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Robotics

Robot Market Takes a Hit from COVID-19

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The robot market was just coming out of a manufacturing slump when the pandemic hit. That took positive forecasts and turned them upside down. Meanwhile, the cobot market may actually survive the pandemic’s blow to the robot market and come out with positive results for the balance of 2020 and into 2021. The good news for cobots, is partly a result of higher sales in Asia where manufacturers are emerging more quickly from the pandemic.

 

According to data from Interact Analysis, a market research firm that specializes in smart manufacturing, industrial robot shipments experienced negative growth for four consecutive quarters from mid-2018. The downward results happened in the context of a slowdown in general global manufacturing activity, which led to weak spending on machinery and automation equipment. By the end of 2019, recovery signs appeared, and the mid-term growth rate turned positive.

After a weak-but-recovering 2019, Interact Analysis originally expected the 2020 robot market to recover strongly, but COVID-19 changed the market revenue forecast from positive growth of near 5% to negative growth of mare than 3%. Interact expects the market will return to rapid growth in 2021 and, in the long run, the pandemic will accelerate existing trends for industrial automation.

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Revised 2020 and 2021 Forecasts

Interact’s new base scenario predicts that the global industrial robot market will drop by 3.6% in revenue, and by 3.7% in shipments during 2020. That compares to a pre-COVID forecast of positive growth of 4.8% and 7.7% respectively. The firm does forecast a strong rebound in 2021, with end users advancing automation plans and projects that were delayed in 2020. All three scenarios suggest a rebound from 2021, albeit in the worst case at a slower pace. The worst-case forecast assumes a much longer pandemic which cannot be contained during 2020, and therefore leads to a prolonged period of high unemployment and low wage growth.

To reflect the rapidly changing nature of the COVID-19 situation, Interact produced neutral, positive, and negative scenarios. The pandemic will lead to a long-term increase in rates of factory and warehouse automation but, even in the best possible case scenario, the firm does not expect revenues to return to pre-COVID forecast rates before 2022.

“This acceleration should be a longer-term trend within 3-5 years. In the short term, it is actually the delay and recovery of the market's original demand,” Maya Xiao, an author at Interact Analysis who is responsible for industrial automation, tells Packaging Digest's sister publication Design News. “From experience, the V-shape of market volatility in 2021 should be pulled up. The meaning of the V is that it will follow the previous SARS experience, or the financial tsunami of 2008, and there will definitely be a big rise after reaching the bottom. But when to start depends on the control of COVID-19 worldwide.”

 

A Rosier Outlook for Cobots

Collaborative robots are expected to maintain a double-digit growth rate in terms of both revenue and shipments throughout 2020. Growth for all other types of industrial robots is either negative or flat. Applications in non-manufacturing environments such as logistics, and service industries will be hit harder, but they will also recover faster. In addition, many collaborative robot manufacturers are concentrated in Asia, meaning they are further through the crisis than their competitors and customers in non-Asian markets.

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As for the reasons, cobots are still forecast for positive growth, Xiao points to a number of reasons. “Cobots will be quickly placed into effective use for three important reasons,” says Xaio.

  1. Compared with the traditional robot market, the collaborative robot market in its bursting period when the slowdown and pandemic hit. The original growth rate forecast for 2020 was over 30%. COVID-19 has impacted the market, but it still maintains positive growth.
  2. From the perspective of the application industry, the industries with more applications of collaborative robots, such as electronics, semiconductors, and logistics, are not as adversely affected by COVID-19 as the automotive industry.
  3. The installation, commissioning, and training of industrial robots require manpower. The COVID-19 control measures of make these impossible. Relatively speaking, collaborative robots are easier to use, which reduces the need for extensive training during a pandemic.

 

Which Industries Are Taking Hits

Automotive has been particularly hard-hit. While some large robot orders of more than 1,000 units still being announced, there is no sign of improvement in traditional automobile manufacturing. While traditional cars will not show a quick recovery, new-energy vehicles will be a different story.

Most new production-related investments in automotive are associated with new-energy vehicles. That includes production of automotive electronics and lithium-ion batteries. In Interact’s report, robots used in automotive electronics and LI battery production are not attributed to the automotive industry, and most of that production is in Asian countries. Collaborative robots have experienced strong growth in these areas in the last 12 months.

Industries that were already highly automated, such as semiconductors, were less affected by the COVID-19 lockdown. Hence, COVID-19 has joined other factors, such as general long-term labor shortages in many countries, as a reason for increasing interest in automation among manufacturing companies.

 

Recovery Will Vary by Region

As for what regions are likely to emerge first, Xiao noted that it depends on how a given region is overcoming the effects of the pandemic. “The impact of the virus will vary considerably by region,” says Xiao. “It depends on the speed of measures being implemented to contain COVID-19. That will occur over shifted timescales: APAC first, followed by Europe, and finally North America. As such, APAC will see the first and quickest recovery with less impact on 2020 compared to other regions.”

