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A Smart Watch That Monitors Blood Pressure?

Courtesy of Biobeats A Smart Watch That Monitors Blood Pressure?

A Tel Aviv, Israel-based company is taking blood pressure monitoring cuff-less with its latest device. Biobeats has developed and received FDA clearance for a wearable medical-grade product that would allow health providers to care as efficiently for patients outside of their facility as on-site.

“We’re the first company to receive FDA clearance for the optical measurement of blood pressure,” Arik Eisenkraft, MD, MHA, and CMO of Biobeats, told MD+DI. “This is a cuff-less device. We have two configurations either a wristwatch or a patch.”

Biobeat's sensors are based on Plethysmography (PPG) technology. The company said its products feature a cloud connectivity capability that allows second parties and physicians to gauge results remotely either through a smartphone or dedicated gateway.

Eisenkraft made it very clear that the device wasn’t another wellness technology and that it was a medical-grade offering. The technology has a much broader indication in Europe.

“We gather about 20 different vital signs,” Eisenkraft said. “All of them have already been approved [in Europe]. But we’re also seeking FDA clearance for these vital signs. [In the U.S.] we have clearance for blood pressure; pulse rate; and oxygen saturation. These vital signs are regarded as the main cornerstones of monitoring.”

Eisenkraft said the company will continue to work with FDA to approve additional parameters for its devices.

Study Finds Abbott’s Blood Test More Successful in Detecting TBI than CT Scans

Pixabay Study Finds Abbott’s Blood Test More Successful in Detecting TBI than CT Scans

Abbott Laboratories could have the golden touch when it comes down to detecting traumatic brain injuries (TBI). A new study shows the Abbott Park, IL-based company’s blood test, which is still under development, could help detect mild TBIs even when a CT scan could not.

Data from Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI), a 450-patient study, shows how the technology could help catch patients that would normally go undiagnosed.

Researchers from TRACK-TBI evaluated patients admitted to the emergency department of 18 U.S. Level 1 trauma centers with a suspected TBI, who also received a negative CT scan, to determine if the brain-specific glial fibrillary acidic protein (GFAP) could be a biomarker, or indication, that helps physicians detect TBIs.

The study used Abbott's i-STAT Alinity device – a handheld, portable blood analyzer that is only available outside of the U.S to measure a patient's GFAP protein level. The device that produces test results in minutes right by a person's side.

Among these participants with a negative CT scan, researchers evaluated GFAP levels in their blood and then reviewed their MRI scans taken up to two weeks later to confirm the TBI. When looking at the people who had detectable levels of this protein, the study found that among the 90 people with the highest levels of GFAP detected, 64% were confirmed to have a TBI by the MRI scan.

By contrast, for the 90 people with the lowest levels of GFAP, 8% were confirmed to have a TBI. The research showed that GFAP could be used to determine which group of people should be screened further or referred for an MRI to confirm their TBI.

The study also looked at three additional brain biomarkers to assess any association between elevated levels of those proteins and brain injury: S100 calcium-binding protein B (S100B); ubiquitin C-terminal hydrolase L1 (UCH-L1); and neuron-specific enolase (NSE) protein. Researchers found that elevated GFAP levels were more sensitive for detecting brain injury in patients with a negative CT scan than were elevated levels of UCH-L1, S100B or NSE.

"Healthcare providers rely on blood tests for a variety of conditions because of their accuracy and speed, yet we haven't had a blood test for the brain as part of the standard of care,” Beth McQuiston, MD, RD, neurologist and medical director, Diagnostics, Abbott, said in a release. “Abbott's i-STAT device has become a trusted brand in hospitals globally today. In the future, our TBI test and next-generation device could also be added to the standard of care, working together with CT scans and other diagnostic tools to provide doctors with a more complete understanding of a patient's condition.”

The research was published online August 23rd, in Lancet Neurology.

More than 4.8 million people in the U.S. visit the emergency room each year to be evaluated for brain injury, according to Korley, FK et al. J Head Trauma Rehabil. 2016; 31(6): 379–387.

The industry has taken notice of this statistic and has offered a number of solutions. In February of 2018, FDA granted a De Novo request to Banyan Biomarkers to market the Banyan Brain Trauma Indicator. The test identifies two brain-specific protein biomarkers (Ubiquitin Carboxy-terminal Hydrolase-L1 or UCH-L1 and GFAP that rapidly appear in the blood after a brain injury.

Earlier this year, Chembio Diagnostics formed a collaboration with Perseus Science Group to develop a point-of-care diagnostic test for TBI. The terms call for Chembio to receive funding from Perseus, subject to satisfying certain milestones, to advance the development of the test. This agreement builds on previous agreements between the two firms that resulted in the completion of technical feasibility to detect Perseus’ patented biomarker.

