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Global automotive additive manufacturing market value at $5.3 billion in 2023

Global automotive additive manufacturing market value at $5.3 billion in 2023

Industry analyst firm SmarTech Publishing has issued a new report that examines the current market for automotive additive manufacturing (AM) market including prototyping and tooling applications while focusing specifically on production of final parts. In the new report, SmarTech expects the overall automotive additive manufacturing market to reach $5.3 billion in revenues in 2023 and then grow to an impressive $12.4 billion by 2028.

Automotive industry stakeholders worldwide are now racing toward full industrialization and integration of the AM process within their end-to-end production workflow, beginning with software and materials, passing through the actual AM hardware, and ending with services and a growing number of possible applications. 3D printing is thus well positioned to expand its use as the primary technology for automotive prototyping as well as tooling, while also establishing a stronger than ever opportunity for serial and mass customized part production.

The company’s third dedicated study of automotive AM expands coverage to consider the greater long term potential for additive manufacturing as a key production technology for the massive global automotive industry, paving the way to widespread adoption of both metal and polymer AM technologies. This comprehensive report includes:

  • Ten-year 3D printing opportunity and market data forecasts in volume and value terms for automotive additive manufacturing. These cover hardware, materials, software, services and overall printed parts value.
  • Expanded market data to include key metrics at a country level, better capturing the regional attitudes towards introducing AM in the production workflow for prototyping, tooling and final parts.
  • Complete lists and descriptions of key AM hardware and AM materials (both polymer and metal alloys) used in automotive AM, including upcoming production-ready technologies.
  • Complete analysis of software used in the end-to-end automotive production cycle, in light of recent advanced in generative design software and PLM software solutions.
  • The latest trailing twenty-four months activity and competitive analysis to reflect the rapidly evolving landscape in which major automakers, automotive tier 1 and tier 2 suppliers and “application agnostic” 3D printing service are finding new cost-effective solutions through AM adoption.
  • Complete and detailed analysis and forecast of the potential for final parts production through AM

 

Supplier Stories for the Week of June 17

This is a compilation of the latest news from suppliers in the medical device industry.If you have news you’d like to submit for potential inclusion in this weekly roundup, please send a press release and any related images to daphne.allen@ubm.com with the subject line “Supplier Stories.”[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

Senseonics Wins Nod for Implantable Long-Term CGM

Courtesy of Senseonics Senseonics Wins Nod for Implantable Long-Term CGM

Senseonics Holdings said it has received a PMA for the Eversense Continous Glucose Monitoring (CGM) system. The Germantown, Md-based company said the system is the first and only CGM to feature an implantable glucose sensor and provide long-term continuous monitoring for up to three months.

“We’re very pleased to receive this FDA approval that allows us to make Eversense available in the U.S., as it is in many European markets,” Tim Goodnow President and CEO of Senseonics said in a release. “With the parallel trends of wearable personal devices and medical implantables for people to manage their health, this product exemplifies the natural evolution for diabetes devices, and Senseonics is excited to help lead the way. More importantly, we believe the unique features Eversense offers will help open up CGM to millions of people with diabetes who, up to this point, have been hesitant to try CGM despite the clear health benefits it provides.”

The Eversense System addresses many of the barriers to CGM use. The system consists of a fluorescence-based sensor, a smart transmitter worn over the sensor to facilitate data communication, and a mobile app for displaying glucose values, trends and alerts. The sensor, which is inserted subcutaneously in the upper arm by a physician via a brief in-office procedure, lasts up to three months, thereby eliminating the need for patients to self-administer the weekly or biweekly sensor insertions required by traditional CGM systems.

The Eversense CGM System’s PMA application was based on the previously-reported results of the PRECISE II U.S. pivotal trial in which Eversense was studied in 90 adults with type 1 or type 2 diabetes at eight clinical centers in the United States. The study clearly demonstrated the system’s safety and effectiveness over 90 days of continuous glucose sensor wear.

In March, FDA’s Clinical Chemistry and Clinical Toxicology Devices Panel of independent medical experts voted unanimously, 8 to 0, that the system not only was safe and effective, but also that its benefits outweighed the risks.