She notes that the supply chain for the robot industry has not been hard hit by the 2018/2019 slowdown, so it’s in good shape with withstand the effects of the pandemic. “Compared to automobiles and other manufacturing industries, the supply chain of the robot industry is not too long,” says Xiao. “The inventory of most system integrators is not low, so the supply chain has not been greatly affected by COVID-19.”

 

Anellotech Secures Funds to Develop Innovative Plastics Recycling Technology

Coloures Pic/Adobe Stock sustainable business

Anellotech Inc., a sustainable technology company located in Pearl River, NY, announced that joint-venture enterprise R Plus Japan Ltd. will invest in the development of Anellotech’s innovative Plas-TCat technology for recycling difficult-to-recycle plastics. Tokyo-based R Plus Japan was established in June 2020 by 12 cross-industry partners within the Japanese plastics supply chain, including Suntory Monozukuri Expert Ltd., a subsidiary of Suntory Holdings Ltd., Rengo Co. Ltd., Toyo Seikan Group Holdings Ltd., J&T Recycling Corp., and Asahi Group Holdings Ltd., among others.

Unlike the existing multi-step processes that first liquefy plastic waste back into low-value synthetic oil intermediate products, Anellotech’s Plas-TCat chemical recycling technology uses a one-step thermal-catalytic process to convert single-use plastics directly into basic chemicals, such as benzene, toluene, xylenes (BTX), ethylene, and propylene. They can then be used to make new plastics. The technology’s process efficiency has the potential to significantly reduce CO2 emissions and energy consumption. Once utilized across the industry, this technology will be able to more efficiently recycle single-use plastic, one of the world’s most urgent challenges, stated Anellotech.

Suntory began collaborating with Anellotech in 2012 to develop the Bio-TCat process for making aromatics (including paraxylene) from non-food biomass (pine wood), required to make 100% plant-based PET bottles. Anellotech is leveraging and adapting composite films and other difficult-to-recycle materials, at industrial scale into the same basic chemicals — aromatics and olefins — already used to make most virgin plastics, including PET.

“We believe this initiative by Anellotech and R Plus Japan, combining enabling Plas-TCat chemical recycling technology with the concerted efforts of committed supply chain players, illustrates the best model to aggregate and apply the required resources in amelioration of the problem of plastic waste,” said Anellotech CEO Dave Suldolsky. “Plas-TCat’s unique capability to directly produce basic chemicals (used today to make most virgin plastics) from mixed plastics waste, at large scale, represents an economically viable and impactful solution to the plastic waste problem. We are excited by the opportunities ahead and look forward to collaboration with R Plus Japan in tackling this challenge.”

Tsunehiko Yokoi, CEO of R Plus Japan, commented, “The significance of chemical recycling is its ability to transform and convert plastic waste into its original chemical components, to eventually produce new plastics. Turning used plastic into secondary raw materials enables the sustainable use of resources for various industries across the plastics supply chain.

“Through the development of this innovative technology, we hope to contribute to solving the global plastic waste issue, which has long been a challenge due to its difficulties in recycling. We’re very excited to work with our industry partners to move this important work forward,” Yokoi added.

With the engagement of various industries throughout the value chain, from raw materials manufacturers and packaging suppliers to beverage companies, the newly established R Plus Japan, together with Anellotech, will advance the development and commercialization of this eco-efficient plastic recycling technology by 2027, said the release.

Fraunhofer ICT Introduces Upcycling of Post-Consumer PLA Waste

PLA polymer at Fraunhofer ICT
Depolymerization of waste PLA at Fraunhofer ICT uses a conventional and commercialized eco-friendly, organic catalyst.

In the bio-based plastics space, polylactic acid (PLA) has proven to be one of the most promising polymers because of its versatile applications ranging from disposable cutlery and degradable sutures to rigid packaging and extrusion coatings. Fraunhofer Institute for Chemical Technology (ICT), with help from Fraunhofer Institute for Structural Durability and System Reliability LBF, has developed a strategy to chemically recycle post-consumer PLA waste into a lactate ester (ethyl lactate) with commercial applications in chemical synthesis, magnetic tape coatings, plastic, and more, primarily in the food industry.

PLA is a bio-based alternative to fossil-fuel-based plastics, but its production is very raw material and energy intensive, according to Fraunhofer ICT: It takes 2.39 kg of corn cobs, 50 kg of water and 54 Ml fossil energy to produce one kilogram of PLA. The use of these renewable raw materials as feedstock for PLA production can compete with their use in food production. Though PLA is a potentially high-volume raw material, it often ends up in other conventional waste streams, thereby contaminating them and disturbing municipal recycling strategies.

Depolymerization of waste PLA at Fraunhofer ICT uses a conventional and commercialized eco-friendly, organic catalyst. Image courtesy Fraunhofer ICT.

