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DSM and Briggs Automotive Company announce collaboration on Mono R supercar

DSM and Briggs Automotive Company announce collaboration on Mono R supercar

DSM has announced a collaboration with Briggs Automotive Company (BAC), the British supercar manufacturing company based in Liverpool. Together, the two companies will co-develop 3D printing applications for the new BAC Mono R and showcase the potential of additive manufacturing in the automotive industry thanks to weight reduction and increased customizability.

The BAC Mono R features new, 3D-printed air inlets that are lighter, more durable, and more cost-effective to produce than traditional inlets.

The BAC Mono R's steering wheel features 3D-printed grips that are custom-made for the driver.

DSM and BAC will work together to unlock the full potential of additive manufacturing in the automotive industry. Both companies are convinced that integrating 3D printing in car manufacturing allows for the creation of parts that are not only lighter, but also stronger and customizable to meet specific customer needs. In addition, 3D printing enables original equipment manufacturers (OEMs) to explore new designs that would be impossible to produce using traditional manufacturing methods.

The new Mono R features a series of new, 3D-printed parts. For instance, BAC and DSM developed 3D-printed grips for the Mono R’s steering wheel that are fully customizable to its driver. The car also features new 3D-printed air inlets that are lighter, more durable, and more cost-effective to produce than traditional inlets. Thanks in part to design, computer aided engineering (CAE), and manufacturing changes to key parts of the Mono via 3D printing, BAC and DSM were able to limit the weight of the new supercar to 560 kilograms – a record low.

Other innovations are still to follow. For instance, DSM and BAC are currently exploring the design and production of 3D-printed parts incorporating new, organic shapes and hollow internal structures – radically reducing weight while maintaining strength. Additive manufacturing also enables OEMs to replace materials now common in car manufacturing with newer, high-performing and recyclable materials.

By using state-of-the-art CAE tools, DSM is supporting BAC in designing lightweight parts using the full potential of design for additive manufacturing (e.g. allowing design for function, which limits material to places where it is needed to support mechanical loads). Many of DSM’s traditional and high-performing polymers are already commonly used in the automotive sector. By re-engineering these tried and tested materials and optimizing them for 3D printing purposes, DSM Additive Manufacturing is enabling new and innovative designs to surface, as showcased by the record-breaking Mono R.

In time, the weight-reducing and durable properties of additive manufacturing will undoubtedly also be integrated into designs for mainstream vehicles.

Patrick Duis, segment leader Automotive at DSM Additive Manufacturing, says: “The BAC Mono is the perfect showcase for the potential of 3D printing to reshape the automotive industry. Additive manufacturing offers unparalleled options for small-series production and customization of cars, and we are excited to work together with BAC to optimize our materials for car manufacturers. This brings us another step closer to Manufacture Tomorrow.”

Ian Briggs, Design Director of BAC says: “We pride ourselves on being the ultimate pioneers at BAC, and joining forces with DSM means we can once again lead the way – this time in terms of additive manufacturing. Keeping the car as light as possible is of paramount importance, and by using 3D printing we not only keep the kilograms down, but also keep sustainability and safety on the up. We’re excited to see how our work on Mono R can translate to the automotive industry as a whole.”

DSM and BAC will continue collaborating closely to explore new technologies, materials and applications for 3D printing in the automotive industry. Both companies will also look for opportunities to improve sustainability in vehicle and other manufacturing processes. In 2018 BAC became the first car manufacturer to go climate positive, which means it removes more carbon dioxide from earth’s atmosphere than it emits.Adding additive manufacturing to the mix will enable BAC to cut its emissions even further, for example because 3D parts can be printed on site rather than having to be shipped across the globe. The company will also have access to DSM’s line-up of recyclable materials, further aiding its sustainability ambitions.

Edwards Drops Centera to Focus on Sapien 3 Ultra

Pixabay Edwards Drops Centera to Focus on Sapien 3 Ultra

Edwards Lifesciences said it is discontinuing work on its Centera Transcatheter Aortic Valve system. The Irvine, CA-based company said it will instead turn its attention and energy to the Sapien 3 Ultra Valve.

The news came during Edwards’ 2Q19 earnings call. The TAVR pioneer said the reason for halting the Centera program was due to the costs associated with expanding its indications to match the Sapien 3 valve.

“Given the pending approval for patients at low risk and the continued excellence and versatility of our balloon-expandable platform, we have made the difficult decision to discontinue the Centera program,” said Mike Mussallem, chairman and CEO of Edwards, according to a Seeking Alpha Transcript. “While the Centera valve has demonstrated excellent clinical outcomes and is performing well for patients, the time and resources required to optimize deliverability as well as expanding the indications to max Sapien 3 are significant. Going forward, we believe we best address patients’ needs by focusing resources on our robust pipeline of next-generation balloon-expandable technologies and indication expansion trials.”

