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Articles from 2019 In August


Another Breakthrough Designation for Concept Medical

Pixabay Another Breakthrough Designation for Concept Medical

Concept Medical’s MagicTouch AVF might have the “magic touch” when it comes down to nabbing breakthrough device designations. The proposed indication for the latest breakthrough device designation is for the treatment of stenotic lesions of Arteriovenous Fistulae or Arteriovenous graft in the hemodialysis treatment of renal failure.

Concept Medical said its first pilot study to investigate the safety and efficacy of Magic Touch PTA Sirolimus balloon was started in Singapore in 2018.

Led by Principal Investigator, Dr. Tan Chieh Suai, a multi-disciplinary team of doctors consisting of interventional nephrologists, vascular surgeons and interventional radiologists, is conducting the study entitled “Sirolimus coated angioplasty balloon in the salvage of thrombosed arteriovenous graft” in Singapore General Hospital.

Suai is also Senior Consultant and Director for the Interventional Nephrology Program in the Department of Renal Medicine in Singapore General Hospital and Duke-NUS Medical School.

“The award of the breakthrough Device Designation for the use of sirolimus coated balloons in dialysis access is fantastic news for patients on hemodialysis, as there is an urgent need for effective and durable treatment for narrowing (stenosis) within the dialysis circuit,” Suai said in a release. “We are very encouraged by the early results of our pilot study in Singapore and grateful to all patients who had participated in the study. In particular, I am most touched by feedback given by one of the patients: ‘So far so good. This new study helped me a lot, saved me from repeated procedures in which I used to need intervention every three months; Now, I can have more time at home, rather than in a hospital.’ We look forward to the launch of a larger multi-center randomized study to confirm our results.”

This marks the second breakthrough device designation the company received in a 30-day-period. In mid-August, the firm said the MagicTouch PTA was granted breakthrough designation for the treatment of Peripheral Artery Disease (PAD) Below-the-Knee (BTK).

Innovation in Telehealth and Patient Monitoring Driving Success for Medtech Companies

Innovation in Telehealth and Patient Monitoring Driving Success for Medtech Companies
Image by romnyyepez from Pixabay 

The market for patient-monitoring equipment is valued at more than $5 billion. The telehealth market is expected to grow most rapidly, with the growing interest in remote healthcare and the declining number of hospitals in the United States. However, the landscape of the pulse oximetry and electroencephalogram (EEG) monitoring markets will experience the biggest shift, given the emergence of disruptive technologies.

The iData Research report suite on the U.S. market for patient-monitoring equipment includes multi-parameter vital signs monitoring, wireless ambulatory telemetry monitoring, telehealth, intracranial pressure monitoring, electromyogram monitoring, cerebral oximetry, fetal and neonatal monitoring, cerebral oximetry, cardiac output monitoring, blood pressure monitoring, and electrocardiography monitoring.

Growth of the Telehealth Market

Telehealth refers to the remote monitoring and clinical management of patient’s vital signs through the use of devices in the home environment. Some common peripheral devices include blood pressure cuffs, weight scales, blood glucose monitors, and pulse oximeters.

The telehealth monitoring market has grown tremendously in recent years, fueled by increasing awareness of the benefits of remote monitoring and home healthcare. Growth was heavily driven by telehealth monitoring for disease management, which represented approximately 60% of total telehealth revenue in 2018, both from purchases and leased devices. Cardiac implantable electric devices accounted for the remainder of the telehealth market.

Currently, the United States boasts the most mature telehealth market in the world as well as a diverse competitive landscape, attributable to a trend toward reimbursement reform and the successes of large-scale deployment initiatives. Moreover, the Veterans Health Administration (VHA), America’s largest purveyor of home telehealth, continues to rapidly expand the size of its remote patient monitoring (RPM) programs and funding.

There had been some anticipation regarding more inclusive Medicare policies that would potentially cover a wider range of telehealth services in 2019, most notably face-to-face teleconsultations. Patients with Medicare Part B medical insurance may be covered for telemedicine services, such as video-chat communications, although coverage is contingent on location and proximity to what may be considered as a rural area. The telehealth segment is expected to grow rapidly over the forecast period at an 11.4% CAGR, representing the fastest-growing patient-monitoring equipment market.

Source: iData Research Inc.

