Tekni-Plex is announcing the formation of the Tekni-Plex Medical business unit, which will facilitate the supply of mission-critical, high-value components.
Medical device companies will now have a dedicated sales and customer service team representing all product lines. “Our goal is to be a trusted advisor, helping our customers make the best decisions on their most important business issues through deep engagement, expertise, innovation, and quality,” says Paul Young, president and CEO, Tekni-Plex. “Our globally integrated operations will help us provide better and faster solutions to meet customer needs.”
Manufacturing will continue in the same locations, with the ability to run the same material specifications on the same equipment around the world for multinational customers. Going forward the Colorite, Natvar, and Dunn names will be used as product brands.
The Colorite brand’s advanced medical-grade compounds are used by the world’s foremost healthcare and medical device manufacturers. They are globally recognized for consistently meeting or surpassing rigorous regulatory and industry standards. The Colorite brand also includes an extensive line of PVC and TPE medical-grade compounds that have been engineered to meet product objectives.
The Natvar brand includes multilayer and multi-lumen tubing, as well as a range of value-added options including tapered, striped, thermoformed, and special profile products. These extruded tubes are used in applications including intravenous therapy, dialysis, respiratory, and surgical equipment.
The Dunn brand features precision extruded tubing for endovascular catheters and minimally invasive devices. Dunn also manufactures custom medical tubing for diagnostic and interventional devices from a wide range of thermoplastics.
Solar Atmospheres of Western Pennsylvania adds Haas CNC Lathe
Solar Atmospheres of Western Pennsylvania
Solar Atmospheres of W. Pa. adds machining capacity
Supporting rapid growth within its mechanical testing department, Solar Atmospheres of Western Pennsylvania invested in a Haas ST-10 CNC lathe.
Solar Atmophere's of Western Pennsylvania's new Haas ST-10’s 6,000rpm spindle features an automatic tool changer with a 12-station, bolt-on tool turret, allowing Solar’s machining center to automatically change tools at the push of a button. This results in significant time- and cost-savings compared to Solar’s original TL-1 Haas lathe, which requires up to five manual tool changes to produce one tensile specimen. The investment in an automated lathe results in a 50% savings in the production of a variety of round tensile specimens. The TL-1 lathe will be retained as back-up in the case of an unexpected breakdown.
The increased machining efficiency of the Haas ST-10 improves turnaround for the customer at the final stage in the thermal process, obtaining the tensile test results of processed materials. Previously performed by an outside company, the opportunity to bring this testing in-house saves the customer time and money.
Says Bob Hill, president of Solar Atmospheres of Western Pennsylvania, “This new CNC machining center will ultimately support our overall goal of becoming Nadcap Laboratory Testing AC 7101 approved. We have learned in the past that keeping these processes in-house is a benefit not just to Solar, but to our customers, as well.”
Titan is focused on the design, development and commercialization of new robotic surgical technologies.
Titan Medical
Titan Medical, Cambridge Design expand instrument development program
CDP engineers have improved Titan’s multi-articulating instrument designs, demonstrating performance improvements, along with the potential for reductions in the target costs of commercial devices.
Titan Medical Inc., a medical device company focused on the design, development, and commercialization of a robotic surgical system for application in minimally invasive surgery (MIS), and Cambridge Design Partnership Ltd. (CDP), a leading patient-centric product and technology innovation company specializing in the healthcare sector, announced an expanded engagement in respect of the instrument development program for Titan’s single-port robotic surgical system. Additionally, CDP has subscribed for common shares of Titan.
David McNally, president and CEO of Titan, says, "We are pleased to announce our expanded engagement of CDP, and welcome them as a shareholder. Since engaging with them only a few months ago, their highly qualified engineers have leveraged their deep domain experience while demonstrating an ability to understand the exacting requirements of Titan’s robotic surgical system. The location of CDP’s U.S. office in Raleigh, North Carolina is ideally situated in close proximity to our planned Chapel Hill, North Carolina facility. Yet, CDP’s corporate culture and level of integration with their headquarters in Cambridge, UK allows Titan to draw upon CDP’s depth of experience and breadth of capabilities.”
