Computational modeling is an important supplement to physical testing and clinical trials for design and performance validation of medical devices. The Food and Drug Administration’s (FDA) guidance material, “Reporting of Computational Modeling Studies in Medical Device Submissions”, includes guidelines for providing statistical proof and validation of simulation results such as inclusion of “the sensitivity of the QOI(s) [quantity of interest] on key parameters and provide a systematic analysis of the uncertainty in relation to the key parameters, as appropriate” (FDA Guidance Section 10a, 2016).

The performance of periodic sterilization dose audits is required, where a sterilization dose has been established using Method 1, Method 2, or Method VD_max. This webinar will focus on the purpose and activities associated with such audits in order to demonstrate the continued effectiveness of the established sterilization dose. Participation in this webinar will provide you with the understanding of why the sterilization dose audit is needed and how to complete a dose audit for a wide variety of medical devices that have been validated using the ANSI/AAMI/ISO 11137.

Robots will perform spinal surgery with greater accuracy than humanly possible as part of a ground-breaking research project. A research team has created a system that allows two robotic arms to semi-autonomously drill holes in individual vertebrae.

A novel spinal exoskeleton has undergone a comprehensive evaluation of the newest version. The SPEXOR exoskeleton is designed to prevent low-back pain and support workers with existing low-back pain. The team found the device performed better than existing devices.

A flexible endoscopic surgical robot opens a new chapter for minimally invasive robot-assisted surgery with its precision control of 3.7 mm diameter robotic arms. The two arms, placed at the end of flexible endoscopes, demonstrate precision control and robust mini-joint design technologies. While cruising through the complicated inner body pliably, it carries out procedures on the spot with its robotic arms.

A U.S.-based training program has been launched for Versius, a next-generation surgical robotic system that uses biomimicry to perform like a human arm. CMR Surgical has partnered with the Nicholson Center to train 27 surgical teams, which include more than 100 healthcare professionals.

The medical robotics market is expected to exceed more than US$13.0 billion by 2022 at a CAGR of 21.1 percent. These systems are shifting the design of the surgical suite, changing physicians’ surgical strategies and enabling more surgical precision.

The new Medical Device Regulations (MDRs) become enforceable May 2022. After that, all new devices set for market in the European market will have to demonstrate compliance with ISO 10993, even if the device has been on the market for years.

A team of neuroscientists and engineers has developed a tiny, implantable device that has potential to help people with bladder problems bypass the need for medication or electronic stimulators. The team created a soft, implantable device that can detect overactivity in the bladder and then use light from tiny, biointegrated LEDs to tamp down the urge to urinate.

The device works in laboratory rats and one day may help people who suffer incontinence or frequently feel the need to urinate.

A new neurostimulator can listen to and stimulate electric current in the brain at the same time, potentially delivering fine-tuned treatments to patients with diseases like epilepsy and Parkinson’s. The device, named the WAND, works like a “pacemaker for the brain,” monitoring the brain’s electrical activity and delivering electrical stimulation if it detects something amiss.

These devices can be extremely effective at preventing debilitating tremors or seizures in patients with a variety of neurological conditions. But the electrical signatures that precede a seizure or tremor can be extremely subtle, and the frequency and strength of electrical stimulation required to prevent them is equally touchy. It can take years of small adjustments by doctors before the devices provide optimal treatment.

A technique that enables biologically active enzymes to survive the rigors of inkjet printing presents a promising alternative to routine blood screening exams faced by diabetic patients. A team of researchers used this approach to make disposable devices that can measure glucose concentrations in human saliva.

Strips of pH-sensitive paper are commonly used to test whether a liquid is acidic or alkaline. Researchers are now working to apply similar principles to create paper sensors that quickly indicate disease biomarkers. Key to this approach is replacing traditional electronic circuitry in the sensors with low-cost plastics that can be manufactured quickly and in large quantities.

A technique using microneedles able to draw relatively large amounts of interstitial fluid — a liquid that lurks just under the skin — opens new possibilities. Previously, microneedles — tiny, hollow, stainless steel needles — have drained tiny amounts of interstitial fluid needed to analyze electrolyte levels but could not draw enough fluid to make more complicated medical tests practical. The new method’s larger draws could be more effective in rapidly diagnosing cancer and other diseases.

The relatively large quantities of pure interstitial fluid extracted, which have never before been achieved, make it possible to create a database of testable molecules, such as proteins, nucleotides, small molecules and other cell-to-cell signaling vesicles called exosomes. Their presence or absence in a patient’s interstitial fluid would then indicate, when an individual’s data is transmitted by electronic means to a future data center, whether bodily disorders like cancers, liver disease or other problems might be afoot.

Making changes to a regulatory process is usually difficult, slow, and often painful — after all, it involves lots of bureaucracy and many “cooks in the kitchen.” But I’m encouraged by FDA’s recent announcement that it plans to modernize the 510(k) pathway. In today’s culture of connectivity, smartphones, artificial intelligence, and exploding innovation in materials and manufacturing, it’s time to give the 42-year-old process an overhaul.

This white paper was developed to help avoid the downtime, costs and frustration involved when the wrong plastic tubing or reinforced hose is ordered. Topics include pressure and vacuum requirements, taste and odor transfer, surface characteristics, flexibility, kink resistance, temperatures and more. The tips highlight details that can be overlooked, present questions to ask your supplier, and suggest research you can do to help avoid buying errors.

Engineers often want to know whether an adhesive is low outgassing or generic. And while there are cases when nothing but a low outgassing product will do, the truth is that many so-called generic adhesives inherently have low outgassing levels. What's more, most bonding, potting, encapsulation and sealing applications don't need to meet a defined outgassing specification. Here's a guide to understanding when low outgassing adhesives are the right choice.

