In the healthcare industry, computational modeling and simulation (CM&S) is gaining in use for understanding, designing, and optimizing medical devices and processes, allowing for efficiently tackling key questions related to patient safety, product quality and effectiveness, and regulatory compliance. Multiphysics simulation, in particular, helps engineers to accurately represent how devices and drugs interact with the human body.

In this eBook, you will learn how four teams from around the world are using CM&S to create safe and effective medical devices while reducing costs and the need for in vitro and in vivo testing.

Topics include:

• MRI Systems
• Ablation Technology
• Safety of Medical Implants
• Wearable Systems
• Hemocompatible Pump
• Design Optimization

Your download is sponsored by COMSOL.

*Please see www.comsol.com/privacy for COMSOL’s Privacy Policy. Contact COMSOL at www.comsol.com/contact for more information. Note that COMSOL will follow up with all registrants about this eBook and any related questions.

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This simple, quick guide not only underscores the critical importance of prioritizing security but also advocates for a proactive “security-first” approach throughout the manufacturing process of connected devices. It emphasizes the principle of security by design, urging manufacturers to integrate robust security measures from the outset rather than treating it as an afterthought. Through this proactive stance, devices can better withstand the evolving threat landscape, ensuring the integrity and reliability of IoT ecosystems for both businesses and consumers alike.

Your download is sponsored by DigiCert.

The post The 7 Habits of Highly Trustworthy Medical Devices appeared first on Engineering.com.

This white paper illustrates how to attain higher image quality, speed and accuracy using plane wave and synthetic aperture imaging with Versal adaptive SoCs from AMD. These approaches offer substantial frame rate improvements and accuracy. The white paper also highlights how deep learning algorithms can be used for further improvements.

Your download is sponsored by Avnet and AMD.

The post Learn how AMD Enables Image Quality, Speed and Accuracy in Medical Ultrasound Applications appeared first on Engineering.com.

This eBook illustrates how AMD is leading the industry in differentiating healthcare products with low-latency and deterministic processing for higher-quality image processing. The broad portfolio of SoCs and processors provide the efficiency and functional safety your application needs.

Your download is sponsored by Avnet and AMD.

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AMD provides a wide range of functionality in its hardware and software development resources which are strategically designed to meet medical standards. The Zynq UltraScale+ MPSoC platforms adhere to the IEC 61508 and IEC 62443 standards. Discover the valuable opportunity for medical device developers to align with the joint objectives of reliability and protection in electronic healthcare systems with this white paper.

Your download is sponsored by Avnet and AMD.

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This episode of the Engineering Roundtable is brought to you by Siemens. 

The smart factory has been essential for manufacturing success. Since the dawn of mass production. Traditionally embodied in paper processes and in the minds of manufacturing professionals, modern hardware and software enables production processes to generate, aggregate and process large amounts of relevant data with speed and complexity impossible for human minds to handle in real-time. Success in manufacturing today frequently boils down to a company’s ability to make good decisions based on intelligent use of data aggregated from the shop floor, front office and from the field.  

Learn more about solutions to engineering and manufacturing challenges for small and medium businesses.

Panelists:

Mike Denley, Senior Director of Strategic Programs and Initiatives, Siemens Digital Industries Software:

Mike currently leading the Siemens Cloud Application Solutions Program & Initiatives team. That team helps the development and coordination of strategic key Industrial IoT programs and initiatives to increase and improve outcomes involving product, customers and partners working with Product Management, Research & Development and Strategic Partners. This His academic and industry experience includes graduate and post-graduate work in Total Quality Management, Software Design & Development, Organizational Change, Lean Six Sigma and Business Analytics with a focus in Sustainability.

Rahul Garg, Vice President of Industrial Machinery and Small to Midsize Business Programs, Siemens Digital Industries Software:

Rahul’s multiple roles deliver solutions to help manufacturers develop competitive products and fill portfolio gaps using tools such as software as a service to great effective go to market strategies, as well as business practices that support small and medium-sized manufacturing customers achieve high performance. Rahul holds graduate and undergraduate degrees in computer science and computer engineering. 

