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Articles from 2020 In December


Identifying Recycling and Circularity Opportunities for Healthcare Plastics

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The global business market for healthcare plastics is almost 15 billion pounds today and is projected to grow 5% year over year to reach 18 billion pounds in 2025, explained Peylina Chu, executive director for the Healthcare Plastics Recycling Council (HPRC), during the Virtual Engineering Week panel discussion, "Recycling & Circularity in Healthcare Plastics." HPRC seeks to improve the recyclability of those healthcare plastic products.

Chu discussed recycling challenges and opportunities with industry experts Nick Packet, MD&M specialist and packaging engineer at DuPont, and Bob Render, business development manager for sustainability at Ravago Recycling Group. The panel also discussed the challenges and opportunities in healthcare plastics recycling during the COVID-19 pandemic.

Chu began the session by explaining that the HPRC is a private technical coalition of companies across the healthcare plastics value chain that came together to enable and improve the recyclability of plastics products and plastics packaging within the healthcare industry and to increase the recycling of these materials. She said that HPRC’s mission is to ensure that all healthcare plastics are safely and effectively recycled and widely accepted as a valuable resource. 

“Early on, we understood that the barriers to recycling were all across the value chain,” Chu said. “And so, really, this is a collaborative effort of the stakeholders to come together to identify those barriers and bring solutions to market that will remove or minimize those barriers.”

In the panel discussion, Chu focused on common healthcare plastics because they can be easily collected without patient contact, which removes the fear of infectious materials being transferred to the recycler. “It's the polypropylene trays and basins,” she said. “It's the packaging trays that are used to protect the different medical instruments, saline bottles, the Tyvek and the rigid trays, and sterilization wrap, as well as IV bags.”

Chu started off by asking the panel what they thought the common challenges in recycling healthcare plastics were.

Packet mentioned three. “I think the first comes in the collection of materials out of the hospitals and nurses or healthcare professionals understanding what can and can't be collected from a recycling perspective,” he said.

The second, he said, was the perceived notion on the recycler’s part that the materials could be contaminated because they are coming from a healthcare facility.

Last, he explained, are the materials themselves. “They're often a mixed material stream,” Packet said. “So you have multiple types of polymers, as well as multiple types of forms—flexible packages along with rigid packages.”

Render agreed with Packet’s assessment, saying that some of these materials may be a little more challenging because they may incorporate laminate films and multiple materials. “But, in general, materials slated for healthcare applications are the highest quality, with the best mechanical properties, and therefore they are attractive to recyclers,” he said.

Chu then brought up the topic of advanced recycling, referencing a project the HPRC had undertaken this past year that studied whether healthcare plastics might be good feedstock for these new technologies. She asked Packet, who was one of the leaders of the study, what lessons came of it. One of the big takeaways, Packet said, was that these advanced recycling processes are more flexible because they can take a variety of different polymers. However, he said, it is more of a complementary versus competitive idea. “There are other components or packaging materials that you can get out of a hospital that are easily identified that could be collected to create a very clean stream and go into a mechanical recycling process,” he said.

Render said of mechanical recycling, “It is a proven technology. It's proven to reduce emissions and carbon footprint.” But he said that advanced recycling is more flexible for a wider variety of materials and that there are other, more niche processes within advanced recycling, like filtration and polymer decomposition. “So I think that we have to design systems that take advantage of both mechanical and advanced recycling.”

Chu next asked what challenges and opportunities were associated with reverse logistics.

Render answered: “It starts with the internal collection systems within a healthcare institution. Some of those are inconsistent or hit-or-miss—they rely on individuals who are also tasked with preparing operating rooms and actually doing the procedures,” he said. There is also the question of exactly what to collect, he noted, so there is an opportunity to clarify that and create collection systems.

He said that these materials cannot go into traditional methods of removal from an institution like a recycling compacter, so systems must be developed to densify these materials, either in bales or compressing them in carts.

Last, he said, is that the network of collection vehicles used to remove them from the institution and transport them to where the recycling will take place must be further developed.

Chu asked Packet to remind design engineers of some practices that make packaging easier to recycle and make it more attractive to recyclers. Packet acknowledged that it is sometimes difficult to change materials in a regulated market, but that there are some opportunities. “Designing a package that's made up of one polymer type would be ideal because you create a cleaner stream of materials versus having different types of polymers,” he said. Size also matters and looking at packaging that can be compressed easily is key, he noted.

When Chu asked Render what he saw in the near-term future for healthcare plastics recycling, he mentioned additives first. “There are many new additives that have come into the marketplace that are both enhancing the performance and the properties of the base resins once they're being recycled,” he said. “But also compatibilizers can make disparate resins that don't seem to work together, work together.” In fact, he said, there is a lot of discussion about building the additives into the structures in the beginning, so those items are already prepared to be recycled.

Advances in machinery are also important. “There's been advances in compression molding, where instead of having to rely on plastic being injected into a mold, the plastic is placed in charges into a mold, and then compressed down, so the reality is different and it's a much more forgiving process,” Render said. “We're going to witness the evolution of advanced recycling, everything from the purification technologies that take resins and run them through a purification process and remove colorings and odor and fillers, leaving you with an FDA-grade material, to depolymerization from one resin being depolymerized and repolymerized,” Render continued. 

