Opportunity Information: Apply for RFA HD 15 024
Apply for RFA HD 15 024
- The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Use of 3 D Printers for the Production of Medical Devices (R41/R42)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Dec 10, 2014 and posted on Dec 9, 2014.
- Applicants must submit their applications by Feb 10, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $3,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $150,000.00 in funding.
- Eligible applicants include: Small businesses.
- Other Eligible Applicants include the following Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture SBIR and STTR. Be a concern which is more than 50 directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50 directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these OR SBIR only. Be a concern which is more than 50 owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50 of the concern OR SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with 121.705(b) concerning registration and proposal requirements. Has, including its affiliates, not more than 500 employees.
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Opportunity Summary:
The NIH funding opportunity titled "Use of 3 D Printers for the Production of Medical Devices (R41/R42)" (Funding Opportunity Number RFA-HD-15-024) supported Small Business Technology Transfer (STTR) research projects aimed at making 3D printing a practical, clinically useful way to produce medical devices specifically sized and designed for premature infants and neonates. The core problem behind the announcement is that many devices simply are not manufactured in neonatal-appropriate sizes, so hospitals often have to rely on pediatric-sized alternatives that do not fit well and can lead to harmful outcomes. Traditional medical device manufacturers also have limited financial incentive to produce very small runs for this population, so the FOA framed 3D printing as a way to overcome that economic and manufacturing barrier by enabling short lead times, customization, and production of complex, patient-matched components on demand.
From a technical standpoint, the FOA focused less on printing novelty for its own sake and more on closing specific capability gaps that were preventing 3D printing from meeting neonatal device needs. Applicants were invited to propose R&D to develop (1) 3D printers suitable for this purpose, (2) polymers and other printable materials, and (3) validated process specifications that together would allow production of devices intended for external use or for short-term insertion and implantation in the human body. The announcement noted that while research was progressing in areas like bioresorbable scaffolds and tissue engineering, there were no commercial suppliers offering complete printer-and-material systems capable of producing flexible, implantable medical devices. In other words, NIH was signaling that the missing piece was not just a better printer or a better polymer alone, but an integrated, reliable manufacturing approach that could produce safe, functional, flexible neonatal devices with repeatable quality.
The intended impact was practical clinical improvement in neonatal care. By enabling devices that actually match the anatomy and clinical requirements of premature and newborn patients, the FOA anticipated reductions in complications driven by poor fit and inappropriate sizing. The announcement also implicitly emphasized that the solution needed to be feasible in real health care settings, where speed, quality control, and reproducibility matter. 3D printing was positioned as a pathway to deliver customized or small-batch devices without the long tooling cycles and high per-unit costs that discourage conventional manufacturers from serving a small patient population.
This was a discretionary grant opportunity under the health-related activity category and was listed under CFDA 93.865 (Child Health and Human Development Extramural Research). The funding instrument was an STTR grant using the NIH R41/R42 mechanism, meaning it supported a phased small business technology transfer approach (Phase I feasibility followed by Phase II development), typically involving collaboration between a U.S. small business and a research institution as required under STTR rules. There was no cost sharing or matching requirement stated for applicants.
Eligibility was limited to U.S. small business concerns, generally defined by being for-profit, having a place of business in the United States, operating primarily in the United States (or making a significant contribution to the U.S. economy), fitting an allowable business legal structure, being appropriately U.S.-owned and controlled under the applicable small business rules, and having no more than 500 employees including affiliates. The announcement text included detailed ownership/control conditions that reflect standard SBIR/STTR eligibility language, including provisions addressing ownership by individuals who are U.S. citizens or permanent residents and certain venture-backed ownership structures (though this FOA itself was specifically for STTR).
In terms of the timeline and funding levels, the FOA was posted in December 2014 with an original and final closing date of February 10, 2015, and it was archived in March 2015. NIH estimated total funding of about $3,000,000 for the opportunity, and the listed award ceiling was $150,000 (a figure that typically aligns with Phase I budget expectations, though actual project budgets can depend on the specific NIH small business policy in effect at the time and any FOA-specific limits). The sponsoring agency was the National Institutes of Health, and the full announcement had been available through the NIH Grants Guide. Contact support for access or linking issues was routed through the NIH Office of Extramural Research webmaster addresses provided in the notice.
Overall, the FOA can be read as a targeted push to move neonatal 3D-printed medical devices from a promising concept into a manufacturable, standardized, and clinically dependable reality. It asked small businesses, working through the STTR model, to build the enabling infrastructure: printers, printable biocompatible and flexible materials, and validated processes that would make it realistic for health care providers to obtain appropriately sized devices for premature infants and neonates when conventional supply chains do not meet the need.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this NIH grant?
The opportunity is titled "Use of 3 D Printers for the Production of Medical Devices (R41/R42)" and the Funding Opportunity Number is RFA-HD-15-024.
What is the main purpose of this funding opportunity?
The purpose is to support Small Business Technology Transfer (STTR) research projects that make 3D printing a practical, clinically useful way to produce medical devices specifically sized and designed for premature infants and neonates.
