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Articles from 2019 In November


Medtronic Fires More Claims at Axonics

Image by Okan Caliskan on Pixabay Medtronic Fires More Claims at Axonics
In an amendment filed Nov. 26, Medtronic added three more patent infringement claims to its lawsuit against Axonics, a new entrant in the sacral neuromodulation market.

Medtronic filed an amendment Tuesday to its lawsuit against Axonics Modulation Technologies, adding three more patent infringement claims to the suit. The original lawsuit, filed earlier this month, alleged infringement of four patents related to Medtronic's sacral neuromodulation lead placement procedure and implant recharging technologies.

"Medtronic believes competition drives innovation and broader market awareness, which is good for the industry and for patients, and we welcome competitors who play by the rules and existing laws," Medtronic reiterated in a statement e-mailed to MD+DI on Wednesday. "We are also committed to protecting our proprietary technology and intellectual property, which drives our continued innovation. We believe these additional claims further confirm the merits of our complaint."

Axonics CEO Ray Cohen has previously said he believes Medtronic's claims are without merit and are an attempt to suppress competition. He also noted during a recent earnings call that Axonics has invested "substantial" time and resources to understanding the sacral neuromodulation competitive landscape since the company's inception in October 2013, and "we have been very careful to respect the intellectual property rights of all others in the design of our products."

Global trade, auto crisis keep Europe’s plastics professionals up at night

Global trade, auto crisis keep Europe’s plastics professionals up at night

Uncertainty about global trade tops the list of concerns of Europe’s plastics industry, well ahead of the regulatory and taxation issues that typically bedevil the sector, according to a new survey from Plastics Information Europe (PIE; Bad Homburg, Germany). Almost three quarters (71%) of the more than 200 plastics industry professionals who participated in the survey cited trade conflicts as a significant concern that is “negatively impacting business performance.”

chart from Plastics Information Europe
Global trade tops the business concerns of Europe's plastics industry. Chart courtesy Plastics Information Europe.

Serving as an epilogue to the narrative that came out of K 2019 in October, where many plastics processing machine makers offered grim outlooks, the PIE survey notes that almost 30% of respondents expect business results to be worse in the second half of 2019 compared with the first six months of the year. The depth of that deficit and the overall mood of Europe’s plastics industry going into 2020 changes markedly, however, by geography and by sector.

More than half of respondents from companies in the Nordic countries reported that business had improved in the first half of 2019 compared with the last half of 2018. Only 35% of respondents from Spain and 32% from German-speaking Europe made the same claim. Across sectors, plastics processors appeared to fare the best, with almost half rating business as better. “Looking ahead, 29% expect business in [the second half of] 2019 to be worse than in [the first half], with 44% foreseeing it as staying the same. Businesses in the UK (43%) and France (37%) make up the highest shares having an optimistic outlook in [the second half of] 2019,” said PIE.

Generally speaking, though, Europe’s plastics industry should buckle  up, because it’s going to be a bumpy ride. As Wittmann Battenfeld General Manager Michael Wittmann noted during a press conference at K 2019, “from 2010 on, there was only one direction for industry, and that was up.” We knew there would eventually be a downturn, he added, it just took a longer time coming than has been the historical norm.

In addition to uncertainty on the global trade front—which affects distributors and compounders (89%) to a greater degree than brand owners (83%) and processors (around 70%)—the downturn in the automotive sector and, to a lesser extent, regulations are having a negative impact on businesses. Just a little more than half of respondents said that the slowing in automotive is having a direct or indirect effect on their business. The German-speaking countries of Europe are feeling it the hardest: 90% of respondents from those countries said they were negatively affected. As we reported recently in PlasticsToday, Germany saw an approximate 12% decline in car production in the first half of 2019, according to research from Global Market Insights. In the Nordic countries, only 22% of respondents said that the automotive crisis was having a negative effect.

The regulatory landscape, while still worrisome, featured less prominently as a primary concern for respondents in this year's survey. Forty-three percent said that “EU regulations were not expected to negatively impact business.” The remainder were concerned about the ban on single-use plastics (26%), REACH regulations (19%), food-contact legislation (15%) and microplastics regulation (12%). Carbon dioxide reduction programs, the Brexit mess, a new EU-mandated emissions test for cars, taxes on plastic packaging and recycling-related guidelines also made the list of concerns, but in relatively small numbers.

