A request for applications (RFA) with set aside is proposed, entitled “Use of 3-D Printers for the Production of Medical Devices” using the R43/R44 Small Business Innovation Research (SBIR) Grant and the R41/R42 Small Business Technology Transfer (STTR) grant mechanisms.
Simple medical devices for premature infants and neonates are not always available in appropriate sizes. Presentations at an FDA meeting on devices for rare pediatric diseases held January 8, 2014 highlighted this deficiency in medical logistics. “Jury-rigged” solutions often involve adapting adult sized devices, sometimes with deleterious consequences. Medical device companies find it difficult to break even producing the small quantities of such items needed, and health care providers are challenged to store the full range of sizes of items with finite shelf lives. Thus, pediatric surgeons and intensivists may not have feeding tubes, drainage tubes, urinary catheters, endotracheal tubes, oxygen masks, and other such devices available in the necessary sizes.
3-D printing provides a potential solution to this problem. Modern 3-D printers can produce quite complex mechanical components within thirty minutes. The principle is that much like an ordinary ink-jet printer, a 3-D printer sprays a fine layer of plastic polymer. Successive layers are laid down to create a 3-D structure. Much research is currently underway to create printers capable of producing bioresorbable scaffolds with implanted stem cells for construction of new tissues and organs. However, only one company to date has announced any 3-D printers capable of producing medical grade silicone plastic. No companies are currently supplying 3-D printers for producing medically implantable products. If such printers were available, health care providers could produce custom sized medical devices upon demand.
The work to be supported by this FOA requires three components:
- Development of 3-D printers and polymers that can produce medical grade plastics
- Testing of such plastics to confirm biocompatibility and sterilizability
- Development of FDA approved procedures to ensure appropriate mechanical and chemical performance for different medical applications
For example, production of gastric feeding tubes will require plastics that are non-irritating to skin and intestinal mucosa, can withstand exposure to gastric contents, and have adequate mechanical strength and mechanical compliance.
While the potential range of medical devices that could be produced by 3-D printers is enormous, for the purposes of this initiative we divide the potential range into the following categories:
- Devices that contact skin, but are external
- Devices for short term insertion into body orifices, e.g., gastric feeding tubes
- Devices for short term implantation into tissues, e.g. drainage tubes, peritoneal dialysis catheters
- Devices for short term insertion with blood stream contact, e.g. cardiac catheters
- Devices for long-term implantation, e.g., cerebrospinal fluid shunts
- Device for long term implantation with high mechanical load and or blood contact, e.g. heart valves
This FOA will support research to develop 3-D printers, polymers, and approved design specifications to produce devices in categories 1-3.
Katerina Tsilou, MD
Obstetrics and Pediatric Pharmacology and Therapeutics Branch
Michael Weinrich, MD
Senior Advisor for Device Development, Biotechnology and Bioengineering
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