One-of-a-Kind Technologies Disrupt the U.S. Patient-Monitoring Equipment Market

Sales of patient monitoring devices are largely driven by advancements in technology, which is especially apparent in the pulse oximetry and EEG monitoring markets. With regards to pulse oximetry, Rhythmlink is the only company that currently has FDA clearance for MR-conditional electrodes for 1.5T and 3T scanners and has been the only competitor in the market since 2013. Increased adoption of MR-conditional electrodes will accelerate market growth as specialists consider switching to these premium consumables. The benefit to the purchaser lies in the long-term cost savings, as the ability to avoid electrode replacement helps to save time and labor costs and to enhance workflow efficiency. Rhythmlink currently does not have any reusable electrodes and is anticipated to continue to grow through ongoing product innovation in the overall EEG electrode market. Ongoing product improvements include innovations that ensure electrodes stay on longer and are more efficient. Other anticipated product innovations will aid user friendliness and speed and reduce the margin of error. Ives EEG Solutions received FDA clearance for its MR Conditional Cup Electrode in December 2017. Nonetheless, competition is not expected to intensify in this segment as it is a difficult market to enter. Aside from the long process for clearance, MR-conditional electrodes are a risky space to break into, as they do incorporate the aspect of patient safety risks.

Kestrel Labs was another product pioneer in the patient-monitoring equipment market. Although its NiCO Noninvasive CO-Oximeter product has to yet to receive FDA approval, it holds great potential to revolutionize the pulse oximetry space. In the past, Masimo emerged with sophisticated Rainbow Pulse CO-Oximetry and Rainbow Acoustic Monitoring solutions. In addition to SpO2 monitoring, the Rainbow SET (signal extraction technology) platform allows the measurement of respiration rate and blood constituents that previously could only be measured through invasive tests, such as hemoglobin (SpHb) and fluid responsiveness Pleth Variability Index (PVI). The associated sensors integrate around 8 to 15 LED light sources. As such, these products demand a significant price markup relative to alternative products, which has limited their growth on the market. Concerns regarding LED technology have also grown over the years, as “noisy light” may interfere with signaling for monitoring devices and subsequently lead to inaccurate readings. Kestrel Labs has developed a laser-based oximeter to overcome inaccurate readings, while providing sophisticated data at a competitive price relative to Masimo’s current business model. Laser technologies are expected to revolutionize the total pulse oximetry space once it hits the market.

Competitive Analysis

The leading companies sustained their ranking in the overall patient-monitoring market through product innovations and, more notably, strategic mergers and acquisitions. The respective space was led by key players such as Medtronic, Philips Healthcare, Masimo, and GE Healthcare in the United States.

In 2018, Medtronic acquired Mazor Robotics in a deal of approximately $1.2 billion. This transaction is forecasted to expand the technological smartness of Medtronic products through the integration of Mazor robotics’ guidance system platform, which is currently indicated for spine and brain surgeries. In the same year, Philips Healthcare announced it will be building upon its IntelliVue X3 transport monitor by creating a continuous record of patient monitoring, including data produced in the ICU, during transport and in the OR. The company has also engaged in numerous acquisitions over the years. For instance, in 2018, Philips Healthcare acquired Xhale Assurance, a company best known for its specialized pulse oximetry sensors, thereby increasing Philips Healthcare’s footprint in the pulse oximetry market.

Masimo entered into a partnership with Midmark in 2017, integrating its SET pulse oximetry platform with Midmark’s IQvitals Zone Bluetooth monitoring device. The objective of this deal is to increase both the accuracy and efficiency of clinical vital signs monitoring and is forecasted to further Masimo’s market presence in the patient-monitoring equipment market. GE Healthcare also participated in the acquisitional growth process, which was demonstrated in its 2017 purchase of Monica Healthcare. Monica Healthcare’s workhorse product is a fetal/maternal ECG electrode system that will further GE Healthcare’s presence in the total patient monitoring equipment market.

Reference

Patient Monitoring Market Analysis, Size, Trends | Global | 2019-2025 | MedSuite by iData Research

Formosa Plastics announces $332 million expansion

Formosa Plastics announces $332 million expansion

Louisiana Gov. John Bel Edwards and Formosa Plastics Corp. (FPC) Plant Manager Paul Heurtevant jointly announced the company will invest $332 million to expand its production of PVC resin. Formosa Plastics also will add production equipment in two other units of the company’s Baton Rouge manufacturing facility, which FPC has operated since 1981.

business growthThe project will create 15 new direct jobs with an average annual salary of $77,667, plus benefits. Louisiana Economic Development (LED) estimates the project will result in 66 new indirect jobs, for a total of 81 new jobs in East Baton Rouge Parish and the Capital region. Formosa Plastics also will retain 230 existing jobs. The expansion work is expected to create 500 construction jobs beginning in early 2020.

“Formosa Plastics has operated in Louisiana for decades, and we are happy to see its continued success result in this significant capital investment in Baton Rouge,” said Gov. Edwards. “As the company looks to a substantial increase in production and sales of PVC, Louisiana’s skilled workforce is at the ready. Permanent manufacturing jobs are particularly beneficial for our economy, and this major expansion also will support hundreds of jobs in our construction sector.”  

