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Articles from 2020 In November


Caption Health Receives Grant to Develop AI-Guided Lung Ultrasound

Image courtesy of Caption Health CaptionHealth2web.jpg

“Because of the pandemic, hospitals are seeing an increase in patients with issues around the heart and the lungs,” said Kilian Koepsell, CTO and cofounder of Caption Health, in an interview with MD+DI. “Both of them are very important, and lung ultrasound in particular plays a critical role in triaging the patient to assess the severity of what's going on and then monitoring them throughout the disease and recovery.”

Koepsell said that the severity of COVID-19 can be reflected in the degree of pulmonary involvement, which can be seen on a lung ultrasound on exam. “When the patient arrives in the emergency department with suspicion of COVID-19, the lung ultrasound can be used for early detection, and it has been shown to be more reliable than a chest x-ray, for example,” he said.

But, clinicians who are well trained in ultrasound are not always available, especially during the current pandemic. The AI-guided lung ultrasound that Caption Health is developing could enable even inexperienced clinicians to perform a useful examination to assess different conditions.

“The big problem for adoption [of lung ultrasound] is that it is difficult for healthcare providers not versed in ultrasound to acquire the good images, to decide when you have a high-quality image, and then to interpret it,” Koepsell noted. “We help with all three steps.” He said the AI gives the user feedback on how to place the probe and manipulate it to get a good image. It also detects when the image is good enough to record and then gives guidance on the assessment.

“On a high level, our goal is to enable the clinicians to assess for a range of pulmonary pathologies and this will include pneumonia [as well as] pulmonary edema, pleural effusions, and pneumothorax,” Koepsell said.

Both the guidance and the assessment algorithms of the lung ultrasound use deep learning, a type of artificial intelligence that uses an artificial neural network. “The ultrasound image is processed by multiple layers of artificial neurons,” Koepsell explained. “Each layer processes the output of the previous layer, and in the end, the last layer of the network makes predictions, for example, [on] where to move the probe to get a better image or also about the likelihood that certain conditions are present in the image,” he continued. “The image processing is based on our current understanding of how that might be working in biological neural networks, like in the brain. The big advantage of doing it this way is that the network can be trained similarly to how we retrain the brain.”

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Caption Health’s first foray into AI-guided ultrasound was in the cardiac space. The company received a Breakthrough Device Designation for its software and is the first and currently the only FDA-cleared AI-guided ultrasound system. The company rolled out Caption AI to 20 leading medical institutions in the United States in September 2020 and it is currently in use at Northwestern Memorial Hospital, amongst others.

Koepsell shared one example from an institution that used the cardiac ultrasound technology. The cardiac ultrasound was performed by novice users on patients presenting with COVID-19 symptoms, and in 70 percent of cases, the patient’s course of treatment was changed from what it would have otherwise been. “There are definitely more controlled studies necessary,” he said. “But these early results show that there's a really great potential for impact on patient care and patient outcomes with this technology.”

The company’s current focus is the lung ultrasound, but it expects to adapt its AI to other organ systems in the future. “Our goal is really to empower and enable front-line care providers in any clinical environment to use ultrasound effectively for whatever they would like to look at,” Koepsell said. “And then the nice thing about ultrasound is that you can really image a lot of different organ systems almost everywhere.”

The Bill + Melinda Gates Foundation has awarded a $4.95 million grant to Caption Health for further development.

“This idea to democratize ultrasound to democratize medical Imaging, it's so powerful,” he continued. “Accessing visual images of organs like the heart or the lung, and being able to give this capability to any healthcare professional in any setting, just has enormous potential. This technology can be used anywhere, even in very resources-limited settings. This is I think why the Gates Foundation is so interested, in that it can really have a big impact on people all over the world,” Koepsell concluded. 

BellaSeno Takes a No-Touch Approach for New High-Throughput Additive Manufacturing Facility

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Mohit Chhaya, CEO of BellaSeno, reports that the same equipment can be used for prototyping and for manufacturing.

Manufacturing silicone or polyurethane implants usually involves a lot of hands-on activity by several people. “There is a lot of touching going on because they are made by technicians who have the mandrel and they dip it inside the silicone precursors and so on,” explained Mohit Chhaya, PhD, and CEO of BellaSeno, in an interview with MD+DI. “So, there's probably 10 to 15 people who touch it throughout the production process. And every time somebody touches it, there's always a chance that you get contamination on the surface, whether it's lint from the gowning that they're wearing or bacteria from the skin or something.”

He explained that manufacturing in BellaSeno’s newly opened facility is different thanks to 3-D printing. “This means nobody needs to touch it,” Chhaya said, noting that the risks of any inadvertent contamination are therefore reduced. “If you look at the whole chain, you have the feedstock of the printer that gets filled in automatically and then you have the printed part, which then gets put into the packaging right within the print chamber. The technician never touches the implant. The first person who touches it is actually the surgeon,” he said.