Earlier last year, Edwards received CE mark for its Centera valve to treat severe, symptomatic aortic stenosis patients at high risk of open-heart surgery. In October of 2018, the company launched a pivotal trial of the valve.

Centera could have softened the edge of some of Edwards’ competitors in the TAVR market. The firm is already dueling with Medtronic’s CoreValve. On top of that Boston Scientific is gearing up to launch its Lotus Edge valve, which won FDA approval in April.

“We know that Boston Scientific is in the process of launching and we expect that to have some impact,” Mussallem said, according to a Seeking Alpha Transcript of the call. “So those are going to be some headwinds.”

FDA Asks Allergan to Recall Textured Breast Implants

MD+DI/Amanda Pedersen FDA Asks Allergan to Recall Textured Breast Implants
Allergan agreed to voluntarily recall its Biocell textured breast implants and tissue expanders worldwide after FDA updated the company on new data regarding the incidence of BIA-ALCL.

FDA has finally drawn a line in the sand on an issue that has plagued the breast implant industry for years.

On Wednesday the U.S. regulatory agency called on Allergan to take specific models of its textured breast implants off the market due to the risk of a rare type of cancer.

"To protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) associated with Allergan Biocell textured breast implants, [FDA] requested that Allergan recall its Biocell textured breast implants and tissue expanders," the agency said in a safety communication. "Allergan agreed and is removing these products from the global market."

Allergan said it is recalling the devices as a precaution following notification of recently updated global safety information concerning the "uncommon incidence" of BIA-ALCL. Neither FDA nor Allergan recommended removal or replacement of these implants in patients who have not shown any adverse symptoms.

"Patient safety is a priority for Allergan," the Dublin, Ireland-based company said. "Patients are advised to speak with their plastic surgeon about the risks and benefits of their implant type should they have any concerns."

In March the agency said it was taking a harder look at materials used in medical devices and potential adverse biological response resulting from contact of certain materials with the body over extended periods of time. Silicone breast implants were one of the specific types of medical device materials mentioned in that statement.

Breast implants on the market today have a silicone outer shell, with either a textured or non-textured surface, and are filled with silicone gel or saline. Over the years there have been reports of risks associated with breast implants, such as capsular contracture, implant rupture, and BIA-ALCL. More confirmed cases of BIA-ALCL have been reported in patients with textured surface implants than in patients with smooth-surface implants, the agency said in March.

BIA-ALCL is not to be confused with breast cancer. BIA-ALCL is a type of non-Hodgkin’s lymphoma (cancer of the immune system), FDA noted.

The recall does not affect Allergan's Natrelle smooth or Microcell breast implants and tissue expanders.

The United States is not the first country to take action against these devices. In April, France banned several types of textured breast implants due to the BIA-ALCL risk, followed by Canada and the Netherlands.

In a table updated Wednesday on the agency’s BIA-ALCL webpage, FDA reported a new worldwide total of 573 unique cases of BIA-ALCL and 33 patient deaths. Most of the cases of BIA-ALCL (481) were attributed to Allergan implants.

FDA said that based on the currently available information, including the newly submitted data, the risk of BIA-ALCL with Allergan Biocell textured implants is about six times the risk of BIA-ALCL with textured implants from other manufacturers on the U.S. market.

Continued distribution of Allergan's Biocell textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL, FDA said.

Ablative Helps Lead the Charge in the Renal Denervation Renaissance

Courtesy of Ablative Solutions Ablative Helps Lead the Charge in the Renal Denervation Renaissance
The Peregrine System

Ablative Solutions has enrolled the first patient in a clinical trial of its Peregrine System Kit, a renal denervation therapy for uncontrolled hypertension. The TARGET BP I global randomized clinical trial will look at 300 patients in up to 70 sites between the U.S. and Europe.

The Peregrine System Kit is comprised of an infusion catheter and dehydrated alcohol. The device is used in a minimally invasive procedure with the goal of deactivating the nerves surrounding the renal (kidney) arteries and thereby reducing blood pressure, said Kate Rumrill, president and CEO of Ablative Solutions

“We’ve negotiated with FDA, that if the results [of TARGET BP I] are positive that would lead to approval of our Peregrine Kit, which is comprised of both the catheter and the alcohol,” Rumrill told MD+DI. “It’s a combination kit that we would have approval for, for the treatment of hypertension.”