Moderator:

Jim Anderton, Multimedia Content Director, engineering.com:

Jim was formerly editor of Canadian Metalworking Magazine and has contributed to a wide range of print and on-line publications, including Design Engineering, Canadian Plastics, Service Station and Garage Management, Autovision, and the National Post. He also brings prior industry experience in quality and part design for a Tier One automotive supplier.

The post Small Factory, Smart Factory: Advanced Systems Boost Manufacturing SMB’s appeared first on Engineering.com.

NextFlex, a U.S. Department of Defense-sponsored Manufacturing Innovation Institute funded by the Air Force Research Laboratory, announced $8.45 million in funding on Monday for flexible hybrid electronics (FHE) innovation.

The funding includes $4.25 million in cost-sharing contributions from participants and will go toward nine new projects that are part of NextFlex’s Project Call 7.0 to promote FHE development and adoption throughout the U.S.’s advanced manufacturing sector.

FHE combines the flexibility of low-cost printed plastic film substrates with semiconductor chips to create a new class of electronics. FHE devices and components are generally lightweight, thin and can be manipulated, bent, folded and stretched. It’s an emerging area of tech innovation largely funded by governments, investment firms and academic institutions that are trying to push the development of technological devices that can withstand a broader range of environmental conditions and applications.

These circuits are often made of a plastic polymer film and can be printed on different kinds of surfaces. Some semiconductor chips can be manufactured with metal oxide lithography and placed on a flexible substrate, bypassing the need for printing. However, chip placement poses technical challenges whether it’s done by forcing the chip into place, creating a depression in the substrate to place the chip, or by performing mechanical exfoliation via substrate cracking.

FHEs have many applications, but one of the most notable is for wearable devices and medical devices that need to softly adjust to the contours of the body. They’re also used in prosthetics, rollable displays, Internet of Things (IoT) devices, and sensors for a variety of applications.

NextFlex’s projects include the development of additive manufacturing approaches for integrated circuit (IC) integration into complex multilayer FHE devices, improved environmental sustainability of electronics with FHE manufacturing, manufacturing FHE-enabled automotive components, and manufacturing and safety assessments of wearable devices.

The funded projects under Project Call 7.0 represent a diverse set of companies and academic institutions that are working to advance FHE capabilities. Several of the projects will focus on expanding additive manufacturing approaches for FHE while addressing critical needs required to enhance domestic advanced semiconductor packaging capabilities that are part of the recently passed CHIPS and Science Act.

“These important new projects will enhance the state of the art in hybrid electronics, support national efforts for semiconductor package manufacturing, and help to transition an increasing number of new capabilities into the U.S. industrial manufacturing sector for further advancement of the industry,” said Malcolm J. Thompson, NextFlex executive director, in a news release. “The NextFlex member community is accelerating FHE and additively manufactured electronics toward commercialization in a number of critical application areas addressed in these projects.”

One of Project Call 7.0’s areas of focus is to improve environmental sustainability in electronics manufacturing. This will entail incorporating water-based inks and lower-temperature processing, and assessing the manufacturing reshoring of low-cost, single-use medical devices that are manufactured in a more sustainable manner and use less toxic materials.

Seven companies will receive funding under the Project Call 7.0 initiative. Lockheed Martin Advanced Technology Laboratories will use the funds to create FHE interposers for heterogeneous integration of a high-density fiber optic multi-chip module (MCM) for thinner interposers with finer feature capabilities.

GE Research and Binghamton University will develop radio frequency (RF) MCM with embedded die, printed substrates, antennas, and interconnects for low-loss, high thermal conductivity as well as manufacturing approaches for low-cost, sustainable, single-use medical devices.

Raytheon Missiles & Defense will develop printed interconnect solutions for microwave multi-chip packaging for improved die density. Meanwhile, General Dynamics Mission Systems will develop additively manufactured, doubly curved multilayer circuits with active and passive components for embedded RF functionality in complex structures.

Auburn University will put the funds toward sustainable, additively printed electronics featuring water-solvent inks, greater repairability for FHE, low-temperature processing with high reliability as well as the development of in-mold electronics interconnection and thermoforming for 3D-integrated applications in automotive, aerospace and medical device industries.