Chu ended the presentation by bringing up the COVID-19 pandemic and its impact on recycling this past year.

Packet said that the pandemic has probably stifled some of the momentum that was building within hospitals and potentially at recyclers, who are starting to see the healthcare plastic waste stream as valuable. “But my hope is that as this subsides, recyclers again, and maybe even the advancements in technology, can move past that,” he said. He spoke of developing systems that limit human interaction, and technologies that may not need as much sorting, which may ease some concerns about contamination. 

Render added that he thought one of the major impacts of COVID-19 has been freight costs. “Freight costs have gone up by 30, 40, 50, 60 percent,” he said, noting that when these costs go up, recyclers have limited flexibility to take materials from long distances.

However, he said there are opportunities in advanced recycling, where there are some processes that are never touched by a human, thereby eliminating the risk of COVID-19 contamination. Also, sorting technologies, which use robots to replace human beings also are evolving.

“Healthcare facilities, as well, have seen huge increases in packaging waste and probably in some ways, it’s gotten worse,” Render said. “So, if we can figure out a way to solve this problem now, when we're all under stress, it bodes well for us.”

Chu ended the presentation by inviting anyone interested in joining the HPRC to contact her at peylina.chu@anteagroup.com.

Producing 'Unmoldable' Parts with 3D Printing

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In the Virtual Engineering Week presentation, How Do You Prototype & Produce the Unmoldable?, the story of producing a difficult-to-mold consumer product using 3D printing technology was told from three perspectives—the product OEM, the component manufacturer and printer, and the 3D printing technology supplier.

Gage Cutler, owner of FinMan Fishing Innovations, had a great idea for a new product that would help address concerns people encounter when fishing. This is no fish tale—it is the story of additive manufacturing technology delivering a flexible, durable, intricate product that may not have been possible with traditional manufacturing.

The FinMan Original is a rod-mounted tool that slices, snips, and stows gear. It has an intricate design, which made manufacturing a challenge. “For reference, the parts are around 1¾ in. long, around ½ in. tall, and just by looking at it, you can see there's a ton of detail,” Cutler said. Another big requirement for the product is that it be flexible, yet strong.

Aesthetics were also a consideration as the product is meant to look like a fish.  

When it came to manufacturing the FinMan, Cutler said he and his engineer did not want to be limited by traditional manufacturing constraints that would have taken away from both the functionality and the aesthetic qualities of the product.

“That's really what pushed me in the 3D printing,” he said. “For example, from the financial point of view, I didn't want to have to spend $15-, $20-, $25 thousand for a Gen 1 part and then immediately want to go to a Gen 2, and have to pay for another $20,000 mold,” he explained. “With 3D printing it was a $250 non-recurring engineering charge to change the digital file,” he said, enabling Gen 2 parts to be processed the next day, if needed.

Time to market was also reduced, he said. “We were able to use the same technology from prototype to production really at any scale,” he said. This would also allow for customization opportunities, which Cutler said opens up white labeling and private labeling opportunities for his company.

John Gallagher, president of the Gallagher Corp, described the manufacturing process for FinMan. The first thing they looked at were some design features, the first of which was texture. Another thing was the width of a horizontal slot on the bottom of the FinMan where a razor blade is inserted.

“That slot is 1 in. long, and 0.0048 in. wide, and we're holding that width to better than +/-0.005 in.,” Gallagher said. “Early on, it was unknown what width was needed to get the right fit for the razor blade. So we used prototyping to look at different slot widths.”

Gallagher mentioned that they also wanted to add a logo on the bottom of the FinMan and did a couple of iterations of this quickly to see what looked the best. “We print the same way, same process, same material, whether we're making prototype or production parts,” he said. “I think everyone recognizes the benefits of 3D printing for prototypes, but sometimes they're surprised that 3D printing can be a viable option for production.”

Gallagher explained that his company evaluates production viability in three ways. First, he said, was efficiency. “Is the part size within the printer’s envelope, and are the parts geometry printable? Assuming yes to both of those, then efficient printing is all about cycle time and number of parts per cycle,” Gallagher said.

Cycle time depends on how tall the part is, and parts per second depends on how many parts can fit on the platform. “So, in general, things that are FinMan-size or smaller can be efficiently produced," he said. 

The second question revolves around economics. “Often the comparison point here is between injection molding and 3D printing,” Gallagher said. “It's all about cost per part and I expect honestly that 3D printing is going to have a higher part cost.” However, he said what is likely not being included in the part cost is the cost for tooling, which can be significant for injection molding, especially as designs evolve over time.

The cost of lead time is also not included in that part cost. That can be significant for injection molding, but only days for 3D printing, he said. “For injection molding, there could be eight, twelve, sixteen weeks required just to fabricate the mold. So, saving the upfront investment in tooling and saving time is valuable. And that can really flip at the economics advantage to 3D printing,” Gallagher noted.

