America Makes’ Ambassador Program’s 2020 class represents a cross-section of the industry whose work helped further advance additive technology and showed the resilience of the AM community. “The additive manufacturing industry has been challenged like never before this year. This year’s class represents individuals who have continued to be at the forefront of pushing additive manufacturing to new heights,” says America Makes Executive Director John Wilczynski. “Their important work is setting the trajectory for the industry’s future and we are honored to have them as part of the America Makes program.” Launched in 2017, the Ambassadors program recognizes individuals who have continually demonstrated outstanding dedication to advancing America Makes and its mission.
Qosina partners with Resolution Medical
Sterile 3D-printed nasopharyngeal COVID-19 testing swabs for nasal mucosa specimen collection are available from Qosina. Developed by Resolution Medical, 3D-printed sterile swabs are produced quickly by using Carbon’s digital light synthesis (Carbon DLS) 3D printing process. The swab is 5.9" long and the swab head features a soft, lattice-style cage around a flexible helical core, allowing it to easily conform to the organic pathway of the nasal cavity. The lattice-structured dome tip combines comfort and durability for optimal patient experience and captures sufficient specimen for testing. This sterile swab comes individually packaged and has a shelf life of six months.
Crisis inspires innovation
Features - Thermoforming
Thermoformer’s knowledge fills an emergency product void.
For those who see opportunity in adversity, a crisis can spur innovation. Kruger Family Industries (KFI), the largest heavy-gauge industrial thermoformer in North America, has a 45-year history through its two Portage, Wisconsin-based brands – TriEnda and Penda. Purchased in 2014, TriEnda produces pallets, dunnage, and material handling materials. Penda, purchased in 2016, focuses on truck bed liners and other automotive components. Located only about 1.5 miles apart, and with two factories in Mexico, there are about 1,000 employees and 1 million sq. ft. of manufacturing space housing 39 thermoforming machines, each with a forming area of 64ft2. So, when the automotive manufacturing plants announced they’d be shutting down indefinitely in March 2020, a lot was at risk.
Countdown to creativity
“Wednesday, March 18, is a day that sticks out to me pretty vividly,” says KFI Founder David Kruger. “When the OEMs announced their COVID closings, we knew we had to take some drastic steps.”
No company wants to put people on furlough or out of work, so KFI had to figure out quickly if there was something considered essential in the market it could produce. By Friday of that week, Kruger sent a note to the engineering group, challenging them to think about what the company could make to serve the medical industry – face masks? Hospital beds? Face shields? Wall partitions?
“It was fun for the team because they got to let their minds run wild,” Kruger notes.
The goal was to evaluate all ideas by Monday morning and see where there was a fit with TriEnda and Penda capabilities, considering time to market, efficient price point, and scalability.
“There was reported to be an anticipated shortage of hospital beds, and this product became our focus for a couple of reasons,” Kruger says. “First off, we actually make fold-down beds for the Class A truck industry.”
With previous experience making sleeping systems, KFI was well versed in push and pull points and had existing finite element analysis (FEA) modeling of stress and deflection points for people sleeping in thermoformed beds.
“When it comes to emergency situations, it’s all about having something when you need it and being able to store it when you don’t,” he adds. “Our experience with returnable packaging was perfect for understanding these requirements.”
After that meeting, engineers and industrial artists brainstormed and created concepts for an emergency and disaster relief bed for presentation later that day.
“At that meeting, we debated on what we liked and didn’t, while really focusing on our ability to get something to market very, very quickly,” Kruger comments. “By Friday (March 27), the team had come to a solid design from a thermoforming perspective for the bed itself, while needing to further its work on the armrests, wheel, IV bag attachments, and so-on.”
In simpatico supplier
In this situation, time to market was of the utmost importance.
“The shutdowns had many worried. ‘What’s going to happen to our business and what can we do to attack this pandemic’? We talked to several of our tooling suppliers, but Tooling Tech Group (TTG) viewed it similarly to us, and brought an entrepreneurial spirit to the challenge,” Kruger says.
Working with Gary Poeppelman, president of TTG’s compression and thermoforming division, Kruger saw a shared understanding of the need and why it was essential to hit timelines.
