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Op-Ed: Why America remains to be stricken by PSA Deficiency and what we have to do about it

Nurses and supporters attend a vigil at UCLA Ronald Reagan Medical Center during a nurse shift change amid the global coronavirus pandemic on March 30, 2020 in Los Angeles, California.

Mario Tama | Getty Images

Six months after the Covid-19 crisis, there is still a major shortage of personal protective equipment (PPE) for our healthcare workers, especially on the front lines of the coronavirus pandemic. Doctors and nurses are still using single-use N-95 and suffering from a lack of face protection and gloves. How did this happen in a country ranked number 1 by WHO in terms of pandemic preparedness. This country accounts for 40% of total global pharmaceutical spending and accounts for 24% of global economic output?

At the start of the crisis, the federal government's Strategic National Stockpile comprised 12 million N95 masks and 30 million surgical masks, about 1% of the 3.5 billion needed in the US in the first year of the pandemic.

The reason for the shortage was clear at the time: the dependency on the outsourcing of PPE production to China. The White House had to order 500 million respirators from China and was given a delivery time of 18 months or more. But despite the efforts of large US companies and innovative market players to manufacture PSA (HanesBrands, Tesla), why does this shortage persist?

There are already signs that PPE manufacturers are stopping production in order to avoid the risk of excess inventory. With the prospect of another wave of Covid cases in the fall, this could create additional shortages.

As the co-founder and CEO of 3DBio Therapeutics, which bi-prints medical implants throughout New York City, I wanted to help when Covid-19 started. I have seen firsthand how doctors, nurses and other healthcare workers grappled with the shortage of PPE at the height of the crisis that was threatening their safety. In response, we turned and worked nights and weekends building a Powered Air-Purifying Respirator (PAPR) under the name American PAPR. PAPRs, an essential PPE for health professionals treating infectious diseases, consist of a plastic hooded mask and breathing tube that block 99.97% of the small particles. PAPRs were most famously worn by doctors in the movie Outbreak.

What is hindering the PPE supply?

We were honored to be one of only a handful of manufacturers, along with Ford, to receive rapid regulatory approval from the National Institute for Safety and Health at Work (NIOSH). However, the main barriers to making PPE available to health professionals are the three core issues that have slacked American ingenuity and productivity during this crisis.

First, budget constraints have been a concern for hospitals throughout the pandemic, as critical care and inpatient services are their least profitable areas. Hospitals nationwide lost over $ 161 billion due to abandoned procedures from March through June 2020, while uninsured visits increased 114%. This has resulted in limited budgets for PPE.

Second, the unpredictability of demand poses another risk to PPE manufacturing. Existing players or newcomers like us need to build capacity by investing in expanding production. In the midst of a crisis, when the curve flattens or the regions rise, demand is difficult to predict given budgetary constraints and high local volatility. In a chaotic marketplace, investing in manufacturing defects puts your main business at significant risk.

Finally, fraud concerns bind hospitals to well-known manufacturers. Regulators, including the FDA and NIOSH, have shortened the deadlines to get safe PPE into the hands of healthcare workers. Inundated by a deluge of unreliable PPE imported from China, institutions cannot easily distinguish quality products from counterfeit ones. Unpredictable pandemic demand spurts require nimble and local manufacturing in the US, but hospitals need to work with new entrants.

As a nation we can try band-aid solutions, but I propose a simple concept to meet this urgent need, ensure our pandemic readiness for decades, while creating jobs for our stalled economy: Funding a dynamic ecosystem of the USA-based medical manufacturing facility, a Manufacturing Reserve Corps.

In the next healthcare emergency, imagine a network of thousands of trusted, US-based, pre-approved digital manufacturing companies ready to step into gear. Digital manufacturers coordinate production with the help of computer software and can flexibly manufacture a wide range of medical devices with minimal conversion costs. These companies could grow the Strategic National Stockpile, as could aerospace and defense companies with government contracts. This could be a modern World War II equivalent of the War Production Board converting factories from peacetime production to war needs.

Building this network of US-based manufacturing companies would have a clear economic and social return. Although manufacturing makes up only 9% of US employment, it drives 35% of productivity growth, 60% of exports, and 70% of private sector research and development, according to the McKinsey Global Institute.

A reserve corps could focus on traditional industrial manufacturing in peacetime, creating thousands of U.S. jobs in industrial centers and small towns across the country.

Covid-19 is the biggest crisis of our lives. It was made clear that flexible medical manufacturing is a must for economic safety and public health in the US today. We urgently need federal incentives to build it.

– By Dan Cohen, CEO and Founder of 3DBio Therapeutics

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