As the disturbing scenes of healthcare workers wearing garbage bags in place of proper protective equipment splashed across the headlines at the height of the COVID-19 pandemic last year, a trio of women—more accustomed to designing haute couture gowns for fashion runways than isolation gowns for frontline workers in hospitals—formulated a plan.

Furloughed from their design jobs at Oscar de la Renta in New York’s Garment District, they answered the public call for assistance from New York Governor Andrew Cuomo, who urged New York designers and manufacturers to come up with creative solutions for lifesaving personal protective equipment, or PPE, to help protect healthcare workers fighting the pandemic.

Together, the three fashion designers, with more than 40 years of combined experience in luxury apparel development, sprang into action.

After consulting with healthcare professionals and the Food & Drug Administration (FDA), they reached out to the strong local manufacturing network and diverse industry relationships they had built over the years with New York factories and began designing prototypes of isolation gowns.

“Within a week we pooled our resources and made our first batch of 300 gowns to donate [to local, underserved hospitals] under our non-profit organization—Garment District for Gowns,” said Rachel Rothenberg-Saenz, co-founder and CEO of the non-profit. She is also CEO of Goldatech, a separate company founded by the three women that is FDA-registered and minority-owned and women-owned certified.

Rothenberg-Saenz co-owns the organization with two of her former design team colleagues at Oscar de la Renta—Alexandra Baylis, chief operating officer of Goldatech, and Amy Tiefermann, chief product officer.

A new member of NCTO, Goldatech’s journey and story is emblematic of the U.S. textile industry’s herculean effort to retool production lines and stand up a virtually non-existent domestic supply chain for critical PPE items in this nation’s time of need.

It also underscores the urgent need for state and federal policymakers to craft robust policies to help onshore PPE supply chains, create a permanent domestic supply chain, and support a nascent domestic industry that has exhibited its innovative strength to provide more than 1 billion PPE items.

 

Building an American Medical Gown Supply Chain

To fund their endeavor, the Goldatech team initially raised $70,000 through a GoFundMe fundraiser, funneling 100 percent of the funding back into manufacturing and donating gowns.

They won a state grant—the first applicant out of a total of 33,000—to be awarded New York State’s Empire State Development (ESD) COVID-19 Retooling Grant, to “establish a NY-based PPE supply chain and get medical gowns into the hands of healthcare workers,” Rothenberg-Saenz said.

“The main objectives behind this grant were to create jobs and bring back furloughed employees, expand our business beyond the immediate needs of the COVID-19 pandemic, build a robust local supply chain and grow the production of American-made PPE,” she added.

With a team of just five people, the company has used the grant to facilitate the manufacturing of isolation gowns, supporting and investing in a network of subcontractors who were facing closures as a result of the pandemic. With an intimate knowledge of the capabilities of New York’s Garment District, they were able to meet and exceed demand for these critical supplies.

The efforts have supported the rehiring of 1,200 previously furloughed workers across the country, including fabric mill, manufacturing and logistics personnel. In addition, many of the subcontractors have also invested money into new machinery to support the ramp up.

“The majority of the subcontractors under our umbrella were previously manufacturing high-end fashion, and all were happy to pivot,” Rothenberg-Saenz reflected, citing one example of a subcontractor who they are partnering with now, who has a history of manufacturing for Ralph Lauren’s Collection (including for the American Olympic team), Donna Karan, and The Row, among others.

“At the beginning it was rapid self-educating, phone calls with the FDA, CDC, AAMI, and keeping up to date with evolving policy. Having never been subjected to meeting FDA standards, we were rigorous in third party testing and ultimately able to ensure the utmost compliance,” she added. “Many of our subcontractors now have the opportunity to slightly shift back into manufacturing fashion, however would rather stay producing PPE.”

Goldatech’s manufacturing capabilities are currently 7 million units of reusable and disposable gowns per month.

Baylis said the team has connected with the majority of USA textile companies making both wovens and nonwovens and has established a family group of manufacturers that they are working closely with to develop new products.

Goldatech designs and develops the gowns, adhering to the strict FDA standards and AAMI levels, and oversees production, securing and sourcing raw materials and coordinating with the entire production chain.

“We work directly with each mill within our network, facilitating orders, freight and logistics to our New York facilities. We are heavily involved in every step of the process, including raw material (fiber) procurement in some cases.” Baylis said.

The company also gives a percentage back to the non-profit Garment District for Gowns and continues to donate to underserved communities across the country. To date they have donated 22,000 reusable gowns to over 51 hospital networks across the country.

“Together with the help of the state, we were able to bring factory workers back, particularly in the garment district, which we view as a national treasure, and help keep many of these factories from shuttering their doors,” Rothenberg-Saenz said.

Goldatech has fulfilled high-volume contracts for New York state—rebuilding its stockpile—New York City’s Department of Health, the Arizona Department of Public Health and other government entities.

 

Sustainability and Innovation

One of Goldatech’s primary goals is to help mitigate the environmental impact of PPE manufacturing.

