MPN NA Issue 26

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OLIVIA FRIETT

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There’s always something new to learn about in the medical plastics sector, in fact trying to keep up with regulatory updates has become a common struggle.

As someone who is relatively new to the sector, I’m constantly finding myself learning new things about regulations and having to search for updates and further information on a weekly basis – but it seems regardless of how long you’ve been in the field, everyone is in the same boat.

The government has put in legislation that amends the UK MDR to extend the acceptance of CE marked medical devices on the market. This means devices that are compliant with EU MDR or EU IVDR can be on the GB market until 30th June 2030. This is not to be confused with the indefinite recognition of the CE mark announced by the government for other sectors – so medical devices are indeed getting some special treatment. Whether it’s the right treatment remains to be seen.

On the second day, Dr Nicola Thorn, CEO, AND Technology Research, discussed how to navigate regulatory hurdles for software/ technology-based products. Thorn described how software products fit, how developers can navigate the challenge around regulatory submission, along with her expertise in the area.

Regulation was also at the forefront of the HealthTech Integrates conference focused on technology, diagnostics, devices, and therapeutics.

James Fry, partner and head of life sciences, Mills & Reeve facilitated a session with panelists from iMed Consultancy, British Standards Institution (BSI), ORCHA and Element Materials Testing. By having panelists from different departments in the sector, the audience were able to capture a gauge on if regulation is keeping pace with innovation.

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In the past few months, I’ve had the privilege of being invited to some incredible talks and shows and undoubtedly, “regulation” was the word on everyone’s lips.

At Med-Tech Innovation Expo, there were several talks on regulation each day.

There was a live MedTalk Podcast on the subject “The Latest in the Med-Tech Regulatory Landscape”, which featured Professor Laurie Rowe, founder and CEO of Red MedTech, Fiona Maini, principal global compliance and strategy manager, Dassault Systemes and Laura Friedl-Hurst, principal consultant and managing director, LFH Regulatory.

The topics covered included ‘The latest developments surrounding UK requirements’, ‘How recent fast-track approvals from EU, US and Japan may affect the UK’ and ‘International regulations: The effect on UK innovators and the effect on overseas innovators coming to the UK’.

Additionally, a talk on navigating the regulatory pathway and how to prepare the regulatory strategy to enable a rapid route to market and select the right regulatory pathway was facilitated by Hugh Harvey, managing director of Hardian Health, and again the panelists were from different departments and at different levels of regulation in the sector – BSI, Prosoma, Decode X, Mills & Reeve and 52 North Health, meaning the audience could have a clearer picture and the best advice on which route to take.

Forgive the list but what I’m getting at is regulation discussions are everywhere in the industry, but with talks of transition, amendments and still not a clear picture of how the landscape will end up, especially in the UK, even those who know a lot feel like they know little.

Picking the right regulatory pathway is probably the biggest choice companies are having to make – is it worth paying to be UKCA marked? Do you stick to the bigger markets such as EU and US? Or the UK? Will choosing incorrectly affect the company? The lack of clarity makes things so uncertain.

EXPANSION UPDATE

https://www.conventuspolymers.com/

Conventus Polymers announces opening of Singapore subsidiary

Conventus Polymers has established a subsidiary in Singapore, which will offer the company’s portfolio of products to processors and end users throughout Southeast Asia. The expansion into Singapore is part of the company’s overall business strategy to grow into key geographic regions.

Establishing a legal entity strengthens its position in the Southeast Asian market and allows the company to offer local service and support to both local customers and US-based OEMs that it currently supports.

Conventus chose Singapore based on several factors including geographic location, ease of doing business, and tax laws.

MACHINERY UPDATE

With a legal operating entity in Singapore, Conventus can offer its international customers import and export capabilities, local inventory and warehousing, local currency transactions, and Delivered Duty Paid (DDP) Incoterms. Conventus will handle all exporting, importing, insurance, customs clearance, duty costs, and freight from port to warehouse to the customer.

https://www.plastekgroup.com/

THE PLASTEK GROUP PURCHASES EQUIPMENT FROM SODICK

ACHIEVEMENT UPDATE

https://www.trelleborg.com/

Trelleborg achieves ‘Masters’ supplier status with Daimler

Trelleborg Sealing Solutions receives the 2022 Masters of Quality Award from Daimler Truck North America (DTNA).

DTNA evaluates suppliers based on a scorecard measuring a supplier’s quality, delivery, technology, and cost performance. The suppliers must also demonstrate dedication to continuous improvement of the quality of their products, support to DTNA and overall performance.

Jill St. John, sales engineer, Trelleborg Sealing Solutions, says: “It took the hard work of many people at Trelleborg to achieve this prestigious award. We navigated various challenges to get everything set up correctly including multiple shipping locations, warranty claims, valid quality certificates, and quick response to questions.”

Carsten Kirchholtes, general manager of procurement and

supply chain management, DTNA, says: “This is a very big accomplishment within DTNA as it recognizes the ‘best of the best’ suppliers.”

Trelleborg began supplying DTNA a custom axel gasket in 2021 and is now at full-ramp up and production. This is the first time Trelleborg has received the Masters of Quality Award.

The Plastek Group has announced the purchase of equipment from Sodick, a specialist in precision EDM technology.

This decision comes after an evaluation process led by a team of Plastek’s toolmakers and stakeholders, in collaboration with counterparts in Brazil.

“Our main objective throughout this evaluation was to identify the equipment manufacturer that we could partner with to meet The Plastek Group’s long-term needs, in North America and Brazil.” said James Jergens, tooling general manager.

The evaluation process comprised 32 key points

of interest, encompassing machine test cuts, service availability, accuracy, longterm pricing, and equipment availability. Sodick’s reputation in precision EDM equipment and their dedication to providing support and service solidified them as the partner for the company’s expansion efforts.

The Plastek Group anticipates the new equipment’s delivery in September. Implementing Sodick’s Wire EDM, Sinker EDM, and EDM Drill will bolster productivity and enable the company to pursue new opportunities and address the ever-evolving demands of the global market.

https://www.technipaq.com/

Technipaq, a specialist in sterilized packaging solutions for medical devices and healthcare organizations, has announced the acquisition of two new header bag machines at its Crystal Lake facility. The first of the 48” wide web pouch machines arrived in June and the second in July.

As an expert in the manufacturing and development of header bags, Technipaq owns and continues to operate one of the first machines developed for manufacturing medical header bags for sterile use.

“We are excited to increase the capacity with such high precision, quality machines.” said Brian Rosenburg, president at Technipaq.

This acquisition strengthens Technipaq’s ability to produce header bags for healthcare systems and customers across North America. With the expansion of Technipaq’s machine operations, the organization now has the capability to produce twice as many header bags as before.

To make way for these new machines, Technipaq recently expanded its manufacturing cell at the Lutter Drive facility in Crystal Lake by over 3,600 square feet.

TekniPlex Healthcare will provide insight on ways to bolster sustainability in the healthcare sector at Pack Expo, Las Vegas.

Melissa Green, head of global marketing for TekniPlex Healthcare, will present Minimizing Healthcare’s Sustainability Gap at the show’s Innovation Stage 2.

During her presentation, Green will discuss a key aspect of TekniPlex Healthcare’s commitment to enhancing eco-friendliness: a dedicated adherence to sustainability’s three “R’s” - reduce, reuse and recycle.

https://www.nonwovens-innovation.com/

NIRI opens Innovation House

NIRI has relocated to new headquarters, with a £1.2 million investment that more than doubles the size of their facilities and includes seven new laboratories with increased R&D capability.

The new facilities at Innovation House have been designed in close collaboration with NIRI’s textile engineers and material scientists, a 40-strong team with combined experience of more than 400 years of textile science and industrial expertise.

Chris Fowler, NIRI group founder, said: “We’ve invested in more equipment, more people, bigger and better-equipped labs. This move will help enable us to deliver our three-year strategy for growth, with

While no perfect panacea exists, substantial sustainability gains can be realized through methods such as light weighting certain packaging elements, reducing energy consumption, reusing materials wherever practicable, and maximizing the amount of packaging substrates compatible with existing recycling streams.

At booth SL-6620, TekniPlex Healthcare will showcase its latest sustainable invention: a fully transparent recyclable mid-barrier blister package.

The mid-barrier blisters feature a polyolefin blister film paired with a barrier PP lidding film. This marks the first time a formed blister + lidding combination is certified as recyclable.

the expansion of our functional chemistry, formulation, and polymer engineering capability.”

Over the last 17 years, and guided by the vision of its founders Chris Fowler and Professor Stephen Russell (group technical director), NIRI has transformed raw materials into fully functional prototypes, ready to be scaled up and developed for commercial release across consumer and industrial sectors.

The new facilities at Innovation House allow for continued expansion and for further scientific R&D.

WEAR IT WELL

DAVE LIEBL, CHIEF COMMERCIAL AND TECHNOLOGY OFFICER, INTRICON, HIGHLIGHTS THE MAIN CHALLENGES FOR DESIGNING WEARABLE DEVICES.

Medical biosensors represent lucrative opportunities for innovative companies to disrupt and lead a market destined for growth. Wearable medical devices are an exciting frontier for startups and OEMs, but there are significant obstacles to the commercial viability of any device.

There is a need to take an approach to medical biosensor development that accounts for manufacturing, quality, and cost controls – early in the design process - to not only meet regulatory requirements but also enter the market with a commercially viable product.

Consider these key wearable medical device challenges and solutions:

1. Cost and commercial viability

Designers often wait to consult manufacturers until they’re ready for production quotes. At that advanced project stage, manufacturers are constrained by the design concept. They must find a way to manufacture the device to specifications, but those specs might not be the most efficient or cost-effective. Changes are limited only to those required for production feasibility, not those that could enhance the product or manufacturing process.

