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Global medical device packaging market projected to reach $57.6 billion by 2024

Medical packaging

The global medical device packaging sector is forecast to achieve a compound annual growth rate of 6.3% between 2018 and 2024, according to a report from Zion Market Research (New York). It is projected to reach a value of $57.6 billion in 2024, compared with $37.5 billion in 2017.

The report, Medical Device Packaging Market by Packaging Type, Material and Application: Global Industry Perspective, Comprehensive Analysis and Forecast, 2017–2024, covers a full range of packaging that is used to store, transport and protect medical devices.

Medical packaging must maintain sterility of the medical device until point of use, notes the report. Its primary role is to keep the products free from microbial contamination and to maintain a sterile condition.

Demand for flexible packaging is on the rise, according to the report; transparency, chemical resistance and moldability are expected to contribute to market growth during the forecast time period.

Longer shelf life requirements are also a major factor driving the market. Materials typically need to have barrier properties and be able to withstand disinfectants.

The report segments the medical device packaging market by type (bags & pouches, trays and boxes); materials (polymers, non-woven fabrics and paper/paperboard); and application (disposable consumables, monitoring and diagnostic equipment, and therapeutic equipment).

The major players operating in the medical device packaging market, according to the report, are 3M, DuPont, Amcor, Bemis, SteriPack, Siemens Healthcare, GE Healthcare, West Pharmaceutical Services, Wipak, Riverside Medical Packaging, Placon and Oracle Packaging.

Image courtesy Georgiy/Adobe Stock.

What Is Synthetic Biology? And How Will it Transform Manufacturing?

Just Egg is created by using plant cells to produce a product with the same texture, taste, and nutritional value as real eggs. (Image source: Just)

When engineers think of raw materials they often think of the various ores and minerals that make up our devices and their components. Biologists, on the other hand, think in terms of the cells that make up the basic building blocks of various organisms.

But that distinction may be dissolving thanks to an emerging field called synthetic biology. It's a field that combines engineering principles and biology. And if its ideas proliferate we may someday use more and more biological materials in our devices...and we may be crafting those materials in a manner similar to how we assemble electronic and mechanical components in a factory. Imagine being able to assemble food products in the same way we assemble cell phones or cars – by combining a standardized and reliable set of base components.

“The world is changing and traditional means of manufacturing and sustenance aren't going to get us where we need to go,” Sridhar Iyengar CEO of Elemental Machines, a data science and Internet of Things (IoT) solutions provider to companies in the synthetic biology industry among others, told an audience at the recent 2019 Pacific Design & Manufacturing Show. “It's estimated there will be 10 billion humans on the planet by 2050. It's a problem in terms of transportation, food, sustainability, housing, and building materials...We can't continue manufacturing products for human sustenance the way we have.”

But synthetic biology offers a solution by aiming to use biology to make products, Iyengar said. Imagine, for example, if biological materials could be created in factory, using machines that can build biological systems using artificial means.

Iyengar was first to admit the concept sounds like science fiction. But there are actually some striking examples of synthetic biology being applied today that he pointed out to the audience.

The Chicken or the Egg

Can you make eggs without chickens? According to San Francisco-based Just you can. And the company does. One of its products Just Egg is an egg product made from plants. “An egg is just a bunch of molecules and proteins,” Iyengar said. “[Synthetic biology] sees animals as manufacturers. If you deconstruct it, an egg is a bunch of proteins. Proteins are hard to make in a lab, but guess what's extremely good at making proteins...cells.”

By exacting proteins from mung beans the company is able to use those proteins to create a substance with texture, consistency, and taste of egg yolk. It is also cholesterol-free and requires less water and fewer carbon emissions than raising chickens, according to Just.

Another company, Not Company, is taking a similar approach to milk, creating milk without cows (it's called Not Milk). From a biological standpoint, “milk is a bunch of proteins with additional molecules like fats and carbs,” Iyengar pointed out, meaning again, it can be produced using the right combination of reconfigured cells.

He added that widespread use and production of cow-free milk would also have a positive environmental impact. “Cows emit methane. Methane is about 20 times more damaging to the environment than CO2 from cars. In that sense, cows are more dangerous than cars.”

And if you think all of this is limited to less hearty foods, Just and other companies like San Francisco-based Memphis Meats are developing cell-based meat that doesn't require animals.

