Monday February 6, 2023

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RAUMEDIC Inc: High-Quality Polymer Products Developed and Produced to Meet Specific Customer Needs Human health is at the core of RAUMEDIC Group’s business. The company specializes in processing medical-grade thermoplastic polymers and silicones at five production sites in Germany and the United States. As a partner of the international medical technology and pharmaceutical industry, the polymer specialist develops and produces customized components continued on page 66

Design, Development, Manufacturing — A SingleSource Partner Article Courtesy of Nordson MEDICAL Nordson MEDICAL (Nasdaq: NDSN) is a global expert in the design, development, and continued on page 61

Build Better Patient Experiences With Precision Converting

Matrix and its Master Distributor Brands Bring Latest Vertical FFS Packaging Technologies to West Coast in Booth #5231 at WestPack 2023 Live demonstrations of how its VFFS, sachet, and premade pouch machines can improve your productivity and sustainability goals. SAUKVILLE, Wis. — Matrix Packaging Machinery and its continued on page 43

Article Courtesy of Precision Converting, A Division of Hisco Medical device technology has the power to change lives. As an ISO 13485-certified continued on page 28

Steer Medical — We Steer You To Success

Medical Clad Wire Designed for Implantable Devices

We sat down with Michael Froncioni, CEO of Steer Medical (Booth #2121), to learn more about the Montreal-based contract prototyping and design company. Froncioni, a Medtronic alumnus, started the company in 2019 with co-founder, continued on page 48

Newly Commercialized FLEXcon® OMNI-WAVE™ Hydrogel-Free Dry Electrode Components Eliminate the Need for Hydrogel in Diagnostics and Therapeutics

Anomet Products, based in Shrewsbury, Massachusetts, offers custom composite medical clad wire that can combine up to three different materials for use with CRM, neurostimulation, vascular, and related devices. Anomet Medical Clad Wire can combine up to three materials to meet specific design requirements, performance, and cost criteria; especially where solid wire is

Ultra-High Contrast and Color Displays: DATA MODUL’s Deepest Blacks With Mini-LED Displays the for and has

There is now an alternative to hydrogel! FLEXcon® OMNI-WAVE™ is an industry-first, patented, hydrogel-free biosensing technology that allows you to get the most out of sensors

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Article Courtesy of DATA MODUL DATA MODUL, one of world’s leading experts industrial display, touch, embedded technologies,

Preshow Edition • Monday, February 6, 2023

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Contract Manufacturing and ETO Sterilization for Medical Devices Centerpiece is a medical device contract manufacturing and in-house ethylene oxide (ETO) sterilization company headquartered in San Diego, California. Primary operations are in Tijuana, Mexico — North America’s leading medical device production center for U.S. markets. Centerpiece is ISO 13485-certified, ISO 11135-compliant, and FDA-registered. Our business model is to serve as the “operational centerpiece” for complex medical device supply chains, by directly

linking manufacturing with in-house ethylene oxide sterilization processing. “We assessed the ecosystem of our industry and built an organization around its needs. There’s only one medical device company that has both contract manufacturing and in-house ETO sterilization capabilities of this scale, and that’s Centerpiece,” comments Matt Jordan, CEO of Centerpiece. Centerpiece’s ETO sterilization facility is located 15 minutes south of the U.S.

An independent publication not affiliated with any other organization Gary Cox Steve Cox Publishers

border and 45 minutes from San Diego International Airport. Centerpiece’s contract manufacturing facility is located nearby and offers clean room assembly and sterile-barrier packaging as primary services. The company manages all processes continued on page 43

Crescent Industries Is an Engineering-Driven, TechnologyBased, Injection Molder Crescent Industries’ team is an injection molding and mold-building expert. What makes them different? Crescent’s upfront engineering support. Their design engineers not only contribute to DFM feedback but offer guidance by evaluating your entire project for manufacturing. This includes optimizing your mold design to meet your project requirements and sending those designs to

their in-house tool shop, where journeyman mold makers fabricate the injection molds to ensure a robust and repeatable molding process. However, what truly sets them apart is their ability to be a reliable partner to their customers by meeting their expectations with quality results and long-term value. From the initial design to the last part ejected from the press, their molding

Matt Crown John McQuaig Deb McQueen Andrew Oseman Senior Associate Publishers Jessica Attoe Allison Honeycutt Shari Kether Jennifer Kinsman Damaris Mungaray John Pechota Kamraan Quddus Camille Reyes Grant Wadsworth Associate Publishers Carl F. Shifflette III Art Director Clinton Ellis Graphic Artist Brianna Ward Digital Marketing Joshua Espinal Jordi Espinasa Samuel Rickert Editors Ashley Davis Content Coordinator Monique Carter Tiffany Webster Administration Manufacturing + Design Today is published by Source Group LLC. ©2023. All rights reserved. Business License #45-4600703 Advertising Inquiries: 520-722-2000

workflows are designed and operated according to Decoupled II and Decoupled continued on page 66

635 N. Craycroft Rd. • Tucson, AZ 85711 Phone: (520) 722-2000 • www.sourceg.net

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The Industry Network and Signaling Weight Verification the Smarter Way Standard in One Place Find Fortress Technology, Inc. at Westpack 2023, Booth #5431.

Don’t settle for less — get the industry standard network protocol from a global leader in signaling with IO-Link network products from PATLITE. The versatility of IO-Link’s open-standard network paired with PATLITE’s commitment to safety, security, and innovation results in products with superior signaling that enable the communication of on/off states of equipment while also providing detailed diagnosis information in the workplace. PATLITE’s lineup of IO-Link devices includes some of our most state-of-the-art products, like the fully modular LR6-IL signal tower and the versatile NE-IL compact LED beacon. Typical signaling is not enough in a busy warehouse to provide workers and supervisors with a clear indication of various workstations while also reporting machine information accurately, but with PATLITE’s IO-Link products, you can stress about things other than in the workplace. For example, our flagship IO-Link signal tower, the LR6-IL, is fully modular, making it easy to configure with various mounting, color, and voltage options to fit

Verifying the weight of packaged food commodities continues to evolve rapidly. In addition to inspecting under- and overweight packages and ensuring compliance with net content regulations, deploying smart checkweighers at the end of food processing lines can provide a source of untapped quality assurance, continued on page 48

any factory application. If you only need one tier of signaling on a wall mount, the LR Series can do it for you; if you need five tiers of signaling in a pole mount option, the LR series is there for you. The LR6-IL is a signal tower that can easily integrate into your IO-Link system using a single cable. If you’re looking for IO-Link signaling in a more compact design, look no further than the PATLITE’s NE-IL LED beacons. This multicolor LED beacon features continued on page 61

Formacoat Celebrates Their 20th Anniversary by Staying on the Cutting Edge With a Very Simple Formula MINNEAPOLIS — Formacoat LLC, a leading provider of contract medical device coating services, has over 90 different coatings from over 45 different vendors from all over the world to solve all your coating needs! Located in the diverse medical wonderland that is Minneapolis, their 38,000-square-foot headquarters includes 8,400-plus square feet of ISO Class 7

cleanroom designated for catheter and medical device coating, as well as film coating and drug-elution coating. Formacoat’s solution-based coating selection process allows customers to compare a variety of coatings in a quick and cost-effective manner, which allows our customers to get to production that much faster! Formacoat Stays on the Cutting Edge

Customer Focus the Primo Medical Group Way Primo Medical Group was established in 1953 as Stoughton Tool & Die by Primo Tallarida. The Stoughton, Massachusettsbased company is a recognized leader in the development, manufacture, and assembly of quality medical devices and precision machined products. The company has stood the test of time by providing custom-made products of the highest quality, and by providing its customers continued on page 63

by Keeping It Simple With Its Own Formula for Success What makes a niche business like Formacoat work? The answer lies in its expertise, integrity, and methodology. Formacoat has a holistic approach that aims to address what customers want from their medical devices — and why. Mark Gross, owner and CEO, refers to this as the Formacoat Formula: “What do you want and why?” This simple question has been at the heart of Formacoat’s evolution over the last 20 years. When Gross founded the company, the focus was on one type of hydrophilic coating, with the option for them to enable

