DEFENSE HEALTH AGENCY DHA USA Tender

The Medical Technology Enterprise Consortium (mtec) Is Excited To Post This Summary Announcement For The Request For Project Proposals (rpp) To Solicit Current Mtec Members For A Broad Range Of Medical Prototype Technological And Knowledge Solutions Related To The Focus Areas Of Interest (also Called “focus Area(s)”) Listed Below. Proposed Solutions May Include Medical Techniques, Knowledge Products, And Materiel (medical Devices, Drugs, And Biologics). Military Relevance Is A Key Feature Of This Rpp. Awards Resulting From This Rpp Are Expected To Be Made Under The Authority Of 10 U.s.c. § 4022 (authority Of The Department Of Defense To Carry Out Certain Prototype Projects). 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: current Wartime Operations Assume That The United States And Our Allies Will Maintain Air, Land, Maritime, Space And Cyber Superiority. Future Conflicts Against Peer And Near-peer Adversaries Are Expected To Be Layered Stand-offs And Fought Across Multiple Domains. Mission Success Will Be Determined By Our Ability To Compete To Expand The Competitive Space, Penetrate Both Strategically And Operationally, Disintegrate Enemy’s Defenses, Exploit Enemy Weaknesses, And Re-compete To Consolidate Gains. Medical Capabilities Play A Critical Role In Each Aspect Of The Future Battlespace And Must Modernize Rapidly To Maintain Force Readiness And Increase Soldier Lethality. technology Focus Areas: to Meet The Intent Of This Rpp, Each Enhanced White Paper Proposal Shall Specifically Address Only One Focus Area Of Interest Described Below. Offerors Are Not Limited To A Single Enhanced White Paper Submission. Projects That Fail To Align With Only One Of These Focus Areas Of Interest May Not Be Considered For Funding. Focus Areas Include: prophylactic To Prevent Infection In Battlefield Wounds From Complex Traumatic Penetrating Injuries In A Far-forward, Austere Environment pathogen Agnostic Countermeasures For The Treatment Of Sepsis Caused By Wound Infection antivirals For The Prevention And/or Treatment Of Endemic And Emerging Infectious Diseases (non-biothreat Pathogens) prevention Of Endemic Diarrheal Diseases knowledge Product Solutions For The Prevention Of Infection In Traumatic Penetrating Wounds musculoskeletal Injury sensory Systems intracranial Pressure Monitor precision Nutrition Development vector-based Surveillance quick Sterilant For Stainless Steel Medical Instruments full Descriptions Of These Focus Areas Including Specific Requirements (to Include Minimum Technology Readiness Levels) And Considerations Are Included Within Section 3 Of The Full-length Version Of The Rpp. 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(s) (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 Initial Period Of Performance (pop). Follow‐on Work May Include Tasks Related To Advancement Of Prototype Maturity, And/or To Expand The Use Or Utility Of The Prototype. Examples Of Potential Follow‐on Work Are (but Not Limited To): prototype Development, Refinement, Maturation nonclinical And Preclinical Studies Required For The Technical Data Package For A Regulatory Application clinical Studies establish Robust Quality System improve Efficiency And Reproducibility Of Manufacturing Process For Scale Up work Towards Fda Clearance/ Approval military Environmental And Operational Assessments ruggedization For Operation In Military Environments advanced Technical Testing In Relevant Or Simulated Operational Environments offerors Are Encouraged, As Appropriate, To Discuss Potential Follow‐on Work In The Enhanced White Paper Submission To Demonstrate The Ability To Further Advance The Project Maturity Beyond The Proposed Pop. This Will Also Allow The Offeror To Highlight The Potential Capabilities That Can Be Explored/achieved Through Short Term And/or Long‐term Advancement Of The Project In A Way That Is Beneficial To The Government. potential Funding Availability And Period Of Performance: due To The Wide Variety And Inherent Diversity Of Focus Areas Being Solicited For In This Rpp, The Funding Amount, Expected Pop, Number Of Anticipated Awards, And Timing Of Funding Availability For Each Focus Area Is Outlined Briefly Below And Again In Section 3.3 Of The Full-length Version Of The Rpp. The Funding Amounts And The Number Of Expected Awards Will Be Limited And Is Contingent Upon The Availability Of Federal Funds For Each Program. The Estimated Total Available Funding Per Focus Area Is As Follows: musculoskeletal Injury: The Government Anticipates Making Multiple Awards For This Focus Area. Awards For Research Studies (other Than Those For Clinical Research) Are Anticipated To Be ~$750k With A Pop Not To Exceed 36 Months. Awards For Clinical Research Studies Are Anticipated To Be ~$3m With A Pop Not To Exceed 48 Month. These Awards Are Likely To Be Made With Fy26 Funding.* sensory Systems: The Government Anticipates Making Up To Eight (8) Awards Of Approximately $2m Each With Pop Not To Exceed 24 Months. These Awards Are Likely To Be Made With Both Fy25 And Fy26 Funding.* intracranial Pressure Monitor: The Government Anticipates Having ~$5m Total For One Or Two Awards With A Pop Not To Exceed 36 Months.* vector-based Surveillance: The Government Anticipates Making A Single Award Of ~$3-4m With A Pop Not To Exceed 36 Months.* quick Sterilant For Stainless Steel Medical Instruments: The Government Anticipates Having ~$2m Total For One Or Two Awards With A Pop Not To Exceed 24 Months.