Launched within the existing CoroPlus Tool Path software, the OptiThreading software module helps manufacturers overcome an issue within thread turning – chip jams and their associated downtime.
Launched within the existing CoroPlus Tool Path software, the OptiThreading software module helps manufacturers overcome an issue within thread turning – chip jams and their associated downtime.
As part of the solution, CoroPlus Tool Path helps users develop OptiThreading tool paths that overcome the challenge of chip control and optimize thread turning by offering tool paths that deliver controlled, oscillating movements for interrupted cuts on all passes except the last one.
Using OptiThreading eliminates long chips that can damage a component’s surface and interfere with the cutting zone. It also results in less manual work to remove long chips jamming the tool, component, or chip conveyor, resulting in fewer unplanned machine stops. OptiThreading allows increased cutting speeds for shorter cycle times and improved productivity.
OptiThreading creates high cutting forces and needs a tool that can withstand them, so the CoroThread 266 has an iLock interface delivering stability for insert indexing, making it able to handle extreme forces. The tool is available with a selection of grades and geometries covering most materials and applications.
OptiThreading is available as part of a subscription to the CoroPlus Tool Path and is developed specifically for CoroThread 266 tools and inserts. Offering programming support for external and internal thread turning operations, CoroPlus Tool Path generates NC codes based on cutting data parameters to secure the correct number of passes with evenly distributed cutting forces for optimal productivity, tool life, and process security.
Kindeva Drug Delivery enlisted systems integrator Keller Technology to design, build, and integrate an aseptic dip coating system. The solution relied on a Stäubli robot.
Drug delivery systems, such as those developed by Kindeva Drug Delivery, are the culmination of a series of carefully coordinated steps, where the active pharmaceutical ingredient (API) meets the patient. Preserving the sterility and efficacy of the product, and ultimately the safety of the patient, is paramount.
With a nearly 175-year history, Kindeva has played a role in bringing hundreds of drug products to fruition. Among the Minnesota-based company’s innovations is a proprietary solid microstructured transdermal system (sMTS) platform. The microneedle-based device is patient-friendly, making it ideal for self-administering abaloparatide, a biologic that stimulates bone formation for postmenopausal women at high risk for bone fractures due to osteoporosis.
Since abaloparatide is a biologic API, it can’t be terminally sterilized. Therefore, coating and packaging the abaloparatide-sMTS combination must take place entirely within an ISO Class 5 environment. In the lead-up to a new drug application (NDA) filing, Kindeva sought to reduce the product’s manufacturing cycle time. Only an automated system, capable of operating optimally within an aseptic isolator, could accomplish this.
The company turned to Keller Technology, a partner in robotic applications in biotech and pharmaceuticals. So, it was up to Keller to identify a key component: a robot that meets all the customer’s specifications.
Stäubli Robotics was the choice for the sterile coating and packaging system as its Stericlean range of robots are designed specifically for these applications. Some of the features that enable Stericlean robots to operate in a good manufacturing practice (GMP) Grade A environment and maintain high performance under strict, aseptic conditions include:
Keller had been successfully integrating Stäubli robots for years in various applications – including a Stericlean for a nearly identical sMTS application for Kindeva – so they knew it would deliver cleanliness, repeatability, and accuracy. A Stericlean 6-axis robot, exceeding Kindeva’s requirements with an ISO Class 4 rating, was selected for integration into the system.
The system Keller devised performs precision dip coating and primary packaging within an aseptic isolator. It begins when the sMTS devices are transferred into the isolator on trays, while the sterile liquid API is fed into a coating system, designed by Keller.
The Stericlean’s pinpoint accuracy is critical in the dip coating operation that follows. The dexterous robotic arm picks up the individual sMTS devices, each smaller than a postage stamp, and immerses them in the liquid API bath, loading the microneedles with the biologic API. The process is carefully calibrated to achieve repeatable, uniform coating on each unit.
The robot then lifts out the coated sMTS vertically, carefully places it back on the tray, and repeats the process. Once the tray is full, it’s transferred to a tray sealer, also custom-designed and built by Keller. Sealed trays are then transferred out of the isolator, completing the sterile primary packaging operation.