His third criteria is that the printed material can meet requirements such as strength, durability, or ability to handle high temperatures.

Gallagher concluded his remarks by saying that FinMan answered yes to all of these questions. “FinMan is a design that Gage was having trouble even making, and yet we've optimized it to print 100 at a time, in a 105-minute print cycle.”

Bob Gafvert, production partnership sales manager at Carbon, then spoke from his years of experience in injection molding as well as additive manufacturing. He said that when looking at materials, it is not only the cost that should be considered but mechanical performance is more important.  

For FinMan, because it needed to be flexible and strong, they ended up using Carbon’s rigid polyurethane 70, which is similar to ABS, and has a UL 94 horizontal burn flame resistance classification.

“The advantage mechanically with Gage’s product with a Carbon material is the process that the material goes through,” Gafvert said. “These are dual-cure materials, so it's a two-part material, whether it's a two-part urethane or two-part epoxy.”

In the company’s process, the shape of the part is set up with UV light and then it is cured in a thermal oven where the mechanical properties are set, Gafvert said. “It's where the UV cross links that were established in growing the part from a liquid resin, from an STL file, and taking advantage of all the different cross sections into a fully functioning mechanical part, similar to ABS.

“One of the keys to that process, why Gage is able to have that flexibility and that strength, is isotropic properties of that rigid polyurethane 70,” Gafvert continued. “The process with Carbon really allows you to develop an isotropic part because you don't have the traditional layering that you do with traditional additive. You don't have the porosity that you do with say a powder system. When you're working with liquid, you're able to achieve fully dense parts in the X, the Y, and the Z dimensions,” he concluded.

'United in Efforts to Innovate': Virtual Engineering Week

Image by Mark Mags from Pixabay Virtual Engineering Week

Virtual Engineering Week, an all-new virtual event connecting the global medtech, automation, design, packaging, materials, plastics and sustainability, and product development communities, took place from November 30 – December 4. Organized by Informa Markets – Engineering, the producer of MD&M, BIOMEDevice, and other events as well as the publisher of MD+DI, the online event offered daily conference sessions and a virtual expo with more than 160 virtual booths. The event drew more than 7400 registrants becoming Informa Markets – Engineering’s largest digital event to-date.

The conference dove into timely issues and trends affecting all engineers with sessions on topics ranging from digital health and miniaturization to 3D printing, smart manufacturing, medical device product development, robotics, and more. While the global pandemic continues to disrupt supply chains, attendees were given keen insights on how COVID-19 has impacted advanced manufacturing and predictions on how the industry will astutely respond.

Notably, Cynthia Star, director of technology transfer for Johnson & Johnson 3D printing team, led the session, “How Has the COVID-19 Pandemic Affected Adoption of 3D Printing in Medtech,” where Star showcased 3D printing’s role in medtech and its diverse applications in combating the virus. She noted how the technology allowed J&J to develop and put into prompt use critical cutting-edge products such as the Ventilator Expansion Splitter that allowed doctors to double the number of patients each ventilator could serve when the onset of COVID-19 made for scarce resources. Read MD+DI's coverage here: 3D Printing Helps J&J’s Ethicon Design Prisma Health’s Ventilator in 10 Days.

Industry 5.0 also was another primary focus. Another timely session was led by Shalabh Bakshi, director of digital enterprise and head of automotive vertical market at Siemens (Canada). The session, “Industry 5.0: Creative People, Collaborative Robots & Smart Factories” discussed the forces that are currently shaping advanced manufacturing and how manufacturing processes may change. Bakshi also spoke to the importance of the “circular economy,” which emphasizes cutting costs and energy consumption with a large focus on sustainability. Another key event session was “The Future of Industrial Jobs & Manufacturing” featuring session leader Ryan Chan, founder and CEO of Upkeep, speaking on the big push towards digitalization, a trend that has been pushed into full throttle amid the pandemic due to the continued need for people to connect and receive care when in-person interactions are not safe or even possible. Read MD+DI's coverage here: Manufacturing’s Digital Transformation Is Here to Stay, Says Industry Expert.

“As the producers of the nation’s largest advanced manufacturing events, we are proud to serve the industries that have been at the forefront of the fight against COVID-19 from a technology perspective,” said Steve Everly, event director, Virtual Engineering Week. “This year, more than ever, it has been imperative we stay connected and united in our efforts to innovate. Although nothing can compete with the value of face-to-face interactions, we’re thrilled Virtual Engineering Week has been able to provide these industries a source for learning and connection.”

Check out MD+DI's coverage of Virtual Engineering Week:

Can AI Help Identify Problems in Manufacturing?

Using Appropriate Controls to De-Risk Medical Devices

Overcoming the Limitations of Additive Manufacturing

AI and Machine Learning in Medical Devices: It’s Getting Better All the Time

In Pursuit of More Sustainable Packaging Solutions

Manufacturing’s Digital Transformation Is Here to Stay, Says Industry Expert

Sensors Are Helping to Put Medical Devices in the Hands of Consumers

Medical Device Design: 3 Practical Tips for Great User Interface and User Experience

Can Design Controls Accelerate Medical Innovation?