Genesis Develops Film Calendering for Medical PEEK Polymers CYPRESS, Texas — Genesis Medical Plastics now offers calendering services to convert its customers’ medical-grade, and implantable, PEEK into thin sheets and films. The new capability adds to the medical polymer conversion capabilities it already provides in injection molding, extrusion of machinable shapes, and CNC machining. PEEK has seen exceptional growth in applications for the medical device industry. Unlike standard formulations sold commercially, implantable grades are available to device manufacturers from

polymer producers under highly restrictive conditions. The device manufacturers then either process the polymer in-house or align themselves with a medical polymer conversion specialist, such as Genesis for toll production services. Injection molding and machining of stock shapes have been the prominent methods for producing medical-grade PEEK components. The lack of calendering technology has limited the availability of the polymer in the form of film and thin sheets on a commercial scale. According to Stephen Kramer, Gen-

esis’ general manager, “Our investments in developing calendering for medical PEEK grades came in response to requests from our customers. Hitting the necessary targets for reliable production with consistent thicknesses, physical properties, and overall quality led us to engineer our own production equipment and process control systems.” Genesis’ calendering operation cur-

products to be lubricious if required. Gross quickly realized that in order to carve out a niche for Formacoat, we must say “yes” to things other people considered outside our core business. “Quite simply, we really strive to try and understand why the customer is coming to us, what needs they have, and what fit is going to be right from the very beginning,” says Brecon Gross, manufacturing engineering manager. “By listening to our customers in great detail, we realized that we need to expand our solutions.” Formacoat boasts an impressive array of over 90 different coatings from 45 different vendors all over the world. And if you have something new or that they haven’t worked with before, they never back down from a challenge. “We are the only ones in this niche. continued on page 43

rently converts customers’ medical PEEK grades into thicknesses from 0.1 mm to 1.0 mm on a project basis. Product forms include rolls, spools of strip, and custom sheet sizes. Kramer also noted that the company welcomes projects of new sizes and formats. “Genesis is a project-based conversion service for customers’ medical polymer formulations. Our mindset is all about adapting or developing technology to deliver whatever customers need for their medical devices,” he stated. “In film calendering, we see new development challenges as opportunities to help our customers bring the proven benefits of PEEK to more applications.” Device manufacturers have already initiated projects with Genesis for PEEK continued on page 43

Preshow Edition • Monday, February 6, 2023

Redefining AC Servo Drive Capability and Ease of Use Article Courtesy of DMM Technology Corp. DYN5 Servo Drive The new DYN5 servo drive from DMM Technology redefines the AC servo motion control’s capabilities. This servo drive and motor were developed to achieve the optimal balance between performance, cost, and ease of use, without sacrificing versatility. The servo drive accepts 110 to 240 VAC input on one single unit. All con-

ventional command types are supported, including pulse and analog. Ethernet options are also available in Modbus TCP/IP, Ethernet/IP, and EtherCAT. We strive to make the product easy to use. A free program is provided to set up the servo drive. The drive also features auto-tuning or manual tuning, which can be completed within minutes. Documentation and video are also available to provide step-by-step instructions, from unboxing to commissioning.

Innovative Pouch From Schur®Star Makes Potato Prep Easy A two-compartment pouch with some special features makes it easy to transform fresh potatoes into a well-prepared and tasty meal, using nothing but a microwave. A two-year project with many different prototypes has resulted in the award-winning zip pop bag, developed in close collaboration between Potandon Produce and Schur®Star Systems Inc. Potandon Produce is the largest marketer of fresh table stock potatoes in the

U.S., as well as a leading marketer of fresh onions. Potandon’s headquarter is located in Idaho Falls, Idaho, and the company is the exclusive marketer of fresh potatoes and onions from the Green Giant brand. Two recent innovations from this iconic brand include “One Step…Done!” and “Minute Mashers With Gravy.” “One Step…Done!” contains a 1-pound serving of fresh potatoes in a dual-chamber bag that includes patented butter and seasoned disk in its own sepa-

21 The DMM AC servo product line is entirely self-developed, allowing us to closely control cost and lead time. The servo drive, encoder, and motor are all developed in-house. No other competitor can match the value, performance, and reliability of a DMM servo solution. Throughout even the most difficult manufacturing times, we have focused on investing and maintaining our production efforts, resulting in zero lead time for standard products. Parts and orders can be fulfilled within not weeks or months, but days. For small-capacity applications, DMM also offers a DYN2 servo drive powered by 24 to 75 VDC input. Ideal for applications within 750-watt motor size, this compact servo drive that fits in your rate chamber. Once in the microwave, a specialized zipper releases the herbs and the butter from the top chamber just at the right time during the microwave process. Just put the bottom-gusseted pouch in the microwave oven, set it for six minutes, and after it is cooked, tumble the bag a few times to distribute the seasoning, and serve. In other words, “The product cooks in the microwave in just one step.” The brand-new potato pouch is invented in collaboration with Schur®, a Danish-owned, global packaging company. The bag is a part of their unique Schur®Star Systems concept, and Schur® has also constructed the Schur®Star 2060C packaging machine that stands behind it. In the making of this pouch, Potandon

hand is also full-featured and high-performance. continued on page 43

has had a close collaboration with both the American division of Schur®Star Systems and Schur’s technology group based in Denmark. Based On an Increased Need for Convenience “We know that 60% of consumers don’t continued on page 66

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Klinger IGI — Innovative Solutions for Precision Parts Fabrication

Vibrac — Precision Test Systems

When you think of industrial product manufacturing, the first thing that may come to mind are molded or machined parts. Yet, beyond these parts we commonly think of, there are other essentials to the construction of some of the most important devices on (and above) Earth. Cut parts like gaskets, shields, washers, and seals are essential items used in the buildup of mission-critical components found in aircraft and space vehicles; medical and scientific devices; automobiles; computers and displays; and power generation systems. It’s in that custom fabrication space that niche manufacturing companies, like Klinger IGI, contribute their expertise. Pat Moody, Klinger IGI’s president, shares how this build-to-print specialist innovates solutions to the often-challenging cut parts requirements of some of the world’s top aerospace, electronics, medical device, and industrial automation product manufacturers. Klinger IGI is an AS9100-; ISO 9001-; and ITAR-registered, build-toprint contract manufacturer. Klinger IGI’s precision fabrication capabilities include cutting raw materials into parts using a high-speed CNC water jet, laser, and die cutters, as well as router workstations. OEM and Tier 1 manufacturers in highly regulated industries contract with Klinger

Vibrac is a precision test-equipment manufacturer. Its unmatched, highly sensitive torque measurement systems yield data for improving quality, reliability, performance, and design of manufactured devices that employ small or very small rotating components. Founded in 1960, Vibrac began as a clutch and brake manufacturing

IGI to make their critical parts to print specifications. Typical custom parts include electronics thermal interfaces and gap pads; vibration and sound dampeners; RFI/EMI shields and seals; and a range of high-performance gaskets for sealing vital components. One thing that sets Klinger IGI apart in the fabrication industry is that it adds technical consultation to its comprehensive build-to-print offering. By emphasizing engineering reviews that can offer insights about the best materials and fabrication techniques, Klinger IGI helps customers understand how their products can be improved in performance, cost, and delivery. To achieve this outcome, Klinger IGI works with a customer’s new product introduction (NPI) teams. In this collaboration, Klinger IGI teams share different raw material options or recommend the best continued on page 48

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A Winning Formula: Global Manufacturing With Local Support As medical device manufacturers become increasingly global and establish manufacturing and development sites throughout the world, it is vital to partner with suppliers that also have a global manufacturing footprint and can effectively provide local support and customized solutions. In the last decade, Trelleborg and Minnesota Rubber & Plastics (MRP) have both focused on expanding their global reach and broadening their R&D, materials development, and manufacturing and testing capabilities. The acquisition continued on page 61

Polysciences — Custom Solutions Through Chemistry Beyond the Ordinary Access to and Experience in the Technology and Science Needed for Your Medical Devices. Enter Polysciences — a leading developer and manufacturer of custom medical device coatings. Established in 1961, Polysciences is a subsidiary of Ott Scientific, a medical device component manufacturing organization with diverse device manufacturing companies under its umbrella.

