Josh Blackmore, Global Healthcare Manager, M. Holland Company03.03.21
In early January, the first U.S. dose of the COVID-19 vaccine was administered in New York City to Sandra Lindsay, a critical care nurse. Around this time, people began to realize a sobering truth: Countless vaccines can be produced, but without a means to store, transport, and get them into peoples’ arms, the progress the world so desperately needs will never be achieved.
At the pandemic’s onset, the plastics industry was crucial in meeting the surging need for PPE and medical supplies. And now—With some estimating the U.S. needs at least 850 million syringes for every person to receive the required two doses of the vaccine—plastics will play a significant role in ending the pandemic.
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Companies have had months to prepare for the vaccine rollout, and suppliers ramped up production to ensure they had enough raw materials to power the first phase of the immunization campaign. However, last spring, the healthcare industry learned that supply chains optimized for cost are less flexible and unable to adapt to meet spikes in demand. At the time this article was written, there were two vaccines approved for use in the United States, with 90 others in varying phases of development. As more vaccines are authorized, the demand for materials will continue to rise. Suppliers must plan for the possibility that these vaccines may be approved at any time, so they must be prepared to meet the ensuing materials demand.
The COVID-19 vaccine rollout presents similar but different challenges than the testing effort. The vaccines require subzero temperatures and could possibly trigger different material shortages than those that occurred in the pandemic’s early days. These issues go beyond producing enough vaccine. Both the Moderna and Pfizer vaccines require extreme temperatures, -4° Fahrenheit and -94° Fahrenheit, respectively. To transport doses safely and without contamination, they must be shipped via a cold supply chain, which requires specific equipment that some state government agencies and many healthcare facilities don’t usually have.
The vaccine journey from factories to states and territories and finally to local facilities for administration would be challenging even without the current realities of the pandemic. Normal vaccine supply chains are fairly straightforward, with doses going from manufacturers directly to primary care physicians or retail pharmacies. But the pandemic presents a complex logistical challenge in an already complicated logistics environment. Demand would likely far exceed supply capabilities.
There are steps suppliers and manufacturers can take now to prepare for what certainly will be waves of increased demand over the next 12 to 24 months. First, companies should work with distributors to develop stocking plans. Firms with factories set in areas at risk for natural disasters would be wise to consider stocking an additional location as a backup. Suppliers and manufacturers also need to stay abreast of resin supply, which continues to experience widespread production issues. Companies also should consider placing orders 90 days in advance as appropriate. Those sourcing resin from outside of the United States should be prepared to add two to four weeks on top of normal shipping times. And finally, remember that distributors are a valuable resource. They can advise manufacturers on the supply risks for each resin, help select resins with regulatory profiles appropriate for use in the application, are supply-chain secure, and are easier and quicker to access.
These challenges and potential bottlenecks have forced manufacturers, suppliers, pharmaceutical companies, governments, and others to course correct as needed. There’s no roadmap to guarantee a smooth vaccine distribution of this magnitude. However, one silver lining is that crisis tends to breed innovation, and that innovation has been apparent in both medical device manufacturing and distribution.
Crisis Breeds Innovation: Syringes and Vials
Since May 2020, the U.S. Department of Defense and U.S. Department of Health and Human Services have been awarding multi-million-dollar contracts to companies to increase production and create solutions that meet high demand for syringes and vials. By partnering with these companies, the government hoped to circumvent equipment shortages or supply chain obstacles ahead of the vaccine rollout. The failure to anticipate shortages of swabs, PPE, and reagent chemicals derailed early coronavirus testing efforts and set the nation back significantly in understanding the magnitude of the pandemic.
One of the more innovative companies in which the government has invested is ApiJect, a manufacturer that employs a Blow-Fill-Seal aseptic technology to create plastic, prefilled syringes. To produce these syringes, ApiJect uses a Blow-Fill-Seal technique and then joins a polypropylene injection-molded needle hub. ApiJect claims the time to produce these syringes is far less than that of standard syringes, which is paramount to meeting the timeline and scale of the vaccination effort. It’s important to note that, despite the more than $750 million the government has put toward the company, the U.S. Food and Drug Administration has not yet approved the ApiJect prefilled injector.