Boosting Medical Device Quality and Profitability via a Common Product Model

Boosting Medical Device Quality and Profitability via a Common Product Model
Figure 1: When considering the design-to-manufacturing process, compare the typical serial approach with a concurrent and integrated approach, the latter of which could save about 25% in time and money.

Medical device manufacturers face hurdles taller than ever in getting high-quality products to market faster, cost-effectively. Hindering their efforts are not just external factors but also internal processes for designing and producing those products. That is why it’s time for medical device companies to adopt a design-to-manufacturing environment where designers, engineering, and production teams are synchronized on a common product model. This approach improves both product quality and profitability by reducing errors in production while increasing yield rates.

Let’s look at the challenges medical device manufacturers face in bringing products to market today, the principles behind design-to-manufacturing, and how this approach can help companies to transform their business.

The Challenges of Creating High-Quality, Innovative New Products

Design, engineering, and research and development (R&D) costs for creating a new medical devices are among the highest in manufacturing today. According to a 2010 study completed by Stanford University, FDA’s Impact on U.S. Medical Technology Innovation, it costs $31 million to develop a medical device from concept to market. Pre-Market Approvals (PMA) cost medical device manufacturers on average $94 million per device, and $75 million of the PMA is for FDA-based compliance alone.

At the same time, a proliferation of new products reaching PMA levels puts pressure on medical device manufacturers to achieve product and feature parity from a product roadmap perspective with their competitors. According to a 2019 Drugwatch article, FDA’s Center for Devices and Radiological Health (CDRH) reports that they receive about 22,000 submissions for clearance or approvals of new medical devices every year.

Adding to the competitive intensity is the strategy many medical device manufacturers have of introducing low-end models that compete on price. Accepting all of these challenges while complying with regulatory and industry reporting and quality standards makes medical device manufacturing one of the most capital-intensive industries there are.

Given how tight the new product development timelines are and how expensive each product is to produce, designers, engineers, and production teams need to be completely synchronized. Knowing the specifics of product models across manufacturing reduces errors in production and increases machinery yield rates that prolong the life of machinery across production centers. But too often, medical device companies’ computer-aided design (CAD), simulation/finite element analysis (FEA), electrical, computer-aided manufacturing (CAM), inspection, and work instructions that feed into the design-to-manufacturing process run at completely different cadences or clock speeds than the enterprise resource planning (ERP) systems on which manufacturing teams rely. For medical products manufacturers to achieve their time-to-market, quality, and cost goals, each of these systems needs to be integrated and synchronized within a design-to-manufacturing workflow supported at the platform level.

Creating a Design-to-Manufacturing Environment

Syncing the diverse base of manufacturing systems together creates a single design-to-manufacturing environment where designers, engineers, and production teams can collaborate together in real time. By taking a concurrent and integrated approach, engineering, quality, and manufacturing teams have the ability to share data on existing and new products under development, and fewer errors are made in defining how they will be produced. This change, alone, extends the life of machines on the shop floor, enabling them to produce consistently higher quality products.

Figure 1 (at top) contrasts the typical serial approach versus a concurrent and integrated approach to the design-to-manufacturing process. Notably, the latter approach can save medical device companies roughly 25% in time and money.

In moving to concurrent and integrated design-to-manufacturing process, engineering, quality, and manufacturing teams need to take more of a lifecycle-based view of each product, relying on their CAD systems’ representation of product models as a single source of the product definition.

When designers, engineers, and manufacturing teams aren’t using the same product definitions, product quality drops fast. Production machines and the teams running them don’t receive accurate work instructions, and suppliers send components and materials that don’t match the product design.

When there is an accurate, multifaceted definition of every product model in the CAD systems, product models can serve as the single source of a product definition, and all changes to the product at the bill of material (BOM) level can be propagated automatically through all functional areas. Concurrent design and manufacturing are possible at a significantly faster pace, since there’s no need to freeze designs to include any product changes.

Increasing Quality and Innovation While Cutting Costs

Medical device companies that adopt a concurrent and integrated design-to-manufacturing process—where their CAD, simulation/FEA, electrical, CAM, inspection, quality management, work instructions, ERP, and manufacturing execution system (MES) software are synchronized, with CAD systems’ product definitions serving as the central product definition—can increase their quality and innovation while cutting costs in three key ways.

