Attachment-4-AMM SOO - DRAFT v5 CS edits.docx

Template Version: Sept 2015 <do not alter this version month and year. It is assigned by USAMRAA>

STATEMENT OF OBJECTIVES (SOO)

Original Date: 26 February 2025 Title: ADVANCED MEDICAL MONITOR (AMM) DEVELOPMENTAL EFFORTS Requiring Activity/Agency Name: Defense Health Agency (DHA) Warfighter Expeditionary Medicine and Treatment (WEMT) Project Management Office (PMO) Program Name: Advanced Medical Monitor (AMM)

1. PURPOSE

The purpose of this SOO is to obtain Family of Systems (FoS) devices that meet (Threshold level) or exceed (Objective level) technical performance standards of the Advanced Medical Monitor (AMM), to provide enhanced noninvasive monitoring and decision support capability to the Joint Services’ medical providers. Successful FoS components will improve providers’ situational awareness regarding casualties and patients, will allow for data-sharing as patients transfer between Roles, or during reach-back for expert advice, will provide alerts for the most pressing cases, will be small, lightweight, durable and demand low power consumption and will be fully interoperable between the Services, facilitating patient hand-off throughout the care continuum. A key objective is to reduce cognitive workload for the limited number of providers in a Joint All Domain Operations (JADO) environment, where provider to patient ratio is expected to be challenging. Open system architecture will allow for addition of incremental capability over the life of the AMM FoS, as new functionality emerges in the marketplace. Common solutions will be deployed within the Joint Services to improve logistics and sustainment considerations, in addition to a holistic approach to providing care for all Service members. Prototype hardware, software and compatibility with interface standards for the Battlefield Assisted Trauma Distributed Observation Kit (BATDOK) compliance must be achieved by end of the period of performance (PoP).

Both NGMM and EMM must be FDA approved or cleared, and certified as airworthy/safe to fly for all hardware items which will remain with patients during patient movement, i.e. Carry On Medical Devices. The long-term goal of the AMM program is to deliver advanced noninvasive physiological monitoring solutions to the Joint Services medical community, to provide actionable information enhancing casualty triage, informing treatment and evacuation priorities and monitoring vital signs of patients receiving medical care. FoS components will facilitate transfer of patient data through the care continuum. Enhanced patient evaluation via advanced medical monitors and triage algorithms will provide early indication of life-threatening complications, provide decision support capability to assist in determining medical priorities, reduce the amount of unnecessary evacuation, and improve return to duty timelines.

AMM system components will include the Next Generation Medical Monitor (NGMM) and the Expeditionary Medical Monitor (EMM). Each component must first meet the AMM performance parameters, and additionally has its own performance requirements, and each will contribute to the larger AMM goals. The program level is known as AMM, and the NGMM and EMM are devices which fit under the AMM umbrella. AMM product development will be conducted in two phases:

a) Phase I. Obtain prototype devices and related documentation to support Governmental testing and evaluation (T&E) activities and planning for FDA approval or clearance. During this phase T&E activities will include environmental testing (ET), an early operational assessment (OA), an initial logistics evaluation and initial cybersecurity or Risk Management Framework (RMF) evaluation. If FDA approval or clearance is pending, the performer’s strategy will be defined and Pre-Submission documentation completed. The Government may award one or multiple contracts for each system component, i.e. the EMM and NGMM. If multiple awards are made, a down-select decision will be made prior to award of the next phase.

b) Phase II. Optional award for further development of successful candidate systems from Phase I. Procure updated, more mature prototype devices and associated documentation updates to implement any changes needed per Phase I evaluations, complete system validation and qualification for full compliance to all performance capabilities as demanded for deployment to military use cases. FDA clearance or approval must be obtained within this phase, with an indication for use which addresses the entire planned patient population, i.e. all Military adult patients (aged 18-65). Additionally, Airworthiness/Safe-to-Fly criteria must be met. Governmental T&E and cybersecurity evaluation as well as authority to operate (ATO) will be concluded, allowing the Government to proceed to a production and deployment (P&D) decision.

c) Optional award for limited procurement of P&D systems will not be included under this SOO. However, following successful completion of Phase II efforts, the Government intends to separately award contracts for to-be-determined-quantity procurements of deployable NGMM and EMM capabilities, if proper authorities and funding are in place.