Emeryville, CA-based Bolt Threads creates fabrics and other materials using yeast proteins to create synethic spider silk. Aside from making a $314 tie (which Bolt Threads sells), spider silk is hailed by many researchers for its tensile strength and other properties that could lead to the development of next-generation composite materials.

A video from Just explains how the company was able to manufacture meat for chicken nuggets by re-engineering proteins. 

The Cancer Question

Synthetic biology can utilize plant or animal cells. Think of each cell as a factory, only one that makes biological products instead of electrical and mechanical components and parts. By modifying those cells in a lab by inserting new raw materials (in this case DNA, instead of raw minerals) cells can be configured and reconfigured to produce whatever is needed. Thus a plant cell can produce egg-like protein, or an animal cell can produce meat without the need of having to raise and slaughter an animal.

But this is also where limitations and challenges come in, according to Iyengar. “One of the problems of using animal cells is that they grow old and die. So on one hand you need to continuously get more and more donor cells and when you do that the growth phase can be very tricky,” he said.

“Ideally what you want is the same cells over and over again,” Iyengar added. This is because different cells are like their own separate factories, each requiring unique protocols. Once you differentiate a cell it needs its own process, which defeats all of the efficiency offered by synthetic biology.

There is one type of animal cell that doesn't die however – a cancer cell. Cancer cells will grow ad infinitum and provide an endless number of factories and materials for synthetic biologies. “But in order to make this work you're using donor cells that are in a way cancerous...That's not very appealing,” Iyengar said.

The current solution, he said, is to take donor cells and grow them up inside of bioreactors that facilitate their development as though they were in a natural environment. He also said the larger industry is moving toward the idea of creating repositories of stem cells that can be used to create any type of cell needed for synthetic biology.

Would You Brew Your Dinner?

There are still significant technological and social hurdles for synthetic biology, Iyengar said the biggest ones today have to do with public perception. After all, it's not very appetizing to tell someone their steak dinner was made with cancer cells.

There is also the issue of cost. 3D printing has been suggested as a viable means of producing meats for example by companies such as Spain-based Nova Meat, which creates meats with the texture and taste of real meat, but using plant-based means.

“The challenge with 3D printing is cost,” Iyengar said. “Mass-produced foods are costly and won't scale with 3D printing.” He did however note that molding is an option that could scale. “[Synthetic biology companies] are actually borrowing a lot of ideas from injection molded plastic and things like that,” he said.

But even with that scale there's still a need to bring down the overall manufacturing costs. “Manufacturing the first lab-grown burger cost $3000, that was seven or eight years ago. Now it still costs a few hundred, he said. “The price is coming down with new tools.”

And none of this even factors in the regulatory side. Iyengar noted that FDA, FTC, various lobbying groups, and more are going to have a vested interest in the technology. Is a lab-grown steak still a steak? Should it then be regulated like meat, for example?

The bright side is there are already examples of synthetic biology moving away from self assembly and moving toward mass production. Beer is probably one of the oldest examples. “Most beer is genetically modified,” Iyengar said. “The idea of brewing your steak dinner may not be very attractive, but humans have been doing it for hundreds of years. You can brew your dinner the same way you brew beer. That's one way synthetic biology will massively transform sustainability.”

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

ESC, Embedded Systems Conference

ESC BOSTON IS BACK!
REGISTER TODAY!

The nation's largest embedded systems conference is back with a new education program tailored to the needs of today's embedded systems professionals, connecting you to hundreds of software developers, hardware engineers, start-up visionaries, and industry pros across the space. Be inspired through hands-on training and education across five conference tracks. Plus, take part in technical tutorials delivered by top embedded systems professionals. Click here to register today!

 

Correction:  A previous version of this article said the spider silk tie from Bolt Threads cost $700. The correct price is $314.

Why Cybersecurity Demands Are Outpacing Mitigation Efforts

On January 28, the U.S. Department of Defense released a report from the Pentagon’s combat testing office announcing that the U.S. military’s cybersecurity capabilities “aren’t advancing fast enough to stay ahead of the ‘onslaught of multipronged’ attacks envisioned by adversaries.” On January 29, news broke of a bug in Apple’s Facetime software, allowing users to access someone else’s microphone without their consent. Both of these organizations, leading their respective industries, within a week have demonstrated the overwhelming challenge of software security.

