Frequently Asked Questions

Categories:   General | Design Related | NIH Related | VA Related | Manufacturer Related | Health Care Related

General Questions

(G1) Why was this repository put together?

America Makes has developed this repository to address personal protective equipment shortages resulting from COVID-19.  This repository will aid in connecting U.S. healthcare providers, who submit their equipment requests, to industry partners in the U.S. additive manufacturing supply chain.  America Makes is collaborating with its member, the Food and Drug Administration (FDA), the Department of Veterans’ Affairs (VA), and the National Institutes of Health (NIH), to help ensure the additive manufacturing industry can effectively and safely meet the needs of America’s healthcare workers on the front lines of the Coronavirus crisis.

(G2) Who is America Makes and why are they gathering this information?

America Makes is the Department of Defense’s Manufacturing Innovation Institute (DoD MII) for additive manufacturing. As the national accelerator for additive manufacturing (AM) based in Youngstown, Ohio, America Makes is the nation’s leading and collaborative partner in AM and 3D printing technology research, discovery, creation, and innovation.

Comprised of member organizations from industry, academia, government, non-government agencies, and workforce and economic development resources, the America Makes membership community is working together to innovate and accelerate AM to increase our nation’s global manufacturing competitiveness.

Our mission is to drive collaboration within our industry to meet the needs of the U.S. government and manufacturing base. Our mission could not be clearer than it is today with the ongoing COVID-19 crisis and the pending supply shortages throughout the country. We believe this repository will play a critical role in meeting the needs of front-line health care workers.

(G3) Who is this repository intended for?

This repository is intended for U.S. manufacturers and 3D print designers that have the authority within their organization to speak on behalf of the company and dedicate necessary resources.

This site is also intended for authorized procurement representatives from within any U.S. healthcare system to communicate the needs of their work force.

America Makes is capturing the needs of the U.S. healthcare community, additive manufacturing capabilities of U.S. manufacturers, and publicly releasable 3D printing designs to be reviewed for use in a health care or community setting.

(G4) What happens to the information collected in this website?

The data collected will be used to:

1. 1. Act as a pathway for designs to be reviewed for use in a health care or community setting.
   2. Connect the manufacturing community’s capability with the needs of the health care community to streamline supply chain structure

(G5) Will this website really meet the needs of the supply chain in real time?

This website and the data collected are not intended to be an overnight solution for immediate needs. This collection process will streamline the review process for uploaded designs, allowing manufacturers to rapidly create those items to prioritize delivery where it is needed most.

(G6) We are an international company. Can we participate in the repository?

We cannot ensure a place for international organizations within this effort at this time.

(G7) Who do I contact to get or give more information?

Currently the most appropriate way to communicate with America Makes is via email. Contact us at covid19@americamakes.us.

You can also stay up to date by continuing to visit this page or sign up for email updates at https://www.americamakes.us/join-mailing-list/.

(G8) What is the NIH 3D Print Exchange?

The NIH 3D Print Exchange provides a searchable repository of open-source models in formats that are readily compatible for use in additive manufacturing equipment and 3d printers. Designs submitted through the America Makes process will be reviewed for use in a health care or community setting and placed on the NIH 3D Print Exchange with appropriate review designation.

(G9) Is this site intended for just additive manufacturing or any manufacturing?

The information America Makes is gathering is specifically focused on additive manufacturing (3d printing).

Designer Related Questions

(D1) What happens after we submit our design?

Upon submission, designs will be placed on a fast track review process by FDA, VA and NIH for recommended use. Designs will be placed on the NIH 3D Print Exchange with one of the following review designations:

• • Reviewed for clinical use
  • Designs optimized for community use
  • Prototypes in progress or under review
  • Warning: Designs with safety implications

Designs submitted in this process are intended to be open source and freely shared with industry. All designs will be publicly accessible on the NIH 3D Print Exchange with their respective designation from the review process. This allows manufacturers and providers to have confidence that certain designs are appropriate for use.

Please also refer to the VA’s Quick Guide & FAQ.

(D2) How do I connect with a manufacturer to produce my design, or a health care provider to purchase my design?

This site is not intended for direct connections. America Makes will be recommending connections based on needs, capabilities, and capacity.

(D3) Can I connect directly with the FDA or NIH on this effort instead of going through the repository?

The America Makes design submission form places your design into a fast track workflow that provides an opportunity for rapid approval. Designs not submitted through the America Makes process may not be considered for the fast track workflow.

(D4) Is there any requirement to submit additional material or support documentation with my design?

There is no requirement to submit anything more than the minimum requirements of the web submission form. However, if your design has been reviewed by an independent source or other party, it is recommended that you provide as much support documentation as possible to assist in the review and approval process.