The NGMM will be designed for use primarily at Roles 2 and 3. Size, weight and power consumption are important considerations and should be minimized. The NGMM must be designed for expeditionary medical use, meaning capable of being transported and used under extreme environmental conditions, and highly reliable. Modularity of functional capabilities is a plus, example to allow providers to include or exclude add-on capability such as printing or defibrillation. In addition to vital signs (VS) monitoring and decision support capability, the NGMM must capture and retain patient data, and be able to bi-directionally transfer the data to/from health records, to/from telemedicine consultants and to/from higher roles of care via networked capability.

The EMM will be designed for use primarily at the point of injury (POI), en route care, and Role 1. As such, it must be small, lightweight, durable in harsh environments, easy to interpret by personnel with limited medical training, and able to operate on batteries or other approach which precludes a need for wall power. In addition to VS monitoring and decision support capability, the EMM must capture and retain patient data, and be able to transfer the data to telemedicine consultants and to higher roles of care in accordance with networked hardware and software compatibility standards.

For additional details regarding medical roles of care, see References appendix, item 1, Roles of Medical Care.

2. BACKGROUND

In contrast to recent Counter Insurgency (COIN) Operations, future Large-Scale Combat Operations (LSCO) conducted during JADO will generate casualties in numbers not seen since World War II. Medical provider to casualty ratios will become a significant challenge. Many of the casualties will present with occult injuries that cause internal hemorrhage or other injury or illness, which are not readily apparent to medical providers at the POI and throughout the roles of care. Regardless of severity, all casualties must be triaged. The AMM will give medical providers the information needed both to support triage decision-making and to inform treatment decisions.

· Injury or illness may result in urgency of immediate intervention, and adverse consequences if not readily recognized at the POI. Currently fielded equipment provides little to no diagnostic or decision support capability in far forward settings. To address this, the AMM project aims to field decision support capability as far forward as POI.

· As an example, uncontrolled occult hemorrhage would lead to rapid circulatory collapse which is invariably fatal if not immediately treated. Additionally, casualties might present with signs and symptoms that suggest potential occult hemorrhage when in fact this condition is not present. A predictive indication of presence or absence of occult hemorrhage will be a valuable tool for triage support, including both prioritization of the most critically wounded and support for return-to-duty decisions. Hemorrhage detection is a threshold-level decision support capability for AMM, for both the NGMM and the EMM devices.

· VS data for all patients is important to medical treatment decision-making and important to retain as part of patients’ electronic health records (EHRs). AMM will provide potential to retain digital records of patient VS beginning at first response, thereby providing a comprehensive account of clinically relevant data as the patient progresses through the care continuum.

· Noninvasive medical monitoring capability to determine priorities for increased levels of care or evacuation will reduce decision overload on medical responders and improve macro level survivability.

· Evacuation to and treatment by a Role 2 facility with a surgical capability or to a Role 3 facility that has both a surgical and CT capability will be enhanced by AMM’s generating and flagging key mortality indicators.

· Additionally, the AMM will seek to combine functionality of currently deployed monitors, as well as potentially adding capability to monitor more than one patient on a single device, thus allowing for optimization of the total number of medical monitors required at a given site.

The envisioned AMM capability is for use from POI to Role 3, including en route care.

3. SCOPE/MISSION

The Consolidated Performance Parameters (CPPs) define the end state capability the devices must be able to achieve, following all developmental activities. Throughout developmental phases for the devices, the Performer will conduct effort required to mature toward the end state capability. Details within this SOO regarding Phases I and II are intended to characterize anticipated efforts, however, they should be read as “may include but not limited to”, rather than as finite constraints. All effort under Phase I needed to mature capability from TRL 4 to TRL 6 is considered in scope. All effort under Phase II needed to mature capability from TRL 6 to TRL 8 is considered in scope. Should the Performer identify tasking needed to achieve these ends, which are not overtly stated in language under this section, it may be proposed.