One of the unique features of the new facility is that BellaSeno can prototype and manufacture on the same equipment, Chhaya said. “It's a very seamless transition from when you are just developing the product to when you are producing it en masse.”

Also, BellaSeno reports it is one of the first European companies with an ISO 13485 certification covering the entire additive design and manufacturing process for resorbable implants. The company can reproducibly and routinely manufacture scaffolds with feature sizes down to 150 microns, which also sets the company apart in the additive manufacturing sector.

The new facility was created through a partnership with the Fraunhofer Institute for Cell Therapy and Immunology IZI in Leipzig, Germany. “We were partners in a grant that was funded by the state government of Saxony Germany, and as part of the project, they helped us develop these good manufacturing practices and processes for the additive manufacturing that we do,” Chhaya explained. “We were based in the Franuhofer’s cleanroom for the last three years, but the idea was that at the end [of] the three years, they would then transfer the know-how to our cleanroom.”

Chhaya sees great possibilities for future manufacturing processes at the facility. “We want to have even more artificial intelligence–driven workflows inside the facility,” he said, mentioning one idea of connecting each printer to a network, with a system that can assign the right printer to the right project at the right time.

“We still need technicians at the start of the process, when they are filling the raw material from the packaging into the reservoir, and when the implants are packaged at the end of the manufacturing to remove them to make space for the next one,” Chhaya said. “We're now trying to automate those processes so that you don't need to have people present in the facility to run the manufacturing.

“At the end of the day, we want to be at a point where we can have lights-out manufacturing,” Chhaya concluded.

Your Biggest (and Smallest) Miniaturization Questions Answered

Miniaturization

At Virtual Engineering Week, Accumold's Aaron Johnson tackled several key questions about miniaturization and micro injection molding, from the most basic to the more complex. Johnson, vice president of marketing and customer strategy at Accumold, is recognized as a leader on the subject of micro injection molding and has worked for Ankeny, IA-based Accumold since 2005.

What is micro molding?

Image courtesy of Accumoldmicro-molded parts for miniaturization

"What is micro molding? In one sense it is still injection molding," Johnson said. "It's the process of melting plastic into a form and letting it harden, and you have a variety of different constraints around that."

So in the most basic sense, micro molding is injection molding. Beyond that, however, Johnson defines micro molding in one of three ways.

Certainly the size of the molded part is a big factor in defining micro molding, Johnson said, noting that the smallest commercial part Accumold manufactures today is only about 800 microns long.

Micro molding can also be defined in terms of tolerances, Johnson said.

"It's not uncommon for us to have positional or some kind of geometry tolerances in plus or minus just a few microns in some cases," he said.

The third way that Johnson defines micro molding is in terms of micro features.

"It can be larger parts, something that has micro features to it, maybe it's a housing but it has a little micro-fluidic section to it that requires very high precision, high quality components," Johnson said. "So it's micro in size, micro in tolerance, micro in features, and in a lot of cases it can be all three of those. But usually there's some compelling nature to the component to make it true micro molding."

Another good indicator that your project requires micro molding, he said, is if you've taken a part to a traditional injection molder and they tell you it's too small or the tolerances are too tight for them.

Where do you start when embarking on a miniaturization project?

Johnson recommends that engineers start with their ideal in mind. He said he's often been at a trade show where someone will tell him they're not quite ready to talk about micro-molding needs yet because they're still designing their part. But that's actually the best place to start talking to a micro-molding partner, he said.

"We want you to be able to maximize your creativity, maximize what you're after through your design, and perhaps there are things you can do that you might not know you can do," Johnson said. "We love the napkin-sketch idea because we want you to start with your ideal in mind."

He says he once had a mechanical engineer customer tell him that everything he designs is the size of his monitor.

"It sounds funny, but we've seen some incredible designs come across the way, but just because you can draw it in CAD doesn't mean you can mold it, or just because you can 3D-print it doesn't mean you can mold it," Johnson said. "So looking at, what are you after? What is the ideal state that you're looking for? Then we start looking from there to see how close we can get to your ideal, and in some cases, you might be pleasantly surprised."

The moral of the story is it's never too early to start talking with your micro molder about your design.

How do you do more in the same amount of space or less?

"When we think about today's smartphone technology, there was a race not that long ago to see how small they can get. Then they got big again, and now they seem to have stabilized," Johnson said. "But if you take the form factor of the smartphone you have in your pocket today and you just go back five years and you think about storage space, the speed, the camera quality, the functionality ... it's just so much faster and better today, and a lot of that is enabled by micro technology. By making things smaller you can have more functionality."

Miniaturization is especially important in medical device development. From drug-delivery devices to implantables and surgical tools, smaller tends to equate to less invasive procedures, faster recovery times, and better patient outcomes.

