Post-processing report from Wohlers Associates; DMC will test the flexible Renishaw AM machine

Wohlers Associates Inc. published "Post-processing of AM and 3D printed parts", detailing the steps of post-processing parts produced by additive manufacturing (AM), including support material removal, surface finishing, coloring and coating, and heat treatment.

Post-processing is one of the three main stages in the production of 3D printed parts. According to Wohlers Report 2021, nearly 27% of the cost comes from post-processing. The study involved the opinions of 124 service providers from 27 countries.

The AM organization has post-processing knowledge and experience, but few system documents are available, causing the company to spend time and money unnecessarily to complete the work. The methods and techniques described in this report can reduce the trial and error used by many organizations.

The Digital Manufacturing Center (DMC) was one of the first companies to receive Renishaw's RenAM 500 Flex machines. Through long-term cooperation with Renishaw, DMC has been selected as a key test site for industry testing. The final stage of the development plan will verify the functionality and versatility of RenAM 500 Flex in a busy commercial production environment.

RenAM 500 Flex allows users to switch between material types without affecting the quality of parts, improving pre-production testing and material selection, while allowing users to establish parameters that can be easily transferred to more automated machines (such as RenAM 500) to speed up batches Production production.

RenAM 500 Flex combines the airflow capability and build chamber of RenAM 500 with a simplified non-circulating powder system to complete material changes in one shift-approximately 8 hours.

Flex offers single-laser and four-laser configurations, including the same process monitoring functions as the conventional RenAM 500, allowing transferable molten pool analysis.

The OptiThreading software module is introduced in the existing CoroPlus Tool Path software, which can help manufacturers solve the problem of thread turning-chip jam and related downtime.

The OptiThreading software module is introduced in the existing CoroPlus Tool Path software, which can help manufacturers solve the problem of thread turning-chip jam and related downtime.

As part of the solution, CoroPlus Tool Path can help users develop OptiThreading toolpaths, overcome the challenges of chip control and optimize thread turning. The toolpaths provided can provide controlled interrupted cutting on all paths except the last path. Oscillatory movement.

Using OptiThreading eliminates long chips that can damage the surface of the part and interfere with the cutting area. It also reduces manual work to remove long chips that block tools, components, or chip conveyors, thereby reducing unplanned machine downtime. OptiThreading can increase cutting speed, thereby shortening cycle time and increasing productivity.

OptiThreading generates high cutting forces and requires a tool that can withstand them. Therefore, CoroThread 266 has an iLock interface that provides stability for insert indexing and enables it to withstand extreme forces. The tool has a variety of materials and geometries to choose from, covering most materials and applications.

OptiThreading is provided as part of the CoroPlus toolpath subscription and is specifically developed for CoroThread 266 tools and inserts. CoroPlus Tool Path provides programming support for external and internal thread turning operations, and can generate NC codes based on cutting data parameters to ensure the correct number of passes and evenly distributed cutting forces to achieve the best productivity, tool life and process safety .

Kindeva Drug Delivery hired system integrator Keller Technology to design, build and integrate an aseptic dip coating system. The solution relies on Stäubli robots.

Drug delivery systems, such as those developed by Kindeva Drug Delivery, are the culmination of a series of carefully coordinated steps in which the active pharmaceutical ingredient (API) meets the patient. Maintaining the sterility and effectiveness of the product, as well as the safety of the final patient, is the most important.

Kindeva has a history of nearly 175 years and has played a role in bringing results to hundreds of medicines. One of the innovations of the Minnesota-based company is the proprietary solid microstructure transdermal system (sMTS) platform. This microneedle-based device is patient-friendly and is therefore very suitable for self-administered abaloparatide, a biological agent that stimulates bone formation in postmenopausal women who are at high risk of fracture due to osteoporosis.

Since abaloparatide is a biological API, it cannot be terminally sterilized. Therefore, the combination of covering and packaging abaloparatide-sMTS must be completely carried out in an ISO 5 environment. Before submitting a new drug application (NDA), Kindeva tried to shorten the product manufacturing cycle. This can only be achieved by an automated system that can operate in an optimal manner in a sterile isolator.

The company turned to Keller Technology, which is a partner for robotics applications in the biotechnology and pharmaceutical fields. Therefore, Keller needs to identify a key component: a robot that meets all customer specifications.