  • Speed time-to-prototype. Syncing the diverse base of systems enables medical device manufacturers to reduce the time-to-prototype exponentially while increasing product quality. When centralized product models managed in CAD systems are the main product definition engineering and manufacturing rely on, teams have the analytics, data, and information they need to take action, in the language or lexicon they speak. As a result, companies adopting this approach are seeing a proliferation of new product prototypes with fewer initial design and prototype errors while also protecting against and future production issues.
  • Foster collaboration. Medical device manufacturers who adopt a design-to-manufacturing approach to managing the lifecycles of their products free up engineers and production teams to work interactively and solve manufacturing challenges faster. Manufacturing product engineers can use design-to-manufacturing environments or platforms to evaluate new product designs earlier in the product development process. And manufacturing scheduling teams can look at the impact of new models on existing shop floor workflows as well as wear and tear on new machines. This results in the ability to both increase manufacturability and reduce costs.
  • Pursue configure-price-quote selling. The total available market for medical devices increases the more a given medical device manufacturer can offer customers and distributors flexibility in product designs. Taking a lifecycle-based approach where the centralized product model serves as the single product definition company-wide can free medical product manufacturers up to pursue a configure-price-quote (CPQ) and product configuration strategy. This, in turn, can deliver higher gross margins by attracting customers who otherwise would not have purchased devices.


Taking a centralized product model approach that scales across the entire design-to-manufacturing process combined with a collaborative working environment helps to increase the levels of innovation medical products manufacturers can achieve. A concurrent and integrated design-to-manufacturing process makes it possible for medical device manufacturers to deliver products faster, at a higher overall level of quality, and at lower costs. It’s time for medical device manufacturing to adopt a more lifecycle-based approach to creating new products, one that brings together design, engineering, and manufacturing interactively on a real-time collaborative platform.

Canadian General-Tower acquires French plastic film supplier

Canadian General-Tower acquires French plastic film supplier

CGT logoCanadian General-Tower Ltd. (CGT; Cambridge, ON), a global provider of coated fabric and film products, announced today the acquisition of Liancourt, France–based companies AlkorDraka Industries and Alkor Medical Tubing, specialists in the formulation of plastic films. CGT has successfully acquired the assets and retained the employees of both companies. Effective immediately, the new trade names for the European businesses will be CGT Alkor and CGT Medical Products.

With 60 years of experience in calendering, printing and laminating, Alkor employs a team of highly skilled and dedicated employees and is recognized on a global scale for its commitment to quality, technology and innovation.

As a previous supplier of high-quality pool liners to CGT Europe, AlkorDraka Industries now covers eight business sectors: Ceiling and wall decoration, coatings for window marketing, dance floor films, consumer product packaging, pool liners, containment film, movie screens and various technical applications.

The acquisition of Alkor’s medical tubing division will bring new potential to CGT with the production of tubing and film products for the highly regulated medical industry.

“This new development is an important strategic opportunity and comes with great excitement for the future of CGT as we continue to fulfill our global growth endeavors,” said CEO Craig Richardson in a prepared statement. “The initial reaction we have received from our stakeholders has been extremely positive as CGT moves toward investing both personnel and capital into the European markets to grow these newly acquired businesses.

“With the goal of increasing sales to our valued customers in both the industrial and automotive sectors, this investment will add to our capacity and geographic presence so that we can continue to serve our growing global customer base,” Richardson added.

The acquisition will provide CGT, which is celebrating its 150th anniversary this year, with a strategic base of operations in Europe, adding to the company’s existing portfolio in North America and China.

Microplastics in drinking water not a health hazard, says WHO

Microplastics in drinking water not a health hazard, says WHO

Myths surrounding the harm that various chemicals used to create plastic can do to humans have been around for decades. First there was the “don’t heat your food in a plastic container in a microwave because the chemicals (dioxins, bisphenol-A and phthalates) will leach out and poison you. According to several reports, including one from Harvard Medical and Web MD, the one about dioxins is a myth.

Myth-busting file folder

Dioxins are released into the atmosphere when garbage and organic matter are burned. The dioxins then fall back to Earth and animals eat the grains and grasses and we eat the animals. Of course these dioxins also fall onto our vegetable gardens, so it’s a losing battle. However, the real key here is that you can’t be harmed by dioxins from plastic because plastic doesn’t contain dioxins!

As for bisphenol-A (BPA), which is used to make clear, hard plastic, and phthalates, used to make soft, flexible plastic, several decades of studies and experiments have shown that BPA in the minute amounts that humans are exposed to has shown no evidence of being harmful. The same is true of phthalates. Of course one of the things that makes plastics so durable is that the molecular chains that create these materials are so tightly connected that they cannot easily be broken apart.

As for heating food in a plastic dish in a microwave, food would have to heated to temperatures above 700°F before the plastic would start breaking down enough to release any chemicals. By that time your food would be burned so badly you wouldn’t eat it anyway.