Davide Pico, head of Research Group Polymers and Additives, Department of Environmental Engineering, at Fraunhofer, responded to Packaging Digest sister publication PlasticsToday regarding the challenges of collecting and recycling PLA without contaminating recyclable plastic waste streams. “At present, due to a lack of an appropriate collection infrastructure, PLA waste often finds its way into conventional plastic waste streams like PET or PP. Since PLA is presently a contaminant in a conventional plastic waste stream, it lowers the quality and processability of conventional mechanically recycled plastics,” acknowledged Pico. “We already find concentrated PLA waste streams in venues such as theaters, concerts, football stadiums, or other big events with cups, food boxes, etc., but due to its lower diffusion, PLA is not being designated as a sorted material yet.

“However, with an increase in its production capacity and its usage, it will be necessary to institute a separate collection infrastructure for PLA. At that time we will receive sorted and selected PLA streams,” Pico added.

Fraunhofer ICT’s process represents an economically and environmentally sustainable recycling strategy capable of nearly completely depolymerizing the PLA substrate along with a high yield of ethyl lactate (80%) in a relatively short period of time (

The low-boiling solvent is capable of selectively dissolving the PLA fraction from a mixed plastic waste stream, consisting mainly of PET and PP. This flexible process scheme is capable of handling virgin PLA of different grades as well as post-consumer PLA cups. The process was developed in 2019 from a laboratory scale to a technical scale (15 L) and its robustness was demonstrated by recycling post-consumer waste PLA cups, without any effect on the yield of the lactate ester.

“The depolymerization process for PLA developed in my group by PhD students will selectively and in an environmental way dissolve PLA only, thereby leaving PP and PET untouched and PLA-free,” Pico stated.

Healthcare Packaging

Here’s How America Can Bring Back Pharmaceutical Packaging

Photo credit: Pongvit – adobe.stock.com Pharma-packaging-line-AdobeStock_271269455-web.jpeg
Puerto Rico can increase pharmaceutical manufacturing and packaging production quite easily.

The penicillin antibiotic piperacillin used to be made in Carolina, Puerto Rico, USA.

Pfizer and its predecessors manufactured antibiotics, oncology, and other drugs on that site since the 1970s. In 2003, it built an 85,000 square foot modern facility to make piperacillin.

Twelve years later, the company moved piperacillin production offshore and closed the plant. By 2016, all that remained was the former administration building and a large empty lot.

Image from Google Maps, used with permission.Piperacillin-plant-site-web.jpg

Several pharmaceutical plants were closed down in Puerto Rico after the US tax credit expired, including this one that used to produce the penicillin antibiotic piperacillin.

 

The current COVID-19 pandemic has exposed a serious national security issue with this type of offshoring. Our pharmaceuticals come largely from outside the US, mostly from China (see chart below) and India. Many that are still made in the US rely on imported Active Pharmaceutical Ingredients (APIs). Many inactive ingredients are imported as well. Excessive reliance on imports puts us at serious risk as a nation. Should we disagree on tariffs, politics, or anything else, these other countries have immense leverage to squeeze our healthcare system.

Data from Invest Puerto Rico; chart created by Packaging DigestPharma-reliance-chart-web.jpg

Many people think our reliance on China for Active Pharmaceutical Ingredients (APIs) and other drugs presents a national security issue.

 

Companies find offshoring attractive for several reasons. Lower labor costs are highly visible and often cited. They are lower, but so is productivity. It may require two low-cost offshore workers to do the work of one medium-cost US worker.

Other costs — such as shipping and sometimes byzantine legal environments — also negate some of the expected savings. Another deterrent: Protection of intellectual property can be close to non-existent in some countries.

The US has several alphabets worth of regulatory agencies. The big one for pharma is the FDA (Food and Drug Administration) but there are many others. Companies manufacturing offshore must comply with all FDA requirements. At least in theory. In practice, it is much harder to enforce these requirements from 10,000 miles away. Reduced enforcement lowers costs and complexity but at a risk to the US public. There have been serious instances of contaminated products getting into the US marketplace.

It is time to bring our pharmaceutical industry home. The best place to bring it home to is Puerto Rico.

Puerto Rico’s pharmaceutical industry dates back to the 1950s. In 1976, Congress passed Section 936 giving favorable tax treatment to companies manufacturing in Puerto Rico. This resulted in an explosive growth of manufacturing in general, and pharmaceutical manufacturing in particular. By 1990, there were more than 140 pharmaceutical manufacturing plants on the island.

Section 936 began to phase out in the 1990s, fully expiring in 2006. Fortunately, not every company was in Puerto Rico just for the tax breaks. Many plants, such as the piperacillin plant, closed but some stayed open. Today, there are currently 49 pharmaceutical plants in operation, according to the Puerto Rico Industrial Development Corp. (PRIDCO).