Your Chance to Drive Innovation in Medical Device Packaging

Your Biggest (and Smallest) Miniaturization Questions Answered

Be a 'Game-Changer' in Medical Device Packaging

 

Can AI Help Identify Problems in Manufacturing?

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With clean, reliable data, companies can use existing artificial intelligence (AI) tools to diagnose outliers in the manufacturing process, which could lead to the discovery of root causes of any problems in the line. Intraratio's President and Founder Ryan Gamble and Data Scientist Daniel Gutierrez shared such insights in their Virtual Engineering Week presentation, “AI for Manufacturing: How to Implement it Today.”

The first thing a manufacturer should do to incorporate AI into its manufacturing process is to capture transactional data and parametric log-type data from all its machines, suppliers, and systems, Gamble said. “And it needs to be a robust and automated collection, it needs to be scalable, and it needs to be properly catalogued,” he said.

He noted that this can be done rapidly and at low cost with technologies available today, but it is important that it is done correctly. “AI needs to be driven by systems that will make it properly catalogable and immediately data mineable, and trustable,” Gamble said. “So that's a key thing in the game.”

Gutierrez gave an example of what a company can do with that data, citing identifying outliers. “Outliers have often been seen as the low-hanging fruit for various manufacturing issues, whether it's root cause, machine issue, or raw material,” he explained. “So with the power of AI and machine learning, we could easily apply these various algorithms to automatically detect these different outliers across the whole manufacturing production line.”

He said that outliers are important because they can point in the direction of a root cause of a problem. “They could tell us if there's a potential issue with a machine or piece of equipment, if there's an issue with some type of measurement equipment that's being outputted from an operator’s tool or machine, and lastly any issues with various suppliers in a material, a lot number, or a serial number of the BOM.”

Gutierrez then spoke about an application that Intraratio is developing for outlier detection, called the Isolation Forest algorithm, which has been used in other industries, such as to detect credit card fraud. “But for us here in the manufacturing sector, what we're looking for is production fraud,” he said. “Is a machine acting up, is it throwing out variables that are not normal, was a new lot number introduced, was a new supplier introduced that we didn't know about?”

Gutierrez said Intraratio chose Isolation Forest because of its ease of use. It can be used in different programming languages and takes categorical data and numerical data without much transformation involved.

“Also, it's high dimensional,” he explained. “So instead of going one by one, versus a graph, you can actually group a bunch of different features together and it can look for outliers of the whole,” he continued, noting that Isolation Forest takes the features and dissects them into a decision tree and isolates that very uncommon data point as being the outlier.

“And once it does that, it flags that outlier and outputs it into a table where the engineer could further investigate where it comes from,” Gutierrez said. “What serial number is it? Is it really an outlier? Should it be scrapped or should it be fully investigated?”

Gutierrez emphasized that the key to using AI in this and future applications is having a well implemented and robust data collection system.

“These tools are out there,” Gamble said. “This technology exists. We're just applying it now to manufacturing.”

Disruption in Medical Device and Diagnostic Manufacturing: 3 Lessons Learned

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“By failing to prepare, you are preparing to fail.” - Benjamin Franklin

There’s a reason we have so many adages about being prepared; unexpected disruption comes at us from all directions. To continue to grow, businesses have to be ready for whatever comes next.

COVID-19 has disrupted the world, and it’s had a significant effect on the medical device and diagnostics industry. The pandemic upended routines and forced many facilities to shift their focus and begin manufacturing critical PPE (personal protective equipment) and other life-saving devices. Supply chains worldwide experienced massive confusion as some manufacturers switched to 24/7 production, others experienced extreme slowdowns, and others closed their doors either temporarily or for good.

But medical device manufacturers face interruptions from multiple sources every day— changing customer demands, market shifts, increasing regulatory pressures, new technologies, mergers and acquisitions, and more. Any change in the status quo poses a risk to the delicate balance of the manufacturing process and puts a company’s profitability at risk.

As we struggle through the current disruption, it’s time to prepare for what’s next. Here’s what medical device and diagnostic industry manufacturers can take away from the current crisis to help them prepare for the next one.

Lesson 1: Keep innovation alive

Innovation is the lifeblood of any industry, and especially the medical device industry. Innovation thrives on collaboration, and it’s taken a hit during COVID-19 because more teams are working from home. And innovation can also fall behind during a disruption. When R&D labs have to spend time on crisis management, there’s simply less time to create.

Medical device and diagnostic manufacturers can nurture innovation during even the most turbulent time by designing their operations to be more agile. They can adopt technology solutions that work in a cloud-based environment so data and information can be accessed anywhere, at any time, and through most devices.

Lesson 2: Untangle the supply chain

On a good day, life science manufacturers have supply-chain challenges—siloed supply-chain operations, limited visibility into supply-chain partner activity, and shipments that show up at the wrong time and in the wrong place. Disruption can magnify those issues. 

When disruption strikes, a dependable, well-connected supply chain can make the difference between being profitable or not. Connected supply-chain management isn’t just about grabbing and sharing data with partners; it’s about communicating in real-time and automating proactive and intelligent decisions across the span of a company’s global supply-chain operation. An agile, adaptive supply chain can speed up a manufacturer’s response to supply-chain disruptions.