If manufacturers are consulted earlier in the process, they can recommend adjustments that minimize late-stage changes, significantly reduce costs, and accelerate time to market.

The need to scale production volumes influences cost and commercial viability. You must be able to design and manufacture a product that will hit cost targets at scale. Whether you design ten, 100, or 1,000 workable parts, success lies in your ability to sell it profitably at scale at prices the market will accept.

2. Manufacturability

Designers sometimes overlook the value of consulting with manufacturing experts, but working with a proven and trusted manufacturer from start to finish is best practice. Create a concept and then consult a manufacturer to complete a Design for Manufacturing (DFM) review. Lean on manufacturers and stay open to suggestions and modifications. Proven manufacturers know the best way to execute the design vision efficiently and cost-effectively.

With medical wearables, a manufacturing expert can help designers understand limitations and opportunities, especially as demand increases to make components smaller without sacrificing structural integrity and functionality. For example, connectivity is crucial for many medical biosensor devices, so designers often want to encapsulate antennas, magnets, and other components in plastic. However, that isn’t easy to do without affecting functional integrity. Plastic molding involves high temperatures and pressures that shift components around and reduce the functionality of magnets in electronics.

There are better ways to encapsulate an assembly, but designers aren’t always aware of the manufacturing options. Overmolding is a good example. Think of an Easter egg with two halves: you can put anything inside, and the egg will protect it. With overmolding, a base component (called a substrate) is molded and allowed to cure and then, a second layer is molded directly on top to create a single, solid piece with a hermetic seal.

3. Clinical and regulatory requirements

The global biosensor market is constrained by existing and evolving regulations, complicated reimbursement policies, and slow adjustments to new technologies. A National Institutes of Health time-to-market analysis found that the main bottleneck is the clinical trial stage, where failures are rooted in insufficient design, poor understanding of user requirements, and lack of testing early in the development process.

Knowing the device’s classification and researching regulatory guidance and precedents is vital. However, that can prove challenging when real-life requirements often extend beyond documented rules and include the experience of precedents and related submissions. An experienced partner can help develop the regulatory strategy and craft the submission to earn FDA approval. It might seem like an extra step, but it’s far more cost effective to solve potential issues during the design stage than to re-engineer after FDA denial.

HIGH PERFORMANCE SOLUTIONS FOR LEADING MEDICAL APPLICATIONS.

Precision meets speed and cleanliness. The all-electric ELION is the ideal injection molding machine for the cost-effective mass production of consumables for in-vitro diagnostics, primary packaging and drug delivery systems, as well as healthcare and medical disposables.

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SCAN ME

MICK FRY, ENGINEER, MINNETRONIX MEDICAL, EXPLAINS HOW TO SIMPLIFY THE COMPLEXITY OF YOUR MEDICAL DEVICE DESIGN TO MAKE PRODUCTION MORE EFFICIENT.

REDUCE THE PARTS, reduce the headaches

The ultimate success of your medical device can be greatly affected at its inception –during the design phase. This early stage is the ideal opportunity to partner with others, especially those who will be responsible for producing and scaling up your device while keeping timelines and costs under control, for insight on how to achieve your goals for the device.

Manufacturers can lend valuable recommendations during design, including ideas on ways to reduce the complexity of the device to increase success of the project, without affecting the device’s functionality.

Take the number of parts, for example. At the design stage, consider having a manufacturer assess the number of parts that will be required to produce the device. There may be ways to combine or eliminate parts in various design and production scenarios. With fewer parts, development and manufacturing can be streamlined. With less parts to procure, there will be fewer supply chain issues, reduced risk of quality issues, and less time and cost needed for manufacturing, assembly, inspection, packaging, and shipping.

REDUCING COMPLEXITY FROM THE START

The primary short-term goal when creating a medical device is to prove its safety and efficacy – making sure it works. The longterm goal is to bring the device successfully to market – helping patients and driving revenue.

And then there is the goal that should be ever-present: the ability to make the product efficient enough to meet clinician and patient demand while building the OEM’s business. Producing the product in the most efficient, cost-effective manner – from its first run to large volume scalability – should be on everyone’s minds and agenda, throughout the development of the device.

At the design stage, device engineers are motivated by the short-term goal, and they design devices using what they have on hand, relying on their own experience with other devices they’ve designed. They typically build in a Lego-style format: take a part, add a part to it, add another part, and so on. As features are added to the device, the parts add up.

Complexity begins to be baked into the device from the start. The farther they go down the design road, the more ensconced in design the multiple parts become, more tooling is built, more processes are created, and it gets increasingly difficult to change and/or correct the device later.

At a basic design level, there is a part. That part is designed into a larger assembly. It’s one part that must be controlled. There must be drawings, specifications, and manufacturing methods for that part.

When the design grows to include 10 parts, that requires 10 different drawings, specifications, and manufacturing methods. For every addition and revision, there’s a ripple effect - a material non-conformance or a deviation that must be engineered, accounted for, and controlled. This leads to a systemic impact on the engineering workload required for the product. If you have fewer parts to control, revise, and track, the workload goes down.

DESIGN FOR MANUFACTURABILITY

When a designer invites a manufacturing expert into the design process to discover opportunities to reduce complexity, such as by reducing parts, the result is a device that’s designed for an optimal development and manufacturing process. This process of collaboration between designer and manufacturer is called Design for Manufacturability (DFM).

The design stage is the easiest place to reduce the number of components or parts. If a DFM process is not used as early as possible, there is still an opportunity to identify ways to use different methods of manufacturing the product, later down the line, to combine features of what would have been separate parts, into one part.

An initial analysis at the design stage keeps score on a couple of things: the number of designed parts and the number of total parts. If a part is used multiple times, like a fastener or screw, there’s an opportunity for one design. The specifications control that fastener screw but, if it’s used 15 times in the design, then it’s a component part that must be considered in the production system.

In the analysis, you can keep count of the before- and after-concepts and compare and contrast DFM-driven improvements that can be made to the device. The analysis lets you quickly see the results on the system architecture and the complexity of the entire manufacturing and engineering systems that are required to build that device.

REDUCE THE RISKS

Risk is a direct result of the total number of parts and their critical features and dimensions. Reducing risk by reducing parts is done by dimensioning and assessing the tolerance stack-up of the parts – those that are made on the minimum material condition and those that are made on the maximum material condition – that must always fit together to give you the result you want from your device. If you combine two parts into one, you now have one part tolerance, and, if that part is made with the net shape manufacturing process (like molding, casting, or stamping), those variations

in parts and features are going to be smaller over the lifetime of that part than if you had multiple parts added together.

REDUCE SUPPLY CHAIN SETBACKS

Reduction of parts in a medical device also means having to procure fewer parts, which reduces supply/availability and shipment setbacks during production. The overall workload is reduced, as is the number of things that could potentially go wrong during firstand next-generation manufacturing if there is a multitude of parts that must always be readily available and affordable.

Certified parts received by the manufacturer don’t need to be inspected, but, when they are subject to a lot of variation, an inspection step is added to the production process. It takes time for 1,000 parts to come in the door, get measured, and be deemed acceptable before they can be put into inventory and eventually make their way to the production line.

Reducing the headaches by reducing the parts in your next medical device is simple math: There is less process, problems, time, and money involved with one part vs. the multiplier effect of several. The earlier this equation is understood, the better chances you have to increase the success of your project, and your company.

LUCA RAGUZZI, BUSINESS DEVELOPMENT MANAGER, ANALYTICAL & MEDICAL, EMERSON, DISCUSSES THE CHALLENGE OF NEW REGULATIONS FOR DIALYSIS EQUIPMENT SUPPLIERS.

Medical equipment suppliers are meeting the world’s ageing populations need for advanced medical therapies, such as hemodialysis, that offer greater convenience, fewer infections, and improved outcomes. In the case of dialysis, for example, manufacturers are now building hospital-quality hemodialysis machines that have cut clinic-based hemodialysis sessions from 12 hours to four hours and have made at-home, peritoneal dialysis a reality and a preferred option for increasing numbers of physicians and patients.

But dialysis equipment builders and their suppliers face a formidable task. They must not only manage the medical side of the process with precise blood filtration and purification procedures, but also implement the technology through components and products that meet ever-higher regulatory standards while simultaneously improving consistency, reliability, and costeffectiveness. So, any technological advance to make a treatment like dialysis safer, faster, more portable, and more effective for the patient has been hard-won.

Europe’s new Medical Device Regulation (MDR), as well as rules by the US Food and Drug Administration (FDA) and other global bodies, require dialysis equipment manufacturers to rely on suppliers of fluid-system automation and control to help them meet regulatory requirements such as strict change controls, while also offering the range of necessary valves and fluid controls.

THE CHALLENGES OF HEMODIALYSIS

The fluid pathways of hemodialysis machines directly handle human blood and related bodily fluids, so MDR and FDA rules require

every wetted surface of these pathways to be made of thoroughly tested biocompatible materials — subject to source-to-end-use change controls to ensure their consistency and purity. In addition, any mechanical flow-control components, such as pumps or valves, must incorporate biocompatible materials while ensuring complete “isolation” — a hermetic separation between their power/control/actuation mechanisms and the fluid path that carries the blood being purified. This isolation prevents the risk of contamination due to metallic particles or external pathogens.

Of course, device reliability is essential since clinic-based hemodialysis machines are subject to constant use. In this context, improved reliability means flow-control valves that can operate reliably over a life of five million to six million cycles for a three-to-four-year period. Device configurability is also essential and can take several forms. For example, a large hemodialysis machine can require 20 or 30 valves, enough to run three or four identical dialysis/filtration circuits simultaneously.

