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New laser welder automates assembly of small plastic parts

Emerson's new Branson GLX-1 Laser Welder offers users flexibility to meet the growing demand for joining small, complex, or delicate plastic components and assemblies. Its compact footprint and modular design make it compatible for use in ISO-8 cleanroom environments, while an integral automation controller simplifies installation and interfaces with production robotics. The precise, servo-based actuation controls allow for greater freedom to design and join components with three-dimensional contours in small-part applications for the medical, electronics, automotive, and appliance industries.
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Slip clutch real-world applications

When design engineers think about slip clutches, they first think of using them for overload protection. While this is certainly a valuable application, there are a surprising number of other applications that solve many engineering problems. See real-world applications of Polyclutch slip clutches, from conveyors and military robots to vending machines, printers, and more. There's a good Selection Guide here too.
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Precision profile rolled steel products

Need steel products with a special edge? NIPPON KINZOKU CO. of Japan offers its Fine Profile cold-rolled technology that produces metal pieces with irregularly shaped cross-sections of different thicknesses. By rolling the uneven pattern on the roll surface, it is possible to process various designs and functions such as unique designs, oil grooves, gloss prevention, identification grooves, etc. Final products can be delivered in a variety of forms such as record rolls, oscillate rolls, fixed-length products, and secondary processing. An interesting alternative to machining processes such as cutting and grinding.
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Pneumatic Shaft Locking Clamps for automated machine changeover

Discover the power of Fixtureworks' expanded line of Pneumatic Shaft-Locking Clamps. These compact pneumatic locks are perfect for secure clamping of sliding shafts and spindles after positioning and adjustment of machinery equipment. Two types available: Light Duty and Heavy Duty. Sliding shaft options include horizontal and vertical locking. Multiple shafts can be clamped at a time from a distance too.
Learn more and see them in action.

Improving gear hobbing setups by 50%

Buffalo Gear partnered with Helios Gear Products to install a new Hera 350 CNC gear hobber. Helios visited Matt Davis, Russ Jagow, and Bob Kasperek in Buffalo, NY, to see how their processes and productivity have improved since the installation, and to learn about what they have in store for the future.
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Lead screw selector tool: Your perfect configuration

Thomson Industries has added the ability to configure end supports and machining for their acme lead screws. Get the exact solution you need using the company's lead screw selector tool. Options include the ability to add standard machining, supports, and/or handwheels to your acme screw. Spec selections are updated in real time graphically.
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Multi-material laser cutting tech for automotive, aerospace, more

Achieve precise cuts with the SaberTech TiTAN FX from Laser Photonics. This expansive flatbed laser cutting system is engineered with state-of-the-art laser piercing technology to provide a high-power solution for large-scale industrial cutting applications. Featuring a work envelope with an area of up to 6 x 12 ft, this system can function independently or get integrated into production lines. It processes a wide range of materials, including plastics, metals, reflective metals, and alloys. Other than power, the SaberTech TiTAN requires no consumables and no routine part replacements, delivering long-term consistency and reliability.
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Best high-speed rotary bearing in THK history

THK has developed its best-performing, high-speed rotary bearing ever: the High-Speed, Double-Row Angular Contact Ring BWH. This rotary bearing has balls aligned inside a cage between the inner and outer rings and is part of the THK Rotary Series, along with the cross-roller ring. The main features of this product are its ability to receive loads in all directions as well as its high rigidity and rotational accuracy, which are equal to that of cross-roller rings. By adopting a new structure to change the rolling elements from rollers to balls, this product achieves the greatest high-speed performance ever offered by THK.
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Dowel pins, drill bushings, and knurled screws with hex

The JW Winco product range now includes dowel pins, drill bushings in numerous dimensions, and knurled screws with and without internal hex. Dowel pins DIN 7979 with internal thread are used primarily in connection with blind bores, where they cannot drive out from the opposite side. Drill bushings DIN 172 or 179, also known as guide bushings, are indispensable parts used wherever bore holes require wear-proof linings. Knurled screws GN 464.1 with internal hex are made of zinc-plated heat-treatable steel and expand the range of applications for these versatile fasteners.
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How ball spline coatings enhance performance and extend component life

