Description
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; HUBZone small businesses; service-disabled, veteran-owned 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 notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only.
This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement.
This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement, to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Small businesses are encouraged to respond.
Background: Innovators developing groundbreaking medical device technologies face a number of challenges along the translational path from bench to bedside. The Blueprint MedTech program is an NIH incubator that aims to address such challenges and support the innovators by accelerating the development of cutting-edge medical devices to diagnose and/or treat disorders of the nervous system. The mission of the program is to catalyze the translation of novel neurotechnologies from early-stage development to first-in-human clinical studies. The program will provide: (a) non-dilutive funds to support medical device development activities led by investigators, and (b) additional resources and support services.
The Blueprint MedTech External Oversight Committee (EOC) is a group of industry, clinical, regulatory, and academic experts in device development and translation whose role is to provide individual and not consensus feedback and suggestions to the Blueprint MedTech Core Team regarding:
• Scientific and strategic input for Blueprint MedTech projects and their proposed research plans
• Suitability of proposed milestones for each project, at each stage
• Project progress relative to milestones and options for going forward
• Strategies for overall portfolio management by Blueprint MedTech
• Strategies for developing and improving the program and addressing problems as they arise
The Institute and Center (IC) Directors who provide the funding for the Blueprint MedTech program make the final decisions regarding project continuation/discontinuation, based on summary input provided by the Blueprint MedTech Core Team based on feedback from the EOC and NIH consultants, broader NIH portfolio considerations, and available funding. Therefore, EOC guidance is vital to provide objective feedback to Blueprint leadership in managing the Blueprint MedTech project portfolio and the overall program.
Purpose and Objectives: The purpose of this requirement is to procure medical device consulting services with appropriate expertise in support of the Blueprint MedTech Initiative, a multi-IC effort to support development of translational neurological medical device technologies. The NIH seeks to procure a highly experienced subject matter expert with expertise in neurological medical device research and development. The consultant must be a scientist or engineer with specific experience in neurological medical device research and development through academic research, including research in animal models and testing through clinical research in human patients. The consultant shall provide feedback to the NIH program leadership and technical guidance on medical device development projects within the Blueprint MedTech initiative portfolio. The Contractor will serve as a Blueprint MedTech External Oversight Committee member, providing strategic guidance on Blueprint MedTech projects and grants funded through the Blueprint MedTech initiative.
Project requirements:
The Contractor shall provide consulting support services to the Blueprint MedTech EOC and Blueprint MedTech Program Leadership in relation to the neurological medical device development programs as follows:
• Review operations and processes of Blueprint MedTech grantees/program participants and provide recommendations regarding advancing medical device development studies, validation activities, clinical trials, and directing collaborative research among multiple institutions or teams (if applicable).
• Advise regarding suitability and relevance of proposed Blueprint MedTech program milestones, recommend revised milestones for Blueprint MedTech programs as needed, and evaluate project progress relative to established milestones.
• Analyze potential opportunities and concerns for future Blueprint MedTech program projects under consideration.
• Recommend potential solutions and assist in implementation of selected strategies to resolve programmatic challenges related to medical device development as they arise.
• Mentor Blueprint MedTech program participants executive team and project leaders in scientific entrepreneurship, including but not limited to managing medical device development projects, directing collaborative research among multiple institutions or teams, and regulatory regulations and guidelines, for continued development and improvement of the Blueprint MedTech program.
• Provide feedback to assist in successful work towards scientific and business goals and aspirations of program projects
• Participate in web-enabled virtual meetings and teleconference calls with Blueprint MedTech staff on both a monthly and an ad-hoc-as-required basis.
Anticipated period of performance and/or delivery date:
Period of Performance: Twelve (12) months base period from the date of award and two (2) 12-month option periods.
Other important considerations: It is anticipated that a minimum of 30 hours of support is required in the base period and each option period with additional option quantities at 5 hours per quantity.
Capability statement /information sought:
Companies that believe they possess the capabilities to provide the required products or services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.
Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number.
One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing.
The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required.
The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested.
All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted.
The response must be submitted to Tracy Cain, Contracting Officer, at e-mail address tracy.cain@nih.gov.
The response must be received on or before October 21, 2024, at 10:00 AM Eastern Time.
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).”
Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the 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 presolicitation synopsis and solicitation may be published in Beta.SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation.