The FPC Baton Rouge facility consists of three operating units producing PVC used in the construction industry, including as insulation in electrical wires, in flooring or buildings needing a sterile environment, and as piping and siding. 

“Louisiana is one of only a few areas uniquely qualified with the resources and infrastructure to support our industry, allowing us to diversify our production across our locations, further adding to the reliability of supply for our customers,” Heurtevant said. “This expansion of our existing PVC unit will not only result in nearly 300 million additional pounds of annual resin production and sales, providing our customers with the quality and consistency they have come to expect from Formosa Plastics, but will also provide for additional permanent jobs and several hundred construction jobs for our community.” 

Differences Between Through Hole and Surface Mount PCB Designs

One of the first decisions involved in laying out a printed circuit board (PCB) is choosing the type and style of components to be used. This decision is mainly driven by the PCB’s electrical requirements, but once those are satisfied, it is often possible to choose from a variety of available configurations and footprints for common component types, such as resistors, capacitors, and diodes. The component types selected will influence the size and appearance of the finished printed circuit board assembly (PCBA).

In the past, components with long leads would be inserted, usually by hand, into plated through holes on the PCB. The leads would then be soldered to form permanent interconnections with the holes. This was known as through-hole assembly.

Through-hole technology, PCB, surface mount PCB, surface mount technology, SMT, SMT components

Through-hole PCB with 14-Pin DIP. Lead spacing for DIP is 0.100” x 0.300”, with 14 holes and associated pads. (Image source: Epec Engineered Technologies)

Increasingly, designers prefer to use a more modern (though by now fully mature) assembly method, which utilizes components whose leads attach to the PCB surface only, without the need for a mating hole. This method, originally known as “planar mounting,” has since become more widely known as surface mount technology (SMT).

The following is a concise comparison between the through-hole and SMT methods for use as a decision-making reference guide for PCB designers.

Through-Hole Technology

While through-hole components represent the older of the two technologies, there are still valid reasons for using them. For example, any hobbyist with a soldering iron can assemble a through-hole PCB or a small lot of the same with a minimum of fuss, because the holes which accept the component leads are spaced farther apart than the surface pads on an SMT type. Typical spacing from hole center to hole center is generally 0.100” or greater, even for DIP processors. Such generous spacing makes through-hole PCBs easy to hand-solder. There is almost no potential for accidentally creating bridges between the pins on a single component or between those on adjacent components. This cuts down on troubleshooting and rework once the board is fully assembled and powered-up.

Through-hole technology, PCB, surface mount PCB, surface mount technology, SMT, SMT components

A through-hole PCB in a hobbyist application, in this case a guitar effect pedal. Notice the ICs, which are all either 8-pin or 14-pin on 0.100” x 0.300” centers. . (Image source: Epec Engineered Technologies)

Through-hole boards can also be useful in more professional settings, particularly at the prototype stages of a project. The prototype layout can temporarily use through-hole components so the board may be assembled quickly for basic proof-of-concept evaluation. After the board has been proven to function correctly, the designer can swap in smaller SMT types of the same values and revise the PCB layout within a smaller footprint for final testing and eventual production. Doing things this way may save up-front costs for a project, especially those associated with subcontracting a small lot to an outside assembler. Keep in mind that small lots often command premium pricing from outside service providers, who naturally prefer to set up large volume production runs that keep their machines going.

Cost Saving of Through-Hole Technology

With a through-hole PCB there is no need to generate a new solder stencil each time the PCB undergoes a revision change. This can save hundreds of dollars on a design which goes through two or three spins before it is deemed to be functional. It is also unnecessary to set up pick-and-place equipment, or to purchase accompanying reels of SMT components, until the final PCB configuration is working and ready for production.

In-circuit testing after component assembly can often be done manually and in-house for a small batch of boards, thereby eliminating the expense of fixtures or associated set-up charges. It is also possible to use tin-lead solder (the least costly surface metalization) when working with through-hole boards. The inherent non-planarity of hot air solder leveling (HASL), which can make placement of fine-pitch surface mounted components difficult, is not an issue with through-hole designs.  

Another advantage beyond the avoidance of SMT-related cost adders is that it is possible to evaluate mechanical issues (such as excessive warp and twist) during validation, and to compensate for them during redesign without causing insurmountable assembly difficulties, as might occur with SMT. This is because warp and twist is not nearly as critical on a hand-assembled PCB as it is on one populated using pick-and-place equipment. A human assembler can simply change their wrist angle to improve the fit of a stubborn component, but an automated machine requires a PCB with a high degree of flatness in order to function properly. Your through-hole prototype can expose design-related mechanical shortcomings before they become costly and time-consuming “line-down” three-way screaming matches between your PCB fabricator, your contract assembler, and yourself.

