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AsEditor’s Comment
OLIVIA FRIETT
we continue to see advancements in medtech, it’s hard not to feel a mix of excitement and apprehension.
The rapid pace of innovation brings with it challenges, particularly when it comes to ensuring that new products are safe, effective, and accessible to the patients who need them. This is where medical regulations play a crucial role - a framework designed to balance the drive for innovation with the importance of patient safety.
The complexities of regulatory frameworks such as the EU Medical Device Regulation (EU MDR), the UK Conformity Assessment (UKCA), and the guidelines set forth by the U.S. Food and Drug Administration (FDA) are shaping the future of our sector.
In the UK, the MHRA (Medicines and Healthcare products Regulatory Agency) is at the forefront of overseeing the safety and efficacy of medical products. Following Brexit, the UK introduced the UKCA mark, which ensures that products meet UK regulations. While the transition to the UKCA mark is intended to simplify the regulatory process, many manufacturers are still navigating the complexities of aligning their products with these new standards.
deadline. Moreover, regulatory uncertainty and the COVID-19 pandemic have further complicated the certification landscape.
Many medical devices remain unable to obtain CE marking, restricting their access to the EU market and impacting manufacturers’ revenues and growth potential. Additionally, the increasing costs associated with this can cause strains, especially on smaller companies.
Given these complexities, collaboration among regulatory bodies, manufacturers, and industry stakeholders is essential. By fostering open communication and sharing best practices, we can work towards a more streamlined regulatory environment that promotes innovation while ensuring patient safety.
As we move forward, it is important for all stakeholders to remain engaged and informed. The future of medical regulations will significantly impact the development and availability of technologies that enhance patient care.
Medical Plastics News is published by: Rapid Medtech Ltd, No. 3 Office Village, Chester Business Park, Chester, CH4 9QP, UK
While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved. Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited.
In the United States, the FDA operates under a different framework, focusing on the safety and effectiveness of medical devices and pharmaceuticals. The FDA has implemented various pathways, such as the 510(k) process for devices that are substantially equivalent to existing ones and the De Novo classification for novel devices. While these pathways provide opportunities for manufacturers, the process can still be lengthy and complex.
The EU MDR, which took effect on 26th May 2021, aimed to enhance the safety and performance of medical devices across Europe. However, the transition from the previous Medical Devices Directive (MDD) has been affected by significant delays. These delays stem from several factors, including the complexities of the new regulations, the limited capacity of notified bodies, and the increased demand for certification as manufacturers rush to comply before the
The intersection of medtech and regulation is particularly fascinating as we embrace innovations like artificial intelligence (AI). Such advancements hold potential but also challenge existing regulatory frameworks.
The future of medical regulations is undoubtedly dynamic. Emerging technologies will continue to challenge existing frameworks, pushing regulators to adapt in real time. As professionals in the medical technology space, we must remain engaged and advocate for regulations that protect patients while nurturing innovation.
Regulators, manufacturers, and healthcare providers must work together to navigate the complexities of medical regulations. By fostering open dialogue and sharing insights, we can ensure that new medical products meet the highest safety standards while addressing the pressing needs of patients.
The future of medical innovation depends on all of us—let’s embrace the challenge together. Let us collectively advocate for solutions that benefit our industry and, most importantly, the patients we serve.
DIGITAL spy
ADHESIVES NEWS
https://www.hardiepolymers.com/
Founded in 1924 as J&G Hardie, Hardie Polymers, the Glasgowbased polymer supplier, celebrates its 100th anniversary.
During the 1960s and 70s, Cycolac ABS was one of the earliest engineering plastics available.
By the 90s, the business had evolved to be a major distributor of injection moulding machines (the equipment used to shape liquid plastic resin into manufactured plastic products).
The engineering polymers that Hardie supplies are essential for the manufacturing of indispensable products in a wide range of industries –enabling lighter, less carbon-intensive, and more sustainable products.
In 2021, Isy Ferguson, managing director, and Bartosz Komanski, commercial director, completed a management buyout, that was backed by the team at Nevis Capital LLP.
Adhesives
specialist LOCTITE is holding a Medical and Wellness Symposium at its R&D Centre of Excellence in Dublin, recently awarded ‘My Green Lab Green Certification.’
The Symposium – being held on Thursday 24th October at brand owner Henkel’s facility in Tallaght – is open to anybody involved in the manufacture of medical or wellness devices. The open day will address many of the common challenges facing the sector in terms of design, production, sustainability and regulations.
LOCTITE has been involved in the medical device sector for over four decades and today offers 70 adhesives in five key technologies. Many new solutions are created at its Dublin Centre of Excellence, which became Henkel’s
REGULATORY NEWS
Ferguson said: “With our decades of industry experience, we’ve built many longstanding, collaborative, customer relationships, and we’re proud to have supported so many vital industries throughout the years, and to still be a critical part of the supply chain that brings lifesaving technology to the world.” LOCTITE invites
first site worldwide to receive ‘My Green Lab Green Certification’ status. As well as learning about LOCTITE’s latest innovations to support medical device manufacturers, there will be private surgeries where LOCTITE engineers & chemists can answer visitors’ questions confidentially. Free follow-up line surveys will also be available.
https://nvisionbiomed.com/
Nvision Biomedical Technologies and Invibio Biomaterial Solutions have announced that the FDA has granted clearance of the first 3D-Printed PEEK Interbody System made from PEEKOPTIMA.
The 3D-Printed PEEK Interbody System from Nvision Biomedical Technologies was co-developed with Invibio Biomaterial Solutions. The system consists of Cervical and Anterior Lumbar Interbody Fusion (ALIF) spine devices, each incorporating extensive porous structures that have the potential to promote multi-directional bone ingrowth and improve device fixation, whilst also maintaining PEEK-OPTIMA’s inherent benefits in modulus and imaging.
The use of PEEK-OPTIMA - a material that has already been used in over 15 million implants - offers the benefits of mechanical properties closer to those of bone and also superior imaging capability
than titanium implants, the latter allowing surgeons to more accurately monitor fusion progression. Nvision’s 3D-Printed PEEK Interbody System is a standout in the field of spinal devices as it is the first to combine PEEK-OPTIMA with the design freedom enabled by the Bond3D additive manufacturing technology to print solid and porous areas for bone ingrowth.
Placon, an innovator in the medical packaging market, announced the release of a new stock line of BargerGard TPU pouches and tip protectors.
The new product line includes pouches with and without flaps, and a variety of tip protectors to safeguard rough and sharp medical components, including catheters, needles, screws, drills, and porous coated implants. The product line is made from thermoplastic polyurethane (TPU), a nonabrasive material which protects finished, polished, and other surfaces from
damage, as well as preventing denting or scratching to devices and trays.
“Our new stock BargerGard line is a smart alternative to foam and vinyl protective packaging,
and gives our customers a great resource for stock TPU without long custom lead times,” said Joyce Verstegen, director, medical sales.
The new stock line comes in six sizes, and are die cut, and welded in ISO Class 8 cleanrooms, ensuring the highest levels of cleanliness for sterile barrier requirements. The products are also compatible with ethylene oxide (EtO), gamma, and eBeam sterilisation. TekniPlex Healthcare to debut strong paper for medical packaging at Pack Expo
TekniPlex Healthcare is set to unveil its strongest-ever reinforced paper for medical device packaging applications at Pack Expo 2024, 3-6 th November in Chicago. At its Booth W-14065, the company will debut its HPC74 Series of reinforced medical paper, whose heat-seal coated construction can withstand exceptionally demanding needs for protection, distribution and sterilisation.
The HPC74 Series features the highest puncture and tear strength of all TekniPlex Healthcare reinforced papers to date, as well as outstanding porosity levels. Available in various proprietary coating formulations, the paper provides a clean peel and wide processing windows for rollstock and lidding applications.
A cost-effective breathable sterile barrier material, TekniPlex Healthcare’s HPC74 Series significantly outperforms traditional paper products in tear and seal strength values, while providing exceptional microbial barrier protection. The paper’s consistent coating is applied utilising the company’s advanced air knife coating technologies, and seals effectively to a wide variety of flexible and rigid forming films, including polyvinyl chloride (PVC), polyethylene terephthalate glycol (PETG) and TekniPlex Healthcare’s proprietary copolyester, TekniMD PX. For confidence-instilling seal integrity assurance, upon opening the paper exhibits dense white adhesive transfer to the film surface.
WITTMANN BATTENFELD will present the latest solutions for time and cost optimisation in the production of parts with nano structures at Compamed, booth No. F03-1 in hall 8b.
As an international medtech trade fair, Compamed is a suitable platform for WITTMANN BATTENFELD to present its latest solutions in the field of micro injection moulding, since miniaturisation now plays a vital part especially in medical technology.
At this year’s Compamed, the company will demonstrate in cooperation with NanoVoxel, based in Vienna, the use of a 4-cavity mould produced by 3D printing to manufacture a micro part on which nano-scale structures are formed. The MicroPower, specially designed for injection moulding of micro parts, is equipped with a twostep screw-and-plunger injection unit, via which thermally homogeneous melt can be injected with shot volumes ranging from 1.2 to 6 cm³. In this way, it is possible to produce parts of outstanding precision in an absolutely stable production process and within minimal cycle times.
MIKE
HODGIN, DIRECTOR
OF STRATEGIC APPLICATIONS, MERIDIAN ELECTRONICS DIVISION DISCUSSES ENABLING AND PROTECTING VITAL MEDICAL IMPLANTS WITH EPOXIES.
The human body is a hostile environment for medical implants. Gastric acid, sweat, synovial fluid, saliva, blood, mucus, cerebrospinal fluid, and others, create a highly corrosive “bio-broth”. To ensure medical implants are secured or that sensitive electronics stay protected from this harsh environment, liquid epoxy resins (LER) are the only practical answer.
Epoxy Technology Inc. (ETI), a brand of Meridian Adhesives Group, has pioneered the biocompatibility of epoxy adhesives for medical-grade use in a broad range of applications, including orthopaedic, dental, vascular and electronic implants since the 1980s.
Introducing EPO-TEK Epoxies, which are two-part polymer resins, are naturally resistant to the acidic electrolyte chemistry found in bodily fluids and will not degrade over time, since long-term implant stability is always paramount. Low viscosity is another advantage and makes ETI’s EPO-TEK formulations easier to shape by allowing for liquid injection moulding. Processing at less than 60˚C also allows a polymerisation process at low temperatures (close to room temperature), whereas thermoplastics and other thermosets require a higher respective melt or curing temperature. Depending on the application, higher temperatures can result in Li-ion battery failure.
Of the 25 biocompatible formulations in the EPO-TEK line, many have been developed over the last 10 years and are used with medtech for surgical and therapeutic procedures.
EPO-TEK MED-301
EPO-TEK MED-301 is certified to meet ISO 10993 biocompatibility standards; this ensures that the material does not induce cytotoxicity or other adverse biological reactions. The resin has a low viscosity, which is advantageous for moulding applications. It allows for easy filling of moulds and creates detailed, precise implant structures.
MED-301 exhibits strong resistance to chemicals and bodily fluids, ensuring that the moulded implants remain stable and do not degrade over time when exposed to the body’s environment.
