21 minute read
Cover story
from MPN EU Issue 53
by MPN Magazine
ARJUN LUTHRA, COMMERCIAL DIRECTOR, BIOINTERACTIONS, EXPLAINS HOW THE COMPANY IS INNOVATING POLYMER COATINGS TO IMPROVE MEDICAL DEVICES.
COMPLICATIONS OF BIOMATERIAL RESPONSE Innovations in the field of medicine and surgery are in constant demand for new and improved materials to enhance the quality of the therapy. Biomaterials play a critical role in improving the biocompatibility of surfaces which improves the quality of the therapy. Biocompatibility of materials involves critical complications such as inflammation, fibrosis, infection and thrombosis. The successes of applications are dependent on a variety of biological events occurring on the surfaces and these events intensify the complications which have to be addressed during innovation. The challenges of infection and thrombosis are two significant factors which hinder long-term applications, as these biological events are potentially linked to each other and are critical to improving the performance of biomaterials. Biological responses are complex processes which are governed by a variety of factors. These factors range from surface properties which include the chemistry, topography, wettability and composition of a surface to the biological entities present at the interface.
Materials used in medical devices are likely to interact with blood first, and this interaction is in itself highly complex. The contact of biomaterials and blood induce protein adsorption, platelet activation, platelet adhesion, coagulation and thrombosis. Plasma proteins adsorb onto the surface initially which leads to activation of the blood and subsequently causes additional biological responses. These responses lead to complications which impede the performance of medical devices, reduce the efficacy of therapies and can cause harm to patients. Catheter thrombosis can be seen in the form of venous thrombosis or the formation of fibrin sheath which accounts for up to 40% of catheter failures. These challenges interrupt strict dialysis schedules, reduce the flow rates of catheters and can result in the use of costly measures. The reduction of flow rates has been a consistent complaint when delivering blood for dialysis. Central venous stenosis can be a devastating complication resulting in pain and disfiguring arm swelling and treatments can be used to temporarily relieve the issues; however viable surgical options are still required.
Infection is likely to be the most significant challenge which impedes long-term applications. A variety of preventative techniques have proven not to be significantly effective. It has been seen in a randomised study of surface treatments to prevent infections that silver surface treatments have failed to reduce infection rates. It has also been seen that the use of silver-impregnated collagen cuffs may impede catheter fixation due to the killing of fibroblasts which can cause the catheter to dislodge. Furthermore, it has been recommended that any catheter which has caused bacteraemia should be immediately removed and only replaced once results of blood cultures are normalised. Although, there has been progress with this therapy as newly emerging strategies to treat these complications allow for medical treatment whilst the device remains in place. This approach has had limited success, requiring the use of antibiotics, and is still seen as a sceptical approach by many nephrologists.
The interactions mentioned above are only a few of the many complications seen when biomaterials are used within the human body e.g. thrombosis, infection, reduced efficacy of the intended use of the device and insertionrelated complications. The complications and the biological responses are influenced by critical factors such as surface chemistry, surface energy and surface topography. Hence, the biological events which occur on a surface are complex and are a result of interactions between the surface, the proteins and cells which are present at the device-body interface
MULTI-FACETED SOLUTIONS REDUCE CHALLENGES The complications experienced by biomaterials requires a multi-faceted approach which considers all the factors in order to provide an ideal surface which prevents the biological responses.
BioInteractions innovates high-performance biocompatible coating technologies such as Astute Antithrombogenic Coating, AvertPlus Antimicrobial Coating and Assist Lubricious Coating. Through our commitment of advancing healthcare through innovation, we have a range of proprietary polymer coatings to target the specific complications of biocompatibility. Our coatings enable medical devices to perform their intended function, as well as reduce the patients’ complications throughout their therapy.
Astute Antithrombogenic Coating prevents thrombosis formation using a multi-layered approach. We have developed the coating to use an active antithrombogenic agent heparin and combined this with additional passive components to provide a high-performance, non-leaching
antithrombogenic coating. Active functionalised heparin actively prevents blood activation and hinders thrombosis. The prevention of blood activation reduces the risks of a thrombus forming downstream. The additional passive components physically prevent blood
components from interacting with the surface to provide an additional level of protection.