TTG, a longtime supplier of thermoforming tools to Penda and TriEnda, was already an established partner. As the bed design solidified on Friday, March 27, engineers issued a purchase order for tools for the bed base and backrest.
“One thing about our culture,” says Nate Ruhenkamp, TTG thermoforming and compression division sales manager, “If there’s a deadline to be made, no one asks questions why. We focus on delivering on time, every time. Our team became very invested in this project and proud of their work to help those in need.”
As a vertically-integrated supplier, TTG was able to offer services not always available from other tooling suppliers. Although KFI often cuts its own foundry patterns in-house, the company could turn to TTG to cut the bed pattern for this project, using a medium density fiber-board (MDF).
“Another key advantage at Tooling Tech,” Ruhenkamp adds, “is our in-house foundry, where we can cast all our own aluminum molds. In an instance like this requiring speed and efficiency, you want somebody that has all the operations or capabilities in-house.”
Kruger adds that, “Like everything in this time-sensitive situation, nothing could happen without a lot of things going right. Tooling Tech definitely had the skill set as well as the right attitude for this project. They put in the extra hours to make sure we were taken care of, and we couldn’t have met this timeline without them.”
Penda retooled its facility and TTG delivered four sets of tools (two beds and two backrests) in record time. Bed production started on April 16, less than a month after KFI’s team drafted its initial concept sketches. KFI ran bed components on two different machines, producing about 1,100 units per day with the ability to scale up if needed, with two more sets of tooling provided by TTG.
“If you ask anyone in the industry, they will tell you that producing molds for a project like this normally takes five- to six-week turnaround,” Ruhenkamp notes. “Getting the initial set of tooling produced within 10 days was astounding. I couldn’t be more impressed with our team in what they accomplished.”
For the KFI group, the speed of this project changed the company’s attitude about what it was able to achieve.
Kruger says that, “Our engineering manager joked with me and asked, ‘From here on out when you ask how long something is going to take, is that in regular time or COVID time?’”
New market potential
In addition to the engineering and manufacturing teams having to hustle to produce beds, the sales team had to sell it, which they managed exceptionally well, especially considering this was a new market for KFI. The first companies interested included the local Portage hospital, Divine Savior, the Boston Field Hospital with an order for 600, and the Federal Emergency Management Agency (FEMA). All early buyers were pleased with the performance and the price. Although these beds don’t qualify as fully functional hospital beds, they fit any emergency and cost one-tenth the price.
Quickly moving into a new market was a challenge and a learning experience for the KFI group.
“We are still dipping our toe in,” Kruger says. “But we have unique capabilities as a company to turn around products in mass quantities very, very quickly, and that’s what’s needed in emergencies.”
In addition to the bed, the company also developed a modular and portable wall partition. It can help in stand-up field hospitals or any situation where a temporary structure needs to be constructed quickly. It’s already being sold to homeless shelters and field hospitals.
The company is now developing an emergency disaster services (EDS) cot for situations where many people must quickly be housed in temporary shelters. Existing standard cots are small, not very comfortable, and do not store well. Kruger thinks this product is natural for his company, creating a better answer at a better price point. However, he noted that in emergency situations, speed is more important than cost.
Taking this sort of initiative has earned KFI and TTG some nice kudos.
“I have peers that run companies I very much respect,” Kruger reflects, “and they sent nice notes to me and were extremely impressed by this effort and appreciative of what we were doing. That means a lot when a competitor of yours takes the time to send you an unsolicited note.”
Happily, much of the business for both companies has gone back to something closer to normal.
“In general,” Kruger adds, “we’re adding medical products where we see a gap. But I’m glad to say our bed-liner business is back to 80%-to-85% of where we were earlier in the year. And we definitely will continue to rely on Tooling Tech, as they have more than proved their ability to support us in all situations.”
Sequel System with single molecule, real-time (SMRT) technology.
PHOTO COURTESY OF PACIFIC BIOSCIENCES
In its continuing efforts to revolutionize discovery-based research into complex biological systems, Pacific Biosciences has released its next generation of automated, long-read genomic sequencer with single molecule, real-time (SMRT) sequencing technology – the Sequel System.