Lesson 3: Go digital

When disruption strikes, a manufacturer can lose time syncing up data across the operation. The COVID-19 crisis has caused life science manufacturers to reconsider how data is collected, stored, and used. Digital manufacturing solutions can help companies collect and effectively use data, so that it’s not just numbers—it’s real-time insights.

Embracing digital technology can result in improved efficiency of manufacturing operations, real-time access to production data, inventory accuracy, shop floor visibility, and asset utilization. It can help connect the manufacturing floor to the rest of the business. Advanced technologies like machine learning, AI, IoT, and robotic process automation can be used to modernize manufacturing operations. Using technology, manufacturers can better communicate, analyze, and use information to overcome disruption and meet cost and quality objectives.

We've learned a great deal from COVID-19 and how it has impacted businesses. We've learned that the medical and healthcare industries have to arm themselves in advance with the right technology solutions and talent to be able to meet whatever new challenges arise.

There will be more disruption. Companies that are prepared with a robust cloud-based technology solution and an adaptive infrastructure will find themselves with a competitive advantage. The paradox is that an adaptive infrastructure that allows a business to be more nimble and able to weather disruption is the most solid and dependable foundation.

Using Appropriate Controls to De-Risk Medical Devices

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Justin Metcalf, director of engineering services at MED Institute, spoke about the importance of using the correct tests to de-risk medical devices, in a presentation at Virtual Engineering Week.

“When we think about de-risking a medical device, engineers often speak in terms of source requirements,” Metcalf said, in his session, “De-Risking Medical Devices & Ensuring Patient Safety with Appropriate Controls.”

“These source requirements can include how strong a device needs to be, how long the device needs to be to reach its intended location, and how flexible it needs to be to interact with the clinical environment,” he said. “From there, we can identify a problem to solve, while understanding there are non-engineering types of complexities that we have to entertain if we want the safe device to be used clinically.”

He said that strong engineering principles and a strong clinical understanding are of the utmost importance when talking about what potential failure modes or problems a device could encounter. He noted that some of the tools that have helped his company over the years are a robust quality system and learning how to stay in tune with global expectations that are changing as more is learned about the human body and how devices interact with it.

“Another important tool is understanding the standards development process,” Metcalf said, noting that it is important to know that standards generally lag, so having a regulation strategy based on science and engineering and a clear clinical understanding is key. This is especially true when devices are novel and standards or predicate expectations may not even exist.

He then presented three case studies that met clinical expectations for a de-risked medical device ready for clinical use.

The first case study looked at what it takes to execute a fatigue test on an implanted cardiovascular device. “This road map consists of reviewing all Summaries of Safety and Effectiveness (SSED) data sheets, predicate devices, reviewing the clinical literature, and confirming our findings with physicians with experience using similar devices,” Metcalf explained.

This device was a second generation, so there were standards and an established validated method to execute, he said. “If none of these were true, like during our experience working on the first-generation devices, we rely more heavily on clinical understanding, working with physicians treating the disease under clinical study. In first-generation devices, it is important to have a physician team to collaborate with on the unknowns and potential problems the device will encounter and work with them to design experiments from an engineering perspective to de-risk the best you can and then iterate as more information is learned,” he continued.

One challenge he related was that guidance documents can be overly general and hard to comply with, without a significant investment in time and research. “Other challenges could be that a previous or similar device had some unrelated clinical or testing issues unknown to you that will need to be discovered and then understood and duly mitigated against,” he said.

The second case study Metcalf mentioned was determining the MRI labeling conditions for a prosthetic knee.

There are three types of MR labeling--MR safe, MR conditional, and MR unsafe. “Generally for reference, MR safe are non-magnetic devices like cotton sheets,” he said. “MR unsafe are items that should not enter the MRI suite and cannot be scanned. And, finally, MR conditional is the majority of what we work on. These devices, under the right MR scanning conditions, can be imaged, and the risk of a bad scan or a patient injury is mitigated by performing appropriate de-risking activities.

“Using the physics and method development of our CM&S [computational modeling and simulation tools], we were able to determine the worst-case configurations and produce MRI labels with confidence that the device can be imaged safely under the right parameters,” Metcalf continued. This saves time when the MRI is ordered and, as with most implants, MR conditions are important to ensure not only a fast trip in and out of the scanner, but a safe one, he explained.

The last case study focused on de-risking a guidewire from a particulate identification and counting perspective. Particulate releases from devices is a growing regulatory concern, Metcalf said, and that makes it a growing engineering concern as well. “Many studies from researchers have been published on clinical identification of particulates, and from a testing perspective it is important to know what is shedding or releasing from your device--how much and why,” he said. “Executing this testing under validated methods is very important and ever more necessary as we push the engineering limits of size and materials.”