The company offers over 3,000 researchgrade materials in its catalog, bioprocessing/transfection materials, and Custom Synthesis Services (CDMO) for its client’s medical devices needs. Polysciences CDMO model provides custom-grade materials and is supported by a highly experienced team of world-class scientists, analytical facilities, regulatory experts, and manufacturing capabilities.

cal device material’s effectiveness and to validate it for use as per ISO 134845 cGMP regulations.

Right-Sized and Properly Equipped Facilities The enterprise consists of multiple, flexibly designed manufacturing suites and ISO cleanrooms capable of synthesizing, purifying, and processing materials for your medical device needs in different scales — varying from a few grams to several tons. Polysciences also has and continues to invest heavily into its analytical capabilities — both in methods and equipment which can be used to test your medi-

CENTAURI IVD — High Throughput Injection Molding Automation The market for precision-molded medical consumables is growing. These singlepiece devices are often used in high volumes by diagnostic testing laboratories. Patient samples are collected and processed using a variety of single-use or disposable components. Medical screening or testing for infectious diseases requires many molded devices, while the validity of each test is dependent on the accuracy of each piece. To meet the rapidly

growing demand for these consumables, manufacturers require precise control of injection molding, vision inspection, and post-molding processes to deliver highquality products to market. Pipette Tips are small, relatively simple components used to aspirate and dispense accurate volumes of sample material and reagents. Though used in manual laboratory settings, the exponential increase in demand for patient testing called

for automated diagnostic testing. Now, robotic handling of samples requires many pipette tips for high throughput testing. Total pipette tip manufacturing demand is significantly greater than ever before.

Ability to Keep Costs and Timelines In Check Controlling costs during early-stage product development, as well as sticking to a realistic, though likely very aggressive timeline, relies on the knowledge of an experienced team who have worked with advanced technologies and state-of-theart medical device partners. Polysciences also boasts a significant analytical capability, including NMR, ICP-MS, GPC, and much more — to manage program timelines and keep testing in-house. Be sure to talk to them for a complete view continued on page 61

To meet the push for more and more disposable pipette tips, cuvettes, reaction tubes, and other similarly sized precision molded plastic components, manufacturers need high-performance post-molding automation. “Shoot and ship” molding is not an option for these types of components. Accuracy of diagnostic tests is dependent on the precision of molded parts and the reliable transfer of samples within the diagnostic process. Parts must be carefully handled, and orientation maintained without damage to critical features and surfaces. To support medical device manufacturers in their quest to meet increased continued on page 61

Preshow Edition • Monday, February 6, 2023

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From Prototype to Product — The Back Story Article Courtesy of Prospect Life Sciences (PLS)

Qosina President and CEO Scott Herskovitz spoke with Manufacturing & Design Today about his company and products.

When Spinal Stabilization Technologies (SST) engaged with us seven years ago, they had a prototype and the goal of developing a less invasive surgical solution for patients with degenerative disc disease. Inspired by their vision, we worked with their engineers to learn how we could meet their needs. In a matter of days, we had created the initial manufacturing procedures necessary to build their first-generation device.

Q: What’s the most common challenge customers inquire about, and how do you address it?

Documentation Is Critical The documentation required to obtain clearance on a new medical device can be daunting. Best practice for achieving regulatory compliance is implementing a stage-gate development procedure in which all design inputs, outputs, verification and validation, and risk management activities undergo a formal review and approval process. As a startup, SST had neither the time nor the internal resources to efficiently complete those activities. They instead entrusted PLS to accelerate development and handle all documentation responsibilities and Quality System compliance through market release. At PLS, we know that medical device manufacturing is as much about documentation as anything. We embrace that reality

and are relentless in the pursuit of bringing documentation through a robust set of SOPs to ensure compliance with ISO 13485:2016 and FDA QSR for all products manufactured in our facility.

PRECISION CONVERTING

proach. Our medical application engineers are the brightest and most experienced material experts in the field, trained to help you select the best options for your design, from “skin-friendly” materials to aggressive adhesives for your device’s actual construction to improve its reliability, enhance performance, and reduce costs. We will help you source the right materials, expand faster, and solve problems.

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and FDA-registered medical manufacturing and assembly leader for more than 50 years, Precision Converting will partner with you during every step of the journey to ensure exceptional outcomes. A solution-driven team, we use our converting expertise to ensure the manufacturability of medical device components that meet the requirements of applications, like wound care, patient monitoring, medical device fixation, diagnostics, and more. We will work side by side with you to source the right materials, expand faster, and solve problems to bring your products to the market quicker. A 3M-preferred converter, Precision Converting is a division of Hisco and a part of the HiscoMed team. From cleanroom assembly solutions to specialized medical VMI programs, our medical manufacturing solutions help you create products to improve the lives of patients everywhere. Consider us the experts at turning our customers’ medical converting challenges into better patient experiences as we customize, convert, and fabricate high-quality medical device components based on your requirements. We will ensure the viability of these components to meet the stringent quality standards of your medical manufacturing application with a fully customized ap-

Qosina Is the One-Stop Source for Thousands of Medical Device Components

Build. Refine. Repeat. At PLS, we work hard to get our clients’ devices into production as quickly as possible. Doing so allows us to anticipate the next obstacle in the development life cycle. It also gives us the foresight and time needed to adapt to the best path for successfully overcoming design challenges, testing alternate manufacturing solutions, and developing more efficient, cost-saving methods of building our clients’ devices. While it can sometimes feel never-ending, continued on page 66

Materials — We convert innovative materials from key partners in the industry, including 3M, Rogers, LOCTITE, and more. Engineering — Our dedicated medical application engineers apply advanced manufacturing techniques to improve your processes and reduce your bottom line. Quality — We collaborate with you to identify opportunities for improvement and implement the exact certifications required for each application. Customer service — We’re here for you throughout the entire product life cycle, from development and manufacturing to packaging and distribution. Let us turn your biggest medical manufacturing challenges into better patient care. Contact Precision Converting today at 828-315-7723 or visit us online at www.precisionconverting.com.

A: The most common challenge is how to find an off-the-shelf component, so customers don’t have to invest in their own tooling. Qosina addresses these challenges through the website features, plus our world-class customer service team and technical sales representatives that work with customers to address the needs of their particular project. One question that frequently comes up is, ‘How do I find the right component for my application?’ Qosina has the largest selection of stock components for medical device manufacturing. And most design engineers know that we offer free samples of our medical OEM components. Engineers experiment with many different products while determining what to spec into a design. They evaluate size, color, materials, and pricing, all of which are considered pivotal to the decision-making process. Qosina’s components are perfect for building prototypes, testing different sterilization methods, and validating bond-