When the necessary component types are available in through-hole form, the use of through-hole technology during the development cycle can keep your project on track and simplify the process of assembling prototype and small-lot projects without paying for third-party services. Timelines may be more predictable and controllable with fewer side issues that might delay your product’s critical time-to-market. It may, therefore, be worth considering at least the temporary use of through-hole components during early development and validation stages, whether you as the end user are a hobbyist, an industry start-up, or an established electronics supplier.

Surface Mount Technology

Regardless of the justifications for using through-hole components on your PCB, surface mounted components offer many advantages through-hole types simply cannot match.

One of the most immediately obvious advantages is that it is possible to achieve far greater levels of component density and processing power while fitting everything within a much smaller and lighter overall PCBA. As the devices controlled by PCBs become smaller and smaller, efficient use of available surface area becomes increasingly more critical. SMT technology becomes a necessity.

For instance, it would require several 14-pin or 16-pin dual in-line processors, each measuring around 0.80” x 0.35”, to even approximate the computing power available in a single surface-mounted BGA or 64-pin QFP processor, which might fit within a total area one square inch or smaller. In addition to the larger component footprints for through-hole types, the interconnections on the PCB would require additional space for via placement.

Through-hole technology, PCB, surface mount PCB, surface mount technology, SMT, SMT components

Miniaturization on the march: The 64-pin surface-mounted QFP processor measures only 0.472” x 0.472”. . (Image source: Epec Engineered Technologies)

By contrast, when using SMT components, the plated through-hole required for each through-hole component lead is eliminated and replaced by a relatively small surface pad. It is then possible to drill small vias into the surface mount pads themselves, directly underneath the SMT component leads, allowing for Z-axis interconnections, which can then fan out from the wall of the via to one or more internal signal layers. All these interconnections can now occur either within or immediately adjacent to the device’s own footprint, saving significantly on available real estate. The space around the SMT component can then be used for placement of additional components. The higher densities possible with SMT are a byproduct of both the smaller footprint size of the components themselves and the space reclaimed by the elimination of drilling component mounting holes. A related advantage is that it is common for SMT boards to utilize both sides of the PCB for component mounting.

With such advantages come several considerations, which must be kept in mind when designing for SMT PCBs. Materials, surface finishes, and mechanical characteristics become increasingly important. Problems with any of these elements can cause major headaches when it comes time to assemble the PCBs on automated equipment.

Surface Mount Design Considerations

Materials and surface finish play a critical role and are, to some extent, interactive with one another. The leaded solder used in HASL is a poor choice for SMT work (particularly on components with pin pitches less than 0.050”) because it tends to puddle at one end of the pad, where it then cools in a non-planar state. The component leads need to sit flat in order to avoid positioning problems, so even when RoHS compliance is not an issue, it is best to select a more planar finish, such as Electroless Nickel Immersion Gold (ENIG), Immersion Silver, or Immersion Tin when dealing with finer-pitch SMDs.

Through-hole technology, PCB, surface mount PCB, surface mount technology, SMT, SMT components

64-pin SMT BGA, 0.031” pitch. Notice that the ball pads have small dimples, indicating that they have been used for placing vias-in-pads to allow for internal layer escape routing. . (Image source: Epec Engineered Technologies)

It is also important not to under-spec your base laminate. SMT boards generally require higher soldering temperatures than through-hole boards, primarily because of the lead-free surface finishes that are most often used. Materials that meet IPC-4101D/126 (Tg 170C, Td 340C, with inorganic fillers) will stand up to high soldering temperatures. They will also withstand multiple thermal cycling shocks, which will occur when assembling two-sided SMT boards, or boards that use multiple component technologies.

Gerber artworks need a few extra features so that the SMT assembly process will go smoothly. Add at least one set of fiducial pads to the external layers (most commonly in an “L” pattern along the outer edges of the PCB) so that pick-and-place equipment will have a reference for squaring the PCB and for establishing a dimensional datum point. Consider eliminating soldermask openings for vias to minimize the potential for solder shorts and to eliminate reflections that may confuse the pick-and-place unit when it is trying to identify the fiducials. For in-circuit testing, it is often good practice to add test point pads wherever you need them. Depending upon the test equipment, these can be SMT type or they may include holes to accept test probes. Work with your assembler or test service to determine which type is best.

Given the importance of dimensional accuracy and the nature of automated assembly equipment, it is important to “design-in” flatness. Do this by balancing copper coverage as evenly as possible from layer to layer and by pouring copper into large blank areas wherever you can. This will prevent uneven stresses from pulling the material in a particular direction after etching.

