SPECIAL NOTICE
A -- MTEC-23-05-NavyMultiTopic Request for Project Proposals Announcement
- Notice Date
- 1/20/2023 5:21:15 AM
- Notice Type
- Special Notice
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- W4PZ USA MED RSCH ACQUIS ACT FORT DETRICK MD 21702-5014 USA
- ZIP Code
- 21702-5014
- Solicitation Number
- MTEC-23-05-NavyMultiTopic
- Response Due
- 2/20/2023 9:00:00 AM
- Point of Contact
- Dr. Chuck Hutti
- E-Mail Address
-
chuck.hutti@ati.org
(chuck.hutti@ati.org)
- Description
- The Medical Technology Enterprise Consortium (MTEC) is excited to post this Request for Project Proposals (RPP) focused on the advancement of engineering and medical prototypes and knowledge products related to a broad range of medical technological needs identified in the focus areas listed below. Relevance to the enhanced readiness and resilience of Navy and Marine Corps health and performance is a key feature of this RPP. As stated at the end of this announcement, the full RPP is posted to the MTEC website (mtec-sc.org); this notice is intended only to notify interested parties of the available solicitation. Background: Due to the Navy and Marine Corps� diverse warfighting capabilities, Sailors and Marines (and Joint Service members) operate in a vast array of challenging and austere environments. Combination of physical and mental stress from extreme conditions compromise human performance capability, increasing risk and possible failure of mission objectives. In addition, operating environments cause complications and challenges in medical logistics and casualty management, both vital elements to ensuring survivability of combat casualties. To maintain warfighter lethality and operational effectiveness in challenging environments, next generation biomedical products are required. Technology Focus Areas: Proposed prototype solutions shall address ONE of the Technology Focus Areas and ONE of the associated Specific Areas of Interest (if applicable) outlined below in support of the NAMD. Offerors are not limited to a single white paper submission. White Papers not aligned to ONE of these Focus Areas (and ONE of the associated Specific Areas of Interest) may not be considered for award. These Technology Focus Areas are not listed in order of importance. 1) FOCUS AREA #1: MILITARY DENTAL RESEARCH This area focuses on prevention and treatment of dental and maxillofacial injuries, pain, and infections to improve care for and outcomes of wounded warfighters. Research topics may encompass routine clinical dental care to maintain the resilience and readiness of the warfighter as well as methods or products to treat injuries to the oral cavity, face, and facial bones sustained during combat (e.g., combat density, fracture, burns, etc.). Also of interest are development activities focused on manufacturing readiness of technical solutions. Specific areas of interest are as follows (Offerors shall address only one of these in each White Paper submission): Clinical solutions for dental diseases and emergencies, which may include diagnostic aids, prevention or treatment modalities (e.g., dental composite resin for austere environments), restorative biomaterials, medications, therapeutic techniques, clinical guidelines, and/or knowledge products relevant to clinical practice. Methods or products to treat maxillofacial injury and trauma sustained during combat for restoring the cosmetic and functional aspects of the face, including fabrication, manufacturing, and performance testing of products Military Dental Research Solutions to provide emergency dental care in austere or forward combat environments �(e.g., field sterilization of dental instruments / materials) 2) FOCUS AREA #2: HUMAN PERFORMANCE: FATIGUE MITIGATION AND DIVER PHYSIOLOGICAL MONITORING This area focuses on the prediction and improvement of health status during operations using advanced biomedical electronics and other technology solutions. Optimizing performance and operational readiness mitigates the risk of physiological and environmental stressors that could result in fatigue, physiological discomfort or impairment, cognitive impairment, loss of life, and / or failed mission. Specific areas of interest are as follows (Offerors shall address only one of these in each White Paper submission): Biomedical solutions for complex military-relevant environments associated with the onset of fatigue (e.g. circadian misalignment) that predict, track, and mitigate the negative effects of fatigue or fatigue-induced stressors and optimize the performance of Navy personnel to enhance operational outcomes. Technical solutions for underwater operational environments (including salt and fresh water, shallow and at depth, short and long durations, and communications-limited scenarios) that detect changes in physiological conditions associated with the onset of dive-related performance gaps.� Technical solutions could include body-worn devices with sensing modalities of interest (such as core temperature, muscle oxygenation (SMO2), oxygen (O2), carbon dioxide (CO2), nitrogen (N2), and / or hydration); enabling capabilities that increase effectiveness and potential for fielding (such as specialized device hardware components; enhanced acceptance, wearability, and security; algorithms for Decompression Sickness risk identification; underwater communications capabilities); and / or environment-specific commercial off-the-shelf (COTS) assessments, or analysis and tests of specific COTS in a salt-water environment. 3) FOCUS AREA #3: DETECTION AND DIAGNOSTICS This area focuses on the development of novel rapid immunoassays with improved detection technology and reagents. In particular, environmental niches that can be occupied by toxin-producing species are expanding largely due to climate change. As the prevalence of toxins increases in the environment, so does their accessibility and therefore their potential concern from a biodefense perspective. However, we currently have a limited ability to detect and diagnose emerging toxins, especially in far-forward settings. Therefore, the goal of this project is to identify improved rapid detection technology and high affinity reagents for emerging toxins to support forward deployable testing efforts. Currently, rapid, field-portable toxin detection is typically achieved with the traditional gold nanoparticle-based lateral flow immunoassay. This technology is simple to use but typically suffers from poor sensitivity and can be difficult to multiplex. Technological advances in nanoparticle reporters, miniaturization, and imaging increase sensitivity and multiplexing capabilities of detection. However, ease of use, rigidness, stability, and portability are essential qualities that must be maintained but are often lost when these technologies are applied. Specific area of interest: New rapid, toxin detection technology with the following requirements and characteristics: Highly sensitive requiring minimal equipment Ability to easily develop multiplex assays Single-use cartridge containing all reagents needed for detection Stability in extreme environments without need for cold storage Simple to use and a ruggedized reader Development of a pipeline to rapidly produce new antibodies/affinity reagents for toxins Potential Follow-on Tasks: Under awards resulting from this RPP, there is the potential for award of one or more non-competitive follow-on tasks based on the success of the project (subject to change depending upon Government review of completed work and successful progression of milestones). Potential follow-on work may be awarded based on the advancement in prototype maturity during the PoP. Potential follow-on work may include tasks related to advancement of prototype maturity, and/or to expand the use or utility of the prototype.