The Peregrine System has FDA clearance for the infusion of diagnostic and therapeutic agents into the perivascular area of the peripheral vasculature. In addition to a nod from FDA, the device has a CE mark for the infusion of a neurolytic agent to achieve a reduction in systemic blood pressure in hypertensive patients. However, the company hasn’t released the item for the sale in either place.

Instead, the firm is building data for the technology. In Europe, the company is conducting the TARGET BP OFF-MED trial - a proof-of-concept blinded, randomized sham-controlled study evaluating the safety and effectiveness of Ablative Solutions' Peregrine Kit for the treatment of patients with uncontrolled hypertension who are not taking anti-hypertensive medications. This study was initiated earlier this year and is actively recruiting.

The company also released results from the Peregrine Post-Market Study, a European multicenter open-label trial that evaluated the safety and performance of the Peregrine System Infusion Catheter, during the 2019 Cardiovascular Research Technologies (CRT) meeting in Washington, D.C. Ablative Solutions said the efficacy endpoint of the study was met, with a reduction in mean systolic 24-hour ambulatory blood pressure of 11mmHg 14 mm Hg, p<0.001) at six-month follow-up.

“We will have more data by the end of next year with our TARGET BP OFF-MED [study],” she said. “Our commercialization is probably closer to … three years out. I really can’t get more specific than that because there are so many dependent variables. We see ourselves a year to 18 months behind Medtronic, who will be the first to get approval.”

Renal Denervation Resurgence

Trial enrollment of TARGET BP I comes on the heels of Ablative Solutions raising $77 million in a Series D financing. The financing raise showed that investors were still interested in renal denervation for uncontrolled hypertension – after many companies abandoned the space a few years back. The firms had put distance between themselves and the market because Medtronic failed to meet its endpoints in a clinical trial for the Symplicity Renal Denervation System in 2014.

Medtronic has since doubled down on its efforts in treating uncontrolled hypertension and in April of 2018 won FDA approval for a pivotal trial evaluating the Symplicity Renal Denervation system.

Shortly after Dublin-based Medtronic revealed it was re-entering the scene to treat uncontrollable hypertension, Otsuka Holdings made a play to enter the space and acquired ReCor Medical for an undisclosed sum.

The acquisition came just days after Palo Alto, CA-based ReCor Medical received approval from FDA for a pivotal trial of Paradise, an ultrasound renal denervation system. Enrollment for the trial began in October of 2018.

Rumrill commented on the recent surge in activity for the market. She said it will be the data from clinical trials that will ultimately be the determining factor for renal denervation used to treat hypertension.

“I think between [Medtronic], ReCor and our early results here with the post-market study, we’ve all been able to show that renal denervation is a safe and what appears to be an effective treatment for patients suffering from hypertension,” she said. “Granted we all are continuing to do the large randomized control trials now and three of us have those studies ongoing. Those results will be the final proof that we can kind of raise the flag and say we are correct in our assumptions.”

Business outlook for electric and autonomous cars still stuck in neutral

Business outlook for electric and autonomous cars still stuck in neutral

The business outlook for electric and autonomous cars hasn’t improved much in the past year, according to a report from global consultancy AlixPartners (New York). Last year’s report projected a “pile-up of epic proportions” for the industry “as investments necessary to an electric and autonomous future balloon just as the market slows.” The latest report, released in June 2019, describes the auto industry as “entering a profit desert, as heavy spending on new mobility and stagnation in key markets take hold simultaneously.” Spending on connected, autonomous, shared and electric vehicles, particularly for electric and autonomous vehicles, along with stagnation in key markets globally, including the United States, will adversely impact the automotive market, said the new report.

Autonomous vehicles in cityscape

Last year, AlixPartners predicted the auto industry would face “a monumental capital drain in the near term, as hundreds of players, including non-traditional ones, pour unprecedented sums into electric and autonomous vehicles years before those technologies are fully cost-competitive in the market.” AlixPartners notes in the 2019 report that the new mobility future isn’t yet at hand and technology costs are still inhibiting sales.

Powertrain costs for electric vehicles (EVs) are identified as being two-and-a-half times higher than for traditional vehicles, yet sales per model through 2022 are predicted to be just 15% of traditional models historically. Total global industry sales are forecast to grow just 1.6% annually through 2026, as China cools significantly over the next two years and the United States begins a cyclical downturn to 16.9 million units this year and down to 15.1 million units in 2021, said the 2019 report.

Reflecting fluctuations in consumer preferences, the 2019 study cites a new consumer survey, which finds that “Americans seem to be quite open” to battery electric vehicles (BEVs), “with 14% saying that their next vehicle is likely to be a BEV, rising to 20% for how they think they’ll feel in 2025 and to 33% in 2030.” However, the cloud hanging over this survey is the fact that it also found that “concerns about the cost of electric vehicles are up significantly from responses in a similar AlixPartners poll a year ago, with 51% of Americans citing cost as a top-three concern, up from 29% in last year’s survey,” said AlixPartners.

