MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.


Articles from 2019 In June

Osborne Industries named top supplier by Altec

Osborne Industries named top supplier by Altec

It is always gratifying when a customer recognizes the hard work of its suppliers. Custom plastics molding firm Osborne Industries Inc. (Osborne, KS) recently was presented with the Quality, Cost, Delivery and Sustainability (QCDS) award from Altec (Birmingham, AL), a provider of products and services to the electric utility, telecommunications and other markets in more than 100 countries.

Osborne Industries, founded in 1973 and a 100% employee-owned (ESOP) company since 2007, has been a long-time supplier of fiberglass-reinforced composite aerial platforms and other components for Altec’s utility vehicles. Osborne’s long history with closed-molding via resin transfer molding (RTM) technology has allowed the company to remain one of Altec’s top-producing suppliers since the two firms first collaborated in the mid-1980s.

The QCDS award is presented to only a select number of Altec suppliers. Osborne’s overall on-time delivery of 99.7% and exceptional quality score earned the company this year’s award for its resin transfer molded composite components. Altec’s sustainability score is based on an assessment of characteristics, some of which include management and financial stability, supplier longevity and a supplier’s cultural fit with the organization.

“Osborne’s commitment to the success of Altec is evident in our excellent on-time delivery and very low number of quality issues,” stated George Eakin, President and CEO at Osborne. “Even with the increased volume of RTM-molded platforms, we continue to exceed Altec’s supplier performance.” Eakin and Manufacturing Supervisor Doran Schurr accepted the QCDS Award on behalf of Osborne’s employee owners.

QCDS award for Osborne Industries
Doran Schurr, Manufacturing Supervisor, Osborne (center) is shown holding the award. Joining him on the podium left to right are Jon Styslinger, President of Altec; George Eakin, President and CEO, Osborne; Jason Oakley, Fiberglass Commodity Manager, Altec; and Joe Gonenc, Head of Supply Management Altec. 

Osborne Industries is a composites manufacturing firm specializing in resin transfer molding and reaction injection molding for a variety of original equipment manufacturers around the United States. Osborne’s expertise in the use of a diverse group of thermosetting materials allows for the molding of complex plastic parts for industries such as agriculture, medical, corrosion and waste control, transportation and more.

New phthalate-free plasticizer gives flexible PVC an environmental edge

New phthalate-free plasticizer gives flexible PVC an environmental edge

flexible plastic tubingPVC has long battled detractors in spite of its amazing properties that make it popular in building and construction, automotive, plumbing, medical and wire and cable applications, among others. The fact that the material has suffered over the years from its poor image of not being “green” in this era of sustainability, due in large part to misinformation surrounding plasticizers, hasn’t helped.

Perstorp (Malmo, Sweden), a global leader in pro-environment polyols, announced the launch of a new renewable polyol ester (non-phthalate) plasticizer, Pevalen Pro. According to the company, Pevalen Pro will make flexible PVC an even more attractive choice of plastic because of its significantly lower carbon footprint versus competing materials and technologies. Pevalen Pro not only gives PVC an environmental boost as a truly renewable non-phthalate plasticizer but also provides superior performance properties, said the company.

“Brand owners and consumers are searching for new plastics and materials with a sustainable profile and low carbon footprint,” said Jenny Klevas, Perstorp Global Marketing and Product Manager for the polyol ester plasticizer platform. “We believe that flexible PVC with Pevalen Pro is the perfect combination, as it offers precisely what they are looking for—a high-performance product with a significantly better environmental footprint.”

Pevalen, a true non-phthalate plasticizer, was launched by Perstorp in 2014 as a premium performance alternative to phthalates, especially in sensitive and close-to-people applications where health concerns were, and are, in focus. Pevalen provided PVC converters with a cost-effective, low environmental impact solution due to its plasticizing efficiency (less material required), faster processing time (less energy), low volatility, high UV stability (prevents premature aging) and “unbeatable softness for long-life performance,” said Perstorp.

According to Perstorp, PVC is already a “very sustainable material” with one of the “smallest shares of carbon atoms” and is lightweight, flexible and durable. It also promotes sustainability through its properties by giving products longer and often maintenance-free lifetime use. While many claim that PVC is not recyclable, Perstorp notes that PVC actually is a recyclable material “if made the right way," which the proactive Vinyl Plus initiative in Europe, to which Perstorp belongs, is focusing on. “This PVC industry-funded commitment to sustainable development aims to increase the recycling capacity of PVC and improve the overall sustainability performance,” said Perstorp’s information.

The launch of Pevalen Pro this year represents a timely and significant contribution to lowering the carbon footprint of PVC, underlining its importance as a sustainable plastic, said Perstorp.