What role does miniaturization and micro molding play in imaging, sensing, and medical applications?

Johnson shared some examples with Virtual Engineering Week attendees of some cool technologies enabled by miniaturization and micro molding, such as micro-optics (micro lenses and mirrors used for imaging, sensing, and medical applications).

"Micro optics take on a very special injection molding process because not only are we talking about small parts, fine details, and certainly small tolerances, micro-optics takes that to an even higher level," he said.

There are a number of considerations and challenges involved with micro-optics projects, such as optical-grade surface finishes and material clarity, but Johnson said micro-optics is one of the fastest-growing sectors of the sensor market and miniaturization.

"When you think about the types of imaging or the sensing of the diagnostics that you can do in the med device space is just phenomenal today, in large part due to a lot of micro technologies like micro molding," Johnson said.

What if I have miniaturization or micro-molding questions that are not answered here?

It's not too late to register for Virtual Engineering Week to listen to Johnson's presentation on demand. Another good source of information about micro molding, and Accumold in particular, is the company's Qmed directory listing, which includes contact information along with other useful content.

Finally, you can read more of Johnson's miniaturization and micro-molding tips here, based on a similar presentation at BIOMEDigital in early November.

3D Printing Helps J&J’s Ethicon Design Prisma Health’s Ventilator in 10 Days

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3D Printing could be argued as the silver bullet in overcoming personal protective equipment challenges during the onset of the pandemic.

Cynthia Star, the director of Technology Transfer for Johnson & Johnson’s 3D Printing team spoke about the importance of the process in a session titled ‘How Has the COVID-19 Pandemic Affected Adoption of 3D Printing in Medtech,’ during Virtual Engineering Week.

Star noted that very early in the pandemic, the company asked itself how it could harness the power of 3D printing to provide solutions. Two areas stood out -global reach and manufacturing speed.

“Since this was a global crisis, what about fulfilling local demand with regional printing,” she said during the conference. “We considered the impact of this disease around the world and wanted to make sure we produced a global solution. And from a manufacturing speed perspective are there medical device needs where 3D printing can provide a quick solution. As the disease spread, the solution had to keep pace.”  

J&J ’s Ethicon would have its 3D printing prowess tested during the pandemic through a collaboration with Prisma Health. The Greenville, SC-based healthcare system received emergency use authorization from FDA for a ventilator. The EUA came at a time when there was a shortage of ventilators in the U.S.

J&J’s Ethicon was able to use its 3D printing manufacturing technology to manufacture and distribute Prisma Health’s VESper Ventilator Expansion Splitter at no cost to healthcare providers. VESper is an expansion device that allows a single ventilator to support up to two patients during times of acute equipment shortages.

News of the ventilation system hit March 25 and by March 27 J&J had its first conversation with Prisma Health. The project kick-off was on the same day Star said.

It took about 10 days from prototype to launch. She noted that partners were printing parts of the device only two days after receiving the 3D model.

“By leveraging J&J 3D Printing capabilities allowed engineers to transfer the concept from a digital design to a 3D-printed commercial product,” Star said. “It demonstrated that with 3D printing, ideas can come to life quickly. The value of 3D printing allowed our teams to move from concept to design and then prototyping to commercialization enabling a rapid response to an emerging critical patient need.”  

In a race against the virus, the collaboration was quick, efficient, and effective.

“It was a physician at Prisma that had the original idea and additive manufacturing allowed the design to be realized rapidly,” Star said. “J&J’s healthcare expertise, especially its medical device supply chain, combined with its additive manufacturing footprint enabled the delivery of a safe and quality device to healthcare providers.”

Nanowear Weaves Multiple Markets Together to Provide Remote Diagnostic Platform

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There’s little to no doubt that COVID-19 has given a shot in the arm to the digital health and telehealth market. Nanowear, a company that has developed a connected-care and remote diagnostic platform and plays in several digital health markets has seen the increased attention in the space.

Last month, the New York-based company won a nod from FDA for SimpleSense, a cloth-based diagnostic platform. The technology is a multi-parameter remote diagnostic undergarment and machine learning digital platform, which simultaneously, and synchronously monitors and assesses the heart, lungs, and upper vascular system.

Venk Varadan, co-founder and CEO of Nanowear said FDA clearance of SimpleSense comes at a time when demand is high for digital health and remote monitoring solutions.

 “Pre-COVID our tech was super cool, and everyone could say, hey this is going to transform the game one day with all the different applications the platform can do,” Varadan told MD+DI. “But when COVID hit people were calling us up and saying, ‘hey we need your [technology] yesterday.’”

He added, “I think it accelerated everyone’s need to look at digital and remote solutions around telemedicine. COVID gave the whole world that shock that it needed to evaluate innovation seriously and not look as this is cool, as opposed to I need to implement this in practice.”

