Consulting Services in relation to Medical Device Development under Blueprint MedTech Initiative – Subject Matter Expert in Medical Device Research and Development
ID: 75N95025Q00015Type: Presolicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH NIDABethesda, MD, 20892, USA

NAICS

All Other Professional, Scientific, and Technical Services (541990)

PSC

SUPPORT- PROFESSIONAL: OTHER (R499)

Set Aside

SBA Certified Women-Owned Small Business (WOSB) Program Set-Aside (FAR 19.15) (WOSB)

Original Source

https://sam.gov/opp/89c3bf6f296244cf9571a4bba64b0f5d/view
Timeline
    Description

    The Department of Health and Human Services, through the National Institutes of Health (NIH), intends to award a sole source contract to Luminescent Consulting LLC for consulting services related to medical device development under the Blueprint MedTech Initiative. The objective of this procurement is to secure a subject matter expert with at least 20 years of experience in medical device development, including a minimum of 10 years in a Program Director role, to provide strategic guidance and feedback on projects aimed at advancing translational neurological medical device technologies. This initiative, which has allocated $32 million from 2019 to 2027, seeks to facilitate the transition of innovative medical technologies from early development to clinical trials, with a goal of conducting at least ten first-in-human studies. Interested parties may submit capability statements by November 8, 2024, to Tracy Cain at tracy.cain@nih.gov or Llakim Dubroff at llakim.dubroff@nih.gov, although the government is not obligated to enter into a competitive procurement process.

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    NOI SS Luminescent.pdf
    The National Institute on Drug Abuse (NIDA) intends to award a sole source contract to Luminescent Consulting LLC for medical device consulting services under the Blueprint MedTech Initiative. This initiative aims to advance translational neurological medical device technologies by providing support to innovators developing new medical devices. The contract is being pursued non-competitively due to the specific qualifications required for the consultant, including a minimum of 20 years in medical device development and at least 10 years in a Program Director role. The contractor will play a key role as a subject matter expert, offering strategic guidance and feedback on the Blueprint MedTech initiative's projects, which seeks to facilitate the transition of innovative medical technologies from early development to clinical trials. This program, established by the NIH, has allocated $32 million from 2019 to 2027 and aims to conduct a minimum of ten first-in-human clinical studies over its duration. Interested parties may still submit capability statements by November 8, 2024, although the government is under no obligation to enter into a competitive procurement process. Responses must be submitted electronically and include various business identifiers and pricing details.
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