Currently, Pevalen has a clear cradle-to-grave sustainability advantage over leading plasticizer competitors such as DINP, DOTP and CINCH, based on GWP (Global Warming Potential), according to Perstorp. Plasticizers make up a significant part of PVC (up to 40% in some applications), so the availability of Pevalen Pro can help producers to lower their carbon footprint. Using the new Pevalen Pro will increase that pro-environmental advantage, and will be initially available with up to 40% renewable content, with the long-term potential of becoming fully renewable, said Perstorp.

Pevalen Pro is a direct replacement for Pevalen with no compromise on quality or performance. The renewable grades are made under the Mass Balance concept and are backed by third-party ISCC certification, which guarantees that the bio-based input is sustainably sourced.

Image: aquatarkus/Adobe Stock

Reusable Vent Enables Development of New Case for Autoclaving Surgical Instruments

Reusable Vent Enables Development of New Case for Autoclaving Surgical Instruments
Images courtesy of Porex

A medical technology company sought to develop a new container for surgical instruments that could be used in autoclave sterilization. Guangdong Xianfeng Medical Technology Co. Ltd had previously been offering containers that utilized single-use paper and textile filters for steam penetration during sterilization and to maintain sterility post sterilization. Because of some material limitations, the Chinese manufacturer reached out to Porex for help with developing a robust, reusable bacterial barrier as a cost-saving alternative, explained Jack Chan, Ph.D, global marketing director for Porex.

Guangdong Xianfeng Medical was also driven by new legislation and regulations emerging in China intended to improve patient outcomes and healthcare worker safety. “As a result, there is a tremendous need to deliver high-quality innovations for decontamination and sterilization for the medical device industry,” Chan told MD+DI. “Lifesaving and health betterment procedures often leave patients vulnerable to healthcare-associated infections (HAIs), especially when the instruments used in these procedures lack proper sterilization. In fact, about one in 31 hospital patients acquires a HAI on any given day as a result of poor cleaning or disinfecting practices around a surgical procedure at a healthcare facility.”

Porex suggested use of the Porex Virtek PTFE venting and filtering solution made from the company’s proprietary medical-grade sintered PTFE hydrophobic membrane. The filter consists of particles fused together through heat and pressure and does not require supporting layers (or a scrim), unlike expanded PTFE film. It allows high airflow for optimal venting during the autoclave sterilization process and features high bacterial filtration efficiency to maintain sterile integrity during transport and storage, the company explained in a statement.

“Generally, PTFE is a high-performance material with high temperature resistance and chemical resistance,” explained Chan. “The Porex sintered PTFE manufacturing process of Virtek results in an intricate network of open-celled, omni-directional pores, that is strong and durable. This offers a different level of performance, as the manufacturing process of the material begins as fine particles with a tight size distribution. The material then undergoes a forming and sintering process to create a bulk microporous structure. The process fuses the fine particles together while creating voids. The resulting porous structure is then skivedto a precisely controlled thickness. Ultimately, a durable, design-flexible 3D material that does not require a supporting layer (scrim) and has long-term value is created.”

Chan said that the Porex sterilization vent introduced a new concept to the market, which became known as a permanent, or “fit and forget,” filter. “The flexibility of Porex’s manufacturing processes provided a cost-saving alternative to traditional materials, along with substantial performance and convenience advantages,” said Chan.

Porex’s Virtek PTFE venting and filtering solution remains in place during sterilization. “The sterile container [shown below] is fitted with a robust, reusable sterilization filter that is engineered to improve the autoclave sterilization process and helps reduce the risk of infection to patients and healthcare workers alike,” said Chan. “The Porex Virtek PTFE venting and filtering solution vents the steam that sterilizes the instruments as well as blocks bacteria during subsequent storage until use in surgery.”

The PTFE typical thickness is 0.65 mm-1.00 mm, but it can be thinner, Chan said. “Its pore structure has minimal shrinkage at elevated temperatures and is safe to handle without risk of damage,” he said.

Chan added that the vent can be used for up to thousands of autoclave sterilization cycles without any performance degradation. “The filter has a printable surface, so the user can record the date it was sterilized and keep track of the number of sterilization cycles,” Chan said. “The robust 3D sintered pore structure enables the filter to be reused and improves cost, performance, and production efficiencies. It eliminates the need for single-use paper and textile filters, which are wasteful and ineffective vents for sterile containers.”

3 Critical Considerations for Evaluating Off-the-Shelf Software for Medical Devices

Pixabay 3 Critical Considerations for Evaluating Off-the-Shelf Software for Medical Devices
When evaluating software vendors, medical device manufacturers must mitigate three critical risk factors: clinical risk, human factor risk, and cybersecurity risk.

