The ZEISS METROTOM 6 scout used by Exact Metrology digitizes complex parts including the internal geometries at the finest level of detail.

Exact Metrology: A Division of In-Place Machining Company and a comprehensive 3D metrology service provider and hardware sales company, scanned a titanium cervical spine locking plate. The scan was completed by Brendon Belongia, an applications engineer at the Brookfield, Wisconsin office using the ZEISS METROTOM 6 scout.

The METROTOM 6 scout digitizes complex parts including the internal geometries at the finest level of detail. Users obtain a complete 3D image for GD&T analysis or nominal-actual comparisons. High- resolution images can be captured for precise measuring tasks or detailed inspections of internal structures. Be it shrinkage holes, pores, cracks, sink marks or warpage, all defects or deviations can be detected nondestructively.  Furthermore, the combination of a 3k detector and 225 kV X-ray enables ZEISS METROTOM 6 scout to provide high contrast, high-resolution measurement results and exceptional sharpness of detail. As a result, even the smallest defects in the part become visible and can be analyzed to the last detail. A 5-axis kinematics with integrated centering table helps clients optimally position the part in the measuring volume and the control of the device and the metrological evaluation of the data are combined in a single software package, making additional software or intermediate steps redundant.

With this CT scan, the company demonstrates its ability to scan even the smallest part, such as 4mm. This vertebrae plate was measured within a 5-micron resolution and used a deviation color map with the GOM Volume Inspect software. The color representation of a point cloud or mesh data set is compared to its intended, nominal CAD model.  This spectrum of colors can tell users how far a value deviates compared to the CAD surfaces. Thus, a weak spot can be detected and can be fixed before a part is used.

The ability of the ZEISS METROTOM 6 scout to see the tinniest defect or detail is especially crucial for medical devices, especially those that go into the human body.

New Association for Advancing Automation (A3) report shows $2 billion in sales (39,708 units) in 2021 – up 28% from 2020 and 14% ahead of previous high in 2017.

Propelled by a surge in non-automotive sectors, the number of robots sold in North America set a new record in 2021, with 39,708 units sold at a value of $2 billion, a 14% increase over the previous high in 2017.

According to new industry statistics released today by the Association for Advancing Automation (A3), the number of robots sold in 2021 rose 28% over 2020. Record robot sales in the fourth quarter of the year – up 9% over Q4 2020 – demonstrated the strong momentum already realized through the previous nine months as more industries look to automation to increase productivity and alleviate ongoing labor shortages.

“More industries recognized that robotics could help reverse productivity declines and fill repetitive jobs human workers don’t want. It is no longer a choice whether to deploy robots and automation,” says Jeff Burnstein, president of A3. “It’s now an absolute imperative. As we’ve long believed – and users continue to confirm – robots help companies compete, ultimately creating more jobs to handle their growth.”

2021 shows continued trend of non-automotive ordering more robots Non-automotive orders now represent 58% of the North American total. Unit sales to non-automotive industries saw the following increases in 2021 over 2020:

“Improvements in technology, new financing models and simpler applications continue to be positive trend lines leading into 2022, in particular helping small companies automate and join the global stage,” Burnstein adds.

"Hiring technicians and machine operators in the Bay Area is always difficult, and it became even harder during the pandemic,” says Joe Montano, president and CEO of Delphon, a customer of A3 member Rapid Robotics. “Meanwhile, a new generation of rentable robots had made the costs feasible for facilities like ours to make a measured entry into automation. By hiring robots to operate machines for pad printing and component cleaning, we were able to redeploy eight operators to other jobs and see a $70,000 return on investment in less than a year."

Q4 sales and value explained October through December of 2021 marked the highest and second-highest quarter on record for units and revenue, respectively. Non-automotive customers ordered 6,618 robots in Q4, which represents 61% of total units ordered. Automotive-related customers purchased 4,211 units, 39% of total orders. The following non-automotive industries in Q4 saw increases over the same quarter in 2020:

A look at the trends transforming the orthopedic devices market as forecast through 2027.