The isolator features a monitoring system to ensure no septic antigens are present. It also provides laminar airflow, so the entire body of air within the isolator is uniform in velocity and direction. All system components are designed to minimize airflow disruption, preventing disturbances such as eddies, voids, and shadows that could retain antigens.
Keller’s automated system transformed a slow, difficult, and complex pharmaceutical manufacturing process into an inventive one, which includes the precision and repeatability of the Stäubli robot.
Crucially, the risks that are inherent to exposing a biologic API such as abaloparatide during dip coating are eliminated. Keller engineered and integrated its customized system into an aseptic isolator to maintain sterile conditions and shield the product from contamination. The specialized design of the Stericlean robot brings added assurance. This protects the operators, the product, and the patient.
While careful precautions are taken at every step of the production process, the automated system delivers the high speed and efficiency Kindeva needed to achieve its goal of reducing its abaloparatide-sMTS combination product’s manufacturing cycle time. Speed and efficiency gains through automation have enabled the company to scale up the product for commercial manufacture. The robot’s control software enhances traceability, optimizes process control, and has the potential to bring long-term benefits for years to come.
Considering these 3 critical capabilities when choosing enterprise resource planning (ERP) software will help medical device manufacturers leverage all of its benefits while improving business operations and adhering to complex regulatory requirements.
The U.S. medical device market size was $176.7 billion in 2020 and is anticipated to grow at a compounded 5% during the next eight years according to 2021 research by Grand View Research. But, continued global uncertainty means only those with deep, accurate, and up-to-the-minute operational insights and production agility will be equipped to weather coming storms and capitalize on fleeting opportunities.
That’s why medical device manufacturers are looking to modern, cloud-based enterprise resource planning (ERP) software to collect and aggregate data, manage production, generate reports, and provide the insights to improve business operations within a complex regulatory environment. In addition, companies must maintain quality data and track all product information across the entire supply chain to comply with government and industry standards, including, 21 CFR Part 820, 21 CFR Part 11, ISO 13485:2016, cGMP, ISO 9001:2015, and more. They also need an automated, comprehensive approach to the compliance process, providing complete product history, full traceability, and audit trails.
A forward-thinking approach to ERP software can address these requirements, but what are the most important capabilities to consider when evaluating ERP solutions?
Simply moving ERP to the cloud won’t do. It takes time to find a cloud designed for medical device manufacturers, suited to a specific strategy, with capabilities for the unique regulatory challenges of the medical industry that’s easily customizable.
Including these points in a vendor review and selection process will help in finding a comprehensive solution to manage, streamline, and automate everything from order processing and production management to product traceability, compliance reporting, and financial management.
1. Government industry standards. Medical device manufacturers must maintain detailed quality data and product information across the entire supply and manufacturing chain such as purchase order receipts, inventory material movements, shipments, and returns.
Modern medical device manufacturers need an automated, comprehensive approach to the compliance process, with the ability to drill down into complete product histories. They also need detailed and readily accessible audit trails and seamless integration with quality and other compliance systems. Additional integrations with production equipment and systems help identify and minimize waste and rework and further provide audits across operations. Traceability is particularly important for compliance, but it becomes complex when devices have numerous parts, components, and subassemblies.
ERP can track and trace what’s being used down to the component’s lot and/or serial number and are automatically removed from inventory and added to the as-built bill of materials (BOM) tree. ERP can also record the as-maintained record of lots and serial numbers used in the field as devices are repaired or undergo maintenance.
This provides ongoing audit ability and traceability across the entire medical device lifecycle. ERP provides the foundation for easy auditing, fast and accurate compliance reporting, and useful dashboards to view product quality, compliance, and traceability roadblocks and opportunities.
2. Precise inventory management. This is critical to achieving revenue and profit targets, and for complying with the myriad requirements of the medical device industry. Effective use of inventory helps optimize production while balancing supply chain costs and constraints.
