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The spectre of EU MDR is looming large over the medical device industry in what is bound to be a continuous flow of new regulations coming down the pipeline for different types of medical devices in the coming years. Bob Tilling, VP Global Sales at Kallik, shares his experiences of working with Class III manufacturers to prepare for May 2021 – and highlights the need for Class II businesses to learn from mistakes made and not delay preparations to meet their own UDI labelling deadline in 2023.

Many manufacturers have learned harsh lessons in terms of the preparation and workload required to update their labelling and packaging to meet the end of May 2021 deadline for thenew EU MDR requirements for Class III medical devices. Indeed, some manufacturers still run the risk of missing the date altogether.

Looking forward, Class II manufacturers – those supplying products including catheters, syringes, teeth implants, etc. – should have been watching these compliance developments closely with their 2023 deadline in mind. The race for Class III compliance has exposed some key issues which Class II providers should focus on during their own EU MDR efforts. 

Fail to prepare, prepare to fail
During my work on label and artwork management with numerous medical device customers, I have seen the full spectrum of attitudes towards the EU MDR shift. The challenge is two-fold. Firstly, manufacturers must detail the scale of the impacted devices and the work required, and secondly, they must then set about physically changing their labelling and packaging. From my experience one thing is clear – those who start to prioritize and put in place a plan earlier on have fared better.

This is not a case of a simple internal review and enacting a few changes – failure to meet these new regulatory deadlines will cause significant business damage. From a financial perspective, non-compliant manufacturers will not be allowed to sell their products into the EU market, with some minor exceptions for critical supplies. Non-compliant businesses could also be placed on a specific watchlist to be inspected and audited, impacting brand trust and even negatively influencing share price.

Class II manufacturers should act now to avoid being caught out. Two years may sound like ample planning time, but they need a full understanding of the task at hand and how to execute the required changes. Here are three key takeaways to learn from their Class III counterparts.

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1. Added complexity means getting to grips with the scale of impacted devices
With Class II devices further sub-categorized into IIa and IIb devices – this only adds to the complexity and reach of the necessary EU MDR changes.

Businesses that are yet to begin their compliance process must initially try to identify how many impacted labels and artworks exist within their organization. Many business leaders underestimate the quantity of assets, and this task will typically unearth siloed data, scattered labels and artworks that will instantly broaden the scale of the compliance work.

Manufacturers operating facilities and systems on a global level will find they must also contend with challenges such as individual phrase translations for each device into every applicable target market language. This adds a further level of complexity to label and packaging compliance tasks – the EU alone, for example, has 24 official languages, leading to further translation expense and the risk of ‘doubling up’ translations when considering both labels and IFUs need translations.

Businesses that grow through mergers and acquisitions will also see the complexity and scale of compliance tasks multiply, as product lines and further data silos are absorbed that require all the above tasks to be worked through from scratch.

2. Automation provides the silver bullet for speed, cost efficiency and accuracy
It has become clear that relying on manual work and processes to make the shift is not feasible. We have seen with the Class III deadline just two months away, many organizations are still battling to get their label and packaging operations up to standard. The cost of hiring extra staff – or simply the operational cost of diverting existing capacity and finances – to complete repetitive tasks is slow, prohibitively expensive and introduces potential inaccuracies.

Automated label and artwork management solutions offer a modern, future-proof lifeline to help medical device manufacturers manage all assets from a centralized location hosted in the cloud. Automation eliminates the need to manually search for, identify and edit assets to ensure compliance, with features such as artwork generation saving significant time and eliminating the need to involve costly third-party design agencies. Simply put, automation gets the task right first time, every time – there is little scope for human error to be introduced into the process.

Indeed, the most advanced providers of automated solutions are already exploring ways to streamline remaining bottlenecks such as de-duplication and translation checks by introducing advanced technology to further improve efficiency. At Kallik for example, we’re already building strong academic partnerships to explore the application of AI for this purpose.

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3. Future-proofing for further regulatory and business challenges
There will be continued major medical device regulatory changes in each of the next four years – so medical device manufacturers cannot afford to sit back and wait their turn to comply with each one individually.

Looking beyond further phasing in of MDR, UKCA marks must be placed on medical devices destined for the UK market from July 2023. Companies that find they barely scraped by to comply with a previous round of regulation will be hard-pressed to repeat the same manual processes for future regulation changes coming along.

Pandemic disruption is no excuse to kick the can down the road. The shift to remote operations and cloud-based solutions has been far smoother than expected, with in-house technical experts and external consultants both adapting to remote compliance tasks by using new software implementations to help them prove and maintain compliance.