The rapid pace of technology innovation has led to the medical device sector becoming an integral part of the healthcare industry, delivering benefits such as reduced patient recovery time and lower cost of instruments. Unfortunately, the average time-to-market for a medical device still falls between 3-7 years.

In order to speed time-to-market, medical device manufacturers form strategic partnerships to leverage commercially available, off-the shelf components and software from vendors, and manufacturers augment their development teams with third-party professional services. When evaluating software vendors, medical device manufacturers must mitigate three critical risk factors: clinical risk, human factor risk, and cybersecurity risk. As a result, manufacturers would be wise to understand the impact of these three risk factors, and the considerations they should make when choosing the right software partners to get to market faster and safer. 

Clinical Risk

Clinical risk is a risk that the device does not work as intended by the manufacturer. The stakes are as high as can be here, because if a device does not work as intended, patients will be at risk of serious (or even deadly) harm. For example, consider an infusion pump that is set to deliver a pain medication, such as dopamine, at a certain dose rate. If the pump malfunctions by delivering the drug at a higher rate than programmed, the patient could face significant harm – or even death.

To address this risk, medical device manufacturers implement development processes under ISO 13485, safety standards such as EN 60601-01, and institute software life cycle processes under IEC 62304. Pre-developed software that is generally available, but not specifically developed to be incorporated into a medical device, is defined as SOUP (Software of Unknown Provenance) under IEC 62304. This type of software is not required to be certified to IEC 62304; however, the medical device manufacturers must de-risk SOUP per the IEC 62304 requirement as follows:

  • The software toolkit provides the functionality and performance that is depended upon
  • The device provides the support necessary to operate the software toolkit within its specification
  • The software toolkit performs as required for the medical device manufacturer’s system

In light of the SOUP requirement, medical device manufacturers should choose partners that support their IEC 62304 process, as well as other compliance needs such as quality and standards audits – and their global regulatory strategy and process. Support of these standards and processes means transparency into testing, verification, validation, quality system, and bug reporting processes – among other development process logistics which ensure that the off-the-shelf technology, and the company developing it, is low-risk.

Human Factor Risk

Human factor risk is a risk that the device is not used properly by patients/providers. In addition to harming a patient, if a device is not used correctly it might deliver false or inaccurate information, impacting long-term patient treatment and care. Returning to the infusion pump example: the device can work exactly as it’s intended, but if the user interface is not intuitive – and the user experience overall is adverse – the risk of an operator (such as a nurse, doctor, or technician) misusing the pump is critically high.

To address this risk, medical device manufacturers should offer user interfaces that are as comprehensive, easy-to-use, and intuitive as possible. Manufacturers should aim to deliver user interfaces and experiences that are on par with modern smartphones, which have set the standard for immersive user interfaces and stellar user experience across numerous industries.

However, this innovation has to be carefully delivered in order to not lose sight of the pre-smartphone generation of patients and providers. For example, the largest part of our population – baby boomers – are reaching the age where they require more from the healthcare system in the form of preventative and clinical care. Since care is not only delivered in hospitals but also through independent care centers and care in the home, medical device developers must be mindful of the older population that might not be comfortable with the most modern of technology.

Why should medical device manufacturers implement third-party software that is easy-to-use, easy to develop upon, and allows for easy and efficient iterative prototyping? Because the end-goal of the manufacturers’ Human Factors Testing should not be simply “passing the tests”; rather, it should be converging to the best possible and most adoptable device design. Being able to build prototypes quickly and easily – and iterate on these prototypes just as rapidly – helps manufacturers reach this goal. Furthermore, the prototypes are never wasted, as each successive prototype iteration influences the final device design – and since the prototype iterations are informed by the users through the Human Factors Testing, this also lowers the human factor risk.  Choosing development tools and environments which facilitate the ability to prototype rapidly and implement changes quickly and efficiently allows developers to achieve designing the best possible and most adaptable device design.

Cybersecurity Risk

Cybersecurity risk is a risk that the device can be hacked, which not only potentially compromises the patient’s safety, but also can result in sensitive patient data being stolen – which is a huge issue in itself. Once again, going back to the infusion pump example, if the infusion pump is hacked, the worst-case scenario is that the dose rate of the drug being infused can be changed to a dangerously high level, and the patient can be harmed or killed. Furthermore, the theft of patient data infringes on patient privacy rights.