With the continued push toward renewable sources of electricity, which are not reliable, costs of electricity are on the rise nationwide.

Technophiles are always on-board for new techie products, but all too soon the bloom is off the rose as reality sets in. An article in the July 24 Wall Street Journal noted that Tesla’s sales of higher-end cars have eroded in the company’s largest and most important market, the People’s Republic of California. Citing new data from research firm Dominion Enterprises, the stylish sedan that arguably changed car buyers’ view of electric cars is losing its luster, said the WSJ article, “Tesla’s Sales of Higher-End Cars Erode in California.” Registrations of new Model S sedans in the second quarter plummeted 54%, to 1,205 in California, according to the Dominion Cross-Sell report.

Besides, cost, another big obstacle to BEV ownership is driving range—you just can’t drive very far on a charge, even with the new longer-range batteries. Driving to San Diego recently, I noticed that from Phoenix to Gila Bend (where I can get on I-8) is just under 100 miles. On a full charge with the smaller batteries in an EV, I might make it to Gila Bend; on the west side of town just before entering I-8, there are six Tesla charging stations in a fast-food parking lot. So, I figured that if I want to spend a couple of hours in Gila Bend (I’m not sure anyone wants to do that, though), I might be able to make it to Yuma, but that’s doubtful unless I'm driving a vehicle with a longer range.

AlixPartners’ 2018 report noted that with the “crush of upcoming electric-vehicle launches over the next few years,” a variety of incentives will be needed to sell them. It boggles the mind reading about how much General Motors will invest in EVs and autonomous vehicles, actually believing that consumers want these vehicles in spite of study after study proving otherwise. When was the last time you saw a TV commercial for the 2019 Chevy all-electric Bolt (which, at 238 miles on a charge, would just about get me to Yuma, assuming that there are any charging stations there)?

GM’s ubiquitous ads promote large trucks and SUVs, the bread-and-butter of that company because that’s what consumers want.

Mark Wakefield, global co-leader of the Automotive and Industrial Practice at AlixPartners and a Managing Director at the firm, concluded the 2019 report from AlixPartners by noting, “This industry is about to enter what could be a multi-year profit desert, as spending on new mobility [by automotive OEMs] ramps up massively just as key markets around the world stagnate or fall. Whether players emerge on the other side of this desert, and what kind of shape they’re in, will be determined by the action they take in the next few months to proactively transform their investment approaches and operations.”

Thin-Strut Bioresorbable Vascular Scaffold Shows Promise

MeRes 100 thin-strut sirolimus-eluting bioresorbable scaffold by Meril Life Sciences
Image of the MeRes 100 thin-strut sirolimus-eluting bioresorbable scaffold courtesy of Meril Life Sciences

A next-generation bioresorbable scaffold (BRS) system called MeRes 100, developed by Meril Life Sciences, is thinner than first-generation similar devices, with a low strut thickness of 100 microns. Two recent clinical studies have shown that this feature, along with some other innovations, have made it more successful than first-generation similar devices, and more important, safe and effective.

First-generation devices were thick, took a long time to resorb, and easily fractured, according to ProfessorAlexandre Abizaid, chief of coronary interventions at Institute Dante Pazzanese de Cardiologia in Sao Paulo, Brazil, and principal investigator of the MeRes-1 Extend study. “The first-generation BRS device wasn't so successful because these devices were bulky and the absorption time was perhaps a little bit too long—close to four years,” he said in an interview with MD+DI.

“I think MeRes is a good example of a second-generation device because it is thinner,” he continued. “Because it is thinner, you're going to have a less thrombogenic device.”

The device features radiopaque markers at its edges to make it more visible and therefor easier for the operator to deploy, Abizaid said. In addition, “MeRes 100 has a hybrid cell design, which is a closed cell at the edges and open cells in the middle. Because of the design, when we deploy the stent and inflate the balloon, there will be less injury at the edges of the stent,” he explained.

He said that the MeRes 100 is designed to resorb naturally within two to three years, compared with the almost four years required by first-generation devices.

The two recent clinical studies that have borne out the safety and efficacy of the MeRes 100 are the MeRes-1, the first in-human study with the device, and MeRes-1 Extend. MeRes-1 used multimodality imaging and concluded that at three years, the cumulative MACE endpoint, which includes cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization, is 1.87%. This is better than data reported from first-generation BRS in-human trials with double-digit MACE rates.