Putting off the inevitable is no longer an option
With EU MDR and further regulatory change on the horizon, Class II medical device manufacturers can no longer keep their businesses compliant through manual labelling and artwork management updates. Making the early switch to automated label and artwork management solutions not only significantly reduces the burden of future regulatory compliance on the manufacturer, it also provides a platform for other product changes and business growth. With all labels and artwork housed in a centralized cloud-based environment there are no information silos and – from a compliance perspective – access, edits and audit trails can be tracked and monitored down to each individual asset.

Thankfully, Class II medical device manufacturers have two years to make the necessary move to automate their label and artwork management, but changes are not made overnight. By laying the groundwork now, across the entire organization, manufacturers can begin to devise a compliance strategy and let technology put those plans into action now, and into the future.

Manufacturing and Supply Chain Expert Lisa Anderson, MBA, CSCP, CLTD, president of LMA Consulting Group Inc., predicts Manufacturing as a Service (MaaS) will emerge as a result of that manufacturing transformation that’s replacing the more traditional manufacturing model. LMA Consulting Group works with manufacturers and distributors on strategy and end-to-end supply chain transformation to maximize the customer experience and enable profitable, scalable, dramatic business growth.

“The customer experience has changed. The need for a faster, flexible and more customer-centric, personalized response has had reverberating effects on manufacturing. Long lead times, predictable demand, and traditional inventory management have made way to last-minute order changes, immediate delivery, evolving customer requirements, and easy returns. Manufacturers need to be more flexible, adaptable, and technologically savvy if they are going to survive. That means they need to embrace innovation and resiliency. In turn, the entire supply chain must be adaptable, flexible and respond to constant change,” Anderson comments.

Much like Software as a Service (SaaS) upended software delivery from machine-based purchase delivery to cloud-based licensing, Manufacturing as a Service (MaaS) emerges as a means to be part of product innovation, on-demand scalability and the integration of artificial intelligence and data analytics.

“Think of it like this, Company A is a pharma device company. Through research, they identify a need that will significantly impact patient monitoring and care. They have the idea but not the financial resources to scale. By identifying a MAAS partner, they can produce prototypes, make adjustments during testing and identify customization options for customers. Company A can now focus on product development, sales, and marketing, while the MaaS partner focuses on managing the supply chain, inventory, and transportation to scale and meet demand. Where this differs from traditional contract manufacturing is in leveraging the strength of the MaaS partner supply chain by integrating technology and data to drive customization. Manufacturing is evolving. MaaS has the opportunity to replace traditional manufacturing by emerging as an integrated (manufacturing and supply chain) solution for everything from start-up and new products to line extensions,” Anderson says.

Anderson recently released “Emerging Above & Beyond: 21 Insights for 2021 from Manufacturing, Supply Chain & Technology Executives,” a special report that provides critical elements in the roadmap for manufacturing and supply chain success. Manufacturing and distribution leaders and experts in technology, finance, sales and marketing, and human capital contributed insights into best practices for 2021.

“Manufacturing is evolving. The manufacturers that proactively embrace the transformation and look for ways to add value through customization will find significant opportunities for growth,” she concludes.

Star Cutter Elk Rapids facility adds machine tool demo area

Recent upgrades by Star Cutter Company to its Elk Rapids, Michigan, facility, where it produces tool and broach grinders, include a complete modernization of the 25,000ft² climate-controlled building featuring state-of-the-art workspaces and conference room with virtual meeting capability. In addition, a 1,500ft² area has been created on the plant floor that is dedicated to customer run-offs and demonstrations with space for two machines at any time. Video and remote demonstrations and run-offs are also available.

For companies interested in visiting the facility, the demonstration grinders are NXT 5-axis tool grinders performing: 1) automated medical broach grinding with Esprit through the NUMROTO interface, and 2) automated round tool and insert grinding. 

Star Cutter has maintained a northern Michigan presence since the mid-1960s, and this most recent facility upgrade confirms its ongoing investment in its local communities.

To visit the facility or to request a demonstration, email sales@starcutter.com or visit https://www.starcutter.com. 

Open Mind Technologies celebrates 25 years in North America

© Open Mind Technologies USA Inc.
https://www.openmind-tech.com/en-us.html

Open Mind Technologies USA Inc., the North American subsidiary of Open Mind Technologies AG, announced it is celebrating its 25th anniversary of CAM software achievements this year. Open Mind is the developer of the hyperMILL software suite, and is one of the world’s leading CAD/CAM solutions.

“We are excited to reach this important milestone,” says Alan Levine, Managing director of Open Mind Technologies USA Inc. “We attribute our sustained growth to the strong product provided by our global headquarters, together with our local sales, engineering, and service delivery. Our team is dedicated to providing customers with an optimal CAD/CAM experience including outstanding technical consultation and service.”

Levine continues, “Our team is strategically located across the nation as well as in Canada and Mexico to closely collaborate with customers on local and regional levels, and stay up-to-date on market requirements.”

