MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.


Articles from 2019 In December

Greening Operating Rooms One Product at a Time

Image by David Mark from Pixabay
Image by David Mark from Pixabay 

Healthcare organizations are responding regarding their contribution on climate change, said Rob Chase in an interview with MD+DI. Chase, who is the founder and president of NewGen Surgical, explained that plastic production and disposal from single-use disposables for the hospital supply chain generates a large portion of "Scope 3 CO2 emissions."

Chase will be speaking in the upcoming MD&M West 2020 panel discussion, "Sustainability, Environmental Responsibility, and the Medical Device Community," on February 11, 2020.

“Why is it important that the medical device industry start to pay attention to sustainability and environmental responsibility?” asked Chase. The answer, he said, is that hospitals understand the disproportionate amount of CO2 emissions they are producing and need help from their supply chain. Recently the largest healthcare sustainability advocacy group, Health Care Without Harm, cited some sobering numbers—4.4% of all global CO2 emissions are contributed by healthcare organizations. Of that percentage, 71% of these CO2 emissions are Scope 3 related to the production, transport, and disposal of goods and services. Hospitals are in the business of delivering patient care, not manufacturing, and so they seek solutions from the greater industry.

To that end, Washington State recently announced the formation of the Washington Health Care Climate Alliance to help find ways to collectively lower emissions. There is a similar alliance among California hospitals. In another case, a regional healthcare system reached out to NewGen Surgical because the local government is requesting solutions to reduce their respective emissions and plastic waste. “These alliances and even legislative efforts are coming, and it's going to be impacting the medical device industry as the hospitals will be actively looking for solutions to help reduce emissions,” Chase said. “That's why there needs to be a change in focus in product design and manufacturing and the industry as a whole working to achieve a more responsible production and consumption pattern.”

NewGen Surgical approaches product design with its three-part Smart Sustainable Design process. The first component of the program is performance, Chase said. “That's having an in-depth, detailed knowledge of the clinical performance criteria that the products need to meet,” he said. It is also important to design devices that look and perform very similarly to existing products. And to ensure ease of adoption, products should be designed to limit any disruption in the current work flow. Chase explained that generally personnel do not have time to learn a different or new step in their established processes. “Our products are designed to minimize the change in workflow or any change in the user experience of what they're currently used to,” he said.

“The second is sustainability. Can we redesign the traditional product with a more sustainable material?” he continued.

The third is economics, Chase said. NewGen Surgical’s materials are upcycled agricultural and agricultural byproducts, which cost more than fossil fuels. There is no cheaper material than plastic, but its lifecycle can be costly to the environment and its inhabitants, he said. Therefore, the company’s challenge as a manufacturer is to produce the more-sustainable product at a competitive market price so hospitals can make the conversion.

Bringing sustainable devices into hospitals is not an easy task, however. “There are what I call structural barriers to market,” Chase said. “Things like distribution and purchasing agreements—these things that hospitals are tied into how they buy products now and purchasing outside the status quo can be cost prohibitive."

However, once NewGen Surgical’s products are in the OR, the surgical staff is happy to see the positive changes in their workplace. “They've finally got something that they can use to cut out all the plastic waste that they see in every case, every day,” he said. “And our goal is to try and green the OR one product at a time, working upstream in product design so that there's minimal impact, if any, into the workflow and performance of the product.”

Changing things one product at a time summarizes NewGen Surgical’s philosophy that making small changes adds up to a larger positive impact on the environment. The company has developed the Small Change, Big Impact EPP program, to help hospitals measure the environmental results of the changes they make. For example, a large healthcare system has eliminated six tons of plastic waste and reduced its Scope 3 CO2 emissions by 9,700 kg with the use of the NewGen Surgical needle counter product line, in a little more than a year.

And a national distributor could eliminate 50 tons of polystyrene foam packaging from their procedure kits with the NewGen Surgical plant-based trays. These trays are made with upcycled material and can be recycled with paper—the definition of circular economy.