In addition, configurability can also include anything from the ability to modify individual valve bodies to combining multiple valve flow paths — and associated actuators/controls/printed circuit boards (PCBs) — into compact manifolds that meet dimensional requirements. Configurability also encompasses the ability to modify controls, wire leads and connections or a valve’s noise output, since dialysis valves are typically actuated using pneumatics and must operate in a relatively quiet hospital or clinical environment, or even while a patient sleeps at home.

It is only after a valve complies with all regulatory requirements, materials, isolation, design, manufacturability, and assembly that its actual function comes into play. Within the hemodialysis process, the pressure and flow of fluids must be carefully and consistently managed through a series of dialyzing circuits. These circuits expose a volume of blood to physical filtration and a process of diffusion/osmosis where wastes are transferred from blood to a dialysate fluid.

The task of making better dialysis valves and ensuring their regulatory compliance is ongoing for the team of analytical and medical specialists at Emerson. But in addition to engineering quality and meeting regulatory requirements, these valves must also satisfy customer requirements for performance, configuration, flow rate, reliability, and ease of installation. For example, the ASCO 283/383 Series miniature solenoid valves met requirements for durability and biocompatibility, with valve bodies and fluid paths made of polyetherimide (PEI). However, a prospective customer and dialysis equipment builder asked Emerson to modify the valve to increase flow rates at required pressures (three to four bars) and to provide a special coil with flying leads that would eliminate a manufacturing step and reduce product assembly costs.

In other situations, customers might ask for a manifold assembly, which links a series of valves such as ASCO Series 188 general-service valves into a single assembly mounted on a printed circuit board along with customerspecified tubing. One such manifold design was produced for a dialysis equipment builder that sought a high-flow/low-leakage solution that would “plug and play” as part of a hemodialysis machine. As the list of regulatory and safety requirements grows, the Emerson team continues to develop new capabilities to meet them in other dialysis-related products such as the ASCO Series 284/384 pinch valves and Series RB general-service valves.

PERITONEAL DIALYSIS APPLICATIONS

In the case of peritoneal dialysis, the blood is cleaned using the lining of the body’s own peritoneal cavity as both a filtration mechanism and as a container for dialyzing fluid. Because the procedure can be done at home

— sometimes even while a patient sleeps — the latest ambulatory peritoneal dialysis (APD) machines feature compact design, lightweight componentry, low power consumption and low noise. However, the fluid components in these machines are subject to the same biocompatibility and isolation requirements as hemodialysis equipment since the fluids they carry are in direct contact with the human body.

To simplify manufacturability of APD equipment, while also meeting the latest MDR and FDA requirements, Emerson often provides equipment builders with modular, multivalve manifolds or assemblies. Like those mentioned earlier, these manifolds or assemblies may be built atop a compact printed circuit board that incorporates valve-mounted pneumatic connections, data links, and multi-pin electrical connectors.

In one such case, a PCB-based modular assembly built to hold 21 modified 10 mm miniature generalpurpose valves offered two key benefits for a maker of APD machines.

First, the pneumatically actuated assembly is lightweight and easy to install yet fits within the tight confines of a tabletop APD machine. Second, and more important, the manifold functions reliably for patients by precisely managing the inflow and removal of dialysate within the peritoneal cavity, maintaining the fluid levels and pressures essential for an optimal dialysis process.

CONCLUSION

For decades, medical professionals, dialysis equipment makers and equipment suppliers have collaborated to develop and deliver newer, safer, and more effective dialysis treatments that meet stringent regulatory requirements. With longer lifespans and ageing populations worldwide, the need for and the importance of dialysis technology for use in both clinics and in at-home settings will only grow in the years to come, creating new treatment opportunities and technical challenges for the medical device industry.

DELIVERING

Why are we seeing a higher prevalence of On-Body Delivery Systems in recent years?

The goal of On-Body Delivery Systems is to lessen the burden of treatment on the patient. These devices decrease the amount of time that patients must spend in clinical settings. This allows complex treatments to be brought directly into the user’s home.

From the human element, they improve patient comfort. Due to the nature of bolus doses or medication with longer deliver times, patients previously were required to spend hours or days at a treatment facility. Now, On-Body Delivery Systems are attached to the patient, and they can go about their business in their own homes while staying on their medication schedule.

What are the current testing standards for On-Body Delivery Systems?

These devices follow a brandnew standard, ISO 11608 Part 6. Released in 2022, the new standard references previous guidance from the 11608 series, including Parts 1-5. Part 1 covers dose accuracy, general requirements, and defines sample size. Part 2 covers needles and Part 3 addresses containers. Part 4 covers the device’s electronics, and Part 5 covers the automated function of the device. By design, there is a requirement for On-Body Delivery Systems to fulfil needs from all the parts of the 11608 standard.

Non-standard tests must also be considered. For example, if a device uses LED lights to indicate different stages of use

for that device, you must test that those function correctly across various environments and use scenarios.

Do you test for weather and waterproofing?

The intended use of these devices will often be a user’s home environment, but laboratories should also be testing scenarios that mimic the most extreme or challenging environments that the device is likely to encounter. This can include testing under cold, dry, hot, and humid conditions. Testing should clearly show at what point these devices failed, and Smithers can assist in determining the likely cause of failure.

These environmental conditions can impact the dose accuracy standard mentioned earlier. In addition, we can also conduct testing and simulated use in those environments in real time, combine this with exposure to free fall drops, and vibration conditioning and transport simulation.

What are some risks that people might not think to test for?

We have recently been specializing in is occlusion testing, back pressure testing, and the evaluation of dose delivery profiles. These are complicated and time-consuming tests that many in-house laboratories find more convenient to test through independent laboratories like Smithers.

Occlusion is particularly important for pump devices, in which there is a separate cartridge, and the product is delivered through a line to the patient. There is potential for the line to become blocked or occluded if the line becomes kinked or pinched, allowing the pump to create pressure within the line. Once that line is unblocked, the line could then deliver an unintended bolus.

Orientation is also an element people do not always consider. It may impact the functionality of the device if the patient puts it on upside down. This may

CHRIS BERRY AND GARETH WYNNE, SMITHERS, DISCUSS WEARABLE ON-BODY DELIVERY SYSTEMS, INCLUDING SOME OF THE KEY CHALLENGES FOR LABORATORY TESTING AND FUTURE TRENDS IN THE PHYSICAL AND FUNCTIONAL EVALUATION OF THESE DEVICES.

sound silly, but these devices are intended to become part of a patient’s daily routine. If that person is getting ready in the early morning or it is dark, it needs to be expected that these devices may be applied in unpredictable orientations.

The more technology and functionality included in a device, the higher the number of potential risks. If the device has a pause function, for example, how does it interact with the dose accuracy? If the user pauses it for a second, it should give a zero dose. When the patient restarts, does the device continue and give an exact dose, as per the acceptance criteria, or does it give a little bit more, a little bit less. You must design your experiments to test for these scenarios.

What unique challenges do miniaturization pose for device testing?

The device’s physical design, especially if it included ergonomics, can complicate testing, as it can impact the mounting or fixture of these devices. You want a skilled laboratory testing provider to ensure that they have the expertise and approaches necessary to customize the testing to meet that design. At Smithers, we use technologies like 3D printing to rapidly produce purpose-built fixtures to work with unique sizes and dimensions of devices.

What does the future of testing On-Body Delivery Systems look like?

Integration with more sensors is coming rapidly. You see this with the recent release of diabetes systems, with blood glucose monitoring systems

Smithers Performs Chemistry Analysis & Physical & Functional Testing

working in tandem with insulin pumps. Now, patients can have a pump communicating with a separate sensor, measuring the blood glucose level, and automatically delivering the appropriate dose of insulin.

The truth is that the industry has consistently increased the complexity of these devices over the years, so expertise in testing these devices is more important than ever. We are seeing an increase of in-house testing operations default to independent laboratories like ours because it is becoming harder to secure the expertise necessary to perform adequate testing of these devices.

WHEN TPE CAN REPLACE SILICONE

Thermoset silicone has always been considered one of the materials of choice for the fabrication of medical devices and components for healthcare and personal care, due to its qualities stemming from both its optical and haptic appearance as well as its high temperature resistance and elastic characteristics that result from being a vulcanized rubber.

But it’s being a vulcanized rubber that lies at the root of its production complexity as well as the high cost of finished components made of medical silicone, in addition to the environmental impact generated by a raw material.

Recent raw material shortages and the concentration of production capacity in the hands of a few players make alternatives based on TPEs based on hydrogenated styrenic block copolymers increasingly attractive.

In fact, medical TPEs based on hydrogenated styrenic block copolymers, such as the MARFRAN.MED compounds offer numerous advantages of both process and economic, lower environmental impact, as well as an aesthetic and haptic appearance essentially identical to that of silicone.

While silicone remains unsurpassed in terms of high temperature resistance, MARFRAN.MED TPESs perform better on numerous fronts, as they are lighter (density 0,9 g/cm³ vs. 1,20 g/cm³), cheaper if compared with medical grade platinic silicone, environmentally friendly (100% recyclable), easier and faster to be processed (30% shorter thermoplastic process cycle vs. thermoset cycle) and easier to be overmolded onto plastic substrates.

Furthermore MARFRAN.MED TPE-S medical grade compounds and MARFRAN HEALTHCARE TPE-S compounds are phthalates-free, odor-free, plasticizer-free, allergenfree, transparent, soft (hardness down to 10 Shore A), easy to process, 100% customizable.

MARFRAN TPE-S compounds are a real alternative to silicone for medical and healthcare applications.

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AXELSSON, CEO, SIGMA CONNECTIVITY, SHARES THE IMPORTANCE OF SAFEGUARDING THE FUTURE OF WIRELESS MEDICAL DEVICES.

