MPN NA Issue 25

Device

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BPA- and DEHP-free: CYROLITE® acrylics have just what it takes to save lives.

editor | olivia friett olivia.friett@rapidnews.com

group portfolio sales manager | caroline jackson caroline.jackson@rapidnews.com

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head of studio & production | sam hamlyn

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Editor’s Comment OLIVIA FRIETT

A YEAR IN THE MAKING

After celebrating my first-year anniversary as the editor of Medical Plastics News in March, I thought it was only fitting to reminisce about the amazing experiences I have had due to the role.

The first thing to mention is obviously being able to travel with the incredible Medical Plastics News team; being able to visit Düsseldorf for Medica and Anaheim for MD&M West with some of the most talented people I’ve ever met, is of course a plus.

In February, I had the opportunity to record a live podcast at MD&M West along with my colleague Caroline, Arjun Luthra from BioInteractions and Aaron Johnson from Accumold – a couple of the many amazing connections I’ve made throughout the past 12 months.

Speaking of amazing connections, to be able to connect with new people and see familiar faces is probably the best thing about this job. To be recognized by connections I have made from shows gives me a great sense of accomplishment.

Another huge sense of accomplishment is seeing our magazine being showcased at some of the biggest medical expos in the world.

live on-stage pitching about their company and products.

I enjoyed watching the PITCH last year and learning about these new innovative devices in the early stages of their journey, it’s inspiring to see products being designed and developed to make the lives of others easier and safer.

Another aspect of the show that I can’t contain my excitement for is the Med-Tech Innovation Awards; last year I wasn’t too sure what to expect as it was my first awards show, but it exceeded my expectations.

Being able to get dressed up to the 9s, socialize with nominees and cheering on the winners – especially for the awards sponsored by Medical Plastics News – what could be better?

The finalists for 2023 have recently been announced for the five Med-Tech Innovation Awards – 3D Printing Award, Connected Health Award, Design Award, Materials Innovation Award and Sustainability Award – and there’s a lot of big names from the medical plastics industry, for example Kraiburg TPE is nominated for a Materials Innovation Award and AstraZeneca’s autoinjector is nominated for a Design Award.

© 2023 Rapid Life Sciences Ltd

While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved. Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited.

ISSN No: 2047 - 4741 (Print) 2047 - 475X (Digital)

Of course, the highlight of the last year was the Med-Tech Innovation Expo. Being behind the scenes, seeing the show come together and helping people - whether that be setting up or once the show was in full swing - was an experience.

Thinking back on how successful the 2022 show was, I can’t wait for MedTech Innovation Expo 2023.

Not to mention, this year, the host for the black-tie event is the presenter, speaker and Invictus Games medalist JJ Chalmers!

The show in general will be incredible, it’s a not-to-be-missed event - I know it’s easy for me to say that, especially since 2022 was my first year, but if the 2022 testimonials are anything to go by, I know it was an undeniable success.

For myself, there are so many things I’m looking forward to this year’s expo, one of which is the PITCH conference. The PITCH is a competition where medtech start-ups will be we schedule

There’s a lot to look forward to for the 2023 MedTech Innovation Expo, and I can’t wait to see some you there! Please let me know if you will be there and we can schedule a time for a chat.

THERMOPLASTICS UPDATE

https://www.teknorapex.com/

Teknor Apex develops portfolio of TPEs as silicone alternatives

Teknor Apex has launched a portfolio of Medalist thermoplastic elastomers (TPEs) as medical-grade alternatives to liquid silicone rubber (LSR).

These materials provide a cost-effective, easy-toprocess alternative to liquid silicone rubber (LSR) and feature flexibility and rubberlike elasticity for medical applications.

Medalist TPEs are excellent candidates for tubing used in drug delivery, gas supply and chest drainage.

Teknor Apex states that the benefits for this material choice with medical tubing include a low level of extractables, low drug interactions, excellent throughput rates, and a wide operating temperature range.

SUSTAINABILITY UPDATE

Unlike LSR, Medalist TPE is completely recyclable during processing, which can result in manufacturing efficiencies. In addition, no refrigeration is needed to store TPE.

The company also claims this material is economical, saying Medalist TPE is five times more cost-effective than LSR, considering LSR is prone to longer cycle times, complicated molding processes, and higher production costs.

https://www.plasticingenuity.com/

Plastic Ingenuity strives to improve sustainability

ACQUISITION UPDATE

Formerra completes acquisition of Total Polymer Solutions

Formerra, a distributor of engineered thermoplastic resins, additives, and other specialty polymers in North America, has acquired Total Polymer Solutions (TPS). The acquisition of TPS is to enhance Formerra in the healthcare market and align with the company’s plan of expanding into Europe. TPS’s market presence in Ireland and the United Kingdom are particularly attractive to Formerra due to both countries’ growing leadership in medical device and equipment production.

Ronan Kennedy and Eamonn Keane, TPS’s co-founders and owners, will join the Formerra team and remain invested in the business going forward. TPS is the first add-on acquisition that Formerra has completed since H.I.G. acquired the Company from Avient Corporation in November 2022.

“Total Polymer Solutions will enable Formerra to strengthen its global healthcare distribution platform while building on both companies’ shared capabilities around rapid product development, innovation, and regulatory support,” commented Cathy Dodd, chief executive officer of Formerra. “This acquisition enables us to better serve our global healthcare customers in Europe with streamlined supply chain management and faster go-tomarket support, driving significant value for all stakeholders.”

Plastic Ingenuity, a specialist in custom thermoforming for multiple industries including healthcare, is optimizing designs to make packaging more sustainable.

Jason Crosby, general manager, healthcare, Plastic Ingenuity said: “Sustainability is a big buzz right now; historically it hasn’t been of interest for this market until the last two years.

“The reason why it has taken so long to be incorporated into the healthcare game is because there’s this balance of needing to be sustainable, but also needing to think about hygiene and patient safety.”

With regards to packaging sustainably, Crosby admits that it’s a little more challenging

and costly as the company would need to use virgin-grade materials. This has resulted in Plastic Ingenuity working on optimizing designs to make them more sustainable

In some cases, the company has been able to look at how parts are used, how they run through automated equipment and change the density of the parts, meaning the packaging is smaller and twice as many parts can now fit on a truck (originally 200,000 and now 400,000), resulting in reduced emissions in the transportation process. In other cases, Plastic Ingenuity utilizes its ISSC PLUS certification to enable the use of circular plastics from advanced recycling technologies.

https://www.element.com/

ELEMENT LAUNCHES EXTRACTABLES AND LEACHABLES SERVICE

https://www.guardtechgroup.com/

Guardtech offers decontamination package

The Guardtech Group is providing a package of decontamination services –either as part of a Cleanroom Service Plan or scheduled separately

The Decon Team works to GMP standards and specializes in restoring control to critical environments, offering cleaning programs and multi-stage cleaning as and when required.

two leaders of the team with 30 years’ experience in decontamination.

The company claims the team can conduct full microbiological/bioburden testing with TSA & SDA plates and preclean and post-clean contact plate testing, as well as cleanliness verification tests with full reporting.

Guardtech provide a hydrogen peroxide fogging service, either as part of their Cleanroom Service Plan or a Decon-only Program.

Element Materials Technology

(Element) has launched a global offering for its Extractables and Leachables (E&L) services.

The new service brings together capabilities across Europe and North America through the recent acquisitions of Avomeen, Hall Analytical and VR Analytical totaling over 75 experts across laboratories in Ann Arbour and Bend in the US, Toronto in Canada and Manchester in the UK.

Regulatory agencies are requiring more and increasingly complex E&L studies before drugs and products come to market. The impact of extractable and leachable substances on product safety and drug product interaction is now studied and evaluated throughout the drug development process to make sure certain drug efficacy and patient safety are not compromised.

Sarah Brophy, global scientific director for extractables and leachables, life sciences, Element, said: “Our combined knowledge and experience helps us deliver an unequalled expertise in the rigorous testing for E&L on a whole range of products across the world’s regulatory authorities. Keeping up with ever increasing demands for product testing and delivery is a significant part of the approval process.”

Guardtech’s operatives follow client SOPs and use specific validated chemicals and equipment when required, with the

COMPANY UPDATE

https://www.microcare.com/

MicroCare announces the hiring of senior quality control chemist

MicroCare has announced the hiring of Rebecca Mahoney as senior quality control chemist. Mahoney brings over 12 years of experience in the pharmaceutical and industrial biotechnology industries, where she conducted analytical techniques to support product development.

As senior quality control chemist, Mahoney will be responsible for developing, conducting, and overseeing analytical methods to test incoming raw materials and approve outgoing MicroCare products.

The Decon Team utilizes EndoSan SHP dry misting technology – and say it’s proven to achieve greater than log 5 reduction (99.999%) in bacteria and at least a log 3 (99.9%) reduction in virus of the coronavirus family.

“Rebecca’s extensive experience and skill in analytical methods, development and validation will undoubtedly make a great contribution to the continued success of our organization. We are excited to add her to the MicroCare team,” said Marufur Rahim, technical laboratory director at MicroCare.

Before coming to MicroCare, Mahoney held analytical chemist and quality assurance chemist roles at Pfizer, Thor Specialties and most recently, Invicro.

“I am thrilled to be joining MicroCare, a company that is at the forefront of innovation in the critical cleaning industry,” said Mahoney. “I look forward to using my expertise to ensure that the quality control criteria at MicroCare is met and to assist in the development of new products.”

Mahoney earned a Bachelor of Science in Chemistry from Western New England University in Springfield, Massachusetts, and a Master of Science in Chemistry from Sacred Heart University in Fairfield, Connecticut.