(D5) If we submit a design through America Makes, do we have any control over who picks up the design?  Do we get some sort of notification?

There is currently no mechanism in place to notify individuals or organizations who upload designs to the NIH3D Print Exchange when their design is downloaded.

(D6) Would we go through a licensing process with each manufacturer that picks up the design?  (I’ve seen the NIH licensing options, but I’m not familiar with how the NIH process works).

All submitted designs are open-source, so there is no licensing model.

(D7) Do foreign manufacturers have access to designs submitted through America Makes?

All designs submitted through the America Makes process are open-source and housed on the NIH 3D Print Exchange which is a public website and accessible by anyone.

(D8) What about patent applications?

Consult your organization’s legal council to understand what actions are appropriate for your organization and business model prior to sharing any technical data. All designs submitted through the America Makes process are expected to be open-source.

NIH Related Questions

(N1) Which designs are clinically tested, and in what order?

We want to inform you of the process is for prioritizing clinical testing. Each submission is given a score. This score determines where the submission fits in the queue for testing.

Scoring includes the following criteria:

1. 1. 1. Demand – Has this item been identified by the community and/or logistics supply chains as being in short supply or at risk of running out?
      2. Feasibility – Is this design printable as described, and does the design appear to reasonably work as described?
      3. Completeness – Is the submission complete, with detailed instructions on how the part will be printed and used?

Please also refer to the VA’s Quick Guide & FAQ.

(N2) What happens if your design is evaluated and it does not pass?

If design flaws or other concerns, are discovered, you will be notified by email and given constructive feedback. The goal is to help make your design a success. After iteration, the design will be re-evaluated and if the concerns have been successfully addressed, the design will move to the clinically reviewed category.

(N3) What does Prototype mean?

All submissions begin the process as prototypes, with the exception of submissions requiring an emergency use authorization from FDA. These submissions will be placed into a category distinct from prototypes and will be clearly marked as “Warning – requires FDA approval”.

(N4) What can I do to speed up the review process of my proposal?

Designs that have been marked “Reviewed for clinical use” are a great resource for understanding what good documentation looks like. In general, you should provide information about the type of printer used to print your design, what types of materials should be used, identify any clinical indications of the design, and how the design should be constructed and used. 

Manufacturer Related Questions

(M1) How do we get connected with a health care provider in need?

America Makes will provide a best effort to connect the capabilities of manufacturers to the urgent needs of the health care community. This ‘match making’ activity will be conducted through the website portal.

(M2) Who will be able to see our company’s capabilities?

Manufacturers capabilities will be visible by the America Makes team and government partners (FDA, NIH and VA) only.

(M3) Who will be paired with our capabilities?

A health care organization that has expressed a need of your services.

(M4) How will our manufacturing services be paid for?

Once a connection has been made between a manufacturer and a health care provider, both parties will negotiate payment and delivery and any other terms necessary to complete the transaction.

(M5) What about other manufacturing processes beyond additive? Will you accept capabilities from manufacturers that have capacity in other technologies beyond additive?

This site in only taking capabilities and design information for the additive manufacturing industry.

(M6) The manufacturer submission form for COVID-19 does not allow new technology or Other. We have a new AM technique and submitted info the best we could but the selections forced some answers that do not fit with the technology.

We are constantly improving our website and forms.  If we need additional information we will reach out to you, but we encourage you to explain in detail the file formatting requirements and nuances to your AM process which may impede a smooth transition of the technical data package and production with your organization.

Health Care Related Questions

(H1) What happens after we submit our specific need to the website and how do I get connected with a manufacturer?

Once you have submitted your organization’s needs, the system will match that need to a manufacturer with capabilities in your geographic area. As the repository is not a marketplace, the manufacturer will be notified of your need and connect independently.

(H2) I see an immediate need in my facility, can I submit the form individually?

To ensure an accurate recording of needs, we are asking that individuals coordinate their needs submissions through their appropriate procurement process.

(H3) How do we know if the designs being submitted will be safe to use in a health care setting?

All designs will be reviewed by the FDA, VA and NIH, and have one of the follow designations. allowing you to have confidence that they have been reviewed for us:

• • Reviewed for clinical use
  • Designs optimized for community use
  • Prototypes in progress or under review
  • Warning: Designs with safety implications

This allows you to have confidence that certain designs are appropriate for use in clinical and community settings.

(H4) How can my organization be certain manufacturers can manufacture to our specifications?

Once a connection has been made between a health care organization and a Manufacturer, it will be the responsibility of each party to negotiate in good faith. It will be expected that a manufacturer can produce evidence of their quality assurance capabilities and any certifications necessary to produce the products being requested.