Cybersecurity, SmartBear, Collaborator, mitigation strategies
If companies want to ramp up their security efforts, it requires both contextual and scalable approaches working in tandem. (Source: SmartBear)

Software teams in 2019 are building more complex projects, with more distributed teams, in a more competitive technical landscape. On top of this immense challenge, teams have to mitigate against the risk of cyberattacks, in both their new software and in their existing code. To date, most companies have shown that they don’t have a reliable practice in place.

The Unstructured Heritage of Cybersecurity

The field of cybersecurity is still relatively nascent. The spread of viruses by lone malevolent actors through email and websites started in the 90s, but there was little financial gain. In response, antivirus software solutions were developed and deployed. Following the turn of the century, cyberattacks started to target companies primarily, turning credit card hacks and corporate breaches into routine headlines. This not only exposed the vulnerabilities in systems for companies like TJX, Target, Home Depot, and Staples, but it also revealed that most companies weren’t focused on cybersecurity as a business priority.  

Companies then began to introduce new security programs to discourage attacks, rewarding hackers with bug bounties and positions at their companies. While these new recruits brought technical expertise to teams, hackers by nature have a penchant for setting off on their own and subverting systems. The challenge now is for companies to create structured and predictable security workflows that mitigate against unstructured and unpredictable attacks.

Scalable Security Practices and Limits of Automation

One way that teams have added some security structure to their development is by adopting tools for penetration testing, vulnerability analysis, and monitoring. In Cisco’s 2018 Annual Cybersecurity Report, 39 percent of chief information security officers interviewed said that their organizations were completely reliant on automation. Complete reliance specifically on machine learning and artificial intelligence was also prevalent, 34 percent and 32 percent respectively.

This shouldn’t be surprising, given that organizations that really need to scale quickly can’t reasonably do so through hiring alone, especially given the complexity and breadth of some organizations’ software. Automation does and should play a critical role.

However, automated tools inherently lack a contextual sense for business risk. Assessing risk is one of the most challenging aspects of security efforts since every project is likely to have vulnerabilities.

The Open Web Application Security Project (OWASP) advocates for a focus on manual security code reviews, saying, “A human reviewer can understand the context for certain coding practices, and make a serious risk estimate that accounts for both the likelihood of attack and the business impact of a breach.” Extending more context to security teams means including them at every stage of the software development lifecycle (SDLC).

Building a Security Review Quality Gate Across Your SDLC

Bugs and vulnerabilities are cheaper to remedy the sooner that they are can be found in the SDLC. That’s why so many teams are looking to shift their testing left. The same principle applies to security. OWASP outlines how security teams should be involved reviewing:

  • Application security requirements in the planning phase
  • Security architecture in the design phase
  • Source code, coding practices, and test plans in the development phase
  • Penetration testing in the testing phase
  • Configuration management and secure deployment

With all of these touchpoints, cross-functional collaboration is critical. For code reviews specifically, there are often limits to how effective security professionals can be at fully understanding what code is doing if they aren’t proficient in the applied language or framework. Effective communication between development and security teams is critical in order to cross-pollinate subject area knowledge and best practices. In a report published by SmartBear in 2018, 73 percent of survey respondents found “sharing knowledge across their team” as one of the key benefits of code review.

If they aren’t already, teams should set a regular cadence for meetings to discuss application architecture, related services, and key inputs and outputs. It can be challenging for teams to ensure that all of these reviews are taking place in a documented and organized way. This is especially true for teams that track their reviews manually, over email, or in a spreadsheet. Tools like Collaborator facilitate a structured review process for all the code and documents associated with a project. Teams can customize approval workflows and ensure that their process is captured with review metrics and defect reports.

Cristina Chaplain, director of the U.S. Government Accountability Office, reflected on the recent Pentagon report saying, “DoD testers routinely found mission-critical vulnerabilities in systems under development, and in some cases, repeatedly over the years tended to discount the scale and severity of the problem.”

Scanning tools can identify critical vulnerabilities, but without a tool-based review structure in place as a development quality gate, the tangible deadline pressures can encourage teams to move on without addressing issues.

When teams adopt a structured review process with security practices embedded, knowledge sharing becomes central to the project culture. This is especially important given that training and skill development is in such great demand across industries.