SYBRIDGE, A TECHNOLOGY DRIVEN DESIGN AND MANUFACTURING COMPANY, SHOWCASED ITS NEW BRAND CAMPAIGN AND SHARED THE NEWS OF ANOTHER ACQUISITION AT MD&M WEST. MEDICAL PLASTICS NEWS SPOKE TO DEEPAK PRAKASH, VP OF MARKETING FOR SYBRIDGE, TO FIND OUT MORE.

While the company boasts about its medical device capabilities, it wants to expand this more, with an emphasis on life sciences going forward. With this goal in mind, the company announced the acquisition of Cavoform, a company that specializes in molding for medical devices.

Prakash said: “One of Sybridge’s secrets to success has been having all these acquisitions.

“They’ve come at a fairly brisk pace, but you know every one of those has brought on some capabilities that speaks to the unique and transformative journey Sybridge is on.”

After acquiring another company – Fast Radius in December –Sybridge was able to take the first step in creating a new brand

campaign. The company was a digital manufacturing company and a “very exciting start up” that focused on multifaceted manufacturing capabilities, including 3D printing and CNC machining.

Prakash explained how one of the things Fast Radius did very well was to have a portal where you could upload and analyze your designs. So, whether a wall needed to be changed it could be analyzed and then 3D printed once the customer was satisfied.

“We love that capability because we can now put a lot of power in the hands of designers. This new campaign works by just sitting in front of the computer. The client can just upload the part into our portal and have it analyzed digitally.

“The client can approach the company and say ‘I have this design - can you test it? Can we manufacture it now?’ All of that can be done through a simple portal. Then if they’re interested and everything looks good, they can have a quick analysis of how much it would cost.”

The campaign was launched on 31st January, but had been in the works for several months beforehand. After successive acquisitions, the company is now able to bring the kind of scale it had set out to do.

Prakash claims the company is transforming the whole industry, bringing not only a digital transformation but also a ‘unique’ single platform to help customers along the journey and put the designer or manufacturer in control.

“You’ll see us being a prominent player in this digital transformation journey in this industry,” Prakash said. “Especially given some of our capabilities speaks very nicely to the life sciences marketplace, so you’ll see greater push from us putting our name out there.”

The future looks bright for SyBridge as the company position themselves as disruptors in the manufacturing space by bringing in technological capabilities that serve customers along their end-to-end development journey. A key aspect of that will be acquisitions, and SyBridge will continue to look for opportunities that allow for strategic expansion into high value market segments including medical and life sciences.

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SCAN ME

OLIVIA FRIETT, EDITORIAL CONTENT PRODUCER OF MEDICAL PLASTICS NEWS SPEAKS TO IAN BOLLAND, GROUP CONTENT MANAGER FOR MED-TECH INNOVATION AND MEDICAL PLASTICS NEWS ABOUT WHAT TO EXPECT ON THE CONFERENCE STAGES AT MED-TECH INNOVATION EXPO ON JUNE 7-8.

TAKE TO THE STAGE

With the 2023 running of Med-Tech Innovation Expo in Birmingham just around the corner as part, it’s only natural to be curious of what to expect.

Whether you’re an intrigued buyer, an enthusiastic exhibitor or just want to come for the experience, there is something for everyone – especially in the medical plastics industry. Some recognizable names from the industry such as Boddingtons, Shawpak and BioInteractions are exhibiting on the show floor, while the Connect Lounge offers you the perfect meeting space for you to make connections that way.

Besides speaking to people face-toface, you can listen in on a seminar or panel session on one of the conference stages to hear experts discuss important topics throughout the course of the two days.

There are two stages: MedTech Innovation Conference and Introducing Health-Tech Stage. Both stages will have back-to-back speakers throughout the event. The Med-Tech Innovation Conference

stage will hold two keynote speeches on each day while the Introducing Health-Tech Stage will have the PITCH competition featuring start-ups on the Thursday afternoon.

MED-TECH

INNOVATION CONFERENCE

At the Med-Tech Innovation Conference, there’s so much to look forward to on the first day alone.

Ian Bolland, group content manager for Med-Tech Innovation and Medical Plastics News said: “We’ve got talks on supply chain strategy, medical device outsourcing and digital health is always a massive factor too. We’ve got a great presentation from ORCHA that’s going to be delivered on the Med-Tech Innovation Conference stage.”

The opening speech on day one will be the keynote speech by Heather Hobson, head of regulation and access, innovation and growth for Office for Life Sciences on the topic of the life sciences vision. The hour-long session will provide an overview of the Government’s 10-year strategy for Life Sciences, the Life Sciences Vision. It will provide an insight into government

priorities for the sector as well as a progress update on the key themes of the Vision.

There’s also going to be a seminar on the future of UK medtech by Mark Oakes, head of life sciences (exports) for the Department for Trade and Business. Of course, the future of medtech is always going to be on everyone’s minds and having someone who works in exports for life sciences will be beneficial for those in attendance. Oakes will articulate the Department’s range of levers to support UK medtech in the coming years and provide examples of opportunities to export to key markets such as the USA. He will also speak to how the sector is evolving and the potential the UK has to advance its leading position in research and innovation.

The last seminar of the day will be presented by the headline speaker – Michelle Sullivan, head of public affairs, UK & Ireland, Boston Scientific (who are a finalist for the Connected Health award at Med-Tech Awards 2023) on how to make net zero healthcare a reality. So many companies in the industry now are trying to become eco-friendly so this seminar will be a must-see, especially for anyone in the medical plastics sector.

On day two, according to Bolland, one thing to look out for is the talk on GlucoRx’s Bioxensor – a true, non-invasive blood glucose monitor by Professor Adrian Porch, professor at School of Engineering, Cardiff University. “I heard him speak about health and he was very impressive. So, I’m really hoping for a packed audience for that speech. I’m kind of expecting it too, so please come along,” said Bolland.

INTRODUCING HEALTH-TECH STAGE

Regulation has been at the forefront of the industry for the past couple of years with the new EU and UK regulations being put in place. So, it makes sense for Ian Bolland to be bringing the Med-Talk Podcast to the live stage to discuss the latest in the medtech regulatory landscape for a second successive year. With Bolland talking to Professor Laurie Rowe, founder and CEO of Red Medtech, Fiona Maini, principal global compliance & strategy manager at Dassault Systems (Medidata) and Laura Friedl-Hurst, principal consultant & managing director at LFH Regulatory live on stage about the current regulatory landscape, it’s bound to be an incredibly insightful chat and not one to miss.

There are so many talks throughout the two days on this stage covering all aspects of the industry; some topics are broad, such as sustainability, digitalization, design etc and others are very specific to parts of the industry. A couple of the seminars that particularly stand out for the medical plastics industry are “The evolution of coatings: why coatings are the future for medical device OEMs” by Arjun Luthra, commercial director at BioInteractions and “The latest in medical adhesives” by Kevin Brownsill, head of technical, learning and development at Intertronics.

The final session of the expo on the Introducing Health-Tech Stage is the PITCH. In my opinion, the PITCH is a staple of the Med-Tech Innovation Expo. The hour-long competition will see numerous start-ups share their pitches on stage to a live audience and judges. After listening to all the pitches, the judges will then choose a winner.

“Every company has to start somewhere. These are the people with the budding ideas. They’ve got the ideas of tomorrow. It’s really important that we hear what these new ideas are, and we should be celebrating new innovation.” Bolland said, “The PITCH sessions over the past couple of years have been very well attended. I think there’s always interest from people who visit.”

Overall, the conference is expected to be a huge success with a mix of experts within the industry. I implore everyone to come and hear what they have to say across both of the stages.

BIOINTERACTIONS EXPLORES THE QUESTION OF “HOW MANY HEALTHCARE-ASSOCIATED INFECTIONS MUST OCCUR BEFORE WE YELL ‘ENOUGH’?”

In the past century, modern medicine has broken countless barriers towards a safer, more effective healthcare protocol. One of the most important discoveries came in 1928 at St. Mary’s Hospital, London, when Alexander Fleming discovered penicillin. Penicillin, an antibiotic, was found to weaken the cells’ walls and cause bacteria to die, allowing a person to recover from a bacterial infection. This scientific breakthrough led to the widespread use of antibiotics, which in turn resulted in a large (positive) impact on clinical outcomes, improvements in public health, and a significant reduction in death and disabilities derived from infections.

Unfortunately, antibiotics are not always the solution to hospitalborne infections. As revealed by the European Centre for Disease Prevention and Control, more than 4 million people acquire a HealthcareAssociated Infection (HCAI) each year, resulting in 37,000 deaths. Combatting HCAIs is a significant problem for the healthcare sector globally. HCAIs are the sixth leading cause of death in western countries. However, treating all these infections with frequent use of antibiotics is leading the general population to develop antibiotic resistance, in turn lowering the effectiveness of the treatments and the public trust in medicine.

Researchers have been able to pinpoint the cause of most of these infections: bacteria-infested surfaces inside of hospitals. There is an identified need to protect surfaces from germs and microbes. This is not only true for healthcare devices and surfaces, but also for materials like equipment, walls, textiles—the list is almost endless. Everything is susceptible to microbes, which find their way to humans through ineffective hand hygiene. It is not always possible to clean, disinfect or use strong chemicals on surfaces to prevent the growth of germs during regular intervals.

Thankfully, scientists have now found a solution to this problem: antimicrobial coatings.

A novel biocompatible antimicrobial coating such as BioInteractions’ innovation is an application of a chemical agent on a surface that can stop the growth of disease-causing micro-organisms. Apart from increasing the surface’s durability, appearance and corrosion resistance for example, these coatings also protect from harmful disease-causing microbes. When medical equipment is coated with an antimicrobial solution, it can prevent up to 99.999% of a wide range of germs, significantly reducing the risk of infection for the patients. Non-leaching antimicrobial coatings stick to the surface they are applied on and remain at a consistent level of efficacy for a long period, defining them as one of the best options to fight bacteria in this environment.