* *note: These Funding Amounts Are Subject To Change And Represent The Total Available Funding For The Specified Focus Area And Would Include Both Direct And Indirect Costs. other Focus Areas: The Government Is Unable To Identify The Funding Availability For These Focus Areas And Has Not Specified An Estimated Period Of Performance. offerors Are Encouraged To Propose Budgets And Pop Commensurate With The Nature, Scope And Complexity Of The Proposed Research. Offerors Should Submit Budgets That Include The Entire Pop Of The Research Project. Yearly Budgets Should Include All Direct And Indirect Costs, Based On Supportable, Verifiable Estimates. Offerors Are Encouraged To Scope Out Their Budgets In Alignment With Major Deliverables Of Their Proposed Work So That Large Budgets Are Easier To Evaluate, And Sponsors Can More Easily Allocate Available Funding. for Informational Purposes, The Average Value Of Mtec Awards For An Initial Pop Is Approximately $2.0 – 3.5m Over A 2-3-year Pop. selection Of Prototype Projects Is A Highly Competitive Process And Is Based On The Evaluation Of The Proposal’s Technical Merit, Programmatic Considerations (to Include Program Portfolio Composition), And The Availability Of Funds. The Quantity Of Meaningful Submissions Received Normally Exceeds The Number Of Awards That The Available Funding Can Support. Any Funding That Is Received By The Government And Is Appropriate For A Focus Area Of Interest Described Within This Rpp May Be Utilized To Fund Enhanced White Papers. Awards Resulting From This Rpp Are Expected To Be Made In Fy 2025 And 2026 Under The Authority Of 10 U.s.c. § 4022. 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). award Funding May Be Structured Incrementally And Based Upon Completion Of Milestones And Deliverables. dependent On The Results And Deliverables Under Any Resultant Award(s), The U.s. Government (usg) May, Non‐competitively, Award Additional Dollars And/or Allow For Additional Time For Scope Increases And/or Follow‐on Efforts With Appropriate Modification Of The Award. acquisition Approach: this Rpp Will Be Conducted Using The Enhanced White Paper Approach. In Stage 1, Current Mtec Members Are Invited To Submit Proposals In The Form Of Enhanced White Papers Using The Mandatory Format Contained In The Full Length Version Of The Rpp (see Section 8 Of The Rpp). The Government Will Evaluate Enhanced White Papers Submitted And Will Select Those That Best Meet Their Current Technology Priorities Using The Criteria In Section 5 Of The Rpp. Offerors Whose Proposed Solution Is Selected For Further Consideration Based On The Enhanced White Paper Evaluation Will Be Invited To Submit A Full Cost Proposal In Stage 2 (and May Be Required To Submit Additional Documentation Or Supplemental Information, Upon Request). Notification Letters Will Contain Specific Stage 2 Proposal Submission Requirements. pending Successful Completion Of The Total Effort, The Government May Issue A Non‐competitive Follow‐ On Production Contract Or Transaction Pursuant To 10 U.s.c. § 4022 Section F. the Government‐selected Prototype Project(s) Awarded As A Result Of This Solicitation Will Be Funded Under The Other Transaction Agreement For Prototype Projects (ota) Number W81xwh‐15‐9‐0001 With Mtec Administered By The Consortium Manager (cm), Ati. The Cm Will Negotiate And Execute A Base Agreement With Mtec Members (if Not Yet Executed). The Same Provisions Will Govern This Base Agreement As The Ota For Prototype Projects Between The Government And Mtec. Subsequently, Any Proposal That Is Selected For Award Will Be Funded Through A Research Project Award (rpa) Issued Under The Member’s Base Agreement. The Mtec Base Agreement Can Be Found On The Mtec Website And Members‐only Website At Www.mtec‐sc.org. at The Time Of The Submission, If Offerors Have Not Yet Executed A Base Agreement, Then Offerors Must Certify On The Cover Page Of Their Enhanced White Paper That, If Selected For Award, They Will Abide By The Terms And Conditions Of The Latest Version Of The Mtec Base Agreement. If The Offeror Already Has Executed An Mtec Base Agreement With The Mtec Cm, Then The Offeror Must State On The Cover Page Of Its Enhanced White Paper That, If Selected For Award, It Anticipates The Proposed Effort Will Be Funded Under Its Executed Mtec Base Agreement. for More Information Regarding The Requirements Of The Enhanced White Paper Process And Template, Refer To The Full Length Version Of The Rpp Which Has Been Posted To The Mtec Website (mtec‐sc.org); This Notice Is Intended Only To Notify Interested Parties Of The Available Solicitation. Mtec Membership Is Required For The Submission Of An Enhanced White Paper. To Join Mtec, Please Visit Http://mtec‐sc.org/how‐to‐join/. mtec Member Teaming: while Teaming Is Not Required For This Effort, Offerors Are Encouraged To Consider Teaming During The Proposal Preparation Period (prior To 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. Refer To The Rpp For Resources That May Help Offerors Form A More Complete Team For This Requested Scope Of Work, Such As The Mtec M-corps, Mtec’s Database Collaboration Tool, And The Dedicated Mtec Teaming Connect. 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-sc@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 Program Manager, Mr. Evan Kellinger, Mtec-sc@ati.org to View The Full-length Version Of This Rpp, Visit Www.mtec-sc.org/solicitations/.