Dallas, Texas--(Newsfile Corp. - December 5, 2022) - Stronghold Group, a globally experienced team of Iraq and Afghanistan war veterans, has announced it has onshored the intellectual property and manufacturing of isolation gowns and other medical products to manufacturing facilities stateside. The President and CEO of Stronghold Group, David Henderson, states that the company has also partnered with several raw material manufacturers and medical distributors based in the United States with the ultimate goal of creating medical products that are 100% created in America.
"Simply put, we would like to see accountability, manufacturing, and intellectual property back where it belongs and serves US-based customers the best - in the United States," says Henderson. According to the United States Government Accountability Office report published in January 2022, FDA foreign facility inspections have significantly decreased in recent years, almost coming to a complete halt for over 8 months during the pandemic. As inspections resume, unique challenges exist that limit proper oversight of overseas production facilities - particularly those located in China. In many cases, inspections generally must be preannounced, and investigators rely on the establishment being inspected to provide translation services.[1] Reshoring these facilities allows us to not only have the access to these critical medical products, but also the peace of mind that proper regulatory controls and compliance procedures are being abided by to ensure product safety.
Stronghold Group states that through a basic analysis of the HTS (Harmonized Tariff Schedule) codes from United States International Trade Commission and the United States Customs and Border Protection import data shows that more than 2 billion disposable isolation and surgical gowns were imported in the year 2020.[2] However, less than 1% of those gowns were manufactured in the United States even at the height of the pandemic. The vast majority of disposable isolation and surgical gowns are manufactured in China, where raw material and labor concerns[3] often cause wholesale recalls or Withhold Release Orders from the CBP.[4]
"There seems to be this narrative that the U.S. can't compete anymore in the manufacturing and innovation space, causing an overreliance on China for manufacturing," says Henderson, "But I think that's just not true. We have sent people to the moon. We created GPS. And the internet. American ingenuity knows no bounds. That's the America I believe in, and we're seeing it real time in the US-based manufacturing space."
"We realized that there was a need and a demand in the marketplace for intellectual property that would support manufacturing isolation gowns and other medical products here in the States," says Henderson. "So, that is exactly what we did - we established manufacturing facilities and brought the expertise and automation stateside. This, we hope, will lead to thousands of jobs returning to America from overseas and greater transparency in the supply chain. We are very happy to be one of the companies leading this charge."
Stronghold Group has partnered with cutting-edge manufacturers to produce isolation gowns, surgical gowns, nitrile gloves, and other medical products in its Stateside facilities. The company aims to increase the number of medical products it produces and currently has almost one dozen additional 510(k)s that are in process, with their first 510(k) K213859 for Nitrile Exam Gloves approved in July 2022.[5] All of the new 510(k) submissions are for medical products with intellectual property, processes, automation, and manufacturing that will be 100% based in the United States.
Since the pandemic, several companies that hoped to establish US PPE manufacturing operations have scaled back or shut down, largely due to high operating costs driving noncompetitive price points. Many of these facilities were capitalized with millions of dollars in federal or state funding aimed at bolstering American production capabilities. "What we saw was a copy-and-paste approach that was reliant on government purchase orders to subsidize higher domestic labor and material costs vs China," says Henderson. "To be competitive long-term, we need to add value. By investing in advanced automated manufacturing solutions that increase productivity, Stronghold Group is focused on providing a permanent solution to fortify the US PPE industrial base with a risk mitigated, transparent supply chain, at a competitive price."
Stronghold Group is also excited to announce that their own 510(k) nitrile glove, isolation gowns (product code OEA), and surgical gowns (product code FYA) are already being manufactured in America and will soon start delivering to U.S. Federal Customers through their VA Federal Supply Schedule (FSS) contract award.
While Stronghold Group recognizes the importance of on-shoring the manufacturing of medical devices and bringing production stateside, the Company maintains overseas supply chains in allied countries. "We're seeing a geopolitical shift in the world, accelerating the fracturing of traditional supply chains," says Sean Niquette, Stronghold Group’s CFO. "In terms of risk mitigation, it's important that end users keep an eye on their supply chains and prioritize purchases from the right overseas countries with common interests. Stronghold Group continues to help its customers realign supply chains where necessary to mitigate risk while maintaining profit margins."
Stronghold Group states that as it scales manufacturing, it will remain focused on its overall goal: to produce more medical products in the United States so that doctors and hospitals will be better equipped if another large-scale medical emergency occurs. "We all saw what happened when COVID hit: international borders closed along with vital supply lines of certain medical products," says Niquette. "By manufacturing medical products here in America, we aim to avoid this difficulty in the future while providing transparency that is needed in this market. Over-reliance on overseas medical products manufacturing created a perfect storm for healthcare providers, who had to operate in the face of supply chain breakdowns, crippling delays, price gouging, and sub-standard products from ad-hoc facilities."
Stronghold Group is a VA-verified, Service Disabled Veteran Owned Small Business (SDVOSB) comprised of Iraq-Afghanistan Veterans. Stronghold Group is a U.S.-based manufacturer and distributor of medical devices, personal protective equipment, and consumables to public and private healthcare entities, as well as federal, state and local agencies within the United States. Stronghold Group serves its customers through U.S. manufacturing facilities with a clear mission: to strengthen U.S. manufacturing footprint and capabilities, reduce reliance on overseas manufacturing, and increase the U.S. competitive posture through technological innovation and the U.S. labor market. Stronghold Group's globally experienced team of Iraq and Afghanistan war veterans has supported private companies and government/military agencies since 2016. Its services include assisting companies with obtaining 510(k)s, bringing their products to the federal marketplace, and consulting with private corporations to reduce supply chain risk.
For more information about Stronghold Group, please visit its website or contact:
David Henderson, Stronghold Group
info@strongholdcare.com
Sources:
[1] https://www.gao.gov/assets/gao-22-103611.pdf
[2] USITC DataWeb/USDOC/CBP, HTS 6210.10.5000 and 6210.10.5010 (accessed November 1, 2022). Disposable surgical and isolation gowns were broken out into HTS 6210.10.5010 effective January 1, 2021. Data on reusable surgical and isolation gowns are not presented, as reusable gowns are broken out across several HTS codes.
[3] CBP: Uyghur Forced Labor Prevention Act. https://www.cbp.gov/trade/forced-labor/UFLPA
[4] https://www.cbp.gov/newsroom/national-media-release/department-homeland-security-issues-withhold-release-order-silica
[5] https://www.yahoo.com/now/stronghold-group-receives-first-510-220500413.html
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