With more than 70 percent of medical glass made outside of the United States, the federal government also awarded several purchasing commitments to prepare for a possible shortfall of glass vial capacity. Increasing glass production can be time-consuming and costly, as it often requires the construction of new furnaces. To shore up supply, the government issued contracts to Corning—which makes a specific kind of extra-durable medical glass—and an Alabama company, SiO2, a maker of specialized plastic pharmaceutical vials. Until now, plastic has not been considered a viable option for vials due to its inability to create an airtight environment for medicine. To solve this, SiO2 relies on a process called chemical vapor deposition, which bathes the vials in a blue plasma containing microscopic particles of glass, hermetically sealing them. The company currently is producing 10 million vials a month, with each vial holding up to 10 doses.
There’s still abundant room and need for more innovative solutions to efficiently deliver vaccines from warehouses to arms. For syringes, the plunger tip and the plunger rod are molded separately and then assembled. Using a two-shot molding technique could potentially reduce assembly time. Transforming this from ideation to reality would require material optimization for bonding, a detailed review of conformal cooling techniques for multi-cavity molds, and possibly a minor design change.
Forward is the Best Option
Plastics plays an integral role in safe and effective vaccine distribution. However, the importance of COVID-19 vaccines requires every player in the supply chain to be creative in fulfilling their role. Suppliers and manufacturers have an opportunity to establish new processes and procedures to help guide the world through the next unprecedented national health emergency. Working with distributors to develop a strategic and comprehensive stocking plan is critical, and there’s no reason this can’t be done while keeping sustainability in mind. Availability and sustainability aren’t mutually exclusive, and distributors can advise businesses on materials that satisfy both.
The pandemic has accelerated new ways to think, act, and produce essential products during a health crisis, from Ford and GM pivoting to make ventilators to 3D printing bureaus shifting to make face masks. From global supply chain rigidity and inability to supply huge surges in PPE demand to companies, like Ford, pivoting their operations to solve for those shortages, the pandemic has driven the plastics industry to new levels of supply chain creativity. The rollout of vaccines will undoubtedly foster even more innovations and breakthroughs.
Josh Blackmore serves as the global healthcare manager for M. Holland. In this role, he is responsible for implementing a strategic global plan to establish the company as a leader in the healthcare segment, developing the medical sales team, and managing the global project pipeline. He focuses on expanding targeted services for healthcare clients by providing guidance on how medical grade plastics meet device needs and comply with regulatory testing. Josh came to M. Holland from RTP Company, where he was the global healthcare manager for more than 13 years. He has also held positions at GE and The Dow Chemical Company. He earned a bachelor of science degree in medical technology from Michigan State University and an MBA from the University of Notre Dame’s Mendoza College of Business.
At the pandemic’s onset, the plastics industry was crucial in meeting the surging need for PPE and medical supplies. And now—With some estimating the U.S. needs at least 850 million syringes for every person to receive the required two doses of the vaccine—plastics will play a significant role in ending the pandemic.
Best Bottleneck Blockers
Companies have had months to prepare for the vaccine rollout, and suppliers ramped up production to ensure they had enough raw materials to power the first phase of the immunization campaign. However, last spring, the healthcare industry learned that supply chains optimized for cost are less flexible and unable to adapt to meet spikes in demand. At the time this article was written, there were two vaccines approved for use in the United States, with 90 others in varying phases of development. As more vaccines are authorized, the demand for materials will continue to rise. Suppliers must plan for the possibility that these vaccines may be approved at any time, so they must be prepared to meet the ensuing materials demand.
The COVID-19 vaccine rollout presents similar but different challenges than the testing effort. The vaccines require subzero temperatures and could possibly trigger different material shortages than those that occurred in the pandemic’s early days. These issues go beyond producing enough vaccine. Both the Moderna and Pfizer vaccines require extreme temperatures, -4° Fahrenheit and -94° Fahrenheit, respectively. To transport doses safely and without contamination, they must be shipped via a cold supply chain, which requires specific equipment that some state government agencies and many healthcare facilities don’t usually have.
The vaccine journey from factories to states and territories and finally to local facilities for administration would be challenging even without the current realities of the pandemic. Normal vaccine supply chains are fairly straightforward, with doses going from manufacturers directly to primary care physicians or retail pharmacies. But the pandemic presents a complex logistical challenge in an already complicated logistics environment. Demand would likely far exceed supply capabilities.
There are steps suppliers and manufacturers can take now to prepare for what certainly will be waves of increased demand over the next 12 to 24 months. First, companies should work with distributors to develop stocking plans. Firms with factories set in areas at risk for natural disasters would be wise to consider stocking an additional location as a backup. Suppliers and manufacturers also need to stay abreast of resin supply, which continues to experience widespread production issues. Companies also should consider placing orders 90 days in advance as appropriate. Those sourcing resin from outside of the United States should be prepared to add two to four weeks on top of normal shipping times. And finally, remember that distributors are a valuable resource. They can advise manufacturers on the supply risks for each resin, help select resins with regulatory profiles appropriate for use in the application, are supply-chain secure, and are easier and quicker to access.