The company said the SimpleSENSE platform is Gender-neutral and size adjustable and has the potential to replace the digital stethoscope, multi-channel Holter monitor, Capnogram respiration machine, and blood pressure cuff by providing a diagnostic quality monitoring system that remotely captures more than 100 million data points per patient per day across cardiac, pulmonary, and circulatory biomarkers. 

“We have billions of these nanosensors per centimeter of surface area,” Varadan said. “It can capture really low-frequency biomarkers from basic skin contact – without the need for gel, wires or anything like that.”

He added, “what it really results in is the ability to pick up clinical-grade biomarkers from the skin over the same period – synchronously and continuously.”

In addition to the near-term commercialization of SimpleSENSE with select channel partners, Nanowear plans to continue its SimpleSENSE clinical trials in diagnosing worsening Heart Failure and COVID-19.

The company is in a unique position because its solution crosses over into multiple markets. 

“I get this question all of the time. Are you a device company; are you a data company; or are you a telehealth company,” Varadan said. “That’s an antiquated way of looking at this space. You can’t bucket a technology like ours into one of three or four of those categories.”

He added Nanowear differs from other companies because it monitors more than one biometric.

However, companies focused on measuring single sets of biometrics that have been making a lot of noise recently.  Companies like AliveCor and IRhythm are examples of these firms. 

A few weeks ago, Mountain View, CA-based AliveCor raised about $65 million in a series E round. AliveCor also announced former Cleveland Clinic CEO Toby Cosgrove, MD was joining its board.  The company sells the FDA-cleared KardiaMobile device, which is designed to provide instant detection of atrial fibrillation, bradycardia, tachycardia, and normal heart rhythm in an ECG. 

iRhythm presented strong 3-year data from mSToPS, a study that evaluated the effectiveness of Zio, the company’s ambulatory monitoring patch, to detect silent, or previously undiagnosed, atrial fibrillation in moderate-risk individuals.

 

 

 

Will Vectorious Be Victorious in Heart Failure?

Image by Blue Planet Studio - Adobe Stock heart failure

Tel Aviv, Isreal-based startup Vectorious Medical Technologies has secured a breakthrough device designation from FDA for a new heart failure monitoring device. The V-LAP (a left atrial pressure sensor) system is based on a implantable digital and miniature interial sensory device for heart failure patients and is currently in a multicenter first-in-human study dubbed the VECTOR-HF trial.

Image courtesy of Vectorious Medical Technologiesheart failure sensor device

 

William T. Abraham, MD, College of Medicine Distinguished Professor at The Ohio State University, explained that worsening heart failure leading to hospitalization starts with an elevation of fluid pressure in the heart’s left atrium. With the V-LAP, physicians have a remote access to left atrial pressure, potentially informative and effective data for treating heart failure patients, especially those with concomitant pulmonary hypertension and/or mitral regurgitation, he said, adding that remote monitoring of left atrial pressure has the potential to keep those patients well and out of the hospital.

Vectorious CEO Oren Goldshtein said the designation from FDA emphasizes the critical and unmet need for new monitoring devices for heart failure.

"The FDA’s breakthrough designation may provide an opportunity for expedited access of this novel patient management approach to heart failure patients who need better treatment options as quickly as possible," Goldshtein said.

FDA's breakthrough device designation program aims to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program is intended to provide timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization. The program replaced the agency's expedited access pathway program and priority review for medical devices.

Grail in Commercial Partnership with UK’s NHS

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Grail has announced a commercial partnership with the UK’s National Health Service to make its early cancer liquid biopsy test available starting in 2021.

Menlo Park, CA-based Grail said the collaboration was set to confirm the Galleri test’s clinical and economic performance in the NHS as a precursor to its routine use. The plan helps the UK meet its goal of diagnosing three-quarters of all cancers at an early stage by 2028.

The collaboration would involve 165,000 people in the UK and includes two groups. Grail noted the first group will include 140,000 people over the age of 50 without any suspicion of cancer, and the second will include 25,000 people 40 and above with suspicious signs or symptoms of cancer. Based on data from this program, access to the test could be expanded to around one million people across 2024 and 2025 and may roll out to a larger population thereafter.

“Every year, nearly 200,000 people in the UK die from cancer. Many of these people are diagnosed too late for treatment to be effective,” said Lord David Prior, Chair of NHS England. “This collaboration between the NHS and Grail offers the chance for a wide range of cancers to be diagnosed much earlier and could fundamentally change the outlook for people with cancer.”

Galleri is currently available in the U.S. under investigational use in the PATHFINDER study. The firm said the test would be commercially available in the U.S. sometime in 2021.