VIBRAC (continued from page 26)

business for small-scale devices. In the process of this activity, the company developed a method for measuring torque (the work required to rotate something) for precision bearings and actuators, including those used in the space industry. These precision test systems were used for testing bearings and rotary actuators on the Hubble Space Telescopes, the Mars rovers, the space shuttle vehicles, and now the Artemis Mission Spacecraft going to the moon. This experience sharpened the company’s focus on test equipment and launched a reputation for innovation. Seeking to expand its market opportunity, Vibrac built what became the standard for measuring torque for floppy computer disks rotating in their protective jackets; testers for electricwindow motors in cars; Kodak motors that advanced camera film; laptop disc drives; and many other small, rotating objects ensued. In the early ‘90s, the company invented a motorized bottle cap torque tester for Coca-Cola, opening a new market opportunity Vibrac still pursues today. The need was for twist caps to be sufficiently tight to prevent leakage, while being consumer friendly, or relatively easy to remove. Today, Vibrac

ing agents. Q: If you could give one piece of advice to companies seeking a manufacturing partner before they decide, what would it be? A: Qosina can source a product that already exists, preventing you from having to reinvent the wheel. Before companies began offering stock components, product designers had to design the various components they would use in addition to the core product. Tooling has to be created and the components manufactured, which is a costly process. Designers can utilize continued on page 48

features the most advanced automated digital cap inspector, which, unlike analog devices, isn’t subject to temperature changes and is much more accurate. By request, Vibrac a few years ago developed a digital viscometer, which measures the drag on fluid flow (viscosity). The application focused on the oil and gas industry and replaced decadesold technology. Vibrac’s completely new methodology for testing and measuring viscosity resulted recently in a patent for noncontact, high-resolution spring resistance technology for force and torque measurement. This special technology has the breathtaking capability to deliver more than 2,000 points of resolution per degree of movement, opening new horizons in microscopic torque and movement measurement. Torque, position, and speed can now be measured closer to life-like micromovements. As the march to be more and more precise advances, Vibrac is the undisputed leader in an area where testing requirements will increase in the future. It is a mechanical, electromechanical, and software manufacturer whose products are over 90% made in USA. Across the boards, Vibrac test systems are known for high resolution and accuracy for measuring torque at the most minute levels. See them for yourself at www. vibrac.com, or Booth #3443.

Preshow Edition • Monday, February 6, 2023

ANOMET PRODUCTS (continued from page 1)

limited. Typical configurations for implantable devices include platinum-indium-clad tantalum, platinum-clad MP35N®, silvercored MP35N®, 316LVM clad tantalum, platinum-clad nitinol, and gold-clad nitinol. Ideally suited for meeting design criteria for corrosion resistance, wear resistance, contact resistance, biocompatibility, radiopacity, strength, conductivity, solderability, formability, and more, Anomet Medical Clad Wire has a smooth, consistent finish and can be manufactured in sizes from 0.002- to 0.125-inch O.D. with 2% or more cladding thickness. Anomet Medical Clad Wire is priced according to configuration and quantity. Samples and price quotations are available upon request. Leading the Way With Focused Technology Anomet Products has focused exclusively on manufacturing innovative clad-metal wire composite solutions that deliver optimized performance for the most demand-

DMM TECHNOLOGY CORP (continued from page 21)

All motors come standard with DMM’s 16-bit absolute encoder or optional 20-bit absolute encoder. Multi-turn options are also available. DMM Technology Corp. DMM Technology Corp. provides AC servo drivers and motors for industrial automation applications. Our main field of expertise exists in providing smart and cost-effective motion control systems for

MATRIX PACKAGING (continued from page 1)

master distributor brands, INVpack and Pacraft (formerly Toyo Jidoki), are showing off their latest vertical form fill seal packaging technologies in Booth #5231 at MD&M West 2023. Matrix is an industry-leading manufacturer of vertical form fill seal machines operating widely throughout a variety of industries. WestPack attendees can see the following machines on display: Matrix Morpheus Series The Matrix Morpheus, a continuous boxmotion bagger, allows users to package their products with a variety of films at faster speeds with better accuracy. The Morpheus uses a continuousmotion, high-speed jaw system that is unique from other vertical form fill seal machines because the film never stops. The jaw system cuts the film and provides just enough dwell time for the three-bag seams to properly seal. This innovative feature allows users to achieve higher fill rates and proves why the Morpheus is Matrix’s most advanced vertical form fill seal machine.

ing applications and extreme environments. Anomet’s goal has always been to provide superior material quality, product value, and customer satisfaction through service and support that far exceed expectations. For over 40 years, Anomet Products has been designing and manufacturing clad metal wire used in electronics and medical devices throughout the world. As a pioneer in clad composite wire, its team of highly skilled, experienced material engineers has been on the leading edge of many of the following areas during this time. Anomet Products is proud that this unwavering commitment has fostered strong, collaborative partnerships with leading OEMs and design engineers across an extremely diverse range of business sectors — not only including the electronics and medical device industries, but also in the aerospace and defense, automotive, oil and gas, superconductors, and electrochemical industries. For more information about Anomet Products, Inc., be sure to call 857-3022523, email [email protected], visit www.anometproducts.com, or stop by Booth #3167 during MD&M West. the manufacturing industry. We understand the high demands of modern machines, and our products are designed to achieve a level of performance that will optimize the output of each integrated machinery. Our products have proven themselves in many manufacturing and automation industries for worldwide applications. We are also able to collaborate with users to develop new or modify existing systems in order to meet and exceed the target requirements. We integrate smart technology into an industry-proven package. We will be displaying our products at Booth #4548. The Morpheus series comes in three different machines to best meet users’ production requirements: •Morpheus: Standard machine with up to 12-inch bag width. •Morpheus AB: Includes Rockwell controls; up to 12-inch bag width. •Morpheus XL: Accommodates up to 15-inch bag width. Mercury The Matrix Mercury is a high-speed vertical form-fill seal bagger that’s capable of filling up to 140 flexible packaging bags per minute. The Mercury is known for its easy operation, and quick changeover and setup. It can accommodate bag widths between 2 and 11 inches, and bag lengths between 3 and 15 inches. The Mercury is a great cost-effective packaging solution as it features a small footprint, stainless-steel frame, automatic film tracking, a registered film sensor, and more. Pacraft The Pacraft TT-8D-N pre-made pouch filler/sealer is designed for a wide variety of packaging applications. Its pouch formats and product types, including

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GENESIS MEDICAL PLASTICS (continued from page 8)

film in implantable devices. In one case, Genesis converted the customer’s implantable PEEK polymer into 0.25 mm film for evaluation in a new and less invasive cardiovascular procedure. The film can also be precision cut, stripped, or stamped into intricate configurations for various bioelectronic and implantable applications such as connectors and components for defibrillators and pacemakers. About Genesis Medical Plastics Genesis Medical Plastics, based in Cypress, is an ISO 13485:2016-certified

FORMACOAT (continued from page 8)

It’s been carved out and inhabited by us. There’s no one else trying to do what we do when it comes to coating devices,” says Brontë Gross, the company’s marketing engineer. Formacoat is truly unique in its approach to finding coating solutions for their customers. They are not married to a coating of their own design, but instead offer a multitude of solutions and allow the customers to decide based on their own criteria, whether that be physical properties, timeframes, or financial considerations. “When it comes to our flexibility

CENTERPIECE (continued from page 6)

within a medical device’s supply chain, including component sourcing and procurement; product manufacturing and packaging; logistics coordination with its sterilization facility; in-house ETO sterilization processing; and sterile-product flat, stand-up, retort, and press-to-close pouch styles. It can seal up to 55 pouches per minute; pouch sizes range from 4.72 to 10.23 inches (120 to 260 millimeters) with lengths from 5.11 to 15.74 inches (130 to 400 mm). INVpack Finally, MD&M West 2023 attendees will see how INVpack has become a leading provider of high-quality stickpack and sachet systems for the pharmaceutical, cosmetic, and food industries. On display at the show is the sachet form fill seal MVA4 EVO machine, which is designed for small-to-medium production runs that require high-quality sealings. Matrix and its distributor brands maintain a strong commitment to sustainability. Those traits are found by working closely with its customers in developing packaging solutions that exceed their sustainability goals. Multiple film types, including compostable and recyclable films, can run efficiently on many Matrix machines as well as those of its distributor brands. Plan to visit Booth #5231 at MD&M West 2022 to see the flexible packaging