Today’s smart portable devices can collect, process, and analyze information at incredible speeds. With the miniaturization of sensors, batteries, low power consumption and wireless connectivity, medical wearables are on the rise. With the advantage of wireless technologies, data transfer is better for patient mobility as it eliminates cables and allows for easier handling of the devices themselves.

Preventive health is more efficient than curative methods as detecting diseases and ailments at initial stages is often cheaper and likely to improve people’s overall health. But early detection and proper diagnosis cannot be done without reliable biometrics, and to have consistent measurements, a good selection in sensors and proper data analysis is essential. With the global population getting older and living longer, continuous monitoring of vital signs and general biometrics will become not just a trend, but a necessity.

THE SENSOR HUB

The step forward in this new ecosystem is a wireless sensor system which connects multiple wearable medical devices to a central monitoring unit - to simplify, a Sensor Hub. The main function is to collect, distribute, and present data to the healthcare provider, which can pre-emptively act if something is off the regular rhythm of the patient. The Sensor Hub can be adapted to different scenarios according to the needs, from private homes to elderly care, health retreats or sport activities, healthcare centers and hospitals.

A user can wear multiple devices, e.g., a ring on the finger, a wrist band, and a vest for the chest. Each one of these smart devices uses specialized sensors to measure vital signs such as blood oxygenation, respiration rate, and core body temperature. These smart devices, when in reach, will then send the data to the nearest Sensor Hub. The goal is to bring together sensors and smart devices, taking advantage of the proven technology in radio frequency communication, and incorporating the latest innovations cybersecurity has to offer.

SECURITY RISKS

With the increasing reliance on wireless connectivity, the importance of robust security systems to protect sensitive patient data and ensure the integrity of medical devices has become a major concern.

Wireless medical devices are vulnerable to security threats that can compromise patient safety and data confidentiality. Some of the risks associated with insecure wireless connectivity include unauthorized access to patient information, data breaches, interception of transmitted data, potential manipulation of device functionality, and exploiting vulnerabilities by Denial of Service (DoS) attacks which can pose a great risk to patient health.

These risks can be minimized by using what is known as the CIA approach (Confidentiality, Integrity, and Availability) to safeguard both patients and healthcare providers. There are certain aspects during development phases that should be addressed:

1. Robust Authentication - Strong authentication mechanisms, such as unique credentials, cryptographic keys, or biometric authentication, ensure that only authorized personnel, computer systems and authorized networks can access medical devices and patient data.

2. Encryption - Strong cryptographic algorithms and hash-algorithms are important to maintain confidentiality. Equipment’s should be designed

to include Cryptographic co-processors to improve performance and add an extra layer of protection.

3. Secure Network Configuration - Networks should be set with strong passwords, unnecessary services shall be disabled, and devices could be segmented based on the user roles and access requirements.

4. Continuous Monitoring - Intrusion detection systems and security event management tools can identify and respond to potential threats promptly, ensuring the integrity of the wireless medical devices.

5. Device ManagementImplementing centralized device management solutions enables healthcare providers to monitor device status, enforce security policies, and applies necessary patches or updates in a timely manner. A verification protocol should be implemented to check if the signature is valid, and that no tampering has been made to the firmware.

By adopting a proactive approach towards wireless security, healthcare providers can harness the benefits of connected medical devices in this new digital age of medical care.

CHRISTIAN

MEDICAL PLASTICS NEWS TALKS TO DAVE GRAY, HEAD OF CONTENT FOR INTERPLAS INSIGHTS AND BRITISH PLASTICS & RUBBER, ABOUT THE UPCOMING INTERPLAS SHOW AT THE NEC, BIRMINGHAM ON 26-28TH SEPTEMBER AND WHAT THE MEDICAL INDUSTRY CAN EXPECT TO SEE.

Life in PLASTIC it’s FANTASTIC

After 75 successful years of Interplas, why do you think the plastics industry has always been so important?

Plastic remains to this day the material of the future; it’s particularly important in the medical sector, all the applications that are under development at the moment are really made possible by plastic.   There is no other material that has the versatility of polymers. When you think about what we’ve just been through with COVID-19 and you think about things like ventilators, drug delivery for your vaccine, even things like shields and PPE for places of work, all those things would not have been possible.

For people to be able to carry on going to work due to PPE - you cannot make anything as quickly as you can with plastic in terms of mass production, I think that’s one of the reasons why it is such an important area.

The future continues to be strong for plastic. Unfortunately, it does have an image problem at the moment. It’s less about a problem with the material and more about the problem with our recycling

infrastructure and our behavior as people with how we value the product.

If we were talking about gold, people wouldn’t think twice about making sure that they look after it and they protect it. But unfortunately, plastic is seen as cheap and disposable and therefore people treat it that way and that is 50% of the problem.

The other 50% is the infrastructure; there are modern recycling technologies coming out all the time. Unfortunately, they’re very difficult to get approved for use and scale up. So, we’re stuck with quite an old-fashioned, archaic recycling infrastructure, but that’s changing, and I think that will help with the longevity of the industry.

Plastic is not going anywhere, it is a vital part of our everyday lives.

Are you doing anything special to celebrate the 75th anniversary of Interplas?

The fact that it’s the 75th anniversary of the show is really exciting. We’ve had lots of conversations with exhibitors and visitors already, and I think there’s a real buzz about the show now. We’ve got lots to celebrate and we’re doing that with lots of different activities.

We thought about what we could do to mark 75 years of Interplas. I think the thing that defines this industry is the individuals that work within it. We’ve put it out to the industry itself, we designed this survey last year which we sent out to all of our various communities in the plastic space and we’ve asked them to nominate 75 individuals who they feel have been most influential in the industry - could be living or deceased, but it’s got to be somebody who has made an outstanding contribution to the sector.

Whether that’s through developing a certain processing technology or discovering a particular material or an application, design, it could be

anything - but it must be somebody who has really championed the use of plastics.

Other than your 75 most influential people, what else is new this year?  We’re launching the Interplas Insights Conference, which is exciting.

We’ve got a diverse line up of sessions and we’ve played about with the format as well. In previous conferences, there’s been a standard format with half hour or hour-long presentations. What we’re doing this time is having a mix of shorter, snappier presentations throughout the day, all clustered around various themes.

Some of the themes include diversity, sustainability, recycling, contract manufacturing and medical, of course.

One of the things that we’ll be talking about, which I think is particularly pertinent to medical, is contract manufacturing and how the supply chain challenges of recent years have impacted contract manufacturers, for better or worse, whether that’s been an element of reshoring or whether material challenges have slowed things down.

Could you tell us a bit about the diversity in plastics initiative?  Diversity in plastics is not really a new initiative, it’s more of a development of the women in plastics brand that some readers might be familiar with.

The priority for the plastics industry - and I think engineering in general including medical engineering - is really on skills and recruitment; there’s a huge skills gap in engineering in this country and one of the ways we believe that you can start to close that skills gap is by looking at your approach to recruitment, in particular diversity within the workplace.   That’s not just diversity of gender, but also diversity of age, because there’s no secret that in the plastics sector, the skilled workforce is ageing out of employment and unfortunately there’s not the necessary amount of young talent coming into the industry to fill those roles.

Diversity of age is super important, but of course there’s also gender, race, religion, and ethnicity. All the protected characteristics have a part to play, and historically the plastics industry hasn’t been the most diverse.

What can the medical industry expect to see at Interplas?

We’ve got some brilliant contract molders on the show floor - more contract molders than we’ve ever had before at Interplas.

This is important as the medical industry has a burgeoning start-up scene with new ideas for devices being developed all the time, and that’s where your contract molders come in, because they don’t just provide a manufacturing service, they usually provide design expertise and material selection support with your tooling.

There are some brilliant SMEs in the UK who are highly skilled in the medical sector. They understand the regulation, they understand what’s needed from material choice, they understand the processing challenges.

If you’re coming to the show with a design idea for a new medical device, I’m sure you will find your manufacturing partner at Interplas.

On the other hand, if you’re a major brand owner in the medical space already manufacturing medical devices at scale, and you still need to keep on top of your material knowledge, we have pretty much all of the major chemical companies represented via their UK distributors at the show.

Those distributors have in-house medical teams who are dedicated to this marketplace, and they again will be able to guide you through what the latest materials are and how they can help you meet your regulatory challenges.

To find out more about Interplas and to register for free, go to interplasuk.com

SRUTHI CHIRRA, CONSULTANT SPECIALTY CHEMICALS, CHEMBIZR, DISCUSSES THE DYNAMICS OF PLASTIC USAGE IN CATHETERS AND MEDICAL TUBING.

Plastic

materials have monopolized the market for catheters and medical tubing since the 1940s, when they were first introduced and commercialized. PVC was the first synthetic plastic to be used successfully for medical tubing, and it quickly gained popularity. Various other polymers, such as PE, PP, silicone, and PU, were introduced for the segment and adapted for specific use cases over the following decades.

The industry is gradually shifting towards better processible and biocompatible materials while overcoming the industry’s current challenges. The chemical leaching of PVC-based tubes is a welldiscussed limitation of the material. It is caused by the high requirement of the plasticizer dosages to render desired flexibility to the material, which in turn permits high chemical leaching, raising concerns about patient exposure to potentially harmful substances.

Many suppliers are launching plasticizer-free PVC alternatives to tackle the issue. For example, Arkema markets its PEBAX MED, a plasticizer-free Block PEBA (polyether block amide) for the catheter market, claiming “exceptional” flexibility aided with toughness.

Suppliers have also launched several new products involving materials such as PEI (Polyetherimide), PI (Polyimide), Polysulfones and PEEK to address

issues such as yellowing/oxidation to repeated sterilization, better dimensional tolerances to precision extrusion, chemical resistance, and so on.

