Supplier Stories for the Week of August 25

Bimba has launched the BPVA, a compact pneumatic pinch valve that expands the company's pinch valve portfolio with a more cost-effective solution for industrial and medical applications. As with Bimba's other pinch valves, the BPVA is designed as an alternative to traditional wetted valves by opening and closing flexible tubing to control the flow of media so it never makes contact with the valve, the company reported in a news release. According to Bimba, the BPVA:Requires less maintenance and reduces the risk of contamination.Offers high-performance life expectancy of 3 million cycles.Features a compact design that enables operations in confined spaces.Is available at a cost-effective price point.“The BPVA targets a wide range of applications needing a simplified design and a low price per unit for high quantities,” stated Sarah Manuel, product manager, in the release. “By offering four models with different sizes and options, the BPVA adds a versatile yet compact pinch valve design, all at an affordable price to our existing portfolio of pinch valve products. An electrical solenoid piloted version of the BPVA is planned for release in the near future, and will be announced as soon as it is available for ordering.”The BPVA is available in anodized aluminum or stainless steel and in normally closed or normally open configurations. A completely stainless-steel, corrosion-resistant option is suitable for washdown and sanitary environments. Additional options include mounting brackets, various seal materials, and magnetic position sensing.[Image courtesy of BIMBA]

FDA Is Still Trying to Tackle the Dirty Duodenoscope Problem

FDA Is Still Trying to Tackle the Dirty Duodenoscope Problem
FDA took several actions this week to address the ongoing problem of contamination on difficult-to-clean devices used for endoscopic procedures.

In April FDA reported that postmarket surveillance studies indicated higher-than-expected levels of contamination on duodenoscopes after reprocessing. Now, FDA is recommending that healthcare facilities either use fully disposable duodenoscopes or ones with disposable endcaps when they become available. Disposable designs simplify or eliminate the need for reprocessing, which may reduce between-patient duodenoscope contamination as compared to reusable, or fixed endcaps, the agency said.

Duodenoscopes are the flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum) to diagnose and treat problems in the pancreas and bile ducts.

“We recognize that a full transition away from conventional duodenoscopes to innovative models will take time and immediate transition is not possible for all healthcare facilities due to cost and market availability,” said Jeff Shuren, MD, director of FDA’s Center for Devices and Radiological Health. “This is why we’re communicating with healthcare facilities now—so they can begin developing a transition plan to replace conventional duodenoscopes—and those facilities that are purchasing duodenoscopes with fixed endcaps can invest in the newer, innovative models."

Shuren said FDA is also encouraging the manufacturers of these duodenoscope models to assist healthcare facilities with their transition plans.

"While the risk of infection from inadequate reprocessing is relatively low, we are taking action because of continuing elevated levels of contamination in duodenoscopes," Shuren said.

FDA also ordered new postmarket surveillance studies on duodenoscopes with disposable endcaps in order to verify that these new designs do reduce contamination. The agency also requested that real-world contamination rates be included in duodenoscope labeling. And finally, FDA said it has issued letters to manufacturers of certain test strips that have not been reviewed by FDA but claim to assess duodenoscope cleanliness.

Fixed endcap duodenoscopes have a plastic or rubber cap permanently glued to the metal edges around the distal end to prevent tissue injury from the metal edges on the scopes, but when permanently affixed, the endcaps also limit the accessibility to clean the crevices at the distal end. 

Postmarket human factors studies suggest that users frequently had difficulty understanding and following manufacturers' reprocessing instructions and were not able to successfully complete reprocessing, which may leave the devices contaminated. FDA said it will continue to work with manufacturers to conduct additional testing and revise reprocessing instruction manuals, but the best path to reducing the risk of disease transmission by these devices is through innovative designs, such as those with disposable components, that make reprocessing easier, more effective, or unnecessary.

FDA has cleared two duodenoscopes with disposable end caps: Fujifilm Corporation, model ED-580XT and Pentax Medical, model ED34-i10T. Additionally, other firms have publicly announced plans to develop fully disposable duodenoscopes. During a quarterly earnings call earlier this year, Boston Scientific CEO Mike Mohoney said the company 

During Boston Scientific's first-quarter earnings call, CEO Mike Mahoney said the company is on track to launch its Exalt-D single-use duodenoscope. 

"The Exalt model D single-use scope has been designed to address this exact issue by eliminating scope disinfection challenges completely," Mahoney said. "This platform represents a significant opportunity in 2020 and beyond."

Pentax Medical is also attacking the issue from a different angle by promoting a new hygiene solution designed to enhance patient safety in endoscopy. Last year Pentax acquired a controlling interest in Paris, France-based PlasmaBiotics, a company that makes devices for drying and storing endoscopes.