Stäubli Robotics is the aseptic coating and packaging system of choice because its Stericlean series of robots are specifically designed for these applications. Some of the features that enable Stericlean robots to operate in a Good Manufacturing Practice (GMP) Class A environment and maintain high performance under strict aseptic conditions include:

For many years, Keller has successfully integrated Stäubli robots into various applications-including Stericlean for Kindeva's almost identical sMTS applications, so they know it will provide cleanliness, repeatability and accuracy. The Stericlean 6-axis robot exceeded the ISO 4 rating required by Kindeva and was selected for integration into the system.

The system designed by Keller performs precision dip coating and primary packaging in a sterile isolator. It starts when the sMTS device is transferred to the isolator on the tray, and the aseptic liquid API is fed into the coating system designed by Keller.

The precise positioning of Stericlean is crucial in the subsequent dip coating operation. The dexterous robotic arm picks up individual sMTS devices, each smaller than a postage stamp, and immerses them in a liquid API bath to load the microneedles with the biological API. The process is carefully calibrated to achieve a repeatable, uniform coating on each unit.

The robot then lifts the coated sMTS vertically, carefully puts it back on the tray, and repeats the process. Once the tray is full, it is transferred to the tray sealing machine, which is also custom designed and manufactured by Keller. Then remove the sealed tray from the isolator to complete the aseptic primary packaging operation.

The isolator has a monitoring system to ensure that there is no sepsis antigen. It also provides laminar airflow, so the entire air in the isolator is uniform in speed and direction. All system components are designed to minimize interruptions in airflow and prevent interference such as turbulence, voids, and shadows that may retain antigen.

Keller's automated system transforms slow, difficult, and complex pharmaceutical processes into creative processes, including the accuracy and repeatability of Stäubli robots.

It is essential to eliminate the risks inherent in exposing biological APIs (such as abaloparatide) during the dip coating process. Keller designs and integrates its custom system into sterile isolators to maintain sterile conditions and protect products from contamination. The professional design of Stericlean robots brings additional assurance. This protects operators, products and patients.

Although careful precautions are taken at every step of the production process, the automation system provides Kindeva with the high speed and efficiency it needs to achieve its goal of shortening the manufacturing cycle time of abaloparatide-sMTS combined products. Increasing speed and efficiency through automation enables the company to expand the scale of commercial manufacturing of its products. The robot's control software enhances traceability, optimizes process control, and may bring long-term benefits in the next few years.

Considering these 3 key functions when choosing enterprise resource planning (ERP) software will help medical device manufacturers take advantage of all their advantages while improving business operations and complying with complex regulatory requirements.

According to a study by Grand View Research in 2021, the size of the US medical device market in 2020 will be USD 176.7 billion, and it is expected to grow at a compound growth rate of 5% in the next eight years. However, ongoing global uncertainty means that only those with deep, accurate and up-to-date operational insights and production agility are able to withstand the coming storm and take advantage of fleeting opportunities.

This is why medical device manufacturers are seeking modern, cloud-based enterprise resource planning (ERP) software to collect and aggregate data, manage production, generate reports, and provide insights to improve business operations in a complex regulatory environment. In addition, companies must maintain quality data and track all product information throughout the 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. many. They also need an automated and comprehensive approach to compliance processes that provide complete product history, complete traceability and audit trails.

The forward-looking approach of ERP software can meet these requirements, but what are the most important functions to consider when evaluating an ERP solution?

Simply migrating ERP to the cloud will not work. It takes time to find a cloud designed for medical device manufacturers that fits a specific strategy, with the ability to easily customize the unique regulatory challenges of the medical industry.

Including these points in the supplier review and selection process will help find a comprehensive solution to manage, simplify 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 throughout the 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 compliance processes that can gain insight into the complete product history. They also need detailed and easily accessible audit trails and seamless integration with quality and other compliance systems. Additional integration with production equipment and systems helps to identify and minimize waste and rework, and further provides cross-operation audits. Traceability is especially important for compliance, but it becomes complicated when a device has many parts, components, and subassemblies.

ERP can track and trace the batch and/or serial numbers of the components being used, and automatically remove them from inventory and add them to the as-built bill of materials (BOM) tree. ERP can also record maintenance records of batches and serial numbers used on site during equipment repair or maintenance.

This provides continuous auditing capabilities and traceability throughout the entire medical device life cycle. ERP lays the foundation for easy audits, fast and accurate compliance reports, and useful dashboards for viewing product quality, compliance, and traceability barriers and opportunities.

2. Accurate inventory management. This is critical to achieving revenue and profit targets and meeting 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 maintain the correct quantity without over-producing products. When limited inventory limits production, it provides insights into quickly shifting to alternative components or redeploying capacity to other products. Or, when the production line is at full capacity, ERP will highlight potential changes, thereby reducing manpower or schedule changes across shifts, days or weeks.