NewGen Surgical customers use the results generated with the Small Change, Big Impact program for community and industry communications, staff retention, and carbon reduction commitments.

Chase and co-panelists Vipul Dave, senior materials engineering fellow at Johnson & Johnson; Nick Packet, MDM specialist, packaging engineer at Dupont; and Frank Pokrop, senior director, regulatory affairs and quality at Sotero Wireless, will discuss sustainability and environmental responsibility in the medical device industry in the MD&M West panel discussion. Moderated by Len Czuba, president at Czuba Enterprises, it will take place on February 11 from 1:15 to 3 p.m. in Room 210C.

“We at NewGen Surgical feel very passionate about the need for our industry to get on a more sustainable path and to get off our dependence on oil and use more sustainable and renewable materials,” Chase concluded. “That's what I hope our panel can communicate about the urgency and opportunity and get people thinking about how we can achieve this in healthcare.”

Best 3D Printing Articles of 2019

2019 was an amazing year for 3D printing. We’ve seen the development of new materials as well as advances in the production capabilities in additive manufacturing. Here’s a quick look at the progress in 3D printing during 2019.


Additive Manufacturing Automation Brings Down Costs; Increases Productivity 

3D printing, additive manufacturing, automation
(Image source: Digital Metal)

This automation technology uses robotics for the most laborious manual step in metal additive manufacturing, which is de-powdering the system after printing. Previously, this step was done by humans using specially designed glove boxes for safety.





Breakthrough 3D Printed Materials Make Strong, Lightweight Structures 

3D printing, additive manufacturing, automation, lightweight structures
(Image source: ETH Zurich / Marc Day)

New materials that take advantage of a new interior structure could be the way forward for new lightweight, strong materials for myriad uses.





LMD Additive Manufacturing Expands in Aerospace 

3D printing, additive manufacturing, automation, LMD additive
 (Source: Form Alloy)

The 3D printing processes of laser metal deposition (LMD) and directed energy deposition (DED) are revolutionizing how the aerospace industry designs and builds high-value components across the manufacturing spectrum from prototyping to production.




Is 3D Printing Ready for Scaled Production? 

3D printing, additive manufacturing, automation, LMD additive, scaled production
(Source: Forecast 3D)

While additive manufacturing has received attention for its promise of mass customization and generative design, not everyone believes it’s ready for large-quantity production.




Why 3D Printing Is Going to Need Blockchain 

3D printing, additive manufacturing, automation, LMD additive, scaled production, Blockchain
(Image source: Pixabay)

Blockchain has the potential to solve 3D printing's inherent security risks before they become a major issue.









Biorefinery Waste Can Be Used for 3D Printing 

3D printing, additive manufacturing, automation, LMD additive, scaled production, blockchain, biofinery
(Image source: Oak Ridge National Laboratory)

Researchers at the Department of Energy have used lignin, a byproduct of the biorefinery industry, as part of a new composite material that’s well-suited for 3D printing processes.






Using Light to Control Multimaterial 3D Printing 

3D printing, additive manufacturing, automation, LMD additive, scaled production, blockchain, biofinery
(Image source: A.J. Boydston and Johanna Schwartz)

A new light-based technique developed at the University of Wisconsin-Madison allows for more than one material to be printed at a time.





The Untold Truths of 3D Printing You Need to Understand 

3D printing, additive manufacturing, automation, LMD additive, scaled production, blockchain, biofinery
(Image source: Mohamed Hassan from Pixabay) 

With all of the hype surrounding additive manufacturing and 3D printing, it's easy to forget that, as with all new technologies, there is a learning curve.






3D-Printed Robot Merges Additive and Smart Manufacturing 

3D printing, additive manufacturing, automation, LMD additive, scaled production, blockchain, biofinery, robot
 (Source: HP)

Bastian Solutions worked with Fast Radius to create a shuttle system that uses additive manufacturing to design and construct a custom-designed modular robot system.






