Research, Innovation and Technology

Manufacturing doesn’t just use cutting-edge technology—we create it. The manufacturing sector accounts for three-quarters of all private-sector research and development in the nation, giving our industry a critical competitive edge and providing our highly-skilled employees with vital support.

Demystifying Data

How 5G Is Transforming Manufacturing

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More than half of all manufacturers will be testing or using fifth-generation cellular wireless technology (aka 5G) in some capacity by the end of 2021, according to a new study from The Manufacturing Institute. The big numbers:

  • 91% of manufacturers believe 5G connectivity will be important to the overall future of their businesses.
  • 91% of manufacturers indicate speed of 5G deployment will have a positive impact on their ability to compete globally.
  • 88% of manufacturers indicate 5G connectivity will allow engineers to troubleshoot remotely.

All-encompassing: 5G is poised to help manufacturers in almost every part of their businesses, according to the study.

  • Nine in ten manufacturers expect the utilization of 5G to lead to the creation of new processes (88%) and new businesses (86%). It can make supply chains more efficient and both machines and workers more productive. It also will likely lead to new improvements no one has anticipated yet.

Drilling down: Let’s look at just one facet of 5G’s potential impact: its effects on factory operations. This is how comprehensive the 5G transformation is expected to be:

  • Four-fifths of manufacturers indicate 5G technology will be important to inventory tracking (83%), facility security (81%) and warehousing and logistics (81%) within their facilities.
  • Three-fourths of manufacturers indicate 5G will also be important to inspection (76%) and assembly (76%) activities, with seven in ten saying packaging (72%) and employee training (71%) efforts will benefit from the deployment of 5G.

And let’s not overlook the fact that more than 90% of manufacturers expect cost savings of approximately 38% from their 5G connections.

Competitive advantage: “Manufacturers’ competitiveness depends on their ability to continuously improve the efficiency and effectiveness of their operations, and disruptive technologies are changing the way that firms innovate and produce,” said the Institute’s Center for Manufacturing Research Director and NAM Chief Economist Chad Moutray.

More information: You can join the Institute for a webinar on 5G technologies on Tuesday, April 6, at 2:00 p.m. ET. Register here.

News

What It Takes to Manufacture a Vaccine

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You may not know it, but one company has the capacity to manufacture bulk drug substance for more than a billion doses of COVID-19 vaccines annually: Emergent BioSolutions, a global supplier for the Johnson & Johnson vaccine and U.S. supplier for the AstraZeneca vaccine. Emergent Executive Vice President of Manufacturing and Technical Operations Sean Kirk spoke with us recently to explain what goes into the heroic production of all these doses—in other words, what it takes to help defeat COVID-19.

How the vaccine works: The complexity begins with the vaccines themselves, which are amazing feats of bioengineering. The two vaccines have broadly similar structures, though they are made by separate, quarantined production lines in the Emergent facility. (As Kirk says, you can’t even take a wrench from one production suite to the other.)

You can think of this type of vaccine as a sort of beneficial Trojan Horse:

  • Particles of a virus called an adenovirus, which usually causes cold and flu-like symptoms, are engineered to hold the DNA of SARS-CoV-2 (the official name of the coronavirus)—and to not be infectious themselves.
  • Those adenovirus particles enter your cells and program them to produce a component of SARS-CoV-2 called a spike protein.
  • That process provokes an immune response, teaching your system how to defeat the real COVID-19.

So how do you make it? As you might guess, making such a precise vaccine is itself a complicated and delicate process.

  • You need to make a lot of modified adenovirus particles very fast, while ensuring they aren’t infectious and can deliver their payload of SARS-CoV-2 DNA.
  • To cut a long story very short, the production process involves “infecting living cells [with the modified adenovirus] and turning them into virus factories,” as science writer Derek Lowe says.

Where Emergent comes in: Emergent handles the manufacturing process, which results in something called “bulk drug substance,” Kirk explains.

  • “Our facility produces the high concentration active pharmaceutical ingredients, the viral vectors themselves,” he says. “Then we freeze them down and ship them out to what’s called a fill/finish facility, which dilutes the concentrate and fills vials or syringes with it.”

The numbers: That concentrate will eventually become part of the 100 million Johnson & Johnson doses and 300 million AstraZeneca doses purchased by the U.S. government.