Liquid Biopsy Market Kicks into Overdrive

The collaboration with the UK is a little more than a month removed from gene-sequencing giant Illumina announcing it would acquire Grail for $8 billion. The deal is set to close in the second half of 2021.

Both companies have a rich history. Recall that San Diego, CA-based Illumina spun out Grail in 2016. The companies revealed the split during the 34th annual J.P. Morgan Healthcare Conference.

Before Illumina’s acquisition announcement, Grail was making moves of its own to expand its bandwidth by revealing its plans to go public.  

The news of the Illumina/Grail deal was a shot in the arm for the already hyper-active liquid biopsy market. Shortly after the announcement, Exact Sciences said it was going to acquire Thrive Earlier Detection for a total of $2.15 billion.

Exact Sciences said the deal would boost its early cancer detection efforts.

Cambridge, MA-based Thrive is developing CancerSeek, a liquid biopsy test that received Breakthrough Device designation from FDA in June of last year for the detection of genetic mutations and proteins associated with pancreatic and ovarian cancers.

Don't Miss These Solutions from Virtual Engineering Week Exhibitors

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Hundreds of exhibitors will share their latest innovations for medtech, automation, design, packaging, plastics, and quality during Virtual Engineering Week, held November 30 through December 4. Attendees will be able to schedule 1:1 meetings, and see live demos, all online. Below is a preview of some of the solutions covered in sessions and on display.

 

Virtual Product Showcase

The following presentations from medtech exhibitors will explore new technologies and solutions:

Monday, November 30 | 10:45am - 11:00am
The Enabling Benefits of Micro Molding
Speaker: Aaron Johnson  (Accumold)
This presentation will explore the subtleties of micro molding and the keys for navigating a successful project. The presentation will define micro molding and how to approach design and will feature case study examples for review. 

Monday, November 30 | 11:45am - 12:00pm
Delta Modtech: Machines Engineered for Your Toughest Challenge
Speaker: Nick Schmidt  (Delta ModTech)
This presentation will feature a Delta ModTech converter running a complex medical product in-line with a packager. The system will feature a variety of processes including rotary die cutting, precise part placement, vision inspection, and heat seal pouching. 

Monday, November 30 | 2:15pm - 2:30pm
Technology to Overcome Engineering Challenges & Design a Ventilator
Speaker: Steven Murphy  (SolidXperts)
This presentation will explore the technology behind rapid product development by using Solidworks, 3DExperience, and Markforged 3D printers to overcome unique engineering challenges.

Monday, November 30 | 2:45pm - 3:00pm
Distributed I/O for Pneumatics & Electric Automation
Speaker: Sandro Quintero  (Festo Corp.)
This presentation will examine the possibility of consolidating modules such as digital I/O, analog I/O, pneumatics and IO Link. Topics include the creation of power zones and ease of implementation in multiple PLC platforms.

Tuesday, December 1 | 9:45am - 10:00am
Robotic Labeling Brings 21st Century Technology to Applying Barcode Labels on Products & Packages
Speaker: Mark Edwards  (Vanomation)
This presentation examines the potential mislabeling problems for products and packages that can occur with legacy systems receiving control data and print data on different paths that get out of sync. It will cover the potential solution of using robotic printer applicators that use the same path for control and print data. 

Tuesday, December 1 | 10:45am - 11:00am
Epson Vt6l All-In-One 6 Axis Robot
Speaker: Aaron Donlon  (Epson Robots)
This product tour and application demonstration features the VT6L all-in-one 6 axis robot. Suitable for pick and place, machine tending, packaging, dispensing, and assembly, Epson’s robot features a 6kg payload and 900mm reach industrial arm. It is available in cleanroom ISO4 and IP67 specs. 

Tuesday, December 1 | 11:45am - 12:00pm
The Engineers of Heat Shrink
Speakers: Robert Komma  (TE Connectivity), Matthew Osten  (TE Connectivity), Roberto Vidal  (TE Connectivity)
This presentation covers TE Connectivity's development programs in thermoplastics, PTFE etched liners, and FEP technology. The company has more than 60 years in polymeric science and will share how to turn clinical challenges into technical innovations. 

Wednesday, December 2 | 9:45am - 10:00am
Dino-Lite Digital Microscopes in Manufacturing
Speaker: Kerie Roark  (Dino-Lite US)
This discussion will cover the advantages of using Dino-Lite products and software to assist in research, development, quality control, and non-destructive testing. Dino-Lite digital microscopes, eyepieces, and the associated software can expand visual inspection capabilities, improve research, development, and quality control while reducing cost. 

Wednesday, December 2 | 10:45am - 11:00am
Answering the Food & Pharma Industry's Problem to Missed Package Leaks
Speaker: Cole Laux  (INFICON)
This presentation explores testing flexible/rigid packages for costly leaks using the non-destructive Contura S-Series. It is part of series that was presented to the USDA on Capitol hill and could be a good starting point as quarantine restrictions are mitigated. 

