This paper explores how the approach, process, and learnings of the RADx Tech Deployment Core in its support of manufacturing, deployment, and implementation of medical technologies is creating a replicable model for the future. Initially, the key construct of the RADx Tech Deployment Core was helping companies manufacture, commercialize, and develop a digital infrastructure for the purpose of SARS-CoV-2 testing and reporting. However, the team and RADx Tech leadership soon realized that the larger infrastructure to deploy testing in non-clinical environments was nonexistent and that wrap-around services were required to build the necessary bridge between manufacturing and end users. Furthermore, the unique communities that required testing (e.g., manufacturing plants, transportation hubs, K-12 schools, etc.) had different infrastructure requirements and outsized needs for education and support around testing plan implementation. The Deployment Core, therefore, quickly scaled a team to help to complete the picture and provide guidance to end users and ultimately help shape public policy around a useful data model.
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http://dx.doi.org/10.1109/OJEMB.2021.3070822 | DOI Listing |
Clin Infect Dis
December 2024
Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA.
Background: The relationship between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral dynamics during acute infection and the development of long coronavirus disease 2019 (COVID-19), or "long COVID," is largely unknown.
Methods: Between October 2021 and February 2022, 7361 people not known to have COVID-19 self-collected nasal swab samples for SARS-CoV-2 reverse-transcription polymerase chain reaction testing every 24-48 hours for 10-14 days. Participants whose first known SARS-CoV-2 infection was detected were surveyed for long COVID in August 2023.
BMC Infect Dis
November 2024
Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
Shortly after the first case of SARS-CoV-2 was diagnosed a public health emergency (PHE) was declared and a multi-agency response was initiated within the US federal government to create and propagate testing capacity. As part of this response, an unprecedented program designated Rapid Acceleration of Diagnostics (RADx) Tech was established by the National Institutes of Health (NIH) to facilitate the development of point-of-care tests for the COVID-19. The RADx Tech Clinical Studies Core (CSC), located at the University of Massachusetts Chan Medical School (UMass Chan), with partnering academic, private, and non-governmental organizations around the country, was tasked with developing clinical studies to support this work.
View Article and Find Full Text PDFInt Urogynecol J
September 2024
Department of Obstetrics & Gynecology, Columbia University Irving Medical Center, New York, NY, USA.
Introduction And Hypothesis: The objective was to evaluate the safety and effectiveness of an intrapartum electromechanical pelvic floor dilator designed to reduce the risk of levator ani muscle (LAM) avulsion during vaginal delivery.
Methods: A multicenter, randomized controlled trial enrolled nulliparous participants planning vaginal delivery. During the first stage of labor, participants were randomized to receive the intravaginal device or standard-of-care labor management.
IEEE Open J Eng Med Biol
January 2024
Over-the-counter (OTC) diagnostic testing is on the rise with many in vitro diagnostic tests being lateral flow assays (LFAs). A growing number of these are adopting reader technologies, which provides an alternative to visual readouts for results interpretation, allowing for improved accessibility of OTC diagnostics. As the reader technology market develops, there are many technologies entering the market, but no clear, single solution has yet been identified.
View Article and Find Full Text PDFIEEE Open J Eng Med Biol
February 2024
Independent Contractors USA.
Braille is often proposed by the uninformed as the optimal solution to providing an alternative to visual information to the visually impaired. The purpose of this article is to highlight the complexity of the braille user population and discuss the importance of understanding the use of braille as a solution for equal access of information. As part of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) Rapid Acceleration of Diagnostics (RADx) Tech program and its goal to make home tests accessible to people with disabilities, a series of interviews with industry experts was conducted to better understand braille technologies and the braille user space.
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