THE TYPES OF CLASSIFICATION AND EMERGING MARKET TRENDS

The catheter and tubing market can be classified based on the technicalities of usage and is then further divided into distinct anatomical application areas, each with its own set of property criteria. In general, medical tubing is used in fluid transfer locations such as IV drips, ventilators, and so on that does not come in contact with the patient’s body or internal fluids. Catheters, on the other hand, are typically implanted into bodily cavities or convey internal fluids, necessitating great biocompatibility when compared to regular medical tubing.

With the growing healthcare industry, including all aspects of diagnosis, monitoring, and therapy, polymer material demand is expected to grow at a compounded pace of 4-5% over the next five years. Microcatheters, a subclass of therapeutic catheters, are gaining popularity and growing at twice the rate of the overall market.

There are two major reasons for this soaring market penetration of microcatheters:

• The rapid rise in minimally invasive cardiovascular surgery, including procedures for infants that necessitate smaller and specifically designed microtubes that can be inserted into small, delicate blood vessels with minimal trauma to the surrounding tissue.

• The microtubes are being used in areas other than cardiovascular procedures, such as neurovascular, interventional radiology, oncology, and more.

This increase in demand presents a great opportunity for high performance polymers in the microcatheters market, as they provide the tight tolerances required to extrude thin-walled structures, as well as the right mix of desired flexibility and compression resistance, all with no use of harmful plasticizers, which is a major source of impurity concern.

Although PVC, Silicone, PU, etc., currently have high volumetric consumption, the market is expected to shift towards a higher use of Polysulfone, which has little to no concerns about chemical leaching and is also highly suitable for multiple sterilization cycles.

High performance PEEK is also becoming more popular, particularly in applications such as ablation devices, where high heat resistance and strength are required but cost is not a major factor. The market for microcatheters is expected to grow at an 8-10% CAGR over the next five years, with a growing shift toward Polysulfone, PEEK, and a few others such as Polyamide and PEI.

THE TREND ON FLUOROPOLYMERS (FPs)

Fluoropolymers have been used in the medical tubing and catheter markets for decades in a variety of anatomical areas. They currently account for a sizable demand of the catheter and tubing market and are used in interventional cardiology, urology, gastroenterology, and other medical fields.

However, the primary application of Fluoropolymers is in catheters designed for minimally invasive procedures and microcatheters. FPs are also sometimes regarded as the workhorse material of minimally invasive

medical devices. The application of FPs in the segment is aided by lubricity/non-stick, chemical resistance, and coefficient of friction.

THE FUTURE OF MATERIAL USE FOR CATHETERS

Undoubtedly, the market is expected to shift toward high performance polymers in specific and emerging application areas. However, PVC, the most often used material in the industry, is expected to maintain its demand with no significant decline in consumption. Although, the discussion over its limitations has raged on for the past two decades, demand has remained strong in the majority of general application areas.

The actual impact of chemical leaching on the patient or to the outcome of the medical procedure is more speculative and less concrete. As a result, in most circumstances, the preference leans towards its advantages such as low cost and ease of processing.

Asia’s first medical-grade TPU manufacturer: ICP DAS – BIOMEDICAL POLYMERS

ICPDAS – BMP is a medical-grade thermoplastic polyurethane (TPU) manufacturer focused on supplying top-quality materials that prioritize safety and quality. The company provides a diverse range of 80 products and small order quantities with short delivery times.

ICP DAS – BMP produces three product series: Alithane (ALP series), Durathane (ALC series), and Arothane (ARP series). The full range of medical-grade TPUs provides custom color services, different hardnesses, and varying percentages of radiopaque fillers to suit customer-specific needs.

Furthermore, the team performs rigorous quality inspections for each

batch of TPU produced to guarantee the lot-to-lot consistency of our medical-grade TPU pellets.

Peter Chen, vice general manager of ICP DAS – BMP, has a strong background in chemical engineering and previously held a managerial position in the polymer division of ITRI – a world-renowned technology R&D institution in Taiwan.

A smart factory with IIoT systems further sharpens the ICP DAS – BMP competitive edge. By leveraging the 30-year automation expertise and resources of ICP DAS, the parent company of ICP DAS – BMP, the team is empowered to monitor the machine status and environmental factors to optimize production efficiency and ensure consistent and high-quality products.

With an expert team, thorough testing, superior properties and short lead times, ICP DAS – BMP is poised to stand out in this field globally.

The company has laboratories for

Rosti Medical Solutions, a Global Technology led Contract Manufacturing business with ISO 13485, FDA 21CFR820 and MDR accredited facilities offering:

• Concept Development

• Product Design and Process Optimisation

• ISO 14644 accredited Clean Room Production

• Post processing of complex products and components ensuring regulatory compliance

• Accelerated time to market mobilising our digital technovation centers with Carbon® M3 printers utilizing Digital Light Synthesis printing technology

polymerization, physical & chemical properties analysis, and mechanical & cytotoxicity testing. In addition, TPUs that are manufactured are USP Class VI and/or ISO 10993 certified - ISO 10993-4 for hemocompatibility testing, ISO 10993-5 for cytotoxicity testing, ISO 10993-10 for irritation and skin sensitization testing, ISO 10993-11 for systemic toxicity testing, and ISO 10993-23 for irritation testing.

For TPU products and further enquiries, please contact us directly: sales_bmp@icpdas.com

Please visit our booth at COMPAMED 2023 in GermanyHall 8b, Booth C09-1

LUCA CHIOCHIA, BUSINESS DEVELOPMENT MANAGER, ELIX POLYMERS, HIGHLIGHTS HOW ABS MATERIALS CAN CREATE A MORE SUSTAINABLE INDUSTRY.

The demand for new, sustainable Acrylonitrile, Butadiene and Styrene (ABS) materials for drug delivery device applications is growing in the healthcare sector. However, because of the risk of cross-contamination, medical regulatory compliance requirements cannot be fully met with mechanically recycled ABS materials.

Fortunately, new chemically recycled and bio-based ABS materials are already available, which possess the same chemical composition and properties of virgin medical ABS, meaning they fulfil the same medical applications and meet medical regulation requirements.

CHEMICAL RECYCLING

Conversion chemical recycling is the breaking down of a target waste through pyrolysis (a thermal decomposition process without the presence oxygen) to obtain an oil like feedstock.

The ISCC+ certification with a mass balance approach guarantees the sustainable non-fossil content, and the whole supply chain can benefit from this with the already existing production processes, without making huge investments which would make this impossible from an economical perspective.

The chemical recycling processes themselves, the transformations from waste into pyrolysis oil, are represented by different types of expensive alternative technologies that depend on the type of considered waste that need to be optimized and scaled up to make chemical recycling economically feasible.

An example is the incorporation of pyrolysis oil obtained from waste of mixed plastics or from used tires in the supply chain production of Styrene. The only change is the partial substitution of Nafta oil with Pyrolysis oil to feed the steam cracking process, that is needed to convert large hydrocarbons contained in the oil into smaller ones.

As it happens in the case of 100% fossil oil, the same molecules such as Ethylene and Benzene can be extracted, as it occurs for several other ones. These can be used as reagents in the production of Ethylbenzene and use the same exact processes that is used since many years for the fossil version of these input substances.

The next step in the supply chain is the production of Styrene, which is obtained starting from Ethylbenzene with its standard production process which is also the same and has been also optimized for many years. The only difference is that, if chemical recycled content from mixed plastic waste or from used tires is present instead of fossil content, each one of these supply chain steps must be certified by ISCC+ with a mass balance approach.

The same occurs in the following production passage at the ABS manufacturer, where Styrene is used as raw material to be polymerized with Butadiene and Acrylonitrile to obtain ABS.

ISCC+ CERTIFIED

ELIX Polymers has obtained the ISCC+ certification with a mass balance approach and offers ABS grades with chemical recycled, bio-based and bio-circular content to the market. Medical grades such as ELIX M203FC and M205FC have been used in medical applications such as drug delivery devices and medical device housings and are now available with up to 70% ISCC+ certified raw materials content.

Once discussed how it is possible for a medical ABS ISCC+ certified with chemical recycled content to fully comply with medical regulations and healthcare applications, it is important to consider which are the sustainable advantages in comparison with a full fossil-based medical ABS.

DEALING WITH WASTE

The key variables to consider are the type of waste used, the level CO2 emissions related with the waste recycling process, the efficiency of the process and the possible presence of biogenic content in the waste itself. Used tires for example include biogenic content and can employ a more efficient pyrolysis process than mixed plastics waste, with lower CO2 emissions.

When the waste is methodically separated and sorted by type, the related recycling process can be fine-tuned on that specific type of waste, with a consistent reduction of energy inputs required and consequent CO2 emission outputs. Including recycled waste as raw materials, even with low percentages, is the best approach to support an easier transition towards the use of more sustainable ABS medical materials in drug delivery and other medical devices in the coming years.

In an industry where patient health and safety are utmost concerns, it can be challenging to introduce new practices, even when those changes are for the better. There is increasing pressure in the healthcare sector to become more sustainable, and that must be balanced with the need to protect the medical devices and medicines entrusted to save lives.

For the past two years, Plastic Ingenuity, a specialist in custom thermoforming, has conducted listening sessions with key stakeholders, including manufacturers of medical devices, pharmaceutical products and life science applications. These conversations have provided invaluable insights into the initiatives advancing the packaging industry toward a more circular economy. Among healthcare organizations, five priorities have risen to the top.

1. New influences advancing sustainability initiatives

Group purchasing organizations (GPOs) and their environmentally preferred procurement (EPP) policies are influencers in the healthcare industry. EPPs are being

integrated into contract tenders, providing motivation for medtech organizations to increase focus on the sustainability of their products and packaging.