The increasing prevalence of sports injuries owing to higher physical activity in adults and children along with the expanding geriatric population base will accelerate the adoption of orthopedic devices. The U.S. Centers for Disease Control (CDC) estimates that nearly 30 million children and adults annually indulge in athletic activities and sports, and more than 3.5 million athletes are injured per year in the country. Furthermore, the U.S. Department of Health and Human Services has estimated that the number of sports injuries will exceed 8 million every year.

This has considerably triggered the rise in the instances of musculoskeletal injuries. Hence, orthopedic devices are widely adopted in orthopedic surgeries as well as in the management of musculoskeletal disorders.

The higher application of technologically advanced devices has also paved the way for new approaches to conventional surgical limitations. These include lateral approaches in spine procedure and the anterior approach across hip replacement procedures through new procedural streamlining and instrumentation.

Owing to all these factors, it is estimated that the global orthopedic devices market size will cross a valuation of $60 billion by 2027. 

Increasing need for trauma fixation devices Trauma fixation orthopedic devices industry share was valued at $5.1 billion in 2020 and will grow at a rate of more than 5.1% through the analysis timeframe. These devices are witnessing higher adoption in fixing and stabilizing severe bone dislocations given the increasing prevalence of orthopedic disorders.

Besides, the rise in the instances of road accidents and injuries has also added potential to the launch of technologically advanced devices like bioresorbable & drug-eluting implants, and nano-coated devices. The World Health Organization suggested that more than 1.35 million individuals annually die due to road traffic accidents, and more than 20 to 50 million people suffer from non-fatal injuries or physical disabilities. 

Brazil to see higher penetration Brazil was the largest shareholder of the Latin American orthopedic devices market and is anticipated to expand at a rate of 7% up to 2027. The growth can be attributed to the higher disposable incomes and the proliferating medical infrastructure and healthcare expenses.

Regional research has indicated a rise in the instances of orthopedic surgeries and hospitalizations for treatments, such as lower limb surgeries in the country. The increasing awareness through government initiatives, poor diet intakes as well as lack of physical activities will further influence the demand for orthopedic disease treatment in Brazil. 

Competitive and expansion strategies Prominent suppliers of orthopedic devices are working towards inorganic strategies like mergers and acquisitions for increasing their presence across the globe. To state an instance, Zimmer Biomet, in September 2017, introduced the Persona Partial Knee System for use in joint reconstruction. The launch aided the firm in widening its product base while globally catering to a large customer base.

The ongoing COVID-19 pandemic has also positively influenced the industry outlook in terms of innovations for competitive advantages. For example, Orthofix Medical Inc., a leading orthopedic device company, in May 2021, introduced OSCAR PRO, an ultrasonic arthroplasty revision system for all the U.S. and European markets.

The influx of smart implants that are integrated with sensors has helped to offer real-time data to surgeons for enhanced post-operative assessment, positioning, as well as patient care. The increasing risks of periprosthetic infections in orthopedic surgeries are limited by these implants. The deployment of sensor-enabled technologies is also helping healthcare professionals in providing cost-effective products. Moreover, the adoption of digital systems is also giving improved access to data to render higher precision, predictability, and lower treatment cost.

US cutting tool consumption for December 2021 was up 9.5% when compared to December 2020.

December 2021 U.S. cutting tool consumption totaled $164.3 million, according to the U.S. Cutting Tool Institute (USCTI) and AMT – The Association For Manufacturing Technology. This total, as reported by companies participating in the Cutting Tool Market Report collaboration, was up 2.2% from November's $160.7 million and up 9.5% when compared with the $150.1 million reported for December 2020. With a year-to-date total of nearly $2.0 billion, 2021 is up 8.3% when compared to the same period in 2020.

These numbers and all data in this report are based on the totals reported by the companies participating in the CTMR program. The totals here represent the majority of the U.S. market for cutting tools.