MeRes-1 Extend is a global study that enrolled patients from Brazil, Europe, and Asia, and its results were consistent with the MeRes-1, with a MACE endpoint of 1.61% at two years.

“The most attractive indication for MeRes 100 is for younger patients with severe coronary disease,” said Abizaid. He explained that these patients are more likely to have catheterization lab procedures several times in their lives, and that if they have multiple metallic stents that do not resorb, it makes it difficult to find space to place new ones. Resorbable devices will eliminate that difficulty.

The company is currently designing a clinical study to prepare for FDA approval in the United States, which could take at least a year to complete. MeRes has received the CE mark and is commercially available in the EU.

Coca-Cola, PepsiCo exit plastics industry association to boost green cred

Coca-Cola, PepsiCo exit plastics industry association to boost green cred

Proving that your company is “green” no longer involves science. All you have to do is cave to plastic-haters such as Greenpeace, As You Sow and like-minded organizations that advocate ridding the world of single-use plastics and, suddenly, you’ve got green cred. That seems to be the objective of PepsiCo and Coca-Cola, which, under pressure from Greenpeace, are leaving the Plastics Industry Association (PLASTICS; Washington, DC) “as they seek to dramatically reduce single-use plastics in their products and packaging,” according to articles in several news publications based on a Dow Jones Newswire report.

businessman exiting

PepsiCo, in an effort to distance itself from PLASTICS until its membership is up at the end of this year, told Newsweek that “it does not ‘participate in the policy advocacy work of the association or its subsidiaries.’”

A spokeswoman for Coca-Cola commented, “We withdrew earlier this year as a result of positions the organization was taking that were not fully consistent with our commitments and goals.”

Dow Jones Newswire reported that the Plastics Industry Association “came under fire from environmentalists for lobbying to prevent plastic bag bans in the United States." The American Progressive Bag Alliance, which advocates against these bans, argues that conventional plastics have the least environmental impact compared with other bags, requiring 70% less energy and 96% less water to make than paper bags.

It was interesting to note in the Dow Jones Newswire article that the decision of Coca-Cola and PepsiCo to withdraw from the association came as “consumer-goods companies are boosting their recycling efforts in the face of pressure from increasingly environmentally conscious consumers.”

Let me get this straight: Consumer-goods companies are “boosting” their recycling efforts so PepsiCo and Coca-Cola are ditching “recyclable” plastics for non-recyclable materials. Coca-Cola said it aims to reach 100% recyclable, reusable or compostable packaging by 2025 and that more than 87% of its packaging is already completely recyclable.

But, traditional plastics are recyclable! PET, which most beverage bottles are made from, is recyclable! What material will PepsiCo and Coca-Cola switch to that is more recyclable? Glass? I’ll admit that, being a child of the 1950s, one of the favorite pastimes for my two brothers and myself was collecting glass soft-drink bottles from ditches along the roadside near our home. Four glass soft-drink bottles at a nickel refund apiece would get us another soft drink and a candy bar.

Of course, some of the bottles thrown from car windows hit the road first and broke—always a big disappointment. Broken glass was always a hazard. In fact, breakage of glass food and beverage containers was always a big problem for these companies, and resulted in a lot of food waste.

I can only assume that if PepsiCo and Coca-Cola go back to the future with reusable glass bottles, their costs will increase. Heavier bottles result in higher transportation costs and increased energy use, and don’t tell me they’ll go to electric tractor-trailer trucks—it takes a lot of earth-based fuels, such as oil and natural gas, to charge up those huge vehicles. So there goes lightweighting out the window!

Glass bottles will probably get returned to the store as people collect their deposits. Those will then be put back into crates for pickup and transportation back to the filling plants, where they will be washed in very hot water. That’s more energy, not to mention the use of potable water, which is starting to be in short supply. The bottles then will be refilled and reshipped. Gee, all of that sounds so green. Who are you guys at PepsiCo and Coca-Cola trying to fool?

Oh, you say you’re going to use biodegradable plastic that is bio- or plant-based? Let’s look, again, at the environmental qualities of bio-based, aka biodegradable, plastics.

First, you cannot recycle bio-based biodegradable plastics with PET. I’ve not heard of any recycling company that will recycle specifically biodegradable plastics. Care must be taken not to comingle bio-based plastic with traditional PET, so the new biodegradable bottles will have to be specifically marked “not recyclable.” That pretty much kills the idea of consumer-goods companies “boosting” their recycling efforts. Consumers will be more confused than ever!

