Opportunity Information: Apply for RFA HD 15 023
Apply for RFA HD 15 023
- 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 (R43/R44)" 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 grant opportunity "Use of 3 D Printers for the Production of Medical Devices (R43/R44)" (Funding Opportunity Number RFA-HD-15-023) is an SBIR solicitation aimed at helping small US businesses develop practical 3D printing systems specifically suited to making medical devices for premature infants and neonates. The core problem the FOA is trying to solve is that many devices simply are not manufactured in sizes appropriate for very small patients, so hospitals often end up using pediatric-sized products that do not fit correctly. That sizing mismatch can create real clinical risks and complications. Traditional medical device manufacturers also have limited financial incentive to produce tiny, specialized product lines because the patient population is smaller and demand volumes are low. The FOA positions 3D printing as a way to overcome these barriers by enabling short-run, rapid-turnaround production of mechanically complex parts that can be tailored to an individual patient.
From a technical standpoint, the FOA focuses on research and development to create 3D printers, compatible polymer materials, and well-defined process specifications that would allow reliable production of premature- and neonatal-specific devices. The devices of interest are those intended for external use or for short-term insertion and implantation in the body. A key emphasis is on the gap between ongoing research and what is actually available commercially: while work is being done in areas like bioresorbable scaffolds and tissue engineering approaches, the announcement notes that no companies are currently supplying 3D printers and material sets that can produce flexible implantable medical devices. In other words, the NIH is signaling a need for end-to-end, clinically relevant manufacturing solutions, not just proof-of-concept printing demonstrations, so providers could have access to better-fitting tools and components for neonatal care.
The award mechanism is SBIR under the R43/R44 framework, which corresponds to Phase I (feasibility) and Phase II (full research and development) small business grants. The funding instrument type is a grant, and the activity category is listed under Health, Income Security and Social Services (CFDA 93.865, Child Health and Human Development Extramural Research). The opportunity does not require cost sharing or matching. The estimated total funding associated with the FOA is $3,000,000, and the listed award ceiling is $150,000 (as provided in the source data). The opportunity was posted in December 2014, with an application closing date of February 10, 2015, and it was later archived in March 2015, meaning it is not currently open but remains useful as a reference for similar NIH SBIR topics.
Eligibility is restricted to United States small business concerns. To qualify, an applicant must be organized for profit, have a place of business in the US, and primarily operate in the US (or otherwise make a significant contribution to the US economy through taxes or use of American products, materials, or labor). The business must fit an acceptable legal form (such as LLC, corporation, partnership, sole proprietorship, and similar), and must meet SBIR ownership and control rules, including versions that allow certain majority ownership structures involving US individuals or, for SBIR, certain venture capital, hedge fund, or private equity ownership configurations, as long as no single such entity owns more than 50 percent. The company must also have no more than 500 employees including affiliates. The agency running the opportunity is the National Institutes of Health.
At a practical level, the FOA is looking for small companies that can bring together printer hardware capabilities, polymer/material science, and validated manufacturing processes in a way that supports real clinical needs in neonatal and premature infant care. The intended outcome is to make it economically and logistically feasible to produce properly sized, potentially patient-matched devices with short lead times, improving safety and quality of care for a population that is currently underserved by conventional device manufacturing.
FAQs: NIH SBIR Grant - Use of 3 D Printers for the Production of Medical Devices (R43/R44) (RFA-HD-15-023)
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 (R43/R44)" and the Funding Opportunity Number is RFA-HD-15-023.
Which agency is offering this opportunity?
The agency is the National Institutes of Health (NIH).
What type of funding mechanism is this?
This is an SBIR (Small Business Innovation Research) opportunity using the NIH R43/R44 framework, which corresponds to Phase I (feasibility) and Phase II (full research and development). The funding instrument type is a grant.
What problem is the FOA trying to solve?
The FOA targets a practical clinical problem in neonatal care: many medical devices are not manufactured in sizes appropriate for premature infants and neonates. As a result, hospitals may rely on pediatric-sized products that do not fit correctly, which can create clinical risks and complications. Traditional manufacturers often have limited financial incentive to produce tiny, specialized product lines because demand volumes are low.
Why does the FOA emphasize 3D printing?
The FOA positions 3D printing as a way to overcome small-market manufacturing barriers by enabling short-run, rapid-turnaround production of mechanically complex parts. It also supports tailoring devices to an individual patient, which can help address fit and sizing issues in very small patients.
What kinds of projects is NIH looking to fund under this FOA?
The FOA focuses on research and development to create (1) 3D printers, (2) compatible polymer materials, and (3) well-defined process specifications that together allow reliable production of devices designed specifically for premature infants and neonates.
What types of medical devices are within scope?
The devices of interest include those intended for external use or for short-term insertion and implantation in the body.
Is this FOA about printing tissues or long-term bioengineering implants?
Based on the description provided, the FOA acknowledges ongoing research areas such as bioresorbable scaffolds and tissue engineering approaches, but its emphasis is on developing end-to-end, clinically relevant 3D printing manufacturing solutions for neonatal and premature infant devices, including printer-and-material sets and defined processes.
What gap in the market does NIH identify?
