The vice president of North American sales for Quality Vision Int’l Inc. (QVI), explains MultiSensor systems in medical device manufacturing.
Medical manufacturers expect more relative to process control, access, and compliance. ZONE3 workflow on a QVI system enables control of different types of user’s access, certain types of part runs, program edits, failure mode assistance, and corrective action definition. Managers can also approve/adjust validated programs and approve inspections results. The medical industry is all about traceability, documenting all activities throughout a device’s life cycle. Our equipment meets medical device compliance standards needed to comply to FDA requirements.
The medical industry is 30% to 40% of our business, so we understand how manufacturers implement our equipment and we have developed products, software, and services to support this. MultiSensor Metrology Systems and sensors address specific medical device metrology challenges, and we provide documentation services for installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Most important, we tailored our ZONE3 Metrology software to address medical device needs.
Let’s take heart valves and orthopedic implants, high-risk devices. Employees may use a biometric scanner – fingerprint or retina – to determine what level access they have. A manufacturing operator may only be allowed to initiate certain inspection routines, while a higher-level technician, engineer, or manager could access higher-risk part inspections, modifications, or approvals.
Next, the user loads a part, the system displays an image of the part, and the user initiates inspection. A secure and validated program is loaded and can be executed completely as a first article inspection, partially, or for only critical dimensions – the key being that it is only one program – i.e., one validation, with different scenarios of execution in ZONE3.
A pass/fail report is generated with visual representation of problem areas – color deviation report, along with any assignable causes and corrective actions the operator or manager indicates.
For traceability, data is seamlessly dropped into the digital thread of the product lifecycle as part of Industry 4.0.
One big aspect of Industry 4.0 is the support of model-based definition (MBD) and support of product manufacturing information (PMI). ZONE3 supports importing a CAD model with PMI information, simplifying the programming process because it tells the machine a lot about the part that users typically enter manually. This enables efficient programming, quick adoption of new parts, and recommendations for how to improve the manufacturing process. QVI Evolve Suite from our Kotem division delivers design to manufacturing feedback.
Multisensing! We have focused on the MultiSensor systems since 1986. Manufactured parts continued to get more complex, requiring more than one type of data acquisition to quickly, accurately, and completely measure a part. The SmartScope, and more recently the Fusion and FlexPoint offer that capability.
Parts and tools that are made for the human body are not typical, prismatic elements. They contain curved surfaces, intricate details, and are related to high-risk user requirements. MultiSensor systems deliver maximized metrology capability and unprecedented accuracy, without compromising usability, access control, or uncertainty. https://www.qvi.com
A $500,000 grant from the Grand Rapids SmartZone Local Development Finance Authority will fund a 2.5 year collaboration to address cost and time barriers for medical device innovations. Grand Valley State University, the applied Medical Device Institute (aMDI), and MediSurge, will use Carbon Inc. 3D printing technology to create production-grade parts using medical-grade materials and tolerances to accelerate device development and component manufacturing cycles.
More than a dozen undergraduate and graduate students from Grand Valley’s Seymour and Esther Padnos College of Engineering and Computing, along with faculty, will be joining the aMDI team through applied research opportunities.
Costs and time to market for polymer-based medical devices are growing rapidly with increased regulations, steel tooling, and design validation requirements. The AM program’s goal is to find the tipping point, in complexity and number of parts, where 3D printing technology will be the preferred method to reduce startup costs and time to market.
Upon completion of the study and determination of scalability, MediSurge hopes to be the first medical device manufacturing company in the Midwest to offer this service
Since 2016, New York’s Hospital for Special Surgery (HSS) has sourced patient-specific custom implants from Italy-based LimaCorporate. By 2020, a new provider-based additive manufacturing (AM) 3D printing facility, operated by Lima, will leverage its advanced technology with HSS’ expertise in clinical care and biomechanical engineering to accelerate innovation in complex orthopedic joint care.
Lima will be the registered manufacturer for all devices designed and produced at the facility located at HSS. The facility will initially serve hospitals in the region before making the devices available to all providers in the U.S.
Stanford wireless, battery-free sensor monitors blood flow through an artery; can warn doctors of a blockage.
A sensor, developed by Stanford University researchers, monitors vascular surgery outcomes by tracking blood flow through the artery. The compact, wireless, battery-free, biodegradable sensor could allow doctors to track a healing vessel from afar, enabling earlier interventions since the first sign of trouble often comes too late, resulting in additional surgery.
“Measurement of blood flow is critical in many medical specialties, so a wireless biodegradable sensor could impact multiple fields including vascular, transplant, reconstructive, and cardiac surgery,” says Paige Fox, assistant professor of surgery and co-senior author of a paper on the sensor.
Wrapped snugly around the healing vessel, blood pulsing past the sensor pushes on its inner surface, changing its shape. Shape changes alter the sensor’s capacity to store electric charge, which doctors can detect from a device located outside the body, near the skin, that pings the sensor’s antenna for a reading. In the future, the device could be a wearable patch or be integrated into other technology, such as a smartphone.
Researchers tested the sensor by pumping air through an artery-sized tube to mimic pulsing blood flow. Surgeon Yukitoshi Kaizawa, a former postdoctoral scholar at Stanford and co-author of the paper, also implanted the sensor around a rat’s artery. The sensor successfully reported blood flow to the wireless reader.
The sensor is a wireless version of technology that chemical engineer Zhenan Bao has been developing to give prostheses a delicate sense of touch. (See TMD’s previous coverage of some of Bao’s research at: https://tinyurl.com/ybgynra9 and https://tinyurl.com/ydezrsl8).
