Controller Development for Upper Limb Movement

Small Business Sources Sought (SBSS): Controller Development for Upper Limb Movement Notice Number: Sources Sought NIH-NICHD-NCMRR-SBSS-2011-15 Announcement Type: Small Business Sources Sought (SBSS) Agency/Office: National Institutes of Health Location: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Key Dates: Release Date: Response Date: 10 days after issuance Purpose of this Announcement: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; 8(a) small businesses, veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned a code of 541712 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 500 employees. Background and Project Requirements: The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) anticipates continuing the project "Controller Development for Upper Limb Movement." We are looking for capability statements from Small Businesses to determine if there are Small Businesses capable of meeting the NICHD's follow-on requirements for a FES motor control system. The contract goal continues to be the development of a prototype controller that is designed for future use as an external Functional Electrical Stimulation (FES) control system for the restoration of function of one or more movements in the paralyzed upper limbs. The ongoing development of the controller includes a design that incorporates simulation technology for testing and a real-time external FES system that is interfaced with brain signals that are recorded from the motor cortical area of the participant. The extension of the project will enable the highly unique and experienced team of investigators to recruit and test additional participants and acquire and analyze patient data that will ultimately enhance the controller, making it a more powerful tool for translating cortical signals that would eventually drive the FES system for upper limb movement. The additional data will aid in the refinement of the controller and the testing/training technologies necessary for future devices supporting a variety of paralysis. Any new participants for this contract will be implanted with the BrianGate 2 Neural Interface System. To date this study has enabled significant advances in the implementation of the BrainGate implant technology for human participants, the sophisticated software development and computer driven testing of the implant, and the collection and analyses of human cortical signal data pertinent to the eventual control of upper limb motor movement. This research has involved a well established team of investigators who bring unique medical, bioengineering and technological experience, specialized resources and novel approaches that have been essential for the forward progress of the project. Anticipated Period of Performance: The anticipated period of performance is 30 months from the time of award. Capability Statement/Information: The NICHD is seeking Small Businesses capable of meeting the following criteria. 1) Approach-Does the Offeror have the conceptual framework, design methods, analyses, and clinical protocols and assessment in place in order to continue to develop, integrate, and achieve the aims of the project including the engineering capacity to develop appropriate algorithms, design, and test the proposed controller that will interface with cortical implant signals and a FES motor control system? Does the Offeror have the capacity to identify an appropriate patient population to work with an experienced surgical team for implantation of the BrainGate 2 Neural Interface System and to provide the appropriate health care personnel? 2) Personnel and Experience-Does the Offeror have in place a research team that will be involved in the design, development, testing and evaluation of a FES controller that uses cortical signals for human motor control of movement? This must be supported by a track record in designing, developing and testing control systems for physiological functions, device construction, materials and interface issues, translation of engineered devices to clinical applications, and organizational experience in leading a multidisciplinary team of investigators. Does the team include engineers, scientists, and clinicians proficient in the development and testing of controllers, movement deficit, medical rehabilitation expertise that would guide the design of a control system and choice of target upper limb muscle(s), implementation and assessment of the controller and its interface with the human subject, needs of persons with spinal cord injury and upper limb paralysis, clinical research protocols and human safety issues, and previous experience in developing technologies to obtain cortical signals, process signals and input signals to activate limb movement. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. The Government reserves to right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY: No proprietary, classified, confidential, or sensitive information should be included in your response. The government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Interested Small Business organizations that believe they possess the capabilities necessary to undertake this project should submit electronic copies (e-mail to [email protected]) in addition to four (4) hard copies of their capability statement addressing the areas above (hard copies to be mail to Lynn Salo at the address listed below). Please limit responses to 15 pages or less. These pages exclude resumes. Written capability statements should be received by the Contracting Officer by 3:00PM ten (10) days after publication of this notice. Capability statements must identify the business status of the organization. No collect calls will be accepted. Inquiries should be directed to: Ms. Lynn Salo, Contracting Officer, DHHS/NIH/NICHD/CMB, 6100 Executive Blvd., Suite 7A07, MSC 7510, Bethesda, MD 20892-7510, (or Rockville, MD 20852 for express/courier service), telephone 301-435-6962, FAX 301-402-3676, e-mail [email protected]. OR, Ms. Elizabeth Osinski, Contracting Officer, DHHS/NIH/NICHD/CMB, 6100 Executive Blvd., Suite 7A07, MSC 7510, Bethesda, MD 20892-7510, (or Rockville, MD 20852 for express/courier service), telephone 301-435-6947, FAX 301-402-3676, e-mail [email protected].