What it takes: Kirk gave us a glimpse of just how much effort went into getting ready for a new vaccine.

  • 6 or 7 months: That’s all Emergent had, for a process that normally takes years. Consider how much goes into it, Kirk says: ordering equipment, getting that equipment to work correctly and comply with regulations, “working out the kinks from the complex biological manufacturing process”—and then scaling it up and optimizing it to make large quantities of vaccines as quickly and safely as possible.
  • 800 new jobs: Emergent had to increase hiring, adding approximately 800 new jobs in 2020, many of which were dedicated to COVID-19 response across three Maryland sites.
  • Group effort: Emergent works incredibly closely with Johnson & Johnson and AstraZeneca, along with the U.S. government and the company’s own suppliers. “We have leveraged U.S. government rated orders to get access to critical raw materials and equipment. We’ve depended upon certain suppliers, who were likewise rallying to the cause, to really step up and ramp up their overall capability and capacity,” says Kirk.

Why can’t you go faster? Kirk says he gets this question all the time and wants to impress upon readers that these are very complex biologic manufacturing processes.

  • “They are highly regulated, highly technical and have to be highly reproducible,” he continued. “We are growing living cells and then we are infecting them with these viral vectors.”
  • Furthermore, everything that Emergent produces must have the same characteristics of the product used in the clinical trials—“that’s the essence of biologic vaccine development,” Kirk says. “That’s the only way you can ensure safety and efficacy.”

The last word: Kirk tells us what he tells his employees: “It’s unbelievably difficult, more difficult than anything I’ve done in my entire career. But I can’t think of a more awesome opportunity to leave an indelible mark on the course of human history. We are going to help return a degree of normalcy to society. We’re going to help reunite families, open up economies and put a smile on children’s faces when they go back to school. And that’s an honorable and amazing thing.”

This article is the first in an exclusive four-part series on Emergent’s accelerated production efforts.

Policy and Legal

President Biden Gets to Work, and the NAM Responds

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As President Joe Biden took office yesterday, the NAM took a pragmatic stance, calling this new political era “a time for healing.” As NAM President and CEO Jay Timmons put it, “Today, manufacturers recommit ourselves to be part of the solution—to be part of the healing process. We invite all Americans to join us in doing the same.”

And since the new president started his first day with a flurry of executive orders, the NAM responded to those, too. Here’s a rundown of the new policies, plus the NAM’s statements.

Immigration: While also moving to reverse a ban on immigration from certain Muslim-majority countries, President Biden strengthened the Deferred Action for Childhood Arrivals program, offering support to the so-called Dreamers. He called on Congress to pass comprehensive immigration reform that provides Dreamers with permanent status and a path to citizenship.

  • Responding to the DACA action, Timmons said, “Manufacturers are very encouraged by today’s critical first step. . . .  The broad goals of the Biden plan align with many of the core recommendations in ‘A Way Forward,’ manufacturers’ post-partisan roadmap for immigration reform. The path we have laid out is one that we believe can bring the country together, and we look forward to working with the Biden administration to move a comprehensive immigration reform plan through Congress.”

Keystone XL: President Biden also rescinded the permit for the Keystone XL pipeline, at least temporarily erecting a barrier to its progress.

  • “Manufacturers are disappointed with the administration’s decision to block this sustainable project, which can serve as a model for infrastructure of the future, and if not reconsidered, represents a missed opportunity for manufacturing workers in America,” said Timmons. “Manufacturers have a strong commitment to responsible environmental stewardship, and protecting our environment does not require us to walk away from his job-creating opportunity.”

COVID-19: Ten executive orders focused on combating the COVID-19 pandemic, according to CNBC. The NAM had called for aggressive actions to support manufacturers’ COVID-19 response months ago, including in its April “American Renewal Action Plan” and, mostly recently, in conversations with the transition team.

  • The orders included a new COVID-19 response office as well as a pandemic supply chain resilience strategy to help strengthen domestic production of important supplies.
  • President Biden also restored U.S. membership in the World Health Organization and directed agencies to use the Defense Production Act to spur production of critical materials like N95 masks, swabs and other vaccine- and virus-related equipment.

“It’s very encouraging to see [President Biden] is starting off with strong, decisive action to fight COVID-19, save lives and get our economy on the road to recovery,” said Timmons on Twitter. “Manufacturers are committed to ending this deadly pandemic.”