Today's ERP can also provide granular visibility into inventory data, from top-level summaries to batches, facilities, components, raw material specifications, and expiration dates. Artificial intelligence (AI) and multidimensional analysis in modern ERP can further increase productivity, automate reporting, and simplify planning.

Improved forecasts use historical data and allow what-if scenarios to consider changing demand, inventory requirements, or supply chain changes. The ERP system enhances operations, while drag-and-drop scheduling plus features such as load balancing and low-code customization eliminate lengthy and expensive training courses.

3. Close cooperation. For today's medical device manufacturers and suppliers, functions such as planning, production, quality, safety, inventory management, procurement, and logistics require a collaborative approach that optimizes the end-to-end supply chain.

Establishing strong partnerships with suppliers can save costs and minimize availability issues, production and shipping delays, and quality and safety issues. As changes affect production, suppliers and manufacturers can quickly communicate in depth, share data, and make immediate adjustments.

Companies can share visibility into customer inventory levels and the resulting supplier needs, keep everyone in the loop and provide early warning of any potential interruptions, and a center for tracking and sharing supplier key performance indicators (KPIs) Location. The integration between ERP and other business systems also simplifies the business by connecting purchasing and purchasing with upstream engineering and research and development, and downstream sales and customer service.

Following these recommendations when seeking to invest in a modern ERP system can help organizations align supplier orders with expected demand, better manage inventory and cash flow, and quickly launch new or updated products.

About the author: David Stephans is the president of Rootstock Software. He has more than 25 years of manufacturing and technical experience.

SPR Therapeutics uses Rootstock's single platform in its medical device business to provide a unified best-in-class customer relationship management, manufacturing and quality management solution for the entire organization.

The advancement of minimally invasive surgery (MIS) technology is nothing short of a miracle.

The advancement of minimally invasive surgery (MIS) technology is nothing short of a miracle. The combination of surgical skills and new technologies and equipment makes what was once a highly invasive operation simple and minimal, used for instrument/endoscope access (trocar or keyhole) ports, and sometimes even small diameter catheters. path.

However, specialized tools with limited visibility and range of motion are required to perform highly skilled operations, which brings a higher level of expertise to the surgical team, from endoscopic surgeons and robotic surgeons to interventional radiologists. Supporting equipment includes endoscopic cameras, visualization scanners, contrast media injectors, non-magnetic monitors, special instruments and catheters, and expensive robotic systems. Although MIS is expensive to set up, there is no doubt about the value that these advanced surgical procedures bring to the industry.

The equipment required to support MIS technology continues to proliferate at an impressive level. Highly specialized instruments can now perform tasks quickly without the user having to master too much technology, and the number of personalized designs available to surgeons today is very large. It is common for advanced users (key opinion leaders or KOLs) to develop equipment based on their specific technology, which becomes a unique product of co-manufacturers. Miniature sensors and electronics can be integrated into the tips or miniature catheters of these handheld devices to monitor pressure, blood flow, and electric fields, providing clinicians with important anatomical feedback, while working almost blindly. In combination with these sensors, some devices provide synthetic feedback to the user, which may be through tactile vibration and mechanical resistance, or visual and auditory instructions.

Robot-assisted surgery has become a rapidly evolving technology that can improve the accuracy of complex surgery while reducing patient trauma and recovery time. The robot may be as simple as an intelligent guidance device for the insertion of a probe and cannula, or it may be as complex as a floor-standing multi-tool device. It can remotely operate patients from all over the world and is carried out by skilled surgeons through advanced telemetry technology. control. Combining 3D imaging and real-time interpolated anatomical modeling, the efficacy of robot-assisted surgery is driving the spread of targeted robotic platforms to most surgeries and tumor surgeries.

MIS has its challenges-the cost of capital equipment such as imaging systems and robots can be prohibitive, and personnel training requires a team of professional clinicians and facilities. The Cath laboratory has replaced many operating rooms because interventional procedures have proven their value and effectiveness in the treatment of coronary heart disease. Today, we can replace the aortic valve through femoral artery access catheter delivery without the need for thoracic surgery access. A micro pump integrated at the end of the catheter can help pump blood from the ventricle to the atrium until the heart can heal from surgery and function normally.