UES will utilize the funding to create scalable manufacturing systems for ELMNT liquid metal inks for highly stretchable electronics applications. Finally, Sentinel Occupational Safety will put the funds toward safety assessments of FHE wearable chemical and voltage sensors for reduced hazards in industrial occupations. 

The post NextFlex Puts $8M Toward Flexible Hybrid Electronics Innovation appeared first on Engineering.com.

Models showing the pressure from the foot on the outsole during the toe-off phase of the walking gait cycle. (Source: Hexagon.)

In today’s virtual-for-everything research and development world, it is no surprise there is an initiative that focuses on the virtual human. The virtual human has many practical applications such as the study and prevention of trauma or the improvement of diagnosis and surgical techniques. With multi-scale analysis, tissues, limbs, body sections, or complete human models can be used for virtual testing.

The Laboratory of Biomechanics and Application (LBA) is a joint research unit between the Université Gustave Eiffel’s transport, health, safety department and the Aix-Marseille Faculty of Medicine. LBA is located on the premises of the Faculty of Medicine in the northern Marseille Health Center in France. The multi-disciplinary approach in this laboratory combines both engineering and medical science expertise to focus on human impact biomechanics. Supported by 39 collaborating research staff, the LBA is designing tools and human models for virtual testing to achieve their own vision of a “Virtual Human.” Their practical research has taken root in the real world affecting clinical and surgical settings, as well as transportation safety.

An Orthopedic Challenge

The virtual human and limb models created by LBA have practical applications for injury prevention analysis and clinical settings. A developed foot-limb model is currently being used for emerging medical applications such as optimizing orthopedic insoles that can be easily 3D printed right in the clinic. Researchers utilize up to seven different engineering software programs to comprehensively model the dynamics of a realistic walking gait. A digital twin model of the patient’s foot can be leveraged to gain insights on how to improve insoles for a patient’s specific needs. The adjusted custom insole can maximize the intended effect of the insole and the comfort of the patient.

The current foot model requires significant time to accurately render the effects of the insole. LBA used a CAE-centric platform, ODYSSEE CAE from Hexagon’s Manufacturing Intelligence division, to leverage the model and provide easy-to-understand, instantaneous feedback as needed by clinical podiatrists. This platform allows users to apply machine learning, artificial intelligence, reduced order modeling and design optimization to workflows and create cost effective digital twins based on CAE simulation data and physical test data. Complex engineering questions can be answered in real-time that would ordinarily take hundreds of hours to simulate and analyze.

Walking Toward the Solution

The LBA’s foot model provides a complete examination of the patient’s walking gait. The analysis of the walking dynamics was conducted by dividing the gait into four phases, then accounting for details caused by the different properties of bone, soft plantar tissue, skin tissue, ligaments, joint placement, joint stiffness, and the ground. The parameters of the foot and insole models were modified according to the measurements of the patient’s foot. This adjustment creates the numerical (digital) twin of the actual patient, mimicking any kind of foot geometry, gait, and walking pattern.

Utilizing the same CAE software, LBA used thirty simulations of the original foot model to create a reduced order model that accommodates any foot geometry and accurately reproduces the dynamics of the patient’s walking gait. The sensitivity studies of the reduced model showed the parameters with the largest effect on the gait. The software was able to generate near instantaneous feedback using the reduced order model, increasing the usefulness of the model to clinicians.

Enhanced Care and Comfort Results

Real-time analysis feedback aids podiatrists in providing the best possible care to their patients. The resulting reduced foot model accurately predicts the dynamic response of the comprehensive model in less than one second compared to the four hours needed to resolve the full model. The predictions of the reduced model matched very closely the center of pressure displacement observed in the original model. The ability to digitally match different insole designs to the patient’s foot and observe the effects in real time allows for rapid optimization of the design to reach the intended effect.

(Source: Hexagon.)