Researchers have developed a biosensor device that allows them to monitor their anticoagulants such as Sintrom (aceno-coumarol). This device would allow the patient or doctor to regulate the dose and achieve the optimal effect, something key in people medicated with anticoagulants.

Researchers have found a way to use the full beam of a laser light to control and manipulate minute objects such as single cells in a human body, tiny particles in small volume chemistry, or when developing on-chip devices.

A nanoparticle-based technology could be used to improve the speed of diagnosis. This type of sensor could also be used to monitor whether antibiotic therapy has successfully treated the infection.

Device functionality is usually the starting point when designing devices. Another element that needs to be considered when designing devices and their subsequent components is their manu-facturability. Part design should also be focused on the ease of manufacturing because it can help reduce cost and lead to a robust and reliable process. Several aspects should be considered regarding manufacturabil-ity: part geometry, location, and size and shape of critical surfaces, among others. These may seem like more obvious characteristics, but there are a few others that can be overlooked, but should be considered just as important. These are material selection, dimensioning/tolerancing, and the selection of critical dimensions. To better understand the impact of these factors, this article explores each characteristic in detail.

Long-term patient comfort is a key part in any implant surgeries. Accurate placements of implants, of knees, hips, and other medical devices, is crucial to reducing the risk of discomfort and the need for costly revision surgeries. Custom-designed implants and simulation is a field of growing importance, giving clinicians and designers freedom to tailor designs for patients and make more informed surgical decisions. In addition to streamlining the manufacturing process, this approach enables multiple implant variations and pathologies to be considered at the virtual stage through additive manufacturing. This is as opposed to finding and correcting problems through trial and error.

Biosensors and point-of-care devices are poised to change the delivery of healthcare. Biosensor technology can be used in cheap, disposable point-of-care devices, or it can be used to provide continuous monitoring in implantable devices. Measurement in biomedicine presents unique challenges in both implementation and interpretation.

As the medical device and engineering industry grows, there is also demand for better devices and equipment. Trends such as smaller and more powerful electronics, as well as increased focus on improved customer experience, affect the medical device industry as much as any other. Medical devices, though, also need to be portable, and their costs must be judiciously managed. Above all, reliability is crucial.

Around the world, people are living longer with more active lifestyles thanks to continuing advancements in medical technology. This evolution in technology stems from the development of sophisticated metals and alloys that are finding new uses in internal and external medical applications. From improvements in diagnostic guide wires to new alloys for permanent implants in the body, metals continue to find new uses.

When a medical device is placed on the market, it is critical for the manufacturer to demonstrate through appropriate Conformity Assessments (CAs) that the device complies with the Essential Requirements (ERs) as set out in the Medical Devices Directives (MDD). The manufacturer needs to demonstrate that the device achieves its intended purpose, that any known (or possibly foreseeable) risks are minimized and weighed against the benefits of the intended use, and that any claims about the device's performance are supported by evidence.

Landmark test results suggest a promising class of sensors can be used in highradiation environments and to advance important medical, industrial, and research applications.

Ultrasonic Welding Platform

Emerson, Danbury, CT, has launched a highly configurable ultrasonic welding platform. The Branson GSX is a modular system that enables users to execute precise and repeatable ultrasonic welds to meet the broad requirements of their applications. The modular architecture enables shorter build and delivery times. It is available with electromechanical, proportional pneumatic, or pneumatic functionality. To help achieve consistent welds from one welder to another, the platform employs an advanced actuation system and multicore processor that ensures improved welding control and position accuracy. A low trigger force ensures precise, accurate ultrasonic welds. Smart hardware and software enable fast setups and changeovers.

For Free Info Visit Here.

Motors and Gear Motors

Allied Motion Technologies, Amherst, NY, has released a line of fractional horsepower PMDC motors and gear motors. These Globe motors are available off-the-shelf or on short lead time through the company's QuickShip program. Models range in size from 0.75 to 2.25 in. (19-57 mm) in diameter. Rated speed ranges from 2400 to 19200 RPM, with rated power from 3 to 62 W. Planetary gearhead models are available with output torque rated to as high as 62 Nm (8800 oz-in).

Image Sensor Testing

Presto Engineering, San Jose, GA has developed a custom, computer-controlled testing solution that illuminates sections of CMOS image sensors wafers in turn. Integrating the results enables the whole wafer to be tested automatically for an array of large sensors or even sensors that are right up to the size of an entire 12-in. wafer. The Teradyne^® IP750Ex based test solution provides a large (80 × 100 mm), uniform (±2 percent), high-intensity illumination field up to 10K Lux at a range of color temperatures. Built-in IR filtering prevents sensor damage.

Particle accelerators are usually large and costly, but that will soon change if researchers have their way. The Accelerator on a Chip International Program (AChIP), funded by the Gordon and Betty Moore Foundation in the United States, aims to create an electron accelerator on a silicon chip. The fundamental idea is to replace accelerator structures made of metal with glass or silicon, and to use a laser instead of a microwave generator as an energy source. Due to glass's higher electric field load capacity, the acceleration rate can be increased and thus the same amount of energy can be transmitted to the particles within a shorter space, making the accelerator shorter by a factor of approximately 10 than traditional accelerators delivering the same energy.

By using light waves instead of electric current to transmit data, photonic chips — circuits for light — have advanced fundamental research in many areas from timekeeping to telecommunications. But for many applications, the narrow beams of light that traverse these circuits must be substantially widened in order to connect with larger, off-chip systems. Wider light beams could boost the speed and sensitivity of medical imaging and diagnostic procedures, security systems that detect trace amounts of toxic or volatile chemicals and devices that depend on the analysis of large groupings of atoms.