Jez Clements, partner at CDP, says, "We share Titan’s vision for improving patient outcomes with their unique single-port robotic surgical system. We believe the core system architecture to be sound, and once adequate funding is secured, we are confident in the ability of Titan’s management team to resume the development of its single-port robotic system. We are delighted to have the opportunity to apply our deep medical instrument product development experience.
The company is making modifications to production materials and packaging.
Big Kaiser
Big Kaiser ramps up green initiatives
The company is making modifications to production materials and packaging.
As part of an ongoing effort to make processes and products more environmentally friendly, Big Kaiser is making modifications to production materials and packaging. Specifically, they have switched to unleaded steel and recyclable packaging. The new steel uses a Bismuth composite instead of lead. Additionally, new boring head packaging will use cardboard or recyclable PET instead of current Quadro packs with polypropylene.
“These adjustments to our materials and packaging will go a long way toward reducing the environmental footprint of our business and, more importantly, our customers’,” Jack Burley, VP of sales and engineering said. “It’s part of company-wide commitment to care for our customers without sacrificing quality or performance.”
Big Kaiser was recently recognized by the Village of Hoffman Estates for the green efforts at its U.S. headquarters; these include recycling, reducing paper usage, energy and water efficiency, and HVAC monitoring.
Robots already assemble and weld products in factories. Can they make the components parts themselves, too?
Factory_Easy/Shutterstock.com
Medical device technology, manufacturing advancements, bionics
Cadaver heartbeat aids medical device development; Bionic leg & AI; Technology to revive US manufacturing; Bionic pancreas; Cool Idea Award: Healthcare Grant
We are already 4 days into 2020 but I'm dropping back to 2019 to mention a few medical developments I didn't get a chance to cover in December. ProtoLabs's Cool Idea Award: Healthcare Grant focuses on feeding tube developments; a bionic pancreas received Breakthrough Designation from the U.S. FDA; manufacturing could start talking about Robotic Blacksmithing in the near future. Have you heard of this before? What are your thoughts? And, if you want to see a cadaver's beating heart we have just the video to watch...happy reading!
Reviving a cadaver’s heartbeat
Anatomage has digitally restored a cadaver's heart to beat again, making a cadaver heart go through a normal cardiac cycle. This innovation is made possible by combining the digital modeling of 3D cardiac CT data and accurate anatomical details from an Anatomage cadaver.
Using normal CT images of a heart and statistical models, Anatomage estimated the shape of a heart's four chambers and digitally simulated the cardiac cycle's systole and diastole phases. Valve motions, vascular connectivity, and cardiology nerves were accurately modeled, then integrated into the beating heart chambers. The result is a comprehensively detailed 3D heart of the cadaver that beats in a highly accurate manner.
Anatomage's digital cadavers serve as tools for medical device development, education, research, and training.
Robotic blacksmithing: Technology to revive US manufacturing
The basic concept for robotic blacksmithing, formally called metamorphic manufacturing, was demonstrated in 2017 when a team of undergraduates from The Ohio State University added hardware and software to a conventional computer numeric control milling machine to adapt it for controlled deformation. The work was in response to a US$25,000 challenge by the government-funded consortium LIFT (Lightweight Innovations for Tomorrow) to demonstrate the key concepts of digitally controlled deformation-based shaping.
This new approach has the potential to efficiently and consistently make the structural ‘bones’ inside aircraft, ships, submarines and locomotives. Or the concept could be scaled down to make small individualized medical implants.
Advanced bionic legand the team bringing it to life
The world of prosthetics is evolving quickly. It’s no question that researchers, doctors, and engineers want to design more effective robotic limbs that can help paralyzed and amputees live not only more comfortably, but more normal lives. The question is how?
Prosthetics have come to life in a variety of ways, with recent evolvements looking more like a sci-fi depiction of the future. And most of this technology is designed to mimic our body and bring back the function that was lost.
But what if we went further? What if instead of relying on our body to control the technology, we decided to let the technology think for itself? That’s exactly what Dr. Tommaso Lenzi and his researchers at University of Utah’s Bionic Engineering Lab decided to bring to life. And their AI-powered bionic leg will change the future of advanced prosthetics.