Jeff Major, president of USCTI, commented, “The cutting tool industry continues to rebound from the pandemic's impact in 2020. Projections for 2022 are positive for the industry, with expectations of a full recovery to pre-pandemic levels in 2023. With that said, we still face headwinds from inflation, supply chain disruptions, and problems with workforce hiring and retention.”

Bret Tayne, president of Everede Tool Company, also spoke on the difficulties that the cutting tool industry might face, saying, “December cutting tool sales data continue to show a moderate upward trend. Year over year and YTD sales continued to improve at a pace similar to the prior three months but at a slower pace than we experienced for April through August. It will be interesting to see how developments in January, such as the widespread increase in Omicron variant cases and Federal Reserve announcements on policy shifts, affect the next data set.”

Custom engineered miniature rupture disk assemblies are ideal for many medical device original equipment manufacturer applications involving gases and liquids.

Medical devices and equipment depend on highly reliable integrated, application specific, rupture disk solutions for critical life safety, diagnostic, and analytical applications. Rupture disks serve as an effective passive safety mechanism to protect against overpressure, such as in compressed specialty gases in laboratory and analytical instrumentation, magnetic resonance imaging, laser surgery, cryogenic, and other applications.

The disk, which is a one-time-use membrane made of various metals including exotic alloys, is designed to activate within milliseconds when a pre-determined differential pressure is achieved. Such disks also protect against over-pressure conditions in the sanitary chamber of autoclaves, which rely on pressurized heat or steam to sterilize medical instruments and research labware.

Medical equipment reliability is essential, and this demands high integrity from the pressure relief technology used to protect low- and high-pressure original equipment manufacturer (OEM) systems. As a result, medical OEMs are increasingly turning to integrated rupture disk assemblies where all components are combined by the manufacturer, as opposed to standalone components that leave much to chance. These assemblies are tailored to the application, miniaturized, and use a range of standard and exotic materials, as required. This approach ensures the rupture disk device performs as expected, enhancing equipment safety, reliability, and longevity while simplifying installation and replacement.

OEMs like BS&B utilize threading and several other connection types to attach the rupture disk assembly to the application.

Separate components versus integrated assemblies Traditionally, medical device rupture disks began as individual components combined with the manufacturer's separate holder device at the point of use, and installation actions of the user contribute significantly to the function of the rupture disk device. Installed improperly, the rupture disk may not burst at the expected set pressure. There’s a delicate balance between the rupture disk membrane, its supporting holder, and the flanged, threaded, or other fastening arrangement used to locate the safety device on the protected equipment.

For this reason, for medical applications an integrated rupture disk assembly is often a better choice than separable parts. Available ready-to-use and with no assembly required, integrated units are certified as a device to perform at the desired set pressure. The one-piece design allows for easier installation and quick removal if the rupture disk is activated.

The assembly includes the rupture disk and housing and is custom engineered to work with the user's desired interface to the pressurized equipment. The devices are typically threaded or flanged, and can be configured for industry specific connections such as CF/KF/Biotech/VCR couplings. Based on the application conditions and leak tightness requirements, the manufacturer combines the rupture disk and holder by welding, bolting, tube stub, adhesive bonding, or crimping.

There are additional advantages to this approach. Integrated assemblies prevent personnel from using unsafe or jury-rigged solutions to replace an activated rupture disk to save a few dollars or rush equipment back online. The physical characteristics of increasingly miniaturized rupture disks as small as 1/8" can also make it challenging for personnel to pick up the disk and place it into a separate holder.

“Medical device OEMs are driven to deliver the best performance while respecting cost of ownership for their customers,” says Geof Brazier, managing director of BS&B Safety Systems Custom Engineered Products Division. “The use of an integral assembly maximizes the longevity, proper function and trouble-free service of the pressure relief technology.”

The integrated assembly is ideal for numerous hydraulic, pneumatic, and other low-, medium-, and high-pressure applications including pumps, piston & bladder accumulators, engines, pressure vessels, and piping.

