HHS SBIR RFA-HD-15-023

This funding opportunity announcement (FOA) solicits Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) to propose research to support research to develop 3D printers, polymers, and process specifications to produce premature- and neonatal-specific devices for external use or short-term insertion and implantation into the human body. There is currently an unmet need for infant-specific medical devices. Within the current manufacturing paradigm, it is challenging to produce small quantities of devices in the breadth of sizes and anatomies required for infants. This is especially true for minimally invasive/non-implantable flexible medical devices like various tubes, catheters, and even masks. To meet this need in a commercially viable manner, manufacturers need a way to quickly make these devices in the right size and configuration for a small number of patients.

3D printing, a form of additive manufacturing, may potentially provide a solution to meet this need. 3D printing builds parts layer-by-layer from a digital model from metals, plastics, or even ceramics. This process allows for complex components and devices matched to a patient’s anatomy. Most importantly, because 3D printing does not require specialized cutting tools or molds, design changes can be made very rapidly and applied to only a small number of units. The number and type of substances that can be used as raw material for a printer are large and expanding. However, a polymer/printer system has not yet been developed that can make the medical devices with the necessary properties to meet the stated need.

As part of the FDA review process for medical devices, a manufacturer must show that their device meets an appropriate level of biocompatibility, mechanical properties, and functionalities (e.g. sterilizability) for the intended use. To date, no polymer system has been shown to have the necessary biocompatibility properties, pliability, and ability to be 3D printed to meet the needs of infant devices.

This FOA is intended to support cutting-edge research, conducted by small business entities, which would lead to the development of 3-D printing system that can produce plastic devices for clinical use with infants. While the material and printer must work in tandem, the goal is not to create a completely new printing technology but rather develop a material and printer combination that can produce the pliable medical devices that can meet or exceed the expectations applied to comparable devices through FDA Guidance and international consensus standards. While there are many non-permanently implantable devices for infants, this FOA is restricted to:

• Devices that contact skin, but are external, e.g. face masks for delivering oxygen
• Devices for short term insertion into body orifices, which would make contact with mucosal surfaces, e.g. gastric feeding tubes
• Devices for short term implantation into tissues, e.g. drainage tubes and peritoneal dialysis catheters

The work to be supported by this FOA requires two elements:

• Development of a printable polymer or polymer and printer system that can be used to make one or more infant devices in the desired application areas.
• The final printed device would be tested to have the biocompatibility, irritability, mechanical, and functional performance that would be used to support a device submission to the FDA.

Prior to submitting an application, applicants are encouraged to review FDA guidance documents on:

• Investigational Devices
• Premarket Assessment of Pediatric Devices
• Use of ISO 10993
• Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile
• Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
• Medical Device Use Safety: Incorporating Human Factors Engineering into Risk Management