Breakthrough Device designation for iLet Bionic Pancreas
Beta Bionics received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its investigational iLet Bionic Pancreas System, a pocket-sized, wearable investigational medical device that is designed to autonomously control blood-sugar levels. The on-body wear is similar to that of an insulin pump. Unlike insulin pump therapy, however, the investigational system is designed such that users enter only their body weight for the iLet to initialize therapy. Immediately thereafter, the iLet begins controlling blood-sugar levels automatically, without requiring the user to count carbohydrates, set insulin delivery rates, or deliver bolus insulin for meals or corrections.
The iLet is designed to function as three medical devices in one. It can be configured as an insulinonly bionic pancreas, a glucagon-only bionic pancreas, or a bihormonal bionic pancreas using insulin and glucagon. The insulin-only and bihormonal configurations may be helpful in diabetes.
The glucagon-only configuration may be helpful in rare conditions that often lead to chronic, low blood-sugar conditions, such as congenital hyperinsulinism (CHI). Beta Bionics is committed to obtaining regulatory approval and commercializing all three iLet configurations.
The Breakthrough Designation for the iLet Bionic Pancreas System contemplates configurations with most insulin analogs approved for pumping as well as dasiglucagon, Zealand Pharma’s stable pumpable glucagon analog, which has a unique stability profile in a ready-to-use aqueous solution.
Healthcare Grant spurs a pair of creative feeding tube inventions
“Protolabs is proud to champion innovation in the medical field,” says Vicki Holt, president & CEO of Protolabs. “These healthcare grants and the manufacturing services that come with them help important health-focused projects improve hundreds of thousands of lives each year.”
This 3D-printed component serves as a syringe holder for a gravity feed system, similar to an IV.
MedStar Health’s gravity feed syringe holder simplifies the feeding of newborns who spend their early days in special, temperature-controlled incubators while being cared for in the neonatal intensive care unit (NICU). Currently, depending on the number of newborns and how often they feed, a nurse can spend hours each day holding a syringe above an incubator while milk or liquid formula drains into the baby via a stomach tube.
Use of this invention alleviates the need for a nurse to hold the syringe above the baby during the feed and frees the nurse to other duties while still attending to the baby during feeding. The compact device can hold four different sizes of syringes and was designed to be suspended from the top of the incubator or attached to an IV pole expanding its use outside the NICU.
This invention illustrates the premise that simple, well-designed solutions can have a substantial impact on patient care.
The Protolabs grant was used to improve the device’s design. The iterative 3D-printing process helped identify several improvements to the prototype, including: smoothing the corners, adding sturdier syringe clips, and incorporating gaskets to keep infants safe while protecting the incubator. Clamps securely fasten the gravity feeder device to an IV pole.
Design by Andy Williams, these molded parts will help those who rely on enternal feeding tubes to lead more active lives.
Feeding tube device could change half a million lives Life for people with enteral (feeding) tubes can be difficult. Inventor Andy Williams knows this well. He has struggled with an enteral tube for years, so he teamed up with Dr. Eric Blumrosen of Cleveland Clinic in an effort to improve outcomes for these patients. In current practice, a feeding tube is surgically placed directly into the digestive tract, but that interface is prone to significant leakage. The highly acidic fluids can irritate and injure patients such as Williams, requiring emergency room visits and sometimes hospital stays. Leakage can make social lives very difficult, preventing patients from living a normal life.
The device protects the stoma by forming a wide seal around an enclosed hole into which the tube is inserted. This eliminates issues with friction where the tube rubs against the skin. Also, it provides a more focused opening that enhances the seal surrounding the tube and allows limited motion of the tube. In the end, the device will be more comfortable, reduce irritation, and significantly improve long-term quality-of-life.
Protolabs’ in-kind manufacturing grant gave Cleveland Clinic Innovations access to manufacturing engineers who helped improve the device’s design for commercial use. It also helped fund prototype injection molded parts.
About the Cool Idea Award: Healthcare Grant The Cool Idea Award: Healthcare Grant is an extension of Protolabs’ flagship Cool Idea Award program. This extension is open to members of the Cleveland Clinic Healthcare Innovations Alliance, a network of healthcare institutions and corporations focused on innovation. Selected winners are awarded in-kind manufacturing services from Protolabs to support product development, such as building prototypes or supporting initial production runs, with a target for eventual commercialization of products.
Posted by Elizabeth Engler Modic