The attraction now is the operating environment. In the boom years, Puerto Rico developed a highly skilled workforce — from operators, to scientists, to top management, and everyone in between. Puerto Rico developed the infrastructure of specialty contractors, components manufacturers, suppliers, fabricators, laboratories, and consultants needed to support the industry. The compact size of the island means that they are never more than two to three hours away from any site.

Puerto Rico still has a vibrant pharmaceutical industry. Many top global companies — Amgen, Eli Lilly, Bristol-Myers Squibb, Johnson & Johnson, Merck, Abbvie, Pfizer, Glaxo, and others — have major facilities here. Some have more than one plant. Companies — such as Boehringer-Ingleheim, Glaxo, Romark, and others — are setting up shop or returning to the Commonwealth. Others are expanding existing facilities.

Total industry exports, according to PRIDCO, were $13.2 billion dollars, almost as much as Indiana and California combined. Five of the top 10 best-selling drugs globally (Humira, Eliquis, Opdivo, Enbrel, and Xarelto) are made in Puerto Rico.

Section 936 may be long gone but the pharmaceutical industry in Puerto Rico continues strong — and can be easily revved into high gear again. It’s time we do that.

 

Medical Packaging

8-Puff Dry-Powder Inhaler Wins Red Dot Product Design Award

8-Puff Dry-Powder Inhaler Wins Red Dot Product Design Award
Image of the 8Shot Dry Powder Inhaler courtesy of Hovione Technology

Hovione Technology’s 8Shot Dry Powder Inhaler (DPI) has earned the Red Dot 2020 Product Design Award in the Healthcare Daily Living AIDS category.

João Ventura Fernandes, PhD, director of technology development and licensing for Hovione Technology Ltd., told MD+DI that 8Shot “was developed to be the world’s first 8-dose, factory-filled dry powder inhaler device enabling effective and safe drug delivery to the lungs of a range of drugs expected to be developed and reach the market during the next years." It is targeted for "delivery of new pharmaceutical compounds requiring very high doses, such as inhaled biologics, antibiotics, anti-virals, vaccines, pain, or rescue drugs for life-threatening conditions,” he said.

Fernandes explained that the “need for high-dose drug delivery to the lungs is emerging outside the established asthma and COPD drug pipeline, which have typically required the delivery of small drug amounts, in the order of 0.2 to 0.5 mg of therapeutic doses to patients by the current inhaler device technologies. In fact, many new drugs in development to treat patients with serious, life-threatening lung diseases such as lung infections—such as those arising from pneumonia—cystic fibrosis (CF), pulmonary arterial hypertension (PAH), idiopathic pulmonary fibrosis (IPF), or lung cancer are much less potent and thus require delivery of large lung doses, often within the range of 50 to 150 mg,” he continued.

New and effective delivery devices are needed to deliver such high doses of drugs to the lungs, he said. “8Shot provides the inhaler technology compatible with drug doses up to 400 mg, delivered safely and conveniently to these patients from multiple inhalations,” he said.

8Shot consists of only two injection-molded parts. “The fact that it only requires two plastic parts makes this inhaler into an economically viable innovation from acute to long-term inhaled treatments,” said Fernandes. “Following manufacturing, the device provides a patented mechanism for pre-filling the 8-unit doses into the inhaler in an assembled configuration. The filled device is then packaged in aluminium foil for protection from the external environment.”

Fernandes said that 8Shot was developed to be “a patient-friendly solution for daily high-dose delivery without the burden of instructing the patient to reload a device multiple times with a capsule or blister leading to a long, time-consuming, error-prone use sequence.” He explained that the patient “just turns a dose wheel to access the next dose. Its dose wheel is compatible with doses up to 400 mg, including drug-alone or particle-engineered formulations, and provides visual feedback to the patient that the inhalation maneuver has been successful. The large dose is delivered from multiple, sequential inhalation maneuvers for therapeutic benefit and safety.” The device was developed through iterations between product design, manufacturability, and assessment of human factors and usability, he said.

The Red Dot Design Award program recognizes high-quality product design, according to the press release. “The Red Dot jury’s experience and expertise evaluating outstanding product design and technical innovation for more than 60 years is unparalleled. This distinction awarded to our 8Shot DPI is a great success for Hovione Technology,” said Peter Villax, Hovione Technology’s CEO, in the release.

Healthcare Packaging

Can You Reduce Manufacturing Costs of Drug-Delivery Systems?

Can You Reduce Manufacturing Costs of Drug-Delivery Systems?

Sophisticated devices are being charged with delivering many of today’s novel drug therapies. To ensure patient access to such innovations, pharmaceutical companies and their drug-delivery device partners will need to minimize development and manufacturing costs while still achieving high-quality, advanced solutions.