Custom insoles can also be enhanced with differing materials, local densities, and geometries to best meet the patient’s needs. The reduced model has also shown promise in improving the outsoles of some sport shoes. Another major benefit of using digital twin foot models is the ease of 3D printing the custom insole. The practical application of LBA’s foot model has been accentuated through CAE real-time predictive analysis, and this approach has been successfully implemented in partnering podiatric clinics.

To learn more, visit Hexagon.com.

The post Real-Time Design of 3D Printed Orthopedic Insoles appeared first on Engineering.com.

A startup called Esper Bionics is looking to use technology to expand human capabilities at scale. In its quest to develop new devices, the company is starting with a self-learning robotic hand for people with limb differences.

Currently, there are an estimated two million people with limb loss in the U.S. alone, and this number is expected to double by 2050. Unfortunately, current prosthetic devices fall short in terms of their utility and aesthetics. Esper Bionics is developing its robotic hand to improve the lives of those with limb differences and accelerate the development of human-technology interfaces.

The Esper Hand gripping a fork. (Image courtesy of Esper Bionics.)

Esper Bionics Wants to Expand Human Potential

Esper Bionics, which was founded in 2019 by Dr. Dima Gazda, Anna Believantseva, and Ihor Ilchenko, is currently based in New York City, with research and manufacturing offices in Germany and Ukraine. The company is working to expand the full technology stack for electronic implants—developing the devices themselves, low-power electronics, and AI and advanced data analytics.

In conversation with Dr. Dima Gazda, cofounder of Esper Bionics, engineering.com learned more about the company’s history and ongoing R&D. As both an electrical engineer and medical doctor, Gazda has the unique education required to develop effective devices for human augmentation.

Originally, Gazda and his cofounders started the company to develop what they thought was the most important technology stack for the future of humanity: electronic implants. To start its R&D journey, Esper Bionics focused on the prosthetic industry, which is currently low-tech. Most industry-standard prosthetics are purely aesthetic and do not restore a limb’s functionality. Other companies are working to improve the technical capabilities of prosthetics, including Psyonic. However, Esper hopes to stand out with the speed and utility of its device, which actually learns user habits and customizes the functionality to each patient.

The Esper Hand as a Self-Learning Prosthetic

The goal of the Esper Hand is simple: design a prosthetic that can be controlled just like biological human hands.

Consider a hobby like knitting.

Typically, you would start slowly and inefficiently with the knitting and placement of the needles. However, over time, you would learn the mechanics of knitting until it became smooth, easy and effortless.

The Esper team developed its robotic hand with this in mind, focusing on creating a device that can learn from its user and become increasingly customized with use.

A series of digital signal processors, specifically electromyography sensors, currently control the device. The remaining muscles in the user’s limb control the movement of individual fingers, use different grips, and perform almost any task. Therefore, the device is not the same in every individual as it depends on the remaining active muscles for its control.

Gazda highlighted the mechanical precision of the device: “The [Esper Hand] is up to 10 times more precise in detecting muscle movement compared to most prosthetic devices.”

He mentioned that the device has faster activation and hand control, moving the bar of prosthetics closer to the reaction time of biological hands. To improve the device’s utility, it also includes mechanical protection from water and dust.

On the software front, Gazda discussed the company’s proprietary Esper Platform, which encompasses both a server and AI-powered applications. The software uses data inputs from the hand to learn the user’s habits and improve the device’s performance. For example, the hand can detect muscle activity to recognize certain situations and accurately predict the grip that would best fit a specific context, such as picking up a heavy mug or a delicate blueberry. Plus, the company’s proprietary machine learning algorithms can correct for common issues experienced by prosthetic users, such as sweat and differences in their range of motion.

The Esper Hand holding a pomegranate seed. (Image courtesy of Esper Bionics.)

“The server collects data from the hand and updates the control algorithms to fit the user’s everyday routine,” said Gazda.

The device also improves its ability to detect muscle activity over time, improving the activation, reaction time, and overall hand control. Interestingly, users can remotely adjust the features of their devices, and Esper can send automatic setting suggestions to help the user to improve their functionality.