To address this risk, medical device manufacturers must implement updated cybersecurity practices at device inception to eliminate security hazards throughout all stages of the creation process. Cybersecurity regulations and guidance specific to medical devices are continuing to evolve across the globe, especially in the United States and the European Union. As a result, medical device manufacturers should participate in the various medical cybersecurity working groups to stay apprised of the latest advances in the development of these medical-specific cybersecurity standards and guidance.

In addition, medical device manufacturers should select partners who develop third-party, off-the-shelf software solutions that comply with the most current cybersecurity guidance and also participate in industry cybersecurity working groups – which effectively places the manufacturers ahead of the guidance as they continue to evolve.

As an aside, device manufacturers will need to consider how insurance reimbursement folds into their development strategy and timeline, and that is a discussion manufacturers should have with insurance reimbursement experts and specialists. 

Let the Risks Be Your Guide

The three critical risk factors detailed above – clinical risk, human factor risk, and cybersecurity risk – should be of vital importance to device manufacturers when selecting software partners that develop commercial-off-the-shelf software used in device development. To bring safe, effective and innovative devices to market faster, medical device manufacturers must mitigate these three risk factors within their own development program. In parallel, medical device manufacturers should hold their third-party software vendors to the same standards and best practices to mitigate these risks – essentially sharing this burden within their software partners.

By collaborating with their software technology providers to mitigate these risks, device manufacturers will be well-positioned to adhere to the most current and sophisticated regulatory strategies and follow high-tech cybersecurity best practices – as well as deliver the best possible user experience. The end result? Happier and healthier patients.

Eko Employs AI to Help in Detection of Aortic Stenosis

Pixabay Eko Employs AI to Help in Detection of Aortic Stenosis

Eko, a digital health company is using artificial intelligence and machine learning to aid in the fight against heart disease. The Berkley, CA-based company recently unveiled its Aortic Stenosis (AS) detection algorithm at the American Society of Echocardiography (ASE) 2019 Scientific Sessions.

The algorithm was developed and tested in partnership with the Northwestern Medicine Bluhm Cardiovascular Institute. It is significant and stands to be more objective application than current detection methods for AS.

The disease is often initially identified during the physical exam when a provider hears a heart murmur using his or her stethoscope, though due to the subjectivity involved in using a stethoscope, combined with the difficult task of identifying subtle heart sounds like the AS murmur, it’s common for this to be missed in symptomatic patients, who are then sent home without follow-up.

Early study results showed Eko's AI was able to accurately detect AS in a cohort of Aortic Stenosis patients with a sensitivity of 97.2% and a specificity of 86.4%. The Northwestern researchers concluded that assessment using Eko’s platform is a fast and effective method to screen for significant AS and should be validated in a primary care setting.

The company said the algorithm represents a major step forward toward its mission to empower healthcare providers with tools to more accurately detect structural heart disease during primary care visits using the most readily accessible cardiac screening tool, the stethoscope.

“Eko aims to partner with providers to create the highest standard of cardiovascular care,''  Connor Landgraf, Eko’s co-founder and CEO, said in a release. “The ability to detect clinically significant AS with greater accuracy using AI-assisted cardiac screening tools can help providers ensure these patients are referred to the appropriate specialist, are monitored more closely, and receive life-extending interventions in time.”

Eko is only one of a growing number of companies in the space using algorithms and artificial intelligence to help monitor cardiovascular health.

One of the most prominent companies at the intersection of cardiology and AI is, iRhythm Technologies, which has developed the Zio Patch, a wearable technology to monitor heart rate activity for up to 14 days.

Apple became an unlikely player in the space when it announced receiving FDA clearance for an ECG app, a software-only mobile medical application that can classify whether there are signs of atrial fibrillation (AFib), and another software-only mobile medical app analyzing pulse rates for irregular rhythms. 

Finally, Mountain View, CA-based AliveCor has developed the KardiaBand, a clinical grade wearable ECG that uses an algorithm to help detect AFib.

Cybersecurity Risk Prompts Recall of Medtronic Insulin Pumps

Pixabay Cybersecurity Risk Prompts Recall of Medtronic Insulin Pumps
Cybersecurity vulnerabilities have become a big problem for several medical device manufacturers and healthcare organizations in recent years.

At least 4,000 U.S. patients who are using Medtronic MiniMed insulin pumps are vulnerable to potential hacking. The company is working with distributors to identify additional patients who may be using the pumps that are now being recalled due to potential cybersecurity risks, according to an FDA notice issued Friday.

The agency said it is concerned that, due to cybersecurity vulnerabilities identified in the device, a hacker could potentially connect wirelessly to a nearby MiniMed insulin pump and change the pump's settings. This could allow a person to over deliver insulin to the patient, leading to low blood sugar, or to stop insulin delivery, leading to high blood sugar and a buildup of acids in the blood.