Masks on: One of President Biden’s orders will now require masks to be worn on federal property, and he plans to require masks on public transportation as well. The NAM has prioritized face coverings since the beginning of the pandemic, including by launching a “Wear a Face Covering” ad campaign and providing a crucial estimate of how many masks American businesses need.

  • “President Joe Biden is showing real leadership with his executive orders on masks,” said Timmons. “Masks save lives, help us keep our economy open and are vital until we can all get vaccinated.”
Press Releases

Manufacturers Outline Executive Action Policy Priorities for Incoming Administration

Washington, D.C. – The National Association of Manufacturers called on President-elect Joe Biden to help ensure the future strength of manufacturing in America by extending key executive orders into the new administration and rescinding those that have harmed manufacturing.

“For decades, we have worked with policymakers from across the ideological spectrum to craft policies that encourage the growth of manufacturing in the United States,” said NAM President and CEO Jay Timmons in a letter to the incoming administration. “Now more than ever, America needs leaders in Washington who are focused on increasing American jobs, wages and investment.”

The letter outlines executive orders that have had a significant impact, positive or negative, on manufacturers over the past four years, and it urges the president-elect “to reverse the most harmful of these orders and keep or expand those that create an environment that is conducive to growing America’s manufacturing sector.”

The NAM’s recommendations will help manufacturers continue to respond to the devastating pandemic and will also power the United States’ economic recovery by setting the stage for manufacturing growth.

To read the full letter, click here.

Background:

The NAM has requested President-elect Biden repeal the following executive orders and consider executive orders for extension.

Executive Orders

Rescind:

  • “Rescission of the Deferred Action for Childhood Arrivals Program”
  • E.O. 13950 – “Combating Race and Sex Stereotyping”
  • E.O. 13672 – “Revocation of Federal Contracting”
  • E.O. 13769 – “Protecting the Nation from Foreign Terrorist Entry into the United States”
  • “President’s Report to Congress on the Proposed Refugee Admissions for FY 21”
  • Presidential Proclamation 10052 – “Suspending Entry of Aliens Who Present a Risk to the U.S. Labor Market Following the Coronavirus Outbreak”
  • E.O. 13944 – “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States”
  • E.O. 13948 – “Lowering Drug Prices by Putting America First”
  • E.O. 13957 – “Creating Schedule F in the Excepted Service”

Extend:

  • E.O. 13771 – “Reducing Regulation and Controlling Regulatory Costs”
  • E.O. 13805 – “Establishing a Presidential Advisory Council on Infrastructure”
  • E.O. 13766 – “Expediting Environmental Reviews and Approvals for High-Priority Infrastructure Projects”
  • E.O. 13845 – “Continuing the President’s National Council for the American Worker and the American Workforce Policy Advisory Board”
  • E.O. 13932 – “Modernizing and Reforming the Assessment and Hiring of Federal Job Candidates”
  • E.O. 13777 – “Enforcing the Regulatory Reform Agenda”
  • E.O. 13806 – “Assessing and Strengthening the Manufacturing and Defense Industrial Base and Supply Chain Resiliency of the United States”
  • E.O.s – “Strengthening the Federal Government’s Anti-Counterfeiting Efforts”

-NAM-

The National Association of Manufacturers is the largest manufacturing association in the United States, representing small and large manufacturers in every industrial sector and in all 50 states. Manufacturing employs more than 12.3 million men and women, contributes $2.32 trillion to the U.S. economy annually and has the largest economic multiplier of any major sector and accounts for 62% of private-sector research and development. The NAM is the powerful voice of the manufacturing community and the leading advocate for a policy agenda that helps manufacturers compete in the global economy and create jobs across the United States. For more information about the NAM or to follow us on Twitter and Facebook, please visit www.nam.org.

News

Say “Ahhh”: A Manufacturer Makes It Safe for Dentists to Reopen

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What do you do when a pandemic shuts down your customers? That was the problem faced by A-dec, a manufacturer of dental equipment and supplies based in Oregon, when dentists nationwide closed their doors back in March. 

In A-dec’s case, they developed products to help their core customers come back safely.  

The problem: Dentists and hygienists are at particular risk of contracting COVID-19 while treating patients, because their jobs require proximity to their patients’ open mouths.   