Pentax touted the PlasmaTyphoon at the European Society of Gastrointestinal Endoscopy (ESGE) Days in Prague in April. The device is designed to minimize the risk of bacterial contamination through a highly effective drying mechanism and active storing of the endoscopes with plasma, via the PlasmaBag, for up to 31 days.

"The focus is usually on the cleaning of endoscopes, but if you do not dry properly at the end of the whole procedure, then you make all your work for nothing," Ulrike Beilenhoff, former president of the European Society of Gastroenterology and Endoscopy Nurses and Associates, said during a video Pentax Medical provided to journalists following ESGE Days.

Separating Plasma from Smaller and Smaller Blood Samples

I.W. Tremont D-23 plasma separator
I.W. Tremont D-23 plasma separator has been used in products similar to the one shown above.

In diagnostics these days, “a lot of people are after plasma,” reports Jim Averso, vice president, sales and marketing, of I.W. Tremont. “There’s a lot of new research being conducted in plasma-based tests, although it is now very common for diagnoses of endocrine and cardiovascular issues. Prior to that, it was whole blood.” Biomarker analytes are easier to access in plasma, Averso added.

Averso pointed to new research from Market Research Future predicting 11.3% anticipated growth in the lancet market between 2016 and 2022, indicating the growth in the number of small sample volume tests that will be performed. This is primarily driven by increasing prevalence of diabetes and growing need for test devices indicating contagious and non-contagious disease, he shared.

Obtaining enough plasma from patient blood samples for analysis can be a challenge, particularly as sample sizes are shrinking. “There’s a focus on patient discomfort, driving a move to reduce lancet sizes from a traditional 28 gauge down to 33. This of course yields less fluidic volume samples from roughly 20 microliters to 10 or 11,” Averso explained. He pointed to the recently launched micro safety lancets from a number of large global device manufacturers for drawing a smaller blood sample for point-of-care and self-care testing. Diagnostic device designers, therefore, need to separate enough plasma from a smaller volume of whole blood. Some have suggested building up the sample volume using chase buffer, but this could impact the existing test chemistries and design, he said.

To offer such designers an alternative, I.W. Tremont has developed a material with a micro-glass structure that can separate a significant amount of plasma from whole blood efficiently, Averso said. D-23 was first commercialized about 10 years ago, and biochemically enhanced versions with an agglutinating chemistry that more efficiently separates plasma was developed about 6 years ago. The company has worked extensively with a CRO to develop biochemically enhanced materials for this platform of products. “We brought the optimization of the physical characteristics of the material about as far as we could, [and] we then looked to the experts in the chemistry of blood separation,” he told MD+DI.

“The material enables a fast wick and migration rate that is optimized to give up as much plasma as possible,” Averso continued. “Our material can produce more plasma from a sample, so the device designer doesn’t have to change the design. We can get the same yield out of a smaller sample.”

For instance, Averso said the typical yield for plasma separation substrates is about 20% if there is enough available plasma in a sample. “We can achieve 20% with mechanical separation [with standard D-23 and D-23-TC1], and 40% with the biochemically enhanced versions,” he said.

Above: Different plasma yields for different concentrations of the agglutinating chemistry applied to the material. Image courtesy of I.W. Tremont.

The material also minimizes hemolysis during separation and generates an optically clear plasma, supporting newer diagnostics that rely on optical analysis, such as PCR, he said.

In addition to separating plasma efficiently, D-23 can also be used to hold indicative chemistry (a reagent), eliminating the need for transfer to a conjugate pad, Averso said.

With such plasma efficiency and a minimized amount of components and chemistry, device miniaturization is possible, he said. Lab-on-chip support is also possible.

The material is already listed in a couple of 510(k) applications and in one patent, and nearly 100 clients are evaluating the material, he said.

I.W. Tremont continues to study how plasma interacts with the material and to replicate work done by customers.

High-speed closure specialist corvaglia demos sustainable designs

High-speed closure specialist corvaglia demos sustainable designs

K 2019 visitors to the corvaglia (Eschlikon, Switzerland) booth, A 51-10 in hall 12, can see a demonstration of the company’s innovative designs for closures that are attached to bottles, known as tethered caps, that conform to the requirements of EU Directive 2019/904, which aims to reduce the impact of certain plastic products on the environment. Corvaglia has developed solutions for carbonated and non-carbonated drinks.

Tethered bottle cap

On April 5 of this year, corvaglia held a ribbon cutting of its first U.S. manufacturing facility in Newnan, GA. The company manufactures 100% recyclable plastic caps and closures featuring its one-piece closure technology through in-house proprietary molds. The company now has four production facilities in Switzerland, Mexico and the United States.