He noted that having a strong cross-discipline team of engineers, physicians, and scientists has always been important when working on clinically relevant problems such as particulate counting. Another consideration is to perform validation of the counting and sizing equipment. “One way we can do this is through a spike in recovery activity with no particles to ensure your equipment is working and your model adequately collects all particles that are released by your device,” Metcalf said. “We did this on our first-generation particulate counter and found out that the software was doing some strange post-processing of our data, and we think we were able to help the particulate-counting industry understand the importance of validating important parameters, such as how many particles you collect,” he said.

Metcalf reported that unlike fatigue testing, there is less history and consensus with particulate testing, and it is very important to have a solid method validation to fall back on. “The alternative is to get a question from your regulatory body that asks you to justify your testing or please repeat with a valid method,” he said.

Metcalf concluded his remarks by stressing the importance of properly conducting testing. “As my mentor would say, a good test is worth a thousand words, and a bad test is worth a million words of justifications.”

Hologic Delivered ‘Fantastic Performance in a Difficult Year’

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The word cloud above represents the frequency of words respondents used to describe why they selected Hologic as the 2020 MD+DI Readers' Choice Company of the Year.

Hologic had quite a 2020. The company began the year in somewhat of a challenging position, as it had just lowered its revenue guidance for fiscal year 2020 after divesting its Cynosure medical aesthetics business at a loss. However, Mike Matson, an analyst with Needham & Company, observed at the time that Hologic's diagnostics and breast health businesses could play significant roles in its growth opportunities.

Such analysis proved quite insightful. Hologic made news early on in the pandemic as it received Emergency Use Authorization (EUA) for its Panther Fusion SARS-COV-2 Assay and then followed up with an EUA for its Aptima SARS-CoV-2 test.

Hologic acquired Acessa Health, which had developed the Acessa ProVu laparoscopic system combining radiofrequency ablation with advanced intra-abdominal ultrasound visualization and guidance mapping for treating women suffering from symptomatic, benign uterine fibroids.

The company then gained FDA clearance for its Genius AI Detection technology, a new deep-learning-based software that helps radiologists categorize and prioritize cases by complexity and expected read time of breast tomosynthesis images.

Respondents to our Readers' Choice Company of the Year survey applauded Hologic for its accomplishments. The company stood out with the most votes—87% of the total responses to our anonymous survey (706 out 807 responses) were in favor of Hologic. Respondents offered up several reasons why.

“Fantastic performance in a difficult year, delivered what they promised to deliver!” wrote one respondent.

Hologic’s efforts in both women’s health and diagnostics stood out in 2020. “I voted for this company due to their dedication to improving both women's health during COVID-19 and switching gears to produce COVID-19 testing to help with the worldwide pandemic,” according to one respondent.

Such work in developing SARS-CoV-2 diagnostics really resonated with several survey respondents. Many pointed to the company’s quick action. It was “wonderful how they handled the pandemic and how [they] quickly pivoted to produce test kits,” wrote one.

Said another: “This organisation mobilised to produce a SARS-COVID-19 test at levels of speed and accuracy way beyond anything we’ve seen in this industry before.” And another pointed to “fast development of SARS-CoV-2 assay and continued quality of assays.”

Hologic was also praised for its work in women’s health. “With all the new advance[d] [gynecology] equipment and upscale devices this is the best company to vote for,” wrote one respondent. Another pointed to “incorporation of total fibroid management in women's health” and “breast health continuum of care led by introduction of 3D Quorum, which creates efficiency in radiologist reading.”

Hologic’s work in other areas was also recognized. “Hologic has always responded quickly to infectious disease needs in the US and worldwide. They quickly developed a test for West Nile Virus when that was [rampant] and [scary] and won a National Medal of Technology for it.”

Several also mentioned its efforts to combat HIV. “They are working with various non-profit companie[s] to assist with HIV detection in Africa,” noted one respondent.

Survey respondents also pointed to Hologic’s approach as a company. “Their slogan, 'The Science of Sure,' sends a great message, in this day and age where there is lots to be unsure of,” wrote one respondent. 

Added another: “The focus, their driven nature, their patient first outlook, their human feel. You're dealing with professionals whenever you deal with Hologic and their products are gold standard and best in class.”

The Future of Virtual Reality in Product Design

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The pandemic has been a surprising innovation force in all areas of design engineering, from advanced manufacturing developments through product design. Oddly, many remote design teams have become more efficient and more creative than their office-based counterparts. Cormac O’Conaire, creative director at Design Partners, spent time with Design News to explain how virtual reality (VR) has come of age as a design tool during 2020.

 

Part of the advancement in VR as a design tool comes from ongoing advances in the software and hardware delivered by VR vendors. Yet another part of it comes from the necessities of remote teamwork. “Over the years, our team at Design Partners has designed experiences for AR and VR for various applications from healthcare to gaming, but over the past nine months, we've been experimenting with VR in its capability in the design process,” O’Conaire told Design News. “We’re seeing the potential of VR to change the design industry, and more fundamentally, the way we create new ideas.”

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The body’s posture was optimized using Gravity Sketch’s mannequin, and the ideal future controller was built around that human form.


