MODIFICATION
A -- Defense Sciences Research and Technology
- Notice Date
- 3/11/2005
- Notice Type
- Modification
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Other Defense Agencies, Defense Advanced Research Projects Agency, Contracts Management Office, 3701 North Fairfax Drive, Arlington, VA, 22203-1714
- ZIP Code
- 22203-1714
- Solicitation Number
- BAA05-19
- Response Due
- 2/7/2006
- Archive Date
- 2/8/2006
- Description
- PROSTHESIS 2007, SOL BAA05-19, Addendum 4, DUE: 4:00 PM ET 6/1/05. POC: Dr. Geoffrey Ling, DARPA/DSO, Ph: 571-218-4674, Email: baa05-19@darpa.mil; Website Submission: http://www.sainc.com/dso0519. The Defense Sciences Office (DSO) of the Defense Advanced Research Projects Agency (DARPA) is soliciting proposals for research, development, system integration and demonstration of an upper extremity prosthetic. The vision of the Prosthesis 2007 program is to leverage recent research advances in neural sensing, control systems, actuation, power storage and distribution, freeform manufacturing, neural control, microfabrication, sensory feedback, flexure and transmission design, signal processing, and information science to dramatically improve the capability of upper extremity prosthetic limbs beyond those that are currently available commercially. This vision will be realized by increasing the range of motion, strength, endurance, and dexterity of upper extremity prosthetic devices. The final product must be ready for human clinical trials including completed submission of an Investigational New Device (IND) application to the US Food and Drug Administration (FDA) by the end of 24 months. The ultimate goal of this two year effort is to deliver a single prosthetic arm system that is suitable for transhumeral and shoulder disarticulation amputations. The program is comprehensive and will deliver a prosthetic arm system in two years that is sufficiently mature to enter the appropriate approval processes for general medical use. Maturity of the prosthetic will be demonstrated by completed submission of an IND application to the FDA by the end of 24 months. Proposals that do not address the full integration of component technologies into an upper limb prosthesis or do not plan for the appropriate approval process and product commercialization are generally not of interest. However, the development of enabling technologies of extraordinary promise may be considered for support. DARPA has separately published BAA 05-26 Revolutionizing Prosthetics. Prosthesis 2007 (BAA 05-19 Addendum 4) is focused on nearer term improvements in prosthetics capabilities. Proposers are free to propose to both solicitations independently. The technical goal of the program is to develop arm prostheses that significantly improve the ability of the arm amputee to perform the activities of daily living. Design trades and technology choices may dictate that some of the desirable characteristics listed below are not simultaneously achievable, are unnecessary, or are not achievable in two years. The guiding principle to be used when performing design trades is that the device should deliver the maximum capability possible for the activities of daily living within the two year time frame. Desirable characteristics of the upper arm prosthesis system include (1) inertial properties that match the lost limb including arm free swing capability, (2) local control, state sensing, and task-based mode shifting within the device to enable improved functionality, (3) simultaneous control of 3-5 joints, (4) fingertip force detection, (5) local hand grasp slip control, (6) elbow lift capability of up to 20 ft-lbs, (7) grip strength of up to 25 lbs, (8) wrist flexion strength of up to 1.67 ft-lbs, (9) a robust intuitive control approach, (10) 24 hour endurance between refuel or recharge while conducting activities for daily living, (11) minimum of three grasp patterns (fine pinch, lateral pinch, power grip), (12) 2 degrees of freedom at the wrist, (13) humeral rotation, (14) effective cosmetic matching to the amputee, (15) noise below 50 dB(A) at 1 meter, (16) water and grit resistance, and (17) an automated system for fitting the prosthetic to the residual limb that accounts for shape and structure changes due to amputee activities and other normal physiological changes. A level of modularity that will enable adaptation to varying degrees of stump length is also desirable. A critical component of a successful effort is a series of technology demonstrations that will occur regularly throughout the two year work period. These demonstrations will show clear progress toward the goal of delivering a mature arm prosthesis system that meets the requirements