Now, on to microplastics, which we’ve been told are floating around in our drinking water and come from polymer textiles and other types of plastic products in the environment. A new report dated Aug. 21, 2019, from the World Health Organization (WHO; Geneva) says not to worry. “[J]ust because we’re ingesting them doesn’t mean we have a risk to human health,” said Bruce Gordon, WHO’s coordinator of water, sanitation and hygiene, in an Associated Press report. “The main conclusion is, I think, if you are a consumer drinking bottled or tap water, you shouldn’t necessarily be concerned.”

The fear that these microplastics can enter the human body and cause harm is not backed by science. “Based on the limited evidence available, chemicals and microbial pathogens associated with microplastics in drinking water pose a low concern for human health,” stated the report. “Although there is insufficient information to draw firm conclusions on the toxicity of nanoparticles, no reliable information suggests it is a concern.”

While it might call for further research, the WHO does not recommend investing effort in monitoring for microplastics in drinking water because resources would be better spent removing pathogens, a proven risk, according to an article in the Guardian.

WHO’s Gordon agrees, mentioning typhoid and cholera as being more worrisome than microplastics. “[Typhoid and cholera] are things that cause immediate illness and can kill a million people,” he said.

Image: iQoncept/Adobe Stock

Material with Unprecedented Pulling Force Eyed for Artificial Muscles

Researchers have once again found inspiration in nature to improve the design of materials, this time for programmable fibers for artificial muscles that demonstrate an unprecedented amount of pulling force, they said.

A team at MIT were inspired by the growth of a cucumber plant, which sprouts tendrils that seek support to pull the plant upward, enabling it to receive optimal sunlight exposure. Scientists—including MIT Professor Polina Anikeeva, MIT postdoc Mehmet Kanik, and MIT graduate student Sirma Örgüç—used this example to develop a new mechanism that alternately coils and pulls to produce contracting fibers that can be programmed for use in artificial muscles for robots, prosthetic limbs, or other mechanical and biomedical applications, they said.

artificial muscles, MIT, fiber-drawing technique, thermal-expansion coefficients, cyclic copolymer elastomer, thermoplastic polyethylene
The tiny coils in the fiber developed by MIT researchers curl even tighter when warmed up. This causes the fiber to contract, much like a muscle fiber. (Image sources: Felice Frankel, MIT News)

Researchers already have used myriad approaches to create artificial muscles; some of these include hydraulic systems, servo motors, shape-memory metals, and polymers that react to external stimuli. However, so far all of these approaches are limited in various ways, including being too heavy or responding too slowly.

The new approach taken by the MIT team uses a fiber-drawing technique to combine two dissimilar polymers into a single strand of fiber, creating a system that is very lightweight and also highly responsive, researchers said.

Common Approach, New Invention

Researchers took an approach already used commonly to measure temperature in thermostats—combining two materials that have different thermal-expansion coefficients, or different rates of expansion when heated.

When these joined materials get hot, the side that wants to expand faster is held back by the other. This causes the material to curl up, bending toward the side that expands more slowly.

Specifically, MIT researchers used a very stretchable cyclic copolymer elastomer and a much stiffer thermoplastic polyethylene as their materials. They bonded them together to produce a fiber that--when stretched out to several times its original length--naturally formed a tight coil much like the cucumber tendrils.

Researchers discovered the potential for the fibers’ strength almost by accident, Anikeeva said in a press statement. “There was a lot of serendipity in this,” she said.

What happened was that researcher Kanik picked up the coiled fiber for the first time and noticed the warmth of his hand caused it to curl even more tightly. Upon further observation, researchers realized that increasing the temperature of the material made the coil tighten even more, creating a strong pulling force. Then, when the material cooled, the fiber returned to its original length.

Programmable and Versatile

Expanding on the concept further, researchers realized that they can program the degree of tightening that occurs when the fiber is heated by deciding how much of an initial stretch to give the fiber. This means they can tune the material to exactly the amount of force needed for an applications as well as the amount of temperature change needed to trigger that force.

Researchers published a paper on their work in the journal Science.

In tests, the fibers--which can span a wide range of sizes from a few micro-millimeters to millimeters--showed both longevity and extreme capability for lifting loads, researchers reported. Experiments proved that a single fiber can lift loads of up to 650 times its own weight, and the fibers maintained their ability to contract and expand for at least 10,000 cycles, they said.

Also, because the fibers are created on a fiber-drawing system, researchers can incorporate other components into the fiber itself, they said. For instance, in testing, researchers coated the fibers with meshes of conductive nanowires that can be used as sensors to reveal the exact tension experienced or exerted by the fiber, they said.

The fibers also in the future could include optical fibers or electrodes that can heat the material internally without having to rely on any outside heat source to activate artificial-muscle contraction, researchers said. Moreover, they can be bundled together similarly to human muscle fibers--another aspect that makes them well-suited for use in artificial muscles for robots as well as human prosthetics, researchers said. 