2. Expanded understanding of circularity in packaging

Over half (57%) of survey respondents said their organizations are focused on maximizing post-consumer recycled (PCR) content in their packaging to enhance circularity. This is notable given the regulatory requirements constricting the use of PCR in sterile barrier system (SBS) packaging. However, it’s a misconception that materials from a healthcare setting must be incinerated or sent to a landfill – only about 15% of packaging waste from healthcare facilities is hazardous.

3. Innovative technologies improving recycling capabilities

Chemical recycling, is a suite of novel techniques that focuses on hardto-recycle materials. Purification, depolymerization and conversion are the typical methods; each type breaks a polymer down to a precursor and/or removes impurities like colorants and additives. Mass balance systems can also support PCR markets without compromising performance or compliance. Mass balance is a chain-ofcustody protocol that tracks recycled content through manufacturing processes.

4. Increasing need to recover all packaging types

Improving recovery rates of all packaging types is essential to unlock true circularity in packaging. In fact, the goal to increase recovery was cited by 71% of stakeholders as key to their sustainability strategies. Four tactics can help improve recovery rates, including closed-loop recycling, increasing package recovery in practice, making packages from recyclable materials, and designing packages for recovery.

5. Design enhancements supporting waste reduction

Healthcare Plastics Recycling Council (HPRC) provides a resource, Design Guidance for Healthcare Plastics Recycling, to help create packages designed for recovery. Additionally, packaging systems are being evaluated holistically to determine where reductions can be made. A minimalist approach can help reduce weight and material usage, increasing shipping and other downstream efficiencies that may limit GHG emissions.

Another emerging trend is that more healthcare is happening at home, and the industry needs to consider how that could impact packaging design. Specifically, ease of use in packaging becomes more prominent to accommodate users of different ages and physical capabilities. Other factors to consider are ways to reduce packaging waste and how to establish recovery streams in residential settings.

Developing innovative packaging solutions can be challenging in an industry that is heavily regulated and slow to change. Yet healthcare and life sciences organizations are beginning to recognize that transitioning to a circular economy is necessary to help secure a future for generations to come.

ZACH MUSCATO, CORPORATE SUSTAINABILITY MANAGER, PLASTIC INGENUITY, SHARES THE FULL-CIRCLE SOLUTIONS FOR SUSTAINABILITY IN THE HEALTHCARE INDUSTRY.

ALEX SILVESTRE, INEOS STYROLUTION GLOBAL DIRECTOR FOR HEALTHCARE, EXPLAINS HOW MATERIAL CHOICE HELPS ADAPT TO A SUSTAINABLE WORLD.

Adapting to a Changing market

Styrenics have been a proven material solution in the development of various medical devices. Over the years, the versatility of these materials has helped meet the needs of an ever-changing landscape.

In 2020, as the world was learning how to deal with the COVID-19 pandemic, styrenics were used as foundational building blocks in the development of applications to make test kits, treatment for patients, and help protect our front-line healthcare professionals with PPE.

Original equipment manufacturers (OEMs) are now routinely focused on two major topics: 1) How can we bring costs down as the world struggles with containing inflation, and 2) what solutions are available to help us meet our sustainability objectives?

OPPORTUNITY TO LOWER COSTS

With the desire to drive down their own manufacturing costs, design engineers have been more open to evaluating alternate materials. It begins with properly identifying the physical attributes necessary for the end application vs. simply trying to match an incumbent material’s unique characteristics.

This provides the opportunity to realize potential cost savings by selecting a material that is more appropriately suited for the end task instead of using one that may be over-engineered for the target application and more costly to produce.

There is a wide breadth of products within the styrenic portfolio each with their own set of distinct performance characteristics. Most design engineers are already quite familiar with products such as Polystyrene (PS) or Acrylonitrile Butadiene Styrene (ABS) since both resins are readily used in a variety of labware and/or device housings. However, there are a variety of transparent products, such as Styrene Methyl Methacrylate (SMMA), Styrene Butadiene Copolymer (SBCs), and other impact modified clear resins.

When properly aligning to the end technical requirements, many of these materials have successfully replaced incumbent materials in applications such as syringe bodies, insulin device parts, cryogenic devices, and medical packaging components while also achieving a cost savings initiative.

In fact, beyond potential raw material savings, many manufacturers have also lowered costs due to the density advantage of some products and/or utility consumption reductions related to some materials requiring a much lower processing temperature.

SUPPORTING A SUSTAINABLE WORLD

Like other industries, the healthcare community is focused on achieving carbon footprint reduction objectives within the coming 10-20 years. The challenge has been how to meet these needs while still complying with the stringent traceability requirements indicative of this heavily regulated market space.

The use of bio-attributable feedstocks in the upstream production of key raw materials that are eventually converted to styrenic polymers is one option being explored. By replacing some of the components of the polymer raw

material stream with a non-fossil fuel-based component, the overall product carbon footprint (PCF) of the styrenic polymer is reduced while still retaining the same physical and chemical attributes.

Another area where the styrenic industry is investing heavily is in the development of advanced recycling technologies. This involves collecting post-consumer waste and breaking down the components on a molecular level to re-create virgin feedstock like styrene monomer. In this circular economy concept, waste products are not just re-used, rather they are reborn into new finished goods.

In both technologies above, since the underlying chemical composition is maintained, medical device OEMs have assurances that the resulting styrenic polymers possess the same bio-compatibility, regulatory, and technical attributes.

Mechanical recycling options are also available. In these cases, a controlled waste stream of postconsumer products are collected, and then materials such as PS and ABS are identified, cleaned, and ground up. These materials are then dry-blended back in with virgin material so that they can be re-used.

We design advanced multi-cavity systems equipped with dedicated solutions to meet the most challenging needs of the medical device world: complex geometries, excellent part quality and maximum product safety.

High repetition accuracy

Superior vestige quality

Part to part consistency

Excellent quality parts

Experience with complex polymers

Target dates for the implementation of the EU Medical Devices Regulation 2017/745 (MDR) have been rescheduled, but it is important to be aware that a number of new or enhanced requirements under MDR are already enforceable. In fact, requirements such as:

• Post Market Surveillance (PMS)

• Periodic Safety Update Report (PSUR)

• Post-Market Clinical Follow Up (PMCF)

• Person Responsible for Regulatory Compliance (PRRC) have been applicable since 26th May 2021 for all medical devices sold into the EU, regardless of a device’s MDR CE marking status. However, efforts to comply with the MDR can also prove useful for other export strategies outside of the European market. So, not only is preparedness key to ensure international competitiveness, but effective PMS is also a requirement for continuing market access in other international markets.

PROACTIVE PMS CAN LEAD TO SAFER MEDICAL DEVICES

The MDR gives particular importance to patient safety through the gathering of clinical and safety-related data after the conclusion of the CE certification process. Indeed, it is no longer enough to manage issues in the light of a complaint. Manufacturers are required to gather regular, careful assessments relating to a device’s performance and safety profile. This makes sense, as the objective is to prevent problems related to patient safety through the systematic use of proactive PMS, rather than address issues once they have spiraled into a bigger issue.

PMS DATA COLLECTION: WHAT NEEDS TO BE DONE

PMS requirements include the necessity to create a detailed PMS plan, including consideration for appropriate PMCF planning.

For Class IIA devices, PSUR reports must be completed and updated at least every 2 years. This update frequency increases to at least annually for Class IIB and Class III devices. Additionally, cyclical PMS reports are required for Class I devices.

In a nutshell, PMS requires regular data collection from the following five main sources to identify any potential problems related to patient safety and device performance before they become a more pressing issue:

Risk management data - Best practice suggests that reassessing the risk data for a device should be a cyclical process carried out at least once a year, or as new information materializes. It is important that manufacturers not only prepare risk management documentation for the launch of their products but also ensure documents are adequately updated with new statistics and ongoing data.

Competitor data - Monitoring competitor device performance is both good commercial practice, and also demonstrates compliance with important new elements of the regulations such as the ongoing assessment of ‘clinical benefit’ and ‘state of the art’ (SOTA). Tracking the performance of competitor and similar-functioning devices also gives manufacturers time to assess any issues relating to competitor products and rectify on their own device before a similar patient safety issue occurs.

Literature review dataPublished literature, related specialized magazines and general healthcare periodicals involving the manufacturer’s device and market environment, are vital clinical evidence sources that can highlight risks or provide stronger proof of a product’s clinical benefit. Publications are also an excellent source for covering issues relating to offlabel use or common interactions with other devices or drugs.

Social Media data – Both patients and users share experiences over social media making this an ideal source for opinions, concerns, and insights about the device and how it is being used.

Patient and end user data –Building on the social media, listening is engaging in a two-way conversation with patients and users. This can give important information to manufacturers helping them to identify any potential issues with their product such as discomfort or side-effects in specific groups of patients. Ideally this constant, systematic data sourcing should be carried out by specialist teams with suitable skills who can dedicate the necessary time. Enlisting the support of specialist consultants who are experts in this field, should provide reassurance that manufacturers are meeting their obligations, and at the same time, ease the considerable pressures on busy teams.

TIMOTHY BUBB, TECHNICAL DIRECTOR, IMED CONSULTANCY, DISCUSSES LEVERAGING DEFERRED MDR IMPLEMENTATION TO FOCUS ON PATIENT SAFETY AND COMPETITIVITY.

ALL-ELECTRIC ENGEL E-MOTION MEETS STRICTEST REQUIREMENTS AT FRESENIUS MEDICAL CARE.

In the production of plastic components for dialysis products in the cleanroom, maximum precision is required for every shot. The task is to combine precision with process stability and cost effectiveness.

Fresenius Medical Care masters this challenge with all-electric highperformance injection molding machines by ENGEL.