3D-Printed Tissues Could Help Heal Serious Sports Injuries 

3D printing, additive manufacturing, automation, LMD additive, scaled production, blockchain, printed tissue
(Image source: Jeff Fitlow)

Researchers have achieved new structures that can mimic the seamless interconnection of bone and cartilage needed to repair serious sports-related injuries.







Ceramics Offer Amazing Diversity for 3D Printing 

3D printing, additive manufacturing, automation, LMD additive, scaled production, blockchain, ceramics
(Image source: Ren Services)

3D-printed ceramics offer many industries a range of applications not found in many other materials.





Researchers Invent New Dynamic Material for 3D Printing 

3D printing, additive manufacturing, automation, LMD additive, scaled production, blockchain, dynamic materials
(Image source: Queensland University of Technology)

The polymer properties of new materials developed by a cross-institutional group of researchers respond dynamically to light and darkness in a novel way.




5 Reasons You’ll Need a 3D Printer on Mars 

3D printing, additive manufacturing, automation, LMD additive, scaled production, blockchain, 3D printing on Mars
(Image source: NASA)

3D printing will play a vital role when we get to Mars. Here are five reasons why.









Harvard's new multimaterial 3D printer moves at hummingbird speeds 

3D printing, additive manufacturing, automation, LMD additive, scaled production, blockchain, hummingbird speeds
(Image source: Wyss Institute at Harvard University)

A new technique developed at Harvard speeds up multimaterial printing by allowing up to eight different printing materials to fabricate objects.








New Process can 3D Print Living Cells with Precision and Speed 

3D printing, additive manufacturing, automation, LMD additive, scaled production, blockchain, living cells
(Source: TU Wien)

A novel bioink can integrate living cells into 3D scaffolds at a speed of one meter per second, making it possible to study the spread of diseases and produce tailor-made tissue.






Cool and super cool 3D printed projects 

3D printing, additive manufacturing, automation, LMD additive, scaled production, blockchain, cool projects

Here’s a look back at several cool hobbyist-level gadgets and a few super cool printed car projects.

(Image Source: 3Deddy, via Thingiverse)



Humble beginnings to mobile dominance for 6502 processor

The recent passing of American processor developer, Charles (Chuck) Ingerham Peddle (Nov. 25, 1937 to Dec. 15, 2019), reminded me of a video interview I conducted with Dominic Pajak, ARM's embedded strategist, concerning the 6502 and British Acorn PC.

Chuck Peddle was best known for his design of the MOS Technology 6502 microprocessor, as well as the KIM-1 single-board computer and its successor, the Commodore PC. The 6502 was an 8-bit processor that gain wide use in the late 70s and early 80s. It was so successful that Jack Tramiel, president of Commodore, used it in his famous Commodore Computers.

In Britain, the MOS 6502 gained fame in 1979 when Acorn Computers used it as the basis for the BBC Model B microcomputer, which was the company’s first big success. Acorn went on to design the ARM processor, which spun out into the Arm company whose processors still dominate the mobile markets.

Check out my interview with Dominic Pajak from Arm on the amazing evolution of the 6502.

IoT - From the 6502 Processor to the ARM MCUs

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.

Adding defects to batteries can speed charging

Typically, defects in particular chemical formulas are considered a bad thing. But researchers at Rice University have discovered that defects can actually be used to an advantage in future battery chemistries to improve how quickly the device can charge.

batteries, battery defects, Rice University, Brown School of Engineering, lithium-based battery design

An illustration shows a battery’s cathode undergoing phase transition from iron phosphate to lithium iron phosphate LFP during charging. Simulations by Rice University scientists showed that adding defects--distortions in their crystal lattices--could help batteries charge faster. (Image source: Kaiqi Yang, Rice University)

Scientists from the university’s Brown School of Engineering discovered through simulations that placing specific defects in cathodes of a lithium-based battery design can improve its performance. This finding could lead to charging that’s two orders of magnitude faster than current batteries.