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.

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!


Ford’s Bob Taenaka Looks At EVs' Big Picture

Bob Taenaka has been directly involved in every one of Ford’s electrified vehicles to date. His Keynote address at The Battery Show will highlight how battery technology is helping to lead the EV market. (Image source: Ford Motor Company)

Bob Taenaka is a Senior Technical Leader in Electrified Vehicle Battery Cells and Systems at Ford Motor Company, responsible for battery cell technology and battery system performance in support of Ford's present and near-term future production hybrid and electric vehicles. 

“I’m looking at the big picture—what are the demands of electrified vehicles for the future. Having the electrified vehicles that people really want,” Taenaka told Design News. “It’s the technology and capability that will pull the vehicles. These are advanced electrified vehicles and not regulatory push that says we need to reduce emissions and increase fuel economy and less dependence on fossil fuels,” he added.

Taenaka will provide one of the Keynote Addresses at The Battery Show and Electric & Hybrid Vehicle Technology Expo 2019, on September 12th in Novi, Michigan. His talk, titled “Gateways to the Future: Delivering on Electrified Vehicle Demands” will be presented on Tuesday, September 10th.

Sitting on a Precipice

“It’s actually quite exciting for me because I have been at Ford since 2001, so I’ve seen electrified vehicles expand to where we are right on a precipice where electric vehicles will really take off in the next decade,” said Taenaka. Prior to joining Ford in 2001, Taenaka spent 18 years with Hughes Space & Communications, serving as battery engineer for the Galileo Probe mission to Jupiter, was principal investigator or program manager for several nickel-hydrogen and sodium-sulfur battery development efforts, and held responsibility for in-orbit support on battery usage for satellite customers and ground stations. Rocket science, in other words.

Moving into electrification of transportation will take several steps. “There is a nuance,” Taenaka told us. “There are electric vehicles that are either battery or fuel cell—fully electrically powered. Then there are electrified vehicles which include those, but also include hybrid-type vehicles where you have a gas engine and an electric motor,” he said.

“A lot of industry experts have different projections. In the next ten years, I’d say, some say that electric vehicles may be 25-50% of the total vehicle market,” Taenaka explained to Design News. “As of today, I think the number is maybe around 1-3%, in that ballpark. The battery electric vehicle and also the full hybrid and plug-in hybrids and mild hybrids—a lot of these are geared to help reduce the level of CO2 emissions generated from the transportation sector. I’d say that’s where the regulatory push comes from. So not only the push but also the pull from having the performance.”

Pull as Important as Push

Taenaka thinks that having the right kind of vehicles will create this consumer-generated pull. “Having an enhanced capability will mean that people will want to purchase these advanced electrified vehicles—not only for the sense of environmental responsibility for the customer that’s driving the vehicle, but also having the advanced technology that makes their drive even more enjoyable and exciting,” he said.

Many think that reaching significant market penetration for EVs will only occur when there is cost parity with internal combustion engine vehicles. “The combination of vehicle range and vehicle cost has been one of the big obstacles to lot of people wanting to get electric vehicles in the past. The market is increasing, but to get to the level of market where states such as California are mandating, requires the vehicle costs, in particular the battery cost be reduced significantly. There have been tremendous strides that have taken place in the last 20 years on battery technology, and battery cost. Having vehicle cost parity, or even lower vehicle cost compared to conventional internal combustion engine vehicles, that’s where you are going to have a big uptick in customer demand,” Taenaka told us.

“Having similar range and similar or lower cost, equal or better capability and features—I think that’s really what drives the market,” he added.

“Since I started at Ford, the vehicle range has always been dictated by how much battery you can fit into the vehicle. And that’s another change I see happening in the next decade or so—the energy density of battery cell technology is going to be at the point where the vehicle designs will no longer be constrained by packaging the battery. We’ll start making the battery a little bit smaller and start providing other features that will fit into the space that is presently filled up by the batteries.” “It’s the combination of the range, the charging time, and the battery cost and dimensions,” said Taenaka.

Decoupling Demand From the Cost of Oil

Because Taenaka and has played a key role in battery development for each of Ford’s production electrified vehicle models launched to date, he has seen the ups and downs in the demand for EVs. “Customer desires are highly dependent upon a number of external factors. In the past, gas prices have tremendously driven the selection of big trucks and SUVs versus smaller fuel-efficient cars. When we had spikes in gas prices, consumers went with smaller cars so that their transportation costs would not be excessive. I think today people are becoming more immune to the fluctuations in gas prices and so we are tending to see more customers wanting larger vehicles,” he said.