Medtech in a Minute: LivaNova Nixes TMVR, FDA Tackles EtO, and More

Image by OpenClipart-Vectors on Pixabay Medtech in a Minute: LivaNova Nixes TMVR, FDA Tackles EtO, and More
We know your time is precious so we've drilled down the three most important medtech stories from the past week. But feel free to click the headline to read beyond the blurb.

FDA Wants Medtech to Cut Back on EtO Use

FDA is encouraging manufacturers to reduce the amount of paper included in sterile device packaging in order to reduce the amount of ethylene oxide (EtO) required for effective sterilization. A new voluntary master file program also aims to speed up approval of sterilization site relocations and the implementation of methods that reduce the amount of EtO needed to sterilize FDA-approved medical devices.

LivaNova Says Sayonara to TMVR

LivaNova is scrapping its Caisson transcatheter mitral valve replacement program because of continued declines in revenue from its valve business over the last five years. The company plans to restructure and simplify its heart valve manufacturing network, a move that is expected to impact about 150 employees in Italy, Vancouver, and Minneapolis.

Paclitaxel-Based Devices Catch a Break

For a while there, things were really looking bad for paclitaxel-coated balloons and paclitaxel-eluting stents. But the narrative has slowly improved and a recent FDA approval marked a turnaround in the paclitaxel story. The agency approved Medtronic's IN.PACT AV drug-coated balloon for the treatment of failing arteriovenous access in patients with end-stage renal disease undergoing dialysis.

Technology gifts for the holiday

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.

 

DesignCon 2020 25th anniversary Logo

January 28-30: North America's largest chip, board, and systems event, DesignCon, returns to Silicon Valley for its 25th year! The premier educational conference and technology exhibition, this three-day event brings together the brightest minds across the high-speed communications and semiconductor industries, who are looking to engineer the technology of tomorrow. DesignCon is your rocket to the future. Ready to come aboard? Register to attend!

 

Does your IoT device pass the UL test?

Consumers are quickly losing trust in the IoT due to numerous security breaches from relatively simple attacks. Examples abound, such as smart LED light bulbs that leaked Wi-Fi passwords, or an Internet-connected thermometer in a Casino lobby aquarium that enabled hackers to access its network and extract sensitive client information. The list of easily hackable IoT devices goes on to include everything from IoT sex toys and medical devices to smart phone enabled locks, rooftop weathervanes, and more.

All of these breaches were made possible by rather fundamental security mistakes. In addition to seriously affecting customer willingness to trust IoT technology, these hacks have tarnished company brand value, sales and revenues. With so many inconsistently secured devices, it is easy to see why the IoT is leading to a new category of cybercrime.

Manufactures have found little guidance from professional or national organizations for acceptable security practices for the sensors, devices, mobile phones, gateways and servers that make up the IoT. True, NIST recently issued a Core Cybersecurity Feature Baseline for Securable IoT Devices (Draft NISTIR 8259), which provides voluntary guidance intended to help promote the best available practices for mitigating risks to IoT security. It complements NIST’s Considerations for Managing Internet of Things Cybersecurity and Privacy Risks (NISTIR 8228), which primarily addresses large organizations that have more resources to dedicate to IoT cybersecurity.

Image Source: NIST - NISTIR 8228 IoT road map

But the NIST guidelines are intended for corporate enterprises and government agencies, not IoT manufactures and vendors. Without consistent rules and ways to gauge compliance for cybersecurity protection, manufactures are left to their own approaches and consumers are left in confusion when comparing security features between competing vendors.

This is the problem that UL, a global safety testing lab, is trying to address with its recently released IoT Security Rating Certificates. This rating will help manufacturers demonstrate their proven adherence to cybersecurity best practices. For consumers, this will give an easy to understand rating level listed on product labels, similar to existing ones that certify safety compliance for household electrical cables.

Further, the IoT Security Rating will be essential for manufactures to comply with upcoming regulations. Legislation in California (Senate Bill 327) and Oregon (House Bill 2395) will hold U.S. manufacturers responsible for adding “reasonable security features” in devices or physical objects that are able to connect to the internet directly or indirectly. Both bills become effective Jan. 1, 2020.