This multi-faceted approach mimics
the endothelial layer to give an active antithrombogenic coating. The Astute antithrombogenic coating also
prevents platelet adhesion without leaching to enhance the long-term
effect. Our Astute antithrombogenic coating provides high-performance of biocompatibility whilst reducing risks and complications to the patient.
AvertPlus is a non-leaching, active antimicrobial coating, which targets a comprehensive spectrum of bacteria and prevents biofilm formation. It uses a combination of active agents and passive components to provide a contact-kill mechanism which causes cell lysis and prevents bacterial colonisation. The multi-faceted approach significantly reduces the bacterial presence and stops proteins from depositing onto the service. Our non-leaching AvertPlus coating provides a prolonged antimicrobial effect without any degradation of effect over time.
Our coating provides high-performance antimicrobial activity on a surface and has achieved a five-log reduction activity, without the use of leaching toxic compounds or anti-biotics. Our AvertPlus coating reduces the risk of device related infections without introducing the risks of toxic components to the patient.
Assist Hydrophilic Coating reduces the friction coefficient of a surface, as well as provides complementary non-thrombogenic effects. The technology is available in both UltraViolet (UV) cured and heat cured forms. This enables us to apply our technology to a variety of surfaces and geometries. The coating is thin and flexible, which enhances the coating’s stability on a device such as balloon catheters. The coating reduces friction resistance as well as preventing proteins and cells interacting with the surface to improve
biocompatibility. The complementary non-thrombogenic properties provides support to the surface, enabling the coated device to remain implanted and perform for extended periods.
We can achieve a high-performance lubricious coating without leaching or the use of cytotoxic and toxic components. The technology is also available in both UV and heat-cured variants, which allows us to coat a variety of devices internally and externally to improve function. The coating activates instantly through wetting, removing the need to presoak the surface and reduces the preparation time. Our expertise in coating a variety of substrates and geometries allows application of the coating technology in a range of areas. Assist Hydrophilic Coating significantly reduces the friction, and instantly activates and provides complementary benefits to improve its biocompatibility.
BioInteractions innovates all its coating technologies in-house, provides optimised application processes, coating services and in-house testing services. We have combined our expertise to help our partners through the development process, and our complete coating service focuses on the main biocompatible challenges faced by the devices and the development process, resulting in the organisation providing an all-inclusive coating service.
CHAIN REACTION DEEPAK PRAKASH, SENIOR DIRECTOR, GLOBAL MARKETING, AT AVERY DENNISON MEDICAL, DESCRIBES THE PATH TO PROGRESS IN HEALTHCARE INDUSTRY SUSTAINABILITY.
Environmental sustainability is one of the most important priorities for the healthcare industry and for medical plastics and device manufacturers. The challenge ahead demands that supply chain partners focus on sustainability within their own organisations and across their extended supply chains.
Healthcare sustainability initiatives are gaining momentum. The Healthcare Plastics Recycling Council’s (HPRC) membership has grown to include some of the industry’s largest device makers. Health Care Without Harm is working globally to promote sustainable procurement practices, green hospitals and healthcare waste reduction. Through its “For a greener NHS” campaign, the U.K. National Health Service is tackling climate change on multiple fronts, from reducing hospital emissions to investing in telemedicine.
The medical plastics industry has opportunities to advance sustainability from design inception through product end-of-life for both disposable and durable devices and equipment.
RECYCLING MEDICAL PLASTICS The HPRC said in a recent interview that each year Europe generates about 1 million tonnes of non-infected medical plastic waste which could be recycled. The council offers a HospiCycle toolkit to help healthcare institutions set up programmes to recycle more of this “clean” plastic waste.
There is also growing interest in biobased and recycled films, and in some cases, multi-laminate packaging films which can pose recycling challenges, may be replaced with films that are readily recyclable. ECO-FRIENDLY MANUFACTURING PROCESSES Sustainability advocates often refer to creating circular economies. The Ellen MacArthur Foundation defines a circular economy as one “based on the principles of designing out waste and pollution, keeping products and materials in use, and regenerating natural systems.” This is as opposed to a linear economy, which runs on a “take-make-waste system,” according to the foundation. One example of a circular economic practice is responsible collection, recycling and reuse of chemicals from the medical plastics manufacturing process.
