Inactive

COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: Consulting Services in relation to Medical Device Development under Blueprint MedTech Initiative – Subject Matter Expert in Neurosurgery RFQ: 75N950... COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: Consulting Services in relation to Medical Device Development under Blueprint MedTech Initiative – Subject Matter Expert in Neurosurgery RFQ: 75N95025Q00007 (i) This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is 75N95025Q00007 and the solicitation is issued as a Request for Quotation (RFQ). This acquisition is for a commercial item or service and is conducted under the authority of the FAR part 13—Simplified Acquisition Procedures; and FAR Part 12—Acquisition of Commercial Products and Commercial Services, and is not expected to exceed the Simplified Acquisition Threshold (SAT). A Time and Materials/Labor Hour type of purchase order is contemplated for this requirement. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2024-05, dated April 22, 2024. (iv) The North American Industry Classification System (NAICS) code for this procurement is 541990 - All Other Professional, Scientific, and Technical Services, and the small business size standard is $16.5M. This requirement shall be solicited using competitive procedures as a total small business set-aside. (v) DESCRIPTION The Government requires the following services: 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. (vi) Please refer to Attachment 1 – Statement of Work for details and information describing the characteristics and requirements for the required services. (vii) The Government anticipates award of a time and materials purchase order for this acquisition, and the anticipated period of performance to be twelve (12) months for the Base Period, with two (2) Option Period of twelve (12) months : Base Period: December 5, 2024 – December 4, 2025 Option Period 1: December 5, 2025 – December 4, 2026 Option Period 2: December 5, 2026 – December 4, 2027 It is anticipated that the majority of performance shall be remote at the Contractor’s own facility. Conference calls and email shall be the primary mode of communication; however, the Contractor may be required to work at Government facilities in the continental United States, primarily Bethesda, MD, on an as-needed basis. The Contractor must attend one on-site meeting at a Blueprint MedTech hub location (Boston, MA, or greater Washington, DC) per year. (viii) The provision at FAR Clause 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services (SEP 2023) is applicable and incorporated by reference into this solicitation. (ix) The provision at FAR Clause 52.212-2, Evaluation-Commercial Products and Commercial Services (NOV 2021) is applicable and incorporated by reference into this solicitation. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. Each quote will be evaluated in strict conformity with the evaluation factors, utilizing quantitative scores and written critiques. The evaluation will be based upon the demonstrated capabilities of the prospective Contractor in relation to the needs of the project as set forth in the solicitation. The quote will also be evaluated taking into consideration any price reductions for the requirement being ordered. A price reasonableness determination will be made and a best value analysis will be performed. The best value analysis will take into consideration the results of the technical evaluation, price evaluation, and the ability to complete the work within the Government's required schedule. The analysis will document that the award represents the best value to the Government (considering technical evaluation factors, past performance, and price) to meet the Government’s needs. The Government reserves the right to issue an order to the best advantage of the Government, technical merit, price, and other factors considered. All aspects of a quote are subject to discussion, including price, technical approach and terms and conditions. At the completion of discussions, the Contractor will ensure the technical and price quote reflects the mutual understandings of the requirement and if requested, submit a revised technical and price quote to the Contracting Officer. The Government may request clarifying information from the Contractor, as it relates to its quote. If an award will be made without conducting discussions, Contractors may be given the opportunity to clarify certain aspects of their quote (e.g., the relevance of the contract, the Contractor's past performance information, and adverse past performance information to which the Contractor has not previously had an opportunity to respond) or to resolve minor or clerical errors. Discussions will not be held with any Offeror determined to be technically unacceptable. The Government reserves the right to make a single award, multiple awards, or no award at all as a result of the solicitation. In addition, the solicitation may be amended or canceled as necessary to meet the Government’s requirements. A tradeoff process shall be used for this acquisition because it has been determined to be in the best interest of the Government to consider award to other than the lowest priced Offeror or other than the highest technically rated offeror. All evaluation factors other than cost or price, when combined, are more important than cost or price. For this acquisition, the following considerations will be part of the trade-off process: Technical Evaluation Factors including Past Performance, and Price. The evaluation factors are used by the technical evaluation committee when reviewing the technical quotes. The factors below are listed in order of its relative importance for evaluation purposes. 