�� ��� Potential Funding Availability and Period of Performance: The U.S. Government (USG) currently has available a total of approximately $6 million (M) for anticipated awards to be made during FY2023. Award and funding from the Government is expected to be limited to the funding specified above and is contingent upon the availability of federal funds for this program. Awards resulting from this RPP are expected to be made under the authority of 10 U.S.C. � 4022. The estimated total available funding per Focus Area is as follows (subject to realignment dependent on quality of submissions): Focus Area #1: Military Dental Research ~$2-3M total with award(s) ranging from $1-3M Focus Area #2: Human Performance ~$2.5M total with award(s) ranging from $1.5-2.5M Focus Area #3: Detection and Diagnostics ~$1M total with awards ranging from $300-700K MTEC anticipates that multiple awards may be made under each Focus Area with average budgets ranging from $300,000 to $3,000,000 (anticipated) for the base period of performance. The base Periods of Performance (PoP) may range from 12 to 36 months, dependent upon product type and level of maturation required. Acquisition Approach: The two-stage approach for this RPP is intended to streamline the initial proposal preparation time and effort for MTEC members. Based on the Government�s evaluation of White Papers in Stage 1, select Offerors will be invited to participate in Stage 2 in one of two distinct approaches. Stage 1: White Papers submitted under this RPP shall follow the template provided in this RPP. Stage 2: The Stage 2 process may vary and may require different submissions compared with typical MTEC RPPs. The Government is utilizing two distinct Stage 2 approaches under this RPP. Stage 2 Approach A: This Stage 2 approach will require a solution pitch (i.e., oral presentation) followed by a written detailed research strategy and full cost proposal (after evaluation of the pitch). Stage 2 Approach B: This Stage 2 approach will require a full proposal (to include technical and cost volumes). Note that Stage 2 Offerors will only be required to follow one of the aforementioned Stage 2 approaches. Those Offerors that are favorably evaluated during Stage 1 will receive notification letters which will serve as the formal request for a Stage 2 proposal. These letters will contain specific Stage 2 proposal submission requirements and templates. MTEC Member Teaming: While teaming is not required for this effort, Offerors are encouraged to consider teaming during the proposal preparation period (prior to Enhanced White Paper submission) if they cannot address the full scope of technical requirements of the RPP or otherwise believe a team may be beneficial to the Government. The following resources may help Offerors form a more complete team for this requested scope of work. The MTEC M-Corps is a network of subject matter experts and service providers to help MTEC members address the business, technical, and regulatory challenges associated with medical product development. M-Corps offers members a wide variety of support services, including but not limited to: Business Expertise [i.e., business development, business and investment planning, cybersecurity, finance, intellectual asset management, legal, logistics/procurement, pitch deck coaching, transaction Advisory], and Technical Expertise [i.e., chemistry, manufacturing and controls (CMC), clinical trials, concepts and requirements development, design development and verification, manufacturing, process validation, manufacturing transfer quality management, regulatory affairs]. Please visit https://www.mtec-sc.org/m-corps/ for details on current partners of the M-Corps. MTEC Database Collaboration Tool to help identify potential teaming partners among other MTEC members. The Database Collaboration Tool provides a quick and easy way to search the membership for specific technology capabilities, collaboration interest, core business areas/focus, R&D highlights/projects, and technical expertise. Contact information for each organization is provided as part of the member profile in the collaboration database tool to foster follow-up conversations between members as needed. The Collaboration Database Tool can be accessed via the �MTEC Profiles Site� tab on the MTEC members-only website (https://private.mtec-sc.org/). A dedicated chat forum has been established to facilitate direct interaction amongst MTEC members in relation to this active funding opportunity.� The chat forum can be accessed via the �Discuss Portal� on the MTEC members-only website - https://private.mtec-sc.org/. MTEC: The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting-edge technologies and supporting life cycle management to transition medical solutions to industry that protect, treat, and optimize Warfighters� health and performance across the full spectrum of military operations. MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement (OTA), Agreement No. W81XWH-15-9-0001, with the U.S. Army Medical Research Acquisition Activity (USAMRAA). MTEC is currently recruiting a broad and diverse membership that includes representatives from large businesses, small businesses, �nontraditional� defense contractors, academic research institutions and not-for-profit organizations. Point of Contact: For inquiries, please direct your correspondence to the following contacts: Questions concerning contractual, cost or pricing related to this RPP should be directed to the MTEC Contracts Administrator, mtec-contracts@ati.org Technical and membership questions should be directed to the MTEC Research Associate, Dr. Chuck Hutti, Ph.D., chuck.hutti@ati.org� All other questions should be directed to the MTEC Chief of Consortium Operations, Ms. Kathy Zolman, kathy.zolman@ati.org
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/17615941499c4a64bd00572ed1074e2d/view)
- Place of Performance
- Address: Frederick, MD 21702, USA
- Zip Code: 21702
- Country: USA
- Zip Code: 21702
- Record
- SN06569058-F 20230122/230120230102 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
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