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Manufacturing Processes of Medical, Dental, and Biological Technologies

Description:

On February 26, 2004, Executive Order 13329 (http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/pdf/04-4436.pdf) was signed by President George W. Bush requiring SBIR/STTR agencies, to the extent permitted by law and in a manner consistent with the mission of the Department, to give high priority within the SBIR and STTR programs to manufacturing-related research and development (R&D).  In response to this Executive Order, NIH is expanding its focus by encouraging eligible United States small business concerns to submit STTR Phase I, Phase II, and Fast-Track grant applications whose biomedical research is related to advanced processing, manufacturing processes, equipment and systems, and manufacturing workforce skills and protection.

The NIH encourages research related to advanced processing in the manufacture of biomedical products and the implementation of new technologies in medical care.  New methods, procedures, measures, and controls are needed for manufacturing a broad range of technologies and products with unsurpassed quality and to lower manufacturing costs for existing and/or new processes.  Research is also encouraged that can contribute to the containment and reduction of health care costs and that can improve the cost effectiveness, quality, and accessibility of the health care system.

Manufacturing-related R&D is defined as:

Manufacturing innovation is fostered by research and development of technologies that are aimed at increasing the competitive capability of manufacturing concerns.  Broadly speaking, manufacturing-related R&D encompasses improvements in existing methods or processes, or wholly new processes, machines or systems.  Four main areas include:

(1) Unit process level technologies that create or improve manufacturing processes, including (a) fundamental improvements in existing manufacturing processes that deliver substantial productivity, quality, or environmental benefits, and (b) development of new manufacturing processes, including new materials, coatings, methods, and practices associated with these processes.

(2) Machine level technologies that create or improve manufacturing equipment, including (a) improvements in capital equipment that create increased capability (such as accuracy or repeatability), increased capacity (through productivity improvements or cost reduction), or increased environmental efficiency (safety, energy efficiency, environmental impact), and (b) new apparatus and equipment for manufacturing, including additive and subtractive manufacturing, deformation and molding, assembly and test, semiconductor fabrication, and nanotechnology.

(3) Systems level technologies for innovation in the manufacturing enterprise, including (a) advances in controls, sensors, networks, and other information technologies that improve the quality and productivity of manufacturing cells, lines, systems, and facilities; (b) innovation in extended enterprise functions critical to manufacturing, such as quality systems, resource management, supply chain integration, and distribution, scheduling and tracking; and (c) technologies that enable integrated and collaborative product and process development, including computer-aided and expert systems for design, tolerancing, process and materials selection, life-cycle cost estimation, rapid prototyping, and tooling.

(4) Environment or societal level technologies that improve workforce abilities and manufacturing competitiveness, including (a) technologies for improved workforce health and safety, such as human factors and ergonomics; and (b) technologies that aid and improve workforce manufacturing skills and technical excellence, such as educational systems incorporating improved manufacturing knowledge and instructional methods

Because manufacturing-related R&D is extremely broad in scope, the following examples of research topics may be of interest but are not meant to be exhaustive.

  • Flexible computer-assisted integrated manufacturing equipment and intelligent processing equipment adaptable to the varied needs of biomedical research and medical care device and material production. 
  • Systems engineering and management tools needed for the development of biomedical product manufacturing plants with particular emphasis on the requirements to meet GMP requirements for FDA approvals. 
  • Technology for the manufacture of research instrumentation, such as highly sensitive, high resolution spectrometers, highly selective electrodes, microarray devices, and microfluidic devices. 
  • Technology for the manufacture of clinical diagnostic devices and reagents. 
  • Technology for the manufacture of novel diagnostic imaging devices for both invasive and non-invasive techniques. 
  • Technology for the manufacture and delivery of therapeutic drugs, including for example, synthetic process chemistry, separations methods, formulation, and dosage delivery. 
  • Technology for the manufacture of implantable devices and materials, including drug delivery pumps, prosthetic organs, artificial tissues, electronic sensors and electrical stimulators.  
  • Technology for the production of natural products derived from plant, animal, and microbial sources, such as antibiotics, anticancer drugs, and other therapeutic agents, and useful synthetic starting materials. 
  • Technology for the production and isolation of biotechnology products, such as proteins, antibodies, nucleic acids, vaccines, and vectors for genetic engineering and gene therapy. 
  • Technology for the production of new materials relevant to biomedical research and medical care delivery, including nanomaterials, carbon fibers, polymeric materials, self-assembled monolayers, controlled size, shape, and porosity particles, filters, membranes, silicon substrates for microarrays, superconducting materials for NMR and MRI magnets, and implantable magnetic materials for external magnetic manipulation. 
  • Technology for manufacture of medical device power sources, such as high energy density, long life-time batteries, solar cells, and fuel cells. 
  • Technology for the fabrication of medical care instruments and devices such as minimally invasive and magnetic field tolerant surgical instruments, orthopedic implants, prostheses, and enabling devices for the injured and disabled.   
  • Rapid prototyping and manufacture technology suitable for remote site and on demand production processes.  
  • Technology to promote the recovery, reuse, and remanufacture (recycling) of medical materials and equipment. 
  • Technology for the manufacture of biomedically specialized computational and information technology equipment and software. 
  • Development of innovative products that facilitate the safety and health training of hazardous materials workers, emergency responders, and skilled support personnel.  (See also NIEHS Worker Education and Training Program at http://www.niehs.nih.gov/wetp/home.htm.

Applicants are encouraged to consider additional research topic areas relating to manufacturing listed under each Institute and Center in the SBIR/STTR Omnibus Solicitation of the National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration.

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