How VA Innovative Partnerships and Health Care Systems Can Respond to National Needs: NOSE Trial Example
Background: At the onset of COVID-19, essential supplies were not obtainable from manufacturers. This caused patients and clinicians to have additional risk and exposure to COVID-19 in some settings and the wasting of critical materials when testing was unavailable in other settings.
Observations: The Veterans Health Administration (VHA) developed and enacted contingency plans for depleted supplies under both its First Mission—to care for veterans—and its Fourth Mission—to support the American health care system in times of crisis. A partnership among the VHA, US Food and Drug Administration, the National Institutes of Health, and America Makes addressed national shortages with the curation and development of designs, testing protocols, product evaluation, and product validation. VHA leveraged digital manufacturing to produce nasopharyngeal swabs onsite—3-dimensional-printed nasal swabs—and validate them to cover the gap between stockpile depletion and ramp up of traditional product manufacturing.
Conclusions: This effort involved close collaboration between innovators and researchers within the organization and alongside government, industry, and academic partners. We illustrate this collaborative concept here with a use case of nasal swabs to demonstrate successes and lessons learned that are shaping how the VHA in conjunction with government and industry partners can shepherd this new strategy for crisis preparedness.
COLLABORATIONS
Interagency
Before the pandemic, the US Department of Veterans Affairs (VA) had been coordinating with the FDA, the National Institutes of Health (NIH), and the nonprofit America Makes to bring medical product development and manufacturing closer to the point of care.
At the outset of the COVID-19 pandemic, the collaboration was formalized to address new challenges.8 The objectives of this collaboration were the following: (1) host a digital repository for 3D-printed digital designs for personal protectice equipment and other medical supplies in or at risk of shortage; (2) provide scientifically based ratings for designs according to clinical and field testing; and (3) offer education to health care workers and the public about the digital manufacturing of medical goods and devices.4,9
A key output of this collaboration was the COVID 3D Trusted Repository For Users And Suppliers Through Testing (COVID 3D TRUST), a curated archive of designs. In most cases, existing FDA standards and guidance formed the basis of testing strategies with deviations due to limited access to traditional testing facilities and reagents.
To address novel NP swabs, working with its COVID 3D TRUST partners, the VA gathered a combined list of clinical- and engineering-informed customer requirements and performed a hazard analysis. The result was a list of design inputs for NP swabs and 8 standard test protocols to evaluate key functions (Table).10 These protocols are meant to benchmark novel 3D-printed swabs against the key functions of established, traditionally manufactured swabs, which have a long record of safety and efficacy. The protocols, developed by the VA and undergoing validation by the US Army, empower and inform consumers and provide performance metrics to swab designers and manufacturers. The testing protocols and preliminary test results developed by the VA are publicly available at the NIH.11
Intra-agency
The use of the inputs and verification tests noted in the Table may reduce the risk of poor design but were inadequate to evaluate the clinical safety and efficacy of novel swabs. Recognizing this, the VA Office of Healthcare Innovation and Learning (OHIL) and the Office of Research and Development (ORD) launched the Nasal Swab Objective and Statistical Evaluation (NOSE) study to formally evaluate the safety and efficacy of 3D-printed swabs in the field. This multisite clinical study was a close collaboration between the OHIL and ORD. The OHIL provided the quality system and manufacturing oversight and delivery of the swabs, and the ORD provided scientific review, research infrastructure, human subjects oversight, administrative support, and funding and fiscal oversight. The OHIL/ORD collaboration resulted in the successful completion of the NOSE study.
This study (manuscript under preparation) yielded two 3D-printing production processes and swab designs that had comparable performance to the standard of care, were manufacturable compliant with FDA guidelines, and could be produced at scale in a distributed manner. This approach directly addressed the 3 challenges described earlier.
LESSONS LEARNED
Swabs were an example of supply challenges in the pandemic, but advanced manufacturing (notably, digital designs leading to 3D-printed solutions) also served as a temporary solution to device and product shortages during the COVID-19 pandemic. Digital designs and 3D printing as manufacturing techniques have the following key advantages: (1) they are distributed in nature, both in the breadth of locations that have access to these manufacturing platforms and in the depth of material choice that can be used to fabricate products, which alleviates the threat of a disaster impacting manufacturing capacity or a material stream; (2) they do not require retooling of machinery so new products can deploy rapidly and on demand; and (3) the speed of digital iteration, printing, and revision allows for rapid product development and production.