FDA said it is not currently aware of any confirmed reports of patient harm related to these risks, but because the company cannot update the MiniMed 508 and MiniMed Paradigm pump models to address the vulnerabilities, the devices are being recalled. The agency said patients using these models should replace the devices with models that are better equipped to protect them from hacking. Medtronic is providing patients with alternative insulin pumps that have enhanced built-in cybersecurity capabilities.

Cybersecurity vulnerabilities have been an ongoing battle for Medtronic in the past year. In March the Department of Homeland Security and FDA alerted healthcare providers and patients about cybersecurity flaws identified in a wireless telemetry technology used for communication between Medtronic’s implantable defibrillators, clinical programmers, and home monitors. In that situation, FDA advised healthcare providers and patients to continue to use the devices as intended, however, because the system's overall design features help safeguard patients and the company was already developing updates to further mitigate that particular risk.

Last year the agency reported cybersecurity vulnerabilities affecting the company's N'Vision clinical programmer used in conjunction with certain neurological implantable therapies. Several of the company's peers have also experienced cybersecurity problems, including Abbott, and Guardant Health.

“The FDA urges manufacturers everywhere to remain vigilant about their medical products—to monitor and assess cybersecurity vulnerability risk, and to be proactive about disclosing vulnerabilities and mitigations to address them," said Suzanne Schwartz, MD, deputy director of the Office of Strategic Partnerships and Technology Innovation and acting division director for All Hazards Response, Science, and Strategic Partnerships in FDA's Center for Devices and Radiological Health.

Schwartz said FDA is collaborating with manufacturers, healthcare organizations, security researchers, and other government agencies to develop solutions to address cybersecurity issues throughout a device's total product lifecycle.

“While we are not aware of patients who may have been harmed by this particular cybersecurity vulnerability, the risk of patient harm, if such a vulnerability were left unaddressed, is significant," she said.

Any medical device connected to a communications network like WiFi or the Internet may have cybersecurity vulnerabilities that could be exploited by unauthorized users, Schwartz said. But at the same time, increased use of wireless technology and software in medical devices can also offer safer, more convenient, and timely healthcare delivery, she added.

Biodesix Looks to Become ‘the’ Lung Cancer Detection Co. With New Acquisition

Pixabay Biodesix Looks to Become ‘the’ Lung Cancer Detection Co. With New Acquisition

Biodesix isn’t looking to just be another company with lung cancer detection tests. It wants to be the lung cancer detection company. And with its most recent acquisition, the Boulder, CO-just might achieve that goal.

“Our focus is becoming ‘the’ lung cancer diagnostic solution company,” Scott Hutton, COO of Biodesix, told MD+DI. “With that we know we need multiple diagnostics tests for different times within a patient’s care continuum. With GeneStrat and VeriStrat being our legacy products – we were looking more late stage.”

The firm acquired U.K.-based Oncimmune’s laboratory and incidental pulmonary nodule malignancy test in the U.S. Oncimmune’s U.S. operations, including a CLIA lab in De Soto, KS, will transition to Biodesix on Nov. 1. The lab is the sole U.S. provider of Oncimmune’s EarlyCDT -Lung test.

Hutton added, “last year we did the acquisition of Integrated Diagnostics (for an undisclosed sum) and it was also a nodule management product. It allowed us to go more early stage – way further up the care continuum. This follows that similar where our aspiration is to drop multiple products into the dedicated salesforce bag, so they can provide actionable insights for any individual patient during different time points of their treatment path.”

Oncimmune’s EarlyCDT Lung test helps identify those that could be cancerous. The blood-based lung nodule test enables earlier intervention by helping clinicians detect lung cancer at all stages of disease (I-IV). The extensively validated proteomic test measures seven autoantibodies to tumor-associated antigens created by the body’s response to cancer.

“When we look at Oncimmune’s EarlyCDT Lung, that is a rule in test,” Hutton said. “That differs from the Integrated Diagnostics acquisition of the NOXL2 test and that is a rule out. We looked at these products as complementary. Any given patient that is either low-to moderate risk can see benefit and value from the test results.”

In addition to the lung nodule indication, the Early Cancer Detection Test – Lung Cancer Scotland(ECLS) study, a 12,210 patient study investigating the utility of the EarlyCDT Lung test in lung cancer screening, recently announced meeting primary end-points. ECLS could lead to a future screening indication for the EarlyCDT Lung test. The company said full results from the study will be published in a peer-reviewed publication later this year.

Hutton noted that the company would continue to push growth in the lung cancer detection space. He added that the growth could come organically or through more M&A.

