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6 Things You Should Know About the Emerging TMVR Market

MD+DI/Amanda Pedersen 6 Things You Should Know About the Emerging TMVR Market
The transcatheter mitral valve replacement market is still in its infancy, according to Jason Mills, a medtech analyst at Canaccord Genuity.

For recent MD+DI coverage on the promising field of transcatheter mitral valve replacement/repair, check out these stories:

Abbott Wins Additional Indication for MitraClip

Cardiovalve Makes Crucial Move in TMVR Market

Abbott Makes Strong Statement in TMVR Space with SUMMIT

LivaNova Looks to Be a Standout Firm in TMVR

Viral self-healing gel kills antibiotic-resistant bacteria and devours pollutants

 Viral self-healing gel kills antibiotic-resistant bacteria and devours pollutants

Bacteriophages reportedly are the most numerous organisms on Earth, outnumbering all other organisms combined. And that, apparently, is a good thing, because these viruses kill bacteria. Researchers at McMaster University (Hamilton, ON) have developed a gel containing trillions of phages, as they are also called, that could benefit medical devices via antibacterial coatings as well as environmental cleanup operations, since they could be programmed to devour plastic waste and pollutants.

self-healing bacteriophage gel

In her lab at the university, Chemical Engineer Zeinab Hosseini-Doust and her team grew, extracted and packed together phages that spontaneously assembled themselves into liquid crystals. Bound together chemically, the viruses formed a gelatin-like substance that can heal itself when cut, said Hosseini-Doust. The video embedded below shows a demo.

Resembling Jell-O in appearance, a single milliliter of the yellow gel contains 300 trillion phages. “Phages are all around us, including inside our bodies,” explained Hosseini-Doust in a press release on the university website. “Phages are bacteria’s natural predators. Wherever there are bacteria, there are phages. What is unique here is the concentration we were able to achieve in the lab to create a solid material.”

The research was published on July 24, 2019, in the journal, Chemistry of Materials.

Phage research is a growing field, Hosseini-Doust added, because of its medical applications. “Phages can kill bacteria that are resistant to antibiotics." Moreover, the DNA of phages can readily be modified to target specific cells, including cancer cells. And through a Nobel Prize-winning technology called phage display, it’s even possible to find phages that target plastics or environmental pollutants.

Medtronic Looks to Expand Reach of Artificial Pancreas with New Submission

Pixabay Medtronic Looks to Expand Reach of Artificial Pancreas with New Submission

Medtronic fundamentally changed the diabetes management space when it received FDA approval for the MiniMed 670G hybrid closed-loop system back in 2016. The device – dubbed the artificial pancreas has been highly successful used in more than 180,000 people today.

The Dublin-based company wants to reach even more patients and has submitted a request to FDA that could help it accomplish its goal. Last week, the firm announced a PMA submission to the agency requesting for non-adjunctive labeling for the Guardian Sensor 3, as part of the MiniMed 670G system.

Guardian Sensor 3 is a continuous glucose monitoring sensor that controls the automated insulin delivery via Medtronic’s hybrid closed-loop system, the MiniMed 670G system.

Dr. Robert Vigersky, CMO, Global Medical and Clinical Affairs for the Diabetes Group at Medtronic said the reason behind PMA submission is because Medicare requires a non-adjunctive label for sensor reimbursement.

“If non-adjunctive labeling is approved by FDA, the Guardian Sensor 3 can be considered for Medicare reimbursement, which, if granted, could broaden patient access by allowing for Medicare coverage of the world’s first and still the only commercially available hybrid closed loop system,” Vigersky, told MD+DI via email. “With the Medicare coverage, there are two categories of patients who will become eligible to use our sensor - the 20% of individuals with type 1 diabetes (about 150,000 individuals in the U.S.) that are already Medicare age and those who are aging into Medicare (several thousand per year).

Medtronic’s submission for non-adjunctive coverage follows the launch of the enhanced Guardian Link 3 transmitter earlier this year, which the company said improved the patient experience on the system by reducing the number of system alarms by 60% and allowing patients to spend an additional 2.2 hours per day utilizing the SmartGuard technology in Auto Mode, which automatically regulates basal insulin throughout the day and night.