company and an FDA Class II registered medical device manufacturer. It recently added calendering medical PEEK film to its capabilities for converting customers’ medical polymers into custom configurations. Processes include the extrusion of machinable rods and plates in a range of sizes, injection molding precision components, and CNC machining, from prototypes to production quantities. Its production team has over two decades of processing experience in medical-grade plastics from polypropylene through PEEK. For more, visit www.genesismedicalplastics.com. Visit Genesis at MDM West Booth #1082. and impartialness, we are utterly unique.” So, you’ve got to ask yourself, ”What do you want and why?” About Formacoat LLC Formacoat LLC, headquartered in Chaska, Minnesota, is a creative biomedical company that specializes in the application of an increasingly wider array of different medical device coatings for its customers’ diverse products. The family-owned company streamlines the customer’s R&D and path to commercial production by choosing the best coating options from a variety of vendors. Formacoat is ISO 13485 certified. Come see them in Booth #1657! warehousing. For businesses that outsource device assembly or packaging to Centerpiece, the company guarantees ETO sterilization capacity and offers priority ETO sterilization scheduling. Learn more about Centerpiece capabilities at www.centerpiece.life, or visit Booth #1506. solutions from Matrix, Pacraft, and INVpack in action — and learn how they can help you increase productivity and meet your sustainability goals. About Matrix Packaging Machinery Matrix is an industry-leading manufacturer of rugged, cost-competitive, and easy-to-use vertical form fill seal equipment for all types of flexible packaging, and operates as a master distributor of INVpack-brand stickpack and sachet machines, and Pacraft-brand pre-made pouch-packaging machines. Experienced in most flexible packaging applications, Matrix has the ability and knowledge to tailor highly efficient and sensible packaging systems and is committed to optimizing solutions for customers on a global scale. Matrix is a product brand of ProMach, a global leader in packaging line solutions. As part of the ProMach’s “Flexibles & Trays” business line, Matrix helps our packaging customers protect and grow the reputation and trust of their consumers. ProMach is performance, and the proof is in every package. Learn more about Matrix at www.matrixpm.com and more about ProMach at www.promachbuilt.com.

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STEER MEDICAL (continued from page 1)

Jean-Eric Boucher, both of whom have over 20 years of experience in catheter design and manufacturing. Q: Mike, why did you and Jean-Eric start Steer Medical? A: We started the company because the technology for minimally invasive medical technology is getting more and more complex and innovative. We saw an increasing need for expertise in the delivery of those innovative diagnostic and treatment technologies. Companies were focused more on distal and proximal technology and needed a partner to design and manufacture the delivery system that could handle their needs. Shafts aren’t simple anymore. Q: What do you mean by “delivery system,” and can you give us an example of the most complicated delivery system you’ve designed or made? A: Primarily, we are talking about the shaft of the sheath and catheter and the handle. Modern treatment technology means modern shaft design. It’s hard to say what is the most complicated system we’ve designed or made because they can be complicated for a lot of reasons, like very big, very small, multilumen, quadrupled deflection, deflection in different areas of the shaft, cameras, nitrous oxide, and flush ports. There’s a long list, and we’ve done it all at one point in our careers.

DATA MODUL (continued from page 1)

expanded its growth in the medical display field by introducing a new LCD display family featuring mini-LED backlight technology to its product line. These dynamic local dimming displays bring OLED-like ultra-high contrast and color without the inherent shortcomings of burn-in, color shift, and environment sensitivity that plague OLED technology. This makes the DATA MODUL mini-LED displays perfect for your demanding medical display requirements. The backlight incorporates a dense array of LED zones that can be individually and dynamically controlled in harmony with the display content, creating ultra-high-contrast (1 million-to-1 ratio) images that have to be seen to be believed! The advantages of DATA MODUL’s professional-grade FALD backlight, compared to conventional backlighting technology, are OLED-level contrast and color, superior image quality, and true sunlight readability. Beyond that, power consumption and heat are significantly lower compared to similarly bright displays, making it ideal for medical imaging. “DATA MODUL has been able to take a new approach in controlling the LED backlight of an LCD display to achieve an OLED-level display that is compelling for all industries, especially the medical field,” explains Thomas Klingl, VP of DATA MODUL Inc. “The result is our new LCD series with mini-LED backlights. Com-

Q: Why did you name the company “Steer Medical?”

QOSINA

A: The name, Steer, comes from the fact that we make all kinds of shafts, including ones that are deflectable that the surgeon can ‘steer’ through the vasculature to get to a certain part of the body.

Qosina as their one-stop shop for components without having the hassle of using several different sources for one project, therefore, easily streamlining their vendor lists. We welcome sourcing requests for tool modifications, hard-to-find items, subassemblies, or tubing. Customers can also request an item that is not already in our inventory, and we will work to develop the part to exact specifications.

Q: Does Steer specialize in cardiac catheter shafts? A: Many of the delivery systems we have designed and manufactured are for cardiac access, but we have had customers with neuro, pulmonary, and even spine applications. Q: Thank you for your time, Mike. Is there anything else you would like to tell us about Steer Medical? A: My pleasure. From the whiteboard to the operating room, Steer Medical assists surgeons, entrepreneurs, and small and large companies alike in the design; development; and manufacturing of minimally invasive surgical delivery systems to meet the needs of an ever-innovating industry. Safely and effectively delivering your treatment or diagnostic technology to the heart, brain, lungs, or abdomen is our specialty. Reach out and tell us about your technology or what problems you are facing in its delivery. We love a challenge. Call me or Alan at 888-757-8337 or 514482-9051, or you can email us at info@ steermedical.com. pared to standard LCD displays, significantly deeper black tones and better black level uniformity can be achieved.” DATA MODUL’s mini-LED lineup includes six sizes; 7, 10.1, 13.3, 15.6, 17.3, and 27 inches. The 7-inch WUXGA display includes over 1,000 zones, a wide color space of 105% DCI-P3, and a high contrast. The 13.3-inch 4K UHD display includes 1,296 zones and a wide color space of 99% DCI-P3, while the 27-inch 4K UHD includes 1,152 zones and wide color space of 98% DCI-P3. The 15.6- and 17.3-inch models have a built in backlight controller. Why DATA MODUL’s Mini-LED Displays? •High peak brightness: Higher than l,000 cd/m2 in all models. •Contrast ratio higher than 1 million-to-1. •Reduced power consumption and heat. •OLED performance with LCD long life, wide operating range, and no image burnin. •No differential aging under industrial conditions. DATA MODUL mini-LED displays: You have to see them to believe them! We’d love to talk to you more about how this premium technology that can help improve your professional-grade medical devices. Learn more about our products and how they can work for you by stopping by our Booth #1382 here at MD&M West and by visiting our website, www. data-modul.com/en.

(continued from page 28)

Q: What are the forces driving medical device manufacturers to seek your technology/services over doing it in-house? A: Ordering off-the-shelf products from Qosina enables manufacturers to focus their time and resources on proprietary products. With one purchase order, they can outsource the supply chain for many components to Qosina. We have relationships with many manufacturers that utilize many different technologies. We handle inspection, quality control, have five ISO

KLINGER IGI (continued from page 26)

techniques to convert a particular material type into the desired part. They also consult with the supply chain to refine purchasing requirements in ways that can achieve higher quality, better delivery, and economies of scale. And as everyone experienced in 2022, supply chain disruptions and material shortages can create wide-ranging turmoil for product manufacturers. It was in this environment that Klinger IGI’s solutions teams proved their value. Klinger IGI’s engineers identified alternative materials and sources, as well as validated faster production processes, so that Tier 1