Use stack-ups, which are symmetrical around the center of the stack, so the layers support one another in the Z axis. For example, a six-layer PCB will generally stack as follows: Top Signal L1, Prepreg, Plane L2, FR4 core, Internal Signal L3, Prepreg, Internal Signal L4, FR4 Core, Plane L5, Prepreg, Bottom Signal L6. This will work as long as the copper area on each layer is fairly well-balanced (particularly on the core layer pairs at L2-L3 and L4-L5) and it will place planes where they will be available as reference for impedance control at layers 1+3, 4+6.

If you build a prototype and it does warp or twist, do not attempt to “fix” the problem by adding a drawing requirement for warp and twist that is in excess of what IPC requires. The IPC warp and twist spec are already twice as stringent for SMT as it is for through-hole, and most fabricators will push back if you ask for anything tighter. Instead, revisit the design for potential causes of the problem, and be sure you understand when the problem is happening – on the bare PCBs as-received, during assembly, or both. Then work with the fabricator, who can often make recommendations that will alleviate the problem on subsequent runs.

Through-Hole or SMT?

While SMT is by far the more common technology over the past several years, through-hole can still fill certain needs, as long as it can deliver the necessary processing power within a reasonable footprint size. It is useful to consider both PCB types, and to weigh their pros and cons before launching your development cycle.

Comparison of Characteristics

Through-Hole                                                             Surface Mount

Non-planar HASL finish most common.

Planar finish (ENIG, Immersion Silver, OSP.)

Hole required for component lead insertion.

Components mount to surface pads, no hole.

2-sided assembly rare.

2-sided assembly common.

Component lead spacing typically 0.100” or greater.

Component lead spacing 0.0157” (0.0197” common.)

Manual assembly.

Automated assembly.

Soldering manual or automated.

Soldering typically automated.

Stencil not required.

Stencil required unless small lot, simple PCB.

Vias in pads not possible.

Vias in pads possible.

Standard temperature (130C Tg) laminate.

High-temperature (170C Tg) laminate.

Through-hole test points.

Through-hole or SMT test points.

Lower component and circuit density.

Greatly increased component density.

Larger PCB footprint.

Minimal PCB footprint.

Rework relatively simple.

Some rework more involved.

Moderate warp and twist tolerable.

Warp and twist more critical for assembly.

Fiducial pads not required for component placement.

Fiducial pads required for automated pick-and-place equipment.

Al Wright is PCB field applications engineer at Epec Engineered Technologies.

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Learn everything you need to know at our in-depth conference program with 70+ technical sessions in eight tracks covering topics on battery, electric & hybrid vehicles, and stationary power technologies. 
The Battery Show. Sept. 10-12, 2019, in Novi, MI. Register for the event, hosted by Design News’ parent company Informa.

 

Friday Funny: Mehdi Sadaghar’s Compilation: Electricity Hates Me

Sadaghar’s adventures are hard to watch. But man are they funny. When they start getting stupid, they get even funnier.

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.

 

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Learn everything you need to know at our in-depth conference program with 70+ technical sessions in eight tracks covering topics on battery, electric & hybrid vehicles, and stationary power technologies. 
The Battery Show. Sept. 10-12, 2019, in Novi, MI. Register for the event, hosted by Design News’ parent company Informa.

 

Tiny Robots Powered By Vibration Eyed for Medical Applications

Robotic technology is becoming increasingly more advanced, with robots that are able to move on their own and smaller and smaller form factors being developed for extremely specialized work.

As a new example of the latter, a team of researchers at the Georgia Institute of Technology has developed a tiny, 3D-printed robot that responds to vibration to create self-actuation. The robots, which researchers said could be grouped together to work similarly to ants, could potentially be used to repair injuries inside the human body, move objects, or in other applications.

tiny robots, soft robots, Georgia Tech’s School of Electrical and Computer Engineering, micro-bristle-bots, medical

Researchers have created a new type of tiny 3D-printed robot that moves by harnessing vibration from piezoelectric actuators, ultrasound sources, or even tiny speakers. (Source: Georgia Institute of Technology)

Led by Azadeh Ansari, an assistant professor in Georgia Tech’s School of Electrical and Computer Engineering, researchers drew from various engineering disciplines to design the robot to move by harnessing vibration from piezoelectric actuators, ultrasound sources, or even tiny speakers.

The robots--called “micro-bristle-bots” by the team because their legs look like bristles—are comprised of a piezoelectric actuator glued onto a polymer body. Researchers used a process called two-photon polymerization lithography (TPP) to 3D-print the bodies of the robots, some of which have four legs while others have six, they said.

TPP is a technique that polymerizes a monomer resin material by striking it with an ultraviolet light to chemically develop the resin. Once this is complete, the remainder can be washed away, leaving the desired robotic structure.