5 Priorities

A UL “IOT Security – Top 20 Design Principles” whitepaper describes critical principals that can be taken to increase the security of connected systems. The first five of these principals – or steps – are perhaps the most important:

  1. Provide a manual override for any safety-critical operations.
  2. Ensure parameters which could compromise the system (secret or private cryptographic keys, passwords, etc.) are unique per device.
  3. Test the system to be sure it is free of known, exploitable vulnerabilities prior to release.
  4. Allow for software updates and ensure they are cryptographically authenticated prior to installation and execution. Implement anti-rollback features to prevent the installation of previous vulnerable versions of firmware.
  5. Use industry standard security protocols with best practice defaults for any remote or wireless connections and authentication of connections to management services.

Applying these steps, as well as the other 15 listed in the UL whitepaper, will improve a company’s security rating. The actual compliance testing is done through independent security testers from partners such as UL, Brightsight, CAICT, Riscure and others.

The actual ratings are based on a Platform Security Architecture (PSA) framework established by hardware processor giant Arm and the above-mentioned test labs. The PSA framework is comprised of two elements: a multi-level security robustness scheme and a developer focused API test suite. The security testing is based on third-party lab-based evaluation that is intended to build trust through independent checking of the generic parts of an IoT platform including: PSA Root of Trust (the Root of Trust is the source of integrity and confidentiality), the real-time operating system (RTOS) and the device itself, according to ARM. There are three progressive levels of security certification.

Image Source: ARM

IEEE (Non-manufacturing) IoT Standards

The Arm-UL IOT Security Rating framework is intended as a guideline for manufacturers and vendors of IoT devices. If you are an Electronic Engineers actually designing IoT systems, then you’ll want to check out the latest IEEE standards that address the technical “vibrancy” of IoT systems:

  • Architectural framework: The focus of IEEE P2413 is to develop a standard for the architectural framework for the Internet of Things, which includes descriptions of various IoT domains, definitions of IoT domain abstractions, and identification of commonalities between different IoT domains. The architectural framework defined in this standard will promote cross-domain interaction, aid system interoperability and functional compatibility.
  • Harmonization and security of IoT: The IEEE 1451-99 is focused on developing a standard for harmonization of Internet of Things (IoT) devices and systems. This standard defines a method for data sharing, interoperability, and security of messages over a network, where sensors, actuators and other devices can interoperate, regardless of underlying communication technology.
  • Sensor Performance and Quality: Sensors are fundamental to IoT ecosystem with large volume of different sensors integrated into a complex framework. IEEE 2700 proposes a common framework for sensor performance specification terminology, units, conditions and limits is provided. IEEE P2510 defines quality measures, controls, parameters and definitions for sensor data related to Internet of Things (IoT) implementations.

The new UL offered IoT Security Rating will provide evidence that manufacturers meets standard best practices for IoT security, an important measure that supports upcoming security legislation. Further, this UL rating system should help consumers re-establish trust that their IoT devices meet a minimum of security robustness.

John Blyler is a Design News senior editor, covering the electronics and advanced manufacturing spaces. With a BS in Engineering Physics and an MS in Electrical Engineering, he has years of hardware-software-network systems experience as an editor and engineer within the advanced manufacturing, IoT and semiconductor industries. John has co-authored books related to system engineering and electronics for IEEE, Wiley, and Elsevier.

Henkel, Carbon Revolution, collaborate to commercialize composite wheels

Henkel, Carbon Revolution, collaborate to commercialize composite wheels

Henkel has reached a strategic material supply agreement with Carbon Revolution, the world-leading Australian manufacturer of one-piece automotive carbon composite wheels. The collaboration includes dedicated manufacturing facilities established at Henkel’s existing plant near Melbourne.

As lightweighting components, carbon wheels can make a significant contribution to minimizing the energy consumed when spinning the wheels up and dragging them back down.

The global automotive industry is seeking lightweight solutions. When it comes to wheels, which represent some of the most important mass on a vehicle due to their rotating, unsprung nature, one-piece carbon composite technology is an emerging choice for global carmakers. Single piece carbon fiber composite wheels can offer up to 40–50 percent weight savings relative to conventional aluminum wheels and an attractive surface finish.