To that end, all materials and manufacturing are sourced in the United States and the company partners with industry leaders to “implement a strong domestic supply chain in PPE manufacturing.”

“We are very passionate about reusable gowns as a more sustainable option for the environment,” Rothenberg-Saenz said. “We want to make it easy for hospitals to make the switch, so we developed a straightforward app that goes along with our reusable gowns. Historically, they had a tag with a printed grid that you would manually tick off for each wash.”

“It [the app] digitally records and tracks the lifespan of our gowns. It is built into a back-office software, to monitor inventory levels.  For example, once inventory reaches 90 percent of its lifecycle, the customer can automatically reorder gowns to keep the process seamless.”

She said the demand for reusable gowns is growing slightly and she believes it will continue to grow. “The cost per use is lower than disposable gowns.  These facilities are stuck in old habits, but they should understand there’s a cheaper, bigger-picture option here.”

 

Challenges—Competing Against China on PPE

Goldatech faces challenges associated with China’s dominance in PPE production and imports of low-cost medical products.

According to PPE trade data now being tracked and reported by the Department of Commerce Office of Textiles & Apparel (OTEXA), U.S. imports of PPE grew from $4.8 billion in 2019 to $20.4 billion in 2020, an increase of 325 percent. Imports from China specifically jumped from $1.6 to $13.7 billion, up 756 percent to capture a two-thirds share of the U.S. PPE import market in 2020.

As NCTO has testified, China’s PPE sector has clearly benefited from state planning and predatory trade practices. Its “Made in China 2025” industrial policies were designed to nationalize and corner market share for these products.

“It’s definitely a challenge to meet their prices as we know the Chinese government subsidizes up to 70 percent of the cost of the PPE manufacturing,” Rothenberg-Saenz said. “It is hard to compete when imported products are being sold below cost. As manufacturers ramp up and reach new efficiencies, the USA industry becomes more competitive. Further commitment and investment from Capitol Hill would bolster these efforts.  We have a strong infrastructure across the country, and we are all intent on getting through this battle and convincing procurement teams to purchase American-made PPE.”

 

Long-Term Contracts: Push to Build a Permanent Domestic PPE Supply Chain

“[NCTO President & CEO] Kim Glas has been working on so many important issues in Washington to support the PPE supply chain and it starts with long-term contracts,” said Rothenberg-Saenz.

“There has to be a robust domestic supply chain in place,” said Baylis.  “Without fully supporting the manufacturers who have pivoted to making this product, should these events happen again, it is a security issue for the United States. Legislation needs to swiftly be put into place to ensure the significant investment and retooling that occurred during the pandemic was not in vain.”

In May, Glas testified at the Senate Homeland Security and Government Affairs Committee on the medical supply chain and outlined a series of policy recommendations to incentivize the establishment of a permanent domestic supply chain.

Among the recommendations she highlighted were: creating strong domestic procurement rules for federal PPE purchases and other essential products—substantially similar to the Berry Amendment and the Kissell Amendment which requires 100 percent U.S. content from fiber production forward; implementing long-term contracts to incentivize investment in the domestic PPE manufacturing base; and creating federal incentives for private sector hospitals and large provider networks to purchase American-made PPE.

Glas said the time is “ripe for a revival of American PPE textile manufacturing. It has already begun but we are at a pivotal time. Without the necessary policy response and support, our recent progress will be undone just as quickly, and China’s stranglehold over global medical textile supply will be locked in for the foreseeable future with no reason to invest here. However, with the right policy framework, the domestic PPE supply chains built overnight can endure and grow, creating a level of self-sufficiency domestically that we have learned the hard way is essential to our national health and economic security.”

Her full testimony can be found here.

“We will always have American innovation, but American manufacturing facilities are not guaranteed unless we continue to support them, especially through legislation,” Rothenberg-Saenz said.

 

Goldatech Banks on the Future

The company’s long-term goal is to manufacture its own line of sustainable and innovative performance health wear.

“We definitely want to continue manufacturing PPE. We are optimistic that there will be a future here, but we also plan to expand our PPE portfolio. We’re developing a new line which will merge molecular fabric science with expert tailoring,” Rothenberg-Saenz said.

She cited recent statistics showing the healthcare industry is expected to grow 49 percent by 2028.

“We are hoping to set a new standard in biodegradable products, especially with durable scrubs that would decompose in up to three years, which is a stark contrast to the current standard of up to 200 years, ” she added.

Asked if she missed designing for the fashion world:

“There are many similarities in that we’re on the shop floor, problem-solving and innovating new apparel products. That said, we are intensely more passionate about this new direction, and find it to be meaningful,” she said.  “The biggest difference is in the end use of the garment; this one of course being built to protect its wearer from exposure to infection. The magnitude of the situation and sense of responsibility we feel to keep healthcare workers safe has fueled our passion and purpose.”

“The pandemic exposed the profound fragility in our country [to supply PPE] and we have a chance to rectify it now.”