  • Dentists also use loupes with lights and magnifiers to see inside patients’ mouths—but wearing medical masks and traditional face shields makes it difficult to wear lighted loupes as well.  
  • Meanwhile, traditional face shields are open at the bottom—and because dentists work on patients who recline right below them, those shields provide limited protection. 

The solution: A-dec’s engineers got to work designing and producing a unique face shield for dentists that fits around the collarbone and opens upwards, providing a barrier between dentists and patient. The shield also leaves additional space around dentists’ eyes so they can use lighted loupes 

Image courtesy of Remote Area Medical

The process: The same pandemic that made this work necessary also made it difficult. A-dec had to overcome a series of complications:

  • Research and development: COVID-19 made the company’s customer focus groups impossible to do in person, so it designed and conducted remote focus group sessions. 
  • Sourcing of materials. Shortages and supply chain disruptions also caused problems, with some commodities becoming unavailable at the last minute. That meant A-dec faced delays and had to find alternate sources of materials at times 
  • Product construction. Like many other manufacturersA-dec had to figure out how to keep remote workers and on-site, socially distancing workers in sync with each other—all while creating a new product in record time.

By working around these setbacks and streamlining its processes, A-dec was able to go from the initial idea to the beginning of production in just two months—an extraordinary achievement.

The last word: According to A-dec Vice President of Manufacturing Wesley Snyder, the company benefited from its familiarity with medical regulations—but that doesn’t mean non-medical manufacturers can’t make a difference. “Everything is made by somebody, and the manufacturing industry is uniquely positioned to make tangible contributions to society in a crisis like this,” he said. So find those new points of need, and align them with your capabilities. 

Policy and Legal

The U.S. Needs Better Broadband Access

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Most of us are extremely grateful to have the internet nowadays—it keeps manufacturers’ high-tech operations running and provides entertainment for our socially distanced evenings. But the U.S. needs continued, substantial investment in broadband access and will do so long after the pandemic is over. One reason, of course, is that manufacturing is increasingly high-tech and high-skilled, which means demand will keep rising for fast, reliable and universal connectivity.

So in light of our renewed appreciation of all things digital, here’s a quick reminder of the policies that the NAM is promoting, courtesy of NAM Director of Innovation Policy Stephanie Hall. As she puts it, the federal government needs to take the following steps:

  • Modernize federal partnership programs and appropriate funds to increase broadband deployment in hard-to-serve areas and to close the digital divide.
  • Fund broadband mapping efforts to help us understand where broadband is needed and who needs it most.
  • Create a smart regulatory environment that allows the private sector to design, build, finance, operate and maintain our digital infrastructure.

Recent actions: The NAM—and manufacturers across the country—are calling on Congress to include broadband funding in its COVID-19 response. In a May letter to the Senate Committee on Commerce, Science and Transportation, the NAM asked Congress to “support investment in our broadband infrastructure system, maximize consumer choice in how they connect and reduce regulatory barriers that can slow manufacturers’ ability to deploy current and next-generation broadband infrastructure.”

As Congress continues to work on COVID-19 response funding, the NAM will keep pushing for broadband access.

Business Operations

Can Antibody Find Me…A Treatment for COVID-19

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Manufactured antibody treatments could be the next big thing in the fight against COVID-19, Reuters reports. The therapy is often used against illnesses like cancer, and a range of biotech companies are working together to test this approach.

Who’s involved: Several companies have been allowed by the U.S. government to combine resources to manufacture supplies, should any of the companies’ drugs succeed. Those companies include Eli Lilly and Company, AstraZeneca, Amgen and GlaxoSmithKline.

Meanwhile, The Wall Street Journal (subscription) reports on a Lilly study involving antibody drugs in nursing homes.

  • The study, which aims to enroll up to 2,400 subjects in nursing homes and other long-term care facilities, is intended to test whether the company’s antibody drug can reduce rates of infection.
  • If the study is successful, Lilly hopes its drug could receive government approval by the year’s end.

Go deeper: Revisit our recent writeup of an important new study on America’s effective policies for pharma development—and how these should be preserved.

Business Operations

Wearables Could Predict COVID-19

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Smart watches and smart rings are the newest COVID-19 detectors, according to The Wall Street Journal (subscription). Devices like Oura rings, Fitbits, Garmin fitness bands and Apple Watches pull in vital information that may predict an infection.