for an FDA IND at the end of the two year research and development period. The series will culminate in a demonstration of the complete functional arm system at the conclusion of the project. The formation of multidisciplinary teams with an overall system integrator as the lead institution is essential for effective program planning and execution. Proposals must describe plans to address the technical, commercial, and regulatory issues pertinent to integration of state of the art technologies into a new medical device. The emphasis of this two year effort is on the technical aspects of the upper arm prosthesis system. Commercial development and regulatory approval plans will be used to evaluate the ability of the proposers to ultimately deliver a prosthetic limb that will be widely available to the amputee community. An optional third year of effort should be proposed for the purpose of performing an early clinical trial. Only exceptionally successful programs will be considered for support in the third year. Each proposal should explicitly address tests, demonstrations, and other research activities planned in the area(s) of interest described above; include at least five specific, quantitative 12 month technical objectives that clearly demonstrate the research is on track for meeting the ultimate program goals; and include clear intellectual property arrangements, commercialization plans and transition paths. Upon award, specific deliverables and appropriate demonstrations of the science and/or technology elements will be required periodically and a final demonstration of the deliverable system is required at the end of the program. Proposed efforts should not exceed 24 months plus an optional third year for early clinical trials. If multiple awards are made a down-selection may occur after 12 months based on technical progress and achievements. Proposals with cost share should clearly identify the specific tasks to be cost shared in the technical proposal and separately break out the corresponding costs in the cost proposal. The number of awards will be dependent on the suitability of proposals received and availability of funds. Only full proposals are being accepted under this addendum. Proposals shall conform to the guidelines in DARPA (DSO) BAA05-19 (Parts 1 & 2) of 8 Feb, 2005 (http://www.darpa.mil/dso/solicitations/solicit.htm). To receive consideration under this addendum PROPOSALS ARE DUE TO THE ADDRESS SHOWN BELOW NO LATER THAN 4:00 PM ET 1 JUNE 2005. Proposals received after that date will be considered under the open BAA but not this addendum. Evaluation of the proposals will be in accordance with BA05-19. Please refer to the original FedBizOpps announcement for BAA 05-19 (Parts 1 and 2) for general administrative questions. Proposals involving human use that are selected for funding will be required to comply with provisions of the Common Rule (32 CFR 219) on the protection of human subjects in research (http://www.dtic.mil/biosys/downloads/32cfr219.pdf) and the DoD Directive 3216.2 (http://www.dtic.mil/whs/directives/corres/html2/d32162x.htm). All proposals that involve the use of human subjects are required to include documentation of their ability to follow Federal guidelines for the protection of human subjects. This includes, but is not limited to, protocol approval mechanisms, approved Institutional Review Boards (IRB), and Federal Wide Assurances. These requirements are based on expected human use issues sometime during the entire length of the proposed effort. For proposals involving "greater than minimal risk" to human subjects within the first year of the project, performers must provide evidence of protocol submission to a Federally approved IRB at the time of final proposal submission to DARPA. For proposals that are forecasted to involve "greater than minimal risk" after the first year, a discussion on how and when the proposer will comply with submission to a Federally approved IRB needs to be provided in the submission. More information on applicable Federal regulations can be found at the Department of Health and Human Services Office of Human Research Protections website (http://www.dhhs.gov/ohrp/). ADDRESSES FOR SUBMISSION: Web address for Full Proposal Submission: http://www.sainc.com/dso0519/ DARPA/DSO ATTN: BAA05-19 Addendum 4 3701 North Fairfax Drive Arlington, VA 22203-1714 Electronic Mail: BAA05-19@darpa.mil In all correspondence, reference BAA05-19, Addendum 4. Technical Point of Contact: Dr. Geoffrey Ling, DARPA/DSO; Phone: (571) 218-4674; E-mail: gling@darpa.mil.
- Record
- SN00767205-W 20050313/050311212412 (fbodaily.com)
- Source
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