Mike Kobashi has spent nearly 20 years providing Lean and Six Sigma expertise to multiple manufacturing sites, including those making drug-delivery devices. MD+DI asked Kobashi a few questions about whether lean manufacturing principles could impact the cost of manufacturing drug-delivery devices. Prior to his current role as vice president of operational excellence for West Pharmaceutical Services Inc., Kobashi worked in multiple roles involved with developing the necessary infrastructure, strategic plans, and tactical solutions to create a continuous improvement environment across multiple facilities. He had also developed West Contract Manufacturing’s current Lean Sigma curriculum and had facilitated joint customer improvement initiatives that have resulted in increased quality levels as well as cost savings.

Are there strategies to minimize time and cost of manufacturing drug-delivery systems?

Kobashi: A smart starting point is to first listen to the voice of the customer. Understanding customer needs, including, but not limited to, lead time, quality, and costs, can lead to collective analysis of current-state processes and define any gaps or concerns. Applying lean tools and methodologies helps build in efficiencies to reach a desired future state.

West describes a lean manufacturing business model including tools and methodologies. Can you explain what these entail?

Kobashi: Lean manufacturing is a methodology that focuses on minimizing waste within manufacturing systems while simultaneously maximizing productivity. It is based on a number of specific principles, such as Kaizen, or continuous improvement. This approach to manufacturing drives excellence throughout an organization. For example, the implementation of global training systems helps with the development of problem solvers and “Lean” subject matter experts to help establish a common language of improvement, enabling global networks to connect through continuous improvement activities and the leverage of best practices. Measurement of maturity level is a critical manufacturing and administrative process that helps to improve from instability to stability and to higher maturity (world class) thus leading to customer and employee satisfaction, higher quality manufacturing, safer methods in development, and costs savings.

How can a company minimize cost and development time while still meeting stringent requirements for quality, service, and safety?

Kobashi: Delivering high-quality products that meet the exact product specifications and quality standards is what all customers seek and expect from their manufacturing partners. The focus on both quality and safety includes excellence in manufacturing, scientific and technical expertise, and management. At the manufacturing level, this means producing clean, sterile, high-quality components to minimize disruptions to the supply chain and bringing safe, effective drug products to the market—and to the patient—quickly and efficiently. This should be done through a multi-tiered approach using the following strategies:

  • Develop metrics to measure progress.
  • Establish automated vision verification process to further enhance the safety and quality of products, minimizing the risk of defects in drug products.
  • Create production area viewing corridors to decrease the amount of human interaction and traffic within production areas.
  • Build state-of-the-art laboratories to streamline testing workflows.
  • Reply in a timely fashion to customer needs and when issues or questions arise.
  • Monitor performance against customer requirements.

A culture of quality must be in place to reinforce a patient first focus and to never compromise on quality because patients are counting on us.

Is there a risk that innovation would suffer in the drive to minimize time and costs? How can companies still be innovative?

Kobashi: Designing tools to drive both efficiencies and innovative thinking without sacrificing quality is essential. Two types of improvement strategies help to drive innovation. Kaizen, which means incremental change, is a strategy where employees at all levels of a company work together proactively to achieve regular, incremental improvements to the manufacturing process. Kaikaku, which means radical change, implies a redesign of a production system that is radical and reaches across an entire organization. Both Kaizen and Kaikaku work hand-in-hand and can be applied to activities beyond production.

Kaizen activities are built on the continuous improvement of standards. This resulting level of stability is necessary for Kaikaku success. Kaikaku’s long-term strategies ensure continued success through step-change improvement in automation, software and advanced manufacturing technologies.

West also mentions the need to improve efficiencies and reduce waste. What are some common pitfalls that lead to inefficiency and waste? How can they be avoided?

Kobashi: A common pitfall in Lean implementation is solely focusing on tools and improvement methodologies. A foundation of employee engagement and a spirit of continuous improvement is the fuel that drives business systems. Operational excellence is a key element within a global operations strategy that benefits from the inclusion of passion for customers and leadership in quality.

We also see inefficiencies and waste by not separating clear material flow and level-loading customer demands to our needs. The waste of unevenness (Mura) from the customer perspective, flowing down into the manufacturing site, becomes a challenge to effectively utilize equipment, deliver to the customer’s request, and optimize labor.

How does lead time impact overall cost? What are the opportunities to reduce lead time?

Traditional manufacturing companies often contain sources of waste, often seen in a value stream map (VSM). A VSM is an effective tool to balance customer requirements, create flow, balance labor requirements and work in progress (WIP).

Lead time and inventory are often conflicting measures. Inventory impacts cost but a shorter lead time is a critical customer metric. VSM and supporting methodologies allow us to offer shorter lead times to the customer, while not increasing our inventories. This starts by analyzing our portfolio, along with reducing the described waste of Mura (unevenness) and Muda (waste). This is often done collaboratively with the customer to find the right level between inventory and lead time.