An epoxy that offers flexibility in curing schedules allows for customisation based on the specific needs of the moulding process and the design of the implant. The material is also compatible with various sterilisation methods, including EtO, and gamma radiation, without compromising its properties.
EPO-TEK MED-301 is ideal for orthopaedic implants for structural assembly of parts, such as screws, plates, and joint replacements. It is also used in dental implants to mould crowns, where detailed crown geometries and longterm stability are required.
EPO-TEK MED-H20S
Another example from ETI is EPO-TEK MED-H20S, silver-filled, electrically conductive epoxy commonly used in applications requiring strong electrical connectivity, such as medical implants, including pacemakers.
In pacemakers, MED-H20S interconnects with a quartz crystal oscillator semiconductor chip that functions with the precision of an atomic clock to keep the pacemaker working with precise regularity. To achieve desired conductivity and adhesive strength of MED-H20S, careful attention is paid to the curing process. Thorough validation testing is also required to ensure the material performs reliably under the specific conditions of the implant’s
environment. Given its combination of high electrical conductivity, strong adhesion, and biocompatibility, EPO-TEK MED-H20S is well-suited for the demanding requirements of pacemaker manufacturing, contributing to the device’s overall performance and longevity.
MED-H20S, is used in pacemakers to create reliable electrical connections between the different electronic components, such as bonding wires, SMDs, and diodes.
Choosing the right epoxy adhesive
Epoxy adhesives such as those developed by ETI play a crucial role in enhancing the longevity and performance of medical implants by providing biocompatible, corrosion-resistant, and durable solutions. Whether for structural assembly in orthopaedic devices, encapsulation of sensitive electronics, or ensuring electrical conductivity in life-saving equipment like pacemakers, ETI’s EPO-TEK line of adhesives—including MED-301 and MED-H20S—demonstrates the adaptability and reliability required to meet the stringent demands of modern medical technology. As the field of medical implants continues to advance, these epoxy solutions ensure that critical devices remain effective and protected within the body’s challenging environment.
Sterilisation Sensation
JAMES HICKS, HEALTHCARE APPLICATION DEVELOPMENT AND PROCESSING ENGINEER AT SYENSQO EXPLORES THE LATEST TRENDS, CHALLENGES AND SOLUTIONS IN STERILISATION.
The realm of medical device sterilisation is constantly evolving, with innovations continually reshaping what we thought possible. As we work towards more effective and efficient sterilisation methods, Syensqo is actively involved in developing advanced materials and technologies that meet the healthcare sector’s stringent demands. In this piece, we’ll explore the latest trends in sterilisation, the challenges faced, and the innovative solutions Syensqo is providing.
The evolution of sterilisation techniques
Sterilisation is a critical aspect of medical device manufacturing, ensuring that products are free from contaminants prior to use. The industry has long relied on methods like steam autoclaving, ethylene oxide (ETO), and gamma radiation. However, these methods have their limitations, especially when it comes to materials sensitive to high temperatures or specific chemicals. Steam autoclaving is a mainstay for reusable instruments due to its effectiveness in destroying microorganisms through heat and moisture. Materials like Radel PPSU and KetaSpire PEEK are particularly
suited for this method, enduring over 1,000 sterilisation cycles without degradation, making them invaluable for high-demand applications.
Ethylene Oxide (ETO) sterilisation is often chosen for devices sensitive to heat and moisture. This method requires meticulous control over various factors, including gas concentration and temperature, to achieve thorough sterilisation. Syensqo’s materials, such as Udel PSU, have shown robustness under ETO conditions, maintaining their integrity and functionality.
Gamma Radiation offers an efficient means of sterilising large volumes of medical components. While it is cost-effective, radiation can alter the colour and properties of some materials. Syensqo’s gamma-stabilised options, particularly in the Ixef PARA line often utilised in single-use surgical instruments, are designed to minimise these effects, ensuring aesthetic and functional consistency post-sterilisation.
Emerging technologies: Chlorine dioxide and beyond
Among the newer methods gaining traction, Chlorine Dioxide (ClO₂) stands out for its versatility and efficacy. Ideal for single-use and heat-sensitive devices, ClO₂ operates at room temperature, making it suitable for a range of applications. Syensqo’s rigorous testing has demonstrated the minimal impact of ClO₂ on the mechanical properties and colour stability of our healthcare materials, underscoring the method’s compatibility with our portfolio.
ClO₂ ability to provide broad-spectrum antimicrobial action, including against resistant bacterial spores, positions it as a valuable alternative to traditional methods. Its customisable dosage and concentration further enhances its applicability across different device types and packaging scenarios.
Vaporised Hydrogen Peroxide (VHP) is another innovative sterilisation technique. This method leaves no harmful residues, making it ideal for sensitive equipment. Syensqo’s materials, and particularly AvaSpire PAEK, have proven to maintain their mechanical properties under VHP conditions, adding another layer of versatility to our offerings.
Syensqo’s role in advancing sterilisation technologies
At the forefront of these advancements is Syensqo’s dedication to research and collaboration. By working closely with sterilisation technology experts, Syensqo ensures our materials are not only compatible with new sterilisation methods but also comply with global regulatory standards. This comprehensive approach supports the development of innovative materials and provides essential guidance to medical device manufacturers.
Beyond material supply, Syensqo plays a crucial role in educating clients about the implications of different sterilisation techniques. Their comprehensive technical bulletins and tailored support enable clients to make well-informed decisions, balancing material performance with the specific demands of sterilisation. This client-centric focus helps ensure that final products meet the highest safety and efficacy standards.
The future of medical device sterilisation
Looking ahead, the future of sterilisation is set to prioritise not only the most effective method but also ones that are environmentally sustainable and cost effective.
In summary, the advances in sterilisation technologies and materials science are vital to addressing the ever-changing needs of the healthcare industry. Syensqo’s efforts extend beyond providing materials - they are instrumental in driving innovation, ensuring medical devices are safer, more reliable, and accessible. As new challenges arise, the collaborative efforts among material scientists, engineers, and healthcare professionals will be pivotal in developing the next generation of sterilisation solutions.
Whether you are looking to move your existing Plastic Injection Moulding production or sourcing a supplier for a new product, Pentagon will support you at every stage of the process. Delivering a full turnkey
DR EUAN MCBREARTY, HEAD OF COMMERICAL & INNOVATION, WIDEBLUE SHARES FIVE STEPS TO SUCCESSFUL MEDICAL DEVICE DEVELOPMENT.
A Prescrip ion for Success
As a company Wideblue have been involved in helping medical device companies bring their ideas to market for the past 15 years. During this time, we have identified several key elements needed for success.
MARKET RESEARCH
Great you have a brilliant idea for a new medical device. However, is there a market for it and how scaleable is that market? Market research is essential to establish if there is a need for your device and what the competitive landscape is like. Internet research and speaking to contacts in the industry can be very useful in this respect. If your product is addressing a very rare illness or disease the market might be too small to build a business around. Some of our most successful clients have come up with devices which help with COPD, asthma and sepsis, conditions which impact a
huge number of people globally. Search current patents and see if there are any similar products out there. Your device might not be unique, but it may improve upon what already exists.
COMPLIANCE
The medical device sector is highly regulated and understanding the rules is vital. Too many companies rush into developing prototyping before considering the regulatory framework. The International Organisation for Standardisation (ISO) sets global standards for a broad range of products and businesses, including medical devices, and the International Electrotechnical Commission (IEC) sets standards for a variety of business types including medical devices and the electronics/software contained in them. Although these bodies do not have the force of law, they are used by the regulatory authorities such as the U.S. Food and Drug Administration (FDA) as a benchmark and gold standard for compliance. However, it is important to note that full compliance is not required for approval for manufacturers but any deviation needs to be fully justified.
It is essential to find out how your device will be classified. This will depend on the risk level of the device and which medical conditions it is intended to treat. If the device is to be used in the US market you will need FDA approval. Although the UK has left the EU, European regulations still apply during the transition period. Working with a professional medical device consultancy and IP attorney can help you navigate the legal labyrinthe.
MANUFACTURING
Going from the idea stage to producing an actual product which people will pay money for is a long journey and can be littered with pitfalls if not planned properly. This makes the prototyping stage very important as this allows any design, operational or functional issues to be identified at an early stage and ironed out before going to the full production stage. Prototyping is the process of making either a scale or full-size replica of something that is intended for commercial production. The process, if done properly, can shorten pre-production timescales considerably and help avoid costly mistakes. Fortunately, advances in CAD design, 3D printing, and rapid prototyping technologies make it much easier to create a model which can accurately replicate the physical, visual and tactile quantities of the intended device. This means advanced testing can be carried out and the device can be put in the hands of potential users in focus groups for valuable feedback.
Depending on the medical application, the device may also need clinical trials in either a laboratory or hospital setting or both. This can be a long process and may involve several iterations of the product before the final design is agreed upon.
SUPPLY CHAIN
Great you have gone through all the regulatory and prototyping stages and you are ready to look at going for commercial production. Close collaboration between the design team and the rest of the supply chain is vital for success. Things are currently tough for the manufacture of new products with many supply chain shortages, delays, component issues and raw material price increases. Here are some of the key things to consider:
• Pick a manufacturer who has specialist expertise in medical device production. They might be more expensive initially, but their in-depth knowledge can save costly mistakes further down the line.
• Choose a manufacture location much earlier in the design process. Once selected, the design team can work with the intended manufacturer to identify the long-lead time items, test equipment and tooling.
• Key components can be “locked” into the design and commitments made for sourcing to avoid delays later in the project.
• Key electronic components can be ordered well in advance of completing a PCBA design. This avoids delays in prototyping particularly in the medium volume scenarios between the early low volume prototypes and the larger Beta trial or clinical trial quantities.
• Give early consideration to your tooling strategy for injection moulded parts or die cast parts. If necessary, follow a parallel path.
• Keep a detailed audit trail of all components, circuitry and software being used in the device especially if you are outsourcing manufacture. Should an issue or product failure occur in future it is imperative to have each item used in the device catalogued and recorded for traceability purposes.
• ISO standards are reviewed every five years so ensure that your quality control and risk management processes are aligned with the latest standards.
GOING TO MARKET
Once all the prototyping, testing, audit checks and approvals have been gained it is time to launch your device into the market. Marketing is a complex subject and beyond the scope of this article, but here are some points to consider:
• What is your route to market. Will it be direct to consumers, the health authorities or through some other intermediary. What are the procurement rules and what hurdles might you face in driving sales?
• Packaging – design and what information is required for the device to be used safely and effectively.
• Promotion – is your advertising and PR within the relevant rules and regulations. Have you made any claims which cannot be scientifically or clinically proven.
• Pricing – this can be a difficult issue, price too low and you will not make a profit, too high and you could price yourself out of the market.
In conclusion, designing and bringing a medical device to market can be a long and costly journey but with professional partners to support you, the route can be made less arduous.
“It is essential to find out how your device is classified. This will depend on the risk level of the device and which medical conditions it is intended to treat.”
ABOVE: MRI Scanner head unit that Wideblue worked on for a client called MRI Coiltech in Glasgow
ARJUN LUTHRA, COMMERCIAL
DIRECTOR OF BIOINTERACTIONS, SHARES HOW SURFACE ACTIVE THERAPEUTICS REPRESENT A LEAP IN SAFEGUARDING MEDICAL DEVICES.