“The Sequel System is very multifaceted in operation,” says Kevin Lin, mechanical engineer at Pacific Biosciences. “It encompasses robotics, chemical and biological processing, and photonics. Because it’s intended to be used in diverse settings within research and laboratory environments, excessive ambient vibrations could negatively influence the data sets. So, we needed to implement a vibration isolation component that not only isolated the sensitive components from vibrations, but also was sufficiently small, compact, and integrative.”
Internal and external factors can create vibration – issues from buildings housing the system including heating and ventilation systems, fans, pumps, elevators, adjacent road traffic, nearby construction, loud noise from aircraft, and weather conditions. These influences cause vibrations as low as 2Hz that can create strong disturbances in sensitive equipment.
“With our earlier sequencer model, we used air tables for vibration isolation, which, for the most part, performed adequately,” Lin says. “But use of the Sequel System in more diverse locations, where low-frequency vibrations may be present to a greater or lesser degree, necessitated a vibration isolator that was compact enough to fit into our much smaller Sequel System and could effectively cancel out these low-frequency vibrations.”
Interior view of Sequel System.
PHOTO COURTESY OF PACIFIC BIOSCIENCES
Negative-stiffness vibration isolation
Pacific Biosciences ultimately decided on negative-stiffness isolation to address their needs. Developed by Minus K Technology, negative-stiffness isolators use completely passive mechanical technology for low-frequency vibration isolation without using motors, pumps, or chambers, making them zero maintenance.
Because of their very high vibration isolation efficiencies, particularly in the low frequencies, negative-stiffness vibration isolation systems enable vibration- sensitive instruments, such as the Sequel System, to operate in severe low-vibration environments that wouldn’t be practical with top-performance air tables and other vibration-mitigation technologies.
“Vertical-motion isolation is provided by a stiff spring that supports a weight load, combined with a negative-stiffness mechanism,” says Dr. David Platus, inventor of negative-stiffness isolators and president and founder of Minus K Technology. “The net vertical stiffness is made very low without affecting the static load-supporting capability of the spring. Beam-columns, connected in series with the vertical-motion isolator, provide horizontal-motion isolation.”
Beam-columns behave as springs when combined with the negative-stiffness mechanism. The resulting compact passive isolator supports very low vertical and horizontal natural frequencies and very high internal structural frequencies.
A key factor in negative-stiffness vibration isolation’s selection was eliminating the isolator’s hysteresis. The isolator mounts to the main frame of the Sequel instrument and physically interacts with the internal robot, causing some initial movement of the isolator after each interaction. The speed and repeatability at which the vibration isolator can return and cancel out this movement is critical to system operation. In this regard, the negative-stiffness isolator outperforms pneumatic isolators.
“We were attracted to negative-stiffness because of the isolator’s high vibration cancellation performance, favorable hysteresis, and simplicity of operation,” Lin says. “Air supply and control and electrical connections aren’t needed. It’s also low weight and compact, making it easy to fit into the smaller footprint of our Sequel System.”
If ever there was a time to understand the need for speed in the development of new medical treatments, this year of COVID-19 has been it. It is a call to action for all of us to take a hard look at our processes and determine if we are ready for the future. So, to support rapid and sustainable development, Dassault Systèmes and the U.S. Food and Drug Administration (FDA) have extended our collaborative research agreement by 5 years, recognizing the transformative impact of modeling and simulation on public health and patient safety. This extended agreement also supports the 21st Century Cures Act, legislation introduced in 2016 to modernize clinical trials, speed the introduction of new medical technology, and give the FDA greater latitude to recruit support from scientific and technical experts to that end.
Our extended agreement will advance key technologies such as the digital twin for cardiology developed through the Living Heart Project. Hundreds of researchers, cardiologists, and medical device developers are creating and testing highly accurate, personalized models of the human heart. These fully functioning digital replicas leverage Dassault Systèmes’ 3DExperience platform for uniting in vitro, in vivo, and now in silico (in a virtual being) data. They stand in for patients in the design & testing drug therapies and potentially life-saving implants. Because they can be used safely during all phases of development, they accelerate development by lowering the need for surgery and clinical trials, greatly reduce animal testing, and produce zero side effects. Costs fall, long term effects can be considered, lifesaving treatment delivery accelerates, and patient outcomes improve.