Growing Teams and Training Through Peer Reviews

In the Cisco study referenced earlier, 27 percent of respondents said that “lack of trained personnel” was the greatest obstacle to security, up from 22 percent in 2015. This isn’t to say that companies aren’t hiring for security. The study also found that the median number of security professionals at an organization rose from 25 in 2015 to 40 in 2017. Companies need to accelerate hiring to match security demands and actively create opportunities for those experts to mentor and train junior team members. Since peer reviews take place across the SDLC, they can be an effective, structured vehicle for this kind of onboarding and knowledge transfer.

The Common Weakness Enumeration project supported by MITRE currently lists over 800 known types of software security weaknesses. With every new CWE type identified, the potential business risk stemming from inadequate security practices increases.

If companies want to ramp up their security efforts faster, it requires both contextual and scalable approaches working in tandem. In practice, that means structured workflows that prioritize cross-functional reviews and tooling that can dramatically expand security test coverage, ideally leveraging AI or machine learning to continuously improve.

For most companies, adopting a structured mitigation program means taking a transformational approach. Process change is never easy, but along the way, prioritizing code quality and knowledge sharing in your organization empowers teams to truly excel in all aspects of their development.

Patrick Londa is the digital marketing manager for Collaborator at SmartBear. With a background growing agile startups in the clean tech and digital health space, Patrick is now focused on software quality, process traceability, and peer review systems for companies in highly-regulated, high-impact sectors.

ESC, Embedded Systems Conference

ESC BOSTON IS BACK!
REGISTER TODAY!

The nation's largest embedded systems conference is back with a new education program tailored to the needs of today's embedded systems professionals, connecting you to hundreds of software developers, hardware engineers, start-up visionaries, and industry pros across the space. Be inspired through hands-on training and education across five conference tracks. Plus, take part in technical tutorials delivered by top embedded systems professionals. Click here to register today!

 

Efficient Fabrication Method Achieved for Nano-Sized Processors

More complex electronic and computing devices call for smaller and faster semiconductors, which means scientists around the world are working with new materials on the nanoscale to achieve the design goals for next-generation technology.

To this end, an international team of researchers led by New York University Tandon School of Engineering Professor of Chemical and Biomolecular Engineering Elisa Riedo has made a breakthrough in fabricating atom-thin processors using a new method for fabricating metals that scientists believe can replace silicon for next-generation chips. The work was described in an NYU news release.

Researchers in the PicoForce Lab modified hot-probe equipment called NanoFrazor by SwissLitho to invent a new process of fabricating 2D semiconductors. Here, the equipment patterns a one-atom-deep layer of molybdenum disulfide with electrodes. (Image source: New York University Tandon School of Engineering)

Atomically Small Chips

The team—comprised of researchers in New York, Switzerland, and Japan, among others—has demonstrated that lithography using a probe heated above 100 degrees Celsius outperformed standard methods for fabricating metal electrodes on 2D semiconductors, such as molybdenum disulfide (MoS₂). This is one of the various transitional metals that are among the materials scientists believe may supplant silicon for atomically small chips.

The team’s new fabrication method—called thermal scanning probe lithography, or t-SPL—offers a number of advantages over today’s electron beam lithography, EBL, which is used in metals manufacturing and semiconductor fabrication, Riedo said.

Improved Quality

Thermal lithography significantly improves the quality of the 2D transistors, offsetting what’s called the Schottky barrier, which hampers the flow of electrons at the intersection of metal and the 2D substrate in semiconductor designs, researchers said. Another advantage of t-SPL is that, unlike EBL, the thermal lithography allows chip designers to easily image the 2D semiconductor and then pattern the electrodes where desired.

T-SPL fabrication systems also promise significant initial savings as well as operational costs, researchers said. This is because they dramatically reduce power consumption by operating in ambient conditions, which eliminates the need to produce high-energy electrons and to generate an ultra-high vacuum. Finally, researchers can easily scale up the new thermal fabrication method for industrial production by using parallel thermal probes, Riedo said. Scientists outlined the research results in a paper in the journal Nature Electronics.

Rapid Advancement

The recent work is the result of more than 10 years of study and experimentation that Riedo has undertaken in thermal lithography, first with IBM Research-Zurich and later SwissLitho, a company founded by former IBM researchers. In fact, it’s a process based on a SwissLitho system that the team developed and used for the current research.

Riedo said that she hopes the new method the team developed will take most fabrication out of clean rooms and into individual laboratories, where materials science and chip design can advance at a more rapid pace. Indeed, clean rooms are generally scarce and require expensive equipment and specific conditions, and researchers are limited in the time they can spend there to work on new technologies.