“When we made the strategic decision to become technology agnostic and becoming the lung cancer diagnostic solution company, the one thing we said was we were going to have to be opportunistic,” Hutton said. “We’re going to have look both internal and external. This now means we will have had two acquisitions within a 12-month time frame. We don’t want people to under-appreciate our internal leverage either. We have a very robust pipeline of products in either discovery or development. So for us it really isn’t about going out and growing purely by acquisition, we want to grow by any and all means possible because we do think our strategy for lung differentiates us from everyone else.”

Trump administration gets feds out of apprenticeship and job-training programs

Trump administration gets feds out of apprenticeship and job-training programs

manufacturing apprentice

Every manufacturing study I've read in the past five years, at least, has cited a growing skills gap as the biggest challenge to U.S. manufacturers. On June 24, the Department of Labor (DOL) announced major milestones in the continuing effort to expand apprenticeships in the United States. A Notice of Proposed Rulemaking (NPRM) was made public that would establish a process for the U.S. DOL to advance the development of high-quality, industry-recognized apprenticeship programs (IRAPs). These guidelines will move toward finalizing President Trump’s goal of getting the DOL out of the day-to-day management of these programs.

All I can say is, it’s about time! 

Under the proposed rule, entities such as trade, industry and employer groups or associations, educational institutions, state and local government entities, non-profit organizations, unions, or a consortium or partnership of these entities could become a Standards Recognition Entity (SRE) that sets standards for training, structure and curricula for IRAPs in relevant industries or occupational areas. The SREs would be recognized through the U.S. DOL to ensure that its requirements are met, resulting in only high-quality IRAPs.

Additionally, the department announced awards totaling $183.8 million to support the development and expansion of apprenticeships for educational institutions partnering with companies that provide a funding match component. The DOL also will make available an additional $100 million for efforts to expand apprenticeships and close the skills gap.

Whenever the government gets involved in anything it usually runs off the rails at some point with a lot of money thrown down a rat hole! I’ve long said that industry knows what it needs in the way of skills training, therefore industry—not the government—should work hand-in-hand with local community colleges and trade schools to create a program that works for both employer and employee.

Injection molders have developed successful training programs

Few of these government programs that I’ve seen created over the years have worked in any meaningful way. With the deepening of the skills gap, many employers in the plastics processing and mold manufacturing industries have established their own training, education and apprenticeship programs. I’ve written many articles about these successful programs and how plastics processors are growing their own skilled workers in-house. Many of these companies already work with local community colleges and trade schools to help develop the right curricula for the various skills and knowledge required by plastics processors.

Some of the companies whose training and education programs I’ve covered in PlasticsToday include GW Plastics (Bethel, VT); Plastic Molding Technology (El Paso, TX); Micro Mold and Plastikos in Erie, PA; and many others. If you want to see how custom molder Plastikos developed its program, read "Closing the Skills Gap: How Plastikos meets recruiting, retention challenges."

While the government will still have its hand in the program, giving companies a greater ability to work with local educational institutions and trade associations is a step in the right direction. With the “funding match component” of the program, employers will have an opportunity to develop more skilled employees while sharing costs.

The National Tooling & Machining Association (NTMA) and the Precision Metalforming Association (PMA) applauded Monday’s announcement. “There will be an estimated two million vacant manufacturing jobs by 2025 and the industry cannot close this gap on its own,” said PMA President David Klotz. “The federal programs announced [June 24] mean that the government is listening to our message that, for manufacturing to continue to drive the U.S. economy, this country must invest in helping manufacturers attract and train the next generation of workers. We encourage Congress to provide funding to expand these types of programs.”

NTMA Interim President Doug DeRose commented, “We are proud that in Arizona, NTMA is a recipient of one of the Labor Department’s workforce development grants. NTMA and its chapters have made workforce development a top priority issue for more than a decade and these grants will help our efforts to close the skills gap in our industry.

“We applaud the Trump administration for continuing to make manufacturing and closing the skills gap top priorities.”

The department intends to fund up to 30 apprenticeship grants, with awards ranging from $500,000 to $6 million. Grants may be local/regional, statewide or national in scale, and funding will depend on the proposed geographic scope of the apprenticeship project. Grant funds will be awarded to apprenticeship partnerships of public- and private-sector entities, which together will develop and implement new apprenticeship models or expand existing apprenticeship programs. The full solicitation is published on

Government relinquishing oversight concerns some lawmakers

Already there are some in Congress who don’t like the idea of giving companies and educational institutions too much free rein when it comes to money. (I guess they’re seeing what happened with college tuition loans.) A Wall Street Journal article on June 24 noted that Congress is “concerned about the government relinquishing oversight.” The WSJ quoted a statement from Rep. Bobby Scott (D., Va.), chairman of the House Labor Committee: “The administration’s proposal to establish a new unregistered apprenticeship program, which lacks sufficient accountability for meeting quality standards or ensuring the success of apprentices, diverts valuable funding away from programs that have had a long record of success.”