The team--led by Ming Tang, Rice assistant professor of materials science and nanoengineering--worked specifically with lithium iron phosphate-based cathodes, focusing on the phase transition the cathode makes from iron phosphate to lithium iron phosphate when charging. Researchers discovered that by adding defects, called antisites, to the crystal lattices of the cathodes could help them to charge faster.  “We think we can turn defects into friends, not enemies, for better energy storage,” Tang said.

Antisites typically aren’t something researchers hope to see when designing this type of battery, which is why the research is unique. These defects form when atoms sit on sites of the lattice that should be occupied by lithium, typically limiting lithium movement inside the crystal lattice, researchers said. This is why scientists consider them detrimental to how the battery performs.

Tang and his team turned this idea on its head, however, discovering that in the case of lithium iron phosphate, the antisites actually create detours within the cathode. These detours allow lithium ions to reach the reaction front over a wider surface, thus improving the charge or discharge rate of the batteries.

Optimizing material defects

Basically, when lithium is inserted into the cathode, it changes from a lithium-poor phase to a lithium-rich one, he said. If the surface reaction kinetics are slow, then lithium can only be inserted into lithium iron phosphate within a narrow surface region around the phase boundary, which researchers call the “road,” Tang said. This limits the battery’s recharging speed.

“However, antisite defects can make lithium insertion take place more uniformly across the surface, and so the boundary would move faster and the battery would charge faster,” he said.

Researchers also noted that they can use certain methods to control the concentration of defects, such as annealing the material, or heating without burning it. This would allow them to add other optimal properties to the battery design, such as using larger cathode particles than nanoscale crystals to be used to help improve energy density and reduce surface degradation.

“An interesting prediction of the model is that this optimal defect configuration depends on the shape of the particles,” said Tang. “We saw that facets of a certain orientation could make the detours more effective in transporting lithium ions. Therefore, you will want to have more of these facets exposed on the cathode surface.”

Researchers published a paper on their work in the Nature journal Computational Materials. They believe that their model is applicable not just to the type of cathode with which they worked, but also can be applied as a general strategy to improve phase-changing battery compounds. “For structural materials like steel and ceramics, people play with defects all the time to make materials stronger,” said Tang. “But we haven’t talked much about using defects to make better battery materials. Usually, people see defects as annoyances to be eliminated.”

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.

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!


Happy New Year

Happy New Year

It's full speed ahead into a new year and new decade. We will be back with news and views for plastics professionals on Jan. 2. See you then!

happy new year

Image: Rasica/Adobe Stock

Ineos Styrolution, Agilyx advance PS chemical recycling plant in Illinois

Ineos Styrolution, Agilyx advance PS chemical recycling plant in Illinois

Styrenics supplier Ineos Styrolution and Agilyx, a leader in converting post-consumer plastics to low-carbon fuels, chemicals, and plastics, are advancing the development of a polystyrene (PS) chemical recycling facility in Channahon, Illinois. The facility will be capable of processing up to 100 tons per day of post-consumer polystyrene and converting it into a styrene monomer that will go into the manufacturing of new polystyrene products.

The facility will be capable of processing up to 100 tons per day of post-consumer polystyrene and converting it into styrene monomer. Image courtesy of Agilyx.

The facility will leverage Agilyx’s proprietary chemical recycling technology, which breaks polystyrene down to its molecular base monomers that will be used for the creation of new styrenic polymers. This is a true circular recycling approach that enables everyday products, like a cup, to be recycled back into a cup.

Agilyx recently completed a successful development program for Ineos Styrolution that qualified the styrene product to Ineos’ specifications and the identified post-consumer polystyrene feedstock for the process. The next phase of the project advances the engineering and design of the facility.