In the ever-evolving landscape of healthcare, the need for advanced protective measures for medical devices has never been more critical. Surface Active Therapeutics represent a groundbreaking leap in safeguarding these devices, ensuring they remain free from infections and complications throughout their lifespan. As healthcare-associated infections (HCAIs) continue to pose significant challenges, innovative solutions like those developed by BioInteractions are pivotal. By integrating cutting-edge antimicrobial and antithrombogenic coatings, BioInteractions is leading the charge in enhancing patient safety, improving implant efficacy, and delivering superior therapeutic outcomes.
Surface Active Therapeutics are advanced active treatments which do not need to release their ingredients that are applied directly to the surface of a medical device to help reduce the impact of clinical issues such as thrombosis, Fibrin Sheath Formation or infection. They provide highly effective and sustained protection through therapeutic benefits to the patient. They use enhanced materials that form a continuous protective shield over the surface. This shield is made of a polymer matrix, which combines active and passive components to improve the biocompatibility of the implant, enhance the efficacy of the device and elevates the therapeutic benefits to the patient.
Recent advancements in Surface Active Therapeutics involve applying effective localised therapeutics to various substrates and geometries, including catheters, drainage systems, ventricular devices, heart valves, and neurological stents. Advanced antimicrobial coatings like BioInteractions’ TridAnt create a continuous protective shield that combines active and passive components
to protect against pathogens comprehensively. This matrix ensures a rapid contact-kill mechanism, broad-spectrum efficacy, continuous residual protection, and the ability to disrupt and prevent biofilm growth, effectively combating a wide range of infections for the patient’s entire lifetime.
These coatings offer the best protection, killing a broad spectrum of pathogens, including bacteria, viruses, fungi, and spores. These include E. coli, MRSA, Influenza, Adenovirus, Norovirus, Clostridium difficile, and SARS-CoV-2. The technology is effective on various geometries and substrates, from soft materials like silicone and fabrics to hard materials like metals (stainless steel and nitinol) and polymers (polyamides, polycarbonates, and polyurethanes).
TridAnt is a unique Surface Active Therapeutic that provides a localised effect, making it safe for use throughout the body. It is designed for lifetime efficacy on Class 3 implants in chronic areas of the human body. Its polymeric matrix is biocompatible, targeting only microbes (prokaryotic cells) and remaining effective at the local surface to provide sustained efficacy for the patient. This targeted approach enhances safety by avoiding the systemic effects seen with other eluting coatings, which also reduce in efficacy over time. Consequently, TridAnt-coated
EVOLVING SURFACES FOR LIFETIME IMPLANTS
medical devices maintain a highly effective, fast, durable, and localised protective shield against a broad spectrum of pathogens which disrupts and prevents biofilm throughout the device’s lifetime.
BIOINTERACTIONS: PIONEERING INNOVATION
BioInteractions is at the forefront of innovation in the development of biocompatible coatings for medical devices. Recent surgically implanted devices often require removal, re-insertion, or extensive drug regimens for the patient’s lifetime. This has driven the need for coatings that meet both clinical and engineering requirements. Devices like total artificial hearts (TAHs), ventricular assist devices (VADs), vascular stents, and prosthetic mechanical heart valves assist vital organs but face the common challenge of lifetime hemocompatibility, specifically thrombosis.
Surface Active Therapeutic technologies offer superior biocompatibility, lifetime antithrombogenicity, and significantly reduce the risk of fibrin sheath formation. BioInteractions developed AstutePlus, an advanced antithrombogenic coating used on chronic, blood-contacting medical implants for over 25 years. AstutePlus combines active and passive components to provide the highest performance and most durable antithrombogenic coating on the market. The active component prevents platelet activation and halts the blood cascade mechanism to inhibit thrombus formation, while the passive components prevent blood components from depositing on the device surface. This multi-faceted approach ensures superior hemocompatibility without compromising performance of the device whilst reducing the risk of clotting over the patient’s lifetime.
Additionally, the development of miniaturised and minimally invasive procedures presents challenges such as reducing tissue trauma through decreased friction during device insertion and removal. BioInteractions has addressed this challenge by developing Assist, a hydrophilic coating that reduces friction. It is uniquely flexible and durable which enables it to be applied to a wide range of medical devices. Assist fills in surface microstructures, improving the flow of liquids and reducing bodily component deposition and adhesion. This ensures devices remain functional and safe while implanted. Assist is instantly activated through wetting, eliminating the need for pre-soaking and saving preparation time, allowing for straightforward device deployment.
Through these innovations, BioInteractions continues to lead the way in enhancing the safety and efficacy of medical devices, improving surgical outcomes, and providing better therapeutic results for patients.
CURRENT ISSUES FACED BY MEDICAL PRODUCT DEVELOPERS
Medical product developers and manufacturers navigate a highly regulated environment. Under current European Union (EU) regulations, medical devices are tested by the European Medicines Agency (EMA) following a similar approval processes as pharmaceuticals. BioInteractions’ Product Pathway Partnership team works closely with customers to navigate all aspects, including optimising the application process, fixture design, tooling, coating performance testing, regulatory compliance, and providing coating services. This partnership aims to help customers get to market efficiently and effectively with the highest quality coated device.
The expanded Product Pathway Partnership alongside BioInteractions’ integrated service streamline the research and development of new innovative coating materials. With 30 years of expertise and novel analytical resources, BioInteractions creates optimal coatings for various devices. This service further leverages BioInteractions’ experience and technology portfolio to develop bespoke coatings for unique clinical unmet needs that have never been seen before, providing revolutionary and state-of-the-art solutions for their partners.
THE FUTURE OF SURFACE ACTIVE THERAPEUTICS
Surface Active Therapeutics promises to revolutionise medical device technology, making implants safer, improving medical implant performance, and enhancing patient safety. Advanced antimicrobial and antithrombogenic coatings, such as TridAnt and AstutePlus, will play a pivotal role. The TridAnt coating provides quick and sustained, broad-spectrum protection against pathogens, ensuring enhanced cleanliness and reducing post-surgical infections, leading to quicker recoveries and fewer complications.
AstutePlus combines active and passive antithrombogenic protection which prevents platelet activation and fibrin sheath formation, addressing significant risks associated with blood-contacting implants. This innovation will ensure lifetime antithrombogenicity, enhancing the safety and functionality of devices like heart valves and stents, minimising the need for additional surgeries and long-term medication.
Personalised, biocompatible coatings tailored to individual patient needs will further improve outcomes by ensuring optimal performance and minimal adverse reactions. Patients will benefit from improved implant longevity, better therapeutic results, and enhanced quality of life.
JOE ANDERSON, PRODUCT AND PROMOTIONAL MARKETING MANAGER AT HARLAND, EXPLORES THE ROLE OF SURFACE PREPARATION IN THE APPLICATION OF HYDROPHILIC AND HYDROPHOBIC COATINGS.
Prepare Right, COAT BRIGHT
Surface preparation is a fundamental step in the manufacturing of medical devices, particularly when applying hydrophilic and hydrophobic coatings. These coatings significantly enhance the lubricity, stiction, trackability and the medical device’s ability to navigate tortuous paths. However, their effectiveness heavily relies on the quality of surface preparation. The challenge lies in addressing contaminants which can compromise a coatings ability to create a covalent bond, coating adherence and introduce defects. This article explores the importance of thorough surface preparation, and the methods involved in ensuring a clean substrate for optimal coating performance.
THE IMPACT OF CONTAMINANTS ON COATING PERFORMANCE
Medical devices often encounter various contaminants during manufacturing, handling, and transportation. These contaminants can interfere with the application and efficacy of hydrophilic and hydrophobic coatings. Common contaminants include:
1. Grease and oils: Residual oils and greases from manufacturing processes or handling can create barriers between the device surface and the coating. This results in poor adhesion and voids, leading to peeling or flaking of the coating.
2. Foreign Material (FM) and particulate: FM and particulate can settle on the device surface, causing irregularities that affect the uniformity of the coating layer. This can compromise the coating’s effectiveness and the device’s overall performance.
3. Silicon oil and mould release agents: Particularly problematic in devices produced via injection moulding, silicon oil residues can create a slippery surface that hinders proper coating adhesion. This residue can be challenging to remove and, if not adequately cleaned, can lead to significant defects, voids and contamination in the batch.
4. Leaching and cross-contamination: Contaminants that are not removed can leach into the chemistry pot used for coating additional devices, causing contamination across multiple devices in the lot and potentially affecting their performance and safety.
SURFACE PREPARATION: KEY STEPS AND METHODS
To ensure that coatings adhere effectively, and the devices are safe, meticulous surface preparation is essential. This involves several critical steps:
1. Cleaning the surface
a. Cleaning agents and solvents:
• Solvents: Different solvents are suited to different contaminants. For example, hydrocarbons like heptane are effective in dissolving oils and greases, including silicon oil. Isopropyl alcohol (IPA) and ethanol, while less aggressive, are excellent for general residues and dust removal. Each solvent’s choice should align with the contaminant being targeted to ensure thorough cleaning.
• Cleaning agents: Specialised cleaning agents may be used for persistent residues. These agents are often formulated to address specific types of contaminants and can be more effective than general solvents.
b. Cleaning techniques:
• Ultrasonic and turbulent flow cleaning: For thorough cleaning, ultrasonic cleaning can be employed. This method uses high-frequency sound waves in a solvent bath to remove contaminants from the device surface. It is particularly useful for cleaning intricate or complex geometries where manual cleaning might be insufficient. Additionally, turbulent flow cleaning can be employed to enhance the removal of contaminants, ensuring that even the most challenging surface areas are thoroughly cleaned.
• Manual cleaning: In cases where ultrasonic cleaning is not feasible, manual cleaning with appropriate solvents and brushes or cloths can be used. Care must be taken to ensure that the cleaning process does not introduce new contaminants or damage the device.
2. Selecting the right wipes
a. Lint-free wipes:
• Purpose: Lint-free polyester wipes often used for their strength and low particulate shedding are ideal for the final cleaning stage to ensure that no particles or fibres remain on the device surface. Traditional wipes may shed fibres, which can introduce additional contaminants and affect coating adhesion.
• Application: Wipe the surface gently to avoid scratching or damaging it. Use the wipes in a single direction to prevent redistributing contaminants. Multiple wipes may be needed to ensure a thoroughly clean surface.
3. Cleaning methodology
• Ensure that every part of the device, including those with intricate and complex geometry, is thoroughly cleaned. Achieving this often involves employing multiple wipes and using them in various directions to cover every surface area comprehensively. Additionally, rotating the device
while wiping can be an e ective strategy to ensure that all surfaces, including hard-to-reach areas, are cleaned adequately. This meticulous approach helps to ensure that no residual contaminants are left behind, which is crucial for achieving optimal coating adhesion and device performance.
ENSURING EFFECTIVE COATING APPLICATION
Thorough surface preparation is essential for ensuring that substrate modification materials such as hydrophilic and hydrophobic coatings adhere effectively and deliver the desired performance. Proper preparation eliminates contaminants that could interfere with coating adhesion and functionality. To verify the effectiveness of the coating process, a representative percentage of the lot is often subjected to additional testing. This includes staining to evaluate the coating’s uniformity, visual inspection to detect any defects, and friction testing to ensure that the coating performs as intended. These steps help confirm that the coatings adhere properly and that the devices meet performance standards before they are deemed suitable for use.