“Based on a number of years of close collaboration with Carbon Revolution, we have extended our proven portfolio of composite material technologies to create proprietary solutions that meet the demanding performance specifications of the global carmakers,” says Konrad Brimo Hayek, Senior Business Development Manager for Automotive Components at Henkel. “The collaboration with Carbon Revolution is targeted at providing various global OEM carbon wheel programs with the best solutions available and includes active support from Henkel via dual production capacities in the EU and locally in Australia.”

Carbon Revolution’s Carbon fiber composite wheels are now used on some of the world’s most prestigious sports cars. The significant reductions in unsprung rotational mass translates into immediate vehicle handling benefits, from better steering feel and traction to improved accelerating and braking response thanks to the composite wheels’ lower inertia. In terms of sustainability, the technology can also enhance fuel or electrical power efficiency and help automotive manufacturers reduce the CO2 emission balance of their fleets.

“As lightweighting components, carbon wheels can make a significant contribution to minimizing the energy consumed when spinning the wheels up and dragging them back down every time the car is accelerated or slowed. This saves fuel on combustion engine vehicles and battery power on hybrid and fully electric vehicles, maximizing their range,” adds Carbon Revolution Chief Technology Officer Brett Gass. “Henkel’s advanced material technology also adds to the overall reduction of our carbon wheels in noise, vibration, and harshness when compared to steel or aluminum wheels, which means automakers can save weight on additional sound insulation.”

New Biomaterials Speed Trend Toward Smaller Medical Devices and Implants

Image courtesy of Honeywell
Image courtesy of Honeywell

Growth in the medical device industry has long been driven by innovation, and lately that innovation is coming from the desire to make devices and implants smaller.

This trend is exemplified by the move to minimally invasive implants and techniques such as laparoscopic surgery and robotic surgery. The approach leads to faster patient recovery times, less scarring (smaller devices mean the incision can be smaller, too), shorter hospitalization, and a lower total cost of care.

New devices and techniques like these are driving medical device industry growth. The United States is the largest medical device market in the world, valued at $156 billion (in 2017) and expected to grow to $208 billion by 2023, up 33%, according to the U.S. Department of Commerce. The U.S. had 40% of the global medical device market in 2017.

In developing smaller medical devices and techniques, medical device companies look for bio-materials that reduce the profile of devices without compromising strength, durability, flexibility, and bio-compatibility.

One significant advance in the industry is the increased use of ultra-high polyethylene fiber, which has inherent performance advantages over alternatives such as steel, polyester, and nylon fibers. This material known as ultra-high molecular weight polyethylene (UHMWPE) fiber is used in the design of smaller medical devices or implants.

The UHMWPE fiber is stronger and thinner; has a higher resistance to chemicals, fatigue, and abrasion; and has lower friction for easier movement than many alternative fibers. UHMWPE fiber does not pose the same health risks as alternative fibers that can disintegrate over time and potentially enter a patient’s bloodstream, causing infection and pain.

Some of the medical devices commonly using UHMWPE fiber include:

  • Bone Sutures. About five years ago, the fiber was introduced in suture applications to repair bone breaks. This fiber exceeds the strength offered by current materials such as steel, silk, and polyester, but at the same time, it is soft on surgeons’ hands.
  • Guidewires in cardiovascular procedures. The fiber is also used as a guidewire in cardiovascular procedures. As a guidewire, the fiber snakes through a catheter to deliver and/or retract a medical device or implant. Although steel wire is often used in this procedure, the UHMWPE fiber is smaller, lighter, stronger, and more flexible.
  • “Muscles and tendons” for robotic motion. The fiber is used as an actuator mechanism in surgical robots, helping the robotic arms move to perform minimally invasive procedures. They essentially act as the robot’s muscles and tendons.

Safer for Patients and Doctors

These UHMWPE fibers have performance advantages for both patients and surgeons performing procedures as a result of its physical characteristics. Some examples:

  • Conformance to Structure Shapes. The UHMWPE fibers are more flexible and can be used to make sutures that conform to the bone, unlike steel sutures, which can potentially cut into the bone.
  • Higher breaking strength. UHMWPE fibers are stronger than other materials used in sutures for in tendon or muscle repair; sutures that break can cause further injury.
  • Softer and More Flexible. UHMWPE fiber is softer and more flexible than other suture materials, which allows surgeons to navigate sutures through narrower openings than steel cable. Sutures made from UHMWPE also do not leave sharp, jagged individual strands when cut.
  • Inert and Hypoallergenic. UHMWPE is inert and hypoallergenic. In comparison, steel wire in a body can become brittle and disintegrate over time.