Corvaglia has made a commitment to reduce the consumption of materials and energy (and, therefore, also CO2 emissions) required to produce packaging while maintaining, if not improving, packaging specifications. Tethered cap technology is one manifestation of this goal.

Recycling Partnership launches free online tool to simplify recycling for consumers

Recycling Partnership launches free online tool to simplify recycling for consumers

Consumer confusion is seemingly the result of the single-stream recycling method in which people throw nearly everything into the recycle bin. In an attempt to alleviate this confusion, the Recycling Partnership (Falls Church, VA) announced the public beta launch of DIYSigns. The debut of this free online resource promises to help people know what to throw into the recycling stream.

Recycling cart

“We know that consumer confusion is one of the top reasons why trash still ends up in recycling bins and carts,” said Keefe Harrison, CEO of the Recycling Partnership, during her announcement onstage at the Resource Recycling Conference in New Orleans. “Our community partners have asked for our help in creating free and customizable posters, labels and signs and we were happy to deliver. Anything we can do to help public and private sector recycling succeed is a boost for the industry.”

DIYSigns is an online tool with editable templates available in a variety of sizes from bumper sticker to poster dimensions. The tool is available by going to the Recycling Partnership’s website and signing up with contact information. No special software is needed to edit the signs. Through the online tool, all sizes of the signs, labels and posters can be customized for any company or jurisdiction, and for any type of recyclable.

“This tool, available to anyone who needs it, connects to our tested and proven campaign materials and will enable recycling programs to more easily deliver top-rate communications with their public,” said Harrison.

“Engaging consumers on what can and cannot be recycled is key to limiting trash or other non-recyclables from making their way into recycling containers,” said Cody Marshall, Chief Community Strategy Officer at the Recycling Partnership. “Residents need to be informed with clear, concise and consistent education in order for recycling systems to be successful. Our DIYSigns tool complements our other free resources and technical assistance to better inform residents on what they can recycle.”

The Recycling Partnership offers technical, operational and educational assistance to communities in the form of free resources and grants to drive change in recycling programs across the country. A good place to begin, suggests the Recycling Partnership, is the Contamination Kit, which includes all the documents communities need to stimulate conversation and walks through how and when to use them. Second, the Campaign Builder helps customize and design a recycling education campaign.

All of the resources offered by the Recycling Partnership are free to anyone looking to transform recycling for good and help Americans to waste less and recycle more.

12 Robot Companies to Watch

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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Filament, MOBI Partner to Bring Blockchain to Connected Vehicles

Integrating the MOBI Vehicle Identity Standard into Filament's Blocklet Mobility Platform will give embeddded engineers a simplier path toward creating blockchain applications for vehicles. (Image source: Filament)

Filament, a startup known for developing USB-based blockchain products, has entered into a partnership with the Mobility Open Blockchain Initiative (MOBI) to bring blockchain to connected vehicles. Under the partnership, Filament will implement the MOBI Vehicle Identity Standard into its Blocklet Mobility Platform to create a turnkey Vehicle Identity (VID) solution for securing vehicle-based transactions and communications.

“[The MOBI Vehicle Identity Standard] provides a strong foundation on which we can offer a truly neutral and globally available way to discover and validate vehicles,” Filament's CEO, Allison Clift-Jennings, said. “Most importantly, this identity exists for the lifetime of the vehicle, regardless of who owns or operates the vehicle.”

The Blocklet Mobility Platform is designed to give embedded engineers a means of developing and testing blockchain solutions for edge devices and systems without the need for high-level training in blockchain. Using the platform, engineers can even deploy their blockchain solutions into a USB form factor.

Integrating MOBI's Vehicle Identity Standard will allow automotive engineers to design blockchain solutions for vehicles including car-based digital wallets, usage-based payment programs, and other consumer and manufacturer applications. Arguably, the greatest benefit of blockchain is the security it offers for connected vehicles in a landscape where car hacking is becoming a growing concern.

MOBI was started among a group of major automakers in 2018 with the goal of exploring applications of blockchain for automotive and created related standards around the technology. The MOBI's Vehicle Identity Standard (also called the MOBI VID) is the initiative's first major effort toward enabling widespread and trusted data exchange and communication among vehicles across manufacturers and brands. The VID merges a vehicle's VIN number and digital identity and uses blockchain to provide distributed layers of encryption to protect that information and verify a vehicle's identity for digital services such as payment ecosystems. The decentralized nature of blockchain also promotes interoperability among vehicles and various infrastructures they may be communicating with.

