Consulting Services in relation to Medical Device Development under Blueprint MedTech Initiative – Subject Matter Expert in Medical Device Research and Development

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute on Drug Abuse (NIDA), Office of intends to award a sole source contract under the authority of Federal Acquisition Regulation (FAR) Subpart 13.106-1 (b) Soliciting from a single source. For purchases not exceeding the simplified acquisition threshold, contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available. This contract(s) will be awarded to Luminescent Consulting LLC 5025 Newton Ave S Minneapolis, Mn 55419, Woman Owned Small Business (WOSB) to procure Consulting Services in relation to Medical Device Development under Blueprint MedTech Initiative.

DESCRIPTION OF REQUIREMENT

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 medical device research and development. The consultant must have minimum 20 years of experience working for a large medical device company in the United States, including minimum 10 years in a Program Director role. 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.

SCOPE OF WORK

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 including, but not limited to:

• Planning resources to support concept development, team building, needs assessment, and other early translational activities.
• Streamlined access to translational services and expertise (e.g., design and prototyping, bench testing, large animal testing, biocompatibility assessment, manufacturing, medical monitoring).
• Assistance from consultants (e.g., on regulatory, reimbursement, intellectual property, commercialization, and strategic partnership issues).
• Advice from industry experts (e.g., meetings with an external oversight committee).

The overarching goal of the Blueprint MedTech program is to accelerate patient access to groundbreaking, safe, and effective medical devices. The program will provide support to sufficiently develop and de-risk technologies to the point where additional investments are warranted from industry partners, investors, and Government.

Each project is directed by the principal investigator with input from industry consultants hired by NIH and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation. Resources and support services are provided without cost to the PI through NIH contracts and NIH-funded specialized centers.

The NIH Blueprint for Neuroscience Research, a consortium of 12 NIH Institutes and Centers that support neuroscience research, established Blueprint MedTech in 2019 and has dedicated $32 million for the initial Blueprint MedTech infrastructure from 2019 to 2027. The funding strategy is designed to translate promising technologies into at least ten successful first-in-human clinical studies within seven years, with at least three projects receiving industry licensing, partnership, or other external investment. To date, as part of a Blueprint MedTech pilot program, seven seedling projects were selected for funding by a program-funded specialized center. At steady-state, the program expects to maintain a portfolio size of 30 projects.

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.