With any luck, methods like the one Riedo’s team designed can become on par with the same evolution 3D printers have allowed in materials fabrication for various industries, she added. In a similar way, t-SPL tools with sub-10 nanometer resolution—running on standard 120-volt power in ambient conditions—also could become ubiquitous in research labs, allowing for more rapid advancement of technologies.

Elizabeth Montalbano is a freelance writer who has written about technology and culture for 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.

 

 

7 Moments that Defined the MIGS Market

<p><span style="font-family:"Calibri",sans-serif">The Micro-invasive glaucoma surgical space, affectionately known as MIGS has undergone several significant changes throughout the past few years. At one point six companies occupied the space which has often been called one of the fastest growing markets in medtech. Now while the space is strong, many of those original players have been acquired and there have been product failures. <em>MD+DI</em> has charted several key movements in the quickly-growing MIGS market.</span></p>

A Blood Test for Pain?

Pixabay A Blood Test for Pain?

Indiana University School of Medicine researchers have developed a test to measure pain pain in patients. The hope is that such a test could help in the fight against opioid abuse.

The study was led by Alexander Niculescu, MD, PhD and was published in the Nature journal Molecular Psychiatry. The study tracked hundreds of participants at the Richard L. Roudebush VA Medical Center in Indianapolis to identify biomarkers in the blood that can help objectively determine how severe a patient's pain is. The blood test would allow physicians far more accuracy in treating pain - as well as a better long-term look at the patient's medical future.

"We have developed a prototype for a blood test that can objectively tell doctors if the patient is in pain, and how severe that pain is. It's very important to have an objective measure of pain, as pain is a subjective sensation. Until now we have had to rely on patients self-reporting or the clinical impression the doctor has," Niculescu, who worked with other Department of Psychiatry researchers on the study, said in a release. "When we started this work it was a far-fetched idea. But the idea was to find a way to treat and prescribe things more appropriately to people who are in pain."

During the study, researchers looked at biomarkers found in the blood - in this case molecules that reflect disease severity. Much like as glucose serves as a biomarker to diabetes, these biomarkers allow doctors to assess the severity of the pain the patient is experiencing, and provide treatment in an objective, quantifiable manner.

In addition to providing an objective measure of pain, Niculescu's blood test helps physicians match the biomarkers in the patient's blood with potential treatment options.

"Through precision medicine you're giving the patient treatment that is tailored directly to them and their needs," Niculescu said in the release. "We wanted first to find some markers for pain that are universal, and we were able to. We know, however, based on our data that there are some markers that work better for men, some that work better for women. It could be that there are some markers that work better for headaches, some markers that work better for fibromyalgia and so on. That is where we hope to go with future larger studies."

What Role Does Material Development Play in Medtech?

Covestro LLC What Role Does Material Development Play in Medtech?
At MD&M West in Anaheim, CA, Covestro introduced a new high-flow polycarbonate designed for wearable medical devices, surgical instruments, drug-delivery devices and more. The company also introduced own connected drug-delivery device concept using Covestro materials. The concept device was developed by engineers from the application development group at Covestro.

In the fast-paced world of medical devices, sometimes it's easy to get so caught up in the latest trends and the end product that we don't stop to think about all the research and materials science involved with making the product possible. At MD&M West 2019 in Anaheim, CA, one supplier showed how the growing trend of miniaturization and connected healthcare is impacting how products are made.

Leverkusen, Germany-based Covestro, one of the world's largest polymer companies, developed Makrolon Rx2235 polycarbonate, a new medical-grade polycarbonate with high-flow properties designed for a variety of healthcare applications from wearables to surgical instruments. The new polycarbonate is expected to help manufacturers fill very thin walls and accurately replicate intricate design features with lower pressures. It's biocompatible and also designed to withstand gamma or e-Beam sterilization, which is particularly important in the healthcare environment.

"Makrolon Rx2235 polycarbonate is a significant addition to our broad range of medical polycarbonates," said Doug Hamilton, global healthcare segment leader for polycarbonates at Covestro. "This is just the latest example of how we continue to innovate and expand our polycarbonate portfolio, giving healthcare OEMs access to the advanced materials they need to design, develop, and produce their next breakthrough."