“This is an incredibly exciting time to be in this industry,” said Ricardo Cuetos, VP Ineos Styrolution Americas, Standard Products. “Agilyx’s chemical recycling technology is a game changer to advance the circular recycling pathway of plastics. A benefit of chemical recycling is there is no degradation over multiple cycles; the polymers can continue to create new products over and over again of the same purity and performance of virgin polystyrene. This plant will dramatically increase recycling rates in the greater Chicago area, dispelling the myth that polystyrene can’t be recycled. We are thrilled to partner with Agilyx on this project.”

The Agilyx proprietary chemical recycling process can recycle polystyrene contaminated with food and other organics and convert it back into new, food-grade plastic products or packaging. The process demonstrates that so much more post-consumer plastics in the world today can be chemically recycled to new plastic products again and become a renewable resource.

“Polystyrene is the best option for prepared food and beverage containers. It provides cost-effective, high-quality packaging for food service applications,” said Joe Vaillancourt, Agilyx's chief executive officer. “Alternative polymers chosen over polystyrene experience low recycling rates, are less amenable to chemical recycling, with most of those plastics ending up in landfills. We are excited to be working with Ineos Styrolution to advance this chemical recycling pathway that has the ability to significantly increase recycling rates all over the world.”



Medtech Trends to Watch in 2020

MD+DI checked in with a few medical device technology experts for our annual review of 2019 and a look ahead to 2020. Read on for their perspectives, and please feel free to offer your own in the comments. We’ve also thrown in a bonus page on unmet healthcare needs to focus on in 2020 and beyond.

Here’s to a productive to 2020!

10 Ways to Design Error-Resistant Medical Devices

10 Ways to Design Error-Resistant Medical Devices
Image by succo from Pixabay 

Medical devices should be designed to provide the best possible user experience, while reducing the risk of errors that can result in harm, injury, or compromised medical care. To do this, 21 CFR 820:30 states that “…when designing a device, the manufacturer should conduct appropriate human factors studies, analyses, and tests from the early stages of the design process until that point in development at which the interfaces with the medical professional and the patient are fixed…”

However, in an interview with MD+DI, Gia Rozells, director of user experience design at Becton, Dickinson, and Co. (BD) said “many medical devices in use today were developed prior to these human factors guidelines and other regulations. Some of those devices may still exhibit human factors deficiencies that would be eliminated in products designed using current standards and requirements. Advances in medical technology, improvements in human factors engineering guidance, and more stringent requirements all serve to reduce the potential for use errors.”

Rozells will be speaking in the MD&M West 2020 session, "10 Ways to Design Error-Resistant Medical Devices," on Wednesday, February 12, from 2:05 to 3:00 p.m. in Room 210A/B.

Additionally, Rozells said, “Although some devices may have human factors deficiencies, the consequences of use errors can be benign. Other devices may be well designed to eliminate most errors, but the potential harm could be more significant,” she continued, “It’s important to realize that often multiple factors contribute to use errors.”

To reduce or eliminate use errors, Rozells explained “designers at BD employ processes that effectively consider the type of users, their workflow, the environment in which the product is used, and other potential influences. The design of devices used in complex systems with many interrelated factors should be most carefully designed for effectiveness and safety.”

Rozells added that “using proven design principles is one way to reduce errors and increase safety. These principles for medical device design are available from various sources. We’ve gathered 10 into a set of heuristics that will help attendees create good designs and spot designs that can cause use errors.”

She explained that some of the heuristics are fairly simple, but powerful. “For example, be sure it is obvious what state the device is in. Is it on or off? No matter what the device is doing, there should be a clear indicator to the user.” Other heuristics are not as obvious to designers, she said, such as Recall vs. Recognition. “The design should not rely on the memory of a busy user; instead, give users prompts and choices with the information they need when they need it.”

The session will also include interactive examples to allow participants to hone their skills at recognizing error-prone areas of their designs.

When asked what she would like attendees to take away from the session, Rozells said, “I hope they leave understanding that having a strong human factors/user experience process as part of product development will reduce use errors and improve the usability of devices.”

In this session, Rozells will be joined with Tim Goldsmith, a staff human factors engineer and user experience designer at Illumina; and Tressa Daniels, global director of human factors, Teleflex.