FORTRESS TECHNOLOGY (continued from page 8)

waste reduction, and brand protection. For many FMCG manufacturers, price hikes, squeezes on profit margins, the rise in lifestyle-led well-being brands, as well as strict regulatory mandates are tipping the scale towards advanced and precision checkweighing. Fortress Technology’s new Raptor Checkweigher series offers a breakthrough advancement for North American food producers battling the cost of living challenges with domestic and global ingredient and food pricing volatilities. Protecting consumers and brand reputation, as well as meeting legislative weight requirements, the robust Raptor Checkweigher targets operational inefficiencies, including product giveaways, nonconforming food packs, and packaging waste. Saving Good Product Giveaway Even nominal overfilling can rapidly escalate to lost profits. By digitizing the checkweighing process, manufacturers can rapidly achieve productivity gains and save thousands of dollars in product give-

certifications, and offer second-sourcing opportunities for customers. Q: In what ways is your company able to aid in getting a product (project) to market faster? A: Qosina’s products are in stock and available for immediate delivery. Customers start their R&D journey with us by finding stock components that meet specific needs. We offer assurance of supply, along with required documentation and complimentary samples on most products so they can be tested during prototyping and research and development, which reduces their time to market. While Qosina continues to change and grow, one thing remains constant: we are committed to providing you with exceptional customer service and thousands of stock components with backup documentation and quality controls to support finished products in the highly regulated industry we serve. Readers can start to reap these benefits at www.qosina.com/#gref, or Booth #3113. and OEM manufacturing customers could experience reduced impact. Such collaboration illustrates a business approach to product manufacturing that focuses on adding value beyond simply “running a job.” This engagement intentionally produces strong working relationships that result in the recurring use of Klinger IGI’s services. Klinger IGI’s manufacturing facility and corporate offices are in Greater Portland, Oregon. Klinger IGI team members are also in Seattle, Salt Lake City, Boise, and on the road to support sales and consultation. To learn more about Klinger IGI, visit www.klingerigi.com, stop by Booth #3546, or call 800-444-7157. aways. The precision Raptor Checkweigher captures thousands of sample readings of individual packs every second. Sophisticated software adds full transparency to packing processes, and tracking to ensure each unit’s weight meets the set parameters. With integrated data collection software, everything from trends, pack rates, and live OEE data is instantly reported. This information can then be exported or communicated remotely for use by production and QA personnel to monitor and fine-tune production line performance, even prior to the weight check process. Featuring modular electronics, the Raptor Checkweigher and its XL version enable seamless integration with a Fortress metal detector, as well as upstream packaging equipment. The Raptor series also features a user-friendly HMI touchscreen panel that can be preprogrammed to run 500-plus SKUs — Further reducing human errors during product switchovers. Inspection specialist Fortress Technology explores the latest in-line weighing trends at WestPack 2023. Visit Booth #5431 to discover more.

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PATLITE (continued from page 8)

seven standard selectable colors and has a capacitive touch sensor that can connect to an IO-Link master for added flexibility. The 56-millimeter-diameter beacon can display its seven colors in a continuous or flashing pattern and comes standard with eight selectable buzzer tones that house an impressive sound output of 88 decibles. Harsh chemicals and demanding environments will not penetrate its rugged and completely sealed polycarbonate housing that can operate with wet or gloved hands. Additionally, non-IO-Link capable digital or analog sensors and actuators can connect to an IO-Link network through the NE-IL’s built-in inputs. It is no surprise that PATLITE’s signature LR Signal Tower Series and the adaptable NE-IL compact beacon are offered in the industry standard of IO-Link, which allows these products to simplify operations and maximize workplace ca-

CENTAURI IVD (continued from page 26)

demand, Micro Automation developed a modular solution designed to work adjacent to a variety of injection molding machine sizes and types. The CENTAURI IVD platform can be configured to perform component unloading and transfers from 16 to 128 cavity molds, typically running at high cycle rates. Achieving high throughput requires highly accurate parts handling. The CENTAURI IVD uses a customized side takeout robot supported by a support frame weldment. Lightweight end-of-arm tooling (EOAT) is driven by a linear servo motor. The EOAT is mounted to sealed linear guides providing exceptional accuracy and rigidity. This arrangement delivers a lowmaintenance system for use in high-duty cycle environments. Together, these machine elements enable rapid entry, precise positioning, and fast retraction from the

NORDSON MEDICAL (continued from page 1)

manufacturing of complex medical devices and component technologies. As a single-source partner, we enable our customers to save costs, speed time to market, and simplify supply chain management. Our expertise includes heat shrink tubing, catheters and cannulae, fluid management components, medical balloons, medical tubing, biomaterial delivery devices, and nitinol components. We work with companies at any point in the product life cycle, from concept to launch and beyond. With our flexible business model, we can provide a solution that meets the scope and scale of any project to bring innovative ideas to life. Components and Technologies •Balloon catheters. •Engineered shafts. •Cannulae — polymer solution casting. •Medical balloons.

pabilities. For more information on these IO-Link-enabled products from PATLITE and other signaling and audible solutions, please visit www.patlite.com. Consider following PATLITE on LinkedIn, Facebook, Twitter, and YouTube for how-to videos, application examples and news on PATLITE products; or find them in person at Booth #4154. About Patlite For over 75 years, PATLITE has been one of the world’s best-known manufacturers of visual and auditory signaling solutions manufacturers. Backed by years of industry experience and expertise, PATLITE has specialized in offering cutting-edge solutions to the process and automation industries across the globe. Headquartered in Osaka, Japan, PATLITE has more than 1,000 employees in wholly owned sales subsidiaries in the U.S.A., Mexico, Germany, Singapore, Korea, Thailand, Taiwan, and China. production mold. Selecting other components of a modular system depends on molding operations performance and finished packaging configurations. Post-molding operations often include immediate on-the-fly vision inspection with KPIs communicated directly to the injection molding machine and molding tool. Molding parameters are continuously changed to maintain optimal performance at each cavity. Subsequent operations can involve direct loading of racks, cards, or other storage parts or more complex handling of parts can utilize inspection data to drive quality control makeup actions. These are mechanical means of exchanging reject parts with parts drawn from a previously filled buffer of known good parts. Micro Automation’s CENTAURI IVD platform delivers high OEE performance demanded by medical device manufacturers worldwide. But find out for yourself at www.micro-automation.us, or Booth #3960. •Heat shrink tubing. •Polyimide tubing. •PTFE tubing. •Extruded tubing. •Reinforced tubing. •Fluid management components. •Tubing. •Biomaterial delivery devices. •Bone graft delivery devices. •Nitinol components. Unmatched Service We enable our customers’ success through superior products and services with industry-leading innovation, quality, reliability, and responsiveness. Nordson MEDICAL can provide the detailed support you need from idea to market. We offer components 24/7 through our online store. Along with our technical team, we also offer online prototyping tools and project accelerators to help you design and develop to get your innovation to market faster. Markets We Serve

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POLYSCIENCES (continued from page 26)

of the development process and program costing, including the cost differences be-

MINNESOTA RUBBER & PLASTICS (continued from page 26)

of MRP by Trelleborg now ensures that the capability and technology demands of medical device manufacturers worldwide are further supported by a highly experienced team of Trelleborg experts, a broad range of materials and manufacturing capabilities, and a robust global supply chain. Trelleborg’s experts communicate with customers in their local languages so that, regardless of location, they have access to a variety of materials, such as liquid silicone rubber (LSR), thermoplastics, black rubber, bioresorbable, and other polymers and elastomers. Additionally, Trelleborg serves customers globally with capabilities including silicone molding, extrusion, sheeting, dipping, and coating; overmolding; plastic injection molding; multicomponent manufacturing; drugeluting technologies; engineered coated fabrics; and other technologies. Increased Reach With MRP Trelleborg can now leverage MRP’s established excellence in polymer and thermoplastic components, as well as its strategically located manufacturing facilities that complement Trelleborg’s manufacturing network. MRP production facilities in the U.S., Mexico, Europe, and China, enable Trelleborg to have a manufacturing presence close to more medical device customers. Local manufacturing location decisions can be made per component, depending on part complexity, labor content, supply chain risk level, demand, and more. Because of the manufacturing facilities MRP brings to Trelleborg, parts can be produced through efficient geographical •Cardiovascular. •Electrophysiology. •Gastrointestinal/endoscopy. •In vitro diagnostics. •Neurovascular. •Ophthalmic. •Orthopedics/spine. •Patient monitoring. •Structural heart. •Urology gynecology. Quality Assurance We hold ourselves to the highest standards of quality. With over 50 years of medical device experience, we have developed a thorough understanding of the complex regulatory environment. Every product is manufactured to your specifications, and in full compliance with FDA guidelines, at one of our ISO-certified facilities. We host over 100 audits per year from customers and regulatory bodies. Certifications and Registrations •ISO 13485 and 14971 risk management