The only reason to go to a bio-based, biodegradable plastic material is that you—PepsiCo and Coca-Cola—approve of disposing of beverage bottles in the environment where they can do what they are designed to do—break down into tiny pieces on land and in water. The alternative—to keep them from accidentally getting into the PET recycling stream and mucking up the works—is to put all biodegradable bottles into landfills. As one biodegradable plastic material maker told me recently, the landfill is a good place for biodegradable plastics if you’re looking for a place where the material will never degrade, because sanitary landfills do not have the proper environment for the fragmentation of biodegradable plastic!

Compostable plastics were also mentioned as an alternative to traditional plastics. Without repeating another recent blog of mine, there are few, if any, commercial composting companies that will take so-called compostable plastic because it does not compost properly, leaving pieces of micro plastics in the soil. I’ve personally called dozens of commercial composting companies across the country and I get the same story: Compostable plastics are a non-starter.

Both PepsiCo and Coca-Cola can reach 100% recyclable bottles if they use traditional PET, but certainly not if they shift to biodegradable plastic. PET is in high demand. I recently wrote to the Association of Plastics Recyclers to inquire about supply of PET for rPET. I was told that “demand for rPET continues to greatly increase every year” and that “in general those companies that recycle PET and HDPE are operating at about 60% capacity and have the ability to recycle much more material.”

PepsiCo and Coca-Cola may have won accolades from Greenpeace and other plastic haters but they deny the science that has proven many times over that plastic is far greener than alternative materials such as glass and paper.

Actually, in my retirement years I’m looking forward to collecting glass bottles on the roadside. I’m sure the price of a returned glass bottle has gone up to at least 25 cents! I’m hoping to supplement my Social Security.

By the way, I don’t drink sugary or diet soft drinks anymore, and I haven’t for years, since I read that they are bad for my health.

Image: Elnur/Adobe Stock

Living Heart project beats on for five more years, as Dassault, FDA renew partnership

Living Heart project beats on for five more years, as Dassault, FDA renew partnership

The Living Heart Project kicked off in 2014 with the aim of producing the first simulated real-life heart powered by the 3DExperience platform from Dassault Systèmes (Velizy-Villacoublay, France) in a five-year partnership with FDA. The goal, as stated by Dassault, was to “target the development of testing paradigms of the insertion, placement and performance of pacemaker leads and other cardiovascular devices to treat heart disease.” The project has achieved several milestones in the first five years, and Dassault announced today a five-year extension of the collaboration with FDA.

Living Heart Project, Dassault Systemes and FDA

The 3DExperience platform will be used to develop a new digital tool to enable more efficient regulatory review of cardiovascular and medical devices, said Dassault in a press release. Researchers hope the first-of-its-kind process will increase industry innovation and pave a way forward for patients to access safe, effective new treatments for heart disease, the leading cause of death in the world.

 

Milestones in the first phase of the project include:

  • Public release of the first 3D human heart simulator in 2015;
  • simulation of blood flow in the beating living heart and extension of the 3DExperience platform to simulate medical treatments in the brain in 2016;
  • the Living Heart is uploaded to the cloud in 2017, allowing organizations of all sizes with access to leading edge digital design and testing tools;
  • the Living Heart is extended to predict the safety of drugs prone to cause arrhythmias in 2019.

The second phase of the collaboration supports FDA’s 21st Century Cures Act, using virtual patients based on computational modeling and simulation to improve the efficiency of clinical trials for new device designs. A groundbreaking project with the simulated 3D heart model will examine the use of heart simulation as a source of digital evidence for new cardiovascular device approvals. This includes an in silico clinical trial (meaning that the trial is conducted via computer simulation), aiming to reduce animal testing or the number of patients required while producing results that reliably demonstrate device safety and efficacy. The digital process also could be more efficient and less expensive than conventional clinical trials, and possibly accelerate patient access to novel treatments, according to Dassault. The FDA has publicly recognized its potential health benefits.

“Modeling and simulation can help to inform clinical trial designs, support evidence of effectiveness, identify the most relevant patients to study and assess product safety,” said Tina Morrison, PhD, Deputy Director in the Division of Applied Mechanics, Office of Science and Engineering Labs, Center for Devices and Radiological Health, FDA. “In some cases, in silico clinical trials have already been shown to produce similar results as human clinical trials.”

“Our collaboration with the FDA underscores the relevance and sustainability of digital twin experiences created with the 3DExperience platform to test devices and drugs in scientific and medical innovation,” said Claire Biot, Vice President, Life Sciences Industry, Dassault Systèmes. “Enriching technology already well established in regulated industries such as aerospace and automotive, virtual patients support the complex development of therapies for the heart, brain and more by eliminating traditional cost and time bottlenecks. With this new review process, Dassault Systèmes and the FDA can be partners in the transformative impact of the virtual world on industrial innovation, new treatments and the patient experience.”