3D-printed flexible mesh supports customization of prosthetic and implantable medical devices

3D-printed flexible mesh supports customization of prosthetic and implantable medical devices

Leveraging one of the game-changing capabilities of 3D printing, engineers at the Massachusetts Institute of Technology (MIT; Cambridge, MA) have designed pliable, 3D-printed mesh materials in which the flexibility and toughness can be fine tuned to support soft tissues such as muscles and tendons. The intricate mesh structures can be tailored to match individual anatomies in ankle and knee braces and even implantable devices, such as hernia meshes, according to a press release on the MIT website.

3D-printed flexible mesh developed at MIT
The 3D-printed flexible mesh structures can be tailored to match individual anatomies in ankle and knee braces and even implantable devices. Image courtesy Felice Frankel/MIT.

As a demonstration, the research team printed a flexible mesh for use in an ankle brace. They tailored the mesh’s structure to prevent the ankle from turning inward—a common cause of injury—while allowing the joint to move freely in other directions. The researchers also fabricated a knee brace design that could conform to the knee even as it bends and a glove with a sewn-in 3D-printed mesh that conforms to the wearer’s knuckles, providing resistance against involuntary clenching that can occur following a stroke.

“This work is new in that it focuses on the mechanical properties and geometries required to support soft tissues,” said Sebastian Pattinson, who conducted the research as a postdoc at MIT. Pattinson, now on the faculty at Cambridge University, is the lead author of a study published in the journal, Advanced Functional Materials.

“3D-printed clothing and devices tend to be very bulky,” said Pattinson. “We were trying to think of how we can make 3D-printed constructs more flexible and comfortable, like textiles and fabrics.”

Inspired by collagen

Inspired by the molecular structure of collagen, which makes up much of the body’s soft tissues and resembles “curvy, intertwined strands” under a microscope, Pattinson designed wavy patterns that he 3D-printed using thermoplastic polyurethane. He then fabricated a mesh configuration to resemble a stretchy yet tough, pliable fabric. The taller he designed the waves, the more the mesh could be stretched at low strain before becoming more stiff, a design principle that can help to tailor a mesh’s degree of flexibility and helped it to mimic soft tissue, explained the article on the MIT website.

The researchers tested the mesh on the ankles of several healthy volunteers. In general, they found the mesh increased the ankle’s stiffness during inversion (i.e., when the ankle turns inward), while leaving it relatively unaffected as it moved in other directions.

“The beauty of this technique lies in its simplicity and versatility. Mesh can be made on a basic desktop 3D printer, and the mechanics can be tailored to precisely match those of soft tissue,” said Associate Professor of mechanical engineering A. John Hart, who participated in the research.

The ankle brace was made using relatively stretchy material, but for other applications, such as implantable hernia meshes, it might be useful to include a stiffer material that is also conformable. To this end, the team developed a way to incorporate stronger and stiffer fibers and threads into a pliable mesh, by printing stainless-steel fibers over regions of an elastic mesh where stiffer properties would be needed, then printing a third elastic layer over the steel to sandwich the stiffer thread into the mesh.

The combination of stiff and elastic materials can give a mesh the ability to stretch easily up to a point, after which it starts to stiffen, providing stronger support to prevent, for instance, a muscle from overstraining.

3D-printing innovation adjusts material's stickiness

The team also developed two other techniques to give the printed mesh an almost fabric-like quality, enabling it to conform easily to the body, even while in motion.

“One of the reasons textiles are so flexible is that the fibers are able to move relative to each other easily,” Pattinson says. “We also wanted to mimic that capability in the 3D-printed parts.”

In traditional 3D printing, a material is printed through a heated nozzle, layer by layer. When heated polymer is extruded, it bonds with the layer underneath it. Pattinson found that, once he printed a first layer, if he raised the print nozzle slightly, the material coming out of the nozzle would take a bit longer to land on the layer below, giving the material time to cool. As a result, it would be less sticky. By printing a mesh pattern in this way, Pattinson was able to create layers that, rather than being fully bonded, were free to move relative to each other. He demonstrated this in a multilayer mesh that draped over and conformed to the shape of a golf ball.

Finally, the team designed meshes that incorporated auxetic structures, patterns that become wider when you pull on them. For instance, they were able to print meshes, the middle of which consisted of structures that, when stretched, became wider rather than contracting as a normal mesh would. This property is useful for supporting highly curved surfaces of the body. To that end, the researchers fashioned an auxetic mesh into a potential knee brace design and found that it conformed to the joint.