In part based on the success collaborating with the FDA, Dassault Systèmes intends to extend virtual twin technology to other body parts.
Imaging shows the mitral valve closed (above) and open (below).
Photo courtesy of Dassault Systèmes
Meet your twin
Digital (also called virtual) twins are computer-based, 3D models that simulate physical objects. Originally developed for space travel, automakers, for example, can log millions of virtual miles annually in electronic versions of their cars and trucks. Aircraft manufacturers fly digital twins through thunderstorms and land them on virtual runways, while governments use them to design smart, sustainable cities. Often, real-world data flows back to the digital twin to improve the simulation or allow operators to then replicate conditions, such as a virtual check-up.
Digital twins and other advanced simulation tools allow designers and engineers to optimize their products. Engineers can run test scenarios that would otherwise be impossible to replicate and better understand the effects of age, usage, environment, and real-world hazards on their designs. They also make collaboration easier, giving multi-facility or even multinational teams the ability to share ideas and offer suggestions in real-time.
And once the tractor, turbine, ventilator, or refrigerator has been deployed, virtual twins can serve as repositories for Internet of Things (IoT) data from sensors in the field, monitoring life cycle and facilitating service calls while providing critical information for future improvement. The result? Better, safer products, shorter design cycles, and far more efficient manufacturing and maintenance processes.
Photo courtesy of Dassault Systèmes
Leveraging virtual patients
Digital twins emerged as manufacturers wrestled with escalating costs of testing and maintaining new products critical to keep them competitive. Nowhere is this pressure greater than in the medical industry. Global competition, delocalized manufacturing combined with massive costs of clinical trials that suffer from safety concerns, low patient turnout, and yield ambiguous results are just a few of the obstacles facing the medical community. Even trials deemed successful often produce solutions that are less than effective, with costs that can sometimes outstrip their profit. Further, COVID-19 has highlighted an unexpected weakness in the accelerated regulatory process. Through emergency authorization, developers have the authority to treat all patients, eliminating the historic untreated control group due to moral and legal concerns.
A personalized virtual twin of each subject created prior to testing, however, might safely serve the role of the control group. Physicians could collect data from patient wearables and apply it to the twin, identifying trends and potential concerns in real-time. The effects of medications and doses can be simulated before treatment, eliminating guesswork. Virtual patients as a synthetic control group could overcome speed limitations, decreasing cost, trial lengths while outcomes grow more favorable.
And, the technology goes further than that. Innovative doctors are now using digital twins today to develop 3D-printed surgical guides and replicas of organs and blood vessels for training, education, and practice prior to complex surgeries. For life-altering cases such as congenital heart reconstructions, doctors can perform the surgery on the virtual twin of a newborn, to optimize treatment and then go to the OR with much higher certainty. Soon, virtual twins might predict when a hip requires replacement or give trauma surgeons a view of what an accident victim’s knee or skull looked like before the damage.
Engineers can realistically view how medical devices may intereact with the heart, muscles, and bones.
Photo courtesy of Dassault Systèmes
The twin could then be used to reverse- engineer a precise replacement part. Biomedical engineers could confirm the virtual bone for form, fit, and function before being sent off to CNC machine tools and 3D printers for manufacturing. They could become essential technology as telemedicine emerges as a primary care mechanism, providing a visually informative framework that doctors and patients can understand. This is routinely done for dental replacement, so why stop there?
COVID-19 may have shined a light on the need for speed, but the problem was there. Rising healthcare costs are poised to cripple economies and with aging populations worldwide, it is truly the challenge of our times. Unchecked, this trend will only continue as people live longer, placing additional burdens on governments, insurance providers, and medical practitioners. The stage is set, the technology is ready, and we must rise to this challenge.
The Living Heart model allows engineers, surgeons, and researchers to look at the human heart in a whole new way.
Photo courtesy of Dassault Systèmes
The next 10 years
A great deal of work remains before you or I have our own virtual twin, one that our physicians can use to digitally develop and optimize healthcare plans without the traditional poking and prodding and guesswork that we’ve all come to expect. We need to take control and our virtual twin is the way forward. Leading institutions, including the FDA are already incorporating these tools into their practice, gathering critical experience, and setting the stage for the future. Along the way, we are laying the foundation for these types of scenarios to become commonplace.