Volker Nesenhöner, CEO, Open Mind Technologies AG says, “We congratulate Alan and his entire team in North America. Open Mind continues to expand market share in the United States, Canada and Mexico as the hyperMILL software suite is a superior choice for highly productive machining.”

Leading the way in 5-axis processing, Open Mind developed the world's first CAD/CAM system utilizing an automatic multi-axis simultaneous machining strategy for mold and die, and also introduced many CAM software techniques including strategies for conical barrel cutters, auto-indexing, and 5-axis helical drilling.  In addition to providing a high-performance and innovative CAM software solution, Open Mind's hyperMILL software offers connectivity to CAD systems, feature and macro technology, tool management systems, automation, simulation, probing, and more. The company continues to be at the forefront of key and emerging technologies, such as providing integration with additive manufacturing processes and supporting Industry 4.0 initiatives. hyperMILL is successful in a wide range of industries including mold and die, aerospace, automotive, turbomachinery, energy, medical and more.

Open Mind's focus on CAM, and its continued commitment to the latest technologies, produces trend-setting innovations that make it significantly easier for customers to achieve substantial quality, time, and cost improvements. hyperMILL software is a state-of-the-art CAM solution with 2.5D, 3D, 5-axis milling and turning strategies, as well as specialty applications, that are all available in one interface. 

Labeling issues cost manufacturers worldwide more than $1.31 million each year

US manufacturers on average incur losses of around $1,174,000 per year due to production line shutdowns caused by label printing problems, a global study of IT directors in manufacturing organizations has revealed. This is slightly below the global average, with many companies losing more than $1.31 million each year.

The study of 300 IT directors globally, including 100 from the US, found that on average more than two-thirds of manufacturers (67%) were having to shut down their production line for more than an hour if there was a problem with label printing, with an additional 21% saying the line had to be shut down for more than 30 minutes. Recovery time was slightly faster but still problematic for US manufacturers, with just over half (51%) experiencing downtimes of 60 minutes or longer.

The study also revealed that manufacturers – both globally and in the US – were having to pause production lines just under six times a year on average due to such problems, with nearly three-quarters (77% globally and 69% in the US) saying their production line had to be paused four times or more in the past year as a consequence of labeling issues.

Ken Moir, VP marketing, NiceLabel, says: “Any business disruption or shutdown can significantly impact any manufacturer causing loss of revenues and ultimately even putting the business itself in jeopardy. The danger of that being caused by mislabeling becomes a growing concern as labeling becomes a key part of business and supply chain strategy.”

Given the losses they are incurring due to shutdowns, it is unsurprising that 29% of the US survey sample see ‘reducing costs’ and 22% see productivity gains among the main benefits of modernizing/automating their manufacturing processes, including labeling, with technology, while 31% reference ‘eliminating errors’ as a key driver.

As Moir explains: “Ultimately, the risks to production operations extend well beyond full shutdowns. Decentralized labeling for example, also adds risk to production operations. An ERP system is supposed to provide “a single source of truth” to business users. However, at many organizations there are as many versions of the truth as there are labeling locations. That is because in decentralized labeling operations, each facility may not be integrated with ERP and will be creating their own label formats and duplicated product and customer data. 

“After all, without centralization,” continues Moir, “manufacturers are generally not integrated to the same source of truth and that creates redundancies of data – making enterprise-wide updates unmanageable and adding significantly to inaccuracies and inconsistencies.”

Tekni-Plex announces new Tekni-Plex Medical business

Tekni-Plex Medical is launching a Prototype Solutions Services initiative to support medical device manufacturers at the design stage of new tubing products used in critical fluid-transfer applications.

The prototypes created as part of the service are instrumental for testing tubing used in sensitive medical applications, including torturous paths, extremely tight tolerances, layered extrusions, pump applications and lubricity requirements.

“This service enables us to leverage our extensive knowledge of PVC, urethanes, Pebax and TPE material science and process technology to enable medical device companies to solve their most critical fluid-transfer design challenges,” says Gary Mizenko, technical operations manager, Tekni-Plex Medical. “With this launch, medical device professionals can access our people earlier at the design stage to develop tubing products that meet a wide range of challenging performance criteria.”

Prototype Solutions Services are also designed to enable the company to react quickly to customer production requests.

“Combining these services with our material science knowledge really puts us in an ideal position to help fine-tune designs, quickly deliver prototypes, and ramp up production in a quality-driven, efficient manner,” Mizenko says. “In addition, because we also manufacture compounds, our vertical integration allows us to better address both quality and speed-to-market deliverables for medical device companies.”