Modern ERP can provide intelligence to help operations teams keep the right quantities on hand without overproducing products. When limited inventories constrain production, it provides insights to quickly shift to alternative components or redeploy capacity to other products. Or, when production lines are at capacity, ERP highlights potential changes, easing manpower or schedule changes across shifts, days, or weeks.
Today’s ERP can also provide granular visibility into inventory data, from top-level summaries down to lots, facilities, components, raw material specs, and expiration dates. Artificial intelligence (AI) and multidimensional analytics within modern ERP can further improve productivity, automate reports, and ease planning.
Improved forecasts harness historical data and allow what-if scenarios to account for shifting demand, inventory needs, or supply chain changes. ERP systems enhance operations, while features such as drag-and-drop scheduling plus load balancing and low-code customizations eliminate long, expensive training sessions.
3. Tight coordination. For today’s medical device manufacturers and suppliers, functions of planning, production, quality, safety, inventory management, procurement, and logistics demand a collaborative approach that optimizes the end-to-end supply chain.
A strong working relationship with suppliers delivers cost savings and minimizes availability problems, production and shipping delays, and quality and safety issues. As changes impact production, suppliers and manufacturers can quickly drill down to communicate, share data, and make on-the fly adjustments.
The company can share visibility into customer inventory levels and the resulting supplier needs, keeping everyone in the loop and providing an early warning to any potential disruptions, and a central place for tracking and sharing supplier key performance indicators (KPIs). Integration between ERP and other business systems also streamlines business by connecting purchasing and procurement with upstream engineering and R&D and downstream sales and customer service.
Following these suggestions when looking to invest in a modern ERP system can help organizations align supplier orders with expected demand, better manage inventories and cash flows, and quickly bring new or updated products online.
About the author: David Stephans is president of Rootstock Software. He has more than 25 years of manufacturing and technology experience.
SPR Therapeutics adopted a single platform from Rootstock for its medical device business that delivered a unified best-of-breed customer relationship management, manufacturing, and quality management solution to the entire organization.
Advancements in minimally invasive surgical (MIS) techniques have been nothing short of miraculous.
Advancements in minimally invasive surgical (MIS) techniques have been nothing short of miraculous. Surgical skill sets coupled with new technology and devices have enabled what were once extremely invasive procedures to now simple, minimal incisions for instrument/scope access (trocar or keyhole) ports, and sometimes small diameter catheter vascular access.
However, the need to perform highly skilled actions using specialized tools with limited visibility and motion range has introduced higher levels of expertise for surgical teams, from endoscopic surgeons and robotic procedure specialists to interventional radiologists. Support equipment includes endoscopic cameras, visualization scanners, contrast injectors, non-magnetic monitors, specialized instruments and catheters, and expensive robotic systems. Despite the setup overhead for MIS, there’s no disputing the value these advanced surgical procedures bring to the industry.
The devices required to support MIS techniques continue to proliferate at impressive levels. Highly specialized instruments can now perform tasks swiftly without requiring much technique from the user, and the number of individual designs available today to surgeons is quite daunting. It’s common for a power user (key opinion leader or KOL) to develop a device based on their specific technique, which becomes a unique offering from a partnering manufacturer. Miniaturized sensors and electronics can be integrated into the tips of these handheld instruments or within tiny catheters to monitor pressure, blood-flow, and electrical fields, providing clinicians with vital anatomical feedback while working virtually blind. Combined with these sensors, some devices provide synthesized feedback to the user, which may be through haptic vibration and mechanical resistance, or visual and audible instructions.
Robot-assisted surgery has become a fast-moving technology that enhances the accuracy of complex surgeries while reducing patient trauma and recovery time. Robots may be as simplistic as a smart guidance fixture for probes and cannula insertions, or as complex as a floor-standing multi-tool device that operates remotely on patients from across the globe, controlled by skilled surgeons via advanced telemetry. Combined with 3D-imaging and real-time interpolated anatomical modeling, robot-assisted surgical efficacy is driving the proliferation of targeted robotic platforms into most surgical and oncological procedures.