CONCLUSION
Surface preparation is a critical and multifaceted step in the manufacturing of medical devices, especially when applying hydrophilic and hydrophobic coatings. Thorough cleaning, appropriate solvent selection, and the use of lint-free wipes are essential to ensure that the device surface is free from contaminants such as grease, foreign material, and silicon oil residues. By meticulously preparing the surface, manufacturers can achieve effective coating adhesion, enhance device performance, and ensure the safety and reliability of medical devices. This process not only improves the functionality and durability of the coatings but also mitigates the risk of cross-contamination and defects, ultimately benefiting both the manufacturer and the end-users.
Putting the PLA in bioplastic s
MARC VERBRUGGEN, CEO, EMIRATES BIOTECH, EXPLORES THE ROLE
OF
ABIOPOLYMERS
IN
ADVANCING
SUSTAINABILITY IN THE MEDICAL INDUSTRY.
s the world increasingly focuses on sustainability, the medical industry, known for its reliance on high-performance materials, faces a unique challenge. Balancing the need for sterile, reliable, and durable materials with the global push for sustainability is a formidable task. However, biopolymers, particularly PLA (Polylactic Acid), offer a promising solution, contributing significantly to the circular economy and aligning with the industry’s sustainability goals.
The sustainability challenge
The medical industry relies heavily on plastics for a wide range of applications, from packaging and disposable medical devices to surgical instruments and implants. While plastics offer unparalleled benefits in terms of hygiene, sterility, and cost-effectiveness, they also pose significant environmental challenges. Traditional plastics are derived from fossil fuels, contributing to greenhouse gas emissions throughout their lifecycle, from production to disposal. Furthermore, most of these plastics are not biodegradable, leading to accumulation in landfills and oceans, exacerbating the global plastic pollution crisis.
Biopolymers: A sustainable alternative
Biopolymers, such as PLA, offer a promising alternative to traditional plastics. Derived from renewable resources like corn starch or sugarcane, PLA is both bio-based and biodegradable, distinguishing it from conventional fossil-fuel-based plastics. The production process of PLA is inherently more sustainable, as it involves the fermentation of plant sugars to produce lactic acid. which is then polymerised into PLA. Lactic acid is very environmentally friendly substance and is also produced in our own bodies daily. The production process for PLA not only reduces reliance on finite fossil resources but also lowers the overall carbon footprint, as plants absorb CO2 during their growth, offsetting some of the emissions generated during production.
PLA is also biodegradable. Under appropriate conditions, PLA can be broken down by microorganisms into water, CO2, and biomass, leaving no toxic residues or microplastics behind. This property is particularly advantageous in the medical field, where single-use items cannot always be recycled due to contamination. These PLA-based products, could be anaerobically digested, to recover the energy, and composted in a second step, thereby lessening its environmental impact.
Contribution to the circular economy
One of the most compelling arguments for the adoption of biopolymers like PLA in the medical industry is their potential to be easily recycled. A circular economy emphasises the need to keep materials in use for as long as possible, extracting the maximum value from them, and regenerating products at the end of their life cycle.
Recycling PLA involves collecting, sorting, and reprocessing it into new products, thereby maintaining its value within the circular system. This capability is crucial for the medical industry, where the need for sterile, single-use products often conflicts with sustainability goals.
Applications in the medical industry
PLA biopolymers are already being used in various medical applications, demonstrating their versatility and effectiveness. In medical packaging, PLA is employed to create transparent high quality packaging solutions that
maintain the necessary sterility while reducing environmental impact.
In addition to packaging, PLA is used in the production of medical devices such as sutures, drug delivery systems, and orthopaedic implants. These applications benefit from PLA’s biocompatibility, which means it can safely interact with the human body without causing adverse reactions.
Medical grades of PLA are ideal for temporary implants and devices that do not require surgical removal or self-dissolving surgical wire. PLA’s ability to degrade within the body to lactic acid, which is a body’s natural substance, makes it ideal for these applications.
Overcoming challenges
The performance of biopolymers in terms of strength, durability, and stability must match that of traditional plastics. Advances in research and development are continually improving these properties, making PLA a viable option for an expanding range of medical applications.
Conclusion
As we move towards a more sustainable future, the role of biopolymers in the medical industry will likely expand, driven by ongoing innovations and a growing commitment to environmental stewardship.
NICK GUERIN, CSP, DIRECTOR OF ENVIRONMENTAL, HEALTH & SAFETY AT TESSY PLASTICS HIGHLIGHTS HOW CONTRACT MANUFACTURERS ARE DRIVING SUSTAINABILITY IN THE MEDICAL PLASTICS INDUSTRY.
Manufacturing medical plastic products with stringent specifications is a challenge Tessy Plastics Corp. (Tessy) has taken head on for over 50 years, and the company commits to reduce absolute scope 1 and 2 GHG emissions 42% by 2030 from a 2022 base year. Tessy also commits to reduce absolute scope 3 GHG emissions from purchased goods and services, upstream and downstream transportation and distribution, and end of life treatment of sold products 25% within the same timeframe.
Achieving these targets will require strategic partnerships with both customers and suppliers.
Sustainable raw material and product design Tessy proactively collaborates with partners and vendors to source material as sustainably as possible. While medical products and finished devices have limited flexibility with resin, there is always opportunity to enhance the packaging solution. Researching and testing bio-degradable or recycled packaging is one way to move toward a more sustainable medical product. Another way to tackle this is by limiting the amount of packaging/material that is needed to ship the product and preserve the shelf life.
In addition to material selection for packaging, partnering with a vertically integrated company will provide design, research & development, and continuous improvement services all under one roof. If a customer asks how they can make their product more sustainable without changing any material, there are often various solutions to explore in regards to product design.
Redesigning the product in such a way that reduces the amount of plastic required to produce it is a common option that is presented. This approach is known as “light weighting” in the world of plastic injection moulding. Another alteration that can be proposed is taking a multi-component medical product and redesigning it to reduce the number of components necessary for production. Maintaining product quality and performance as these changes are considered is top priority.
Enhanced production efficiency – automation and assembly Tessy is ISO 13485:2016 certified, FDA registered, and offers ISO Class 5, 7, and 8 cleanroom moulding and assembly. These certifications and cleanrooms enable the production process for finished medical devices to be as seamless and sustainable as possible. Cleanrooms contribute to sustainable manufacturing by reducing waste and minimising the risk of defects and contamination. Due to the fact that cleanroom environments are humidity and temperature controlled, there are also gains in energy efficiency. Quality is the highest priority in medical manufacturing, but continuously finding ways to improve sustainability and efficiency is what sets Tessy apart in climate action.
Alongside material modifications, designing the moulding and automation lines with the objective of minimal energy use is another avenue that yields decreased carbon footprint. Contract manufacturing companies provide the technical bandwidth such as research & development and engineering teams to support these particular efforts. With injection moulding, there are several ways to design moulds to use less energy and reduce scrap. One method is to use a hot runner system instead of a cold runner system, which minimises material waste during the moulding process. Additionally, enhancing efficiency and energy consumption can be achieved by increasing cavitation within a single mould, rather than using multiple machines to produce the same volume for a single component.
Moulding and assembling medical products with multiple components all in one automation line is the most efficient. When various components have to be moulded separately, warehoused, and re-introduced to the production floor for assembly, there is a significant amount of time and energy wasted. The more machines and manufacturing processes required also means more operator intervention is needed. The solution that vertically integrated contract manufacturers provide is a seamless process from design and development of the product to design and development of the moulding and automation equipment resulting in the most efficient and sustainable workflow.
Streamlined transportation and distribution
With production lines being designed for the leanest operation all in one facility, contract manufactures are able to take it a step further by reducing the number of warehouses and final pack out touch points. By moulding, assembling and packaging in one location, there is significantly less carbon footprint. Reducing the number of trips that trucks need to make moving product between facilities is not only minimising carbon footprint, but also
provides speed to market. Contract manufacturers are able to save time, energy, and money by producing and packaging finished medical devices in one place and distributing directly to physician’s offices for patient use.
A vertically integrated contract manufacturer like Tessy is a strong ally for customers pursuing ambitious sustainability objectives. The company can streamline the supply chain, reducing waste and energy consumption at every stage of production. Additionally, by overseeing all aspects of manufacturing, we can implement sustainable practices more effectively, ensuring that materials are sourced responsibly and processes are optimised for minimal environmental impact.
“Cleanrooms contribute to sustainable manufacturing by reducing waste and minimising the risk of contamination.”
ANDREW FILACHEK, VICE PRESIDENT
OF ENGINEERING FOR TEKNIPLEX HEALTHCARE SHARES THE MOST IMPORTANT TIPS FOR WHEN CHOOSING STENT AND CATHETER PARTNERS.
Stenting Success
Increasingly, MedTech companies are seeking contract design and manufacturing partners that can accompany them on comprehensive product journeys – from initial concept to validation to large-scale manufacturing, and everything in between. The ability to combine ideation and earlystage development with materials science and process technologies has, in recent years, become a differentiator across a variety of device categories.
STENTS & CATHETERS: PRODUCTS INFORMED BY PROCESS
A comprehensive dissertation encompassing the myriad varieties of stents and catheter combinations would require a book rather than a few pages, so instead let’s explore one sliver of this market – a “niche within a niche within a niche,” so to speak. Let’s take a deep dive into a category known for its heightened levels of design, engineering and manufacturing challenges: neurovascular stent systems.
All stents are miniscule; neurovascular stents are exceedingly so, frequently measuring just two or three millimetres. The tiny tubular devices are implanted within blood vessels in the intracranial cavity to treat a vascular abnormality, such as those resulting from aneurysms or strokes.
Here, the bird’s eye view becomes the proper perspective. Neurovascular stents are an exceptionally intricate device that, after being coupled with another device (a catheter), will be the focal
point of a delicate, difficult medical procedure. The entire process – not only design through manufacturing but design through implantation – must be as optimised as possible. This optimisation requires not just individually perfected steps but the synchronisation of those steps.
Here, categorisation comes into play. Whereas many stents come preloaded into their complementary catheter delivery systems, neurovascular stents occupy too limited a landscape for such conveniences. Given the narrow, twisting tortuous path that must be navigated for successful placement, preloading a neurovascular stent in a catheter would make the latter too stiff for the task at hand.
Rather, neurovascular stents are placed by first inserting a small-diameter microcatheter, typically about 150 centimetres in length. Once the microcatheter reaches its destination, the guidewire is removed; the stent is then fed through the distal end and, ever so gently, pushed to the precise implant spot.
Obviously, this process places a premium on the interaction between a neurovascular stent and its microcatheter. The tracking must be smooth and free of bunching, and the final step – the removal of the stent from the microcatheter’s tip – must be seamless.
Already, we can see the pitfalls of a multi-partner building block approach. The various parties involved would need constant, ultra-detailed interorganisational communication to ensure best possible compatibility between the stent and its delivery device. In this example, optimised stent concepting and prototyping must consider more than the attributes of the stent itself. While stent-specific elements like size, radial force and crimping characteristics are invaluable, equally invaluable is understanding how that stent will conform to its delivery vessel: the catheter.