Hamilton told MD+DI that he attended the J.P. Morgan Healthcare Conference in January to see how Covestro's products align with the messages that OEMs were conveying to the investment community. It's no surprise that one of the key takeaways for him was the increasing importance of wearable devices in the industry, along with home healthcare devices that create an opportunity to take costs out of the healthcare system, improve the patient experience and compliance, and also improve physician monitoring.

"They're almost like a control tower of patients where they're checking to make sure the vital signs are aligned, checking to make sure patients are taking their medications, it's really the future vision of healthcare, it's very interesting," Hamilton said.

Meanwhile, Lauren Zetts, North America market manager for healthcare and consumer products at Covestro, was at the Digital Health Summit at CES hearing similar messages.

"With the launch of this new high-flow material, drug delivery devices is really a key application," Zetts said. "So we created our own connected drug-delivery device concept, which we introduced at MD&M West, using our materials and really highlighting how you can use our materials in this particular concept. And of course, as we know, connected is really the future for healthcare ... we definitely see that in drug delivery as well. We see it taking on different forms, whether screens are on the drug-delivery device itself or maybe it's just communicating with your smartphone or smart device, but what we display in this particular concept is different indicators on the screen and how it can communicate and remind you of when you need to take it next with the thought of improving compliance using different lighting indicators to show when the drug is actually ready to be injected."

Zetts also said that with some drugs it's very important to know what temperature the drug is at before it is injected, so that's another example of how lighting indicators would be useful.

"We're really trying to do what we can to show how our materials can help make that happen in a drug-delivery device," she said.

Engineers from the application development group at Covestro combined their knowledge of healthcare trends and technologies across multiple industries to develop the concept drug-delivery device to benefit device manufacturers and, ultimately, patients. The concept was in development for more than a year.

"What hit me was how engaging with the consumer blurs the lines between a healthcare device and a consumer electronic," Hamilton added. "The design and the interface is very much aligned with the consumer and you start to see some of the design features pulling in from some of the leaders in that area. And, in fact, you see companies like Apple, like Google, getting involved in connected digital health and positioning their devices in the wellness space."

The drug-delivery concept device is different from devices currently on the market, said Jesse McCanna, principal engineer at Covestro. He said the device is designed not to look like a typical drug-delivery device in an effort to make it more user-friendly, and increase both comfort and patient adherence.

According to the company, the concept incorporates a direct skinning/direct coating technology, providing exceptional tactile qualities for patients as well as streamlined, efficient manufacturing possibilities. While the technology is not new, it has rarely been used beyond automotive applications. In this design, direct coating is used to encapsulate the body of the device, creating a hermetic and tamper-resistant seal. Both high gloss and matte finishes are present on the outer surface, and the haptics (soft feel) can be varied based on the polyurethane chemistry used. Compared to traditional spray coating, direct coating offers increased design flexibility and streamlines manufacturing, while avoiding paint overspray and the release of volatile organic compounds, Covestro noted.

“With this drug delivery concept, we want to demonstrate possibilities of what the future could be like for manufacturers and patients – and how Covestro polycarbonate solutions can help make it happen,” Paleos said.

15 Hilarious Tweets About Medical Devices and Conditions

15 Hilarious Tweets About Medical Devices and Conditions

Chronic conditions are no laughing matter, but these tweets are proof that having a sense of humor about medical issues can be a great coping mechanism.

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Another Significant Milestone in the Diabetes Space

Pixabay Another Significant Milestone in the Diabetes Space

Tandem Diabetes Care has been given FDA approval for its t:slim X2 insulin pump. Through the approval, the agency has created a new device category – Alternate Controller Enabled Infusion Pumps (ACE Pumps). The San Diego-based company’s recent approval joins the list of several developments that have changed or helped reshape the diabetes market.

Along with this authorization, the FDA is establishing criteria, called special controls, which outline requirements for assuring the accuracy, reliability, cybersecurity and clinical relevance of ACE pumps, as well as describe the type of studies and data required to demonstrate acceptable pump performance.

The approved indication for the t:slim X2 pump states that the pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.

“FDA’s special controls set a new standard in our industry and define another component of the regulatory process for future automated insulin delivery systems,” John Sheridan, executive vice president and COO of Tandem Diabetes Care, said in a release. “Having the t:slim X2 pump approved with this new designation, combined with its ability for remote software updates, will enable more efficient and predictable development of new systems with current and future technology partners, and allow faster delivery of new innovations to our customers.”

