The 715 Series machining center for complete machining of all six sides of complex parts fits between the vertical Chiron FZ 08 S mill-turn Precision+ machining center and the Stama MT 733 machining center. Designed for fully automated, complete machining tasks, part size range is bars up to 65mm or chuck parts up to 200mm, with 20kg maximum workpiece weight.
Two versions are available: Chiron MT 715 (mill-turn) and Chiron MP 715 (multi-profile). The machines include a direct-drive 20,000rpm milling head, a horizontal main spindle, and a matched, opposing counter-spindle to permit continuous multifunctional machining in a single setup – capabilities used to machine hip stems.
Both machines accommodate 128 tools and include integrated workpiece handling and workpiece storage to support automated manufacturing of workpieces in small- and medium-batch sizes. Convenient tool magazine loading and unloading can occur during machining.
The machines can integrate digital systems from the Chiron SmartLine portfolio, including automatic condition monitoring, integrated machine and process diagnostics, machining simulation, preventive machine protection in every mode of operation, remote diagnostics and maintenance, and intuitive operation.
If there’s one thing the last 18 months has highlighted for manufacturers it’s that design and manufacturing projects need to be optimized from the beginning for consistent success. As some facilities slowed production of their typical product lines, many pivoted to producing a range of personal protective equipment (PPE) and other medical devices and equipment that were (and still are) in demand. It was also a time when companies took a close look at their current processes to determine where improvements could be made, what new technology they should add, and how best to implement these changes for more streamlined production as demand returned.
The U.S. Food and Drug Administration’s (FDA) stringent requirements for safety in medical devices and equipment require the production process be approved, but determining how is key to efficiently manufacture everything from face masks to surgical equipment. These decisions go beyond what machine to use, encompassing everything from design to material choice, components, testing, production, software, and the process; and traceability from start to finish.
This issue is filled with insights regarding where and how to optimize design and manufacturing, starting with the cover story. Alan Levine, managing director at Open Mind Technologies USA dives into how medical manufacturers can successfully manage the tools in their manufacturing workflow. The answer is using optimized NC programs that offer an extensive database for users to manage tools of all types – from drills and milling cutters to complex turning tools – which can all be mapped virtually and linked with data.
It’s also necessary to consider what process to use, discussed by Nigel Flowers, UK managing director of Sumitomo (SHI) Demag, as he examines additive manufacturing (AM) and injection molding, noting how each has distinct advantages and when used for the right application, they complement each other nicely.
EOS’ Global Medical Development Manager Laura Gilmour and Global Key Account Manager Fabian Krauss weigh in on producing products via AM and consider material choices. EOS’ patented 3D-printed flexible lattice, Digital Foam, delivers fine-turned, customized products – from orthotics to prosthetics and more. But how do you know if the material and approach is the right fit? Don’t just attempt it by using a file for subtractive and applying it to AM; testing it on a new project can lead to the best success.
What components can help the Internet of Medical Things (IoMT) achieve full potential? InnoPhase’s Talaria TWO platform delivers low-power Wi-Fi, extended battery life, and direct-to-cloud connectivity, enabling design engineers to add more intelligence and functionality to IoMT devices.
Enterprise resource planning (ERP) systems are the backbone of operational excellence – so turn to page 18 to learn the six key capabilities medical device manufacturers should look for in their ERP systems to support shifting business models and requirements.
Staying current on the best available machine, software, components, materials, and other solutions is essential to continually produce the safest medical devices in the most efficient manner.
EDWARD JENNER ILLUSTRATION: Mario Breda | ADOBE STOCK | ALL OTHER ICONS: ADOBE STOCK AND ISTOCKPHOTO.COM
The history of vaccines
Departments - Medical Infographic
The origin of smallpox is unknown, though research says it has existed for centuries. Edward Jenner’s inoculation of eight-year-old James Phipps with matter from a cowpox sore proves that inoculating a person can give immunity from smallpox. That was just the start of medical advancements in vaccines; here’s a look at some milestones.
1796 – English physician-scientist Edward Jenner inoculates eight-year-old James Phipps with matter from a cowpox sore – proving that inoculating a person with cowpox pus can create smallpox immunity.
1800 – Harvard physician-scientist Benjamin Waterhouse performs first smallpox vaccinations on his four children.
1813 – U.S. Vaccine Agency established – then and now, continues to ensure safety, efficacy of vaccines.
1820 – Drastic decrease in smallpox mortality after vaccination begins.
1879 – French biologist Louis Pasteur develops technology for attenuated vaccines (uses weakened viruses).
1885 – Spanish physician Jaime Ferrán develops a cholera vaccine – first against a bacterial disease.
1926 – Gaston Ramon, a veterinarian at the Pasteur Institute in France, develops diphtheria toxoid; working independently at the Wellcome Research Laboratories in London, physician Alexander Thomas Glenny does likewise.
