and safe, non-leaching shield for the entire lifetime of the device.
What do 2024 medical device innovations and trends look like?
There have been many impressive products released over the last few years in the areas of surgically implanted devices and many of them must remain in contact with blood. This has prompted developers to introduce biocompatible coatings that can meet not only the clinical but also the engineering requirements for these devices. Devices such as total artificial hearts (TAHs), ventricular assist devices (VADs), vascular grafts, and prosthetic mechanical heart valves are examples of technologies used to assist vital organs in functioning normally. However, they share a common constraint: hemocompatibility.
Surface modification is one way of providing blood compatibility. BioInteractions have developed Astute, which is an antithrombogenic coating which has been used successfully on chronic implants and on blood-contacting medical devices for over 25 years. Astute is a non-leaching coating that uses an active antithrombogenic component combined with additional passive components to mimic the natural endothelial layer. The active component gives the coating the ability to interrupt the blood cascade mechanism, preventing platelets from activating and hinders thrombus formation. The additional passive components prevent blood components from depositing on to the device surface. This multi-faceted approach provides superior hemocompatibility to the surface without any reduction in performance over long periods of implantation.
In addition, the burgeoning development of miniaturised and minimally invasive procedures includes a variety of challenges like reducing the amount of tissue trauma by way of smaller incisions, and that leads to a potential reduction in infection risk, less pain, and more comfort during recovery. Also, this improves movement in joint locations without the risk of wear and tear. Addressing the dynamically increasing needs for smaller medical devices demands several key qualities from the components used to produce them. For example, size must be reduced without compromising quality and application-specific features that improve the functionality must be reliable.
At BioInteractions, we have sought to meet this challenge by developing a Hydrophilic Coating called Assist, which is lubricious and flexible resulting in reduced friction, and has no particulate formation and delamination in high-stress and high-movement applications such as joints. Assist uses a two-factor approach to reduce friction at the device-body interface for long periods of time, hindering occlusion of the device and allows the device to remain in position for extensive use. This significantly reduces tissue damage and improves comfort when delivering or removing devices from the patient, improving the functionality and safety of therapeutics. Assist is instantly activated through wetting, eliminating the need for pre-soaking the surface. This not only saves preparation time but also allows increased usage of the device. At BioInteractions, we can achieve high-performance without utilising cytotoxic and toxic components.
What are the most common challenges customers are facing today?
Universally, medical product developers and manufacturers navigate a highly regulated and particularly constrained environment. Under today’s European Union (EU) regulations, medical devices are considered medicines and are therefore tested by the European Medicines Agency (EMA) following the same tests and approval processes that drugs do. Our Product Pathway Partnership team closely work with customers to navigate all areas including optimisation of the application process, fixture design and tooling, biocompatibility testing, regulatory compliance and providing services as an organisation’s commercial manufacturing partner. We provide guidance along a strategic pathway with a focus on offering a flexible approach to meeting all of the ever-revolving regulatory demands on a wide variety of devices with varying geometries and substrates. The aim of our Product Pathway Partnership is to enable customers to get to market in the most efficient way possible.
Alongside the expanded Product Pathway Partnership, our integrated service streamlines the research and development of new innovative coating materials using its 30 years of expertise and a range of novel analytical resources to determine the optimal coating for your device. BioInteractions’ 30 years of experience and broad range of products allows us to create bespoke coatings for a wide range of applications building on the innovative solutions provided today. This unique aspect of the service draws on our expertise and knowledge in applying innovative solutions to a wide variety of devices and enables us to provide revolutionary and state-of-the-art solutions for our partners.