Researchers modified the sensor’s material to be sensitive to pulsing blood and rigid enough to hold its shape. They moved the antenna to a location where it would not be affected by pulsation and re-designed the capacitor so it could be placed around an artery.
The idea of an artery sensor began when former postdoctoral fellow Clementine Boutry of the Bao lab reached out to Anaïs Legrand, who was a postdoctoral fellow in the Fox lab. Boutry connected those groups, along with the lab of James Chang, the Johnson and Johnson Professor of Surgery.
The collaboration won a 2017 Postdocs at the Interface seed grant from Stanford ChEM-H, which supports postdoctoral research collaborations exploring transformative ideas.
The researchers are now finding the best way to affix the sensors to the vessels and refining their sensitivity.
Additional Stanford co-authors include Clementine Boutry (co-lead), Christopher Vassos, Helen Tran, Allison C. Hinckley, Raphael Pfattner, Simiao Niu, Junheng Li, Jean Claverie, Zhen Wang and Yukitoshi Kaizawa. This work was funded by the Swiss National Science Foundation, the European Commission, Stanford ChEM-H, and the National Science Foundation.
Rosler USA’s mass finishing sales manager addresses how best to post-process metal additive manufactured parts for the required finish.
Metal additive manufacturing (AM) is moving from prototype to mainstream manufacturing and, with the increase in printer speeds, a variety of manufacturers are adapting metal AM as a normal production process. Yet the challenges of post-processing remain the same. Rosler has worked with manufacturers for more than 60 years to find better ways to finish their parts, and the AM adoption is another challenge the company is ready to tackle.
Understanding the materials, production methods, and final finish requirements of the part is just the starting point. Rosler has always focused on understanding the entire process. With AM parts, this is no different. Being able to understand how design and print parameters influence the printed part is key to providing solid advice to the engineer. Changing build parameters or the orientation in the build chamber can make it harder or easier to achieve the desired finish. So, bring in the expert early and don’t make post-processing an afterthought!
A lot of engineers involved in AM ask us this question. For us, AM is just another manufacturing process, and we treat it the same way as casting, forming, stamping, or machining. Nobody is expecting to achieve a finished part right out of their die-cast machine. These parts go through multiple post-processing steps such as trimming, vibratory finishing, machining, plating, and the like. AM parts are no different.
We start with comprehensive fact finding to help us understand the manufacturing process from start to finish and then develop a combination of solutions with the customer. Often, the final finish on a 3D-printed part can be achieved by wet blasting the part after printing – this also removes any residual powder – and then vibratory finishing the part with specially formulated finishing media that reduces the surface roughness to the desired value.
Rosler has been forming partnerships with other experts and companies in the field to bring the most relevant post-processing solutions together. Our AM Solutions brand (https://www.am-postprocess.com) and global coordination of post-processing efforts ensure that we have access to the most suitable solutions for our customers. Sometimes, the best solution might include some hand work before the finishing process to achieve the desired result.
Rapid improvements of printing speeds, generative design, and the adoption of metal AM as a production method is exciting. As the AM production volumes increase, companies will be demanding post-processing solutions that are optimized and automated. This will require bringing an experienced expert to the table early in the design and development phase. It will also require finishing solution providers, such as Rosler, to stay ahead of the curve to provide new, innovative solutions for AM parts.
Beta LaserMike measurement system; Branson ultrasonic welding platform; Mazak's multi-tasking machine
The Beta LaserMike BenchMike off-line diameter and ovality measurement system offers expanded connectivity, communication, and control. Industry 4.0 ready, BenchMike Pro provides fast, accurate, and repeatable dimensional measurements of diameter, multiple ODs, ovality, part position, multiple part dimensions (OD and ID), wall thickness, and total runout. With ±0.90µm accuracy and ±0.25µm repeatability, users gain increased performance capabilities and accuracy.
Beta LaserMike, an NDC Technologies Brand https://www.ndc.com/betalasermike MD&M West 2019 Booth #3129
Faster communications processing: More efficient data logging, sharing; improved production reporting, analysis; increased quality control
The Branson GSX ultrasonic welding platform, with Emerson’s Electro-Mechanical Advanced Actuation System, improves position accuracy for faster, high-performance welding of fragile, intricate components. The configurable platform accommodates different parts and applications through many welding parameters and actuation modes during a single weld. A multicore processor and linear encoder drive allows the system to instantaneously adjust using real-time feedback, ensuring precision and repeatability across multiple welders.
Simple, intuitive software lets operators perform faster, correct setups, reducing application testing time, and up to 60% faster start-up. By retaining alignment information and setup within the assembly, a GSX stack and tooling can be replaced in less than 5 minutes, allowing various components to be welded with limited production schedule disruption.
When paired with the GR50 robot automation solution, the QTU-200MSY multi-tasking machine brings efficiency, accuracy, and value to high- volume small parts production. The 2-pallet shuttle table accompanying the GR50 robot allows operator access to the opposed table for part changeover and continuous production. With a maximum workpiece diameter of 4.92" (125mm) and length of 5.90" (150mm), the dual, parallel three-jaw robot hands can handle various workpiece applications.
The QTU-200MSY’s integral spindle/motor headstock provides precision in high-speed turning applications. A variable-speed AC motor powers the headstock for smooth acceleration and deceleration, while its motor braking design provides C-axis positioning within 0.0001°.
MAZATROL SmoothC CNC technology allows operators to generate programs for basic turning, milling, drilling, and tapping operations with EIA/ISO and MAZATROL conversational programming.
The GR50 has ±0.2mm repeatability and features a B-axis design that uses a B1 and B2 segmented axis configuration, doubling the system’s traverse speed to 9,842ipm (250m/min) for faster cycle times and increased productivity.
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