Beyond the hardware and software, Gazda highlighted the industrial design that went into the production of the Esper Hand. The current design notably considered the aesthetics of the final device, incorporating feedback from individuals with limb differences who were looking for something that they would be excited to wear. Gazda added that at 380 g, the Esper Hand is currently among the lightest prosthetics available on the market.

As part of its industrial design, Esper Bionics is looking to develop alternative materials for a model that can be priced for developing countries. Other organizations are also working on prosthetics for developing regions, including the Victoria Hand Project.

FDA approval of the prosthetic is currently in progress, and the company has 10 users in the New York area, with 10 more users expected by the end of 2022. Gazda considers the company to be in beta testing right now and hopes to see the device expand beyond the U.S. before long.

Nika, an Esper Hand user, playing a video game. (Image courtesy of Esper Bionics.)

What’s Next in Electronic Implants?

Gazda emphasized that his focus is on the future of wearable technology and human augmentation. Expanding from its robotic hand, Esper Bionics is working to develop prosthetics that can assist people with limb losses below the elbow, as well as help those with lower limb losses. As such, the company was chosen to assist with efforts in Ukraine to innovate prosthetics for veterans.

But Gazda wants to look well beyond prosthetics when considering the future of Esper Bionics. The goal is to develop electronic implants to improve human health and well-being. Instead of the Neuralink approach of integrating directly with the central nervous system, Esper is focused on integrating with the peripheral nervous system to improve the utility and accessibility of implants.

“Humanity as we know it is 150,000 years old. We have made major advancements in infrastructure in terms of transportation, buildings, and more. But this is the first time we can advance humans directly with technology,” said Gazda. “When we look back in 10,000 years, there will be a clear divide in the evolution of humans and a shift in our thinking about technology.”

Gazda added that in his opinion, electronic implants in humans will have a bigger impact on humanity than the automotive or space industries.

Although Esper Bionics is still at least five years away from implanted devices, the company is actively developing Esper Control, a wearable brain-computer interface device. All the devices in development will utilize the Esper Platform to help the products customize to each user’s individual habits.

It will be exciting to see how the company further develops the robotic hand and the other devices in its R&D pipeline over the next few years.

The post This Prosthetic Learns Your Habits and Gets Better the More You Use It appeared first on Engineering.com.

Over 500,000 Americans require dialysis three or more times per week, a treatment for failing kidneys that can take upwards of five hours to filter toxins from the blood. Most dialysis in the U.S. today takes place in clinics or private treatment centers, but there’s a better setting: in the home. Not only is at-home dialysis more comfortable for many patients, it’s also cheaper for taxpayers—enough so that in 2019, President Trump launched the Advancing American Kidney Health initiative, one goal of which is to boost the number of at-home dialysis patients by 2025.

It’s not just kidney disease patients that are shifting to in-home care. The trend toward telemedicine—healthcare at a distance—has been building for decades, and is helping drive complex new requirements for medical devices: low power, light weight and small size are just some of the constraints device designers must now consider. It’s imperative to choose sensors that are up to the task.

Mini Medical Devices

There has been one major health concern on everyone’s mind for the past few years, and while the COVID-19 pandemic didn’t ignite the trend to telemedicine, it has accelerated it.

“There’s a greater emphasis now in thinking outside the box on some of these therapies, like glucose monitoring and oxygen concentrators, that used to be done in the hospital,” says Martin Murray, Global Application Engineer at Honeywell for board-mount pressure sensors, airflow sensors and force sensors.

Hospitals have germs—an obvious fact upon consideration, but one that didn’t resonate with many until the threat of COVID. “If you can do these procedures at home, that not only limits the exposure to other people that might have COVID, but it also will alleviate overworked resources at these clinics and hospitals,” explains Alfredo Arteta, North America Product Manager for Honeywell’s medical vertical.

At home doesn’t necessarily mean in the house, either. Rethinking therapies for mobility (ambulatory care, to use the industry jargon) ultimately means a greater quality of life for the patients. “You’re allowing grandpa and grandma to go to their grandson’s baseball game because they’re not tied to a big tank of oxygen,” Murray says.

But that kind of mobility means battery power. Medical device designers must think more carefully about their power usage, selecting sensors and other components that won’t drain the battery. Mobility also means that someone must lug the device around, necessitating lighter weight and smaller size.