For applications as intricate as stents, catheters must be designed with their payload in mind. The right catheter will meet its stent’s needs for column strength without an overabundance of compliance, because if it stretches too much or too unpredictably, the procedure becomes more complicated and less informed. Deployment accuracy also is critical; for example, a particularly springy stent will need a custom designed catheter mechanism to prevent premature deployment.
With catheters and stents, there are typically several design tradeoffs when holistically considering the tortuous path, stent radial force, and catheter compliance. Striking the right balance among these attributes will yield an optimised stent-catheter combo whose procedural application is repeatable, and whose ultimate effects are positive and enduring.
Notably, such intricacies apply not only to stent-catheter combos but also a wide array of adjacent and next-generation solutions. For example, it’s becoming increasingly common for complex catheter systems to include stent-like devices like stentrievers and other devices for thrombectomy. Unsurprisingly, such sophisticated constructions also benefit greatly from extensive experience in traditional stents, catheters and other interventional medical devices.
Finally, it’s worth noting that catheter design also must consider compatibility with other devices besides stents, including interactions with ancillary, non-proprietary components such as guidewires, introducers and guide catheters.
GREATER THAN THE SUM OF ITS PARTS
All this leads to one destination: the operating room. While the stent may be the star, the stage is just as important. Considering the complexities of stentcatheter combinations – and neurovascular stent implantation in particular – healthcare personnel conducting such procedures take on crucial supporting roles. Everything from stent design to catheter compatibility to skillful implantation must coalesce in support of one goal: successful acute deployment and long-term device viability.
Can this process be successfully conducted through a multi-partner approach? Certainly. But there are indisputable insights and best practices that can be more thoroughly developed and honed with an overarching view of how both stents and catheters are designed, produced and utilised. The whole of the process is greater than the sum of its parts.
One substantial benefit to containing the entirety of the development and prototyping process in one facility is expedient trial and error. Savvy designers often have in-house simulation labs that precisely mimic how doctors would utilise the stent-catheter combo. This can inform potential modifications to stents, catheters or both.
Compatibility simulations and the foresight they afford are but one area in which medical device CDMOs can showcase value to potential MedTech customers. Further upstream from such prototype trials, CDMOs with inhouse materials testing and analysis programs help MedTech companies understand parameters and potential pitfalls before component construction even commences. Here, experience matters; an outsourcing partner with firm roots in stent-catheter development can draw upon a deep well of
knowledge and seasoned team of engineers who’ve successfully designed, produced and launched unique yet similar combinations.
Indeed, even in scenarios involving novel, patented designs, ingrained niche knowledge helps a stentcatheter development process hit the ground running for enhanced speed to market. For example, new stent and catheters concepts typically require approval from regulatory authorities. This includes design stress tests, such as how a stent will handle the strain of crimping. Here, expertise becomes an expediting agent, because even new designs have similarities with existing ones. This means that certain device modelling parameters can be largely informed from an established knowledge base of stent development.
The human body is an exceptionally complicated, interconnected design. Companies providing invasive or implanted medical devices naturally must develop their products in relation to this – and, crucially, according to the operatory procedures used to introduce or employ them. With so many considerations to juggle, more MedTech companies are finding reassurances with turnkey partners, whose comprehensive product and process expertise make them less likely to drop the ball.
HUW OWEN, NOMENCLATURE DEVELOPER, GMDN AGENCY EXPLORES HOW REGULATORS DEFINE INNOVATION WITHIN THE INDUSTRY.
KEEPING UP WITH
The medtech industry is rapidly changing, with new developments regularly replacing existing technology. As a medical device nomenclature, the Global Medical Device Nomenclature (GMDN) helps to categorise, sort, and track the everchanging landscape of the medical device industry. Within this article, I’m going to tell you a bit about how we manage the GMDN Database to capture innovation and keep up with the hard work of researchers and manufacturers as well as how regulators define innovation within the industry.
If a new device can’t be accurately described by an existing GMDN Term, then either an existing Term must be expanded or a new Term must be created. Does this mean that each new and expanded Term represents an innovation? The short answer is no. New Terms and expansions for non-innovative technologies may be required for a few reasons. The device may be an existing technology, not previously regulated as a medical device (e.g., furniture or athletic training equipment). Alternatively, the device may require a new Term to represent a variation of an existing technology. Examples of this include single-use/reusable counterparts and devices where clinically relevant features, such as antimicrobial properties, have been added.
WHAT IS AN INNOVATION?
Two of the Regulators leading the charge on defining innovation
are the Food and Drug Administration (FDA) in the US and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Both have different definitions of an innovative device, but it does seem there is a common understanding that innovation presents in different ways. Below is a diagram displaying the relationship between the two Regulators different methods of defining an innovation.
THE FDA
The FDA refer to innovative devices as Breakthrough Devices and have a range of criteria, two of which must be met for a device to be considered as such. The first must be met by all hopeful innovations and states ‘The device provides for more effective treatment or diagnosis of lifethreatening or irreversibly debilitating human disease or conditions. There are then four options for the second criterion, of which one must be met. In the interest of future reference, I am going to refer to these as FDA A, B, C, and D and they are as follows: The device represents breakthrough technology (A), no approved or cleared alternatives exist (B), the device offers significant advantages over existing approved or cleared alternatives (C), or finally, device availability is in the best interest of patients (D).
THE MHRA
Like the FDA, the MHRA has opted for a multi-class approach with devices falling into three separate classes: Incremental, Transformative or Disruptive innovation. Incremental innovation is defined as ‘an improvement to a device that already exists within the health system that
positively affects the delivery of care or wider system’. Transformative innovation is defined as ‘an existing technology that is applied to the healthcare system for the first time or the application of a technology which is already in the healthcare system in a novel way for example, an existing device being applied to a new speciality’. The third class of innovative device according to MHRA definitions is Disruptive innovation. which is completely novel, with a foundational technology which doesn’t exist elsewhere, in or outside of the healthcare sector.
COMPARING FDA AND MHRA
Despite the different approaches, there is some alignment between these concepts. The devices most likely to create headlines are FDA A and MHRA Disruptive innovations as these definitions describe a truly novel device. Within the GMDN, these devices will always require a new GMDN Term as, by definition, no existing device will utilise the same or similar technology.
Whilst not an exact match, FDA B most closely aligns to the MHRA’s Transformative innovation definition. These can be existing devices seeking clearance for a new clinical application and will typically trigger an expansion to an existing GMDN Term to add an additional use case to a device with the same technology and other attributes.
FDA C and the MHRA’s Incremental innovations represent the most common form of innovation, an existing technology which has been improved upon to provide better outcomes for the same intended use. As technology and intended use are two of the key attributes used to group devices into GMDN Terms, this type of innovation may not necessarily warrant a new Term, rather it may trigger an expansion to an existing Term. For example, the GMDN Term, Custom-made talus prosthesis, was recently expanded to include a custom-made talus prosthesis which is also transferable to other parts of the body (e.g., the carpals, cuneiforms, and femoral condyles), as a result the Term was renamed Custom-made hand/ foot bone prosthesis. In some cases, the expansion required to include these innovations can blur the boundaries between two or more Terms. Because GMDN Terms are written to be mutually exclusive, and narrowing the scope of Terms is not allowed because it would result in the exclusion of previously assigned devices, the only option we have in this situation is to make one or more Terms obsolete.
The remaining definition - FDA Ddoesn’t specifically align with any of the MHRA’s definitions. In some cases, FDA D is likely to refer to the production and distribution processes which improve the availability of the devices; in such cases this innovation is unlikely to be captured by the GMDN. However, technological advancements can provide greater availability and accessibility, in which case FDA D begins to overlap with the MHRA’s Incremental innovation definition. An example of this is portable versions of existing technologies, which can improve access to patients unable to make it to a clinical setting and home-use devices intended to be operated by a patient or other lay person which can help to account for shortages of clinical professionals. These are both concepts by which GMDN Terms are differentiated and the creation of either a portable or home-use version of a device will always be captured within the GMDN with the creation of a new GMDN Term.
SUMMARY
As a medical device nomenclature, global harmonisation of the language surrounding the medical device industry is at the heart of what we do. It is for that reason the GMDN are currently working on new resources aimed at facilitating the analysis of innovation across the medical device industry.
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LAURA FRIEDL-HIRST, MANAGING DIRECTOR AT LFH REGULATORY EXPLORES WHAT REGULATORY INTELLIGENCE IS AND HOW IT CAN BENEFIT BUSINESSES.
With regulatory requirements ever evolving and the stringency of medical device regulation, it is no wonder that the complexities are confusing when it comes to regulatory compliance. But what do you understand when it comes to Regulatory Intelligence for medical devices and in vitro diagnostics (IVD’s)? For lower risk devices such as Class I non-sterile, the regulatory intelligence should be pretty straight forward, but what about higher risk devices such as a Class III implantable device with a software application? Using Regulatory Intelligence to implement your strategy can decrease time to market, reduce costs as well as ensure compliance.
As a medical consultancy we understand the challenges that organisations face in keeping up with all the various sources of regulatory intelligence. Factors such as the size of the business and resource will determine the commitments the regulatory professional will have, as well the availability they have to carry out Regulatory Intelligence activities. With advances in information technology there is an overload of information becoming readily available at an ever-increasing speed, from multiple different sources, making it difficult to keep up to date.
So, let’s delve a little more into regulatory intelligence and the benefits of building a robust process.
What Regulatory Intelligence is
To put it simply, it is defined as:
A systematic process of collecting, analysing, and disseminating information about regulatory requirements, policies, and guidelines that affect the development, manufacturing, distribution, surveillance, and regulation of medical devices.
The main stages of Regulatory Intelligence
1. Gathering data: Information can be sourced from websites, blogs and professional newsletters, competitor and product analysis, regulatory e-mails, professional networking and guidance documentation. This list is not exhaustive and should be determined during planning.
2. Process & analysis: Gathering data is the initial step, and so it becomes evident that this data needs to be filtered to obtain relevant information. The activity includes taking care of factors like the latest trends and patterns in the regulatory industry. This helps to understand the impact on current and future regulatory compliance.
3. Regulatory strategy: The aim is to perform the abovementioned to produce the most satisfactory and acceptable regulatory strategy for organisations. Devices may have specific regulatory guidelines in different countries.
4. Dissemination: Sharing the analysed information with relevant stakeholders within the organisation to ensure everyone is informed about regulatory changes and their implications.
The purpose of Regulatory Intelligence Regulatory intelligence is crucial to ensure that your medical devices are safe, effective and compliant with all relevant regulations. This not only protects manufacturers but also benefits patients by guaranteeing the highest standards of product quality.
Where Regulatory Intelligence comes from
Within the European Union, the EU Medical Device Regulation 2017/745 (MDR) & In Vitro Diagnostic Regulation 2017/746 (IVDR) states that manufacturers must stay up to date with regulatory changes and is embedded through both regulations. Although not referenced as regulatory intelligence, it is important to understand what you need to do. Both the MDR and IVDR document regulatory intelligence requirements as stated below:
Annex 1 – General Safety and Performance Requirements states that manufacturers must ensure devices meet safety and performance requirements throughout the lifecycle of the device necessitating regulatory intelligence. Essentially you will need to keep up to date with any changes, including any standards you are complying with.