Senseonics has been on the go lately. Earlier this month, the firm began a collaborating with Beta Bionics. The partnership calls for Boston, MA-based Beta Bionics to integrate Senseonics’ Eversense CGM with the iLet Bionic Pancreas System.

The approval could impact Dexcom, which has taken several hits lately in the CGM market. The San Diego-based received a tremendous blow when when Abbott Laboratories received FDA approval for its FreeStyle Libre Flash, a glucose monitoring system that can be used as replacement for blood monitoring.

Zimmer Biomet Cancels BoneSupport Orders

Pixabay Zimmer Biomet Cancels BoneSupport Orders

Swedish orthobiologics company BoneSupport has decided to cut out the middleman and set up its own U.S. distribution network to sell its Cerament bone void filler in the United States.

The Lund, Sweden-based company currently has an exclusive distribution agreement with Zimmer Biomet that is supposed to be in place until Oct. 20, but now that BoneSupport has decided to take control of its commercial platform in the United States, Zimmer Biomet has canceled the major of its orders for a three-month period starting in June.

BoneSupport CEO Emil Billbäck said the company's evaluation of potential distribution partners is "progressing to plan" and that the company expects to have a strong coverage in the U.S. market in place in late October that will position BoneSupport to create a more direct and stronger relationship with its U.S. customer base.

"This enhanced commercial platform will allow us to successfully market our highly differentiated products, particularly Cerament G, which we aim to launch in the U.S. market in 2021," Billbäck said.

Zimmer Biomet retains the right to sell and distribute Cerament bone void filler on an exclusive basis until Oct. 20, and on a non-exclusive basis until April 20, 2019, BoneSupport noted.

For Zimmer Biomet, the news comes as the company is in the throes of a reboot under new CEO Bryan Hanson, who joined the company last December.

JenaValve Keeps Steady Pace in the TAVR Market

3Dman_eu/Pixabay JenaValve Keeps Steady Pace in the TAVR Market

JenaValve Technology is making steady progress in the development of its next-generation transcatheter aortic valve replacement (TAVR) system. The Irvine, CA-based company said it has implanted the initial patients in a CE mark study for the treatment of severe aortic regurgitation (AR).

The CE mark study is an international, prospective, non-randomized, single-arm trial of the JenaValve Pericardial TAVR System for the treatment of AR in patients who are at increased risk for conventional surgical valve replacement.

“Our goal is to enable the treatment of patients with severe aortic regurgitation while avoiding many of the side-effects with off-label use of other TAVR devices in this patient population,” said Victoria Carr-Brendel, PhD, CEO of JenaValve, in a release. “We are excited to initiate this trial and look forward to expanding enrollment across multiple sites, building on this positive initial experience with our partners at the Heart Center of the University of Cologne.”

The JenaValve system is proprietary and differentiated from currently available TAVR devices due to the Everdur locator-based technology, designed for more predictable implantation using the new 18-Fr equivalent Coronatix Transfemoral Delivery Catheter. The optimized TAVR system has now been used to treat several AR patients in Germany.

JenaValve said it could have CE mark approval for treating patients with severe aortic regurgitation by the second half of 2019. The company completed patient enrollment in a CE Mark study of the JenaValve Pericardial TAVR System for the percutaneous treatment of severe aortic stenosis and expects approval before the end of 2018.

Positive and consistent moves will help JenaValve flourish in the TAVR market, which is already heavily dominated by Edwards Lifesciences and Medtronic in the U.S. Both of the companies popped up several times when MD+DI published six heart-pumping changes in the TAVR market.

Irvine, CA-based Edwards is the noted pioneer of TAVR having received FDA approval for the Sapien Valve in 2011. Dublin-based Medtronic gained approval for its CoreValve system in 2015. Medtronic gained access to the technology when it acquired CoreValve for more than $700 million in 2009.

MedAware Uses AI to Tackle Medical Errors and Opioid Epidemic

Courtesy of MedAware MedAware Uses AI to Tackle Medical Errors and Opioid Epidemic

Artificial intelligence has been used in a wide variety of devices and services in healthcare. MedAware is using AI and machine learning to help tackle medication errors and abuse of opioids. The Raanana, Israel-based company will collaborate with Allscripts Healthcare Solutions to tackle the problem.