According to Thomson, "Precision ball splines have gained popularity as an ideal choice for applications that require low-friction linear and rotary motion. These components, which utilize a single splined shaft, enable complex movements in multiple directions." But how do you keep these ball splines performing at their peak for longer? Coatings can do the trick, and Thomson has three of them: black oxide, hard chrome plating, and nickel plating. Learn more about these coatings and which one makes the most sense for your precision ball spline solution.
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Key factors for ball screw applications

Learn the six key factors that should be considered when specifying ball screw assemblies in motion control applications. PCB Linear gathered a panel of experts in the field of linear motion to concentrate on this important topic -- particularly when it comes to the company's new miniature ball screw product line. Learn about precision and accuracy, orientation, speed and acceleration, duty cycle, linear motion travel, and load capacity. Podcast available too.
Read the PCB Linear blog.

3D printer uses pellet extrusion system instead of filament

The latest addition to 3D Systems' industry-leading portfolio of EXT Titan Pellet systems is the EXT 800 Titan Pellet. With a build volume of 800 x 600 x 800 mm, this thermoplastics 3D printer harnesses the speed, reliability, and efficiency of the company's large-format pellet systems in a more compact unit with lower upfront investment. Use this machine to fabricate more modestly sized functional prototypes, tooling, fixtures, sand casting patterns, thermoforming molds, and end-use parts. Markedly faster than competing FFF and FDM printers, and up to 10X reduced material costs compared to filaments.
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Test your knowledge: High-temp adhesives

Put your knowledge to the test by trying to answer these key questions on how to choose the right high-temperature-resistant adhesive. The technical experts from Master Bond cover critical information necessary for the selection process, including questions on glass transition temperature and service temperature range. Some of the answers may surprise even the savviest of engineers.
Take the quiz.

World's first current-carrying fastening technology

PEM^® eConnect™ current-carrying pins from Penn-Engineering provide superior electrical connections in applications that demand high performance from internal components, such as automotive electronics. This first-to-market tech provides repeatable, consistent electrical joints and superior installation unmatched by traditional fastening methods. Features include quick and secure automated installation, no hot spots or poor conductivity, and captivation options that include self-clinching and broaching styles.
Learn more about eConnect pins.

New flat quarter-turn clamping fastener

IMAO Fixtureworks has expanded its One-Touch Fastener lineup to include a new quarter-turn clamping fastener that features an innovative flat design and is ideal for clamping in limited spaces. The QCFC flat quarter-turn fastener features a recessed body that protrudes only 2 mm from the mounted surface, a knob that rests flush inside the body, visible ON and OFF markings for safety, and an audible click when fully turned to clamped or unclamped position.
Learn more.

Eye-opener: Almost half of FDA-approved AI medical devices are not trained on real patient data

By Kendall Daniels, University of North Carolina Health Care

Artificial intelligence (AI) has practically limitless applications in healthcare, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor removal accuracy. Despite their potential benefit to doctors and patients alike, these tools have been met with skepticism because of patient privacy concerns, the possibility of bias, and device accuracy.

In response to the rapidly evolving use and approval of AI medical devices in healthcare, a multi-institutional team of researchers at the University of North Carolina (UNC) School of Medicine, Duke University, Ally Bank, Oxford University, Colombia University, and University of Miami have been on a mission to build public trust and evaluate how exactly AI and algorithmic technologies are being approved for use in patient care.

Together, Sammy Chouffani El Fassi, an MD candidate at the UNC School of Medicine and research scholar at Duke Heart Center, and Gail E. Henderson, PhD, professor at the UNC Department of Social Medicine, led a thorough analysis of clinical validation data for 500+ medical AI devices, revealing that approximately half of the tools authorized by the U.S. Food and Drug Administration (FDA) lacked reported clinical validation data. Their findings were published in Nature Medicine.

"Although AI device manufacturers boast of the credibility of their technology with FDA authorization, clearance does not mean that the devices have been properly evaluated for clinical effectiveness using real patient data," said Chouffani El Fassi, who was first author on the paper. "With these findings, we hope to encourage the FDA and industry to boost the credibility of device authorization by conducting clinical validation studies on these technologies and making the results of such studies publicly available."