What clinical problem is this FOA trying to solve?
The FOA targets the lack of medical devices manufactured in neonatal-appropriate sizes. Hospitals often rely on pediatric-sized alternatives that fit poorly, which can contribute to harmful outcomes. Traditional manufacturers may have limited financial incentive to produce small runs for this population, so the FOA positions 3D printing as a way to overcome those economic and manufacturing barriers.
Why does NIH see 3D printing as a solution for neonatal devices?
NIH framed 3D printing as a pathway to short lead times, customization, and the ability to produce complex, patient-matched components on demand. This approach is presented as better suited to small-batch or customized production than conventional manufacturing supply chains.
Who is the intended patient population?
The intended population is premature infants and neonates (newborn patients), with an emphasis on devices that match neonatal anatomy and clinical requirements.
What types of R&D projects were encouraged?
Applicants were invited to propose R&D to develop: (1) 3D printers suitable for producing neonatal medical devices, (2) polymers and other printable materials, and (3) validated process specifications that, together, enable production of safe and functional devices.
Does the FOA focus on novel 3D printing for its own sake?
No. The FOA emphasizes closing specific capability gaps preventing 3D printing from meeting neonatal device needs, rather than rewarding printing novelty alone.
What device use-cases does the FOA mention (external vs. implanted)?
The FOA describes devices intended for external use or for short-term insertion and implantation in the human body.
What capability gap did NIH highlight in the 3D printing market?
NIH noted that, despite progress in areas like bioresorbable scaffolds and tissue engineering, there were no commercial suppliers offering complete printer-and-material systems capable of producing flexible, implantable medical devices. The FOA signals the need for an integrated printer + material + validated process approach.
What does NIH mean by an "integrated" approach?
Based on the FOA description, "integrated" refers to combining suitable printers, biocompatible/printable materials (including flexible materials), and validated process specifications into a reliable manufacturing approach that can produce safe, functional neonatal devices with repeatable quality.
What outcomes or impact was NIH aiming for?
The anticipated impact is practical clinical improvement in neonatal care, including reducing complications linked to poor fit and inappropriate sizing by enabling devices that better match neonatal anatomy and clinical requirements.
Is feasibility in real healthcare settings part of the intent?
Yes. The FOA implicitly emphasizes that solutions should be feasible in real healthcare environments where speed, quality control, and reproducibility matter.
What is the funding mechanism used for this opportunity?
The funding instrument is an NIH STTR grant using the R41/R42 mechanism, which supports a phased approach (Phase I feasibility followed by Phase II development).
What does the phased R41/R42 structure imply for applicants?
It implies the project is expected to follow an STTR phased development model, starting with feasibility (Phase I, R41) and moving to development (Phase II, R42), consistent with the R41/R42 structure described in the opportunity summary.
Does this opportunity require collaboration between a small business and a research institution?
Yes. The FOA is an STTR opportunity and references collaboration between a U.S. small business and a research institution as required under STTR rules.
What agency sponsored this funding opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
What program category and CFDA listing is associated with this FOA?
It is described as a discretionary grant opportunity under the health-related activity category and is listed under CFDA 93.865 (Child Health and Human Development Extramural Research).
Who was eligible to apply?
Eligibility was limited to U.S. small business concerns. The description includes standard SBIR/STTR-style criteria such as being for-profit, having a place of business in the United States, operating primarily in the United States (or making a significant contribution to the U.S. economy), meeting allowable legal structure requirements, being appropriately U.S.-owned and controlled under applicable rules, and having no more than 500 employees including affiliates.
Does the FOA mention specific ownership and control conditions?
Yes. The announcement text is described as including detailed ownership/control conditions reflecting standard SBIR/STTR eligibility language, including provisions related to ownership by U.S. citizens or permanent residents and certain venture-backed ownership structures.
Was cost sharing or matching required?
No cost sharing or matching requirement was stated for applicants.
When was the FOA posted and when did it close?
The FOA was posted in December 2014. It had an original and final closing date of February 10, 2015.
Is this funding opportunity still active?
No. The opportunity was archived in March 2015.
How much total funding did NIH estimate for this opportunity?
NIH estimated total funding of about $3,000,000 for the opportunity.
What was the listed award ceiling?
The listed award ceiling was $150,000. The description notes this figure typically aligns with Phase I budget expectations, while acknowledging that actual project budgets can depend on NIH small business policy and any FOA-specific limits.
Where was the full announcement available?
The full announcement was available through the NIH Grants Guide.
Who was listed as a support contact for access or linking issues?
Support for access or linking issues was routed through NIH Office of Extramural Research webmaster addresses provided in the notice.
What is the overall takeaway of what NIH was trying to push forward?
The FOA can be read as a targeted push to move neonatal 3D-printed medical devices from a promising concept into a manufacturable, standardized, clinically dependable reality by building enabling infrastructure (printers, printable biocompatible and flexible materials, and validated processes).
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