“A systematic problem calls for a systemic solution,” Gidi Stein, MedAware’s co-founder and CEO, told MD+DI. “We came in trying to tackle this problem using machine learning and AI on large scale electronic medical records.”

Under this collaboration, Allscripts will implement MedAware’s machine learning-enabled decision support and patient safety solutions to the dbMotion, a healthcare information exchange platform, to provide better patient care.

In order to provide actionable insights at the point of care and after the script was already filled, MedAware monitors patients’ clinical records to detect medication-related risks, evolving adverse drug events (ADEs), and to identify patient-specific risk of opioid dependency. As a result, in live clinical settings, providers mostly choose to revise their prescriptions when they are notified of such risks from MedAware.

MedAware said this level of success is achieved by using its medication monitoring technology that leverages machine-learning algorithms and outlier detection mechanisms to identify adverse drug events and flag potentially life-threatening prescriptions that are in conflict with the profile of the patient, physician, or institution.

The company was formed in 2012 and raised about $8 million in a series A round.

“We’re now in the midst of our series B [round], and the goal of this round is to accelerate the sales and marketing in the U.S.,” Stein said. “Since the founding of the company and development of the core technology and proof of concept in leading institutions … we’re able to pursue the U.S. market.”

MedAware’s business model would not have been quite as effective 10 years ago, Stein said.

“Today, there are several factors to make such a business grow, as opposed to 10 years ago,” he said. “Ten years ago, patient medical record usage was about 10% to 20% in healthcare intuitions in the U.S. … now it’s over 90%. “I think the understanding and the entrance of interoperability followed by meaningful [are key factors].”

He added, there is also more of a focus on stopping medical errors than it was a decade ago.

Wittmann Group celebrates 10th anniversary of integration of Battenfeld Kunststofftechnik GmbH

Wittmann Group celebrates 10th anniversary of integration of Battenfeld Kunststofftechnik GmbH

The Wittmann Group celebrated the 10th anniversary of the integration of Battenfeld Kunststofftechnik GmbH earlier this month in the company of more than 1400 guests at its Kottingbrunn, Austria, facility.

In addition to seeing first-hand the culmination of various plant expansions over the years, visitors received an update on Wittmann 4.0 initiatives, watched demos on more than a dozen machines from the PowerSeries and previewed the new vertical VPower system, which received its first public showing. It wouldn’t be a proper celebration without a dinner party, which was held at the METAStadt (Meta City) in Vienna. In addition to the culinary offerings, Wittmann Battenfeld provided guests with some food for thought, as it served up milestones from the company’s history.

Wittmann Battenfeld VPower
More than 1400 guests attending the 10th anniversary celebration of the integration of Battenfeld Kunststofftechnik GmbH into the Wittmann Group were among the first in the world to see the company's new vertical VPower system.

The two-day event started on June 13, a highlight of which was a keynote speech from Prof. Dr.-Ing. Johannes Schilp of Augsburg University, who spoke about the real-world implementation of cyber-physical production systems.

During guided afternoon tours, visitors were introduced to a new processing line for the larger machines of the SmartPower and EcoPower series. Several expert hubs were set up, where guests could gain insights on process technology, integration and plasticizing systems.

“These last 10 years were successful years for our company. We are glad that so many of our customers and partners were here to celebrate with us,” said Georg Tinschert, Managing Director of Wittmann Battenfeld.

Bridging the Healthcare Interoperability Gap

MD+DI/Amanda Pedersen Bridging the Healthcare Interoperability Gap

Interoperability has been a major challenge in healthcare since the early days of electronic medical records. A 2015 survey of nurses found that the lack of interoperability between medical devices and electronic health records is not only burdensome for them but can lead to dangerous medical errors.

Some healthcare organizations have attempted to integrate their systems to streamline data, but doing so has been a slow, expensive process that is also difficult to maintain. Now, a startup company founded just last year, has developed an integration platform as a service intended to ease some of that pain for healthcare organizations.