The FOA highlights a gap between research activity and commercial availability. It notes that no companies are currently supplying 3D printers and material sets that can produce flexible implantable medical devices, signaling a need for integrated solutions rather than proof-of-concept demonstrations.
What does NIH mean by an "end-to-end" solution in this context?
From the information provided, NIH is signaling interest in complete, clinically relevant manufacturing capability: printer hardware, compatible polymer/material systems, and validated process specifications that can reliably produce properly sized devices with short lead times for neonatal care.
Who is eligible to apply?
Eligibility is restricted to United States small business concerns.
What are the core SBIR business eligibility requirements mentioned?
The applicant must be organized for profit, have a place of business in the United States, and primarily operate in the United States (or otherwise make a significant contribution to the U.S. economy through taxes or use of American products, materials, or labor).
What legal entity types can qualify as an eligible small business?
The business must fit an acceptable legal form, such as an LLC, corporation, partnership, sole proprietorship, or similar entity types.
Are there employee headcount limits?
Yes. The company must have no more than 500 employees, including affiliates.
Are there SBIR ownership and control requirements?
Yes. The company must meet SBIR ownership and control rules, including versions that allow certain majority ownership structures involving U.S. individuals or, for SBIR, certain venture capital, hedge fund, or private equity ownership configurations, as long as no single such entity owns more than 50 percent.
Does the opportunity require cost sharing or matching funds?
No. The opportunity does not require cost sharing or matching.
How much total funding was estimated for this FOA?
The estimated total funding associated with the FOA is $3,000,000.
What is the listed award ceiling?
The listed award ceiling is $150,000 (as provided in the source data).
When was the opportunity posted and when did it close?
It was posted in December 2014, and the application closing date was February 10, 2015.
Is this funding opportunity currently open?
No. It was later archived in March 2015, meaning it is not currently open. It may still be useful as a reference point for similar NIH SBIR topics.
What is the CFDA number and program area listed for this opportunity?
The opportunity is listed under CFDA 93.865, Child Health and Human Development Extramural Research, within the activity category of Health, Income Security and Social Services.
What practical capabilities is NIH expecting from applicant companies?
At a practical level, the FOA is looking for small companies that can integrate printer hardware capabilities, polymer/material science, and validated manufacturing processes to support real clinical needs in neonatal and premature infant care.
What is the intended outcome or impact of projects funded under this FOA?
The intended outcome is to make it economically and logistically feasible to produce properly sized, potentially patient-matched devices with short lead times, improving safety and quality of care for premature infants and neonates who are underserved by conventional medical device manufacturing.
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| Novel Tools to Assess Human Placental Structure and Function (R21) Apply for RFA HD 15 031 Funding Number: RFA HD 15 031 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $200,000 |
| Population Dynamics Centers Research Infrastructure FY 2015 (P2C) Apply for RFA HD 15 009 Funding Number: RFA HD 15 009 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Medical Rehabilitation Research Resource (P2C) Apply for RFA HD 15 010 Funding Number: RFA HD 15 010 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $750,000 |
| The Human Placenta Project Developing Paradigm Shifting Innovations for in vivo Human Placental Assessment (U34) Apply for RFA HD 15 032 Funding Number: RFA HD 15 032 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $300,000 |
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| Intellectual and Developmental Disabilities Research Centers 2015 (U54) Apply for RFA HD 15 033 Funding Number: RFA HD 15 033 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $1,300,000 |
| Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network (UG1) Apply for RFA HD 16 020 Funding Number: RFA HD 16 020 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $200,000 |
| Eunice Kennedy Shriver NICHD Maternal Fetal Medicine Units (MFMU) Network (UG1) Apply for RFA HD 16 019 Funding Number: RFA HD 16 019 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $200,000 |
| Developing Paradigm Shifting Innovations for in vivo Human Placental Assessment in Response to Environmental Influences (U01) Apply for RFA HD 15 034 Funding Number: RFA HD 15 034 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $3,000,000 |
| Enhancing Developmental Biology Research at Academic Research Enhancement Award Eligible Institutions (R15) Apply for PAR 15 149 Funding Number: PAR 15 149 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Postdoctoral Research Training in Pediatric Clinical Pharmacology and Therapeutics (T32) Apply for RFA HD 16 015 Funding Number: RFA HD 16 015 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Studies at Periviable Gestation (R03) Apply for PA 15 199 Funding Number: PA 15 199 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $50,000 |
| Studies at Periviable Gestation (R01) Apply for PA 15 200 Funding Number: PA 15 200 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Studies at Periviable Gestation (R21) Apply for PA 15 198 Funding Number: PA 15 198 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $200,000 |
| National Centers for Translational Research in Reproduction and Infertility (P50) Apply for RFA HD 16 010 Funding Number: RFA HD 16 010 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $1,200,000 |
| Non or Minimally Invasive Methods to Measure Biochemical Substances for Neonatal and Perinatal Clinical Care and Research (R41) Apply for RFA HD 16 028 Funding Number: RFA HD 16 028 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Bioengineering Research Partnership (BRP) Non or Minimally Invasive Methods to Measure Biochemical Substances during Neonatal and Perinatal Patient Care and Research (R01) Apply for PAR 15 285 Funding Number: PAR 15 285 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
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