Thursday, December 3 | 9:45am - 10:00am
PSN Relevance Across the Medical Device Product Life Cycle
Speaker: Corey Linden  (Plastics Services Network)
This presentation will explore how Plastics Services Network (PSN), an ISO 9001:2015 certified engineering firm, can help from concept to post-market phases. It has three main business units: an Engineering Design Center, a Material Processing Lab, and an ISO/IEC 17025:2017 certified Testing Laboratory. Its Engineering Services group can work closely with companies to develop and design to the exact specifications needed for optimal functionality. Its Processing Lab can create the exact formula needed for your material and create prototypes to test the manufacturability, and its Testing Laboratory is capable of analyzing the life-cycle, form, and function.

 

Be sure to check out solutions from these other exhibitors:

Boston Micro Fabrication - BMF

For micro 3D printing, the microArch S240 offers fast printing speeds, a large build volume, and the ability to print with engineering-grade materials. The system uses BMF’s patented projection micro stereolithography technology and is suited for production of larger parts and higher throughputs. Its advanced roller system spreads layers in seconds, resulting in build speeds of up to 10x faster. The microArch S240 can also handle higher viscosity materials, up to 20,000 Cp, resulting in the production of stronger, functional parts.

 

KNF Neuberger Inc.

The FP 150 is the smallest addition to a growing family of KNF low-pulsation liquid diaphragm pumps. With a flow rate of 0.2 – 1.5 L/min, the new FP 150 extends the full line’s linearly-controllable flow rate range from 0.2 – 12.4 L/min. These pumps are suited for recirculation applications that benefit from smooth, gentle flow, such as medical devices, cleaning and disinfection, 3D printing, and more.

KNF low-pulsation pumps combine the advantages of diaphragm liquid-pump technology with pulsation levels comparable to gear pumps. They are self-priming, have run-dry ability, and provide long, maintenance-free lifetimes even under continuous-operation conditions.

 

Snaptron

The RCG-Series is a four-legged dome featuring a unique ring in the center that can reduce impact from contamination, assembly tolerances, or off-centered presses. For instance, the RCG dome could address a crucial pain point for engineers—the loss of electrical contact between the dome and board due to the buildup of debris. This “ring” feature provides a 360-degree ring of contact, which minimizes the impact of contaminants. When debris obstructs the circuit in one area, the ring still makes contact in another area. This feature also ensures that electrical contact is maintained even with off-center actuations. Another feature of the RCG dome is its ability to activate multiple independent circuits. A fingered center pad allows for two or more circuits to be contacted at the same time.

 

RTP Company

RTP Company offers a wide range of materials designed for surgical robotic systems, including moving parts, monitors, single or reusable instruments, and staplers. The company’s thermoplastic compounds can provide mechanical performance, durability, and wear resistance, while meeting demands for reusable sterilization, chemical resistance, aesthetics, and cost reduction. Most materials can offer some level of biocompatibility support and formulation change control to ensure that required specifications are met.

 

Busch Vacuum Technics Inc.

Designed for Industry 4.0, the fully connected Busch R 5 PLUS series vacuum pump offers advanced control and monitoring functionalities. Operating data and the condition of the components can be recorded permanently, and data can be accessed or transferred via a Modbus TCP/IP client/server protocol. Such capabilities enable an intuitive menu structure on the large high-definition color display and remote control of the vacuum pump.

The vacuum pumps operate within a large pumping speed range, thanks to a variable speed drive. For operating modes, users can choose either constant speed mode or pressure control mode, making the vacuum pump energy-efficient. The company says the benefits from using Busch R 5 PLUS series vacuum pump include maintenance planning, reduced operating costs, and increased uptime.

 

Pipeline Design and Engineering

Pipeline has developed a full suite of equipment for reprocessing medical devices (especially catheters and surgical instruments) that can save reprocessing companies time by eliminating the need for developing customized fixtures and machines. The equipment and fixtures have already been designed, tested, and validated and intended to enable companies to accelerate operations not just by weeks but by months.

Pipeline claims the “reprocessing space is fast becoming a strategic operational investment for companies worldwide, and like any competitive landscape those who get their first have an increased chance of becoming dominant in the industry.”

 

EpoxySet Inc.

Flash Bond UV-5608DC, a light-activated delay-cure epoxy, is designed to enable fast processing and fixturing of parts even if both parts are opaque. The epoxy is activated by 365 to 405nm light with an intensity of 150mW/cm2 for 5 seconds. Parts can be mated together and aligned within 45 sec, and parts can be handled in 30 mins. No mixing is required.

The epoxy produces a high-strength bond with low cure shrinkage and a glass transition temperature of over 80°C. Cured product exhibits thermal, water, and chemical resistance. 