Palm Beach Gardens, FL-based Bridge Connector recently raised $4.5 million in seed funding from Tampa, FL-based Axioma Ventures. Bridge Connector allows healthcare organizations to connect disparate systems like electronic medical record systems, billing systems, lab systems, etc.

"We've come up with a system that can really help them automate their data flows," CEO David Wenger told MD+DI

Bridge Connector acts as a secure pipeline between end-points, moving medical data between systems directly, without needing to store sensitive electronic healthcare information in another database. Data is transferred through a local session using AES 256-bit encryption, and all data is cleared once the transfer is complete, the company noted.

The seed funding is backed by Howard Jenkins, former CEO of Publix Super Markets, who joined Bridge Connector earlier this year as chief strategy officer. Wenger said he feels fortunate to work with Jenkins on a daily basis and learning from his leadership expertise.

"He's really mentored me on how to build a company as fast as we're trying to build a company," Wenger said.

In January the company had six employees, today it has 25, and Wenger said he expects the company to grow rapidly and have roughly 45 employees by the end of the year. That growth is what the seed funds will support, he said, but it has been driven largely by the demand for the product.

“Bridge Connector offers an inexpensive solution to an expensive problem, enabling healthcare organizations to streamline their data flows so they can focus on the treatment of their patients, rather than their data management," Wenger said.

He explained that one of the advantages of using a subscription-based model is that when Bridge Connector gets a new client that needs to integrate a system the company has already worked with, "we're 85% of the way there." At that point, he said, it's just a matter of customization and field mapping, and the company can deploy the integration for that customer very quickly.

Bridge Connector is targeting a multi-billion market opportunity that shows no signs of slowing down.

"There are so many devices and apps and different types of technology that really smart people are creating, but at the end of the day there's still no way to connect it to the other systems that exist already ... so to enable true interoperability in healthcare there needs to be companies like Bridge Connector that can connect any two systems or any three systems or any five systems, regardless of what they're built on," Wenger said.

Solvay’s polyarylamide resin stands up to stiff challenges in single-use bone-fixation device 

Solvay’s polyarylamide resin stands up to stiff challenges in single-use bone-fixation device 

In developing a more robust, single-use bone-fixation system than currently available devices, medtech startup Reign Medical (Tulsa, OK) went on the hunt for a biocompatible material with exceptional stiffness properties. A polyarylamide (PARA) resin from Solvay (Alpharetta, GA) stood out and is used to mold several components of the medical device soon to be on the market.

Reign Medical's Clench compression staple system

The Clench compression staple system comprises a disposable sterile surgical tool set for fixating hand and foot bone fragments and performing related procedures. A patented threaded hub allows surgeons to incrementally expand the implant for proper insertion while retaining the mechanical properties of the nitinol staples for continuous compression across the fusion site after implantation. Reign Medical specified Solvay’s Ixef GS-1022 PARA, a 50% glass-fiber-reinforced grade, for the device’s implant sizer, drill guide and each part of the implant delivery instrument, including its handle, the saddle on which the staple sits and the threaded compressor that forces the staples fully open, said Solvay in a press release.

A high-stiffness material was required for this application because of the mechanical strain that the components experience. Offering metal-like strength, rigidity and dimensional stability, the biocompatible Ixef PARA polymer also provides an exceptional surface finish, according to Solvay. Available in a range of gamma-stabilized colors, Ixef PARA is optimized for sterilization using high-energy gamma radiation, showing no significant change in appearance or performance after sterilization. The material has been evaluated for ISO 10993 limited-duration biocompatibility and is supported by an FDA Master Access File.

“Our impetus for this kit was to develop a more robust, single-use bone fixation system than is currently available,” said Daniel Lanois, Development Engineer for Reign Medical’s Clench system. “Many competitive solutions use lower performing plastics that do not reliably withstand the force required to hold nitinol staples open, causing the staples to disengage prematurely. After briefly considering polycarbonate and ABS blends, we chose Ixef PARA primarily for its outstanding stiffness, which enabled even the smaller components of the delivery tool to reliably withstand the compression of the staples, as well as the torsional, tamping and axial loads applied during fixation procedures.”