Insulin pumps to date have either been cleared by FDA as stand-alone devices (class II, moderate risk devices) or approved by the agency as part of a single, predefined diabetes management system (class III, highest-risk devices). Because the interoperable t:Slim X2 insulin pump is interoperable with other diabetes device components, the pump was reviewed through the de novo premarket review pathway.

“The marketing authorization of the first ACE insulin pump intended for interoperable use has the potential to aid patients who seek more individualized diabetes therapy systems and opens the door for developers of future connected diabetes devices to get other safe and effective products to patients more efficiently,” Scott Gottlieb, M.D., FDA Commissioner, said in a release. “Because the FDA’s action creates a new regulatory classification, future ACE insulin pumps will be able to go through the more efficient 510(k) review process, helping to advance this innovative technology.”

Other Significant Developments in Diabetes

Diabetes management remains one of the hottest and fastest growing markets in medtech. The space has been a relative gold mine for companies seeking to get an entry point into healthcare.

Verily (Google’s former life sciences division) solidified its presence in healthcare through numerous partnerships to develop diabetes treatment and monitoring devices.

Beta Bionics, (Reader’s choice for the Medtech Company of the Year), has been making significant strides in the diabetes space. The company received an IDE for its artificial intelligence-driven bionic pancreas – the iLet.

However, one of the most significant changes in recent history to impact the diabetes market occurred when Senseonics was awarded a PMA for the Eversense implantable continuous glucose monitoring system.

3D-Printed Soft Robots Can Be Remotely Controlled

Researchers have developed a new 3D printing method and material for fabricating flexible, soft, mesh structures that can be remotely controlled, opening the door for soft robots with unique capabilities as well as new directions in medical research.

A team at North Carolina State University (NC State) developed the structures, which they can control with applied magnetic fields while floating on water, they said in a news release. The structures can grab small objects and carry water droplets, making them potentially useful soft robots that mimic creatures living on water surfaces, as well as for other uses, such as for cell research.

Researchers at North Carolina State University (NC State) have used 3D printing to fabricate soft, mesh-like structures shown here that can be remotely controlled using magnetic fields. (Image source: NC State)

Two Areas of Study

The work shows the intersection of two scientific areas of study, showing how their combination can be useful for future scientific advancements, said Orlin Velev, a distinguished professor of chemical and biomolecular engineering at NC State. “This research shows capabilities in the emerging field of combining 3D printing and soft robotics,” he said.

Indeed, using 3D printing for this purpose makes the fabrication of soft robots easier and more efficient, researchers said. These robots have a number of advantages over their rigid counterparts, including more safety for human-robot interactions, the ability to move more fluidly, and access to smaller, more confined spaces.

Something Like Toothpaste

To develop the structures, researchers created an “ink” from silicone microbeads that are bound by liquid silicone and contained in water. The resulting material—what’s called a “homocomposite thixotropic paste”—resembles common toothpaste; like the teeth-cleaning agent, it can be squeezed easily out of a tube but then maintains its shape without dripping.

In their research, the team used a 3D printer to shape the paste into mesh-like patterns, which were then cured in an oven to create flexible silicone structures. The resulting structures can be controlled—i.e., stretched and collapsed—by applying magnetic fields to them, researchers said.

“This self-reinforced paste allows us to create structures that are ultra-soft and flexible,” said Sangchul Roh, an NC State Ph.D. student in Velev’s lab and first author of a paper on the work published in the journal Advanced Materials Technologies.

Controlled By Magnetic Fields

Researchers achieved the ability to control the structures using a magnetic field by embedding iron carbonyl particles into the paste, said Joseph Tracy, professor of materials science and engineering and a senior co-investigator on the project. These particles are widely available and have a high magnetization, he said.

“The structures are also auxetic, which means that they can expand and contract in all directions,” Velev explained. This allowed researchers to control the shape both before and after applying the magnetic field using the 3D-printing process, he said.

To prove their method works, the team designed reconfigurable meshes, a structure that could “grab” a tiny ball of aluminum foil, and a structure that can “carry” a single water droplet and then release it on demand through the mesh, they said.

While the experiments show only an early-stage proof-of-concept for a soft robotic actuator, researchers plan to continue their work to create more complex robots, Velev said.

Elizabeth Montalbano is a freelance writer who has written about technology and culture for 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.