A Mix of Surgeons and Gamers

VR technology has advanced in its ability to serve the oddly similar needs of surgeons and gamers. That technology can also be put to use in product design. “Surgeons and gamers share some important qualities – an appreciation of precision and accuracy, visual-spatial skills, depth perception ability, total immersion in a task,” said O’Conaire. “Using a simulation of the human body, VR was used to study the human factors and ergonomic issues of existing solutions in a three-dimensional environment. The body’s posture was then optimized using Gravity Sketch’s mannequin and the ideal future controller was built around that human form.”

The virtual world is ripe for simulation, which helps make the technology appropriate for design. “Whether it’s an operating room, an outdoor environment, or the view from a crane, we can simulate the context and experience the customer journey in the virtual world for which we are designing,” said O’Conaire.

Developing VR Remotely

In so many instances during 2020, the remote-teams aspect of the pandemic has prompted unlikely innovations that will last beyond the lockdown. “Design teams will always adopt tools that maximize both creativity and efficiency, accelerating the ability to innovate at speed. VR as a creative tool has been a novelty until recently,” said O’Conaire. “Instigators of this shift are programs like Flyingshapes and Gravity Sketch, as well as hardware firms like Oculus and Logitech, who are innovating in the space. Then the global pandemic forced creative teams to work remotely.”

Like CAD before it, VR technology can be a shared environment, and it doesn’t matter where on earth the team members work. And the VR environment beats Zoom. “Virtual Reality allows creative teams to connect remotely in a more natural way than staring at Zoom’s rectangles. An unexpected benefit of VR is the relaxed meeting room vibe it creates,” said O’Conaire. “You can look over someone's shoulder on their creations and thought process, or work in your own space within the virtual environment. In these COVID times, this feels both refreshing and liberating. It makes for an immersive, warm, and collaborative experience.”

Like advanced CAD, the VR designs can be tested and validated before they enter the physical realm. “Instead of prototyping large-scale concepts, objects, or environments – costly and time-consuming – you can simply mock them up in VR,” said O’Conaire. “You can simultaneously design and validate workflows and ergonomics in real-time.”

The Ups and Downs of VR Hardware

O’Conaire noted that VR hardware lags in development. While recent advances have been impressive, the hardware still needs to grow. “Despite its incredible promise, VR hardware is still letting us down. The latest Oculus Quest 2 is heading in the right direction, but in general, the headsets are still too bulky and cumbersome, adding friction to the creative process,” said O’Conaire. “Also, the standard VR controllers are not quite intuitive enough to dive right in and start creating. There is a learning curve required that is not natural.”

While the lag in hardware advances stifle the design process to some extent, advances that did come along have helped. “There are some advances in hardware that have made the design processes easier. We have used Logitech’s VR Ink Pilot Edition since lockdown began and found that it turns strange and alien interactions into a more natural experience,” said O’Conaire. “The pen uses familiar paradigms of design – pen, and paper – and translates them into the virtual world. This speeds-up the learning curve in the VR software and helps get into the flow of design quicker.”

Logitech’s system provides a smooth transition from 2D sketches into 3D development. “Part of its magic in Logitech’s Flyingshapes is the VR Ink pen lets you use a flat surface for 2D sketching. This is second nature for designers, but it's something standard controllers can’t do,” said O’Conaire. You can create in 2D on a physical surface and then pull the design into 3D and design in the air. This new way of creating will accelerate the design process making it more efficient in bringing a product to market.”

From a design perspective, VR technology has become an effective way to turn doodles into sketches into 3D designs into validation and prototyping. “Designing and creating in virtual realities has become much more appealing for creativity, prototyping experiences, and collaboration,” said O’Conaire. “In the early stages of the design process, VR is like a turbocharged sketchbook, giving the capability to doodle ideas and explore them in three dimensions. We can create sketches, surfaces, and forms in a kind of infinite three-dimensional space. You can weave forms together like clouds, without worrying about precision and accuracy, almost as freeform as your thought process.”

The Future Waits for Software and Hardware Developments

O’Conaire points to advances that are still needed for VR to become a full-fledged effective design tool:

  • More intuitive and familiar interactions – new hardware controls and interactions to support sketching, sculpting, prototyping, animating ideas (e.g. ARI).
  • Less bulky - slim & lightweight. Considerate of human factors and ergonomics for creative use over extended periods. (HTC Vive is excellent but extremely heavy, tethered, and cumbersome over long creative sessions.)
  • Instant – remove the barriers to jump in. This is the link between hardware and software user experience.
  • Involve the creative community in the product development process to inspire community-driven solutions (just like Flyingshapes and Gravity Sketch are).
  • VR connecting with future prototyping. Perhaps the biggest future advantage of VR will be the way it can enable designers and engineers to be less constrained by what is possible. Product design usually centers on the question, “How do we manufacture this?” Yet the very fluid nature of VR creativity, coupled with 3D printing, means that we may no longer need to jump through the conventional hoops or navigate around the same constraints.

Even with the need for further developments in VR technology, O’Conaire is bullish on the future of VR for design purposes. “Why are the digital tools designers use to create future experiences the same tools project managers use to fill in planning templates, or accountants use to populate spreadsheets?” asked O’Conaire. “The VR creativity space is ripe for innovation. Certainly, having seen and experienced the power of VR, we’re going to continue to experiment and develop fluency in this space.”