HOW DO WE ELEVATE THE STATUS OF ANTIMICROBIAL COATINGS?

Currently, there are many companies in this industry that have turned their resources to the development of a highly effective antimicrobial coating, a new coating technology for medical devices which represents a paradigm shift in infection prevention and protection against a broad range of pathogens. But unfortunately, most of these products are still far from perfect.

SPREADING PROTECTION

The truth is, the medical industry needs to raise its standards, and this will only come through technology innovations. Not every antimicrobial coating on the market will solve the issues the industry is facing, and in this instance, we should not settle for less than perfect. There are already many products being used that offer an antimicrobial coating with a certain level of protection, but they are often silver-based and may also be leaching, in turn leading them to lose their effectiveness over time as well as adding risk to the patient.

The perfect antimicrobial coating needs to prevent growth as well as confront active infections by incorporating both active and passive components to create a non-leaching, effective, safe, and durable solution for even the most sensitive medical devices and implants. There is a solution that has already been tested that is fully compliant with current medical device regulations, has been independently tested to international standards (ISO, EN, PAS) and proven to provide monoclonal protection which kills a broad spectrum of gram-positive and gram-negative (including drug resistant) bacteria as well as enveloped and non-enveloped viruses, including E.Coli, MRSA, Influenza, Norovirus and SARS-Cov-2. It is called TridAnt, a technology innovation from BioInteractions. TridAnt Enhanced Antimicrobial Technology has been proven to be suitable for a range of uses including skin. The Skin Protection allows for the first time, for the user to spread protection rather than spread germs with their touch. The technology is also optimized for use to protect most other surfaces including woven and non-woven fabrics and non-porous surfaces such as metals as well as polymers. Using TridAnt will not only save time needed for medical treatment, therefore raising productivity, but it will also result in a significant reduction in the transmission of HCAIs, and therefore many lives saved.

WHY ISN’T THEIR USE MORE WIDESPREAD?

One of the main factors stunting the widespread use of antimicrobial coatings are the current regulations in place. Under today’s European Union (EU) regulations, medical devices are considered medicines and are therefore tested by the European Medicines Agency (EMA) following the same tests and approval processes that drugs do. Regulators want to make sure that any positive effects an antimicrobial coating has are systematic, able to be replicated across the board, in different settings and for different patients.

In the USA, the use of antimicrobial coatings is more widespread than in the EU. The US Food and Drug Administration (FDA, which oversees drug and medical device developments) allows the use of silver-based coatings, regardless of them leaching and reducing their effectivity overtime. In the EU, however, this is seen as a risk to the patient and regulated against.

Thorough testing and aiming for perfection in all medical-adjacent products are especially important not only for patient care, but also to bring about a continued cycle of technology innovation. This current method of testing

helps hospitals, patients and doctors to be certain that antimicrobial coatings are effective against HCAIs. However, this process can be very elongated, at times up to years, for brands ultimately to earn accreditation, which slows down progress. Regulations need to be thorough and effective, but they also need to move forward to assist with innovation.

WHAT WILL HAPPEN IN THE FUTURE?

The prospect of a biocompatible technology which can enhance the function of medical devices through eliminating existing microbes and actively confronting existing infections within the patient represents a paradigm shift in prevention and treatment of surgical infections. The future will bring further developments in material sterilization, bacterial reduction and bacterial elimination. Antimicrobial coatings like TridAnt from BioInteractions’ are cementing themselves as the golden standard of excellence in healthcare, used in all things that go inside the patient, on and around open wounds. Additionally, they will help prolong the active lifecycle of medical devices, which has a significant economic, health and social care impact.

As time goes on, the focus will switch from infection reaction to infection prevention. Once science begins to prevent infections, we will also be able to prevent pandemics, lockdowns, and raise the public’s confidence in antibiotics.

The future with TridAnt brings an opportunity to raise medical standards. The innovation already exists. All we have to do now is choose to implement it.

KATIE FARLEY, PRODUCT MANAGEMENT DIRECTOR, MASTERCONTROL EXPLORES HOW A NO-CODE MES SOLUTION GIVES USERS CONTROL IN MEDTECH MANUFACTURING.

No MESing about

PROBLEMS WITH A HARD-CODED LEGACY MES

Because they’re built for a specific set of requirements and with narrow architectures, MES tend to be rigid systems. While a traditional off-the-shelf MES can be customized, almost everything is hard-coded. These hard-coded process configurations make legacy MES difficult to adapt when processes, products, product parameters, or quantities need to change. Making changes is time-intensive and can involve significant process reengineering.

User adoption is a challenge, because a traditional MES’s machine-centric design and complexity tend to make user acceptance and usage difficult, and the hard-coded software often requires highly educated and highly skilled employees to configure it. When the MES isn’t user-friendly and requires dedicated support, the barrier to user adoption and use becomes even greater. Digital alternatives to traditional MES mean the common challenges of digitizing manufacturing can quickly be overcome using no-code tools and approaches to achieve automation and digitization goals.

ADVANTAGES OF A NO-CODE MODERN MES SOLUTION

As demand for automation and digitization continues to rise in medical device and diagnostics manufacturing, the need for support and configuration of modern software solutions extends to non-IT roles in manufacturing operations. This poses a challenge in an environment where traditional manufacturing execution systems (MES) are difficult to use.

In a 2022 survey of life sciences manufacturers, MasterControl found that only 9% of organizations have their MES fully implemented at all facilities, due to the complexity and customization typically associated with a traditional MES.

The data indicates a need for light, no-code manufacturing solutions that are configurable and easy to use.

DIGITAL EXPECTATIONS

Today’s manufacturing workers are used to pick-up-and-use smart phones, tablets, and apps in their personal lives, and they expect these easy-to-use digital tools in their business tools.

There is a longstanding view among manufacturers that a legacy MES is the only path to digitizing and automating the shop floor. Yet for most production environments, the barriers of adopting a traditional, hard-coded MES have kept many organizations from digitizing their manufacturing environment.

No-code manufacturing solutions are powerful tools that help manufacturers automate and digitize their processes with human-centric technology across all of production. This is especially true for small manufacturers with fewer resources to invest in large digitization projects, or manufacturers of highly customized products or personalized therapies, as they allow organizations to apply the latest technologies to variable processes quickly and cost-effectively without overburdening IT.

Among the many advantages associated with no-code manufacturing solutions, below are a few that give medical device and diagnostics manufacturing workers greater control.

Flexible Structure

A modern MES solution will offer no-code configuration that allows organizations to quickly adapt processes and parameters. A purpose-built manufacturing solution easily supports existing processes and workflows, eliminating costly process re-engineering.

User-Centric Design

A configurable, no-code MES solution is designed for any manufacturing environment, with a simplicity focused on the operator and their ease-of-use with little training required. A modern no-code MES solution’s electronic device history record (eDHR) is configured to resemble a manufacturer’s current paper DHR, but with a user interface (UI) and user experience (UX) designed specifically for mobile technology on the shop floor. So, the manufacturing solution is easy to learn by any employee.

Easy-to-Use Templates

A configurable, no-code master record builder enables manufacturers to quickly and easily build out and use a variety of eDHR templates – with templates for efficient scaling and an integrated product family tool to simplify recipe and product variant management – requiring minimal training, no technical background, or engagement of a third party.

CONCLUSION

In today’s increasingly digital manufacturing environment, the challenges of implementing and maintaining a traditional hard-coded MES means manufacturers need to rethink what manufacturing automation and digitization looks like. A light no-code MES solution that is configurable, adaptable, and easy to use can bridge the gap between a traditional MES’s rigid capabilities and the digital tools needed by the modern manufacturer to speed up transformation without burdening their IT teams.

BOOSTING productivity

5. Augmented Reality (AR) training programs

Plastics factory managers are always looking for ways to improve productivity and reduce costs. The rise of smart manufacturing has opened new opportunities for you to optimize your operations and achieve better results.

This means plastic production plants must adopt emerging technologies to automate tasks and processes to improve customer satisfaction and increase output levels – all at reduced costs. Here are five areas where businesses can find opportunities to boost their plastic factory productivity, using smart manufacturing solutions:

1. Automation of production processes

Smart manufacturing solutions offer advantages, including automation of production processes that reduce manual labor, increase efficiency, and minimize the risk of errors. Automation also improves the quality of your products by ensuring consistent production standards.

There are a wide range of factory robots available in various shapes and forms, along with a selection of solutions, providers, and costs. This allows factories to update legacy injection molding machines to integrate automated systems that can also help control production processes in real-time, making it easier to identify and resolve issues.

2. Predictive maintenance

Equipment downtime can be costly for plastics factories, leading to production delays, reduced efficiency, and increased expenses. Smart manufacturing solutions, through predictive maintenance, can prevent such issues by identifying potential equipment failure before they happen. By monitoring the sensors and other data, factory managers can use predictive failure algorithms to address equipment problems early, reducing maintenance costs, improving uptime, and enhancing productivity.

3. Quality control

Quality control is crucial for plastics factories, as even minor defects can result in costly rework and waste.

Smart manufacturing solutions can help you improve quality control by using sensors, automated visual inspection and data, to monitor production processes in real-time.

4. Supply chain optimization

Optimizing the supply chain can improve product distribution, sourcing, and margins. Smart manufacturing solutions utilize data to identify inefficiencies, enabling businesses to manage inventory levels and monitor supplier performance. By optimizing the supply chain, businesses can reduce lead times, improve responsiveness to demand and lower costs.

It’s not getting easier to recruit and retain staff. AR technologies can help factory managers shorten the time it takes operators to go from recruitment to the factory floor. They also cost a fraction of what they use to, as the technology is getting cheaper. AR/VR provides an easy means for staff members, within plastic manufacturing plants, to quickly learn different procedures, without the need for traditional classroom training methods. Companies can save time and money while simultaneously reducing errors associated with human labor, resulting in increased productivity levels over time.

