Vision

The vision of the VHA Office of Advanced Manufacturing is to provide personalized, safe and equitable care for eligible Veterans by building advanced manufacturing capabilities across the enterprise.

What is OAM?

VHA Office of Advanced Manufacturing (OAM) guides the use of advanced manufacturing technologies, like 3D printing, in healthcare applications at VHA. OAM is developing national policy, providing oversight, and operating and coordinating VHA clinical Advanced Manufacturing Laboratory Services to provide equitable access to patient-matched medical devices. These innovations empowering frontline clinicians to design and implement product-based solutions to clinical challenges, and strengthening supply chain resiliency by providing in-house manufacturing capability. OAM is building digital and physical infrastructure to bring medical device innovation and manufacturing back onto VA soil, so that Veterans are first in line to receive new products and service innovation. Accomplishments to date include:

• Establishment of an FDA-compliant Quality Management System
• In-house production of patient-matched medical devices
• Collaboration with other government agencies, academia, and industry partners to accelerate the time it takes to go from promising product to clinical market
• Development of training content and pilot programs for existing VA staff and Veterans to learn new skills in advanced and digital manufacturing.

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Consult Process

OAM is building an internal consult process that allows clinicians from across VA to place 3D printing requests to OAM hubs. The consult is a powerful step towards providing personalized, safe and equitable care for eligible Veterans across the enterprise. VA clinicians and staff members can follow the link below for more information.

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(Internal VA Only)

OAM Sites

GioStent: Improving the Quality of Life for a Veteran Experiencing Hearing Loss

Vietnam War Veteran, Michael Nicoletti, noticed that his hearing was off. Even when he doubled his wife’s television volume settings from twenty to forty, he was still straining to hear. Having spent over 30 years of his life as an engineer, Nicoletti started to tinker and found an at-home solution – drinking straws.

With this idea in mind, Nicoletti visited his Audiologist, Dr. Kent Flanagan, at Ralph H. Johnson VA Medical Center in Charleston, South Carolina. Dr. Flanagan diagnosed Nicoletti with acquired atresia, cartilage collapse in both ears preventing sound from reaching his inner ear. While alarmed by the idea of his patient sticking straws in his ears, Dr. Flanagan knew that they could leverage this idea to avoid surgery and find a less invasive solution to improving Nicoletti’s hearing. He reached out to biomedical engineer, Nikki Beitenman, who runs the Charleston VA Advanced Manufacturing Hub, to design and print a stent that the Veteran could use to help prop his ear canals open. 3D Printing (3DP) is an advanced manufacturing (AM) technology that allows people to make unique graspable products, adding material to an object, layer by layer. This process enables the production of complex shapes that use less material than traditional manufacturing methods. After six prototypes that incorporated the Veteran and Charleston Advanced Manufacturing team’s design iterations to fit, finish, and functionality, a personalized ear canal stent was created for the Veteran.

In February 2021, VA received compassionate use approval from the Food and Drug Administration (FDA) for the groundbreaking in-house developed GioStent medical device, named after Nicoletti’s grandson, Giovanni. FDA’s compassionate use authorization enables specific, individual patients to prototype unique treatments outside of clinical trials when there are no comparable alternative therapy options.

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Thermal Fuse Cover: 3D Printing for Fire Safety

3DP continues to be a revolutionizing capability in manufacturing, architecture, and healthcare. One use case for 3D printing in VA is a 3D printed device to reduce the risk of fires for Veterans with at-home oxygen tanks.
Between October 2006 and October 2016, the VA National Center for Patient Safety received 746 patient safety reports from VA facilities describing burns to Veterans and fires involving home oxygen delivery systems. OAM developed a solution to help address this issue - the 3D printed thermal fuse cover.

Innovating the Thermal Fuse
A thermal fuse is a safety device inserted in the oxygen line of patients with at-home oxygen - preventing fire from traveling from the patient to the oxygen tank. This safety risk can happen if a patient smokes while wearing oxygen. Stopping the flow of oxygen removes a major source of fire acceleration, potentially preventing ignition of the oxygen source or nearby materials. Patients often remove the thermal fuse because of confusion about whether it is needed or not. This latest 3D printed thermal fuse cover makes it more difficult for this essential safety feature to be removed.

Innovators Behind the Impact
The Human Engineering and Research Lab (HERL) at the Pittsburgh VA Medical Center created the initial concept in June 2020. The OAM team took the design through the manufacturing, testing, and regulatory process — resulting in the product being listed as a medical device with the U.S. Food and Drug Administration (FDA). Since December 2020, VA has printed 1,700+ Thermal Fuse Covers at the Seattle Advanced Manufacturing Hub within the Puget Sound VA Health Care System. These thermal fuse covers are now being distributed to the field for use by VA patients across the state with at home oxygen systems resulting in fewer oxygen tank related burn accidents.

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Self Catheterization Mirror
Customized 3D Printed Assistive Technology Devices for Women Veterans

A Veteran with a spinal cord injury came to VA in need of a self-catheterization mirror. The off-the-shelf option did not fit her properly and lacked an effective magnifying mirror. The occupational therapist at her Central Virginia VA Healthcare System made a prototype out of thermoplastic material and consulted a rehabilitation engineer to determine if a more durable 3D Printed solution was possible. After multiple designs and Veteran and clinician provided feedback, a real time patient-matched 3D printed solution that folded and could travel with the Veteran.

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Makeup Brush
Customized 3D Printed Assistive Technology Devices for Women Veterans

A Veteran with a spinal cord injury had a goal: to put on her makeup using her universal cuff. The Veteran needed a design that would allow her to grasp a makeup brush and place it in the cuff and a makeup brush holder that would keep the brushes in place. She worked with the Richmond Assistive Technology team at the Central Virginia VA Healthcare System with these specifications in mind and to ensure the design was compatible with several different sized make-up brushes.

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Vietnam Veteran gets Help from a 3D Printed Kidney: 3D Printer the Latest Weapon against Cancer

It's the latest advance in the fight against cancer. It's not a new drug, but a new technique that practically puts a patient's tumor in the surgeon's hands before they even walk into the operating room.
The medical breakthrough comes off a 3D printer in the Veterans Administration Puget Sound Hospital Innovations Lab after around 36 hours. Initially, it doesn't look like much. But peel back the layers and you'll see a replica of a Veteran's kidney. And you'll see his cancer.

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Office of Advanced Manufacturing (OAM)

Delivering Solutions to Veterans at the Point of Care

Vision

Consult Process

Learn More

(Internal VA Only)

Delivering Solutions to
Veterans at the Point of Care