Tekni-Plex Medical’s prototyping equipment is a smaller scale version of its commercial systems, so the company can transition seamlessly from small tubing runs to full production. This is supported by internal compounding capability that enables the company to tailor materials for innovative tubing solutions. 

Dymax & HZO announce strategic alliance in response to market demand for protective coatings

HZO Inc., a global leader in world-class nanocoatings that safeguard electronics, electrical products, and critical applications in an ever-changing market, announced a strategic alliance with Dymax. The partnership will extend HZO's portfolio by adding 3,000 formulations to its existing coating solutions, facilitate joint product development, and accelerate market reach through Dymax's global sales channel.

Dymax is one of the world's leading manufacturers of rapid light-cure adhesives, conformal coatings, potting compounds, and complementary dispensing and curing equipment. These products are used across various diverse industries and applications, including medical device, consumer electronics, automotive, and aerospace. Among the innovative products in the Dymax portfolio are special protective coatings and potting compounds that cure in seconds under UV LED or broad-spectrum light. This technological advantage enables increased production throughput while simultaneously reducing processing costs.

The partnership will directly address product requirements based on trends in IoT adoption, edge computing, ruggedization, electronic miniaturization, and lightweight devices, as well as help manufacturers rethink how they produce and protect their offerings. By 2030, it is estimated that over 100B electronic devices will be connected around the world, in addition to the countless number of stand-alone electrical products. These products will be deployed into some of the most challenging environments and mission-critical situations, from autonomous cars and satellites to health wearables and smart meters. 

"Quick-cure conformal coatings from Dymax and next-generation nanocoatings from HZO, delivered through a single source, will accelerate market entry, streamline procurement, and enhance product performance, delivering a better, more durable offering," says Rich Holder, CEO of HZO. "This partnership aligns with our core strategy of delivering a complete customer solution and builds on years of working together serving some of the biggest brands in the business."

"HZO's leadership in thin-film sub-20-micron solutions will help meet our customer requirements for twenty-first-century device protection," says Jason Maupin, chief commercial officer of Dymax. "The agreement provides for the production of new formulations, including sustainable alternatives, that will drive the alliance to the forefront of innovation." 

Solvay and Carbon22 partner on Creed Cannulated Screws for orthopedics

Solvay’s Zeniva polyetheretherketone (PEEK) resin was chosen by Carbon22, a GLW Inc. company, for its new Creed Cannulated Screw System for foot and ankle surgery. This advanced new screw system recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

To create the new system’s ortholucent, plastic-metal hybrid composite, Solvay’s implant-grade radiolucent Zeniva PEEK resin is overmolded onto a titanium core prior to final processing. This high-performance material solution allows the screw to be seen with X-ray or computed tomography (CT) scanning while enabling the surgeon to accurately assess anatomical details near and behind the implant site without visual distortion or artifacts.

The new Creed Cannulated screws are produced using unique manufacturing technology from Carbon22. This groundbreaking process helps control costs by reducing material waste, compared to traditional titanium screws, which generate significant and expensive scrap during machining. Additionally, the Carbon22 hybrid enables a more-aggressive cutting tip which cannot be realized with all-PEEK screw designs.

“We worked closely with Carbon22 to achieve strong adhesion to titanium, which is not an inherent property of PEEK,” says Anna Maria Bertasa, healthcare global marketing manager for Solvay Specialty Polymers. “Solvay’s broad, deep technical expertise and advanced material technologies are what set us apart from our competition and enabled us to help create the innovative Creed system. We welcome new challenges that address the unique individual needs of our customers to give them a competitive advantage and help them succeed.”

While all-titanium screws are opaque to X-rays, and imaging of all-PEEK screws is affected by their diameter, the Creed hybrid composite screws allow X-rays to pass through to the bone. These new screws generate an outline that greatly enhances visualization of bony structures. Surgeons can use this capability to confirm screw placement during surgical procedures, check positioning post-operatively and determine the status of the healing process at follow-up appointments. The ability to image screw placement gives surgeons greater confidence and can help them achieve better patient outcomes. 

“Solvay is a recognized industry leader for implantable PEEK,” say Vadim Gurevich, CEO, Carbon22. “Their team provided exceptional materials expertise and engineering capabilities that were instrumental in the development of our new Creed system. Together, we are actively engaged in new development projects that promise to further drive the development of next-generation orthopedic devices.”

Qosina partners with Nordson Medical to support single-use bioprocess integrators and medical device manufacturers

Qosina is pleased to announce that it has entered into a distribution agreement with Nordson Medical, a premier manufacturer and supplier of components to the bioprocess and medical device industries.

Qosina offers low minimum order quantities, providing a cost-effective way to order exact quantities needed. Nordson MEDICAL customers who wish to purchase lower quantities of medical device and bioprocess components may place these types of orders directly with Qosina at https://www.qosina.com.