With the availability of integrated, miniaturized rupture disk solutions tailored to the application in a variety of standard and exotic materials, OEMs like BS&B can significantly enhance equipment safety, compliance, and reliability even in extreme work conditions.

Integrated assemblies – Rupture disk design According to Brazier, the most important considerations in rupture disk device design for medical applications are having the right operating pressure and temperature information along with the expected service life – the number of cycles the device is expected to endure during its lifetime. Since pressure and cycling varies depending on the application, each requires a specific engineering solution.

“Coming up with a good, high reliability, cost-effective, and application specific solution for a medical device OEM involves selecting the right disk technology, the correct interface (weld, screw threads, compression fittings, single machined part) and the right options as dictated by the codes and standards,” Brazier says.

Because user material selection can also determine the longevity of rupture disks, the devices can be manufactured from metals and alloys such as stainless steel, nickel, Monel, Inconel, and Hastelloy.

According to Brazier, for medical applications it can be important for rupture disks to have a miniaturized reverse buckling capability in both standard and exotic materials.

“Where economics is the driver, reverse buckling disks are typically made from materials such as nickel, aluminum, and stainless steel. Where aggressive conditions are required, more exotic materials like Monel, Inconel, Hastelloy, Titanium and even Tantalum can be used,” he says.

In almost all cases, “reverse buckling” rupture disks are used because they outperform the alternatives with respect to service life.

In a reverse buckling design, the dome of the rupture disk is inverted toward the pressure source. Burst pressure is accurately controlled by a combination of material properties and the shape of the domed structure. By loading the reverse buckling disk in compression, it can resist operating pressures up to 95% of minimum burst pressure even under pressure cycling or pulsating conditions. The result is greater longevity, accuracy, and reliability over time.

“The process industry has relied on reverse buckling disks for decades. Now the technology is available to medical device OEMs in miniature form as small as 1/8" burst diameter from BS&B. Until recently, obtaining disks of that size and performance was impossible,” Brazier says.

However, miniaturization of reverse buckling technology presents its own unique challenges. To resolve this issue, BS&B created novel structures that control the reversal of the rupture disk to always activate in a predictable manner. In this type of design, a line of weakness is also typically placed into the rupture disk structure to define a specific opening flow area when the reverse-type disk activates and also prevents fragmentation of the disk petal.

“Reverse buckling and therefore having the material in compression does a few things. Number one, the cyclability is much greater. Second, it allows you to obtain a lower burst pressure from thicker materials, which contributes to enhanced accuracy as well as durability,” Brazier says.

Small nominal size rupture disks are sensitive to the detailed characteristics of the orifice through which they burst. This requires strict control of normal variations in the disk holder.

“With small size pressure relief devices, the influence of every feature of both the rupture disk and its holder is amplified,” Brazier explains. “With the correct design of the holder and the correct rupture disk selection, the customer’s expectations will be achieved and exceeded.”

Due to cost, weight, and other considerations, Brazier says that BS&B has increasingly received more requests for housings that are made out of plastics and composites.

Because customers are often accustomed to certain types of fittings to integrate into a piping scheme, different connections can be used on the housing. Threading is popular, but BS&B is increasingly using several other connection types to attach the rupture disk assembly to the medical application. Once the integral assembly leaves the factory, the goal is that the set pressure cannot be altered.

“If you rely on someone to put a loose disk in a system and then capture it by threading over the top of it, unless they follow the installation instructions and apply the correct torque value, there’s still potential for a leak or the disk may not activate at the designed burst pressure,” Brazier explains. “When welded into an assembly, the rupture disk is intrinsically leak tight and the set-burst pressure fixed.”

While medical device OEMs have long relied on rupture disks in their gas-utilizing, hydraulic and pneumatic equipment, compact design suited to high-cycling environments have been particularly challenging. Fortunately, with the availability of integrated, miniaturized rupture disk solutions tailored to the application in a variety of standard and exotic materials, OEMs can significantly enhance equipment safety, compliance, and reliability even in extreme work conditions.