Interestingly, because oil prices have only a secondary effect on the price of electricity, wider-spread adoption of EVs, particularly larger SUVs and pickup trucks that are on several carmaker horizons, may push buyers further away from small cars. Renewable energy might disconnect the size of the vehicle you choose from the cost of gasoline. “Geothermal, wind, and solar are not so prone to (oil) price fluctuations. I would expect the price (of electricity) to be much more stable than you would ever have with fossil fuels. Having electric vehicles plays right into that.”

Taenaka’s Keynote Addresses, titled “Gateways to the Future: Delivering on Electrified Vehicle Demands” will cover many of these topics in greater detail. The talk will be presented on Tuesday, September 10th at The Battery Show and Electric & Hybrid Vehicle Technology Expo 2019, in Novi, Michigan.

Senior Editor Kevin Clemens has been writing about energy, automotive, and transportation topics for more than 30 years. He has masters degrees in Materials Engineering and Environmental Education and a doctorate degree in Mechanical Engineering, specializing in aerodynamics. He has set several world land speed records on electric motorcycles that he built in his workshop.


The Battery Show logoBattery, EV/HV, & Stationary Power All in One Place.
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.


Online-paintable fuel filler flap made from PBT

Online-paintable fuel filler flap made from PBT

Customized compounds based on polybutylene terephthalate (PBT) can be a cost-effective alternative to high-performance thermoplastics in the production of fuel filler flaps. This can be seen in the new Skoda Scala, for example, whose fuel filler flap is made from Pocan B5221XF from materials supplier Lanxess.

PBT fuel filler cap is a lower-cost, yet high-performance alternative to resins such as PPE+PA.

The PBT compound was given preference over a blend of polyphenylene ether and polyamide (PPE+PA). “Our material is less expensive and exhibits comparable performance when it comes to surface quality, paintability, and mechanical properties. In addition, it is suitable for electrostatic painting. It is also paintable online, which means that it can pass through all painting steps together with the vehicle body without any further outlay. This also contributes to cost-effective production,” says Dr. Stefan Theiler, who is an expert in plastic exterior parts in application development in the Lanxess High Performance Materials (HPM) business division. The plastic vehicle body component was jointly developed by Skoda, a Tier 1 parts supplier and Lanxess.

Pocan B5221XF (Xtreme Flow) has been optimized to ensure good paintability and paint adhesion. Depending on the tool, smooth surfaces without unsightly sink marks can be achieved (Class A surface). The material is also suitable for electrostatic painting. When it comes to paint adhesion, standard OEM requirements – such as those defined in delivery regulations TL 211 from Volkswagen and DBL5416 from Daimler – are fulfilled. The paint layers adhere firmly to the plastic surface and can withstand the usual adhesion tests such as the cross-cut test to DIN EN ISO 2409 and steam-jet test to DIN EN ISO 16925.

The material, which is reinforced with 20 percent micro glass beads, exhibits isotropic shrinkage and a minimized tendency to warpage. This means that the fuel filler flap fits in perfectly with the rear fender. “This gives it the edge over polyamide blends, which are less dimensionally stable due to the tendency of polyamide to absorb water,” says Theiler.

Another advantage of the PBT material is its high resistance to short-term temperatures. The heat distortion temperature as per ISO 75-1,-2 (HDT/B, 0.45 MPa) is 165°C, which means that the fuel filler flap can withstand the high temperatures that arise during both cathodic dip coating of the vehicle body and the drying steps of the painting process. As a result, the component can pass through the entire painting line together with the vehicle body (online painting). “This helps to cut costs during painting and in the logistics processes,” says Theiler. By contrast, mineral-filled PBT or PA compounds – which are also used for manufacturing fuel filler flaps – are not compatible with cathodic dip coating processes.

The toughness of the PBT compound from Lanxess is yet another advantage, making the fuel filler flap highly robust against mechanical deformation (e.g. in the event of vandalism). Theiler: “Gasoline and diesel thieves will find it really hard to prise the flap open, even if they use force.”

Pocan B5221XF can be processed at lower temperatures than (PPE+PA) blends. Its high flowability makes it easier to realize complex or large component geometries. “In addition to fuel filler flaps, we also envisage our material being used for exterior body parts such as spoilers and other components designed to improve vehicle aerodynamics as well as in antenna covers, flaps for electric vehicles and mirror housings,” says Theiler.