A) Phase I of this effort will address Technology Maturation and Risk Reduction (TMRR). The minimum Technology Readiness Level (TRL) for entry into this phase is 4, i.e. proof-of-concept and safety of candidate devices/systems must be demonstrated, and a design history file must be initiated to support a 510(k), De Novo or Premarket Approval (PMA) submittal to the FDA. The AMM indication is “to noninvasively monitor, analyze and provide data used to enhance patient triage” and the prototype system or device capability must continue maturing toward:

· Noninvasive VS monitoring and display

· Ability to connect to ancillary hardware items that may be used as sensors for collecting VS, or to supporting systems, ex: connect to a pulse oximeter

· Decision support algorithm(s), at a minimum to forewarn of hemorrhagic shock

· Alarms and/or alerts

· VS data retention and ability to transfer to subsequent Roles in accordance with networked hardware and software compatibility standards; note the devices must not transfer company proprietary data as part of data transfer.

· User agnostic accessibility (i.e. no individual user log-in credentials required)

· Open Architecture (OA) approach to allow for future incremental capability. Planning for software updates, as needed, including regression testing, allowing users to determine timing for adoption of updates and precluding rendering devices inoperable if they have not been updated to the latest available software revision

· Interoperability between NGMM and EMM devices, in accordance with networked hardware and software compatibility standards

· Ability to enable/disable active communications, i.e. ability to turn off electronic signature

· Ruggedization to function in far-forward extreme environments

· Ability to disable wireless connectivity without precluding device medical capability

Additional effort in the Phase I –

· Planning for FDA approval or clearance, including developing the submission package and interacting with FDA through the pre-sub process and meetings.

· Initial documentation to support development of Government logistics documentation, including training and maintenance

· Initial documentation to support initiation of cybersecurity compliance verification

· Rough Order Magnitude (ROM) production cost estimates, in accordance with Contract Data Requirements List (CDRL)

· Submission of any inventions/Intellectual Property (IP) claimed under this contract via iEdison

· Meetings and reporting per defined deliverables

The performer(s) will deliver prototype devices. Independent Government T&E will confirm operational and transport/storage capability in accordance with Services’ needs and per testing conditions as defined in MIL-STD-810H. Initial evaluation of cybersecurity considerations will confirm suitability to operate within military domains and/or identify modifications needed for compliance. The Government will conduct an early User and Maintainer operational assessment to evaluate suitability for use in all anticipated environments, such as hot/cold, lit/unlit, wet/dry, powered/unpowered, and including analysis time, alert or warning indicators, protective gear compatibility and other criteria, as needed.

Supporting documentation from the performer shall include:

· Initial sustainment planning documentation,

· Initial configuration control board planning, including a provision for Government participation,

· Documentation appropriate to the TMRR phase regarding FDA Regulatory clearance/approval in accordance with Data Item Description (DID) # DI-TCSP-82040, Title: RESEARCH AND DEVELOPMENT OF MEDICAL PRODUCTS REGULATED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA). Reference DID found in references appendix, at ASSIST-QuickSearch Document Details (dla.mil)

· Test and evaluation summary reports

Please note, the above bulletted list is expected to be initial or preliminary as of Phase I; final revisions would be included as effort under Phase II.

At the end of the Phase I, the system or device must achieve a minimum TRL of 6, i.e. a fully functional prototype, showing adequate first in human safety studies in preparation for clinical safety and efficacy studies or substantial equivalence to predicate device(s), demonstrated to interface with any supporting systems, and compliant with a simulated operational environment. During Phase I, all effort necessary to mature the end item toward eventual compliance with performance parameters identified in the CPPs document is considered in scope and may be proposed. Also note, the performer should propose efforts across Phases I and II in a way that is logical and most efficient from a perspective of its product; if a detail in Phase I planning partially addresses maturing the product to a TRL higher than 6, this would not render that effort out of scope. The TRL guidelines are not absolutes, and tailoring is appropriate.