1946 – Influenza vaccine approved for civilians.
1957 – Polio vaccine made widely available.
1971 – Combination measles, mumps, rubella (MMR) vaccine released after the individual vaccines were released in 1963, 1967, and 1969, respectively.
1990s – Scientists begin exploring how to simplify vaccines using mRNA, discovering it can create a stronger immunity by training the immune system to make antibodies and killer T-cells which kill cells infected with an intruder.
2017 – BioNTech clinical trial in Germany shows mRNA vaccine effective against melanoma.
2018 – Modern plant opens in Massachusetts to manufacture mRNA vaccines for cancer clinical trials.
July 2020 – Moderna publishes Phase 1 and 2 clinical trial results of COVID-19 vaccine.
August 2020 – Pfizer-BioNTech publishes Phase 1 and 2 clinical trial results.
December 2020 – U.S. Food and Drug Administration (FDA) issues Emergency User Authorization (EUA) for the Pfizer-BioNTech and Moderna COVID-19 vaccines.
February 2021 – FDA issues EUA for viral vector COVID-19 vaccine from Johnson & Johnson/Janssen.
Medtronic plc received U.S. Food and Drug Administration (FDA) approval for Vanta, a high-performance recharge-free implantable neurostimulator (INS) with a device life of up to 11 years. It uses Medtronic’s AdaptiveStim technology for personalized pain relief that adapts to the patient’s movement or body position using a built-in accelerometer. AdaptiveStim technology automatically adjusts stimulation to maintain each patient’s optimal dose. The Vanta neurostimulator also provides full-body magnetic resonance imaging (MRI) access with Medtronic SureScan technology.
The Vanta neurostimulator represents a 10% increase in longevity compared to PrimeAdvanced, Medtronic’s previous generation recharge-free device, while also being 20% smaller with a more rounded, ergonomic contouring for enhanced comfort. https://www.medtronic.com
PHOTO: MEDTRONIC
Articulating instruments for Senhance Surgical System
Asensus Surgical Inc., a medical device company digitizing the interface between the surgeon and patient for a new era of Performance-Guided Surgery, received FDA 510(k) clearance for 5mm diameter articulating instruments, adding to the Senhance Surgical System technology platform. Articulating instruments increase access to difficult-to-reach areas of the anatomy by providing two additional degrees of freedom. These instruments have previously received CE Mark for use in the European Union.
“Bringing the benefits of 5mm articulating instruments to the Senhance Surgical System in the U.S. will widen the clinical utility and value of our platform,” says Anthony Fernando, Asensus Surgical president and CEO. “Combining articulation and haptics with augmented intelligence is a very promising development for Performance-Guided Surgery.”https://www.asensus.com
Current products & technology
Departments - Products + Technology
Adaptable soft jaw; Live tools for Haas BMT turret; Connected digital inspection platform; Fully sealed air chuck
Adaptix Soft Jaw is engineered to be a one-size-fits-all alternative to standard, single-application aluminum soft jaws, using adjustable fingers and interchangeable tips to grip a variety of parts during machining. The fingers easily mold into place to conform to the shape of the target part and are then locked in place. This configuration process takes minutes, instead of hours, on average, with traditional soft jaws. The Adaptix fits directly onto a vise and is currently compatible with Kurt and Schunk brand vises, with other vise compatibility planned in the near future.
An extensive line of Heimatec tooling is available fromPlatinum Tooling Technologies for the new Haas BMT turret. The line includes a variety of driven tools (axial and radial drilling & milling heads) as well as static tool holders. Specialty tools for this turret including multi-spindle, adjustable angle, and speed multipliers, are also available.
Exalta, a smart device for reliable quality control of medical devices, integrates conventional microscopes with cameras into a connected digital inspection platform. The quality process becomes a digital approach where manual steps are minimized, resulting in fewer errors and easier traceability.
Exalta’s guided step-by-step work instructions safeguard consistent visual inspection across multiple operators in accordance with standard procedures. Data is stored during inspection and reports are generated automatically. The approval workflow allows users to track documentation with an audit trail and prepare for 21 CFR Part 11 regulations and GxP guidelines.
SMW-Autoblok’s AcuGrind air chuck features a built-in actuating cylinder (no hydraulic cylinder required) for extreme tolerances during turning and grinding applications. It provides accuracy to 0.000078" and is ideal for miniaturized components found in medical industries and applications requiring precise tolerances. It performs I.D. and O.D. clamping using a boring ring and pin. Its case-hardened base jaws allow for extra rigidity and repeatability within 0.002mm.
Available in 80mm to 250mm sizes, AcuGrind comes fully sealed as part of the Proofline Series chucks, greatly reducing overall maintenance. Permanent lubrication helps maintain consistent grip force throughout shifts.
Posted by Elizabeth Engler Modic