1. Technical Capability and Functionality We will evaluate a vendor’s technical approach for soundness, practicality, and feasibility to accomplish the tasks and requirements in all Performance Areas of the Statement of Work. We will evaluate the vendor’s technical approach for their ability to meet performance/delivery schedules under the required tasks. Also, we will evaluate their technical proposal on how well it shows a comprehensive understanding of the project’s goals, objectives, and tasks as called for in the Statement of Work (SOW). We will evaluate their understanding of the tasks to be performed, their interrelation and complexity. We will evaluate the vendor’s discussion of anticipated problems and constraints likely to be encountered in performing the work, and their plans, solutions, and approaches to resolving them. 2. PAST PERFORMANCE The Offeror should provide past performance information. Past performance information shall cover a minimum of 1 year in relevant services and deliveries of comparable services. The Offeror should provide at least one reference for any project identified under the experience factor that has a performance period within the past three years. For each reference, the offeror should provide: (1) Organization/contracting partner's name; (2) Point of contact's (POC) name and contact information: Current phone numbers. Valid email addresses; (3) Description that precisely explains: General scope of the contract. Specific requirements of the contract. Offerors will be evaluated based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken. Furthermore, the Government will assess the relative risks associated with each offeror. Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance. The assessment of performance risk is not intended to be the product of a mechanical or mathematical analysis of an offeror's performance on a list of contracts but rather the product of subjective judgment by the Government after it considers all available and relevant information. 3. PRICE EVALUATION Offerors price quote will be evaluated for reasonableness. For a price to be reasonable, it must represent a price to the government that a prudent person would pay when consideration is given to prices in the market. Normally, price reasonableness is established through adequate price competition, but may also be determined through cost and price analysis techniques. Price evaluation will not be conducted on any Offeror determined to be technically unacceptable. 4. EVALUATION OF OPTIONS It is anticipated that any contract awarded from this solicitation will contain option periods. In accordance with FAR Clause 52.217-5, Evaluation of Options, (July 1990), the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement, except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests. Evaluation of option periods will not obligate the Government to exercise the options. An evaluation of this factor will only be conducted on offerors and quotes who have been determined to be technically acceptable. (x) The provision at FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Products and Commercial Services (MAY 2024), is applicable and incorporated by reference into this solicitation. (xi) The provision at FAR Clause 52.212-4, Contract Terms and Conditions—Commercial Products and Commercial Services (NOV 2023), applies to this acquisition. SeeAttachment 2. (xii) The provision of FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Products and Commercial Services (MAY 2024), applies to this acquisition. See Attachment 3. (xiii) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xiv) The Defense Priorities and Allocations System (DPAS) is not applicable to this requirement. (xv) Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. Responses to this solicitation must include clear and convincing evidence of the Offeror’s capability of fulfilling the requirement as it relates to the government requirements stated in this solicitation. Basic cost and price information in the Offeror’s proposal must contain sufficient information to allow the Government to perform a basic analysis of the reasonableness of the Offeror to supply the required goods/services. Any other information or factors that may be considered in the award decision may include such factors as: past performance; special features required for effective service coverage; and prompt payment discount terms. The Contractor shall submit its quote electronically. Offerors MUST verify the valid certifications, registrations, and Representation and Certifications from the System of Award Management (SAM) applications at www.SAM.gov, which may be indicated on the Offeror’s cover sheet. In addition the vendor Unique Entity Identifier (UEI) and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses must be received no later than November 21, 2024, 2:00 PM EST. Late responses may not be accepted. All responses must reference solicitation number 75N95025Q0007. Responses must be submitted electronically to tracy.cain@nih.gov. For information regarding this solicitation, please contact Tracy Cain by email at tracy.cain@nih.gov or by phone at (301) 443-6677. (xvi) DATE QUESTIONS DUE: Questions and requests for clarification must be submitted electronically to the Contracting Officer, Tracy Cain, at tracy.cain@nih.gov on or before 2:00 PM EST, November 18, 2024. Fax responses will NOT be accepted. ATTACHMENTS - Attachment 1 - Statement of Work (SOW) - Attachment 2 - FAR 52.212-4, Contract Terms and Conditions - Commercial Products and Commercial Services (NOV 2023) - Attachment 3 - FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Products and Commercial Services (MAY2024) - Attachment 4 – Invoice and Payment Instructions

Inactive

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: ... 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 the areas of neurosurgery and medical device regulation. The consultant must be a neurosurgeon board-certified to practice in the United States; the consultant must possess experience in both clinical treatment of patients with various neurological conditions and clinical use of neurological devices. Additionally, the consultant must have previous experience in medical device regulation, specifically in reviewing clinical trial applications and marketing applications for neurological medical devices. 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 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.