Self-Administration: What Drug-Delivery Device Manufacturers Should Know

Image by Dmitry Lobanov - Adobe Stock Self-Injection.jpeg

Staff shortages, financial pressure and a growing ageing population are the three key drivers pushing forwards the current trend of self-administration of injections for patients suffering from chronic illnesses. By 2060, there will be over 95 million Americans aged 65 and over – nearly double today’s number- and with old age comes greater likelihood of chronic illnesses.1

Hospitals have taken matters into their own hands by ‘outsourcing’ this low-risk medical procedure that drains both precious healthcare professionals’ time and limited space – and handing the baton over to home carers or patients themselves who are able to perform such drug injections in the comfort of their own homes. However, even healthcare professionals carrying out injections within hospital settings continue to be subjected to the risk of needlestick injuries with potentially contaminated needles. It is therefore of utmost importance that the safety of the medical devices being used for injection, as well as the best practices surrounding their usage, be strengthened both within traditional healthcare environments and these newly emerging sites for home-administration. Up until now, most drug-delivery devices for injection have been designed for healthcare professionals as their primary users, but manufacturers will increasingly need to adjust their products to a new breed of clientele, including both patients and home-based carers.

Self-Administration Trend Drivers

Part of the underlying reason self-administration has increased in recent years is the wave of biological therapies entering the market, which are specifically suited to treatment by subcutaneous injection for patients with chronic diseases such as multiple sclerosis or rheumatoid arthritis given that they require frequent and regular injections. When not required to make frequent trips to the clinic and rely on the expertise of nurses, patients are empowered to play a bigger part in their own treatment and disease management, which they can more easily fit around their personal lives.

Sharps injuries from unprotected needles have certainly declined since the introduction of the US Needlestick Safety and Prevention Act (NSPA) almost twenty years ago, yet we continue to see an average of 1,000 injuries reported every day in US hospitals.2 Given that an estimated 50% of non-hospital settings are deemed non-compliant with Occupational Safety and Health Administration (OSHA)3 self-administrating patients are at a much higher risk of contracting a needlestick injury. This risk extends to their family members and other residents if improper safety measures and disposal techniques are applied. With non-users being far less likely to be aware of the contamination of a device, or even know the risks presented by contaminated devices more generally, self-administration leaves non-patients particularly vulnerable to such exposures.

Designing with Self-Administration in Mind

While the general population can be made more aware of these risks, manufacturers can also make a huge difference through device design and should accommodate their devices to patient capabilities. Safety devices should be intuitive and easy to use, requiring minimal effort to activate and inject. Most importantly, manufacturers must be sure to integrate needlestick prevention features into their devices. For example, devices with hollow-bore needles or syringes which retain an exposed needle after patient use present a heightened risk, while retracting and needle shielding mechanisms are much safer.4 Given that safer features of drug delivery devices can reportedly reduce needlestick injuries and contaminations by up to 80%5 it is no surprise then that the safety prefilled syringe market has taken off in recent years. In 2018, global spending on safety syringes reached $772 million, and this is expected to grow an impressive 8.1% CAGR, reaching $1.137 billion by 2023.6 Going one step further, pre-filled safety syringes meet these safety requirements while also having the added benefit of reducing the risk of dosage errors. These instruments not only substantially reduce risks but are especially well-suited to a growing self-injecting patient population.

As self-administration continues to take off, it is important to consider the risks that come with exporting potential needle exposure outside of their typical clinical setting. In some ways, this trend acts as a useful reminder and a prompt to solidify the safety foundations across all healthcare systems and locations. By making self-administration a viable alternative and enabling older and less dextrous patients to securely operate the device without assistance, pre-filled safety syringes and autoinjectors are providing users with a level of independence that would otherwise be unavailable to them were they reliant on hospital staff for medication, while also reducing the risks associated with unsupervised care. With homecare successfully reducing pressure on healthcare systems, manufacturers will play a key role in ensuring the continued upward trajectory of self-administration by continually adapting their drug delivery devices to the evolving healthcare landscape.

 

 

1 Population Reference Bureau (PRB), Fact Sheet: Aging in the United States, July 2019, https://www.prb.org/aging-unitedstates-fact-sheet/

3 Medical Devices: Evidence and Research, Vol 10, Clinical, economic, and humanistic burden of needlestick injuries in healthcare workers, 2 May 2017

4 World Health Organization, Needlestick Safety and Prevention, Independent Study

5 World Health Organization, Needlestick Safety and Prevention, Independent Study

Market Data Forecast, Safety Syringes Market by Technology, Oct 2018

Amcor Joins Healthcare Plastics Recycling Council

Amcor
Image courtesy of Amcor

Amcor has joined the Healthcare Plastics Recycling Council (HPRC), a consortium of companies seeking to improve the recyclability of healthcare plastic products and packaging. Amcor will support HPRC with expertise in packaging design for medical devices and applications in hospitals and other treatment settings, it reported in a news release.