“It’s writing rather than traditional lithography,” Ansari explained in a press statement. “You are left with the structure that you write with a laser on the resin material.”

The piezoelectric actuators used the material lead zirconate titanate (PZT) and  vibrate when electric voltage is applied to them. In reverse, they can also be used to generate a voltage when they are vibrated, researchers said. In this way, the micro-bristle-bots potentially could use this capability to power up onboard sensors when they are actuated by external vibrations.

Vibrational Actuation

Because the bots are so small—about 2 millimeters long, about the size of the world’s smallest ant--batteries won’t fit inside to power them. Instead, the robot’s externally powered actuators generate vibration from various sources--a piezoelectric shaker beneath the surface on which the robots move, an ultrasound/sonar source, or even from a tiny acoustic speaker, researchers said.

The vibrations generated by the actuators move the bot’s springy legs up and down, propelling it forward at a speed controlled by the amplitude of the vibrations, researchers said. Each robot can be designed to respond to different vibration frequencies depending on several factors--including leg size, diameter, design, and overall geometry, Ansari said.

“The legs of the micro-robot are designed with specific angles that allow them to bend and move in one direction in resonant response to the vibration,” she said.

Just as the speed of the robots is controlled by vibration, researchers also can control individual bots in this way, as they respond to different vibration frequencies depending on their configurations. Moreover, the bots can move quite speedily, covering four times their own length in a second, researchers said.

The team published a paper describing its work in the Journal of Micromechanics and Microengineering.

Researchers plan to continue to work on the robots to add capabilities as well as to improve the design process, which at this point is quite time-consuming, Anzari said. “We looking at ways to scale it up to make hundreds or thousands of micro-bots at a time,” she said in the press statement.

One capability researchers are eyeing is steering, which they believe they can achieve by joining two slightly different micro-bristle-bots together, they said. Because each of the bots would respond to different vibration frequencies, the combination could be steered by varying the frequencies and amplitudes, Anzari said.

“Once you have a fully steerable micro-robot, you can imagine doing a lot of interesting things,” she said in the press statement.

Elizabeth Montalbano is a freelance writer who has written about technology and culture for more than 20 years. She has lived and worked as a professional journalist in Phoenix, San Francisco and New York City. In her free time she enjoys surfing, traveling, music, yoga and cooking. She currently resides in a village on the southwest coast of Portugal.

 

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Dow to source pyrolysis oil feedstock made from recycled plastic waste

Dow to source pyrolysis oil feedstock made from recycled plastic waste

Dow Chemical has reached an agreement with the Fuenix Ecogy Group, based in Weert, The Netherlands, for the supply of pyrolysis oil feedstock, which is made from recycled plastic waste. The feedstock will be used to produce new polymers at Dow’s production facilities at Terneuzen, The Netherlands.

Fuenix Ecogy’s pyrolysis process takes a mixed plastic waste stream and converts it to a feedstock for repolymerization.

This agreement marks an important step forward to increase feedstock recycling – the process of breaking downmixed waste plastics into their original form to manufacture new virgin polymers. The polymers produced from this pyrolysis oil will be identical to products produced from traditional feedstocks, and as such, they can be used in the same applications, including food packaging.

This agreement is an example of Dow’s strategy to enable a shift to a circular economy for plastics by focusing on resource efficiency and integrating recycled content and renewable feedstocks into its production processes. By doing so, post-consumer plastics will continue to have value through an extended lifespan. The agreement also contributes to Dow’s commitment to incorporate at least 100,000 tonnes of recycled plastics in its product offerings sold in the European Union by 2025.

“We believe plastics are too valuable to be lost as waste and should be part of the circular economy,” said Diego Donoso, business president for Dow Packaging & Specialty Plastics. “With partners in South America, we have supported the development of construction materials made with recycled plastics for schools, and in Southeast Asia, Mexico and the United States, we have built roads made with recycled plastics. This partnership with Fuenix is an important next step in moving us closer to the future we envision, which is the sustainable production of circular polymers.”

Sirt Mellema, CEO Fuenix commented: “This partnership offers us the opportunity to scale up our technology. Our ambition is to ensure the value of plastic waste is fully used to create new, circular plastic while significantly reducing the global use of virgin raw materials and CO2 emissions. We are excited to be working with Dow on this initiative and look forward to playing our part in helping to produce more sustainable materials.”

Dow will be showcasing their recycling portfolio at K 2019, the world’s largest plastics and rubber trade fair from 16-23 October in Dusseldorf, Germany.

Ineos introduces high flow ABS grade for appliances

Ineos introduces high flow ABS grade for appliances

Ineos Styrolution has debuted a new ABS (acrylonitrile butadiene styrene) grade as part of its Novodur family of ABS specialty copolymers. The new material grade, Novodur P4XF, excels with a high flowability and at the same time offers an attractive balance profile between flowability and impact strength.