KEY TAKEAWAYS

Including smart manufacturing technologies into plastic manufacturing settings requires careful planning coupled with dedication from employees and management. It is important to consider all aspects including investment plans, technological considerations ranging from software platforms through hardware components, mission alignment, etc.

The plastic manufacturing industry’s most prominent challenge is the lack of skilled resources knowledgeable about smart manufacturing solutions. Consequently, most companies do not have the time or resources to integrate smart manufacturing into their production lines. With all the options available in the market there are solutions available for any production line and most budgets. Working with the right smart manufacturing partner can help you get there quicker.

ASHLEY SAYED, CEO OF INTRETECH UK, SHARES THE FIVE AREAS OF OPPORTUNITIES TO BOOST PLASTIC FACTORY PRODUCTIVITY USING SMART MANUFACTURING SOLUTIONS.

ALAN THOMAS, MARKETING AT ZWICKROELL, EXPLORES THE BENEFITS OF DIFFERENT TESTING SYSTEMS.

Testing the mechanics

Over the last 20 years, the use of plastic materials in healthcare has resulted in radical change and complete transformation of this industry. The versatile material properties, excellent biocompatibility and wear resistance are some of the key reasons why plastics are dominating the medical device and prosthetic sectors.

The increased use of plastics in the healthcare industry also means that new quality control standards and systems must be developed and applied across the whole development and manufacturing chain and strictly monitored.

During the manufacture of a finished product or a semi-finished product, the processed polymer is subjected to a variety of mechanical, thermal, and chemical loadings and normally forms orientations for the polymer chains and fillers. Therefore, the mechanical properties of a polymer differ at various points of the component.

To compare material properties of a product produced by injection molding, extruding, or compression molding, a sampling plan for the specimen is defined. This sampling plan is based on the forming process of the product and defines the number, form, size, and direction of sampling of the specimen.

After appropriate conditioning, the specimens taken are tested to the relevant test standards or to specific information found in the product specification.

Regular specimen sampling from ongoing production ensures that specific material properties remain constant in one product within predefined tolerances and over longer production periods.

UNIAXIAL TENSILE TESTING

Uniaxial tensile testing is one of the most common types of mechanical test performed on engineering polymers, but other common tests include flexure, impact, and melt flow. The popularity of the tensile test is due to its ability to not only provide quantitative data on a range of mechanical properties, but also gives insight into the structural changes that occur during testing for example, there is an intimate relationship between molecular structure and performance in the test as exemplified by the significantly different responses obtained when testing thermoplastic, thermoset, and elastomer engineering polymer materials. It is essentially used for determining the mechanical characteristics of isotropic materials that is, materials whose properties are the same regardless of measurement direction.

To determine the strength of the material, loading of the sample is carried out relatively slowly and increased continuously until the sample fails by either ductile or brittle fracture mechanisms; failure mode is dependent on the nature of the material. The maximum test force applied to produce the first local maxima in a stress/strain plot is a measurement of the material strength or the so-called yield strength.

Though the basic dimensions of uniaxial tensile test samples can vary widely in size and geometry, they all have the same basic characteristics. Each sample has a well-defined gauge length of constant cross-sectional area, and a shoulder with a well-defined fillet radius which defines the end of the usable gauge length. The shoulder is the region of the sample that is gripped in a tensile testing machine and hence the available area and its

dimensions will depend on the type of gripping system being employed. Secure gripping of samples and proper alignment are vital as poor gripping leads to slippage and misalignment imparts a bending moment on the sample, leading to non-uniform stress distribution over the sample cross section, resulting in errors in data collection and premature sample failure.

FLEXURAL TESTING

The flexural test measures the force needed to bend a beam under three-point loading conditions. The measured data is often used to select materials for parts that need to support loads without significant flexing. Flexural modulus is used as an indicator of a material’s stiffness when flexed. The physical properties of many materials can vary depending on the ambient temperature, and it is sometimes relevant to test materials at temperatures which replicate the intended ‘in-service’ environment.

In the standard flexural test, the specimen rests on two lower supports and the load is applied to the center by the upper loading nose producing three-point bending. The parameters for this test are the support span, the rate of load application, and the maximum deflection. These parameters are based on the test specimen thickness and are defined in the ASTM and ISO international standards.

CHARPY V-NOTCH IMPACT TESTING

The most common measure of toughness is the resistance to impact as measured in a Charpy V-notch impact test. A vee notch is machined in the center of a test specimen and the specimen is supported horizontally on an anvil. The specimen is subjected to an impact from a pendulum of a specific weight, released from a fixed height such that the pendulum strikes the sample on the opposite side of the vee notch. The specimen fails in flexure under impact. The energy absorbed by the specimen when it is subjected to the impact from the pendulum is equal to the difference between the potential energies of the pendulum before and after impact. The result obtained from this test is resilience and a fracture type. The resilience is expressed as the energy required to break the specimen; this energy is measured via a rotary encoder on the pendulum axis.

EXTRUSION PLASTOMETERS

Extrusion plastometers, also known as melt flow index testers, are used to determine the melt mass flow rate (MFR) and melt volume flow rate (MVR) of a plastic melted mass. Measurement of the flow behavior of the melted material is used to compare different grades of the same polymer and provides an important parameter for quality assurance and incoming goods

inspections, for material selection and the set-up of processing machines by plastics processors. Demands on melt flow indexers vary according to which plastics processing stage is involved.

MFR or melt mass flow rate, formerly melt flow index or MFI measures the rate of extrusion of thermoplastics through a standardized orifice in a die at a specified temperature and load. While MFR is measured in mass per unit time, such as grams/10 minutes, MVR is measured in volume per unit time, such as cm³/10 minutes. The ratio of the two values, MFR divided by MVR, provides a measure of the melt density of a material in g/ cm³.

Because the melt density of a plastic material is not the same as its solid density, knowing these two values is important for plastics processors.

The properties of a component or structural element cannot always be predicted exactly from the material properties. Components are therefore tested in typical ‘inservice’ loading situations. This enables strength and deformation characteristics to be determined and calculation methods validated.

JUHA SAILY, REGIONAL DEVELOPMENT

MANAGER,

HELMEE IMAGING, HIGHLIGHTS

HOW

NEW VISION TECHNOLOGY ENABLES AUTOMATED IN-PROCESS INSPECTION OF MEDICAL DEVICES WITH HIGH GLOSS, SPECULAR AND CLEAR SURFACES.

Inspect the gadget

Quality inspection in the manufacture of medical devices with demanding high-gloss and specular finishes is often performed manually by human visual inspection. This is because traditional machine vision systems cannot capture good enough images of such surfaces, and dedicated systems designed for characterization of high gloss parts are slow and work adequately in sampling-based laboratory applications only. The technical challenge is even more difficult when inspected parts or assemblies have contoured, sloping or complex surface geometries that reflect just a small portion of light, if any, to the system’s cameras or sensors.

A new machine vision technology, Covered Stereo Deflectometry (CSD) by Helmee Imaging, addresses all disadvantages of existing automated systems, and human visual inspection alike. High-speed in-process inspection of complex high gloss parts can now be automated which makes all the wellknown benefits of automatic 100% product inspection available also to more challenging applications.

Deflectometry is a common technique and works well in inspection of flat high-gloss surfaces. Covered Stereo Deflectometry expands from it in several ways allowing the capture and analysis of high-quality high-resolution images also of contoured, sloping and complex surface geometries.

IMAGING HARDWARE

It is important to get light emitted by light sources to the cameras from a highly reflective non-flat surface. This is accomplished by a semicircle-shaped membrane that diffuses light evenly onto the target surface from all directions of the parts the membrane covers.

Setup for a new product is quick with Helmee’s AI/ML (Artificial Intelligence and Machine Learning) software that is currently being implemented in phases. Setup allows configuring the system for detected defect type, size, shape, and frequency. Both 2D defects and 3D imperfections can be detected and analyzed with CSD.

*Figure 1. Imaging hardware.

The system’s wide angle of view reduced the number of cameras making the CSD system simpler, more robust, and easier to setup and maintain than common deflectometry solutions that may contain more than 10 cameras.

IMAGING AND ANALYSIS SEQUENCE

Light sources outside the membrane project a very quick series of striped patterns onto the inspected surface. Pattern direction, width and the number of captured images vary and depends on the inspected object and its surface. The system’s camera(s) capture these raw images that are instantly processed into result images by complex mathematical algorithms. The CSD image processing software can produce about 30 different result image types for handing virtually any surface and defect type from part deformation to missing material to pin holes and anything in between.

The CSD software is recipe-based, and all parameters are selected by it making part changeovers extremely quick. No physical adjustment or alignment for light sources, cameras, or other imaging components are ever required.

Figure 2. Detectable 2D and 3D defects on high-gloss surface. When the software detects a severe enough defect violating any of the acceptance rules, the unit sends a signal to solution’s parts handling automation to remove the part from the production line. Inspection time, reject reason, serial number, image, etc. can be saved in the database for reporting and tracking purposes.

SYSTEM INTEGRATION AND PARTS HANDLING AUTOMATION

A complete CSD solution consists of an imaging core unit and software, and parts handling automation that is based on a conveyor or a robot, depending on the application. Conveyor is a simpler approach and works well with parts that can be inspected without turning them. Robotized infeed and handling is recommended when multiple sides of the part need to be inspected.

Since the CSD core units include all necessary imaging hardware and software, they are easy to integrate into external systems. The core units come even with an integrated PC, and the software is preinstalled. Connecting the system into a PLC, factory network and cloud is simple and straightforward.

JASON MCGLYNN, DIRECTOR AT INDUSTRIAL METROLOGY SPECIALIST THE SEMPRE GROUP, EXPLORES HOW QUALITY 4.0 CAN REVOLUTIONIZE MEDICAL PLASTICS MEASUREMENT.