The lives of two and a half million people with chronic kidney failure depend on what look like inconspicuous plastic cylinders at first glance: dialyzers are the central element in dialysis (artificial kidney) machines. On closer inspection, the FX-class series dialysis cartridges by Fresenius Medical Care are highly sophisticated. They contain up to 20,000 hollow fibers as wide as a hair with microscopic pores, through which toxins, urea, excess salts and water are removed from the blood during hemodialysis. The process takes four hours. The patients need to be connected to the machine three times a week.

Each FX-class filter cartridge needs six thermoplastic components, which Fresenius Medical Care SMAD injection molds in L’Arbresle, about 20 kilometers northwest of Lyon. The components include the transparent cylindrical housing and the blue caps that seal the cylinder with the hollow fiber bundle at the top and bottom and house the connections for the dialysis fluids.

NUMBER OF INJECTION MOLDING MACHINES DOUBLED

According to its own statements, Fresenius Medical Care is the world market leader in the treatment of kidney disease. “At least one Fresenius Medical Care product is involved in every second dialysis performed worldwide,” explains the project manager, Alain Philibert.

L’Arbresle, one of 44 production plants worldwide and the only one in France, produces 36 million cartridges a year.

The top priority is uncompromising quality, and it was also a qualitydriven decision to exclusively equip

the location with all-electric injection molding machines from ENGEL’s highperformance e-motion series.

Today, 26 e-motion injection molding machines – each with a clamping force of 2200 kN – are deployed in the cleanroom. They all operate 24/7 with a utilization of well over 90%.

“We have to be able to rely on the machines’ repeatability, and we need maximum precision and absolute cleanliness,” says Laurent Branchereau, head of the injection molding shop at the plant, explaining the choice of machines. Every four hours, random samples of the parts are visually inspected and the critical dimensions are measured.

CYLINDER HOUSINGS NEED CONSTANT DIMENSIONS

The cylindrical filter housings are particularly demanding. They are injection molded from polypropylene in a 4-cavity mold. The wall thickness is 1.5 mm throughout, but the filigree structures at the ends, each with a circular undercut, require a sophisticated injection profile to be completely filled. Injection takes place from two sides at the center of the cylinder. There are two core pulls for each cavity that move out to the left and right respectively for part removal.

BECAUSE IT’S A matter of life

“The e-motion machines ensure high dimensional accuracy across all cavities,” as Branchereau points out. “This is all the more important because we assemble the cartridges in a fully automated process.”

The material poses a further challenge because PP has a lot of shrinkage. On the other hand, it offers benefits in other areas. While filter housings are often produced from polycarbonate, Fresenius Medical Care deliberately chose polypropylene because it is significantly lighter and therefore boosts efficiency in both logistics and waste management.

TEMPERATURE CONTROL WATER MONITORING FOR ADDED PROCESS STABILITY

“In-house production makes us more flexible,” as technical director Thibaud Robin-Rivoire explains. “We can very easily adapt products to our customers’ requirements, especially since these requirements regularly change.”

Six molds, for three different cylinder diameters, are currently deployed in cylinder production at L’Arbresle. In total, the FX dialyzers are available in five sizes. The version used depends on the patient’s size and weight. A mold change is scheduled at least once a week. This was already taken into account in the design of the machines. The e-flomo electronic temperature control water manifold systems, for example, were installed outside the mold area to allow flexible mounting of different sized molds. Each mold has a different number of cooling circuits.

“E-flomo helps us respond quickly if the flow stalls in a circuit,” says Branchereau. “That gives us a good safety margin, especially at night when there are fewer machine operators on duty.”

Focusing on one type of machine also contributes to the goal of maximum production stability. “The CC300 control unit of the ENGEL machines with its large display is genuinely intuitive to operate and helps us achieve great process stability. And at the end of the day, that gives us better quality.” points out Eric Biguet, a set-up technician responsible for smooth production operations.

LEVERAGING QUALITY POTENTIAL WITH IQ

“ENGEL also customizes the machines to meet highly individual requirements. That’s what characterizes our collaboration with ENGEL.” emphasizes RobinRivoire. Digital solutions, such as the iQ smart assistance systems from the inject 4.0 program, are currently being evaluated.

“iQ clamp control is particularly interesting for us,” says Philibert citing an example. The smart assistance system determines the optimum clamping

force for the injection molding process in question. In most cases, the optimum clamping force is lower than the value set manually. Clamping force correction then not only improves quality consistency, but also saves energy. The trend towards greater sustainability has long since arrived in medical technology, too, and not just following the rapid rise in energy prices.

Energy efficiency, but also material efficiency, is a focus of continuous product development at Fresenius. You can see one example of this by following the path of freshly injection molded dialyzer housings. After a short interim storage period, they are filled with the hollow fibers, which are also produced on-site, and tightly sealed with yellow lids made of polyurethane. It is only after steam sterilization that the yellow lids are replaced by functional closures in blue polypropylene. The polyurethane lids are disposable parts, and that is precisely what is due to change.

“We have developed new closures with a core made of glass-fiberreinforced polypropylene,” Alain Philibert reports. “They are so robust that we can reuse them up to 50 times.”

CHRIS PHILPOTT, COMMERCIAL AND TECHNICAL MANAGER AT BODDINGTONS, HIGHLIGHTS THE IMPORTANCE OF CHOOSING THE RIGHT INJECTION MOLDER AND SHARES THE STORY BEHIND THEIR CLASS 7 CLEANROOM.

Boddingtons factory straightaway, as the company believes that to succeed in medtech device manufacture, Class 7 cleanroom technology assets are essential and mandatory to make approved Class 1 and Class 2 medical devices. The controls, filtration and essentially the bio-burden must all be monitored regularly and maintained to de-risk products that especially come into patient contact.

The Boddingtons cleanroom facility has now doubled in size since the factory opening. Boddingtons commercial and technical manager, Chris Philpott said “The medical sector requires so much from its suppliers in terms of complete control, traceability, process stability and consistency and all following fully validated manufacturing processes within our Class 7 cleanroom was always the way to go, it is why we invested heavily to support the needs of our customers within the medtech sector.

To paraphrase an advert from a leading UK retailer: there’s injection molding in manufacturing and then there’s medtech injection molding.

CHOOSING THE RIGHT INJECTION MOLDER

For many clients in the medical sphere, it’s important to find a company that understands and can take primary legal responsibility for all regulatory matters of medical device manufacture, from concept design following design and development processes and procedures, process optimization & validations, whilst maintaining conformity to international medical standards such as MHRA & FDA including device registrations and working to the Medical Device Regulations (MDR).

Boddingtons is a company that operates a facility in Southeast England for the production of injection-molded components, medical devices and assemblies. All manufacturing is included within the scope of ISO 13485 MDSAP and ISO 14001 accreditations.

WHY CLASS 7 CLEANROOMS ARE ESSENTIAL

A modular Class 7 cleanroom was established within the new

“Now that we are well along the curve of our Class 7 cleanroom expertise, we don’t hesitate to apply manufacturing lessons to other areas of our business; building additional cleanroom resource for specific new projects and applying cleanroom manufacturing disciplines across the whole of our facilities offering flexibility, capability and increased volume manufacturing.”

THE IMPORTANCE OF MEETING CLEANROOM STANDARDS

The full operation of the Boddingtons Class 7 cleanroom means a failsafe and scrupulous approach to standards, now expressed in the pages of the operation and training manual at the company. No staff at Boddingtons are allowed access to the cleanroom without a minimum of two full days of training. There are no exceptions. Just one incident of non-conformance, not following the stringent procedures just to enter the room itself can close the cleanroom for a deep cleanse. Standards are of the highest level, control and discipline has been trained into every staff member to maintain these high levels.

These high standards need to accommodate and prevail for all new Class 7 cleanroom medtech projects in all circumstances: Any item, person or material entering the cleanroom environment is subject to its stringent protocols.

For example, when new injection molding machines were introduced to the Boddingtons Class 7 cleanroom environment, the material feedstock from outside the facility needed to be expanded – but not so as to interfere with existing production and standards. A second materials link was accordingly created ensuring a dedicated material flow to the new molding machines while enhancing material control and full traceability.

Philpott said “Injection molders should take note that, even after investment and capital outlay, Class 7 cleanroom benefits do not come without ongoing costs – in terms of energy, rigorous maintenance, deep cleaning and an audit process that could see customers or regulatory bodies arriving unannounced at any time – day or night. All of which requires us to properly resource and commit to our cleanroom molding, not least in terms of our people where a culture of pride resides.”

Medical diagnostic equipment & biotech applications

ALBIS offers the medical industry an unparalleled choice of high performance polymers from renowned producers. This offering is complemented by customized polymer compound solutions tailored to customer’s needs and made by ALBIS’ sister company MOCOM.

We support numerous projects in the medical and pharmaceutical sector as well as for diagnostic equipment and biotechnology applications. Addressing the latest trend towards an increasing use of sustainable solutions our portfolio includes newest and state of the art sustainable polymers which are specifically developed to fulfil the strict regulatory and service needs of the healthcare industry.

albisuk@albis.com

albis.com

Thereis no such thing as a perfect adhesive, and choosing an appropriate material requires careful consideration at the design stage. Design engineers can weigh up functionality, processability, and commercial factors to strike a balance between performance and production efficiency.

Adhesives are a popular bonding option in medical devices, because they can distribute load or stress, eliminate joint fatigue, improve impact resistance, and provide good aesthetics. Achieving an optimal bonding process requires the design team to consider the bonding method and materials including: joint design, surface preparation, quality control, application, and cure.

SUBSTRATE CHOICE

Choosing bondable substrates is important — successful adhesion depends on the surface energy of the substrate and the adhesive. For wetting to be achieved, the adhesive must have a lower surface energy than the substrate. However, many medical plastics, such as PEEBAX and PEEK, have low surface energies, and if these materials are essential to the assembly’s design, surface treatment or adhesive formulations specially designed for these substrates may be required.