The visualization requirements associated with MIS rely on sophisticated technology to enable clinicians to see through anatomical structures. Without these advancements, most MIS programs will not be able to perform with the required level of accuracy and reliability. Camera complementary metal oxide semiconductor (CMOS) sensors have become so small and affordable that arthroscopy can now visualize anatomical structures in high-resolution video. HD enhancement and color correction software can be used to evaluate features such as tissue texture and relative coloration in real time. The software can be inserted into the scanned anatomy to provide a 3D image, possibly covering the pre-scanned patient anatomy to help guide the user around tortuous paths during device implantation.

Magnetic resonance imaging (MRI), computer tomography (CT), X-ray, ultrasound, fluoroscopy, etc. are all mature technologies, but the latest advances in the combination of digital image enhancement and computer processing capabilities have significantly improved the resolution of MIS applications. MRI imaging has a unique problem: the equipment in the MRI kit must be non-ferrous metal to resist the huge magnetic field generated by the scanner. Patients who need to connect intensive care monitors and life support equipment (such as ventilators, pumps, and monitors) 24/7 rely on these special MRI-compatible devices.

CT imaging requires the introduction of a contrast agent solution into the patient's vasculature to provide a suitable image, and the ability to customize the consistency of the contrast agent solution to match the anatomy of each patient and optimize image clarity. Modern syringes offer a variety of settings, including preset and customizable ratios of contrast agent and saline, pressure and ramp curves.

Perhaps ultrasound (U/S) imaging has recently provided the greatest opportunity for caregivers because it is a compact (briefcase size), simple, safe, and inexpensive technology. The United States is increasingly integrating a wide range of diagnostic and simple treatment procedures in outpatient and doctor's office environments. One example is inflated saline imaging with unobstructed fallopian tubes, where saline-based contrast agents and imaging systems are cheaper and safer than other traditional imaging methods. It is easy to infer the future transformation of US imaging to home health telemedicine (remote care), including patient-operated fetal monitoring.

In addition to the availability of cutting-edge instruments and equipment, MIS experts must also develop a specific skill set. Although open-heart surgery requires superb skills, imagine performing transcatheter aortic valve replacement entirely from the groin area. The external clamp at the end of the long cannula or worse, the hub-based control interface at the proximal end of the 2m-long spaghetti catheter must be able to push, pull, turn and activate features deep in the body. For laparoscopic or interventional techniques, consider the lack of direct interfaces and low to zero tactile feedback and impaired visualization.

Importantly, MIS equipment can minimize errors caused by poor ergonomics, repetitive pressure, and non-intuitive control design. When the clinician’s eyes are on the camera monitor, they should not refocus on the device in their hands because the clinician cannot find the adjustment function. To meet these challenges, some devices can be connected to the controller to provide feedback, such as temperature, pressure, and flow sensing, as well as the high-precision deployment of micro tools integrated in the distal tip of the embedded device. These controllers can help the operator understand the anatomy and provide continuous monitoring of key parameters.

Equipment manufacturers are always looking for ways to reduce MIS process skills so that ordinary operators can succeed without rigorous training. Some designers try to integrate feedback into the device, such as adding electromechanical generated tactile sensations (vibration, pulse, resistance) and auditory and visual feedback to indicate various functional states. Unfortunately, most of these devices are also disposable, so unit costs must also be controlled, which increases the challenge of optimizing ergonomics. One strategy is to build the feedback function into the durable (reusable) part of the device so that the cost can be shared in many cases. Miniaturization technology has also been developed to the point where the cost of medical-grade embedded sensors has become affordable and highly accurate.

Although MIS has made progress, the technology is still in adolescence. As component performance increases and costs decrease, we can expect to see the convergence of many technologies that will enable equipment manufacturers to provide smaller, more accurate, and cheaper equipment that is easier to use in a series of procedures operate. Similar to transcatheter aortic valve replacement is a disruptive innovation. Microrobots, nanoactuators, electronics and higher resolution optics can provide a more powerful remote at the end of a laparoscopic cannula or vascular catheter Features. Perhaps one day, pre-programmed micro-robots may be injected into the blood or lung airways, where they can perform the work of the surgeon autonomously with little trauma to the patient. Bioengineered viruses (such as the recent mRNA COVID-19 vaccine) may also be able to work at the cellular level to eliminate cancer and other abnormalities.

Although these scenes sound like they were stolen from scientific journals, one fact is clear; medical technology in the field of minimally invasive is accelerating at an unprecedented speed. In the long run, this will only benefit the entire medical care continuum. body.

About the author: Philip Remedios is the principal and design and development director of BlackHägen Design.