MIS has its challenges – cost of capital equipment such as imaging systems and robots can be prohibitive, and personnel training requires a team of dedicated clinicians and facilities. Cath labs have replaced many operating rooms as interventional procedures have proven their value and effectiveness in treating coronary disease. Today we can have aortic valves replaced via femoral artery-accessed catheter delivery, without requiring thoracic surgical access. Tiny pumps integrated into the ends of catheters can help pump blood from the ventricle to the atrium until hearts can heal from a procedure and operate normally.
Visualization requirements associated with MIS rely on sophisticated technology to enable the clinician to see through anatomy. Without these advances, most MIS procedures would be impossible to perform with the required levels of accuracy and reliability. Camera complementary metal oxide semiconductor (CMOS) sensors have become so small and affordable that articulating scopes can now visualize anatomy in high-resolution video. Features such as tissue texture and relative coloration can be assessed in real time with HD-enhancing and color-correcting software. The software can interpolate scanned anatomy to provide 3D images, perhaps overlaying pre-scanned patient anatomy to help guide the user around tortuous pathways during device implantation.
Magnetic resonance imaging (MRI), computed tomography (CT), X-ray, ultrasound, fluoroscopy, etc. are all mature technologies, but recent advances in digital image enhancement coupled with computer processing power significantly enhance resolution for MIS applications. MRI imaging has a unique problem: equipment in the MRI suite must be non-ferrous to resist the massive magnetic fields created by the scanner. Patients that require 24/7 hook-up to critical-care monitors and life support devices such as ventilators, pumps, and monitors rely on these special MRI-compatible devices.
CT imaging requires the introduction of contrast solution into the patient’s vasculature to provide an appropriate image, with the ability to customize the consistency of the contrast solution to match each patient’s anatomy and optimize image clarity. Modern injectors provide numerous settings, including preset and custom ratios of contrast-to-saline fluid mix, pressure, and ramp profiles.
Perhaps ultrasound (U/S) imaging has offered the greatest opportunity to caregivers most recently as it’s a compact (briefcase-sized), simple, safe, inexpensive technology. U/S is increasingly being paired with a broad base of diagnostic and simple therapeutic procedures in outpatient and doctors’ office settings. An example is the imaging of air-infused saline for fallopian tube patency where the saline-based contrast medium and imaging system are less expensive and safer than other traditional imaging methods. It’s easy to extrapolate the transition of U/S imaging into home-health telemedicine (distance-care) in the future, including patient-operated fetal monitoring.
Beyond the availability of cutting-edge instruments and devices, MIS specialists must develop specific skill sets. While open-heart surgery requires immense skill, imagine performing a transcatheter aortic valve replacement entirely from a groin-area access site. External grips at the end of long cannulae or worse, hub-located control interfaces at the proximal end of a 2m long, spaghetti-like catheter must be able to push, pull, turn, and activate features deep inside the body. With either laparoscopic or interventional techniques, consider the lack of direct interface and low-to-zero tactile feedback coupled with compromised visualization.
It’s important that MIS devices minimize errors from poor ergonomics, repetitive stress, and non-intuitive control design. When the clinician’s eyes are on the camera monitor, they shouldn’t have to refocus on the device in hand because the clinician can’t find the adjustment feature. To assist with these challenges, some devices can be coupled to controllers that provide feedback such as temperature, pressure and flow sensing, and high-precision deployment of miniature tools integrated within the distal tip of the embedded device. These controllers can help operators feel their way around the anatomy, providing continuous monitoring of critical parameters.
Device manufacturers are always searching for ways to de-skill the MIS process so the average operator can succeed without rigorous training. Some designers have tried synthesizing feedback into devices, such as adding electromechanically generated haptic (vibration, pulsing, resistance), and audible and visual feedback to denote various functional states. Unfortunately, most of these devices are also single use, so unit costs must also be contained, adding to the challenges to optimize ergonomics. One strategy is to build the feedback features into a durable (reusable) part of the device so the cost can be amortized over many cases. Miniaturization technology has also advanced to the point where the cost of medical-grade embedded sensors is becoming affordable and highly accurate.