That’s Quality

The dimensions of medicalgrade, biocompatible plastics and polymers are critical for ensuring medical device functionality, quality and compliance. But what is best practice for their measurement, and how can manufacturers improve the management of quality data?

When using any measurement system to assess plastic medical components, if they operate in silos, key quality data can become isolated. While manufacturers can still collect the data required to validate parts, if systems are kept separate, they are unable to glean insights that can help improve medical device production quality, increasing the risk of unexpected defects or worse, recalls.

A quality management system (QMS) is essential for managing measurement data in line with industry standards. Industry 4.0 has introduced a solution to potentially siloing, by centering upon a datadriven approach that can help medical device manufacturers improve decision making and facilitate communication between their automated measurement systems.

The future of quality management works on these same principles — Quality 4.0 digitizes and connects the entire process from drawing to reporting. This approach removes the challenge of integrating data from fragmented sources,

reduces human error and improves productivity. So, what does Quality 4.0 involve?

FROM DRAWING TO FINAL PRODUCT

Every plastic surgical component, device casing or housing begins with a conceptual drawing. Converting 2D drawings into functioning medical components traditionally required engineers to manually outline all the individual dimensions and create a ballooned image that acts as a guide when manufacturing the final product. As Quality 4.0 capabilities evolve, manufacturers are using automated solutions like High QA Inspection Manager to automatically populate First Article Inspection (FAI), Production Part Approval Process (PPAP) and Initial Sample Inspection Reports (ISIR).

By automating the ballooning process, medical device manufacturers can monitor process control more effectively, identify trends and reduce errors. This means healthcare facilities and other customers can be confident in the plastic part’s compliance and ability to meet the application’s needs. Automation also removes

the risk of human error caused by engineers inputting the wrong data.

Following the ballooning stage, augmented reality (AR) systems like ARKITE can guide operators through the assembly process, by projecting instructions for them to follow. As well as reducing assembly error, this digitally confirms when every operation is complete and records data for full traceability.

IMPROVED VISIBILITY

Prolink SPC universal data collection and analysis software is a good example of manufacturers bringing all of their measurement data together. Prolink allows manufacturers to automatically collect data from any metrology or manufacturing system and outputs the results in the same format for reporting. This plug and play platform extracts real-time result data from any machine, enabling full visibility across multiple site locations.

Quality 4.0 provides medical device manufacturers with a 360-degree view, so they can use data generated insights to improve the production process.

Advances in technology ensure that testing and regulatory support for a wide range of devices and materials across the medical industry are constantly innovating.

Polymers are used extensively in the manufacture of medical devices and must meet demanding industrial requirements.

With devices being generally complex in geometry, material and chemistry, the work plans often need to be thought about carefully to ensure the tests performed give the truest evaluation of medical devices in use.

Companies such as Lucideon work to ISO, ASTM, and FDA standards, as well as novel methodologies with rationale when the standards are not adequate.

One of the most popular methods requested by medical device manufacturers is equivalence testing.

To undertake work in this area, a range of techniques and methods are utilized. These can include:

FTIR (Fourier Transform Infrared Spectroscopy) provides detailed information on the chemical structures within compounds. FTIR depends upon the absorption of infra-red radiation arising from the vibrational and rotational characteristics of dipolar chemical compounds and is a powerful technique for polymer identification.

DSC (Differential Scanning Calorimetry) is a thermoanalytical technique used to study the thermal transitions of a polymer. DSC yields a plot of temperature versus heat flow and provides information on thermal characteristics, thermal history, and curing performance of polymer samples.

TGA (Thermo-gravimetric Analysis) is a method of thermal analysis in which the mass of a sample is measured over time as the temperature changes, thus providing information on the bulk composition and thermal stability of polymers.

GPC (Gel Permeation Chromatography) determines the molecular weight and molecular weight distribution of polymers which are some of the most important characteristics of thermoplastic polymers; they have great impact on mechanical properties and processability.

SEM/EDX (Scanning Electron Microscopy/Energy Dispersive Analysis) provides detailed high-resolution images across the surface sample size measurement and can also provide elemental identification and quantitative compositional information.

It is important for clients to receive analysis and interpretation of test results, and not just the numbers.

Analytical interpretation and rationale support make equivalence studies more robust when they are able to clearly demonstrate why a method is chosen and show what the results mean for the materials and the manufactured devices.

REASONING BEHIND EQUIVALENCE TESTING

There is a growing trend from medical device manufacturers for equivalence testing. The reasons behind this are varied and include the desire to introduce new innovations or change suppliers.

Investigations as part of competitor analysis, which might be needed to help a medical device manufacturer retain their position in the marketplace, also draw on equivalence testing.

Another driver is a legacy from the pandemic; the material shortages and supply chain staffing shortages we saw during COVID-19 are still lingering.

As a result, new materials are being considered and equivalence testing needs to be implemented to ensure alternatives offer the equivalent performance attributes.

There is enhanced pressure across the industry to remove certain raw materials, and/or ingredients to meet new safety concerns and regulations.

Finally, ever changing market pressures to continually add functionality to existing products, in areas such as antimicrobial and antibacterial resistance, need to be addressed.

As a result of all these factors and more, medical device manufacturers might not only look at equivalence and analytical comparison, but also at alternative polymers and other materials. This is where polymer consultancy services can come into play. Addressing factors relevant to the medical device sector, they address the key areas of materials selection and characterization such as biocompatibility of new choices. The services also cover specific details, including how to process, clean, and sterilize the new materials.

Advanced materials are constantly evolving, improving, and transforming the medical device industry. For manufacturers, the options are there to test and challenge how they can be implemented into medical devices for long-term gains.

XI

PENG, TECHNICAL CONSULTANT, POLYMERS, LUCIDEON, DISCUSSES SOME OF THE CURRENT TRENDS IN THE SECTOR AND PROVIDES AN APPLICATION OVERVIEW OF SOME OF THE TECHNIQUES.

Simple Solutions for Secondary Packaging

Transportation of Category B biological samples requires a multi-layered packaging system to meet the legal requirements of the UN3373 regulation. These include:

■ Leak proof secondary packaging

■ Inclusion of adequate absorbent material

■ Separation of multiple tubes

Choose from two secondary sample packaging solutions that provide these features, helping you achieve compliance with ease, speed and reliability.

 Rigid, clam shell construction protects samples

 Built in absorbent gel prevents leaks

 Multi-vial options with tube separation

 Leak-proof pouch for individual vials

 Fixed absorbent material within

 Easy to open

 95kPa compliant options

CAN’T TOUCH THIS

using, what point density, what scan strategy is wanted, and this will all be stored in the CAD model.

3. 3D scanning. 3D scanning is very easy to use and can obtain a lot of information. The ShapeGrabber, OGP’s latest 3D measurement technology, has a lot of benefits in comparison to conventional measuring.

There are multiple things to consider when measuring parts, especially when it comes to measuring medical parts.

Colby Finn, VP of marketing and Dave O’Connor, director of sales and marketing, OGP, share their top tips on measuring parts:

1. Video measurement. The main advantage of video measuring is throughput, it means things can be measured faster. It’s not only the measurement process itself, but it’s also easier to set up the program meaning there’s a lot of time saving involved.

Measuring with video is non-contact, which is optimal for measuring medical parts, as there may be parts that cannot or should not be touched.

“Non-contact measurement is highly suitable for medical parts that might be fragile or made of plastic, and you don’t necessarily want to touch them with force.” says Finn. “With non-contact measurement, not only is it very quick, but also, it doesn’t disrupt the part. It doesn’t move the part. You can look inside parts. Say they are plastic; you can look through the surface to go to the bottom surface. There’s a lot of advantages of using video and other optical technologies on medical parts; from orthopedic implants to plastic tubing for various kinds of medical applications across the board.”

You can get high resolution, precision, and accuracy with video measuring, especially if you’re doing a measurement in one field of view, where you’re not moving your transport. You can easily get submicron accuracy on a video system.

2. Automatic programming. This software can help with easily navigating around the part and easily generate findings through the measurements. Automatic programming, such as Zone3 from OGP, means you can import the CAD model and the tolerances and have it create the routine for you.

The first thing is to import a Quality Information Framework file (GIF) into Zone3, which is an international standard for a CAD model and its tolerances. The software will find features and tolerances in the file and then ask if you would like it to create measurement steps.

The software then allows you to choose the measuring features. In the QIF format, you can store how you want the features measured, meaning a measurement strategy will be made, which includes what tool you’ll be

If a conventional measuring system were to measure something, you would pull-out information on specific features, it would give the measurements and beneath those measurements would be the actual points that are used to define those measurements. Whereas with the ShapeGrabber, it would show you the whole thing rather than just a few points.

This does have a lot of benefits, for example, the whole image will always be archived for if something else needs measuring further down the line.

Another huge advantage is a color map, which is unique to 3D scanning. To get a reliable color map, you need all these data points covering the surface.

“Color maps are a great diagnostical tool, but it is also a communication tool.” says O’Connor. “With the conventional measurement, you’re typically looking at a table of results and you’re trying to relate that back to a drawing. With 3D scanning, you can quickly see the results and determine where we should be looking.”

MEDICAL PLASTICS NEWS ATTENDED OGP’S METROLOGY DAY WHERE COLBY FINN, VP OF MARKETING AND DAVE O’CONNOR, DIRECTOR OF SALES AND MARKETING, OGP, HIGHLIGHT WHY NON-CONTACT MEASURING IS OPTIMAL FOR MEDICAL PLASTICS.

SHAUN KEMP, HEAD OF STRATEGIC PARTNERSHIPS AND MARKETING FOR POLARSEAL, DISCUSSES THE IMPORTANCE OF ADHESIVES CHOICE IN WEARABLE DEVICES.