Amcor sees an opportunity for collaboration within the healthcare industry. “Patient safety and product protection will always come first in any medical packaging innovation, whilst at the same time Amcor strives to also protect our planet through the development of more sustainable packaging solutions,” Amcor Flexibles' Noemi Bertolino, product development director, told MD+DI. “Finding solutions requires a collaborative approach as there is no one-size-fits-all answer to this challenge, which is why Amcor is pleased to be working with the HPRC and their cross-value-chain members, including medical device manufacturers, to consider all aspects of the waste stream.”

Amcor’s HPRC membership builds on its past work in promoting package recycling. In 2018 Amcor pledged to develop all of its packaging to be recyclable or reusable by 2025, and in 2019 the company launched AmLite Ultra Recyclable suitable for recycling in existing polyolefin recycling streams. AmLite Ultra Recyclable can be used for medical packaging for applications that do not require sterilization by high-temperature processes or gamma irradiation, such as diagnostics, MD+DI reported.

When asked how Amcor’s medical device packaging offerings would change to meet its 2025 pledge, Bertolino acknowledged that “healthcare packaging is one of the more challenging areas for the development of more sustainable packaging solutions. Prioritizing patient safety and product protection whilst developing recyclable innovations is an important focus for our R&D teams today and will continue to be so as we move towards 2025.”

Peylina Chu, executive director of HPRC, welcomed Amcor as a member. “As a packaging leader, Amcor is highly focused on creating a circular economy as shown in their 2025 pledge,” she stated in the press release. “With their technical expertise and their commitment to developing responsible packaging in collaboration with likeminded partners, Amcor is a fantastic addition to HPRC.”

Current HPRC members include BD, Baxter, Boston Scientific, DuPont Tyvek, Eastman, Gore, Johnson & Johnson, Medtronic, Nelipak, Ravago, and ThermoFisher. HPRC Europe members include BD, Baxter, and Johnson & Johnson.

StreamOne R from PAXXUS Wins Several Awards

StreamOne R from PAXXUS Wins Several Awards
Image courtesy of Paxxus Inc.

StreamOne R Retortable Recycle-Ready Polyester from PAXXUS has been recognized in the Flexible Packaging Association’s annual competition with several awards: a gold award in sustainability, a gold award in technical innovation, and a silver award in packaging excellence.

“Receiving multiple FPA awards for StreamOne R is the ultimate validation of PAXXUS’s long-term commitment toward developing leading edge technology for the evolving circular economy,” Dwane Hahn, vice president of sales and marketing for PAXXUS, told MD+DI.

Originally designed for a food application that required ultra-high barriers to maintain taste quality and shelf-life requirements, StreamOne R is also proposed for use in medical kits and drug-delivery systems.

The all-polyester StreamOne R was developed for applications requiring retort or autoclave sterilization. In its submission to FPA, PAXXUS explained that singe-stream options have been limited for high-barrier packaging that must undergo high-temperature processing. “Historically, a polypropylene paired with a high-barrier oriented polypropylene (oPP) has been the only choice. Unfortunately, the barrier offered by high-barrier oPP is significantly degraded upon retort or autoclave sterilization,” according to the company.

PAXXUS explained that StreamOne R is the first all-polyester packaging solution that provides an ultra-high barrier and hermetic seals even after exposure to retort/autoclave cycles, the company reported. After sterilization, it has a barrier of 0.01 cc/100 in.2 day atm and moisture barrier of 0.02 g/100 in.day.

In addition to being presented as an alternative to oPP, StreamOne R is also suggested as an alternative for aluminum foil structures for applications requiring protection from moisture and/or oxygen. “Aluminum foil is a very energy intensive material to manufacture,” the company explained in its submission. “The production of aluminum alone consumes approximately 54 MJ/kg. The energy savings by eliminating the use of aluminum foil for the barrier layer ranges from an impressive 1.0 MJ/m2 for 0.00028 in. aluminum foil to 3.7 MJ/m2 for 0.001 in. aluminum foil.”

Another accomplishment of StreamOne R is its broad sealing window described by PAXXUS as “well below the melting point of oriented polyester yet significantly above the 120-130°C (250-266°F) retort/autoclave processing temperatures.” The result is a seal that will withstand under extreme retort/autoclave cycles.

Earning a gold award in sustainability, StreamOne R offers the chance to recycle an ultra-high barrier, retortable packaging material in a single-polymer (#1 polyester) recycling stream. According to the company submission, “the oxide barrier coating is only angstroms thick and therefore does not impede recyclability. Post-industrial waste can be easily recycled and packages made with StreamOne R are recycle-ready for the consumer-waste stream.”

New Nylon Pouch Design Aims to Offer Strength at Reduced Cost

Image courtesy of Oliver Healthcare Packaging Oliver Healthcare Packaging new LF-1050N 40ga nylon pouch

Oliver Healthcare Packaging has developed a new pouch consisting of its new LF-1050N 40ga nylon and Tyvek 1073B that could serve as an alternative to pouches made with thicker-gauge nylons or made with PET/PE. The company believes that pouches using the new nylon could help reduce packaging costs while offering improvements in resisting flex cracking and delamination. 