As with our leadership of The Living Heart Project, Dassault Systèmes is collaborating with others throughout the life sciences value chain. Partners include biopharmaceutical and biotechnology companies, medical device manufacturers, researchers and universities, and governmental regulatory agencies, all of which play a crucial role in determining the future of medicine. We are committed to supporting these companies with innovative tools and technology, pursuing the ultimate goal of a better life for all of us.
About the author: Steve Levine is the senior director, Virtual Human Modeling and founder of the Living Heart Project, a translational project uniting cardiovascular experts in science, engineering, and clinical practice to develop personalized virtual twins of the human heart.
Medical adhesive material trends
Features - Adhesives
Medical adhesive materials have significantly evolved since 1980, with innovation closely linked to healthcare quality, environmental sustainability, cost controls, and better workplace and product safety.
Hot-melt adhesives were a big step forward for environmental sustainability and workplace safety, reducing employee exposure to toxic and flammable solvents.
Photo courtesy of Avery Dennison Medical.
Healthcare is always changing – new disease outbreaks, increases in various chronic conditions, paradigm shifts in delivery of healthcare – and through it all, adhesive medical materials have played a supporting role. Though not as renowned as the artificial heart or genetically engineered wonder drugs, adhesive developments have made a difference, particularly throughout the past 40 years, rising to meet patient needs and changing industry requirements.
Safety, sustainability
Sustainability is a front-and-center priority. Almost every business has sustainability objectives. From healthcare providers to medical device developers and their suppliers, each link in the supply chain is exploring different approaches. This encompasses manufacturing processes, raw material procurement choices, and fresh paths to patient care. The common goal: reduce impact on the natural environment.
For the medical adhesives industry, a keen focus on environmental issues traces back to the 1980s. The 1970s ushered in the U.S. Clean Air Act and the formation of the Environmental Protection Agency and Occupational Safety and Health Administration. By the ’80s, adhesive material producers faced a battery of new regulations intended to improve workplace safety and control emissions from toxic and highly flammable organic solvents.
As the scientific community’s knowledge about solvent toxicity grew, the level of residual solvents and other chemicals in products for human use or consumption became another big concern. Analytical testing capabilities for detecting residual chemicals made historic progress, and laboratory technologies became able to identify parts per billion of a substance in a sample. Many studies explored the toxic properties of different chemicals, with the main concern being cancer and how much exposure caused the disease.
As certain chemicals were flagged as carcinogenic or posing other serious risks, adhesive materials producers sought less-toxic alternatives. In addition, there were improvements in coater drying equipment to better capture emissions, recover solvents, and more efficiently dry materials to reduce residuals in finished products. But the most significant progress came with several major innovations, including:
Water-based adhesives
Ultraviolet (UV) and electron-beam cured adhesives
Hot-melt adhesives
Each of these developments represented a leap forward for adhesive safety, especially in reducing or eliminating solvent emissions and residual chemical risks. Today, there are families and sub-families of medical adhesives that trace their roots to these decades-old developments.
More recently, the medical materials industry has turned its attention to leachability risks of common compounds such as polyvinyl chloride (PVC), polyvinylidene chloride (PVdC), and plasticizers such as phthalates used to soften PVC. Medical barrier films, foams, and other materials free of these substances are becoming more important.
As material science evolves and the list of harmful chemicals grows longer, medical device developers and their suppliers continue the search for safer alternatives. This applies to chemicals used in raw materials and devices and those used in sterilization. In the 2000s, the EPA reported new evidence of health risks associated with ethylene oxide (EtO) sterilization. EtO has long been a preferred method for sterilizing adhesive-containing devices such as wound care dressings. Now, adhesive material suppliers and their customers are evaluating how products will tolerate different sterilization methods, such as X-ray irradiation and vapor phase hydrogen peroxide processes.
In the modern era, sustainability initiatives encompass the entire product life cycle. Leading corporations are embracing circular economics, in which they strive to eliminate waste and reduce their environmental footprint from a product’s inception to end of life. For medical adhesive materials suppliers, that includes finding ways to recover and recycle release liners.