THE STICKING POINT

converting solutions, has been developing fixation devices that provide a drug delivery solution for several years.

CONVERTING SOLUTIONS FOR FIXATION DEVICES

An advantage of PolarSeal’s converting solutions is their ability to be customized to meet the specific needs and requirements of different drug delivery application requirements. PolarSeal’s stick-to-skin adhesive solutions are made from a variety of materials which are skin friendly and can be used in medical applications due to their biocompatibility.

When it comes to drug delivery systems, it is often necessary to attach tubing to the patient’s skin or other surfaces. So it’s important to find a company that can offer a selection of converting solutions, including adhesive and non-adhesive options for tubing and drug delivery applications.

According to the report by Research and Markets, the global wearable healthcare devices market is expected to reach $93.48 billion by 2030, growing at a CAGR of 18.2% annually over 2020-2030.

This growth is being driven by a number of factors, including the increasing adoption of remote patient monitoring technologies, the growing prevalence of chronic diseases, and the need for more cost-effective and efficient healthcare delivery systems.

Medical device manufacturers are constantly striving to improve patient outcomes by developing new drug delivery systems that are safer, more effective, and easier to use. One of the critical challenges in this field is developing fixation devices that can securely hold a drug delivery system in place. PolarSeal, a specialist in medical

For adhesive solutions, PolarSeal uses a variety of adhesives that are designed to be gentle on the skin, while still providing a secure hold. These adhesives are formulated to resist water, sweat, and other environmental factors, ensuring that the device stays in place even during extended wear.

When manufacturing solutions for fixation of medical wearable devices, PolarSeal ensures adhesives and product materials are skin friendly, repositionable, and sterile, with breathable or non-breathable constructions.

Converting solutions for fixation devices are also designed with patient comfort in mind. The materials are made from soft and flexible materials, ensuring that they do not cause any discomfort or irritation to the patient’s skin. The adhesive backings, film strips, and tapes are also designed to be easily removable, minimizing any pain or discomfort during removal.

The company also specializes in non-adhesive solutions, which can be used in conjunction with hook and loop closure systems to hold tubing and other components in place. These closure systems are designed to be easy to use, allowing medical professionals to quickly and easily attach and detach the device as needed.

Over the past 40+ years, PolarSeal’s team of engineers and technicians work closely with customers to develop solutions that are tailored to the unique requirements of their product, ensuring optimal performance and patient safety from R&D right through to high-volume production.

Overall, the growing demand for innovative drug delivery systems presents a significant opportunity for PolarSeal and other companies in the medical device industry. By providing reliable and effective converting solutions that are tailored to the needs of different applications, PolarSeal is helping to drive progress in the industry and improve outcomes for patients.

The Quest for Medical Product Perfection

Medical product manufacturing is a tough job; persistent timelines, exacting quality standards, equipment performance, tighter margins, and staffing shortages are just a few things piled on the plate.

So how to make your job easier?

The answer lies in reliable technology and the forwardthinking potential of digital transformation. Digitalization and “smart factory” technology may already be integrated into the operation. If you are still researching the possibilities, here are some insights to help take the next step.

Let’s examine five areas that impact your daily operation:

1.PRODUCT QUALITY

It is impossible for a human to track every item on a production line and understand the interactions between key components of the system and overall product quality. By using digital transformation and cloud-based analytics, you can avoid being overwhelmed by large amounts of incoming data and hone in on factors that matter the most.

Awareness alerts, such as those in figure 1, deliver the simplified visual your team needs to make informed decisions. No more hunting around through massive lists and wasting precious time. The necessary data is wrapped up into a tidy package and accessible at a glance.

How is this possible? The real-time monitoring that occurs with digital transformation is like having your own personal artificial intelligence agent. Your process technicians, maintenance, engineering, and management teams can all see the current status of the operation to understand what is going well and what needs to be modified.

Visual details concerning quality factors such as OD (outer diameter), WT (wall thickness), and ID (inner diameter) are available during the production run.

2.PRODUCTIVITY

It’s no secret that more uptime and greater knowledge leads to production line system readiness. Stopping mid-run is not an option. Task maintenance features allow you to receive regular reminders generated by the system based on calendar, run-time and on-demand criteria. Digitalization captures data created by process and equipment experts to summarize factors needed to operate at maximum efficiency per OEM specifications. Figure 2 demonstrates what this looks like, highlighting areas that need immediate attention in red.

3.SAFETY

Your employees and your equipment must be in good health; no exceptions. With cloud-based technology utilizing digitalization, your operators have direct access to OEM safety procedures and protocols to keep them and your equipment in tip-top shape.

Is barrel heating causing trouble, or is it time for a barrel inspection? The operator can quickly access the exact information needed in that moment. See figure 3. Regardless of if your operator is highly experienced or new to the job, the information to perform the task is presented with visual aids. Step-by-step procedures and valuable reminders to ensure that equipment maintenance is done correctly and refers to appropriate safety protocols.

JOHN CHRISTIANO, VICE PRESIDENT OF EXTRUSION TECHNOLOGY, DAVIS-STANDARD, HIGHLIGHTS HOW DIGITAL TRANSFORMATION IS USED TO MAKE JOBS EASIER.

Figure 1

Figure 2

4. EMPLOYEE EFFECTIVENESS

Finding skilled operators and keeping them is never easy. What was once handled by multiple operators, is now mostly likely being handled by one operator.

This requires operators to multitask like never before and digital transformation can support them. Since production system analytics are continuously monitored, tracked

and visually displayed, the whole story is available, not just a small part. In the example shown in Figure 4, this is categorized as good trending better, good trending worse, bad trending better, and bad trending worse. As a result, proactive steps can be taken to improve performance, and there’s instant gratification in seeing those actions take effect.

Furthermore, your entire team can gain access anywhere using a browser or mobile application. Accessibility can be tailored to each individual user, allowing system administrators to fully control the level of access and what data is visible to each user.

5. TIME TO MARKET

Your ability to get product out the door on time and on budget is a make-or-break situation. Production and delivery delays do not make for a pretty picture on your customer’s end. Understanding the “golden run” and how to achieve the best conditions over the long haul is critical.

With digital transformation, this process can become automatic. Production run information, including analytics performance parameters and KPIs (Key Product Indicators), illuminate ideal conditions specific to your process and equipment. The example in figure 5 presents the “golden run optimization toolbox.” This guides your team in selecting the best line conditions to maximize performance on future production runs.

Finally, the overall benefit of digital transformation can be summarized in figure 6.

Operational equipment effectiveness (OEE), production time availability, product quality, and line productivity are no longer a mystery. Your experience and innovation have officially been merged with cloudbased analytics to give you a path to perfection. The data is already interpreted and ready for you as you make informed decisions that deliver positive projected outcomes. No more “running to failure” using postfailure analysis. Instead, it’s all about looking ahead and focusing on what matters most, your customers.

Figure 3

Figure 4

Figure 6

Figure 5

WOUTER GEURTS,

TECHNICAL

BUSINESS DEVELOPMENT MANAGER, TEKNIPLEX

HEALTHCARE, SHARES HOW FINDING A FILM’S STERILITY ‘SWEET SPOT’ WILL EXPEDITE SPEED TO MARKET AND MITIGATE COST.

Discovering the GOLDILOCKS ZONE

As medical products manufacturing continues to evolve, the heights to which cleanroom technology has soared is, in a word, incredible. For the most sterility-stringent medical apparatuses, such as implanted devices and certain microchips, the simplest metaphor to convey current purification capabilities involves a really large lake and a really small coin.

Picture Lake Ontario, all 7,300 square miles of it. Now picture 40 penny-sized flecks floating in that lake. That’s equivalent to the level of purity that today’s-controlled environments can achieve when producing medical products.

Meanwhile, another everprogressing field is diagnostics, which has continued to become more exacting even as application flexibility and durability have expanded in tandem. For example, recent years saw the pioneering development of accurate COVID-19 tests with a shelf life lengthy enough to serve less developed, hard-to-reach locales. Here, success hinges on one inevitability: As diagnostics tools like microfluidic cartridges get more precise and sophisticated, so must the components that comprise and contain them.

THE REGULATORY EFFECT

Regulatory agencies have taken notice – and acted accordingly. A nod to both increased cleanroom capabilities and more exacting sterilization needs, the European Union’s Medical Device Regulation published a set of elevated guidelines in 2017 that officially took effect in May 2021. Similar laws exist in the United Kingdom and United States, whose FDA is especially rigorous in regulating medical devices and diagnostics

tools. Crucially, these directives impose stricter monitoring of quality and safety during a product’s lifecycle, starting at the inception of component production. These regulations insist that the sum must not be less sterile than its parts.

Among these key components is diagnostics films. Typically composed of cyclic olefin copolymer (COC), such films are critical to the overall viability of a diagnostics assay device, insomuch as they enable PCR multiplexing with low-noise signal readout and an optimal seal. In other words, COC films simultaneously keep diagnostics tests free of contaminants and, by remaining glass-clear, optimize analysis instrument precision by avoiding accuracy-degrading autofluorescence issues. Another benefit of COC diagnostics films is their versatility, as they can incorporate value-added features such as conductive printing, PCR thermocycling, laser welding and ultrasonic sealing.

For as vital as they are to diagnostics, it’s fortunate that such films require substantively less purification than our Lake Ontario anecdote. If adequately sterilizing diagnostics films required such infinitesimal particulate tolerances, producing such films simply wouldn’t be economically viable. We’d still have diagnostics tools, yes – but they’d be neither as promising nor as prolific.

If you’re familiar with controlled environments, you’ll know that cleanrooms are designated with internationally recognized numbers based on their particulates tolerances. The lower the number, the lower the tolerance.