Article 10 – General Obligations of manufacturers states that manufacturers are required to establish, document, implement, and maintain a system for risk management, which includes staying informed about regulatory updates.
ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes, documents the need for regulatory intelligence. This is implied and documented through the standard under several clauses:
Clause 4.1.2(b) - General Requirements: Organisations are to identify applicable regulatory requirements and ensure they are incorporated into the QMS. This includes staying up to date with any regulatory changes.
Clause 7.2.1 - Determination of Requirements Related to the Product: Organisations must determine and meet regulatory requirements related to their devices. To ensure compliance, regulatory intelligence activities are required.
Clause 7.3.3 - Design and Development Inputs: The clause states that the design and development inputs must
include applicable regulatory requirements and standards, which requires continuous monitoring of the regulatory landscape.
Clause 8.2.1 - Feedback: Create a feedback system to collect data on product performance, ensuring it includes monitoring for regulatory compliance. This involves staying updated on any regulatory changes that could affect your device’s performance.
These clauses collectively underscore the importance of regulatory intelligence in maintaining compliance with EU Regulation as well as ISO 13485:2016.
The benefits of Regulatory Intelligence
Let’s dig a little further and explore several key areas where Regulatory Intelligence can benefit your organisation if you implement a robust process:
1. Design & development: Regulatory intelligence can be used during the development phase of your device by identifying any potential regulatory requirements, including things such as clinical requirements, testing standards, etc. By doing this, you can prevent any future remediation activities, including expensive testing or clinical studies.
2. Strategic planning: Regulatory intelligence supports strategic decision-making by providing a clear understanding of the regulatory landscape, which can influence product development, market access and business planning.
3. Market access: Understanding and complying with regulations in the regions you wish to sell your device will facilitate faster market access and a smoother transition to launch.
4. Compliance and safety: If you stay updated with the latest regulatory requirements, you can ensure your devices meet all necessary safety and quality standards. This assists in the prevention of adverse events, ensuring patient safety and avoiding costly recalls.
5. Risk management: Understanding and keeping up to date with regulatory changes help in identifying and mitigating risks associated with potential non-compliance. Taking this proactive approach can save any business from potential legal and financial ramifications.
Conclusion
Regulatory intelligence is an indispensable tool for medical devices and in vitro diagnostic manufacturers. By systematically collecting, analysing, and disseminating regulatory information, manufacturers can ensure compliance, enhance product safety, and streamline market access.
The benefits of a robust regulatory intelligence process are manifold, including improved design and development, strategic planning, market access, compliance, safety, and risk management. As the regulatory landscape continues to evolve, staying informed and proactive is crucial for maintaining a competitive edge and ensuring the success of your medical devices in the global market. Embracing regulatory intelligence not only helps in meeting regulatory requirements but also fosters innovation and growth within the industry.
ANDREAS MONTAG, BUSINESS DEVELOPMENT DIRECTOR MEDICAL AND REGIONAL SALES DIRECTOR ANDREW SARGISSON AT SUMITOMO (SHI) DEMAG
DISCUSS WHAT’S DRIVING THE GROWTH IN THE CLEANROOM MARKETS.
DUSTING OFF SUCCESS
The global cleanroom market is on another growth curve.
BCC Research indicates that the global market for products manufactured in a cleanroom environment is expected to grow in value from $7.5 billion in 2023 to $10.9 billion by the end of 2028. While maintaining a sterile environment is clearly essential to meet the defined regulatory standards and to ensure the safety and efficacy of medical device products, a cleanroom is so much more than just a white space occupied by people wearing gowns, masks and other PPE.
STANDARDS AND GUIDELINES
Most medical moulders will only embark on cleanroom projects to fulfil regulatory FDA, GMP Annex 1 and CFR Part 211 requirements. These regulatory bodies all publish guidelines and have regulations for cleanroom designs.
In order to comply with these requirements, the equipment used in the manufacture, processing, packing or holding of a drug product needs to be of an appropriate design, adequate size and suitably located.
CLEANROOM CLASSIFICATIONS
A cleanroom is assigned a rating between ISO Class 1 through to ISO Class 9, dependent on the number of particles per cubic metre of air. The lower the cleanroom class, the cleaner the environment. ISO 7 and ISO 8 cleanrooms are typically adequate for most medical device manufacturing processes. ISO Class 5 cleanrooms for sterile medical components are only required if products are exposed to the air or surfaces. A fully configured allelectric injection moulding machine can be a straightforward way to create an instant cleanroom and eliminate one of the biggest contamination risks … people.
THREE ESSENTIAL CHARACTERISTICS
To achieve a controlled cleanroom environment, all three categories must be addressed:
1. Internal surfaces and the equipment contained within the cleanroom should be designed to mitigate contamination and be easy to clean.
2. Filtered air flow is required to maintain a stable temperature and humidity while simultaneously extracting particulate contaminations.
3. Operational standards, including maintenance, training staff and adhering to robust procedures, must always be maintained.
KEEP IT SIMPLE
It is common for people to submit a user requirement specification (URS) request for a cleanroom solution that is superfluous to the medical component being made. Most do this out of regulatory fear.
It is important to note that over-committing to a cleanroom classification could leave medical manufacturers exposed to unwarranted compliance requirements that, once approved, you must continue to adhere to. Sometimes effective ventilation is all that is required. Yet, for sterile medicinal products, the requirements - defined by Annex 1 of the EU and PIC/S GMPs – are stringent.
BE MORE ENERGY AWARE
As filtered air-controlled production environments, moulding cleanrooms are extremely energy intensive. Experts estimate that in some cleanroom facilities, the air units that circulate fresh air and extract particulates can consume around 60% of all production power.
In order to conserve energy, look at your white space. If non-utilised areas can be occupied by additional machinery, this increases production capacity without powering a separate room. A lower ceiling height can also help to reduce the overall atmosphere that requires HEPA filter control.
IDENTIFY HEAT SOURCES
Over cluttering is not conducive to the GMP standards. Remove freestanding periphery equipment from the floor and integrating into the moulding machine cell, including hot runner controllers, cables, and even automation, as this eliminates another surface area and consequently additional sources of heat generation.
Integrated electric direct drives is another consideration. Providing the force transmission, these use considerably less energy. As no belts are spinning, the drives don’t have to work as hard. In turn this means the machine isn’t overworking itself. Thermal imaging can provide a good indicator of any inefficiencies and heat emissions.
CLEVER DESIGN FEATURES
A large platen area can increase productivity as a machine can accommodate higher cavity tooling. Additionally, look for integrated laminar air flow systems which can flood the mould surface and part handling areas with HEPA filtered air.
As a benchmark, the IntElect Medical package comprises GMP-compliant technical features, such as raising the machine 100mm off the floor to help maintain cleaning standards. Additionally, total stainless steel fixed platen coverage on the top, sides and underside without any cut outs ensures air flow is not disturbed. Inside the cell, yet outside the mould space, cooling, temperature and pneumatics can be attached. Eliminating cables and hoses in the mould space.
“It is important to note that over-committing to a cleanroom classification could leave medical manufacturers exposed to unwarranted compliance requirements.”
OPC-UA INTEROPERABILITY
Designed to enhance traceability and optimise processing stability, medical manufacturers can now extract all performance data from the machine and all the contained periphery equipment.
Recording time series data and analysing process parameters, an OPC-UA interface records, channels and collates every processing aspect from all the peripheral devices attached to the cell. This contextualised data is then submitted from the beating heart of the production cell, straight to production and QC managers. Without people needing to enter the cleanroom environment.
SEEK GLOBAL EXPERTISE
Never underestimate the value of high-quality consultancy at the start of any medical cleanroom project. Having access to global technical experts that are all GMP-trained and regularly provide cross-border support makes it much easier to manage each of the defined steps for design, installation, operational and production Qualifications and Validations of cleanroom machinery.
MARK JACKSON, COMMISSIONING AND VALIDATION MANAGER AT ANGSTROM TECHNOLOGY ANSWERS THE MOST COMMON QUESTIONS ABOUT CLEANROOMS FOR INJECTION MOULDING.
Injection moulding in cleanrooms allows medical plastics to be produced in a controlled environment ensuring a high-quality product without fear of contamination. Whether you’re an expert or a novice in the world of cleanrooms, this can be a complicated process, so this article answers the most common questions when it comes to the injection moulding process for medical plastics.
WHY DO I NEED A CLEANROOM FOR INJECTION MOULDING?
A cleanroom is necessary for injection moulding when the products being manufactured require an element of contamination control, where cleanliness, precision and compliance are closely regulated. Manufacturing products for the medical industry means the output of these processes often come into direct contact with the human body, so contamination control is of top priority.
Most cleanrooms intended for the manufacture of medical devices must comply with ISO Class 5 to Class 8 standards, however all active implantable medical devices and their accessories fall under the highest risk category (Class III), which means a GMP cleanroom may need to be used.
By manufacturing in a cleanroom environment, you ensure the process is free from contaminants that could compromise the quality, safety and functionality of the end product.
WHAT ARE THE KEY FEATURES I NEED FOR AN INJECTION MOULDING CLEANROOM?
The specific features of any cleanroom are dictated by variables such as available space, height restrictions, accessibility requirements, the need to be transportable and the overall processes undertaken within the cleanroom itself. Here are some key features to consider when choosing an appropriate cleanroom for injection moulding.
Transportability:
Does your cleanroom need to cover a specific section of machinery as part of the injection moulding process? Does the machine produce non-medical as well as medical components? If this is the case, then consider a Softwall cleanroom on castors for ease of movement and transportability, enabling you to create a controlled environment when necessary.
Tool changing:
Flexibility is key for injection moulding manufacturing as one machine might be used to produce a range of different products. As such, accessibility is required to change the tool used to produce the parts. A transportable cleanroom can simply be moved to gain access to the tooling area, however, a more permanent structure requires a more innovative solution, such as a HEPA-lite canopy with a sliding filter unit to allow crane access from above.
Materials:
Softwall cleanroom panels are often used in injection moulding to achieve an ISO Class environment and benefit from being lightweight, transportable and easy to construct. Hardwall panels accomplish a sturdier structure and have options for extras such as shelving units and transfer hatches. Monobloc wall panels provide further capacity for more stringent environmental control, however, come at a greater cost than Softwall or Hardwall panels and are less flexible in terms of accessibility.
THE PRISTINE PROCESS
Air filtration and ventilation:
Cleanrooms for injection moulding machines often require the fan filter unit (FFU) to be located directly above the platen and moulding tool to ensure optimal filtration where it’s needed the most. This will influence the design and layout of your facility and will dictate the layout of machinery when inside the cleanroom.
Efficient workflow:
Anyone entering the cleanroom to operate machinery will need to enter a change area first, to ensure minimal contamination from the outside environment. Injection moulding machines often have a conveyor belt or shoot to facilitate the movement of the finished product, so your cleanroom process and workflow will need to take this into consideration to ensure that equipment and personnel flow follow a logical, contamination-reducing path.