Within their operations, best practices for medical plastics companies and their suppliers include greenhouse gas emission reduction, energy conservation, landfill waste reduction and recycling programmes for all types of scrap and waste. Sustainable raw materials sourcing is also a priority. Medical plastics material suppliers are identifying and testing alternatives to traditional chemicals and inputs. For example, PolyVinyl Chloride (PVC) has been successfully replaced in some medical foams, and materials producers are exploring alternatives to animal-based gelatine.
Additionally, supply chain transparency is essential. Customers expect suppliers to have visibility and accountability for processes they directly control and those they do not.
HUMAN RIGHTS, DIVERSITY AND INCLUSION Another important aspect of medical industry sustainability is the human side. Every organisation should take responsibility for human rights and workplace safety within its own operations and those of its supply chain partners, monitoring sites with regular audits.
Diversity, inclusion, wellness and corporate giving programmes also support sustainability objectives. After all, without a healthy balance within human individuals, teams and organisations, how can we begin to sustain the natural world that supports us?
CONCLUSION In conclusion, the path to sustainability progress requires every link within the supply chain to be engaged and accountable. Medical device developers, their customers and suppliers must challenge one another to be more sustainable and collaborate with each other to make it happen.
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It’s an Interplas year
This September the UK’s largest plastics industry exhibition is back; with over 500 exhibitors demonstrating their latest machinery, equipment, products and services for visitors to view, test and experience LIVE at the show.
As a visitor you will be able to see the entire spectrum of plastic moulding and forming machines in action, as well as find materials, automation, contract manufacturing and supporting technologies including software, testing, inspection, surface treatments and much more.
No other UK plastics show in 2020 offers you the chance to meet and source new suppliers, products and services, find solutions to challenges, keep up to date with the latest technology and to network with your peers in a friendly and open environment.
CONFERENCE PROGRAMMES The conference programmes at Interplas have been carefully tailored to deliver insight, knowledge and information on the current challenges facing the UK plastics industry from a range of expert speakers. Visiting Interplas will give you the opportunity to ask questions, engage in panel discussions and meet new contacts on all three stages, which include the Advancing UK Plastics Main Stage, The Extrusion Stage and The Sustainability Stage.
SPECIALIST FEATURES Specialist features add value to a visit to Interplas - with key areas and events that enable attendees to understand the issues they face, as well as finding solutions for them. Key features in 2020 include the return of Knowledge Pavilion, where a bank of highly experienced industry personnel will be on hand to answer questions and resolve queries, as well as a dedicated one-on-one meetings programme linking you directly to the right suppliers for your business needs.
NEC BIRMINGHAM, UK | 29 SEPT - 01 OCT 2020
www.interplasuk.com Register now
WITH LIMITED TIME LEFT BEFORE EU MEDICAL DEVICE REGULATIONS (MDR) COME INTO FORCE, NIGEL FLOWERS, MANAGING DIRECTOR AT INJECTION MOULDING MACHINERY SUPPLIER, SUMITOMO (SHI) DEMAG UK, ANSWERS SOME COMMON QUESTIONS TO HELP PUT MINDS AT REST.