ASSEMBLED IN A CLEANROOM

Most diagnostics kits are assembled in an ISO 5 setting. Not quite the equivalent of 40 pennies per 7,300 nautical square miles, but incredibly sterile, nonetheless. Creating and maintaining a controlled environment of that caliber is expensive, and acquiring the regulation-mandated production data is laborious. So, while it’s medically necessary to do some of the kitbuilding work in ISO 5, it’s not ideal to do all of it there.

To meet the latest, more stringent regulations, it is preferred that COC diagnostics films be produced in ISO 7 Cleanrooms, eliminating the need for post-production web cleaning – which adds both time and money to the overall process. That might not seem impressive by comparison, but considering the relative simplicity of a film structure this is exceptionally strong. In fact, it’s a level at which exceedingly few producers are currently providing diagnostics films.

THE REASONING BEHIND THE ISO

From a cost-benefit standpoint, then, an ideal diagnostics tool kit process might assemble at an ISO 5 level, but source components may be produced at individually recommended sterility levels. This is crucial, because the ability to reliably source films produced at an ISO 7 is significantly cost-effective compared to post-production web cleaning alternatives, which in addition to adding cost and time can also result in a percentage of film being damaged during this tension-heavy process.

This sort of “building block” approach to cleanroom production also can expedite regulatory approvals, and therefore reduce time to market. This is because sourcing cleanroom-produced components means those items come pre-certified – a big plus given the escalated data acquisition, analysis and reporting requirements placed on manufacturers of medical device and diagnostics tools.

This is where the sweet spot lies – one that keeps the pace of production up while keeping costs down. Sourcing materials and components produced in cleanrooms suitable for their own specific needs blends fiscal

SHAPE THE FUTURE OF MEDICAL TECHNOLOGY PRODUCTION

Nürnberg, Germany 2023

THE TRADE FAIR FOR DOERS AND DECISION-MAKERS

MedtecLIVE with T4M is the key trade fair for medical technology in Europe – and is also much more. This is where your industry becomes a special experience, knowledge comes to life, trends are addressed, and innovations become real.

The exhibition focuses on the complete manufacturing process in medical technology, from the initial idea to production. Together with the MedtecSUMMIT, you will enjoy a comprehensive programme with top speakers and key players in the industry.

SEE FOR YOURSELF!

responsibility with rapid repeatability… all without sacrificing device efficacy or diagnostics accuracy.

THE GOLDILOCKS ZONE

What’s more, diagnostics tools suppliers sourcing specialty films like COC constructions often will find that dedicated vendors –themselves specialists – can cater to customization and small quantity requests in ways that are both medically sound and economically attractive.

For diagnostics films, the cleanroomproduction Goldilocks Zone does indeed exist. However, kit manufacturers will seldom find it in their own backyards. Through a hub-and-spoke, source-andassemble approach, cleanroomproduced diagnostics devices can meet the economic, regulatory, and high-volume needs of today’s tightly controlled medical products landscape.

Honorary sponsors

EDUARDO ZEPEDA, MARKETING STRATEGIST FOR HISCO, EXPLAINS HOW A JUST-INTIME SUPPLY CHAIN CAN FIX THE DISRUPTIONS THE INDUSTRY IS CURRENTLY FACING.

DEALING WITH DISRUPT

IONS

It’s no secret that many companies struggle with supply chain disruptions and stock shortages in today’s unstable economic landscape. Moreover, supply disruptions can majorly affect production for highly regulated sectors, such as the medical device industry.

For example, the COVID-19 pandemic led to staff shortages and unprecedented demand for respirators and Personal Protective Equipment (PPE), among other critical products. In addition, the extensive review process of medical devices and products in this sector typically causes longer lead times for products to get approved and delivered, so even a minor disruption can cause significant delays.

When COVID-19 first hit China, component suppliers closed and made parts for vital devices, such as ventilators, almost impossible to find. This affected small and mediumsized manufacturers causing critical cash flow issues, but even larger businesses suffered from the high demand-to-supply ratio.

However, despite this climate of global economic uncertainty, suppliers like Hisco have not only overcome these production difficulties but also, thanks to their success, allowed their manufacturing customers to continue their operations and minimize the effects of supply chain disruptions.

DISASTER RECOVERY SUCCESS

Although COVID-19 is perhaps the obvious reference on everyone’s mind concerning disasters, other types of disasters may affect manufacturers. For example, disasters that impact systems like ransomware and other cyberattacks or those that affect premises like fires, burst pipes, or equipment failure are sometimes caused by natural disasters, typically leading to unplanned time.

Unfortunately, estimating unplanned downtime costs, including equipment replacement, recovery labor costs, and lost business opportunities, can be challenging. However, along with Hisco’s converting capabilities, their disaster recovery abilities allow manufacturing businesses to avoid long-lasting repercussions and respond efficiently, ensuring they resume operations as quickly as possible and minimize financial losses.

This is achieved through value-added custom-converted parts for the medical device manufacturing sector and technical capabilities, such as their RFID solutions for inventory management. Hisco’s RFID technology and software streamline production through real-time asset and materials tracking, provides factory floor visibility for their customers.

RFID is a sensor-based tracking system that provides accurate stock data with complete, real-time visibility and intelligent alerts. This technology helps eliminate supply shortages, track asset expiration and calibration schedules, and immediately provides notifications if an expired asset is used in production.

JUST-IN-TIME SUPPLY CHAIN & DUAL SOURCE SUPPLY

The medical manufacturing industry also recognizes Hisco for its just-in-time supply chain, which reduces delays and costs by “perfecting” the timing of ordering materials.

The just-in-time supply chain is a proven method that moves material just before it’s needed in the manufacturing process, reducing the levels of materials stored in a warehouse. This inventory management strategy increases efficiency and decreases waste by receiving goods, only as needed for production, reducing inventory costs.

Hisco also offers dual source supply chain for critical products in medical device manufacturing. Dual sourcing benefits customers if one of their vendors has a manufacturing delay resulting from shortages in essential materials, malfunctioning production devices, or lack of skilled labor, which can all cause havoc on supply chain activity.

A dual-source supply chain benefits customers by giving them more leverage to negotiate prices. The reason is that typically suppliers will not hesitate to increase costs, sometimes on a regularly scheduled basis.

So, by having more than one supplier, medical manufacturers can purchase from the supplier, offering a more attractive price point, sometimes even forcing the other supplier to provide more attractive pricing to avoid losing business.

Also, customers are covered if one of their vendors ceases operations or shuts its doors without warning. This situation often leaves the manufacturers stuck in quicksand until they find another vendor. So, by having a dual-source supply chain model, companies can plan to buy more from vendor B to avoid interruptions to their supply chain in case vendor A closes for good.

OFF THE

There were many factors that led to healthcare’s supply disruptions during COVID-19, such as not having enough workers to transport products, export bans put in place by countries, panic buying, etc.

While this is constantly improving, supply disruptions are still a concern since the pandemic, and it’s hard to predict when things will fully return to normal.

M. Holland believes that in 2023, the healthcare industry will start being more proactive again after spending three years in a reactive mode. The company also predicts more businesses will work with distributors who can carry inventory positions and still provide access to resin-makers’ technology.

The company focuses on distribution “specialities” within certain markets, one being healthcare.

PHARMACEUTICAL PACKAGING DEMAND

In 2021, the pharma packaging market was valued at over $102.6 billion. The company felt it was necessary to get into the healthcare packaging market, as the US is one of the largest pharma packaging markets in the world.

With 2020 being the height of the COVID-19 pandemic, can we assume the pharma packaging industry is even bigger now post-pandemic, or was the market huge in the US as they had to rely on their own products, when exporting from other countries became more difficult?

According to GMI Insights, the pharma packaging industry will reach $40 billion in 2028 in North America. Considering the market was below $30 billion in 2021, we can assume the rapid market growth in the region is not due to the pandemic.

COVID-19 SUPPLY DISRUPTIONS

With the recent increased demand in packaging, M. Holland believes that the medical sector has had severe supply disruptions trying to keep

up and the company are more than happy to help with issues.

Adrian Hogg, strategic account manager with M Holland’s Healthcare group, said: “We are seeing a lot of business moving back to the US, and I think that’s primarily driven by what happened over the last two and a half years given the supply disruptions along with logistics and congestion issues at the ports.”

HOW CAN DISTRIBUTION COMPANIES HELP?

Companies partner with M. Holland to have a specialist in the marketplace who can navigate the development process.

“In the past, companies would typically try to take on the burden of material selection” Hogg said. “Whereas now, with distribution, we understand the development process. We have the expertise to help our customers throughout development, including identifying the right material for their application requirements.”

The company distributes for 25–30 different suppliers. The specialists aim to select globally sourced medical grade resins for their customers, all while retaining formulation control, a strict change management process, reducing supply chain risks and providing full regulatory and compliance documentation that is required for medical devices and medical packaging.

Hogg concluded: “All of these are vital to the healthcare industry and as a distributor, we have the expertise and capabilities to guide our customers down that path through the development cycle.”

M. HOLLAND, AN INTERNATIONAL DISTRIBUTOR OF THERMOPLASTIC RESIN, EXPLAINS HOW IT CONTINUES TO WORK THROUGH THE ENTIRE SUPPLY CHAIN FROM DEVELOPMENT TO COMMERCIALIZATION THROUGHOUT COVID-19 DISRUPTIONS.

MARCH OF THE ROBOTS

It’s no secret that medical manufacturers are braving a slew of challenges – supply chain disruptions, rising demand, global competition and regulatory compliance assurance. On top of that, they’re particularly vulnerable to the current workforce shortage due to the hands-on, labor-intensive nature of the work required to produce specialized equipment.

A recent study by Rapid Robotics found that 51% of manufacturers surveyed won’t be able to perform at their current capacity without a solution to the shortages.