Applications include optical components, optical alignment, fibers, lenses, prisms, and other electronic components where low shrinkage and low outgassing are required. It is suited for ferrite core bonding, magnetics, and general assembly.
 

Sekisui Kydex LLC

Whether it’s matching color, texture, or maintaining a like new appearance over time, when parts for medical device housings are from different sources, achieving visual consistency among materials can be difficult, according to Sekisui Kydex LLC.

Kydex Injection Molding materials are formulated thermoplastic alloys that share the same durable, chemical-resistant physical properties as Kydex thermoplastic sheet. The injection molding materials are designed with integral color and can be specifically engineered to match Kydex thermoformed parts to create and maintain an overall seamless aesthetic and resist staining and degradation caused by disinfectants. 
 

Parker LORD (Subsidiary of Parker Hannifin Corporation)

Chemlok 3Stream is an adhesion-promoting additive that can impart self-bonding properties to non-self-bonding LSR. Using Chemlok 3Stream could result in up to 50% cost savings and the ability to bond to nearly all LSRs, according to the company. Chemlok 3Stream additive can be incorporated into injection molding processes by adding the additive via a standard third stream pump, similar to a colorant. 
 

Oliver Healthcare Packaging 

Oliver Healthcare Packaging offers HDPE CleanCut Cards that can be custom designed and manufactured to safely secure medical devices, protect against damage and contamination, and allow for ease of aseptic transfer. Produced in an ISO 7 and ISO 8 cleanroom environment, CleanCut Cards are manufactured to your device’s unique requirements while being an efficient and cost-effective packaging solution. Various sizes with endless retention elements and design flexibility are possible to accommodate the smallest components to the extra-long catheters.

Designed to ship and store flat, the HDPE CleanCut Cards meet the Packaging Waste Directive for limiting packaging weight and volume as well as green initiatives for the utilization of recyclable packaging materials.

 

Boyd Corporation

Boyd Corp. has manufactured more than 73,000,000 face shields and has supported the donation of 1.2 million face shields to front-line workers across the country. Face shields are essential pieces of personal protective equipment (PPE) that help prevent the spread of pathogens. They can also help protect the face and eyes from harmful splashes, sprays, or airborne particulates while still maintaining functional optical clarity for visibility, according to the company. Many face shields incorporate adhesive foam cushions on the forehead that hold the transparent moisture barrier away from the user’s face. This enables the continued use of additional protective equipment such as safety goggles and particulate masks for multiple layers and levels of personal protection. 

 

Light Conversion

The CARBIDE 80 W, 800 µJ laser with BiBurst option can be used mainly for drilling and cutting various metals, ceramics, sapphire, and glass, as well as material ablation for mass-spectrometry, and many other applications. The ultra-compact and cost-efficient CARBIDE features output parameters and a robust design that has been used in production environment systems operating 24/7.

The CARBIDE 80 W, 800 µJ laser with BiBurst option was announced as the Platinum Honoree at 2020 Laser Focus World Innovators Awards. 

 

TE Connectivity

TE Connectivity offers etched PTFE tubing, which can provide a lubricious lining to catheters that require a very thin wall with a low-friction ID. TE offers extremely tight tolerances with off-the-shelf product at ± 0.0005 in. A unique OD etching process can offer a better bond to the outer jacket of the delivery catheter. The company’s closed-loop manufacturing approach precisely controls the amount of “active” ingredient in the etchant to optimize bonding ability.
 

Endurica LLC

Endurica LLC has issued a new software release featuring aging simulation for elastomers. This feature lets users define tabular master curves that define the evolution of key material properties such as stiffness, critical tearing energy, and intrinsic strength (i.e., fatigue threshold). The simulation captures time-dependent changes in the fatigue crack growth rate law. It can also be coupled to a finite element solver to update stress and strain fields during the solution. Two new outputs for each element include age-equivalent time and age-influenced stiffness. The fatigue life distribution can also be output to determine the shortest lived element.

Be a 'Game-Changer' in Medical Device Packaging

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Amy Stewart, chairperson of the IoPP Medical Device Packaging Technical Committee

Uncertainties surrounding the COVID-19 pandemic have imposed new supply chain and regulatory hurdles for medical device manufacturers and further complicate the process of navigating the strict requirements applied to packaging materials for medical devices. While the market for medical device packaging is projected to grow to just shy of $44 billion by 2026, growth may be restrained by health and safety regulations governing sterilization and a plethora of other compliance issues. In this environment, attention to scalable, innovative, and unconventional production methods could be a key driver for sustained market growth. 