Since 2016, the average number of medical AI device authorizations by the FDA per year has increased from 2 to 69, indicating tremendous growth in commercialization of AI medical technologies. The majority of approved AI medical technologies are being used to assist physicians with diagnosing abnormalities in radiological imaging, pathologic slide analysis, dosing medicine, and predicting disease progression.

Artificial intelligence is able to learn and perform such human-like functions by using combinations of algorithms. The technology is then given a plethora of data and sets of rules to follow, so that it can "learn" how to detect patterns and relationships with ease. From there, the device manufacturers need to ensure that the technology does not simply memorize the data previously used to train the AI, and that it can accurately produce results using never-before-seen solutions.

Regulation during a rapid proliferation of AI medical devices
Following the rapid proliferation of these devices and applications to the FDA, Chouffani El Fassi and Henderson et al. were curious about how clinically effective and safe the authorized devices are. Their team analyzed all submissions available on the FDA's official database, titled "Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices."

"A lot of the devices that came out after 2016 were created new, or maybe they were similar to a product that already was on the market," said Henderson. "Using these hundreds of devices in this database, we wanted to determine what it really means for an AI medical device to be FDA authorized."

Of the 521 device authorizations, 144 were labelled as "retrospectively validated," 148 were "prospectively validated," and 22 were validated using randomized controlled trials. Most notably, 226 of 521 FDA-approved medical devices, or approximately 43%, lacked published clinical validation data. A few of the devices used "phantom images" or computer-generated images that were not from a real patient, which did not technically meet the requirements for clinical validation.

Furthermore, the researchers found that the latest draft guidance, published by the FDA in September 2023, does not clearly distinguish between different types of clinical validation studies in its recommendations to manufacturers.

Types of clinical validation and a new standard
In the realm of clinical validation, there are three different methods by which researchers and device manufacturers validate the accuracy of their technologies: retrospective validation, prospective validation, and subset of prospective validation (called randomized controlled trials).

Retrospective validation involves feeding the AI model image data from the past, such as patient chest x-rays prior to the COVID-19 pandemic. Prospective validation, however, typically produces stronger scientific evidence, because the AI device is being validated based on real-time data from patients. This is more realistic, according to the researchers, because it allows the AI to account for data variables that were not in existence when it was being trained, such as patient chest X-rays that were impacted by viruses during the COVID pandemic.

Randomized controlled trials are considered the gold standard for clinical validation. This type of prospective study utilizes random assignment controls for confounding variables that would differentiate the experimental and control groups, thus isolating the therapeutic effect of the device. For example, researchers could evaluate device performance by randomly assigning patients to have their CT scans read by a radiologist (control group) versus AI (experimental group).

Because retrospective studies, prospective studies, and randomized controlled trials produce various levels of scientific evidence, the researchers involved in the study recommend that the FDA and device manufactures should clearly distinguish between different types of clinical validation studies in its recommendations to manufacturers.

In their Nature Medicine publication, Chouffani El Fassi and Henderson et al. lay out definitions for the clinical validation methods that can be used as a standard in the field of medical AI.

"We shared our findings with directors at the FDA who oversee medical device regulation, and we expect our work will inform their regulatory decision making," said Chouffani El Fassi. "We also hope that our publication will inspire researchers and universities globally to conduct clinical validation studies on medical AI to improve the safety and effectiveness of these technologies. We're looking forward to the positive impact this project will have on patient care at a large scale."

Algorithms can save lives
Chouffani El Fassi is currently working with UNC cardiothoracic surgeons Aurelie Merlo and Benjamin Haithcock as well as the executive leadership team at UNC Health to implement an algorithm in their electronic health record system that automates the organ donor evaluation and referral process.

In contrast to the field's rapid production of AI devices, medicine is lacking basic algorithms, such as computer software that can diagnose patients using simple lab values in electronic health records. Chouffani El Fassi says this is because implementation is often expensive and requires interdisciplinary teams that have expertise in both medicine and computer science.

Despite the challenge, UNC Health is on a mission to improve the organ transplant space.

"Finding a potential organ donor, evaluating their organs, and then having the organ procurement organization come in and coordinate an organ transplant is a lengthy and complicated process," said Chouffani El Fassi. "If this very basic computer algorithm works, we could optimize the organ donation process. A single additional donor means several lives saved. With such a low threshold for success, we look forward to giving more people a second chance at life."

Published September 2024

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