“There’s potential to make all sorts of devices that interface with the human body,” Pattinson said. "Surgical meshes, orthoses, even cardiovascular devices like stents—you can imagine all potentially benefiting from the kinds of structures we show.”

Friday Funny: Dilbert Gets His Diagnosis

Hey, if you see a piece of engineering humor that hits at the core of what it means to be an engineer, send it along to:

Rob Spiegel has covered automation and control for 19 years, 17 of them for Design News. Other topics he has covered include supply chain technology, alternative energy, and cyber security. For 10 years, he was owner and publisher of the food magazine Chile Pepper.


Drive World with ESC Launches in Silicon Valley

This summer (August 27-29), Drive World Conference & Expo launches in Silicon Valley with North America's largest embedded systems event, Embedded Systems Conference (ESC). The inaugural three-day showcase brings together the brightest minds across the automotive electronics and embedded systems industries who are looking to shape the technology of tomorrow.
Will you be there to help engineer this shift? Register today!


Staying Competitive with Virtual Commissioning

Many engineering organizations face major challenges when designing and delivering new products. These challenges include the discovery of key design issues late in the development cycle that introduce unbudgeted costs and delays, especially if design issues arise during the prototyping, or integration stages, where real hardware is involved. For companies in the manufacturing industry, staying competitive will require significant cost reductions, increased productivity and innovation, and the quick adoption of new technologies in order to achieve these goals. With the right set of tools for modeling and virtual commissioning, companies can explore, test, and validate new designs, all while reducing the time and money spent on product development.

Cost-Effective Motor Sizing

A leading manufacturer of injection molding turned to Maplesoft for their virtual commissioning expertise. Their goal was to develop a new design that promised to deliver reliable performance at a new, lower price than ever before. The design, however, had to meet strict requirements for motor sizing, and required a specialized controller that would ensure the same reliability expected from their customers. To ensure accurately sized motors and precise controller design, the company used MapleSim along with B&R Automation Studio to get model-based feedback during their design process. With virtual commissioning, the company could use an accurate, physics-based model of their new design in order to understand the dynamics of their new machine and make informed choices for motor sizing and control design.

By importing the company’s existing CAD information into MapleSim, the physics-based model was set up and customized in a matter of days (Image 1), allowing motor sizing to begin sooner than the company’s traditional processes would have allowed.


Maplesoft, MapleSim, simulation, product design, validation

Image 1. The MapleSim model of the new mold-closing mechanism included mechanism geometries, motor specifications, and other details to ensure a realistic simulation. (Image source: Maplesoft)


The motion profile was implemented in MapleSim, and the simulation results were formulated into a common Speed-Torque graph (Image 2). In this graph, the machine’s duty cycle is seen to be well within the company’s motor requirements. This assured the company that, at every point in the machine’s proposed motion profile, the motor would be operating within safe limits, and that the motor itself was sized without an unnecessarily large margin of error.


Maplesoft, MapleSim, simulation, product design, validation

Image 2. The Speed-Torque graph demonstrated that the required motor torque (green) would stay within operating characteristics of the specified motor (blue) throughout the machine's duty cycle. (Image source: Maplesoft)


Control Strategy Testing
The new machine would split the motor loads in half by using a dual axis closing mechanism, helping reduce the costs of a single, larger motor. A key requirement of the design required that both axes remained in parallel during the opening and closing of the mold. Misalignment of either axis would risk significant damage to the machine; therefore, it was necessary for the control strategy to ensure axis alignment under a variety of conditions. To reduce the risks of machine damage, virtual commissioning techniques were used to test the controller performance against the physics-based model that was previously created.

To prepare the model for virtual commissioning, it was refined to reflect the new dual-axis design. The new mechanism was duplicated and connected to a mold subsystem, which modeled the mold as a spring-damper system. This subsystem provided the required amount of force on the mechanism as it proceeded to close the mold and experience the pushback of the injection molding material. The MapleSim model was then exported as a Functional Mock-Up Unit (FMU), which acts as a standalone, executable model that can be used in a variety of other design tools. The FMU was imported into B&R Automation Studio, where it functions as a variety of inputs (motor torques) and outputs (sensor data) that can run in real-time for control testing.