The MD&M West 2020 session, "10 Ways to Design Error-Resistant Medical Devices,"  will be held on Wednesday, February 12, from 2:05 to 3:00 p.m. in Room 210A/B.

Blood Test Gives Greater Insight on Heart Attack Risk After Surgery

Blood Test Gives Greater Insight on Heart Attack Risk After Surgery
Image by Qimono on Pixabay

A common cardiac blood test done before surgery can predict who will experience adverse outcomes after most types of surgery, said researchers from Hamilton Health Sciences.

The VISION study looked at whether levels of a cardiac blood test, NT-proBNP, measured before surgery can predict cardiac and vascular complications. Higher levels of NT-proBNP, which can be caused by various anomalies in the cardiac muscle, such as stress, inflammation or overstretch, can help identify which patients are at greatest risk of cardiac complications after surgery.

The study included 10,402 patients aged 45 years or older having non-cardiac surgery with overnight stay from 16 hospitals in nine countries.

This phase of the VISION study builds upon six years of research studies to understand pre- and post-operative factors that lead to cardiac complications.

"This simple blood test can be done quickly and easily as part of patient's pre-operative evaluation and can help patients better understand their risk of post-operative complications and make informed decisions about their surgery," said first author of the publication, Dr. Emmanuelle Duceppe, internist and researcher at the Centre Hospitalier de l'Universite de Montreal (CHUM), PhD candidate in clinical epidemiology at McMaster University, and associate researcher at PHRI. "This blood test is twenty times cheaper than more time-consuming tests such as cardiac stress tests and diagnostic imaging."

Results of this simple blood test may inform the type of surgery the patient will undergo, such as laparoscopic or open surgery, the type of anesthesia used during surgery and who will require more intense monitoring post-operatively.

Blood test results can also reduce the need for pre-surgical medical consultations for patients that show no risk for cardiac complications.

Check-Cap is Inching Toward the U.S. Market with Positive Pilot Results

Check-Cap is Inching Toward the U.S. Market with Positive Pilot Results
Courtesy of Check-Cap

Check-Cap Ltd. is reporting positive results from a pilot study of its C-Scan System. The Isfiya, Israel-based company’s C-Scan System is a preparation-free ingestible scanning capsule-based system for the prevention of colorectal cancer through the detection of precancerous polyps.

Results from the pilot study show that no device or procedure-related serious adverse events were reported and all device or procedure-related adverse events were mild in severity. In total, 45 patients enrolled in the study, of which 40 patients underwent the study procedure.

All 40 patients complied with the procedure and completed a questionnaire following the procedure and reported higher satisfaction with the C-Scan System procedure compared to colonoscopy.

A total of 28 patients were evaluable after factoring in technical and physiological dropouts and protocol violations. Analysis of the evaluable patient results revealed an agreement between C-Scan and colonoscopy in detection of polyps was consistent with data from the post-CE approval study.

In a release, Alex Ovadia, CEO of Check-Cap, commented, "We are pleased with the positive results from this U.S. pilot study. Completing our first study in the U.S. constitutes an important milestone for our company as we work towards the initiation of a U.S. pivotal study in late 2020. We are now focused on preparing our IDE submission to FDA and collecting additional clinical data utilizing a new version of our C-Scan System, while at the same time continuing to build out our global operational infrastructure. We believe 2020 will be a meaningful year for Check-Cap."

The company received FDA conditional approval for IDE to initiate the pilot study in December of 2018 and received a CE mark about 11 months earlier.

After being swallowed in capsule form, the C-Scan system's ultra-low-dose X-ray technology is used to produce a 3-D map of a patient's colon. The system differs from capsule technology already on the market by eliminating the need for a bowel prep prior to ingestion and examining the colon in its natural state without distention.

The system produces a 3-D contour map of the colon that can be viewed in different ways to look for polyps, including a "tube" view a flat "fillet" view, or even the outside of the surface of the colon wall.