WHAT TECHNOLOGY DOES A MOULDER NEED? In mould decorating is an automated way to issue mass-produced medical devices with globally-compliant UDIs. It is like issuing each moulded medical device component with its unique birth certificate, with all processing data held securely by a Manufacturing Executive System (MES). It means that any potential quality defect, which might not be picked up for several months, or even years, can be tracked back to the very day and cycle it was manufactured to achieve item-level traceability and conduct root cause analyses on parts and components. Connectivity to a MES is vital. IS REAL-TIME TRACEABILITY IMPORTANT? Yes, having an auditable supply chain traceability system is not purely about compliance and providing mandatory information. Due to globalised production platforms, it’s becoming increasingly imperative to limit operational risk exposures with targeted rather than mass recalls. For high value components or when the margin for error is zero and patient safety could be at risk, real-time traceability provides the means to limit recall exposure by improving end-toend process transparency. Real-time traceability also enables you to call up data and verify the exact settings used on the exact injection moulding machine, when that individual plastic part was made. This can enhance process monitoring and enables moulders to keep a closer watch on risk management, mitigation and containment. A last minute checklist EU MDR E U MDR is due to go live on 26th May 2020, and many medical device moulders, particularly Small and Medium Enterprises (SMEs) with limited in-house resources, are still getting to grips with the impact of the EU MDR. Designed to make products more easily traceable by patients and the care supply chain, many perceive the labelling upgrade investment to be a challenging and costly undertaking. The regulations apply to all medical device products sold in the EU, even if it is made outside of the EU, and failure to comply could result in products removed from sale after the EU MDR deadline. WHAT IS NEEDED TO ACHIEVE TRACEABILITY? With EU MDR, every class III (e.g. implants and pacemakers) and class IIa/b devices (e.g. surgical clamps and trachotomy tubes) or its packaging must be issued with a Unique Device Identification (UDI). Given that healthcare is a high liability market, it requires a fingerprint style approach to traceability. A UDI label must be directly attached to a medical device or to its packaging. Additionally, labels in the future will need to include two identifiers: A Device Identifier (DI) that identifies the labeller and the specific version or model of a device, plus a production identifier. This variable portion of the UDI needs to include the given lot or batch number, serial number, date of manufacture, expiry date, etc.
EU MDR is due to go live on 26th May.
18 The EU MDR replaces the current Medical Device Directive (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/ EEC). Effective 26th May 2020, class III (e.g. implants and pacemakers) and class IIa/b devices (e.g. surgical clamps and tracheotomy tubes) will need to record, index and register each UDI on the European Database for Medical Devices (EUDAMED). Manufacturers of lower risk class I products, for example stethoscopes, will also be
required to collect and save
product data and share with regulators on request.
Traceability in injection moulding is often quite advanced with smart data capture integrated into the machine.
DO I NEED TO MAKE MODIFICATIONS TO MY EXISTING MACHINERY? It will depend upon the age of your machinery, but the latest generations of injection moulding machines are often quite advanced with smart data capture integrated. UK customers will also be able to benefit soon from the digital MyConnect software, which can monitor machine availability, productivity, traceability and processing decisions taken. A launchpad for data-driven efficiency improvements, as well as troubleshooting tools, traceability features like myLifeCycleLog stores a full archive of past service requests and actions taken.
ARE THERE SPECIFIC USER PARAMETERS I NEED TO IMPLEMENT? The key areas that might impact a stable process include changes in pressure, temperature, flow rate and cooling rates. To ensure these processes are not compromised, the latest generation medical packages we offer limit the processing ranges that operatives can adjust. For example, the IntElect S 180- tonne machine unveiled at K 2019 adheres to the explicit ISO 13485 medical device quality management and validation standards and introduces new user parameters. This helps to ensure that processes are kept within specified ranges and operators cannot make adjustments unless they have been granted authorisation.
HOW DOES AUTOMATION FACILITATE TRACEABILITY? Using robotics is central to the in-line manufacturing process, as even a single instance of applying an incorrect code can be a major liability. Modern medical cells typically integrate all of the elements needed in a turnkey cleanroom cell, including plastic injection processing, in mould decoration, robotics and data capture and management. The automation solution deployed will vary depending on the moulding application. For larger medical components it might be a 6-axis robot, which holds the part while codes are etched or bonded onto the component. These are generated by the MES holding system, which reconciles the machine processing data and generates a code or data matrix. In addition to the exact production date and time, process data that’s recorded includes the injection and dosing time, melt cushion, injection pressure and temperature.
For smaller micro-medical parts, such as pipettes, a side entry robot may be used. At K 2019, Sumitomo (SHI) Demag’s medical showcase featured a complete turnkey medical moulding cell with a Hekuma side entry robot with advanced batch tracking and contact-free camera inspection.