These challenges and potential bottlenecks have forced manufacturers, suppliers, pharmaceutical companies, governments, and others to course correct as needed. There’s no roadmap to guarantee a smooth vaccine distribution of this magnitude. However, one silver lining is that crisis tends to breed innovation, and that innovation has been apparent in both medical device manufacturing and distribution.
Crisis Breeds Innovation: Syringes and Vials
Since May 2020, the U.S. Department of Defense and U.S. Department of Health and Human Services have been awarding multi-million-dollar contracts to companies to increase production and create solutions that meet high demand for syringes and vials. By partnering with these companies, the government hoped to circumvent equipment shortages or supply chain obstacles ahead of the vaccine rollout. The failure to anticipate shortages of swabs, PPE, and reagent chemicals derailed early coronavirus testing efforts and set the nation back significantly in understanding the magnitude of the pandemic.
One of the more innovative companies in which the government has invested is ApiJect, a manufacturer that employs a Blow-Fill-Seal aseptic technology to create plastic, prefilled syringes. To produce these syringes, ApiJect uses a Blow-Fill-Seal technique and then joins a polypropylene injection-molded needle hub. ApiJect claims the time to produce these syringes is far less than that of standard syringes, which is paramount to meeting the timeline and scale of the vaccination effort. It’s important to note that, despite the more than $750 million the government has put toward the company, the U.S. Food and Drug Administration has not yet approved the ApiJect prefilled injector.
With more than 70 percent of medical glass made outside of the United States, the federal government also awarded several purchasing commitments to prepare for a possible shortfall of glass vial capacity. Increasing glass production can be time-consuming and costly, as it often requires the construction of new furnaces. To shore up supply, the government issued contracts to Corning—which makes a specific kind of extra-durable medical glass—and an Alabama company, SiO2, a maker of specialized plastic pharmaceutical vials. Until now, plastic has not been considered a viable option for vials due to its inability to create an airtight environment for medicine. To solve this, SiO2 relies on a process called chemical vapor deposition, which bathes the vials in a blue plasma containing microscopic particles of glass, hermetically sealing them. The company currently is producing 10 million vials a month, with each vial holding up to 10 doses.
There’s still abundant room and need for more innovative solutions to efficiently deliver vaccines from warehouses to arms. For syringes, the plunger tip and the plunger rod are molded separately and then assembled. Using a two-shot molding technique could potentially reduce assembly time. Transforming this from ideation to reality would require material optimization for bonding, a detailed review of conformal cooling techniques for multi-cavity molds, and possibly a minor design change.
Forward is the Best Option
Plastics plays an integral role in safe and effective vaccine distribution. However, the importance of COVID-19 vaccines requires every player in the supply chain to be creative in fulfilling their role. Suppliers and manufacturers have an opportunity to establish new processes and procedures to help guide the world through the next unprecedented national health emergency. Working with distributors to develop a strategic and comprehensive stocking plan is critical, and there’s no reason this can’t be done while keeping sustainability in mind. Availability and sustainability aren’t mutually exclusive, and distributors can advise businesses on materials that satisfy both.
The pandemic has accelerated new ways to think, act, and produce essential products during a health crisis, from Ford and GM pivoting to make ventilators to 3D printing bureaus shifting to make face masks. From global supply chain rigidity and inability to supply huge surges in PPE demand to companies, like Ford, pivoting their operations to solve for those shortages, the pandemic has driven the plastics industry to new levels of supply chain creativity. The rollout of vaccines will undoubtedly foster even more innovations and breakthroughs.
Josh Blackmore serves as the global healthcare manager for M. Holland. In this role, he is responsible for implementing a strategic global plan to establish the company as a leader in the healthcare segment, developing the medical sales team, and managing the global project pipeline. He focuses on expanding targeted services for healthcare clients by providing guidance on how medical grade plastics meet device needs and comply with regulatory testing. Josh came to M. Holland from RTP Company, where he was the global healthcare manager for more than 13 years. He has also held positions at GE and The Dow Chemical Company. He earned a bachelor of science degree in medical technology from Michigan State University and an MBA from the University of Notre Dame’s Mendoza College of Business.