Automation:
Automation plays an increasingly important role in cleanroom environments, especially for injection moulding processes. Incorporating automated systems can significantly reduce the risk of contamination by limiting human interaction with machinery and products. Robots can perform tasks such as loading raw materials, operating moulding machines, and packaging finished products. This not only enhances precision and consistency but also improves production efficiency.
HOW DO I ENSURE MY CLEANROOM IS COMPLIANT THROUGHOUT THE INJECTION MOULDING PROCESS?
Ensuring compliance requires a combination of meticulous planning, regular monitoring and adherence to strict protocols throughout the entire lifecycle of the cleanroom.
The first stage of cleanroom compliance is before the construction begins. The development of a User Requirement Specification (URS) is critical for GMP cleanrooms, and must consider both regulatory and process requirements – what GMP classification are you required to work to? Do you have any process requirements, such as temperature or humidity control?
Regular validation and requalification is a requirement for all cleanrooms to ensure you remain compliant – the frequency of requalification will be determined by the regulatory standards your cleanroom adheres to.
In cases where a single injection moulding machine is used to produce multiple products, a clean environment may not be required for every
product. Obtaining a particle counter is highly advised if your cleanroom is used intermittently as you will need to be able to measure the level of particles inside the cleanroom before production starts, ensuring compliance during use.
Ensuring the personnel operating the cleanroom environment are appropriately trained is a critical part of compliance. They will be responsible not only for adhering to strict cleanroom protocols such as gowning, day-to-day manufacturing procedures, entry and exit protocols and ongoing cleaning, but also maintaining proper documentation.
In summary, the answers to the above questions go some way in providing a clear understanding of why cleanrooms are vital in the injection moulding process and important factors to consider when designing such environments.
“The development of a User
Requirement Specification
(URS) is critical for GMP cleanrooms and must consider both regulatory and process requirements.”
AMERICHEM HEALTHCARE LAUNCHES
ColorRx® Medical Grade Polymers Product Line in the European Market
European medical device manufacturers and stakeholders can benefit from local production and worldclass ISO 13485 quality.
Americhem Healthcare, a globally recognised developer and manufacturer of custom colour masterbatch, functional additives, engineered compounds and performance technologies, has intensified its efforts in Europe to support material selection and medical device development.
“We’re furthering our ‘global reach, regional focus’ by extending Americhem’s capabilities to meet increasing European healthcare industry demand for high quality polymer materials. We stand at the forefront of medical device market trends, healthcare application innovation and sustainable solutions,” said Barto DuPlessis, vice president and general manager, Europe.
“Our masterbatch and compounding excellence for advanced surgical instrumentation, robotic-assisted surgery (RAS), drug delivery, catheters, hearing aids and more lines up perfectly with the needs of the European healthcare market.”
Americhem is introducing ColorRx® compounds and masterbatch in a variety of standard colours and base resins to the European market to help OEMs and their moulders kick start their device development. Custom colour
matching and development is also part of the offering and Americhem will be with stakeholders every step of their application journey.
Some of the features include:
• ColorRx® polymers will be produced in one of three ISO 13485 and cGMP compliant facilities throughout the world, ensuring the highest standards of quality and reliability. The formulations are locked and undergo rigorous biocompatibility testing, providing peace of mind for healthcare applications.
• ColorRx® manufacturing includes two state-of-the-art clean compounding facilities, guaranteeing the purity and quality of the polymers. This is crucial for maintaining the integrity of medical devices and ensuring patient safety.
• With a robust process change management system and notice of change protocols, ColorRx® ensures consistency and reliability in every batch. This minimises risks and ensures that your medical devices meet stringent regulatory requirements.
• ColorRx® offers global supply and formulations that are RoHS and REACH compliant. This ensures that your medical devices can be used worldwide, meeting international standards and regulations.
• ColorRx® is committed to sustainability, offering eco-friendly formulations that reduce environmental impact. This aligns with the growing demand for sustainable healthcare solutions.
An ageing patient population, miniaturisation of devices, increased and evolving regulatory scrutiny, demand for sustainable products and growth in emerging markets–just to name a few–are fuelling efforts to help customers stay ahead of the curve.
“Our capabilities in polymeric engineering allow our customers to design their cutting-edge devices to meet the rigor of the medical environment through precise material selection, custom compound design, and colour harmony,” added DuPlessis.
Americhem Healthcare was purposefully created to fully support all phases from a product designer’s vision to prototyping to the full launch of a medical device with the material quality and consistency imperative in the medical industry. For more information, visit www.Americhem.com email: burban@americham.com
MARK WINKER, TECHNICAL SALES EXPERT AT REPLIQUE SHARES THE TOP APPLICATIONS OF 3D PRINTING IN MEDICAL DEVICE INNOVATION.
Improving medtech layer by layer
3
D printing, also known as additive manufacturing, has revolutionised the medical device industry. By building objects layer by layer from digital models, 3D printing enables the creation of highly personalised devices tailored to individual patient needs. Beyond that, the technology accelerates development times and reduces overall costs.
Lab Equipment
In the medical research and diagnostics area, 3D printing has proven invaluable for developing custom lab equipment. By enabling on-demand production of custom fluidic systems, sample holders, and other specialised tools, 3D printing allows for the rapid and cost-effective production of intricate components.
For example, 3D printing enables the creation of specialised vial huggers— devices designed to securely hold and stabilise vials during experiments or automated processes. These custom fixtures enhance accuracy and reduce the risk of contamination.
Prosthetics
One of the most impactful applications of 3D printing in medicine is in the field of prosthetics and orthoses. Traditional prosthetic devices can be costly and time-consuming to produce, often requiring multiple adjustments for a proper fit. 3D printing revolutionises this process by enabling the creation of custom prosthetic limbs and orthoses that are tailored to the unique anatomy of each patient.
Additionally, the integration of generative design with 3D printing is further enhancing the development of prosthetics and orthoses. Generative design algorithms can automatically generate optimised designs that consider factors such as weight, strength, and material efficiency. This approach allows for the creation of lightweight yet durable prosthetics and orthoses that are not only more comfortable for the user but also more functional.
Implants
Traditional implant manufacturing often involves standardised components that may not perfectly fit every patient’s anatomy, leading to potential complications and longer recovery times. In contrast, 3D printing enables the creation of implants tailored to an individual’s unique anatomical structure.
One key benefit of 3D printing in this context is its ability to produce complex geometries and internal structures that traditional methods may struggle with. This allows for the development of implants with enhanced functionality, such as porous structures that promote bone integration.
Surgical tools
The design and manufacturing of surgical tools have been significantly enhanced by 3D printing. Surgeons could now utilise custom-made instruments and surgical guides that are tailored to specific procedures or anatomical challenges. This personalisation helps improve the accuracy of complex surgeries, reducing the risk of complications and enhancing overall surgical performance.
Materials and certifications
The materials used in 3D printing for medical devices are critical to ensuring both functionality and patient safety. Medical-grade materials must be biocompatible, durable, and capable of withstanding sterilisation processes. Common materials include biocompatible polymers like PEEK (polyetheretherketone) and ULTEM (polyetherimide), known for their strength and resistance to high temperatures. These materials must meet stringent regulatory standards to ensure safety and efficacy. The FDA and EU MDR impose rigorous criteria to ensure materials do not cause adverse reactions and maintain their integrity in clinical settings. Certifications such as ISO 13485, which focuses on quality management systems for medical devices, are essential to ensure that manufacturing processes consistently produce safe and effective products.
Outlook
As 3D printing technology continues to evolve, its applications in medical device design are likely to expand further. Future advancements may include more sophisticated materials with enhanced properties, improved printing techniques, and broader integration into various aspects of healthcare. Developments in bioprinting and AI may further enhance the capabilities of 3D printing in medical device design.
JOHN KAWOLA, CHIEF EXECUTIVE OFFICER-GLOBAL
OPERATIONS OF BOSTON MICRO FABRICATION (BMF), DISCUSSES HOW 3D PRINTING IS DRIVING INNOVATION ACROSS MEDICINE.
MANUFACTURING MEDTECH
3
D printing continues to grow and change how we innovate across industries. Though the technology can seem like a buzzword to many, over the past 20+ years I’ve seen how 3D printing has expanded the possibilities of innovation and solved industry pain points that have been plaguing companies for years. Today there’s a unique opportunity for expanded applications in the medical technology industry, where there’s often a need for extreme precision that traditional manufacturing isn’t always able to accomplish. Ultra-high resolution parts are often essential to driving innovation and, as parts get smaller, many scientists are utilising 3D printing to help further medical care and life science research across the field of medicine – from drug development to surgical tools and medical devices.
The magic in the materials
The materials used in the development process are an important consideration for the medtech industry when planning how to manufacture different parts. Given they need to replicate the environment of the body or may even be used in a medical procedure, there is an enhanced need for biocompatibility and sterility of materials. Materials must be able to elicit the desired biological response, oftentimes trying to mimic the organic bodily response. Biocompatible and sterile materials ensure the appropriate level of biosafety to be used in in vivo applications.
While an innovation could have positive impacts on a patient, without safe materials it could have little, or even adverse effects on the body. With 3D printing, engineers can work with various materials, customise product design and manufacture on a smaller scale to test biocompatibility. The technology also allows for more flexibility with lower sample runs than traditional manufacturing, which is ideal in the development process.
Advancement across life sciences applications
Medical procedures rely on tools to help clinicians better understand the patient’s condition. As innovation has advanced the field, these tools have become increasingly high-tech in order to quickly diagnose and address patient problems. In procedures, 3D printed devices can be used where there’s a need for high-precision for micro parts.
The level of precision and size micro 3D printing can achieve is suited for emerging research into new treatment modalities. Immunotherapy is just
one area of research turning to the utilisation of micro-scale tools to change how we treat hard-to-treat diseases, like cancer.
High-precision solutions are also advancing the medical industry in pharmaceutical research and development (R&D). In an area of exciting research, micro 3D printing is aiding the development of microfluidic devices. Devices can be difficult to develop due to the need for very narrow channels that allow fluid to pass through in a specific arrangement, but micro 3D printing solves this challenge with the ability to develop highly accurate distinctive features, which enables a more accurate replication of the human body in a small device.
These devices have the potential to be used in testing new drugs before entering the clinical trial phase, as the 3D printed devices are a more accurate representation for human biology than traditional models, which can help better predict a human body’s response to drugs being developed. 3D printing also allows pharmaceutical researchers to customise these microfluidic devices, and create unlimited devices to conduct non-invasive testing, making their imperative work easier and results clearer to help advance medical research and create new solutions that power clinical use.
Looking ahead: endless potential for medtech
These are just a few examples of 3D printing propelling innovation in the life sciences industry. While it’s clear that miniaturisation is driving immense innovation in medtech and healthcare, high-precision isn’t just a requirement for micro parts. There are many instances where larger parts need the same precision and ultra-high resolution to build a better product. Looking ahead, I expect to see 3D printing’s presence in medtech grow even further, enabling the pioneering of new treatments and modes of care delivery regardless of size.
ROBERT MUSSELLE, CUSTOMER ENGINEERING MANAGER EMEA AT PROTOLABS SHARES WHAT YOU NEED TO CONSIDER WITH 3D PRINTING AND PLASTICS PROTOTYPING.