I’m not sure which programs with a “long record of success” Scott might be speaking of, but I know from writing about these programs for a couple of decades that many of them don’t succeed because the government doesn’t really understand what manufacturing needs. For that reason, plastics processors might be better off sticking with their own in-house programs.

Let me know your thoughts on this program—there have been a number of government programs that have started and failed. I think this one sounds good. Getting the feds out of day-to-day management of this program might give these partnerships enough leeway to be successful. But one never knows when the federal government is involved.

Image: Industrieblick/Adobe Stock

NXP, Momenta Partner to Monitor How Alert You Are While Driving

Momenta’s neural network technology will examine camera images of the driver’s face, placing boxes around the head, eyes, nose, and mouth. From those images, it will determine if a driver is asleep, drowsy or inattentive. (Image source: NXP/Momenta)

Chinese driver-monitoring startup Momenta has announced it is teaming with NXP Semiconductors to help smooth the industry’s autonomy transition from Level 2 to Level 3 and beyond.

The company, considered a rising star in the world of autonomous driving, will collaborate with NXP to put its driver monitoring software on the S32V2 AI-enabled automotive vision processor. “We’ve made the process easier for the Tier One and the OEM,” noted Colin Cureton, senior director of ADAS product management at NXP. “By doing this proactive partnership, we’ve done a lot of the pre-emptive engineering work for them.”

The new Driver Monitoring Solution will combine Momenta’s neural network technology with NXP’s vision processor, which up to now has been used for such applications as front camera imaging and surround-view on vehicles. Together, the software and hardware will enable vehicles to examine the facial features of drivers and “know” if they’re attentive. 

The availability of such systems is considered critical right now because automakers need a way to track the state of the driver. As vehicles move from Level 2 (partial autonomy) to Level 3 (conditional autonomy), the drivers’ state grows more important because Level 3 allows them to take their eyes off the road, but still requires they be available to take control if an issue comes up.

“As the driver, you may be able to look away, but you can’t be asleep,” Cureton told us. Driver monitoring – in which cameras and software watch for signs of drowsiness, distraction, or inattention – is one solution to that potential problem. “It’s able to tell the car how engaged the driver is, and to make sure the driver is in a position to deal with the level of autonomy that the car is providing,” Cureton said.

The neural network – which makes deterministic decisions in a manner similar to that of the human brain – will play a key role in enabling such understanding. The software examines a camera image of the driver’s face, isolating the head, eyes, nose, and mouth for telltale signs of inattention. “The neural net is doing the recognition of the facial features,” Cureton said. “Are the eyes closed? Is the person sleeping? Smoking? Eating?”

If the vehicle detects that a person has fallen asleep, it can vibrate the driver’s seat, vibrate the steering wheel, or make noise, Cureton added.

The new solution is also aided by the S32V2 vision processor’s features. The processor is optimized to run artificial intelligence algorithms. It also incorporates an accelerator capable of running neural networks.

NXP expects the new solution to serve as a bridge while the auto industry transitions from Level 2 to Level 3 autonomy. Today, many OEMs and Tier One suppliers are hesitant to move to Level 3 due to potential liability issues because they have no way of ensuring that drivers are engaged and ready to take the wheel under Level 3 conditions. For such reasons, some now use the terms “Level 2.5” or “Level 2-plus” to describe features that are beyond Level 2, but not ready for Level 3.

NXP also expects the new technology to serve in Level 4 (high autonomy), where drivers may still be called upon under certain conditions. “There may be other ways of solving the problem,” Cureton said. “But today this is the most effective way for the car to understand what the driver is doing.”

Senior technical editor Chuck Murray has been writing about technology for 35 years. He joined Design News in 1987, and has covered electronics, automation, fluid power, and auto.

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!

Ceramics Offer Amazing Diversity for 3D Printing

Ceramic 3D printing can pose a number of advantages such as simplifying the process of  traditional investment casting. (Image source: Ren Services)

We talk a lot about what’s going on with metal powders and resins and the advances in thermoplastics that are adding a whole new level of functionality to FDM printers. However ceramics are coming to occupy their own niche within additive manufacturing. By now you're probably thinking, why focus on yet another 3D printing material? The answer is because 3D-printable ceramics offer a range in technologies and applications not found in many other areas of 3D printing.