In a statement regarding the partnership, Chris Ballinger, Founder and CEO of MOBI, said that working with companies like Filament plays a vital role in MOBI's larger goals. “Participation of technology providers, like Filament, is crucial to MOBI’s initiatives in creating green, smart mobility ecosystems,” Ballinger said, “Filament’s adoption of the first Vehicle Identity standard is a reflection of our shared commitment to enabling trusted data communication among inter-operating stakeholders within the mobility ecosystem.”

Filament has said its Blocklet Mobility Platform with the integrated MOBI VID will be available for production in early 2020.

Chris Wiltz is a Senior Editor at  Design News covering emerging technologies including AI, VR/AR, blockchain, and robotics


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Nanoemulsion Gels Are a New Way to Deliver Drugs Through the Skin

Researchers have been devising numerous new ways to deliver medications and other therapies more directly to patients to make it less invasive and more targeted for specific ailments and diseases.

MIT chemical engineers have come up with one of the latest of those with the development of what are called nanoemulsions that can be used to create materials to deliver medication that can be absorbed by or injected into the skin.

nanoemulsions, gels, MIT, small molecule therapeutics, biocompatible polymer
MIT chemical engineers have devised a way to convert liquid nanoemulsions into solid gels. These gels (shown in red) form almost instantaneously when drops of the liquid emulsion enter warm water. (Image Source: MIT and the researchers)

Nanoemulsions are very tiny droplets of a liquid suspended within another, similar to the mixture formed when one shakes a bottle of salad dressing of vinegar and oil, researchers said.

A team led by Patrick Doyle, a professor of chemical engineering at MIT, discovered how to convert liquid nanoemulsions to a gel when they reach body temperature--98.6 degrees Fahrenheit or 37 degrees Celsius. He and his team said this discovery could be useful for developing materials that can deliver medication when rubbed on the skin or injected into the body.

“The pharmaceutical industry is hugely interested in nanoemulsions as a way of delivering small molecule therapeutics,” he said in a press statement. “That could be topically, through ingestion, or by spraying into the nose, because once you start getting into the size range of hundreds of nanometers, you can permeate much more effectively into the skin.”

Less Energy, Same Stability

A simple way to create an emulsion is to add energy, such as in the example of shaking salad dressing. The drops in the emulsion become smaller and more stable if more energy is used.

Nanoemulsions are some of the most stable of these type of liquid mixtures, with droplets that have diameters of 200 nanometers or smaller, researchers said. They also can carry larger payloads—i.e., medications or sunscreens, for example—because they have a higher ratio of surface area to volume, researchers said.

Doyle and the researchers in his lab have been develop strategies for the past few years to create nanoemulsions with less energy than they typically need. This could help adapt these technologies for large-scale industrial manufacturing, researchers said.

Detergent-like chemicals called surfactants can speed up the formation of emulsions, researchers said. However, many of the surfactants that have previously been used for creating nanoemulsions are not FDA-approved for use in humans.

Doyle and his students chose two surfactants that are uncharged, which makes them less likely to irritate the skin, and are already FDA-approved as food or cosmetic additives. They also added a small amount of polyethylene glycol (PEG), a biocompatible polymer used for drug delivery that helps the solution to form even smaller droplets, down to about 50 nanometers in diameter.

“With this approach, you don’t have to put in much energy at all,” Doyle said. “In fact, a slow-stirring bar almost spontaneously creates these super small emulsions.”

Active ingredients can be mixed into the oil phase before the emulsion is formed, so they end up loaded into the droplets of the emulsion, he added.

From Emulsion to Gel

Once they had developed a low-energy way to create nanoemulsions using nontoxic ingredients, the researchers added a step that would allow the emulsions to be easily converted to gels when they reach body temperature, they said. They achieved this by incorporating heat-sensitive, tri-block polymers called poloxamers, or Pluronics, which are already FDA-approved and used in some drugs and cosmetics, Doyle said in the press statement. Their molecular structure and characteristics allow for the transformation to happen, he said.

Researchers describe their work in a paper in the journal Nature Communications.

To demonstrate their work, researchers created nanoemulsions that remained stable for more than a year, they report in the paper. They also incorporated ibuprofen into the solutions to show that medications could indeed be delivered in this way.

Researchers now are turning their attention to how to incorporate active pharmaceutical ingredients into the gels they created from the nanoemulsions. They believe these gels could be useful for topical medications, such as those applied to heal burns or other injuries of the skin, or cosmetic uses.

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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SurModics Completes Trial Enrollment for SurVeil DCB

Pixabay SurModics Completes Trial Enrollment for SurVeil DCB

SurModics accomplished a huge milestone this week by completing enrollment for a pivotal trial of its SurVeil drug-coated balloon (DCB). About 446 peripheral artery disease (PAD) patients at 65 sites across the world will be evaluated in the TRANSCEND trial.