Through its engineering service HiAnt, Lanxess provided Skoda with comprehensive support in the development of the fuel filler flap. Under this brand, HPM has combined its expertise in material, application, process and technological development. For the fuel filler flap, for example, HPM conducted mold flow and warpage simulations in order to achieve the best-possible tool design and optimize the production process. Theiler: “Our aims here included correctly positioning the cooling ducts in the injection molding tool, defining the ideal parameters for tool tempering and calculating the optimum melting temperature.” In addition, HPM simulated critical load cases during component testing, such as the forceful opening of a sealed fuel filler flap in a body drop test. During the sampling process and start of series production, processing experts from HPM went directly to the injection molders and gave them recommendations for process parameters, reworking the tool (e.g. regarding gating and cooling system) and ventilation.

How to Survive Medtech's 'Death Valley'

Graphic by Amanda Pedersen, based on Marc Oczachowski's recommendations. How to Survive Medtech's 'Death Valley'
There is a lot to learn from EDAP TMS' journey through the U.S. regulatory and reimbursement process.

Medical device companies attempting to market a new treatment in the U.S. often make the erroneous assumption that winning FDA approval is the final destination, and success is theirs. In fact, going through the regulatory process is only the halfway point. The grueling path from FDA approval to reimbursement is like a treacherous walk through Death Valley and many companies don’t make it through.

In this case study, I discuss the trials and triumphs of bringing robotic high intensity focused ultrasound (HIFU), a non-invasive procedure for localized prostate cancer, to the U.S. I'll shares lessons learned as EDAP TMS began its 14-year journey, starting with the FDA pre-market approval (PMA) process, shifting to the more expedient de novo 510(k), and winning FDA clearance. Then getting through the Death Valley gauntlet to finally win the American Medical Association’s (AMA) approval of a new Category 1 CPT code for treating prostate cancer, and reimbursement from insurers.

Jumping Through Hoops: The Rigors of FDA Approval

We faced a protracted process when we first applied for a PMA for EDAP’s first HIFU device. HIFU is a non-invasive option that had been in use in Europe, Asia, and South America since 2000.  It allows the surgeon to destroy only the diseased portion of the prostate, thereby preserving healthy surrounding tissue and nerves. As a result, HIFU minimizes the risks of side effects typically associated with the more aggressive treatments like radical surgery or radiation therapy, including erectile dysfunction and urinary incontinence.

Based on FDA feedback, we commissioned a three-year, multi-centered clinical study of 135 U.S. patients to evaluate the efficacy of HIFU as a treatment for localized prostate cancer. We partnered with a leading urologist at Duke University, as well as urologists from high-level institutions around the United States to conduct this research.

The study demonstrated the efficacy of cancerous tissue ablation using HIFU. Because the study mandated by FDA was performed on low-risk patients and the two-year follow-up was too short to draw a conclusion about oncological control, panel members could not confirm the effectiveness of our device as a prostate cancer therapy. To win approval of HIFU as a treatment for localized prostate cancer would have required a long term, randomized multi-centered study with more than 1,000 patients.

At that point, FDA recommended that we apply for clearance of the device for prostate tissue ablation, based on a de novo 510(k), rather than seeking approval as a device to treat a particular disease. After about six months (October 2015), FDA cleared HIFU for prostate tissue ablation based on the results of the same 135-patient study. But it took 10 years altogether to navigate the FDA path and receive clearance. We also had to convince urologists and hospitals to take a bet on our first-generation device, as patients would have to pay out of pocket for the procedure because it was not yet covered by Medicare or private insurance.

Fortunately, once a medical device is FDA cleared and new iterations of the same technology are released, the approval process is faster and clinical data outside the United States becomes acceptable. When we launched our second-generation HIFU system (Focal One), we could submit clinical data from several European studies, and that expedited FDA clearance.

When we finally got market clearance for Ablatherm in the United States, Focal One had been approved two years earlier and was already in use throughout Europe, Asia, and South America. Focal One is designed specifically for focal treatment of the prostate. It fuses MRI and 3D biopsy data with real-time ultrasound imaging, which allows urologists to view integrated, detailed 3D images of the prostate on a large monitor and direct high-intensity ultrasound waves to ablate the targeted area. With Focal One, urology surgeons can establish precise contours around the diseased tissue and ablate an even smaller portion of the prostate.  This lessens the damage to healthy tissue and minimizes side effects of incontinence and impotence for patients. Using Focal One, surgeons can customize the HIFU procedure for each patient and each clinical condition.

Brian Miles, MD, a renowned Houston urologist who performed the HIFU procedure at Houston Methodist Hospital using our first-generation device observed Focal One in Germany and wanted to bring the new device to the hospital even before it was FDA cleared.

“Focal One gives Houston Methodist Hospital urologists the ability to plumb the depths of something until recently considered heresy," Miles said. "The possibility of focal therapy to ablate only the diseased portion of the prostate is like performing a lumpectomy to remove only the diseased tissue of the breast in women with breast cancer.  We can now take only the infected tissue and leave the healthy tissue intact.  Focal therapy still leaves doctors with the options of radical surgery or radiation, should the cancer return. They don’t burn any bridges.”