Programmed to demould and rapidly place components individually in their corresponding cavity assigned racks, the Hekutip process ensures that if an issue with a specific cavity arises, the rack containing all corresponding cavity parts can be isolated and the rack recalled. This gripper system concept is capable of removing 64 pipettes in less than 0.6 seconds. After each rack is filled with 96 pipettes, a camera visually inspects the components from multiple angles ensuring there are no holes or burrs present.
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For 30 years, Microspec has specialized in advanced medical extrusion services world wide, extruding most thermoplastic elastomers, including fluoropolymers, engineering resins, and custom compounds. 1989–2019
The precision medical parts we extrude are among the smallest and most complex in the industry, with some of the tightest tolerances.
Contact Microspec with your extrusion challenge – we’ll turn it into reality.
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Microspec Corporation 327 JaffreyRd. • Peterborough, NH 03458 USA • +1.603.924.4300 www.microspecorporation.com info@microspecorporation.com
The REVOLUTION
WEB CONTENT EDITOR, IAN BOLLAND, CAUGHT UP WITH NATALI TSHUVA, CO-FOUNDER AND CEO OF STERNUM, AN ISRAELI-BASED COMPANY WHICH OFFERS CYBERSECURITY PROTECTIONS FOR MEDICAL DEVICES.
Tshuva explained Sternum aims to provide its solutions to device manufacturers so they can embed security on the device itself during the manufacturing process. This embedding of protection means that the company focuses on exploitation rather than device vulnerabilities.
Explaining more about the company’s focus, Tshuva said: “Our main focus is IoT, high value devices which are part of a managed network. A good example for that is homecare medical devices like pacemakers and insulin pumps which don’t have security as part of their hospital network because the patient goes home with them. This is a good example of where Sternum’s technology can be embedded inside the device itself to keep it safe during the lead time, institution and operation of the device.
“Every operation on the device itself is being filtered and monitored by our technology. You can describe it as ‘on-device firewall’ because it’s basically checking and monitoring every operation and allowing all the legitimate operations to happen on the device.
“Our solution is integrated at the research and development stage. Once installed, the device manufacturer has the ability to build new firmware, with our protection already embedded. Once this protected firmware is created, all devices – including postmarket devices – can receive relevant updates with the enhanced firmware. “This process is automatic so when new code and functionality is added, it will also be protected by our EIV solution. Our solution works with pre-market and post-market devices, and fits all existing operating systems, hardware, and resources. The same code is implemented to all devices within a managed, or unmanaged network.”
The company contains personnel from a background of cybersecurity, defence and understanding how attackers work – with some receiving training from an Israeli intelligence unit – but with a shared desire of having an effect on the medical industry in some form.
“When we started studying medical devices and the medical industry in general, we discovered this need to secure this connected healthcare. This is what drew us to find the company.”
While cyberattacks on medical devices are becoming more prominent, Tshuva believes there is an increased effort from manufacturers to guard against such threats – and feels that a rise in cyberattacks is a knock-on effect of devices becoming more connected –comparing it to a time when the internet started to become more mainstream where similar issues developed.
“In order to deal with such scale of events and more sophisticated attacks, medical device manufacturers need some advanced solutions – probably not developed in-house to handle this advanced security threat on devices.
“The connected healthcare revolution is happening and we’re seeing more medical devices being connected to enable remote care and remote monitoring of patients. Once devices get connected, they automatically become more vulnerable and more attractive to hackers – whether it’s for stealing sensitive information or to perform ransomware attacks on manufacturers or hospitals.
“There are devices that are under or within the hospital perimeter and there we can see fusion pumps and MRI machines and ECG machines – some of them are IoT devices and they’re vulnerable at the same level as remote medical devices like pacemakers and insulin pumps.
“The difference is that hospitals have their own defence mechanisms like a firewall or other security solutions to secure the hospital network itself. When we talk about distributed medical devices like pacemakers and insulin pumps, they are both vulnerable and lack the network security solution to help secure them. I think that you can think of them as the more vulnerable devices.”
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