Through a collaboration between Avery Dennison Medical and Eloquest Healthcare, this ReliaTect Post-Op Dressing with chlorhexidine gluconate is made of a transparent adhesive material offering antimicrobial, absorbent, and waterproof properties.
photo courtesy of Eloquest Healthcare
Game changers
In the past 40 years, two adhesive advances have had the most impact on wound care. One is hydrocolloids, which offer compelling technology for applications in which moisture management is crucial. They usually are rubber-based, pressure-sensitive adhesives (PSA) containing mixed particles, which allow PSA to absorb a significant amount of fluid. Those particles absorb fluid until they become saturated and form a soft, moist gel – making the dressing conducive to moist wound healing and atraumatic removal.
A second innovation that revolutionized wound care was the introduction of silicone-based adhesive dressings. Known for their gentle adhesion to the skin and equally gentle removal, soft silicone adhesives raised the bar for wound care. In particular, silicone-based wound care solutions improved care and quality of life for the elderly, whose fragile skin often struggles to heal and is susceptible to tears. They may also be ideal for neonatal/ pediatric patients, burn cases, and others with delicate or traumatized skin.
Hydrocolloids and silicones enabled significant advances for the wound care industry, improving patient comfort and promoting healing. Today, new generations of both materials continue to support wound management. There are thin silicone dressings 0.28mm thick designed to be flexible and conformable, and others capable of managing moderate to high wound exudate. Recently, hydrocolloids have been enhanced with the incorporation of additives, which may improve skin health, odor control, and pain levels. The list of additives that could further elevate the performance of hydrocolloids keeps growing.
Silicone-based adhesive dressings revolutionized when they were introduced. With their gentle adhesion and atraumatic removal, they remain a staple today for many wound care applications. In these two examples, soft silicone adhesives form a thin, conformable nonwoven dressing (left) and a highly absorbent foam dressing (right).
Photo courtesy of Avery Dennison Medical.
The next chapter
Photo courtesy of Avery Dennison Medical.
The 2000s mark the age of digital revolution and healthcare consumerization. Patients expect the same frictionless convenience from healthcare that they encounter in other facets of life, whether shopping, watching a movie, or catching a ride. It is the era of transformative care delivery models, as the industry devises new ways to diagnose, treat, and monitor patients outside of traditional settings – remotely, virtually, in less time, with fewer resources and at lower cost.
Medical devices and their materials must do more. For example, wearable devices are on the rise, and their performance requirements run the spectrum. Continuous glucose monitors might need to remain securely adhered for up to 28 days, throughout various daily activities. A drug injector might be worn on the skin for 15-to-30 minutes. Wear times for cardiac monitors or time-release medication patches could fall somewhere in between. There are skin-contact-layer adhesives specially designed for each use case, along with construction-layer adhesives to hold wearable components together.
Robust device requirements apply to more than wearables. Medical adhesives are going into new types of personal protective equipment (PPE), wound dressings, surgical applications, diagnostics and pharmaceutical innovations. New developments in each market serve multiple purposes. For example, Avery Dennison Medical’s BeneHold chlorhexidine gluconate (CHG) antimicrobial adhesive technology can be incorporated into thin, transparent dressings that offer clear site visualization and fight bacterial growth within the device.
Adhesive research and development parallels that of the broader materials landscape. New adhesives are designed to work in concert with next-generation fabrics, films, and other carrier materials, such as:
Soft, stretchable nonwovens
Materials with advanced wicking properties
Substrates enhanced with nanofibers
Novel composites and polymer blends
Special air-purifying filter media
For any new healthcare innovation to be adopted, there must be evidence to prove it performs as well as or better than its predecessor, usually at the same or lower cost. For adhesive materials suppliers, this means constant pressure to focus on a core trifecta:
1. Performance: Meeting functional requirements
2. Use: Enhancing patient experiences
3. Manufacturability: Cost- efficient, scalable production
Before 1980, healthcare providers did not have many adhesive material choices. By 2000, buoyed by hydrocolloid and silicone adhesive developments and others, they had an array of medical adhesives in their arsenals. Fast forward to today, and medical adhesive materials continue to support device innovations, from wound care to wearables. Furthermore, the sustainability movement of 40 years ago carries on with renewed intensity, driving the next chapters of innovation.
Posted by Elizabeth Engler Modic