“Solvay’s practice of open innovation promotes the success of customers like Reign Medical by enabling them to focus on their medical device design while we help navigate issues related to materials science and molding challenges,” said Jeff Hrivnak, Business Manager for Healthcare at Solvay’s Specialty Polymers Global Business Unit. “Solvay also conducted a crystallinity study of molded prototypes of Clench system components to validate the tool and ensure that parts were molded properly.”

Reign Medical’s Clench staple system received FDA clearance in April of this year. The company is now conducting beta testing in advance of its first production launch.

Pilot study takes on curbside recycling of flexible plastics packaging

Pilot study takes on curbside recycling of flexible plastics packaging

MRFF Curbside recycling FPPMaterials Recovery for the Future (MRFF), an industry collaborative a research program of brand owners, retailers, plastic providers and associations whose members include Procter & Gamble, Target Stores and more, announced on June 20 a new partnership with solid waste and recycling services provider J.P. Mascaro & Sons Inc. (Audubon, PA). The agreement is a pilot for single-stream curbside recycling of flexible plastic packaging (FPP) at its TotalRecycle materials recovery facility (MRF) in Berks County, PA. This will be the first pilot to demonstrate the technical and economic feasibility of recycling household FPP from municipal residential single-stream recycling programs.

“Our MRFF collaborative is excited to partner with J.P. Mascaro and demonstrate the recyclability of flexible plastic packaging,” said Steve Sikra (right in above photo, along with Michael Timpane of RRS at left and Larry Baner of Nestlé Purina), MRFF chairperson and associate director of global research and development for Procter & Gamble (Cincinnati). “We are all committed to the success of this program and look forward to adding recycled flexible packaging into the circular economy. As a side benefit, we expect to see the quality of J.P.’s other recycling streams improve as the flexible plastics are processed.” ACC-Curbside-FPP-Steve Sikra quote graphic

FPP, which includes films, wraps, bags and pouches, is not widely recycled today. However, as these lightweight materials that also provide enhanced product performance and protection become a larger part of the packaging waste stream, the need for scalable recycling collection strategies is critical to their sustainability. The pilot is expected to generate data to help inform municipalities and the recycling industry on the most efficient and economical ways to recycle FPP. This will turn used FPP materials, typically destined for disposal, into a bale that can be sold to a variety of end markets.

According to Resource Recycling Systems (RRS), a recycling system consultancy which conducts the MRFF research program, 12 billion pounds of the material is introduced into the market for consumer use yearly, and it is the fastest-growing form of packaging. RRS estimates TotalRecycle will produce 3,100 tons/year of high-quality post-consumer FPP feedstock for various end market uses that are being tested.

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Mascaro director of sustainability and TotalRecycle general manager, Joseph P. Mascaro, said, “Our company is thrilled to partner with the MRFF partners on this project. MRFF Curbside recycling FPP PQ1We are confident that the pilot will be successful and will generate industry data to show FPP generators, municipalities and the recycling industry that FPP can be efficiently and economically recycled and marketed instead of being landfilled.”

Van Dyk Recycling Solutions (Stamford, CT) will add sophisticated sorting equipment to Mascaro’s TotalRecycle facility that will target FPP out of the single stream flow. The FPP will be identified and separated by advanced optical sorters, resulting in a new generation bale of FPP.

The pilot program will begin in late 2018 with the installation of the sorting equipment. After an internal testing period, TotalRecycle will begin accepting FPP for recycling from the municipal residents it serves. From equipment order to acceptance of FPP in curbside carts, the pilot program is expected to last two years time.

A PDF of comprehensive FAQs about the project can be found here.

MRFF members include The Procter & Gamble Company, Target, The Dow Chemical Company, PepsiCo, Nestlé USA, Nestlé Purina PetCare, Amcor, and the American Chemistry Council. Other members include the Flexible Packaging Association, LyondellBasell Industries, The Plastics Industry Association, Sealed Air, SC Johnson, the Canadian Plastics Industry Association, and the Association of Plastic Recyclers. The research program announced Chevron Phillips Chemical Company as a new member.