As the medical device industry evolves to smaller devices and implants, UHMWPE fiber will likely play a significant role in the development of new, effective, and promising innovations that contribute to the growth of the medical device market.

How Are Wearable Medical Devices Changing the Game in Healthcare?

Image by mcmurryjulie from Pixabay
Image by mcmurryjulie from Pixabay 

Trends toward wearable medical devices are growing, both in the consumer sector and in healthcare. “There are many trends, both in the hospital segments and consumer segments, and they go based on specific needs or wants—what the consumer wants or the hospital wants,” said Girish Sripathi, wireless embedded engineer—medical devices, at Philips Healthcare, in an interview with MD+DI. For his upcoming presentation at BIOMEDevice San Jose, he said he would talk very generally about wearable medical devices. Examples he cited are fitness wearables like watches and chest straps, which could increase in the future depending on how people would like to look at the data from these devices. Regarding the trends, it is highly likely that there could be more research and more avenues for analyzing the patient’s historical data and updating them on alarming signals.

Sripathi said that consumers who use wearables can be better informed about their health because they can see things like their blood pressure, heart rate, even their glucose levels on an app right on their phone. “But if they need more detailed information, they will have to visit their clinician at the hospital,” he explained. “These [devices] are more aimed at giving them an idea of what happening with their health, that’s all.”

Some things that medical device manufacturers have to consider when developing wearable devices are the regulatory issues, whether they are to be connected, and if so, what technologies they would employ. In particular, the presentation will touch on how 5G will likely impact wearables and how miniaturization of electronics is enabling the design of more reliable and adaptable wearables.

When asked why attendees should go to his session, Sripathi said, “I don't think it's anything mystical because they already know a lot, but for people who find it fascinating, they might find it interesting to know what's in their new domain, and what the underlying concepts are in this domain.”

Sripathi’s will present, “How Wearable Devices Are Changing the Game in Healthcare,” on Wednesday, December 4, from 11:30 a.m. to 12 p.m., at Center Stage in Booth 641.

Formosa Plastics set to pay $50 million in pellet pollution lawsuit

Formosa Plastics set to pay $50 million in pellet pollution lawsuit

At a time when the plastics industry is under constant scrutiny over plastic pollution from many sources, it’s more important than ever that the industry police itself. That’s something that Formosa Plastics Corp. (Livingston, NJ) learned in a case involving spilled pellets in a Texas waterway.

On Dec. 3, a federal court judge in Victoria, TX, will rule on a consent decree in the environmental settlement between Formosa Plastics and residents of the state’s Point Comfort region. The judge is expected to sign off on the $50-million settlement that Formosa agreed to in October for discharging billions of plastic pellets into the waterways around its Point Comfort facility. The plaintiffs include former shrimper Diane Wilson, represented by attorneys with Texas Rio Grande Legal Aid (TRLA).

 

The decision will be the final step in a case that set precedent:

  • The $50 million settlement is the largest settlement of a Clean Water Act suit filed by private citizens in the history of the United States. It is five times the previous largest settlement of a Clean Water Act suit brought by private individuals. [Public Interest Research Group of N.J. v. Witco Chemical Corp., Nos. 89-3146, C-359-83 D.N.J. Jan. 15, 1993].
  • At a time when plastic pollution of oceans has reached urgent levels, Formosa agreed to rare “zero discharge,” meaning the company’s Point Comfort facility can no longer discharge any plastics into waterways. This is a standard that citizens all over the United States are trying to reach.

The settlement that Formosa reached also requires ongoing clean up of discharged pellets; monitoring and reporting of future discharged pellets; and includes fines for illegal discharges. The decree requires Formosa to hire an engineer to make important changes at the facility to prevent future illegal discharges.

The final consent decree will be modified to reflect that funds for the Nurdle Patrol will be paid to the University of Texas Marine Science Institute.