tween batch sizes and larger runs. Come visit Polysciences to discuss your medical device chemistry needs at MDM West Booth #2092. They look forward to meeting you! supply chain consolidation. For example, some customers purchase the same rubber components in both the U.S. and China. By producing the component in two locations, at both the China and U.S. facilities, Trelleborg can provide customers better supply chain continuity. Navigating International Standards and Regulations Alongside development and manufacturing capabilities, like Trelleborg, MRP facilities complied with all national and international regulations and standards around quality system requirements, risk management, usability, and testing for Class I, II, and III products. Depending on the component or product, they provide customized levels of regulatory compliance and oversight at each manufacturing location. Components can be manufactured in facilities that meet European Medical Device Regulations (MDR 2017/745); FDA 21CFR Part 820, Part 210/2011, Part 11, and Part 4 certification; as well as ISO 9001:2015 and ISO 13485:2016 and associated standards. By the Numbers Accounting for its added reach with MRP, Trelleborg Sealing Solutions now has 10 research and development centers, 41 manufacturing facilities specializing in market-leading solutions, 61 customer solution centers offering local engineering and support services, one customer innovation center, five logistics centers, and three ServicePLUS Centers. Anyone interested in learning about the newly expanded operations, synergies, and capabilities is encouraged to visit Trelleborg at Booth #2301 and Minnesota Rubber & Plastics at Booth #2827 at MD&M West 2023. certified. •FDA registered and compliant with the quality system regulation. •Class I, II, and III medical devices, including Premarket Approval (PMA) products. •Class 7 and Class 8 cleanroom-controlled environments. •US FDA 21 CFR Part 820 compliance. •Canadian Medical Device Conformity Assessment System compliance. •Medical Device Single Audit Program (MDSAP). With all the recent changes in the manufacturing industry, Nordson MEDICAL has introduced and accelerated various initiatives to build resiliencies. We are focused on resource prioritization and have initiated programs that enable us to engage with you and more effectively serve your needs. For more information, please visit us at Booth #2811 or online at www.nordsonmedical.com

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Leland Gas Technologies — Providing CCB Cut-Coil-Band Gases to Enrich Life and Further Science Article Courtesy of Tecnoideal America

South Plainfield, New Jersey is located in an East Coast metropolis with a high-density population, and its proximity to New York City, as well as key institutions, such as Princeton and Rutgers University. This makes it the ideal headquarters for one of the industry’s fastest-growing companies; Leland Limited Inc. Providing packaged gases in non-refillable containers has been Leland’s core business for over 50 years. Making precision pressure-reducing regulators has become Leland’s fastest-growing segment and has put them on the map as a leader in gas handling technology. “We have taken the time to listen to the medical and aerospace communities to understand their requirements and turn that into a viable product line. The improvements made and the design elements which we have included will take us into 2023 and beyond,” said Lee Stanford, director of technology at Leland Ltd., Inc. “Making gas-filled cartridges on highspeed automated production lines has been key to the volume side of the business. However, the medical and calibration field requires a different approach, and that is where Leland has discovered its key resources; at the university level.

FLEXCON® (continued from page 1)

without compromising performance. FLEXcon® OMNI-WAVE™ does not have hydrogel-associated skin reactions, and its performance is not affected by humidity. OMNI-WAVE™ is an approved component in customer 510(k), CEmarked finished good medical devices, and is shipping now worldwide. Attendees at MEDICA 2022 said: •“This product is what the market demands.” •“It’s going to be huge — this is going to replace every electrode.” •“The rumor is out — We came to see what all the buzz is about!” •“[A] colleague — told me that I must see this cool new technology.” FLEXcon® OMNI-WAVE™ technology uses a skin-friendly, medical-grade conductive adhesive that requires no hydrogel or Ag/AgCl to get a signal. It is suitable for diagnostic applications, such as EKG and sEMG, and can distinguish between sympathetic and parasympathetic responses for EDA applications. It is appropriate for therapeutic applications such as TENS and NMES if a secondary repositionable adhesive is used as a part of the electrode design. •FLEXcon® OMNI-WAVE™ disruptive “nonhydrogel” “dry” technology combines capacitive with conductive biomedical signal sensing to eliminate crosstalk.

The work being performed at the universities and the leverage of our relationships with them allows us to see things that we would not have otherwise had accessed. Material sciences will revolutionize the gas cylinder business.” Stanford added. Leland Gas Technologies maintains an inventory of nearly 1 million gas-filled cylinders to support the 4,000 customers they have developed in over 35 countries. They provide over 60 million gas-filled cartridges per year. They are experts in the gas field and have the logistical capability to reach globally. Leland is a privately held corporation and can be seen at MD&M West Booth #1432, and www.lelandgas.com. •No hydrogel means a reduced chance of skin irritation for patients who are sensitive to hydrogel. •Independent clinical studies have shown performance to be equivalent to hydrogel-based diagnostic and therapeutic devices. •Performance is not affected by humidity, allowing patients to shower, bathe, and exercise normally. •FLEXcon® OMNI-WAVE™ technology passes ISO 10993-10 for sensitization and irritation and is AAMI compliant. •It is an approved component in customer 510(k) and CE-marked finished good medical devices. •Two-year out-of-pack life means no expensive barrier packaging is required. •More efficient, less messy manufacturing processes yield cost savings for converters, OEMs, and end users. •In stock and ready to be licensed and shipped worldwide to OEMs for incorporation into finished devices. We’re Small Enough to Customize, Large Enough to Scale. Collaborate with FLEXcon and get access to 65-plus years of industry expertise in healthcare and materials science. We support you during design, scale-up, and commercialization, and together we can design breakthrough healthcare solutions for the future. When you grow, we grow, and we all grow together! Visit us at Booth #1572 or at www. flexcon.com/mdt2. Let’s start innovating for the future!

With over 30 years of experience, Tecnoideal America offers high-added-value services in the area of medical product production that runs the gamut from single-workstation machines to full assembly lines for semi-finished products and medical devices. We now have equipment being used around the world by small- to large-scale medical device manufacturers. In large part, disposable medical kits consist of tubing lengths whose packaging requires them to be coiled and secured by cohesive tape bands. The manual process of cutting, coiling, and banding is quite expensive in terms of required time and dexterity. Tecnoideal has developed a machine capable of treating these three processes as a single, continuous, and highly productive cycle. Advantages and Features An automatic CCB machine offers concrete advantages in terms of productivity and process control: •When the “Start” button is pressed, the machine produces in continuous mode the coils of banded tubing, reaching a high productivity rate (600-800 pieces

PRIMO MEDICAL GROUP (continued from page 8)

with superior service for 70 years. The company’s passion for customer service was quickly noted while speaking to Senior Vice President, Andrea Patisteas. She said, “Having a person pick up our phone to speak to and assess a caller’s requirements is where we set the bar. The last thing we want is for our customers to get lost in a voicemail system. Therefore, we make it a point to be available in order to immediately understand our customer’s needs so we can plan and act accordingly.” Patisteas explained Primo Medical Group’s policy of assigning key people to ensure they can meet their customer’s goals. Depending on the size and scope of a customer’s project, either a program manager or customer champion is selected. A program manager will typically take on a new project. Often, these projects are complex and will require engineering, manufacturing, or design inputs. Program managers have the authority to use various company resources, and procurement abilities to obtain materials and services. Customer champions work with established projects or processes. They coordinate daily activities to ensure that the work moves efficiently through the facility and act as the liaison between the customer and the company. “Having a point-person gives our customers and internal team a single point of contact for the products we make. This saves a lot of time because everyone knows exactly who to call, and who has the most experi-

per hour), without an operator’s involvement, except for the loading of new tube and cohesive tape rolls when finished to continue the production. •The CCB provides continuous and accurate control of the tube length for each coiled product, thanks to an encoder system capable of evaluating product conformity in real-time. •Automatic selection and discarding of lengths out of specs coils without stopping production. •Easy process parameters control through HMI and adjusting and reduced mechanical intervention. •Servo control and synchronized continued on page 66

ence and expertise with a particular project,” said Patisteas. To meet increasing demand for catheters, introducers, and endoscopic sheaths, Primo Medical Group recently built out a facility to focus that development and manufacturing activity in a centralized location. That lessened competition for resources because a Class 7 cleanroom, development labs, and staff were dedicated to meeting those demands. This is nothing new for the company, who, in 2010, opened the Primo Medical Group Innovation Center. Through the company’s Innovation Center, they offer startups office space and related facility amenities along with financial management services, marketing talent, and management, all in addition to the existing suite of services offered by Primo Medical Group. Having its own Class 7 cleanroom, new medical assembly and packaging processes can be worked out on-site before moving into production. This level of commitment is a testament that the company will structure itself in a way to efficiently provide services and support, most important to new and existing customers. Primo Medical Group is an FDARegistered contract manufacturer and is compliant with FDA Quality Systems Regulations. Primo Medical Group is also ISO 13485:2016-certified and is a registered manufacturer with the Office of Defense Trade Controls Compliance. Visit Primo Medical Group at MD&M West in Booth #2501 or visit www.primomedicalgroup.com, or by calling 781-828-4400.