SPC Impact 2019 and the role of bioplastics in sustainable packaging

SPC Impact 2019 and the role of bioplastics in sustainable packaging

 

Green Market ChartThe packaging industry gathered in Seattle in early April for SPC Impact 2019, an event held by the Sustainable Packaging Coalition (Charlottesville, VA) to review the latest trends and innovations in reducing the environmental impacts of packaged goods. I had the privilege of participating in a panel exploring the impact of bioplastics on the industry today and how it may evolve in the future. Here are three key takeaways that were covered during the session.

The difference between bio-based and biodegradable

As new technologies and processes are introduced to the packaging industry, it is critical that every link in the supply chain understands the definition of key terms and buzzwords that are driving the conversation. Dr. Ramani Narayan, a University Distinguished Professor at Michigan State University (Ann Arbor, MI), provided attendees with a clear distinction between two concepts that can be misunderstood when discussing bioplastics: bio-based plastics and biodegradable plastics.

The phrase “bio-based” refers specifically to the beginning of the lifecycle of a material. A bio-based plastic is created primarily from plant material.

Danimer SPC PQ1On the other hand, the phrase “biodegradable” refers to the end of the lifecycle of a material. A biodegradable plastic will organically breakdown in certain environments. It is essential that the packaging industry understand that a bio-based plastic may not necessarily be biodegradable, while a biodegradable plastic may not necessarily be bio-based.

The most effective approach to reducing the environmental impacts of the packaging industry should include a focus on both bio-based and biodegradable plastics. An emphasis on creating bio-based plastics will help reduce the carbon footprint of package manufacturing, while ensuring biodegradability will minimize a material’s environmental impact upon disposal.

Circularity in packaging

An emphasis on sustainability means looking beyond the final product and considering the actual process of creating bioplastics. Carolyn Klindt, Senior Packaging Engineer of Research & Innovation at Danone North America, elaborated on how her company accomplishes this in the creation of eco-friendly beverage packaging. In addition to using plant-based materials for its plastic bottles, the company adheres to a circular approach in creating the packaging.

A circular approach means that the materials the company produces are contained within a closed-loop system, which ultimately ensures that packaging can be safely reused, recycled or composted. This process helps ensure that products stay in the production lifecycle for as long as possible without becoming waste or pollution.

Sustainable packaging in action today

Panelists complemented the discussions around sustainable concepts withDanimer SPC PQ2 PLA real-world examples of materials and processes that are driving eco-friendly packaging. Polyactic acid (PLA) is one of the most prevalent bio-based plastic materials produced globally, and brands are using it to reduce their carbon footprint and their packaging production costs. Derek Atkinson, Senior Business Director at Total Corbion PLA (Gorinchem, The Netherlands), discussed how his company created the first PLA material made from Bonsucro-certified sugarcane. Christine Schaefer, Director of Marketing at Columbus,OH-based Plastic Suppliers, Inc., explained how PSI’s EarthFirst PLA serves as a substitution for fossil-fuel based films.

Another material available to the packaging industry today is polyhydroxyalkanoate (PHA), which is manufactured by our team at Danimer Scientific (Bainbridge, GA). Our Nodax PHA will soon be used by Nestlé to create a fully biodegradable bottle for the brand’s global bottled water business (see Nestlé taps Danimer Scientific PHA for biodegradable water bottle development, published March 2019).

Collaboration leads to success

The most important takeaway from the panel was driven home by Chris Mitchell, Vice President of the Americas at Futamura (Nagoya, Japan), when he emphasized that collaboration is critical to achieving sustainability in the packaging industry. Brand owners must work closely with material manufacturers and development partners to identify the appropriate bioplastics for specific applications, while also dedicating their operations to supporting sustainability at every step of the manufacturing cycle.

Phil Van Trump of Danimer ScientificWe, the packaging industry as a whole, must also collaborate with consumers, government agencies and community leaders to maintain effective recycling and waste management systems to reduce the impact of packaged goods at the end of their lifecycle. The state of sustainable packaging, both in terms of the materials themselves and the processes used to create them, will surely continue to evolve at a rapid pace in the year ahead. Collaboration will be critical to ensuring the industry can stay on top of the latest advancements. 

 

Phil Van Trump serves as Chief Technology Officer at Danimer Scientific (Bainbridge, GA),  which is dedicated to environmentally responsible manufacturing through biopolymer innovations.

Artemis – Apollo’s Twin Sister – Aims for the Moon

The Greek god Apollo had many siblings, but only one twin, his sister Artemis. Quite a fitting, Artemis is the name given to the NASA mission that will take up the work of the 1960’s Apollo program. Even more fitting, in Greek mythology, Artemis rules the Moon.