Once in B&R Automation Studio, the accuracy of the new model and controller were tested to ensure that they could provide meaningful results for the company’s goals. In the weeks following the motion profile testing, the company created a physical prototype of their new dual-axis mechanism. While this prototype would be able to provide them with some testing information, the key piece of information - controller robustness to keep axis alignment - would impose signification machine damage, making repeated testing an extremely expensive choice on a physical prototype. By using a virtual model initially, these risks were avoided.  The results of the realism testing can be seen in Image 3, which show a very close fit between the model performance and the physical prototype performance.  By testing the controller against the virtual model, countless simulations can be run in a fraction of the time it would otherwise take with a physical machine, saving time and money to ensure a robust, reliable machine.

Maplesoft, MapleSim, simulation, product design, validation

Image 3. The MapleSim model, upon importing into B&R Automation Studio, demonstrated highly accurate realism when compared to a physical prototype. (Image source: Maplesoft)

Going Forward

As part of a growing need to speed development and minimize the inherent risk in developing new, innovative products, virtual commissioning is quickly becoming an essential technology. With the right tools in place, it is now possible for many organizations to adopt virtual commissioning techniques for their machine design projects. They may use virtual commissioning in order to reduce their overall commissioning time, to reduce development costs, or to create a more reliable time to market for reputation purposes. While the applications and specifics can vary greatly, a typical virtual commissioning process has many commonalities. In this case, the company was able to create a cost-competitive injection molding machine using a new dual-axis design with smaller, inexpensive motors.

By using tools such as MapleSim, the precise loading requirements of the motors were simulated, ensuring the company had selected the right motor for the job. To avoid the costs and delays of damaging prototypes for controller testing, they were able to ensure the controller’s robustness by using virtual commissioning. Taken together, these techniques have given this company a powerful new set of design tools, helping them continue to stay one step ahead in an already competitive market.

Chris Harduwar is the Vice President of Automation at Maplesoft with two decades of engineering and operations experience. Chris's focus at Maplesoft is on strategic partnerships and exploring new applications for the world's most powerful symbolic math engine.

Drive World with ESC Launches in Silicon Valley

This summer (August 27-29), Drive World Conference & Expo launches in Silicon Valley with North America's largest embedded systems event, Embedded Systems Conference (ESC). The inaugural three-day showcase brings together the brightest minds across the automotive electronics and embedded systems industries who are looking to shape the technology of tomorrow.
Will you be there to help engineer this shift? Register today!


Q2 Review: Takeaways from the Most Prominent Players in Medtech

It's earnings season again, which makes it a good time to check in on the most prominent medtech companies in the public sector to see what kind of a quarter they had and what the back half of the year looks like for the industry.

Stepped-up cooperation between Borealis and Erema tackles challenge of plastics recyclability

Stepped-up cooperation between Borealis and Erema tackles challenge of plastics recyclability

Resin supplier Borealis and recycling systems provider Erema have signed a letter of intent (LOI) for the purpose of deepening their cooperation in the field of mechanical recycling. The shared goal is to advance mechanical recycling technologies in order to accelerate the transition to a circular economy of plastics. The companies also aim to enhance recycling processes in order to satisfy increasing market demand for higher-quality recyclate used in high-end applications.

Manfred Hackl, CEO Erema Group GmbH (left) with Günter Stephan, Head of Mechanical Recycling, Borealis Circular Economy Solutions, Borealis AG. [Photo: Borealis]

While the ultimate aim of the stepped-up cooperation is to effect the more rapid transformation to a circular economy, Borealis and Erema will collaborate most specifically on developing improved technologies and processes in mechanical recycling by leveraging each company’s respective area of expertise: Borealis in polymers, and Erema in engineering; to  this end, there will be joint tests, trial runs and pilot projects.

The companies will also use knowledge exchange and best practices to design and implement new and practical technical solutions. Recyclate should be available in greater amounts, exhibit improved mechanical properties, be suitable for high-end applications and commercialized at a faster rate. Further, they will standardize and harmonize input feedstock and recyclate output (pellets) in order to enable the broader use of recycled solutions for individual end-use applications, and in particular for everyday consumer products.