If the coefficient of thermal expansion (CTE) is different for each substrate, the adhesive may need

to be tough or flexible to withstand differing amounts of thermal expansion, which can incur significant stress on the bondline.

BONDLINE DESIGN

There needs to be room in the bondline for the adhesive, as it will not work if all the adhesive is squeezed out when the part is assembled. A good rule of thumb is to allow 0.100 to 0.125 mm bondline gap. The adhesive bondline thickness should be as consistent as possible across the entire bonded area; variations in bondline thickness can affect the strength and durability of the bond. Nevertheless, if this is impossible, adhesives are available in a broad range of viscosity options, including low viscosity for wicking and high viscosity for gap filling.

Light curable adhesives can only be used if UV light can reach the bondline, and the designer may wish to incorporate substrates that light can pass through if the bondline is not otherwise visible. Light curable materials offer significant productivity benefits due to their easy handling and quick “on demand” curing, which reduces labor, space, and energy demands. The resultant process is easy to automate, control, and validate.

ENVIRONMENTAL CONSIDERATIONS

As well as establishing a successful bond between adhesive and substrate, it is important to consider the subsequent environment. This includes the temperature, solvents, chemicals, weather, stress, and vibration the product is likely to be exposed to during its lifetime.

Most medical products must withstand sterilization after assembly; EtO (ethylene oxide), or E-beam or gamma radiation, are used. Some devices, such as surgical tools, may need to resist multiple autoclave cycles, and this is a more aggressive process to an adhesive joint. The ability to resist the required sterilization method is a key selection factor.

PROCESSING TIME

As well as selecting a material that will effectively bond the substrates throughout the lifetime of the product, design engineers must carefully consider production needs and productivity.

Adhesives could lengthen a production process compared with mechanical fastenings, as manufacturers may need to wait for them to cure before proceeding to the next stage. Choose an adhesive with a cure schedule suitable for the production volumes; UV light curing or cyanoacrylate adhesives provide almost instant cure and can reduce WIP or alleviate production bottlenecks.

A crucial piece of advice is not to request more strength or environmental resistance than is needed. Because there is no perfect adhesive, there will always be a compromise. Over specifying on technical requirements can eliminate adhesives that are equally suitable for the assembly, at a lower cost and with simpler production capabilities.

It is often the case that the cost of bonding per part is more than the cost of the adhesive per part. Focusing on the material cost without taking a holistic view of the entire process may not be good economics.

Intertronics offers ISO 10993 and USP Class VI adhesives and protective materials designed to adhere to most medical device plastics that are solvent free, fast cure, and sterilizable, in a range of viscosities and hardnesses.

PETER SWANSON, MANAGING DIRECTOR OF ADHESIVES AND DISPENSING EQUIPMENT SUPPLIER INTERTRONICS, SHARES SOME ADVICE FOR CHOOSING AN ADHESIVE WHEN ASSEMBLING MEDICAL DEVICES.

MELISSA JAIME, PRODUCT TECHNOLOGY LEADER, AURORIUM, EXPLAINS THE IMPORTANCE OF CHOOSING THE RIGHT BONDING SOLUTIONS IN DIAGNOSTIC CATHETERS.

Electrophysiology catheters and sheaths are used to treat and diagnose disorders in cardiac interventions – heart ablation to treat cardiac arrythmia, replacement of calcified or leaking heart valves or obtaining samples of heart tissue. These multiple-electrode electrogram recording devices are steerable inside the vascular system and provide a high degree of dexterity to reach the target site in the pathway.

The materials used in the construction of these catheters are carefully chosen and their electrical and mechanical properties tested to verify compliance with certain critical requirements for the catheter, such as:

• Appropriate stiffness to resist force from the navigation pathway, yet not so high as to provoke injuries

• Flexibility and maneuverability to navigate the vascular pathways

• Biocompatible and sterilizable for patient safety

• Compatibility with various materials, especially electronic components, to enable precise design functionality

• Secure adhesion and mechanical coupling between various device components and material transition joints for a reliable performance

Biothane 90-M1 and Biothane 228 are some examples of the choices for biocompatible adhesive. These materials have earned a reputation and continue to be used in clinically-proven, diagnostic catheters for critical life-saving procedures.

PROVEN BONDING SOLUTIONS FOR DIAGNOSTIC CATHETERS

Each Biothane system consists of two liquid components – the Vorite prepolymer and the Polycin polyol, which when mixed together cure at room temperature to yield a cross-linked polyurethane. Once combined, adhesive viscosity begins to increase as the chemical reaction develops a cross-linked network and the material cures into a flexible solid. The rate of viscosity increase is a critical factor to consider in the design of a catheter assembly process, which can be optimized by leveraging the relationship between time, temperature, and viscosity.

Catheter assembly typically requires multiple precise applications of small quantities of sealant to adhere tubing, seal ends, and coat sensors. Adhesives having longer pot life are often preferred in these situations, as it allows for maximum utilization of the material before it thickens too much for proper dispensing. Once the adhesive is applied, the assembly can either be allowed to cure at room temperature or cured more quickly at elevated temperatures. Production efficiency is guided by cure behavior, as the delicate assemblies cannot move on to the next stage of the production process until the adhesive has set.

Out of the Biothane portfolio, Biothane 90-M1 is recognized as the choice for diagnostic catheter assemblies, due to its high strength and toughness. Whereas the faster reactivity of Biothane 228 allows for higher assembly throughput, and its greater flexibility provides an additional benefit in certain applications.

As a modular solution, two-part Biothane Systems are formulated to meet adhesive design criteria, as well as provide suitable processability for the application at hand. It is possible for Aurorium to match different combinations of Vorite and Polycin components to customize a Biothane System.

Biothane system reactivity may be characterized by properties such as:

• Pot-life - time until viscosity surpasses a usable value for a given application method

• Gel point - time at which the fluid polymer mixture behaves as a solid

• Work cure - time when sufficient strength is achieved to advance the assembly to the next processing stage

These can be determined via oscillatory rotational rheology measurements.

Choosing the right materials partner can help manufacturers enhance quality of life, support health and wellness, and enable customers to deliver value-added solutions.

AFTER IT WAS ANNOUNCED THAT JAMESTOWN PLASTICS HAD DESIGNED A COSTEFFECTIVE SOLUTION TO THERMOFORMED MEDICAL TRAYS, MEDICAL PLASTICS NEWS SPOKE TO JAY BAKER, CEO, ABOUT THE PROCESS BEHIND THE DESIGN.

my tray MAKE

YOU DESIGNED A MORE COSTEFFECTIVE SOLUTION FOR A MEDICAL DEVICE COMPANY. COULD YOU TELL US MORE ABOUT THAT?

A customer approached us who was frustrated by the continued increasing cost of the material used in their packaging for more than a decade. They asked us how we could help. I pointed out that they were stuck with the one supplier that makes this resin, who controls the market. While there were other materials that would perform, they would need to go through the pain and aggravation of the approval process, which was not an option. So, my design team and I were able to make the same product using less material, therefore saving money.

We looked at this with a clean sheet of paper when we designed it, doing our own testing. We were able to use half as much material while gaining three times the crush strength of the existing product. By incorporating structural geometry, we gained tremendous strength and used less material.

The real challenge is when things look different or are perceived to be different, it may raise red flags in the medical device industry. We had to think outside the box, which we love to do, and we were able to solve a problem for our customer. We do this daily by improving product performance, reducing product cost, saving manufacturing time, eliminating shipping damage, and more.

WHAT DO YOU THINK ARE THE BIGGEST CHALLENGES IN DESIGNING PRODUCTS FOR THE MEDICAL INDUSTRY?

When you look at thermoformed packaging in the medical device industry, much of it has not changed since the 1950s and 60s when it comes to basic design.

In medical device manufacturing, when something has been approved and is working, there needs to be a very good reason to change it. The penalties for failure are so high; if something doesn’t work, it could affect somebody’s life. Unfortunately, what happens is innovation stultifies, because the stakes are so high, and the approval process is so arduous.

DO YOU USUALLY HAVE SUSTAINABILITY IN MIND WHEN DESIGNING, OR IS IT WHAT THE CUSTOMER IS SPECIFICALLY AFTER?

The answer is yes and yes. We always have sustainability in mind. We try to accomplish the tasks set before us, using the least amount of the appropriate material that we can, while also trying to ensure that if there’s a recycling stream available that there’s no cross contamination, which prevents products from being recycled. There’s also the importance of products having to be sterilized in the healthcare market.

IS IT RARE TO HAVE OPPORTUNITIES WHERE YOU CAN BE CREATIVE IN MAKING NEW DESIGNS?

It’s more of a challenge and I’ll get into a little bit of economic philosophy here. If you decide you want to buy yourself a new car, you’re going to go to a bunch of different dealerships. You will do your online research to find the things that you like, then you’ll go to the car dealership.

As the consumer, you may go to two or three car dealerships because you figured out which car you want, what color you want, what options you want: now you’re looking for the best deal. With whom do you feel the most comfortable? Who has the best service department? You finally decide, perhaps playing the three different dealerships off one another, and then buy a car.

When you go into the hospital for a stent, do you research which stent you want? Who’s going to provide it? How much are you going to pay for it? Not at all. You’re going to go to the hospital and believe the doctor or surgeon taking care of you is going to use the product that he or she thinks should be used.

Furthermore, the cost of your stent will in most cases be covered by a third party, the insurance provider. This disconnect between the consumer and the manufacturer is unique to this industry. Consumer dollars drive innovation in all other industries. Patient outcome drives innovation in the medical realm, as it should, but this focus greatly reduces the motivation to change anything not directly linked to patient outcomes.