Despite MIS advancements, techniques are still in their adolescence. As component performance increases and cost decreases, we can expect to see convergence of many technologies that’ll enable device manufacturers to deliver smaller, more accurate and less expensive devices that are easier to operate for a range of procedures. Similar to how trans-catheter aortic valve replacement has been a disruptive innovation, miniaturized robotics, nano-actuators, electronics, and higher-definition optics can provide greater remote functionality at the end of a laparoscopic cannula or vascular catheter. Perhaps tiny, pre-programmed robots may one day be injected into the bloodstream or pulmonary airway where they autonomously do surgeons’ jobs with little or no trauma to the patient. Biologically engineered viruses (like recent mRNA COVID-19 vaccines) may also be able to function at the cellular level to obliterate cancer and other abnormalities.
Although these scenarios may sound like they’ve been pilfered from scientific journals, one fact is clear; medical technology in the minimally invasive space is accelerating faster than ever, which can only benefit the entire healthcare continuum in the long run.
About the author: Philip Remedios is principal and director of design & development at BlackHägen Design.
Updated sliding, fixed headstock automatic lathe; CAM/CAD enhancements in GibbsCAM; Toolholder with streamlined coolant nozzle design
The second-generation Traub TNL12 sliding/fixed headstock automatic lathe with 13mm spindle clearance features two identical work spindles (main and counter spindles) and two tool turrets, both with an interpolating Y-axis.
It can be equipped with a front-working attachment and a back-working attachment for complex rear-end machining operations, providing the user with up to 38 available tools.
The Traub TNL12 can also be switched quickly between sliding and fixed headstock operation. Its compact footprint with the work area ensures a high power density for efficient production.
The Traub TNL12 enables easy operation from the Traub TX8i-s V8 controller, readying the machine for integration into the digital iXworld.
Whether used as a Swiss-type sliding headstock lathe or as a fixed headstock lathe, configuration options from the modular system are diverse to meet most requirements.
Placing the control cabinet in the machine base offers space for custom work area fittings, including workpiece handling.
GibbsCAM 2022 CAD enhancements for solid and surface modelling include the ability to extrude multiple bodies with taper, and to create surfaces as a stitched body directly from closed 2D geometry. In addition, users can automatically create trimmed planar surfaces in any orientation at geometry depth instead of the CS plane. Developments include new alignment capabilities enabling straight edges of solid bodies to be easily aligned with the working coordinate system in preparation for machining, and a new sectional view slicing plane which can be moved in any direction to view and select features within the interior of a solid body.
Among the CAM updates are usability enhancements such as automated multi-shape predrilling and extended control for start/end points of profiling toolpaths. It’s now possible to omit radius moves on outside corners of turning operations so lathe operators can adjust critical diameters and reduce G-code file output sizes.
GibbsCAM 2022 also introduces the ability to hide multipart cutting in all simulation modes, reducing verification time based on the number of components being machined.
tool now have a streamlined coolant outlet design, enabling use of high-pressure coolant at more than 7MPa or 1,015psi to effectively control chips in long-chipping materials such as stainless steel and heat-resistant superalloys.
Featuring a coolant outlet built in the body, the design is more effective than conventional through-coolant toolholders that have an adjustable coolant nozzle or bulky assembly. With reduced number of parts, the toolholders expand the TungTurn-Jet range with an economical option that can contribute to customers seeking further tool cost reductions while maintaining effective chip control and maximum tool life.
TungTurn-Jet toolholder systems for Swiss machine applications are available and can eliminate the hassle of coolant hose connections when used in a Swiss machine that can supply coolant directly into the toolholder from the gang slide. This plug-and-play coolant capability allows operators to mount the toolholders on the gang slide or tool post and use the integrated coolant nozzle for effective chip control and maximum tool life.
Developed for productive OD turning, grooving, thread turning, and ID turning (the ID turning holders are only available in PSC machine-side connection), the series enables high speed machining with effective chip evacuation.