Finally, the will work on upscaling the mechanical recycling industry: exploring the potential of increasing plant size and total production volumes in order to ensure secure and reliable market availability

In recent years, Borealis has expanded its sphere of activity beyond virgin polyolefins by entering the  field of mechanical plastics recycling. It acquired leading German mechanical plastics recycler mtm plastics in 2016 and leading Austrian recycler Ecoplast in 2018. Now, as part of the Borealis Group, both companies also have long-established ties to the Erema Group.

“To make the circular economy of plastics a reality, we as an industry need to take action, innovate, become more customer-centric, and collaborate,” says Lucrèce Foufopoulos-De Ridder, Borealis Executive Vice President Polyolefins and Innovation & Technology. “Taking our collaboration with Erema to the next level is going to yield positive effects that reverberate across the entire value chain and perfectly underlines our EverMinds ambition.”

“We are pleased to have signed this agreement – not only because it is a great step forward for both our companies, but because our intensified cooperation is certain to have a catalytic effect in the transformational process to a circular economy,” states Manfred Hackl, CEO Erema Group GmbH.

Erema to highlight latest recycling developments at K 2019

Erema to highlight latest recycling developments at K 2019

Erema will bring a portfolio of recycling solutions for the plastics industry to the K show in Germany come this October. Vacunite bottle-to-bottle recycling technology will be the headlining development at the company’s stand. It is a combination of the proven Vacurema process with newly patented, vacuum-assisted solid state polycondensation (SSP) by Polymetrix for the production of food-grade rPET pellets.

Erema’s Hackl explains the company’s PET bottle recycling technology at an event in Linz, Austria, in June.

In the in-house and industrial sectors, the new Intarema ZeroWastePro system is a compact solution that is precisely tailored to the requirements of recycling production waste. The optimized design of the machine makes integration into the existing process chain even easier and enables significantly shorter delivery times for customers.

Pure Loop, an Erema Group subsidiary in the shredder-extruder technology segment, will be displaying the new ISEC evo  series as a supplement to its existing product range. In the future, this will enable output rates of more than 1,500 kg/h to be achieved for the first time.

In post-consumer applications, the focus is on an increasingly diverse range of applications for high-quality recycled materials using contaminated plastic waste that can be processed using innovative Erema recycling technology. The most recent example of this is the shower gel bottles of a well-known brand manufacturer that for the first time are made from 100-percent HDPE post-consumer recycled material from Austria's yellow recycling sacks - a world first in the cosmetics sector.

Erema will also be demonstrating its pioneering role in relation to industry 4.0 applications. BluPort, a newly developed customer portal, brings together decision-relevant information and service offers for customers in a clear and user-friendly way. "The networking of virtual data levels with real process sequences will create new solutions for plant operation and new smart service offerings in the future. With a focus on data security and customer benefits, BluPort will be an exciting platform for new applications, which will enable our customers to make the most of the diverse potential that digitalization already offers and will continue to offer in the future," explains Erema CEO Manfred Hackl.

Further, the Erema Circonomic Centre will be a highlight for visitors to the outdoor area. "Circonomic is a word we created from circular and economy to express what we as the Erema Group want to achieve, namely the integration of recycling know-how into the plastics value chain, so that our industry, the environment and society as a whole, can gain ecological and economic benefits from it", is how Hackl describes the objective of the presentations at the Circonomic Centre. How this is possible will be explained to visitors live, directly on site using outstanding cooperation projects as an example. "We make it possible for trade fair visitors to experience the circular economy in the truest sense of the word," notes Marketing Manager Gerold Breuer.

For this purpose, injection molding and film waste collected during the trade fair will be recycled and processed on site. In cooperation with raw material manufacturers, processors, branded goods companies and recyclers, Erema will also present a number of other lighthouse projects that demonstrate the different starting materials and recycling technologies that have already been   used to successfully produce recycled materials for the production of new, high-quality plastic products.

"Products made of recyclate" is also the name of an exhibition that will be on display at the Circonomic Centre to provide an overview of the impressive range of products. These lighthouse projects are important for the industry but also in terms of consumer awareness. "Recycling must become a fixed link in the plastics chain. The players in the plastics industry can only achieve this together. We want to promote working together and at the same time demonstrate that we can provide the best possible recycling technologies for the requirements of the Circular Economy," says Hackl, summing up expectations for the K trade fair.