Fortunately, a new model of robotics is helping medical manufacturers quickly fill empty roles and scale operations.

WHAT IS ROBOTICS-AS-ASERVICE?

Automating even the simplest manufacturing operations can free up human workers for more important tasks, increase production and improve product quality. This makes automation seem like a nobrainer, but hefty capital investment, prolonged time to deployment, hidden integration costs and lack of flexibility have kept many manufacturers from getting started. Today, Robotics as a Service (RaaS) provides a solution that circumvents these barriers.

By partnering with RaaS companies, manufacturers can lease fully integrated collaborative robots, called cobots, on an hourly, weekly or monthly basis, shifting automation to an operational expense, just like a regular employee.

True RaaS removes the need for traditional systems integration or in-house robotics engineers to program, maintain and service machines – your RaaS partner manages that. These cobots – whether there are 1 or 50 – can be pre-trained for their tasks and ready to work when they arrive. This slashes time to deployment, taking just days or weeks compared to the months, sometimes years, it takes to get traditional automation up and running.

HOW CAN I CAPITALIZE ON THE BENEFITS OF RAAS?

In addition to labor shortages and continued supply chain disruptions, medical plastics companies face unique challenges, like a strict regulatory environment driven by contamination risks and product quality. Medical manufacturers can capitalize on the benefits of RaaS to turn each of these challenges into opportunities.

SIMPLIFY REGULATORY COMPLIANCE

The global regulatory environment is only becoming more stringent. Take the European Union Medical Device Regulations (EU MDR) for example – many medical manufacturers must adjust their processes, including increasing technical documentation, to become certified under the EU MDR. While regulations like those under the EU MDR and US Food and Drug Administration (FDA) require well-established, documented and controlled processes that minimize contamination risk, they don’t always equate to operational efficiency.

By incorporating robots into production lines, you can enhance precision and consistency – computer vision enables robots to consistently conduct tasks like visual inspection of labels and parts.

MINIMIZE CONTAMINATION RISKS

A crucial part of manufacturing medical plastics is maintaining the highest standards of cleanliness. As such, human workers require personal protective equipment and are perpetually at risk of spreading viruses and bacteria. By nature, robots aren’t. Implementing robotic automation in cleanrooms can result in the same amount of throughput, and maybe more, with a smaller team and therefore less risk of contamination.

ADDRESSING LABOR CHALLENGES AND IMPROVE WORKING CONDITIONS

The manufacturing labor market is tight – the workforce is rapidly retiring, and the talent pipeline is shrinking with younger generations wanting to flock to other industries. Rapid Robotics’ studies show the current workforce is leaving roles often because of burnout and a desire for more interesting work.

So where do robots come in? When implemented to automate mundane, repetitive, injury-inducing and, in some cases even inhumane tasks, robots can help to do two things: improve the working conditions of human employees and enable them to take on more engaging, high-value work.

TAKE ON NEW BUSINESS

With a more robust and reliable workforce and improved throughput, robotic automation also reinforces the ability to take on more business. For example, one of Rapid Robotics’ customers in plastics manufacturing was able to automate tasks like pad printing and heat stamping, redeploying human operators to more complex work. This afforded them the bandwidth to take on $600,000 more of additional business.

JORDAN KRETCHMER, CO-FOUNDER AND CEO AT RAPID ROBOTICS EXPLAINS HOW TO TRANSFORM MEDICAL MANUFACTURER’S CHALLENGES INTO OPPORTUNITIES.

An RMO grabs an injection molded medical device component to place it first for pad printing, then into an inspection booth where cameras will pass or fail the print job.

FORMER CO-PRINCIPAL, FOUNDER AND DIRECTOR OF RESEARCH AND SYNTHESIS AT BLACKHÄGEN, SEAN HÄGEN, EXPLAINS HOW MEDICAL ROBOTS ARE NOT REALLY ROBOTS. IT IS WITH DEEP SADNESS THAT SEAN PASSED AWAY SHORTLY AFTER WRITING THIS ARTICLE AND EVERYONE AT MEDICAL PLASTICS NEWS SENDS THEIR THOUGHTS TO THOSE CLOSE TO HIM.

INTRODUCING THE NOBOT

user interface of the robotic system and must be considered and often included in the validation test.

IMPACT OF USER INTERFACE DESIGN

User research insights that can inform the use-related risk assessment and regulatory strategy apply to the design and development of the robotic system’s user interface.

Consider the example of the lead surgeon’s user interface. There is a need to understand the negative and positive transfer bias in the physical user interface.

Robot Assisted Surgical Devices (RASD) are not really robots. To be a bonafide medical robot, the system would have to duplicate human activity, and today none of these RASDs are autonomous, or even semi-autonomous with that ability. They are bionic systems created specifically to enhance the healthcare provider’s performance with electronic or electromechanical devices.

This distinction is critical to the design and development of the robotic system.

LOOKING AT THE REGULATORY IMPACT

Many current robotic systems are based on technology that could execute a procedure autonomously but the complexity of validating safety and efficacy for regulatory approval would be cost-prohibitive. Regulations require a demonstration that proves the RASD could safely manage contingencies that are often unpredictable during a procedure. A machine programmed by humans can only do what it’s been trained to do and thus lacks the creativity and quick thinking that a human brings to reacting and managing a contingency.

Sophisticated capital equipment such as a RASD does not have the same ROI that could justify such a massive validation investment. However, as the clinicians are in control and the system is recognized as an extension of their abilities, the human is still responsible for the outcome. This means that the validation process must be viewed as a function of the clinician’s interaction with the robotic system’s user interface.

CASE IN POINT

A surgical robotic system impacts the surgical workflow meaning all the staff involved in the surgical procedure. A conventional surgery is typically a symphony of interactions between a team of clinicians.

The identification of all the people involved is crucial to ensuring a favorable outcome for the patient because there is a new factor in the operating room – the robot. A new physical layout may also be required to accommodate the robotic system in an already congested environment. This can impact how the team members interact with each other. The intention of the robot is to introduce an optimized instrument for the surgeon, but in application, it can affect the responsibilities of the extended surgical team.

These team dynamics are important when it comes time to validate the

The way the surgeon executes a manual procedure can result in either a positive or negative transfer bias depending on how the new control interface is designed. Negative transfer bias can introduce a potentially hazardous condition and use error that could lead to harm. Conversely, the user interface design can afford positive transfer bias by emulating or carefully transitioning from a norm behavior and interface to the new user interface and workflow experience. A proactive approach to understanding the user’s expectations and aspirations with an in-depth understanding of perceived attributes that determine the intended behavior is a robust approach.

MEDICAL ROBOTS WITH A HUMAN TOUCH

Introducing medical robotics into a clinical environment offer advantages to clinicians and patients but must always be considered enhancements to the processes and procedures, not replacements. The human touch will always be important in certifying risk mitigation, patient and environmental safety, and regulatory requirements. Design and development of these devices include a myriad of steps that should be deployed early on to make sure that not only the device itself, but its complex interfaces mirror the users’ behaviors to assure the optimum outcomes for all.

AFTER THE FIRST STOP OF

GREENLIGHT

TRUE

HOW

DID

THE ROAD SHOW PARTNERSHIP WITH GREENLIGHT GURU BEGIN?

As a company that designs develops and manufactures medical devices, we are deeply interested in the industry. We’re also interested in connecting with the people in the industry.

Our business is to take people’s ideas and turn them into reality. The Greenlight platform is pretty solid as a cloud-based platform for quality management and as a result it tends to attract younger companies because it is an outof-the-box quality management system.

And so, at a roadshow with Greenlight Guru, those younger companies sometimes need engineering discipline from companies like ours and so it’s been a really magnifi cent partnership with them for several years now where our goal is to work with the people that Greenlight already knows and help them be successful and turn their device ideas into commercial reality.

WHAT MAKES YOUR PARTNERSHIP WORK?

I’m huge fans of them as a company. I just really like the people there, they have a lot of the same cultural attitude that we have, which is this cando attitude. I sat with a client

yesterday in Minneapolis and I said, “look, we’re not going to get it right the fi rst time every time, but here’s what I can promise you, we will continue to work stubbornly until we do get it,” and I see that same thing at Greenlight. They are just can-do problem-solving people, which I really like.

YOUR FIRST STOP WAS HOUSTON IN MARCH, HOW DID THAT GO?

At the Houston stop, I was a featured speaker. I like to interact with people. I’m an electrical engineer by training, but people are my passion and helping entrepreneurs understand how to navigate culture, attract staff, attract funding, navigate problems - that’s really where I’m strong and so to interact with the audience around that idea is fantastic.

One of the questions that I got from the audience and I’ve talked about several times since the roadshow is - is there a point in time as an entrepreneur that you feel like you have made it? It was fun because I could look that guy in the eye and I could say absolutely.

For me, that time was that exact moment. I started Velentium 10 years ago from nothing. I was the fi rst employee. Now there’s 130 of us and it continues to grow, but there’s that point in time where you go “you know what I think a year from now, this company will still be here whether or not I am”. Not only will Velentium be around, but it’s not so founderdependent and is legitimately established as its own thing, and not just an extension of me.

WHAT WAS THE THOUGHT PROCESS BEHIND THE CITIES CHOSEN?

For us, most of our clients are either in Minneapolis or one of the coasts and you’ve got Boston and California as the areas where all this medtech is happening.

Houston is really trying to become the third coast to create medtech. So, I was glad that the Roadshow came here, just because there is a lot of innovation happening here.

“People are my passion and helping entrepreneurs understand how to navigate culture, navigate problemsthat’s really where I’m strong.”

THE

GURU 2023

QUALITY ROADSHOW, MEDICAL PLASTICS NEWS CAUGHT UP WITH DAN PURVIS, CEO OF VELENTIUM –ROADSHOW SPONSORS – ABOUT HOW IT WENT.