Back to Top Skip to main content

Army, FDA discuss 3D printing at workshop

When a medical device breaks down on a medical unit deployed to a remote part of the world, the closest repair parts could be thousands of miles away (U.S. Army photo by Francis S. Trachta) When a medical device breaks down on a medical unit deployed to a remote part of the world, the closest repair parts could be thousands of miles away (U.S. Army photo by Francis S. Trachta)

Recommended Content:

Military Hospitals and Clinics | Technology | Combat Support | Medical Logistics

FORT DETRICK, Md. — When a medical device breaks down on a U.S. Army unit deployed to a remote part of the world, the closest repair parts could be thousands of miles away.

Even when parts are readily available, the shipping process – sometimes into hostile environments – could take days or even weeks, if it’s logistically feasible at all.

As the Army embraces advanced manufacturing in its modernization strategies, medical logisticians are looking to 3D printing as a potential solution to this challenge.

"The medical industry is one of the fastest innovators in the defense industrial base, so the AMLC is used to working with industrial partners constantly pushing the state of the art,” said Jack Rosarius, director of Medical Maintenance Management Directorate within the U.S. Army Medical Materiel Agency, a direct reporting unit to Army Medical Logistics Command.

Specifically for medical devices, 3D printing technology – also known as additive manufacturing – may enable the Army to develop repair parts that extend the life cycle of equipment and ensure they are ready for use when and where Soldiers need them.

While the technology offers numerous new uses and potential advantages, it also poses regulatory challenges and warrants safety considerations still under review by the U.S. Food and Drug Administration.

On Dec. 9, 2019, AMLC hosted a military-specific workshop at Fort Detrick with FDA leaders on the topic to seek guidance on current policies, concept regulations and potential stumbling blocks as it explores manufacturing its own repair parts and other 3D-printed items.

Representatives from Army Materiel Command, Air Force and Defense Health Agency also took part in the discussion.

‘Really excited’

USAMMA started piloting additive manufacturing in 2015 in partnership with its equipment program managers. Rosarius said a heightened top-down focus from Army senior leadership has only helped to push the 3D printing movement forward.

“I’m really excited about the opportunities,” said USAMMA Commander Col. Timothy D. Walsh, who also serves as deputy commander of AMLC. “It’s an exciting time to be a part of Army medicine.”

The 3D printing process involves building a three-dimensional object using a computer-aided design model by adding material layer by layer, which is why it’s called additive manufacturing.

The process differs from conventional machining, casting or forging, in which material is removed from a stock item or poured into a mold and shaped to form a product.

Through 3D printing, medical devices can be produced using a range of media, including metals, plastics, hydrogels or even biological materials. Most printing systems do this by dividing or slicing a digital design file in two-dimensional layers, then building each layer on top of the previous layer.

According to the FDA, medical companies began embracing additive manufacturing to create devices that were previously impossible to make, personalized to the patient or both.

‘Gray areas’

While the technology has unlocked new production possibilities, it also has prompted the FDA to explore conceptual regulations to safeguard patients and institute performance requirements.

“The FDA is very focused on what the risk is and how to mitigate it” with 3D-printed medical products, said Matthew A. Di Prima, materials engineer for the agency.

Heather L. Agler, a senior program manager for the FDA, said the technology has created new “gray areas,” specifically when it comes to military production and uses.

Patient safety, however, remains the overarching issue under consideration by federal regulators.

Army’s commitment

During the workshop, AMLC officials gave an overview of the Army’s Advanced Manufacturing Directive and briefed the FDA on efforts to date.

USAMMA has made successful use of 3D printing to produce some obsolete repair parts already, like an impeller for a medical sink or a locking pin for a vaporizer used on an anesthesia machine.

Many more are in various stages of development or design.

“The Advanced Manufacturing Directive demonstrates the Army's commitment to getting this right, so we're positioned for multi-domain operations and large-scale combat operations,” Rosarius said. “The medical maintenance community is excited about expanding the ways we can support patient care downrange.”

Di Prima highlighted different additive manufacturing use-cases, in addition to current agency policy considerations for manufacturers.

The group also worked through different Army-specific scenarios to identify possible snags for ongoing or future efforts, as well as several action items for further discussion.

“We’re happy to participate,” Agler said. “The military is always thinking forward. It’s good to be able to learn … and very important that we continue to work together to make sure you have the right things available when they are needed.”

Disclaimer: Re-published content may be edited for length and clarity. Read original post.

You also may be interested in...

Solution Delivery Division

Fact Sheet
1/21/2021

The mission of Solution Delivery Division (SDD) is enhancing Health Service Delivery through exceptional Information and Technology.