How it works: Tech companies are taking in wearable sensor data from smart sensors on both healthy people and those afflicted by COVID-19, comparing results and looking for patterns. They’re hopeful that they can use this information to create artificial intelligence that could alert people with early signs of the virus.

The metrics: There are a range of measurements that might help to detect COVID-19 early on, including:

  • Temperature tracking, which can help give early warnings about possible fevers;
  • Heart-rate tracking, which can reveal an infection early; and
  • Blood oxygen and cough tracking, which keeps an eye on specific COVID-19 symptoms.

Go deeper: Independent testing laboratory UL is at the forefront of these developments, and we recently talked to one of its leaders about how it’s helping to get such devices to market. Read the whole thing.

Policy and Legal

FDA Issues Guidance for Rapid At-Home Tests

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The FDA announced new standards for companies seeking regulatory approval of rapid at-home COVID-19 tests, reports Bloomberg Law.

Why it’s good: Creating a fast, cheap test that can be used regularly at home would allow people to test themselves once or twice a week, or before coming into contact with others—giving them the ability to quarantine when necessary and reduce the likelihood of spreading the illness.

But not so fast: The FDA’S rules for rapid at-home COVID-19 tests are pretty strict, which could discourage some companies from giving it a try, according to USA Today.

Xtra help: On Tuesday, The XPRIZE—a nonprofit organization that hosts public competitions— announced a $5 million prize for “five winners who can produce a test that delivers results in as little as 15 minutes and costs less than $15” (also from USA Today). An additional $50 million will be available to help scale up manufacturing for any contestant.

The NAM’s view: “Long wait times for tests can present a personnel challenge for manufacturers that have workers who might have been exposed outside the workplace,” said NAM Vice President of Infrastructure, Innovation and Human Resources Policy Robyn Boerstling. “The NAM recently joined a letter to ensure more federal resources are committed to testing. We are focusing our advocacy efforts on solutions that will provide more robust and reliable testing solutions in every community.”

Business Operations

Cyber Criminals Take Advantage of COVID-19

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The internet may be saving our sanity (somewhat) with animal videos and Zoom chats . . . but there is a downside. With so much more happening online—such as retail and banking, not to mention all that working from home—hackers have a lot more targets.

The data depressingly bears that out:

  • Large data breaches have skyrocketed by 273% in the first quarter of 2020, according to data from cloud computing company Iomart.
  • Ransomware is up 90%, according to VMware, while attacks that destroy data or networks have risen 102%. And last, “island hopping,” in which criminals infiltrate one company in order to reach its partners or clients, is up 33%.

And here’s a worrying wrinkle: according to Iomart, manufacturing is one of the hardest-hit sectors.

There can be a grim benefit to cyberattacks, in that companies can learn from others that have already survived. To that end, aluminum manufacturer Norsk Hydro’s experience with a massive ransomware attack last year provides a number of (very) hard-earned lessons. From Bloomberg Businessweek (subscription):

  • After the attack, the company had to make sure its employees got paid—but banks wouldn’t connect digitally with the company due to fears of cyber infection. So one executive, at Hydro’s Brazilian location, copied the previous month’s paychecks from their external payroll system, weeding out employees who had left or been fired.
  • At a Pennsylvania plant, which lost access to corporate email and to the software that organizes its orders, employees received orders on their personal accounts. Then, having dug some old computers out of storage, they printed out the forms and distributed copies on the floor.
  • At headquarters, Hydro had to rebuild their entire network. They were so worried about keeping these plans safe that they barred cleaning staff from coming into the room.

Hydro’s leaders consider themselves lucky to have only lost $60 million to the attacks, which unfortunately tells you a lot.

NAM with a plan: Though manufacturers should certainly prepare for the worst, they can also take many steps to minimize, if not eliminate, the danger. The NAM provides many cyber-related resources for members, including most recently a new cyber-insurance program called NAM Cyber Cover.

And here’s good news: the NAM’s Cyber Forum, cosponsored by PwC and eSentire, is on for the fall, in a virtual format. It will be from 11:00 a.m. to 1:00 p.m. EDT on four Thursdays in a row: Oct. 1, 8, 15 and 22. To learn more, email [email protected].

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