Amy Stewart, chairperson of the IoPP Medical Device Packaging Technical Committee (MDPTC), will explore the current state of packaging sterility and safety, including regulations in place to avoid healthcare-associated infection and the gravity of packaging integrity to patient safety, in her keynote presentation at Virtual Engineering Week, an all-new digital event taking place November 30 – December 4, 2020. Organized by Informa Markets – Engineering, producer of Medical Design & Manufacturing (MD&M) events and publisher of MD+DI, the five-day event is designed to connect suppliers with buyers and purchase influencers in the medtech, automation, design, packaging, materials, plastics and sustainability, and product development sectors. It offers world-class education for the close-knit manufacturing community through a comprehensive conference and networking at a time when in-person connection is not feasible.

Stewart answered a few questions for MD+DI, offering a preview into what attendees can expect from her keynote address scheduled for Wednesday, December 2 at 8:15am PST. For anyone interested in tuning in to the event, registration is open at engineering.im.informa.com/2020.

 

As chairperson of the IoPP Medical Device Packaging Technical Committee (MDPTC), you will present the keynote at Virtual Engineering Week, "Leading the Change.” What does that mean?

Stewart: We're an industry with a broad range of technical expertise with one common mission – patient safety. We all have our roles in the supplier value chain to serve the patient through medical device packaging sterility assurance. In the last eight months of COVID-19 support, there have been many activities leveraging the experience of medical device packaging professionals, including educators and media partners in our MDPTC membership. There's no time better time to answer the call-to-action, lean into the conversation, and provide technical leadership.

 

Where are the opportunities in the medical device packaging industry?

Stewart: In my keynote presentation, I share a few highlights from the last 12-18 months where we’ve seen trends and insights from less conventional sterilization methods to new medical device packaging innovation groups. These topics illustrate what’s happening in the industry that may resonate and inspire someone to seek his/her opportunity. Many speakers during Virtual Engineering Week are presenting on facets of medical device and medical device packaging including regulatory changes making a global impact to literally the “global” concern of healthcare waste.

 

If you’re a new packaging professional in this field, how do you break into this industry and be a contributor on game-changing advancements in medical device packaging? 

Stewart: Whether this was 2019 (pre-pandemic) or 2020, a good start is to join Institute of Packaging Professionals and the Medical Device Packaging Technical Committee. Membership offers immediate access to programs and other like-minded professionals who are driven to see medical device packaging...be better, the timeless goal. Also, in my presentation, I share the relationships between IoPP MDPTC and other industry organizations such as Stetilization Packaging Manufacturers Council (SPMC), a council of the FPA; and AAMI and ASTM, who collectively are passionate about advancing medical device packaging technical guidance.

 

Hasn’t this industry had those leading the change already? Will we hear about new faces leading the change? 

Stewart: Yes, and yes. Thankfully, we have had and continue to have strong technical leaders who have built the technical foundational knowledge of medical device packaging. In addition to some leaders’ highlights, lifetime industry contributor John Spitzley was announced at Healthpack 2020 for the MDPTC Honor Award. A key objective in IoPP MDPTC is to be a valuable resource to new medical device packaging professional members from industry education, networking, and professional development. 

 

Well Health Brings Home $45M in Series C Round

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Venture capital’s interest in investing in digital health companies is still going strong. Well Health is the latest firm to gain funding, raising S45 million in a series C round.

The Santa Barbara, CA-based company has developed an intelligent communications hub and has raised $75 million since 2015.

The series C round was led by Lead Edge Capital. Additional participants include Martin Ventures, the healthcare-focused venture capital firm founded by the executive, investor, and entrepreneur, Charlie Martin, and existing investors Jackson Square Ventures, Health Velocity Capital, Summation Health Ventures, Structure Capital, and Freestyle Capital. 

“Well delivers what patients expect today – the ability to engage with their healthcare provider as easily as they’d text a friend,” said Guillaume de Zwirek, CEO and founder, Well Health said in a release. “Although the pandemic fueled the adoption of digital health by many healthcare providers, patients today expect real-time, personalized communication, an expectation that will never fade. This year alone, Well technology will enable 200k-plus healthcare providers to send more than one billion messages with 30-plus million patients.”

The financing follows Well announcing a collaboration with Cerner Corporation, an electronic health records leader. The agreement calls for Well Health to be the patient-communication solution for Cerner’s customers. 

Companies with digital health solutions have managed to break through the clutter and attract the eye of venture capital firms cautious of investing during the pandemic. Digital health funding shattered all previous venture capital financing records for the sector by raising $6.3 billion in the first half of the year, according to a report by Mercom Capital Group released in July.

The Austin, TX-based firm reported that the digital health funding in 1H was 24% higher than the $5.1 billion the space raised in the first half of 2019, despite the pandemic disrupting the economy

The top-funded digital health categories in 1H 2020 were: telehealth with $1.9 billion, followed by analytics with $826 million, mHealth apps with $794 million, clinical decision support with $545 million, healthcare service booking with $326, and wearable sensors with $321 million.