Focal One received FDA clearance in June 2018.

Obtaining Medical Codes and Getting Payers to Reimburse for HIFU

While winning FDA clearance for our first and second generation HIFU devices was a 13-year, complex process and a huge accomplishment, our journey was far from over.  The next hurdle was obtaining medical codes to facilitate reimbursement from public and private payers, which can take up to four years. The pathway to reimbursement is where many companies fail because they don’t produce enough revenue following clearance to take them the rest of the way.

So as soon as FDA cleared our first HIFU device we proceeded with our reimbursement strategy.  First, we worked with the Centers for Medicare & Medicaid Services (CMS) to establish a temporary Healthcare Common Procedure Coding System (HCPCS) C-code. In that process, we had to educate Medicare administrative contractors (MACs) on the value of HIFU. The C-codewhich took effect in July 2017, allows hospitals offering HIFU to submit a claim for Medicare patients although it does not include the urologist’s fee for the procedure, nor does it guarantee that the hospital or patient will be reimbursed.

And the C-code was only part of our reimbursement strategy.  In 2018, we also began working with the American Urological Association (AUA) and the American Association of Clinical Urologists (AACU) to submit an application to the AMA for a new Category 1 CPT code, specifically for ablation of malignant prostate tissue. So while we pursued clearance of Focal One, we also began a concurrent path toward securing the CPT code and reimbursement. 

We brought in urologists from top medical universities that were using our device, as well as the AUA and the AACU's reimbursement committee representatives. We also worked with our competitor, SonaCare Medical, knowing that the AMA prefers to see competitors work together to develop the CPT code language.

Finally, in May 2019 we presented our case at the AMA CPT panel meeting and the following month the AMA accepted our application to establish the new Category 1 CPT code that will facilitate reimbursement for the HIFU procedure. The CPT code description selected by the panel is "ablation of malignant prostate tissue, transrectal, with high intensity focused ultrasound (HIFU) including ultrasound guidance."

The code will be included in the next CPT Codebook, effective Jan. 1, 2021. The CPT code will make it possible for men with localized prostate cancer who have the HIFU procedure to be reimbursed by their health insurer. By issuing a CPT code, the AMA is validating the clinical benefits of HIFU so it can take its rightful place as a standard procedure, alongside prostatectomy, radiation, cryotherapy, etc.

Could More M&A Be on the Way from Alcon?

Pixabay Could More M&A Be on the Way from Alcon?

More M&A could be just what the doctor ordered for Alcon, as the company reported a significant net loss in 2Q19. Last week, during the Fort Worth, TX-based firm’s earnings call executives said there was an interest in tuck-in and technology-related deals.

The quarter was tough for the eyecare specialist as it reported a net loss of $390 million in 2Q19 compared to a net income of $15 million in 2Q18. The company said its separation from Novartis accounted for $78 million in operating loss. Alcon said it expects to have a net sales growth between 3% and 5% for the full year.

During the call, an analyst asked the company’s thoughts on potential M&A, especially in the glaucoma space.

“I think right now, we have an interest,” David Endicott Alcon’s CEO said in response to a question about how the company viewed M&A, according to a Seeking Alpha Transcript. “I think we would just reiterate that we have an interest in deals that are technology-oriented where we think we can add value to the development process or where we can commercialize. We tend to look at things that a little bit more in the ready to develop phase as opposed to the commercialization phase. We obviously would take some things into the commercialization phase if we could afford to buy them or that the markets would allow us to do that, but I think the glaucoma space is of particular interest, of course.”

Endicott, according to a transcript from Seeking Alpha added, “Big picture though, we’re in that $50 million to $300 million deal range. We’ve done a lot of them. We’ll keep doing them. Our bet is that we can find technologies there that we could add some value to over time.”

Even before its split from Novartis, Alcon was focused on building out its portfolio through M&A. In December of 2018, the company acquired Tear Film Innovations, a private company that makes the iLux device used to treat Meibomian Gland Dysfunction, a leading cause of dry eye.

Alcon would go on to make another acquisition in March – paying to $285 million for PowerVision, a Fort Worth, TX-based company that has been working to create fluid-based intraocular lens implants.

Potential acquisitions could help fill a huge hole left by the company (while it was with Novartis) pulling the CyPass Stent for micro-invasive glaucoma surgery off the market, a year ago. The product was scrapped after five-year data revealed a higher rate of cell loss compared to patients who had cataract surgery alone.

Alcon gained access to CyPass when Novartis acquired Transcend Medical for an undisclosed sum in 2016.