The Artemis mission is planned in eight stages beginning in 2021. By 2024 the mission will take men and women to the Moon. The later stages will create a place where humans live a lunar life, even if just on the Gateway vehicle that will become a Moon-orbiting studio apartment.

News about the details of the mission are coming out nearly every day. Just this Monday, NASA revealed its conception of the Artemis Moon Lander. In the statement that included an artist rendering of the ascent vehicle, NASA noted it is seeking comments from American companies interested in providing an integrated human landing system to put the first woman and next man on the Moon by 2024.

NASA, Artemis, Moon program, Apollo Program, Gateway

Artist's rendering of an ascent vehicle separating from a descent vehicle and departing the lunar surface. (Image source: NASA)

Seeking Private Sector Input

NASA anticipates a three-stage human landing system. The agency is interested in alternative approaches that can meet the same long-term goals of global lunar access and a reusable landing system. The three-stage concept includes the lunar Gateway to hover in low-lunar orbit to carry the crew to the surface, and an ascent element to return them to the Gateway. From there, they would board Orion for the trip back to Earth.

In a statement NASA Administrator, Jim Bridenstine, noted that “The Gateway will be our home base in lunar orbit – it is our command and service module for missions to the surface of the Moon. Using it as a port for the human landing system, its orbit around the Moon will give us access to the entire lunar surface, and a place to refurbish and refuel the landing system. This is no small feat. Building a 21st century landing system takes the best of our government and private-sector teams.”

The Plans for Returning to the Moon

In May, NASA announced it will return to the Moon by 2024. Here’s the agency’s details about the program to land men and women on the Moon. In this video, NASA also explains the role nine private companies will have in the mission:

The Artemis Mission in Stages

Artemis 1 (2012):

During Artemis 1, Orion will venture thousands of miles beyond the moon during an approximately three-week trip. Artemis 1 is designed to test all the hardware and operations, and then splashdown in the Pacific Ocean off Baja California.

Artemis 2 (2023):

Artemis 2 will be the first mission to the Moon with astronauts on board. Although taking a different trajectory than Artemis 1, this test flight of the Space Launch System (SLS) and Orion will test Orion’s life support systems with four astronauts aboard for a 21-day mission. 

Artemis 3 (2024):

This is where men and women actually return to the Moon. It will be the first crewed lunar landing since Apollo 17 in 1972. It will be a mission lasting less than 30 days, and it will involve a short rendezvous of the Orion capsule with Gateway, the space station in lunar orbit that will have been pieced together during five launches by private space companies under contract to NASA.

Artemis 4 (late 2025):

Astronauts will continue to help build the Gateway's habitation module and descend to the lunar surface.

Artemis 5 (late 2026):

Astronauts will descend to the lunar surface for various tasks not yet determined.

Artemis 6 (late 2027):

Astronauts will install a robotic arm on Gateway and descend to the lunar surface.

Artemis 7 (early 2028) and Artemis 8 (late 2028):

Astronauts will descend to the lunar surface on one or both of these missions.

Moon Exploration

The first stop on the lunar surface will be the South Pole region, which is believed to contain water ice. It is also potentially rich in other resources, so the area is a good target for future human landing. NASA has studied this region heavily with robots. While this is far from the Apollo landing sites near the lunar equator, NASA’s Lunar Reconnaissance Orbiter has collected precise information offering details about the South Pole’s topography, temperature and locations of likely frozen water – a necessity for sustainable human exploration.

While water ice is important for sustaining human life, it has other qualities that sustain lunar exploration as well. NASA is considering refueling capabilities to make the landing system reusable, while also working on in-situ resource utilization technologies to make rocket propellants using water ice, and rock and dust from the Moon. Once the ability to harness resources becomes viable, NASA could refuel lunar lander elements with the Moon’s own resources.

Ultimately the Artemis mission may lead to Moon colonization. On a recent press visit to NASA’s Houston facility, agency managers proudly showed off lunar vehicles. They even took a handful of eager journalists on lunar vehicle rides. I felt like a kid at Christmas. When asked if a Moon visit was on the horizon, the NASA host noted, “We’re ready to go as soon as the government pulls the funding trigger.” Well, Houston, that trigger has been pulled.

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 cyber security. For 10 years, he was owner and publisher of the food magazine Chile Pepper.

Drive World with ESC Launches in Silicon Valley

This summer (August 27-29), Drive World Conference & Expo launches in Silicon Valley with North America's largest embedded systems event, Embedded Systems Conference (ESC). The inaugural three-day showcase brings together the brightest minds across the automotive electronics and embedded systems industries who are looking to shape the technology of tomorrow.
Will you be there to help engineer this shift? Register today!