Recommended Content:

Technology

DMRTI_EWSC Student Criteria

Fact Sheet
1/8/2021

A reference for potential EWSC students.

Recommended Content:

Emergency War Surgery Course (EWSC) | Defense Medical Readiness Training Institute | Combat Support

MHS operational innovations continue in battle against COVID-19

Article
1/5/2021
Two medical personnel, wearing full PPE, in an operating room

MHS innovations in 2020 include a new registry for real-time COVID-19 data and a system to free up hospital beds and protect patients from the disease.

Recommended Content:

Coronavirus | Research and Innovation | Innovation | Technology

DHA’s IT innovation continues during COVID-19 pandemic

Article
12/31/2020
Three military personnel, wearing masks, in front of a computer screen

IT innovations keep pace despite COVID-19 road blocks.

Recommended Content:

Coronavirus | Research and Innovation | Technology | MHS GENESIS

Barksdale AFB trains medics with Tactical Combat Casualty Care

Article
12/30/2020
Military personnel participating in training exercise, treat a dummy for injuries

Medics of the 2nd Medical Group are becoming a whole lot more lethal, in a good way.

Recommended Content:

Combat Support

MTFs respond to COVID-19 with increased telehealth, drive-thrus

Article
12/29/2020
Military physician sitting at desk, talking to patient on his computer

COVID MTF innovations include more virtual health options and drive thrus.

Recommended Content:

Coronavirus | Technology

Protecting the Force: How the MHS helped sustain readiness in the face of COVID

Article
12/23/2020
Hospital personnel treating a patient on a stretcher

The Military Health System is reviewing how it kept warfighters mission-ready and units online in 2020 during the ongoing pandemic.

Recommended Content:

December Toolkit | Combat Support | Coronavirus

Nurse-led research aims to improve battlefield medicine

Article
12/21/2020
Military nurses working on a simulated patient in a helicopter

[O]ne of their goals is to create novel solutions to optimize survival and functional recovery of burn casualties.

Recommended Content:

Combat Support | Research and Innovation

TRICARE Online Patient Portal

Fact Sheet
12/21/2020

TRICARE Online Patient Portal (TOL) is the Department of Defense (DoD) online patient portal providing eligible beneficiaries access to military hospital and clinic appointing, prescription (Rx) refill, DoD PP Health Record personal health data, Secure Messaging, Service Separation/Retirement and Nurse Advice Line.

Recommended Content:

Technology

Fort Irwin & TDP collaborate to improve dental care for families

Article
12/16/2020
Image of a bus with the words "Military Dental Services" on the side

The need for family dentistry at Fort Irwin was the result of losing their network civilian dentist on base last spring.

Recommended Content:

Combat Support | Health Readiness

USAMRIID scientist recognized by French for distinguished service

Article
12/4/2020
Two military officers on stage; one handing the other a certificate

Kugelman...identified genetic markers of persistence of the Chikungunya virus.

Recommended Content:

Health Readiness | Research and Innovation | Technology

Military medicine confronts an invisible enemy

Article
12/4/2020
Medical personnel set up in an outside military tent

The collective response to the pandemic underscored the MHS reputation for innovation, with practical applications beyond military medicine.

Recommended Content:

Combat Support | Warrior Care | Public Health | Coronavirus | Heroes Behind the Mask | December Toolkit

DGMC medical study looks at plant-based diet

Article
12/3/2020
Man wearing mask and gloves putting container of salad into salad bar

Researchers measured important cholesterol, weight and blood pressure markers at baseline and at 4-weeks.

Recommended Content:

Combat Support | Health Readiness

New report finds military hearing health is improving

Article
12/3/2020
Military doctor inspecting patient's ear

Noise-induced hearing loss is decreasing for active-duty service members.

Recommended Content:

Combat Support | Health Readiness | Hearing Loss | Hearing Center of Excellence Research Coordination Directorate | Hearing Center of Excellence

Seven MTFs recognized by ACS for surgical care

Article
12/3/2020
Military surgeons in an operating room

The MHS hospitals were among 89 recognized facilities and 607 total military and civilian hospitals participating in the program.

Recommended Content:

Combat Support | Health Readiness
<< < 1 2 3 4 5  ... > >> 
Showing results 1 - 15 Page 1 of 24

DHA Address: 7700 Arlington Boulevard | Suite 5101 | Falls Church, VA | 22042-5101

Some documents are presented in Portable Document Format (PDF). A PDF reader is required for viewing. Download a PDF Reader or learn more about PDFs.