Prints Charming
Prototyping is essential when producing plastic parts - where medical device manufacturers must assess the ergonomics and functionality of surgical instrument designs, for example, before delivering them to practitioners.
As a technology for rapid prototyping, 3D printing has evolved over recent years, becoming an increasingly popular way to increase the speed and efficiency of the design process. It does have some limitations though, which are important to consider when deciding how to iterate your product.
THE ADVANTAGES OF PROTOTYPING
Prototyping is the most effective way for businesses to keep costs low during a project. Planning for and producing multiple iterations of a design helps to reduce the risk of the project failing in the long-term and ensures the optimal part design is delivered before going into production. However, before the prototyping phase begins, it’s important to understand what purpose it will serve. Does your designer simply need a concept model for a visual representation of a part or product, or are they looking for a more functional prototype to work with and test with target users, for example?
Concept model - This is likely to be one of the first parts produced during a product cycle and is intended to provide a visual representation of the part or product. 3D printing technologies such as stereolithography and fused deposition modelling are typical manufacturing methods for concept models.
Functional prototype - This gives a design team the ability to test the form and fit of a part, providing an accurate representation of the final part’s material properties. CNC machining or 3D printing technologies like Multi Jet Fusion are often used during this process.
Once you’ve settled on your initial requirements, you then need to choose your preferred method for producing the prototype - be that 3D printing, CNC machining or injection moulding. Each method offers advantages and limitations, which can help businesses determine the one that best suits their needs. Part size, surface finish quality and feature size/resolution requirements should all be factored in as part of the decision-making process.
BENEFITS AND LIMITATIONS OF PROTOTYPING
Benefits
• More cost-effective - Because there are no fixturing or cutting tools with 3D Printing, part costs are generally lower than the alternatives. The process simply involves the raw material, machine time, and whatever secondary post-processing is needed.
• Fast lead times and quick iterations - The elimination of tooling and traditional “setups” that are typical of injection moulding means quicker turnaround times. Many printers also have sufficient build volumes where designers can produce multiple iterations in the same build.
• Fewer design constraints - Many manufacturers use 3D printing to produce complex assemblies in one print, reducing part count and simplifying their supply chain. Ensuring the design can be manufactured at production quantities via injection moulding is key if this is the end goal.
Limitations
Mechanical properties - Resins and powders used in 3D printers are “like” materials. They approximate their moulded and machined counterparts, so they can’t be considered direct replacements.
• Surface finish - Due to the layer-by-layer build process, on a practical level all 3D printed parts suffer some level of “stairstepping”. Surface finishing techniques such as vapour smoothing can add time and cost - however, they are great at removing imperfections.
• Limited colour options - As a rule, 3D printing delivers white, black, grey, or translucent parts. Dying or painting a prototype will require additional postprocessing steps.
When it comes to 3D printing, manufacturers today can choose from a range of technologies, including Selective Laser Sintering (SLS) and jetting processes such as PolyJet and Multi Jet Fusion (MJF). All are excellent for producing prototypes – and several are fast enough to support low-volume, enduse part production.
3D printing is a perfect option for medical parts design, which often require small runs of individual pieces. If you’re looking to produce larger quantities of plastic parts, however, there may be more costeffective methods, such as CNC machining.
The prototyping phase is critical in the success of a product, ensuring it is feasible and reducing costs and risks before production. It’s important that you take time to consider the best manufacturing methods for your project and for each phase of it.
NORMANN FICHTNER, MARKET
DEVELOPMENT
DIRECTOR,
AM AT NANO DIMENSION, LOOKS AT THE RAPIDLY GROWING USE OF AM WITHIN THE WORLD OF MEDICAL DEVICES.
As we navigate a world increasingly focused on personalised medicine, digital health and smart healthcare solutions, advanced technologies such as 3D printing are no longer a novelty, but a core pillar of daily operations for medical professionals across the globe.
While applications are still evolving at rapid pace, the introduction of AM is already redefining and reimagining many areas across the medical device landscape. These span from unlocking the creation of intricate, customised electronic components that can be seamlessly integrated into medical devices, to the micro 3D printing of tiny, precision parts that are proving transformative in everything from surgical tools to diagnostic devices. This technology is not just a glimpse into the future – it’s happening now, and its impact is profound.
POWERING UP THE FUTURE
Enabling unparalleled levels of customisation, integration and innovation, the scope of Additively Manufactured Electronics (AME) is vast, with research rapidly developing, ushering in the next evolution of wearable electronic devices at an unprecedented pace.
Using custom flexible materials, companies like Nano Dimension are working at the cutting edge of innovation to generate novel research of circuits that conform to organic or custom shapes. In real terms, this means opening up new avenues for research into game-changing patient solutions such as smart patches and tattoos for on-skin testing. These devices could be used to monitor biological changes that would help with the monitoring and management of diseases like diabetes in the very near future – making wearables an exciting segment warranting close attention in the years to come.
MINIATURE PARTS, MASSIVE IMPACT
Another aspect central to the ongoing transformation of the medical device industry is the recent advancement of micro-additive manufacturing, or micro-AM: the use of 3D printing to produce minute, micron-level parts that can be used far beyond for a whole host of applications. As we see a rise in demand for small components due to more minimally invasive surgeries, technological innovation in this segment is evolving alongside to meet these needs. The change of pace in the uptake of micro-AM is also fueled by an increased focus on personalised devices and models, and the ongoing miniaturisation of medical devices, as well as the ongoing growth of microfluidics in research.
Unlike traditional methods such as micro injection moulding or CNC machining, which are costly and limited by tooling requirements, micro-AM allows for intricate geometries without assembly hassles –streamlining the production process by reducing both time and effort. The potential of this technology is exemplified in the production of parts such as micro needles, microfluidic chips and personal medical device miniaturisation, where size, accuracy and production times are critical to their successful end use.
In areas such as medical research, we are already seeing advanced, futuristic applications that just a few years ago might have seemed inconceivable. For example, innovative medical device startup, Antishock, has developed a disposable, non-invasive, continuous monitoring system that measures patients’ systemic fluid responsiveness, preventing IV fluid overload. This is a common condition among ICU patients that not only has negative financial and clinical implications, but more importantly can cause organ failure, and in severe cases, death. Antishock’s electro-optical sensing medical device, based on a tiny sensor, is built out of several small mechanical moving components. 3D printing proved critical not only to creating these actual parts, but to the product development and prototyping process, not to mention affording the company substantial efficiencies in time and cost.
Ultimately, these use cases merely scratch the surface in demonstrating the vast potentials of AM in the medical device sphere. It is already making technological innovation more affordable and accessible – with yet more breakthrough advancements and novel real-world applications undoubtedly laying ahead.
Recombinant PYROSTAR™ Neo+ mimics the same cascade reaction as traditional LAL reagents that are derived from Atlantic horseshoe crab blood. With three recombinant factors (Factor C, Factor B, and proclotting enzyme) and the pNA chromogenic group PYROSTAR™ Neo+ offers an assay with high sensitivity and endotoxin specificity.
Colorimetric method, can be used with an absorbance plate reader
Endotoxin-specific reagent eliminates the risk of false positives from (1-->3)ß-D-Glucan
Quantitative range: 0.001 to 50EU/mL
High sensitivity with less lot-to-lot variation
Stable storage after dissolution (4
at
and 2 weeks at -30°C)
Help minimise your impact on wildlife. Choose PYROSTAR™ Neo+ Endotoxin Testing
out more: www.alphalabs.co.uk/pyrostar-neo+
BRIGHTMARK CEO BOB POWELL DISCUSSES PLASTICS RENEWAL TECHNOLOGY AND HOW TO BRING SUSTAINABILITY INTO THE MEDICAL INDUSTRY.
is bright The future
What motivated Brightmark to work with Lewis Salvage?
At Brightmark, our focus is on developing solutions that have a positive impact not only on the environment, but also in the communities where we operate. That commitment is especially important to us with our circularity centre in Ashley, Indiana, and that’s why we’ve sought out impactful collaborations in the surrounding area – namely Fort Wayne and, of course, in Warsaw, where Lewis Salvage is based.
hard-to-recycle plastics, into new, circular products, diverting them from landfills and the environment.
We receive incoming plastic waste from various sources, including plastics (4 through 7) at the end of their lifecycle from multiple sectors. Once we receive plastic waste, we leverage our Plastics Renewal process to break down the material by heating it in an oxygen-free environment through a patented pyrolysis process.
The end product is circular pyrolysis oil that is ISCC PLUS certified. ISCC PLUS is a global sustainability certification system that certifies the product will be used to create circular plastics. These plastics have a lower environmental footprint compared to new virgin plastics made from fossil fuels.
What are the biggest challenges faced in recycling medical plastics, and how does you address these challenges?
Our solution complements the existing mechanical recycling system and provides new ways to deal with waste. These solutions benefit communities with recycling infrastructure challenges and help manufacturing industries and businesses improve their environmental footprint.
Warsaw, the “Orthopaedic Capital of the World,” has the world’s highest concentration of orthopaedic design and manufacturing companies –and many of them work with Lewis Salvage to recycle products that have reached the end of their lifecycles or are no longer usable in the medical field. Lewis Salvage’s system of unpacking medical implants and separating the metal from the packaging pairs extremely well with our Plastics Renewal technology, which can recycle all kinds of plastic types 1 through 7. It’s a collaboration that makes a lot of sense, and we couldn’t be happier with our progress so far.
What specific technologies and processes does Brightmark use in its Plastics Renewal technology?
Brightmark’s patented Plastics Renewal technology is designed to convert plastic waste, specifically
According to the American Medical Association, the United States produces six million tons of medical waste annually, with plastics accounting for about 25% of that total. Despite 85% of that waste being non-hazardous, the overwhelming majority is not recycled. A key reason is the multi-material makeup of plastic healthcare waste, making it extremely difficult for hospital workers to effectively segregate the material into the proper waste and recycling streams.
Brightmark’s strategic partnership with Lewis Salvage helps reduce medical plastic waste because our technology can accept and process all types of plastics 1 through 7, even those plastics that are deemed difficult to recycle.
How does the Minimised Landfill Recycling Program work?
Warsaw, Indiana, is home to one-third of the world’s orthopaedic manufacturing companies and two-thirds of the world’s hip and knee manufacturing companies. Because of this, Lewis Salvage receives medical waste from those healthcare facilities. Among the many services they offer, Lewis Salvage can unpack medical implants and mechanically separate the metal material from its packaging. They can then destroy the implants and send the packaging and additional plastics they receive from implant manufacturers and medical device companies to the Brightmark facility in Ashley. From there, we can turn that material into the building blocks for new circular plastics.
What impact has the strategic partnership had so far in terms of waste reduction and environmental benefits?
To date, we are extremely proud to share that Brightmark has been able to recycle approximately 400,000 pounds of plastic waste as a result of its strategic partnership with Lewis Salvage – effectively diverting this waste from landfills and incinerators.
Brightmark and Lewis Salvage will continue to identify and assess new streams of plastic medical waste to recycle. We ultimately hope this program will inspire other manufacturers—both in the medical space and beyond—to collaborate with companies like Lewis Salvage and Brightmark, allowing us to continuously increase the amount of plastic waste that gets recycled. There is so much more to be done, and we’re always open to conversations with new feedstock suppliers.