The Eden Praire, MN-based company is seeking to treat PAD in the upper leg.

Enrollment completion triggered a $10 million milestone payment from Abbott Laboratories. The agreement between the two companies was formed in February 2018 and provided Abbott with exclusive worldwide commercialization rights for the SurVeil DCB.

Pursuant to the terms of the agreement, SurModics received a $25 million upfront payment and will receive a $10 million milestone payment in connection with the completion of patient enrollment in the TRANSCEND trial.

About $5 million from this milestone payment will be recognized as revenue in the company’s fiscal fourth quarter. SurModics may earn an additional $57 million for other various product development milestones.

With the completion of this milestone, SurModics said it now expects fiscal 2019 revenue to be in a range of $97 million to $99 million, this compares to the company’s previously expected revenue range of $92 million to $94 million.

In the TRANSCEND trial, SurModics’ SurVeil will go up against Medtronic’s In.Pact DCB. In April of 2018, the Dublin-based company received a nod from FDA for the IN.PACT Admiral DCB to treat long superficial femoral artery (SFA) lesions up to 360mm in patients suffering from PAD.

In a release, Kenneth Rosenfield, MD, a principal investigator of the TRANSCEND study said “the [trial] is a rigorous level one, randomized controlled trial that comes at a very important time for the vascular and interventional community. By providing a head-to-head comparison with today’s market-leading DCB, this trial will provide data regarding the relative performance of the SurVeil DCB, which represents a new generation of DCB. Beyond the device itself, the new trial design will ultimately provide insight into clinically important questions regarding long-term results.”

Enrollment completion for TRANSCEND comes shortly after Becton Dickinson & Co. revealed FDA rejected the application to approve the Lutonix paclitaxel-coated balloon to treat patients with below-the-knee (BTK) PAD.

Paclitaxel devices came into the spotlight in late December 2018 after a meta-analysis showed an increased risk of death for patients treated with these devices. After a two-day meeting of the Circulatory System Devices Panel, FDA concluded that there is a signal associated with an increase in mortality through five years of paclitaxel-coated devices as compared to non-coated devices. The agency was not, however, able to attribute this increased risk to a specific cause, and the committee was befuddled by data discrepancies.

Issues surrounding paclitaxel-coated devices likely contributed to FDA’s decision to reject Lutonix. But it hasn’t been doom and gloom for all DCBs, as evidenced by recent developments with Concept Medical. Earlier this month, the Tampa, FL-based company received breakthrough device designation from FDA for the MagicTouch PTA, a DCB catheter for the BTK treatment of PAD.

Most Memorable Medtronic Moments Under CEO Omar Ishrak

The medtech giant with humble beginnings will go through a major leadership change next year.Medtronic announced Wednesday that Omar Ishrak will retire as CEO on April 26, which marks the end of the company's current fiscal year. Geoff Martha, who currently oversees Medtronic's restorative therapies group (and previously led the company's spine business), will succeed Ishrak as CEO on April 27.Ishrak has served as CEO of Medtronic since June 2011 and has led the company through some significant milestones. The news does not come as a surprise given that Ishrak is approaching the company's mandatory executive officer retirement age of 65.Ishrak is expected to serve as the company's executive chairman after he retires to provide counsel and guidance to Medtronic's leadership and oversee the CEO succession. In the meantime, Martha will assume the newly created role of Medtronic president and become a member of the company's board of directors, effective Nov. 1, 2019.“Today, we announced leadership changes that meet both the board’s objective of executing a thoughtful leadership transition as well as my personal desire to begin transitioning my duties as CEO to a new leader coinciding with the start of our next fiscal year,” Ishrak said. “This plan and its timing enable Geoff and I to partner on achieving Medtronic’s key financial performance goals as well as delivering on our critical pipeline milestones, including several important product launches. Leading Medtronic as CEO is an honor and a privilege, and I know that Geoff is the right leader to take Medtronic to the next level of its growth and evolution. Geoff is a results-oriented, dynamic, and innovative business leader who is passionately committed to our mission, the advancement of our growth strategy, and the development and diversity of our people. I am confident he has the right track record, commitment, vision, and judgment to lead our company.”Mike Matson, a medtech analyst at Needham & Co., said he believes Medtronic's CEO succession plan will be received positively by investors."Martha is a strong CEO candidate, in our view, since he has been highly visible to investors and was in our view instrumental in turning around [Medtronic's] spine business which was losing share for years prior to Martha taking the helm," Matson said.