High flow ABS grade targets use in air conditioning devices, vacuum cleaners and coffee machines.

Its product properties make the new grade the material of choice for large and complex applications in the household and electronics industries and contributes to improving their carbon footprint. Large parts for air conditioning devices, vacuum cleaners and coffee machines are just some examples of targeted applications.

Novodur P4XF exhibits high flowability – the melt volume rate (220 °C/10 kg) is at 60 cm3/10 min (ISO 1133). This allows customers to optimize their production tools for faster manufacturing by reducing the number of injection gates for large parts and by increasing the number of cavities in multi-cavity tools.

Artur Sokolowski, Sales Director Household and Electronics EMEA, comments: “Novodur P4XF is truly amazing. For large parts, it is an excellent alternative to many other materials. Depending on what materials customers are using today, they will experience faster cycle times, shorter cooling times, lower warpage, higher stiffness, higher surface quality and scratch resistance and less dust attraction/ electrostatic charge. In addition, less injection pressure allows for smaller injection machines when using Novodur P4XF.”

Could Open-Access Diagnostics Speed Diagnoses?

LexaGene
Images courtesy of LexaGene

Today’s molecular diagnostics testing typically involves either manual processing at a reference laboratory or automated processing by preconfigured instruments in near-patient settings, Dr. Jack Regan, CEO and founder of LexaGene, tells MD+DI. Neither approach would be ideal for detecting a highly infectious novel pathogen, he warned. The inability to rapidly configure a near-patient instrument to identify a newly emergent pathogen could result in delayed detection and increase the risk of the disease spreading. Some healthcare experts fear that such delays could lead to a pandemic that could claim thousands of lives.

Regan believes an open-access analyzer could help clinicians rapidly identify deadly novel pathogens. To that end, his company has developed new open-access technology that can be rapidly configured to detect newly emergent pathogens. This technology is also capable of screening samples for up to 22 pathogens at once, delivering results in about 1 hour, the company reported. The open-access feature allows users to load their own PCR assays onto the instrument for any genetic target of interest.

“LexaGene will sell three types of reagent panels—ones that are fully validated so customers will have high confidence in performance, others that are for open-access use and accordingly only contain the controls, and the third type being a blend of the first two,” Regan said. “The panels that allow for open-access use require the end-user to follow instructions on how to load their own pathogen-specific assays into the reagent panel. This way they have full control over customizing the instrument to screen for only their targets of interest.”

Regan described the length of time required for today’s approach to detecting pathogens in human samples. “Two main methods are currently used, namely culture and manual PCR,” he explained. “Culture is the process of growing up bacteria in an enriched broth, followed by mass spectrophotometry for pathogen identification, followed by a secondary culture to determine if the identified pathogen is resistant to any antibiotics. This process is > 48 hours. In contrast, manual PCR can be much faster, but it requires that highly skilled scientists extract and purify the genetic material from the collected samples, set up a series of tests, and analyze the data. Collectively, this work takes hours and is prone to error due to its complexity.”

LexaGene is commercializing its automated technology to remove the complexity of performing PCR analysis and to shorten the time to result. “To operate LexaGene’s technology, the person collecting the sample needs to merely load the sample and a disposable cartridge onto the instrument, enter a sample ID, and press ‘go.’ The instrument then performs all the necessary functions and reports back a result in just one hour,” Regan said.

He believes that the LexaGene technology is critical to help prevent a pandemic, the risk of which he details in the article, “A Call for Open-Access Molecular Diagnostics,” published in Hospital and Healthcare Management. “In this article, I argue that open-access point-of-care automated pathogen detection devices are desperately needed to help avert the next pandemic,” he said. “LexaGene’s technology can be very quickly configured to detect newly emergent pathogens—such that both strains capable of causing a pandemic and typically circulating pathogens can be simultaneously identified to allow for front-line healthcare providers to rapidly triage patients in emergency rooms settings (i.e., place patients infected with deadly pathogens into quarantine to reduce the spread of the disease).”

He explained how the reagent panel that screens for 22 known pathogens could also help identify an unknown one. “These pathogen tests are split across 11 reservoirs of the reagent panel, which has a total of 15 reservoirs. One of the reservoirs is reserved for negative controls, leaving 3 reservoirs that are essentially unused,” he said. “In the event of the emergence of a new pathogen that starts killing people, the CDC or another group would sequence the pathogen and share the sequence with the public (biotech and diagnostic companies like LexaGene). Our bio-informatics scientist would use this sequence to design a test that is specific to the new deadly pathogen. This new test can be ordered and delivered directly to the hospitals operating our technology. The hospital would receive the new test and follow the instructions to load it into one of the three unused reservoirs. The LX technology would then screen samples for the 22 common pathogens plus the new deadly pathogen, providing critical information for front-line healthcare providers who would be overwhelmed with individuals concerned that they have the deadly strain. Knowing whether they are infected within 1 hour would allow healthcare providers to quickly quarantine infected individuals to minimize the risk of disease spread.”