 Rob Spiegel has covered automation and control for 19 years, 17 of them for Design News. Other topics he has covered include supply chain technology, alternative energy, and cybersecurity. For 10 years, he was the owner and publisher of the food magazine Chile Pepper.

Foldax Granted IDE for Mitral Valve Clinical Study

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Foldax had some significant developments with its mitral valve program recently. The Salt Lake City, UT-based company was granted IDE approval to begin a clinical study of the Tria Biopolymer mitral Surgical Heart valve.

The mitral valve study IDE comes shortly after Foldax won a nod from FDA to expand a clinical study of the device in the aortic valve. Foldax is also working on a transcatheter aortic valve replacement device, which is in the pre-clinical testing phase.

Enrollment for the 15-patient mitral valve trial will begin in January and could end by the beginning of 2Q21. The study will undoubtedly be powered by the $20 million series D round Foldax secured in June.

Ken Charhut, chairman of Foldax said the company’s mission was to “reinvent” the heart valve. In an interview with MD+DI, Charhut spoke about the device’s progress and the challenge of the mitral valve.

“Unlike the aortic position, the mitral side is a tougher hemodynamic environment,” Charhut told MD+DI. “And by that, I mean the pressures that a mitral valve sees are more extreme than what you may see on the aortic side. The structure of the mitral valve in the heart is different, so how you anchor it into the heart is different than the aortic. It’s been a more difficult valve historically to try to come out with one that meets the needs of the patients.”

He added, “This one is truly where you have a trade-off today. There’s a trade-off being a mechanical valve that should last your lifetime and require you to take anticoagulation drugs for the rest of your life, or a tissue valve that doesn’t last as long as they do in the aortic position so you’re likely to need repeat surgeries. There’s no good valve today for this position. And our promise – reinventing the valve is to come out with a valve that balances both of those needs.”

Foldax stands out from other companies in the space because its valves are robotically manufactured. The company said this reduces variability, enables high precision, repeatability, and quality, while substantially improving the economics of heart valve manufacturing.

“Robots don’t get COVID-19,” Charhut said. “They continue to work every day. We are much less affected by COVID-19 today or whatever comes next because we’re just relying on the machines to do work. You can get much greater accuracy out of the [robot]. They can be more dexterous than the human hand. You get consistency.”

Loud Noise in Mitral Valve Market

In 2020 most noise made in the mitral valve space was drowned out by the pandemic. However, there were some developments.

As the pandemic was setting in Mardil Medical was able to have success with its VenTouch, a minimally invasive option and combination therapy that simultaneously treats the distorted valve, the dilated ventricle, and the displaced papillary muscles in patients suffering from Type IIIb Functional Mitral Valve Regurgitation (FMR).

The Minneapolis, MN-based company was able to treat its third patient in its FMR trial.

CardioMech turned up the volume in late August by raising $18.5 million in a series A round. The proceeds would support an in-human feasibility trial for a transcatheter system that it hopes could be used as an alternative to open-heart cardiac surgery to reduce or eliminate mitral regurgitation.

LivaNova’s mitral valve developments began late last year and carried over into 2020. The London-based company announced its exodus of the mitral valve space in November of 2019. LivaNova scrapped its Caisson transcatheter mitral valve replacement program because of consistent yearly declines it had seen in its heart valve business.

LivaNova made plans to get out of the valve business altogether when it announced it would sell the unit to Gyrus Capital investment for $73 million. The measure came after activist investor PrimeStone Capital urged LivaNova to restructure and focus on its neuromodulation and cardiovascular businesses.   

Medtech in a Minute: Medtronic, Verily, and More

Image by OpenClipart-Vectors on Pixabay Medtech

Medtronic Enhances Maxor Robot with FDA Nod

Medtronic won FDA clearance for the use of navigated interbody and Midas Rex high-speed drills with the Mazor Robotic Guidance System. The company said the clearance came earlier than anticipated. The Mazor platform can now provide surgeons with procedural integration by combining the power of Midas Rex drills with the visibility and navigation from the StealthStation software.

Verily Scores $700M Investment

 Verily's latest investment round is expected to help the company accelerate key initiatives such as the Baseline Platform and its Health Platforms. Verily Health Platforms supports population health, clinical care delivery, and chronic disease management through programs like Healthy at Work, Onduo, and Coefficient. The company will also progress several of its life sciences programs across surgery, pathology, and immunology.

And in case you missed last week's Medtech in a Minute report ...

LivaNova Makes Major Changes

Following the recent decision to divest its heart valve business, LivaNova is now making what it calls “a series of enhancements” to its governance. LivaNova came under pressure earlier this year after PrimeStone Capital penned an open letter urging the company to refocus its capital on the neuromodulation business, divest its cardiopulmonary business, and either sell or close its heart valves business. The investor also recommended that the board appoint a new chairman and hire a new CFO. A medtech analyst later suggested that the sum of LivaNova's parts were worth significantly more than its current value, and that value could be created by breaking up the company.