3D printing with ceramics deserves a shoutout for a number of reasons: It has unique material properties making it applicable to a wide variety of fields; those properties allow for a design freedom unique even by the standard of additive manufacturing; that design freedom allows for creating complex geometries that would be tricky, if not impossible, in other materials and certainly impossible with any traditional manufacturing technologies; these unique qualities lead to diverse applications and a wonderfully low-to-zero material waste ratio. Finally, ceramics can be used across a surprising variety of AM technologies.

Ceramic materials can be put into a paste form so they can actually be used in an extruder very much like the FDM process. However you can also get 3D ceramic filament in a powder form to be used in powder sintering technologies like SLS. However, ceramic powders are also available in a form compatible with binder jetting. It's also possible to get resins with ceramic particles embedded in them, making it possible to use photopolymerization technologies with ceramic elements.

Industrial vs. Desktop Ceramic

There are two categories of ceramic 3D printers: industrial and desktop. On the industrial side the prices vary widely but you can get industrial quality 3D printers for as low as $25,000.

A List of 3D-Printable Ceramic Materials

  • Glass Ceramics

  • Bone Replacement Material

  • Tri Calcium Phosphate

  • Fused Silica

  • Alumina & Zirconia Oxide

  • Aluminum Toughened Zirconia

  • Silica-Based Materials

  • Hydroxyapatite/TCP

  • Cordierite

  • Zircon Silica


However, most of them range well above that into the $100,000 or $250,000 mark. These printers span the spectrum of AM technologies from FDM and resin to powder based. I always recommend to the companies I work with if you're looking to bring any industrial 3D printer in house – regardless of the material or technology – work with a manufacturer who will also print parts. The value of working with the service bureau arm of a 3D printer manufacturer is that you can order parts and test them to make sure that their particular technology and material is right for your application.

These materials are available from a variety of 3D-printed ceramic service providers, but some of the better known ones are Lithoz, 3D Ceram, Admatec, i.Materialize, and Shapeways. These companies represent an enormous body of knowledge about what materials and what applications are best for 3D-printed ceramics.

However, you don't have to go industrial size. There are a range of desktop-size 3D-printed ceramic machines that range in price from anywhere from $5,000 to $10,000. Some of the better known ones include 3D Potterbot 7, Bison 1000, and Lutum.

3D-Printed Ceramics for Healthcare and Beyond

But whether you are using an industrial 3D printer or a desktop 3D printer, the applications for 3D-printed ceramics are remarkably broad. NYU Langone recently completed a study in which 3D-printed ceramic lattices were used to successfully guide the regrowth of new bone in patients with bone deformations.

In the NYU researchers' process, a 3D printed ceramic lattice structure is implanted into the body and then bone grows over the lattice structure in the correct orientation of what the bone should be. Clinical trials for this are still years away, but the promise and potential are extraordinary.

It's All About the Thermal Properties

The well-known thermal properties of ceramic, combined with the geometries 3D printing makes possible, open up a new range of possibilities. One of the areas where this can substantial impact is in traditional investment castings. Ceramic filaments used in an additive manufacturing process can reduce the time and cost of investment castings drastically.

For example the traditional process of creating an investment casting typically goes something like this: You machine a die, inject the die with wax, assemble a wax mold tree, coat the wax mold tree with a slurry, then given that tree a ceramic coating, melt out the wax, fire the ceramic, and finally pour in the molten metal, chipping away the ceramic mold so that you are left with your castings. This last step is particularly time consuming and costly.

However, with a ceramic filament it is possible to simply 3D print the mold in the first place (rather than starting with machining a die), do the firing process, and go right to pouring in the metal, remove the ceramic, and then work directly with your castings. Using an additive technology can take your process can from 10 steps to four and quite literally reduce the time and cost by 60, 70, even 80 percent. This has enormous implications for the feasibility of replacing broken parts on old legacy equipment that would be too costly to manufacture otherwise.

The two use cases discussed here don’t even qualify as the tip of the tip of the iceberg for what’s possible with 3D printing ceramics. Few materials are as adaptable to multiple AM technologies (FDM, SLA, binder jetting, and laser sintering) as ceramic. And as design engineers continue to push the envelope with what’s possible we will see novel applications in healthcare, aerospace, space flight, and many other areas.

Jack Heslin is the Founder of 3DTechTalks, an additive manufacturing consulting firm helping companies determine the correct Additive process and materials for their environment. He is also Head of Business Development for Lazarus3D, a medical 3D printing company providing soft tissue anatomical models for pre-operative planning and medical device simulation.

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!