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Freudenberg Medical Expands Handle Design Center of Excellence Freudenberg Medical — a global developer and manufacturer of finished medical devices, components, and minimally invasive solutions for the medical device industry — has expanded industrial design and human factors engineering through the launch of a Handle Design Center of Excellence (CoE) in Jeffersonville, Indiana. With the expanded Handle Design CoE, Freudenberg Medical has centralized handle design and development efforts in one location, with the intent to increase

TECNOIDEAL AMERICA (continued from page 63)

coiling with combing to help lay the tube uniform within each coil. •Servo-controlled taping axis. •Wider range of coils and tube diam-

RAUMEDIC (continued from page 1)

for customers, including tubing, catheters, molded parts, as well as complex groups of components and systems for diagnostic and therapeutic uses. For the clinical areas of neuro-monitoring and traumatology, RAUMEDIC produces high-precision pressure-measuring systems with microchip technology. In doing so, it plays a key role in safe patient care around the world. With 70 years of experience in the areas of extrusion, injection molding, and assembly, the company with a global workforce of 800 people turns customer ideas into mature products. The foundation of this work is formed by a quality management system

CRESCENT INDUSTRIES (continued from page 6)

III processes. Knowledge, experience, and speedto-market focus carriers forward to every project they take on for their customers. You will find collaborative robots and automated work cells on their production floor. Behind the scenes, Industry 4.0 software monitors the molding process on all injection presses, including vertical/vertical and horizontal molding machines. Reporting live data allows responsive decision-making on the plant floor to reduce part rejects and save time. Another corporate strategy includes Quick Response Manufacturing (QRM) work cells to help increase productivity and decrease lead times and scrap. Quality is part of their mindset, so you will find a state-of-the-art quality lab and quality team to ensure your components

the speed of iterations for prototypes and to unify handle learnings across the organization. Freudenberg Medical develops user interfaces for minimally invasive products in a wide variety of therapeutic areas. Freudenberg Medical’s Handle Design CoE unifies in-house capabilities to design and iterate ergonomically focused handles with the development of manufacturable functional mechanisms. This focus ensures shortened development and

eters without mechanical changeover needed. ◦Tube OD, from 2 to 10 millimeters. ◦Coil ID, from 70 to 180 mm. ◦Free tubing ends, from 120 to 250 mm. ◦Tape width, from 11 to 27 mm. based on ISO 13485 and cleanroom manufacturing on an area of 107,000 square feet based on ISO 14644 (Class 7). Its global sales network and its own distribution companies in core markets ensure that medical and pharmaceutical customers, as well as end users in hospitals and doctors’ offices, have a high level of product availability at all times. For more information, be sure to check out RAUMEDIC Inc. at MD&M West at Booth #2844. You can also contact them by visiting www.raumedic.com, by calling 828684-8870, or follow them on social media: •Twitter: www.twitter.com/raumedic. •LinkedIn: www.linkedin.com/company/ raumedic-ag. •YouTube: www.youtube.com/raumedic. are manufactured to specification. They also have an ISO 8 and ISO 7 cleanroom for molding and secondary operations (such as assembly and packaging). Coming late in 2023, a brand-new cleanroom facility. Having one vendor eliminates potential development problems and bridges communications gaps. As a result, you receive an injection molding partner that produces consistent quality parts. Crescent Industries has over 75 years of molding success and is ISO 13845:2016 certified, as well as FDA and ITAR registered. They ensure your components or devices, whether medical, pharmaceutical, dental, defense, or industrial/OEM, are successfully manufactured. To learn how Crescent Industries can manufacture your injection molded components or device, visit www.crescentind.com or stop by Booth #1952 at the MD&M West.

launch timelines with products that are compliant with human factors and essential requirements. “Our industrial design and mechanical development team has over 50 years of combined product design experience, this team is focused on physician interaction and product functionality, and that translates to commercial manufacturability,” said Mark Ostwald, CEO of Freudenberg Medical. “Our extensive clinical knowledge, combined with established suppliers, places Freudenberg Medical as the premier handle design partner.” Freudenberg Medical’s comprehensive catheter development includes advanced extrusion, catheter shaft, and balloon development, which can be seamlessly integrated with the Handle Design CoE for full-service prototype and product development. Manufacturability is a major tenant of the handle design and development process to ensure products will seamlessly transition to commercial ◦Coiling speed 450 rpm. • The touch-screen control display allows the programming of recipes used to quickly change products or machine settings. • It is possible to download in real time the machine’s OEE data.

SCHUR®STAR (continued from page 21)

know what they’re going to have for dinner at four o’clock in the afternoon,” says Carter Bray, SVP-general manager at Potandon. “We also know that whatever they do decide to cook, they want it to be nutritional, and they want the whole process — prep, cooking, eating, and cleanup — to take about 30 minutes. Convenience is key, and that is what drove the development of this package.” Bray says the idea for “One Step… Done!” came during a visit to the Fruit Logistica exhibition in Berlin, where Schur® (www.schur.com) showed its Schur®Star bagging equipment running a two-compartment package of muesli cereal where

PROSPECT LIFE SCIENCES (continued from page 28)

working through multiple iterations is an integral part of our problem-solving process. The Proof Is in the Testing We developed a comprehensive verification and validation plan, established protocols, executed testing, and released objective reports proving that SST’s surgical implant instruments met performance, safety, and regulatory requirements. In collaboration with their engineering and quality personnel, we developed both bench and cadaver tests in our on-site wet lab to verify device performance and usability before putting the implant into surgeons’ hands. Supporting Growth and Optimization. In May 2021, the FDA granted SST’s im-

manufacturing. For more information, visit Freudenberg Medical at MD&M West Booth #2209 or online at www.freudenbergmedical.com. • Remote connection for online support. For more information about Tecnoideal America, please visit www.tecnoidealamerica.com or stop by Booth #2074 in the Exhibition Halls A-E. a spoon occupied the top compartment. Potandon Produce initiated the dialogue with Schur® and shared their thoughts on a microwavable bag. Then, considerable development work kicked off. “For quite some time, it seemed that we could not find the right formula. But both parties kept at it until we had the bag we wanted,” says Bray. Most importantly, the development of the pouch met Potandon Produce’s wish to make a convenient solution for their end customers. The pouch has won the Canadian Produce Marketing Association’s 2019 Packaging Innovation Award, and it is just one of many innovative and customized packaging solutions from Schur®Star Systems available at www.schurstarusa.com, or Booth #5573. plant device “breakthrough designation,” acknowledging its potential for effectively treating an irreversibly debilitating condition, and the company is currently conducting clinical trials. In addition to providing manufacturing, supply chain management, and fulfillment for their trials, we collaborate with SST to incorporate feedback from the field with updates to the device. We also assist with their efforts to maintain the CE mark by updating design history file and technical file documentation as appropriate. Last year, we supported SST in implementing their own quality management system in their Ireland facility. While their company has grown, SST continues to use PLS as an extension of their team. Ready to Learn What PLS Can Do For You? Visit us at Booth #1374 or online at www. prospectlifesciences.com.