Above: LexaGene's LX Analyzer

The LX analyzer’s capabilities could also prove useful in day-to-day medicine. In fact, the company has installed a beta prototype at Assurance Scientific Laboratories (ASL), a certified reference laboratory specializing in providing clinical testing results to physicians nationwide. The lab processes more than 300 urine samples per week for human urinary tract infections. During the beta trial, LexaGene’s analyzer will be evaluated for its ability to test urine samples for the presence of pathogens causing urinary tract infections and to determine if any detected pathogens possess genetic markers for antimicrobial resistance.

“During this beta test period, ASL will take advantage of the open-access feature of LexaGene’s LX technology to compare our tests to their tests for pathogen identification and antimicrobial resistance characterization,” Dr. Nathan Walsh, LexaGene’s VP of applications and bio-informatics, stated in a news release. “The research data generated will help clinical laboratories better assess the available tools to aid in the diagnosis and treatment of human urinary tract infections.”

LexaGene plans to start its pursuit of FDA 510k clearance in the summer of 2020. When asked for what indication the FDA 510(k) clearance application would be, Regan said it is still to be determined but potentially will be Clostridium difficile, which infects 250,000 per year in the United States and kills 14,000. “This disease is estimated to contribute to $1B in excess medical costs per year in the U.S.,” he said, adding that “although getting FDA clearance takes time, in the interim, LexaGene’s technology can still be purchased by directors of CLIA laboratories, who can self-validate the technology and use it for clinical purposes.”

He added that the company anticipates “selling our analyzer into open-access markets that desire easy-to-use technology that can be customized. Examples of open-access customers include biotech and pharma companies as well as reference laboratories servicing both veterinary and human clinical diagnostic needs.”

Study Shows MIGS Makes up Nearly Half of Glaucoma Surgical Device Revenue

Pixabay Study Shows MIGS Makes up Nearly Half of Glaucoma Surgical Device Revenue

Micro-invasive glaucoma surgery (MIGS) stents are quickly becoming the norm. A new study from Market Scope titled “2019 Glaucoma Surgical Device Market Report,” shows that MIGS stents account for almost half of all glaucoma surgical device revenue in 2019.

This is an even more impressive feat for the devices considering the loss of revenue that occurred from the Cypass Micro-Stent being recalled nearly a year ago. Alcon pulled Cypass off the market after five-year data revealed a higher rate of cell loss compared to patients who had cataract surgery alone.

However, the report said Cypass being pulled off the market did slow down the adoption of MIGS devices and opened the door for other surgical and laser treatments.

There are four FDA-approved MIGS stents: the Glaukos’s iStent and iStent inject, Allergan XEN gel stent, and Ivantis Hydrus. That number could grow as Santen Pharmaceutical’s PreserFlow MicroShunt is the next MIGS device in line for FDA approval, the report said.

Earlier this year, Osaka, Japan-based Santen Pharmaceutical that its U.S. subsidiary entered into a multi-year agreement whereby Glaukos will become the exclusive distributor of the MicroShunt solely in the U.S. market.

Glaukos, known as the pioneer in MIGS, has been pretty busy in 2019. Earlier this month, the San Clemente, CA-based company announced it would acquire Avedro, a hybrid ophthalmic pharmaceutical and medical technology company in an all-stock transaction. The deal is expected to close in 4Q19.

The acquisition is part of a plan Glaukos announced at the 37th annual J.P. Morgan Healthcare Conference to become a hybrid surgical/pharmaceutical/medical device” firm.

The Market Scope Report said Glaukos favors highly in the glaucoma device market which is expected to be just over $700 million. The report said Glaukos is “expected to dominate the market in 2019, with a third of total revenue.”

Eight companies will account for nearly 80% of revenue. They are Glaukos, New World Medical, Allergan, Ivantis, Ellex, Alcon, J&J Vision, and Iridex, according to the report.

Market Scope's report also looks at the renewed interest in canal surgery devices, including the Sight Sciences OMNI, Kahook Dual Blade (KDB), Ellex ABiC for canaloplasty, NeoMedix Trabectome, and New World Medical.

Recently, Rancho Cucamonga, CA-based New World Medical launched the Ahmed ClearPath implant, named after the company’s founder Dr. A. Mateen Ahmed. The device helps drain intraocular pressure in patients.