“Oftentimes, medical packaging engineers are crunched for time and do not have the luxury of feasibility testing,” Jenn Goff, director, product marketing, told MD+DI. “This drives risk averse decisions and thicker gauge nylons to ensure design verifications pass the first time when it may be possible to go with a thinner-gauge material and still pass testing. This adds unnecessary cost down the road when production volumes increase. Due to the nature of testing required for a major material change, many MDMs continue to use the original validated packaging. Thinner-gauge nylon offers additional confidence at a reduced price when compared to thicker nylons.”

Goff explained that when packaging engineers are pressed for time and need something a bit more robust than the standard 48ga PET-based film, the LF-1050N 40ga nylon could be a more cost-effective solution than thicker-gauge nylons. “Choosing a nylon out of the gate at a small increase in price creates a win-win solution, [offering] more confidence in passing design verification when compared to standard 48ga PET-based film and minimal cost increase.”

The new nylon pouch is also intended to resist flex cracking issues in some applications. Kevin Zacharias, director, technical services, explained that the term flex cracking “relates to the formation of a crack in the film as a result of repeated flexing. This would result in a breach of the sterile barrier system and can occur during the vibration mode of simulated transportation testing. Some typical causes are oversized sterile barrier systems, oversized cartons/shippers, and choosing inappropriate materials for the sterile barrier system. Rightsizing the sterile barrier system and associated cartons such that there is limited ability of the substrate to flex repeatedly, combined with the selection of substrates that are resistant to flex cracking, is the best approach to mitigate this risk.”

The new nylon film may also help minimize the risk of delamination after multiple EtO sterilization cycles and accelerated aging conditions. Zacharias explained that “there are several different ways to create film laminations and not all employ an adhesive in the process. LF-1050N consists of a layer of nylon that is laminated to a sealant layer using a solvent-less adhesive. The adhesive layer creates a robust bond between the nylon and sealant layers that is resistant to failing during the rigorous test regiments that sterile barrier systems are sometimes exposed to.”

Jenn GoffKevin Zacharias

Above: Jenn Goff, director, product marketing, and Kevin Zacharias, director, technical services, Oliver Healthcare Packaging

If a company decides to switch from PET/PE to nylon, there are some careful considerations to make. For instance, it is a common misconception that thicker materials perform better in all scenarios, explained Goff. “Common pitfalls include choosing a thicker-gauge nylon to solve for all flexible material failure modes,” she said. “It is important to identify potential failure modes before deciding on a solution. Some thinner-gauge nylons perform better for specific failure modes. Thicker isn’t always better.” 

For packaging teams looking to reduce cost while maintaining high quality, reducing the packaging footprint could offer large payoffs for both the MDM and the end user, Goff added. She detailed the following potential payoffs:

  • MDM:
    • Pallet load reductions
    • Reduced storage needs
    • Lower shipping costs
    • Sterilization efficiencies
       
  • End User (hospitals)
    • Reduction of waste in the waste stream
    • Lower price due to lower costs of materials

“With that being said, packaging engineers must meet ever-changing regulatory requirements around the world. Some regions across the globe are implementing requirements to consider waste (REACH, ROHS, EU Waste Directive to name a few),” she continued. “The other area where the packaging footprint is being looked at in more detail is around sterilization capacities. With the latest innovation challenge from the FDA, MDMs are looking at ways to reduce the amount of EtO sterilization their products are exposed to. Packaging can play a key role by optimizing packaging designs and maximizing the number of pallets within each EtO sterilization cycle.”   

Goff said that while “reducing the packaging footprint is part of the equation when identifying value improvement projects for existing products, it is not the only consideration/value. Cost savings, speed/throughput, ergonomic improvements, scrap reduction, and others are areas that reduce cost from the process. When looking to reduce the packaging footprint for new products, it’s more about design optimization and passing design verification. There are so many unique applications that require many design considerations. While the packaging footprint is a consideration, passing testing, fulfilling user needs, ensuring patient safety, designing for manufacturability, and meeting timelines are prioritized.”

New pouch designs could offer further packaging and sterilization benefits. Goff provided the following potential gains:

  • Sterilization
    • The landscape of EtO and FDA’s challenge to identify alternatives. 
      • New pouch designs could help reduce pallet loads. 
      • New materials could allow for alternate and novel sterilization modalities.
  • Packaging
    • Compliance with EUMDR and the requirement for aseptic presentation involves the need for optimized pouch designs. For instance, feedback from end users on the ability for header bags to allow for aseptic transfer has been a common challenge. 
    • Speed to market. Packaging is often looked at as the long pole in the tent or the most “unknown” risk from a “will it pass” standpoint. Identifying appropriate designs and materials for the specific applications that pass the first time helps give project teams more confidence.

Goff will be speaking in the upcoming webinar, Medical Device Packaging as Told Through Design Control, on June 24, 2020. Click here to register.