SPECIAL NOTICE
99 -- MTEC-21-10-Navy Multi-Topic 2021 - Advanced Biomedical Product Development in Support of Naval Operations RPP Announcement
- Notice Date
- 2/23/2021 6:59:07 AM
- Notice Type
- Special Notice
- Contracting Office
- W4PZ USA MED RSCH ACQUIS ACT FORT DETRICK MD 21702-5014 USA
- ZIP Code
- 21702-5014
- Solicitation Number
- MTEC-21-10-NavyMultiTopic2021RPPAnnoucement
- Response Due
- 3/22/2021 9:00:00 AM
- Archive Date
- 04/06/2021
- Description
- The Medical Technology Enterprise Consortium (MTEC) is excited to post this announcement for a 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. Background Due to the Navy and Marine Corps� diverse warfighting capabilities, Sailors and Marines 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 This multiple topic area (�multi-topic�) RPP will require white paper submissions that describe projects that are based on logical reasoning and sound scientific rationale. Projects should not be exploratory in nature and do require a foundation of preliminary data. Note that MTEC-sponsored projects must result in �prototype� research deliverables that transition medical solutions to industry. Proposed prototypes shall be at a Knowledge Readiness Level (KRL) or Technology Readiness Level (TRL) of 5 at the time of submission or by the anticipated award date (at or around September 30, 2021).� Offerors have achieved KRL/TRL 5 if: Knowledge Products: Offeror has completed testing of a priori hypotheses using rigorous scientific design and directly assessed whether and how a tool can work. Pharmaceutical (Biologics, Vaccines): Offeror has determined that sufficient data on the candidate biologic/vaccine exist in the draft technical data package to justify proceeding with preparation of an IND application.� Medical Devices: Investigational Device Exemption (IDE) review by the Center for Devices and Radiological Health (CDRH) results in determination that the investigation may begin.� For a 510(k), preliminary findings suggest the device will be substantially equivalent to a predicate device. Medical Information Management/Information Technology & Medical Informatics: Medical Informatics data and knowledge representation models are implemented as data and/or knowledge management systems and tested in a lab environment. NOTE: Full definitions of TRLs can be found here. More information regarding KRLs can be found here. Subsequent to the completion of performance under the prototype awards resulting from this RPP, the Government reserves the right to award follow-on work. Any follow-on work for the continuation of the prototype development is contingent upon availability of future funding and the successful completion/progression of milestones. Proposed prototype solutions shall address ONE of the Technology Focus Areas and ONE of the associated Specific Areas of Interest outlined below in support of the Naval Advanced Medical Development (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. FOCUS AREA #1: COMBAT CASUALTY WOUND AND INFECTION CARE This area focuses on patient care at and through the continuum of care as well as products and services that sustain patient health in austere environments such as expeditionary, littoral, and deep water. Specific areas of interest are as follows (Offerors shall address only one of these in each White Paper submission): Wound care treatments / therapies for combat injuries. Includes technologies suitable for use at point of injury and/or at medical facilities in theater. Wound care technologies for combat wound infections (e.g., bacterial and other infections of combat wounds) Innovative wound care technologies to treat and prevent biofilm formation FOCUS AREA #2: ENTEROTOXIGENIC ESCHERICHIA COLI (ETEC) DISEASE RESEARCH This area focuses on medical technology and solutions that support the prevention and solutions that treat and/or cure ETEC. ETEC may cause diarrhea, vomiting, dehydration, and other debilitating symptoms for several days or more that often result in incapacitating symptoms. ETEC and ETEC-related illnesses may negatively impact duties and operations by reducing team manning, delaying movement, and increasing costs related to seeking medical treatment and potentially evacuation. Specific areas of interest are as follows (Offerors shall address only one of these in each White Paper submission): a.� ETEC pre-exposure prophylaxis strategies that can be used prior to exposure and / or at the point of infection that may reduce risk, shorten the duration of acute illness and / or mitigate of ETEC and ETEC-related illnesses. b.