Miniaturization is a trend that extends beyond telemedicine. Today, small size and light weight is just as important for equipment in a crowded ICU.

“It used to be a ventilator, for example, could be as big as needed,” Murray says. “Now they’re trying to shrink all that down. Every little component in the system is being looked at, so small size is critical there.”

For example, Honeywell’s MPR Series Pressure Sensors measure just five millimeters square, and its ABP Series Pressure Sensors are just a couple millimeters bigger. Suffice it to say that both of them would be very easy to lose. Murray says these pressure sensors are used in many ambulatory applications.

The Honeywell MPR Series pressure sensors measure just five millimeters by five millimeters. (Image courtesy of Honeywell.)

Cost-Effective Care

Another trend affecting home medical devices and hospital equipment alike relates to sterilization. At home, self-care patients lack the tools and training to properly sterilize equipment. It’s not as easy as breaking out the bleach—while it is an effective disinfectant, bleach eats away at glass and silicon and can easily damage electronics.

Even in a hospital setting, sterilization of medical equipment has become trickier. One common tactic is to use a hot autoclave to kill off harmful bacteria, but the temperatures required to finish the job are increasing. Twenty years ago, 120°C or so was sufficient. But today, as bacteria has gradually gained immunity, temperatures in the 130°C range are necessary. It may seem like only a slight increase, but it’s enough to damage electronic components.

“It’s harder to design a sensor that can withstand that increase in temperature,” Murray says.

While there are other methods of sterilization, such as using ethylene oxide, not all hospitals have access to this treatment. The bottom line is that medical equipment is becoming harder to reuse, and designers must account for this fact. Low unit cost is becoming paramount both at home and in the hospital. “Any sensors or any technology you put in there, a lot of it has to be disposable,” Murray says.

Acute Accuracy

The trend toward lower-cost medical equipment is countered by a trend to improve sensor accuracy. One way to do this is to move sensors as close as possible to the patient, such as putting an airflow sensor in a mask rather than in a machine separated by several feet of plastic tubing. That has ramifications for the sensors, says Murray, as they have to be “wet-capable,” designed to withstand liquids and made with “biocompatible” materials.

The sensors themselves can also be designed for higher accuracy. Take pressure sensors, for instance, which are used in spirometers to measure a person’s breathing and diagnose lung diseases. Spirometers must be capable of measuring a patient’s full lung capacity. That encompasses a wide range of airflow, from the upper limit of lung capacity to the very low-pressure onset of breathing, a fruitful stage for finding lung problems.

“You need a sensor with what is called a high turndown ratio, which means you can measure very accurately over a wide range of flow,” Murray says. “The resolution on the output, how small a pressure change can you discern, is what it really comes down to.”

A decade or so ago, 12 bits of output resolution was considered a good industry standard. Today’s pressure sensors offer four or more times that resolution. Honeywell’s ABP Series Pressure Sensors, for example, offer a 14-bit output. The company’s RSC Series goes even further with a 16-bit resolution, making it a popular choice for spirometers and ventilators.

The Honeywell RSC Series of board mount pressure sensors. (Image courtesy of Honeywell.)

Better sensor accuracy is extremely important for medical lab automation, which has become critical for developing new devices, medicines and vaccines. For example, more accurate sensors mean more tests can be conducted on a limited blood sample.

“There’s an increasing expenditure on research and development for lab automations,” Arteta says. “Helping improve that infrastructure, especially in emerging countries, is definitely going to help present different avenues of growth.”

While the healthcare industry has been in upheaval for two years, valiantly fighting the novel coronavirus, it has also been a period of reflection and transformation. The pandemic put new pressure on trends that have been shaping up for decades: trends toward telemedicine, miniaturization and higher accuracy. For designers of medical devices, it is more important than ever to pay heed to these trends.

“Having a small, low-cost, very accurate and reliable device is critical,” Murray says.

To learn more, visit TTI’s Honeywell Medical Sensor and Switch Solutions.

The post The Doctor Will Sense You Now appeared first on Engineering.com.