NASA’s DART Mission Aims to Save Earth from Asteroids

NASA is well along on a new mission that may ultimately save the earth from an event like the one that caused the extinction of the dinosaurs. To Far Side readers, no, it wasn’t because of smoking. Looks like the dinosaurs went through the trauma that Bruce Willis and Ben Affleck try to avoid in the movie, Armageddon, when Earth was threatened by an asteroid on a direct path to our planet.

The Double Asteroid Redirection Test (DART) is a planetary defense-driven test of technologies for preventing an impact of Earth by a hazardous asteroid.  DART will be the first demonstration of the kinetic impactor technique to change the motion of an asteroid in space.

The Double Asteroid Redirection Test, DART, NASA
The DART mission is tasked with hitting the moon of this asteroid. Project manager choose an asteroid with a moon so they can measure the ability to move one asteroid by measuring its relation to the other asteroid. (Image source: NASA)


The germ of the idea for DART came from the need to protect the Earth from a potential cataclysmic event of an asteroid hitting the planet. “The DART project just started with scientists thinking about planetary defense and how you deflect a threat,” Elena Adams is a space systems engineer at the Johns Hopkins University Applied Physics Laboratory told Design News. “It’s hard to measure the hit on an asteroid that is traveling by itself, so we decided to find an asteroid with a moon. You can measure the moon before the test and after the test. You can see if you hit the moon hard enough to move it from an hour to 52 minutes.”

The Double Asteroid Redirection Test, DART, NASA
DART spacecraft. The DRACO (Didymos Reconnaissance & Asteroid Camera for OpNav) imaging instrument is based on the LORRI high-resolution imager from New Horizons. The left view also shows the Radial Line Slot Array (RLSA) antenna with the ROSAs (Roll-Out Solar Arrays) rolled up. The view on the right shows a clearer view of the NEXT-C ion engine (Image source: NASA)

As well as testing the ability to move a large object in space, the DART mission is also testing a new spacecraft. “We’re demonstrating a NEXT-C engine powered by ions,” said Adams. “DART is the first mission to demonstrate smart navigation, which means we’re going to be guiding ourselves into the asteroid autonomously.”

The Double Asteroid Redirection Test, DART, NASA
DART spacecraft with the Roll Out Solar Arrays (ROSA) extended. Each of the two ROSA arrays in 8.6 meters by 2.3 meters. (Image source: NASA)

Once launched, DART will deploy the Roll Out Solar Arrays (ROSA) to provide the solar power needed for the craft’s electric propulsion system. The DART spacecraft will demonstrate the NASA Evolutionary Xenon Thruster – Commercial (NEXT-C) solar electric propulsion system as part of its in-space propulsion.  NEXT-C is a next-generation system based on the Dawn spacecraft propulsion system that was developed at NASA’s Glenn Research Center. 

As for changing an asteroid’s trajectory the test will help determine the amount of impact necessary to make the difference in the asteroid’s path. “You want to hit the asteroid and see if you can move it. For a larger object, you would use other techniques such as gravity. Then there is the nuclear option,” said Adams. “There will be follow-up missions. The Planetary Defense Coordination Office coordinates different efforts, not just for the US, but for organizations in Europe and other countries. It’s an ongoing effort.”

The DART mission is directed by NASA to the Applied Physics Laboratory with support from several NASA centers:  the Jet Propulsion Laboratory, Goddard Space Flight Center, Johnson Space Center, Glenn Research Center, and Langley Research Center. 

Elena Adams will present the keynote address, Earth Strikes Back with the Double Asteroid Redirection Test, at the Drive World Conference in Santa Clara August 27-29.

Rob Spiegel has covered automation and control for 19 years, 17 of them for Design News. Other topics he has covered include supply chain technology, alternative energy, and cyber security. For 10 years, he was owner and publisher of the food magazine Chile Pepper.

Drive World with ESC Launches in Silicon Valley

This summer (August 27-29), Drive World Conference & Expo launches in Silicon Valley with North America's largest embedded systems event, Embedded Systems Conference (ESC). The inaugural three-day showcase brings together the brightest minds across the automotive electronics and embedded systems industries who are looking to shape the technology of tomorrow.
Will you be there to help engineer this shift? Register today!