� ETEC therapeutic treatments that can be issued to symptomatic patients to treat the effects of ETEC that may be suitable for usage in in a forward environment. FOCUS AREA #3: HUMAN PERFORMANCE / PHYSIOLOGICAL EPISODES This area focuses on the prediction / improvement of health status and outcomes from various sources of combat related stressors that may include advanced biomedical electronics such as sensors and microelectronics and other medical technology solutions that mitigate the risk of physiological episodes (PEs). PEs may be a result of hypoxia, toxic exposure, decompression illness, hyperventilation, spatial disorientation, or other physiological conditions that occur in operational environments. Occurrence of PEs may result in physiological discomfort, loss of consciousness, 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): Body-worn devices that detect changes in physiological conditions associated with the onset of PE including a risk alert to the user during tactical performance in time to implement corrective actions. Enabling capabilities that increase the effectiveness and fieldability of PE detection and alert systems including, but not limited to, physiological risk profiles, specialized device hardware components, improved wearability. Pre- and post-exposure treatments or biotechnology solutions that enhance / restore operator performance or reduce operator impacts /susceptibility from / to PE conditions, thus maximizing operator resilience / recovery. Potential for Follow-on Work There is potential for award of one or more follow-on tasks based on the success of any resultant Research Project Awards (subject to change depending upon Government review of work completed and availability of funding). Note that any potential follow-on work is expected to be awarded non-competitively to resultant project awardees. Follow-on work may include tasks related to advancement of prototype maturity, and/or to expand the use or utility of the prototype. Acquisition Approach MTEC recognizes that considerable effort is required to prepare a competitive proposal to MTEC. 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 and will be required to submit a full proposal for more detailed evaluation.� Stage 1: White Papers submitted under this RPP shall follow the MTEC White Paper Template provided in Section 8. 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) using the MTEC Proposal Preparation Guidelines (PPG). 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. Potential Funding Availability The U.S. Government (USG) currently has available a total of approximately $25 million (M) for anticipated awards to be made during FY2021. The estimated total available funding per Focus Area is as follows (subject to realignment dependent on quality of submissions): Focus Area #1: Combat Casualty Wound and Infection Care ~$12M Focus Area #2: Enterotoxigenic Escherichia Coli (ETEC) Disease Research ~ $10M Focus Area #3: Human Performance / Physiological Episodes ~$3M MTEC anticipates that multiple awards may be made under each Focus Area with average budgets ranging from $1,750,000 to $10,000,000 for the base period of performance (exclusive of any proposed options). Award funding will be structured incrementally and based upon completion of Milestones and Deliverables. The base Periods of Performance (POP) may range from 12 to 36 months, dependent upon product type and level of maturation required. Dependent on the results and deliverables under any resultant award(s), the USG may apply additional dollars and/or allow for additional time for follow-on efforts with appropriate modification of the award. Cost sharing, including cash and in kind (e.g., personnel or product) contributions are strongly encouraged, have no limit, and are in addition to the Government funding to be provided under the resultant award(s). Pending successful completion of the total effort, the Government may issue a non-competitive follow-on production contract or transaction pursuant to 10 USC 2371b section f. MTEC The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting-edge technologies and supporting effective materiel 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� government contractors, academic research institutions, and not-for-profit organizations. Administrative Information White Papers are due no later than March 22, 2021 at 12:00pm Eastern Time. The RPP is posted to the MTEC website (mtec-sc.org) and a notice is posted on www.beta.SAM.gov to notify interested parties. MTEC membership is required for the submission of a White Paper in response to this MTEC RPP. An Offerors submitting a White Paper as the prime contractor must be an MTEC member of good standing by March 17, 2021. To join MTEC, please visit http://mtec-sc.org/how-to-join/ A Proposers Conference via webinar will be held for interested parties to have their questions answered by the USG DoD after the RPP is posted. MTEC Members will be notified when the Proposers Conference is scheduled. Points of Contact Please direct your inquiries and correspondence to the following contacts: Questions concerning contractual, cost or pricing related to this RPP should be directed to the MTEC Contracts Administrator at� mtec-contracts@ati.org Technical and membership questions � Dr. Lauren Palestrini, MTEC Director of Research, lauren.palestrini@mtec-sc.org Administrative questions � Ms. Kathy Zolman, MTEC Director of Program Operations, kathy.zolman@ati.org To view this solicitation, click here.
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- Record
- SN05923934-F 20210225/210223230110 (samdaily.us)
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