If more than one contract was awarded per component, the Government will down-select prior to awarding the Phase II efforts.

B) The Phase II, optional, phase of this effort will address Engineering and Manufacturing Development (EMD) requirements, and will be awarded following a successful Milestone B decision. Efforts during this phase will further develop prototypes completed during the Phase I, refining device functionality, form factor, ruggedization and any needed improvements for final design. The performer(s) will deliver updated prototype devices. Supporting documentation will be updated, including guides, manuals and drawings and all other supporting documentation as noted in Phase I details; additionally, training and software update development and plans will be finalized. Independent Government T&E will confirm final compliance with all performance parameters, environmental and cybersecurity standards, airworthiness/safe to fly, a logistics evaluation, and suitability via an operational assessment. Finalized FDA submission will be completed and clearance/approval must be obtained and manufacturability demonstrated. The system components must achieve a minimum TRL of 8, i.e. a final product proven to work in its final form and under expected conditions. An ATO will be requested for all scenarios in which the items will be employed.

All effort that serves to achieve the above goals is appropriate, and may be proposed.

C) Following a successful EMD Phase II, the Government intends to separately contract for production quantities of both NGMM and EMM, if all proper authorities and funding are in place. Production is not included in scope for this solicitation.

4. PERFORMANCE OBJECTIVES – BASE TASKING – TMRR PHASE I

4.1 Developmental Effort

Provide program management, engineering, quality management, regulatory and other expertise required to achieve the Scope of Effort as defined in section 3, (A) Phase I, including device capabilities, additional efforts and supporting documentation. Ensure adequate time is planned for expertise in providing detailed support and iterative responses related to documentation requirements. Estimates for expertise should pay particular attention not only to engineering developmental activities for design and test of items, but should also include focus on cybersecurity / RMF documentation and FDA and/or other regulatory documentation.

Note – Offerors may propose solutions for the NGMM capability – OR – for the EMM capability – OR – for both the NGMM and EMM capabilities.

4.2 Performance Parameters

Reference document titled, “Advanced Medical Monitor (AMM) Consolidated Performance Parameters (CPPs)” for detailed critical and desired performance parameters. Note, the overarching parameters apply to both NGMM and EMM. Additionally, for the NGMM and EMM, each has its own set of parameters. This referenced CPPs document is part of the solicitation package.

4.3 Regulatory Concerns

FDA approval / clearance is a critical parameter and must be achieved. Documentation regarding FDA Regulatory clearance/approval shall be provided in accordance with Data Item Description (DID) # DI-TCSP-82040, Title: RESEARCH AND DEVELOPMENT OF MEDICAL PRODUCTS REGULATED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA). Reference DID found in references appendix, at ASSIST-QuickSearch Document Details (dla.mil). During Phase I, efforts that must be completed are:

· An Indication for Use that suffices use in the referenced care continuum (POI, Roles 1-3, en route care), for adults (age 18-65), body-position agnostic, all demographics in Military populations

· The Performer shall be the FDA regulatory sponsor in accordance with Code of Federal Regulations (CFR) Title 21 Food and Drugs, and shall designate the Government as a third party who may have direct interactions with the FDA.

· The Performer should submit an initial Regulatory Strategy in accordance with (IAW) MRMC DID DI-TCSP-82040 with the proposal and update as requested. The Regulatory Strategy should include a schedule with corresponding regulatory activities to ensure accomplishment of approval or clearance no later than 2030.

· The Performer shall prepare a Pre-Submission package to the Food and Drug Administration, as needed, to support the clearance or approval of its product. At a minimum, a Pre-sub should inform a GLP study. Please reference DID MRMC DID DI-TCSP-82040 for details.

· The Performer shall include the Defense Health Agency (DHA) Contract Officer’s Representative (COR) or his/her designee in all meetings both formal and informal with the FDA. It is the intention of the Government to be present (physically whenever possible or via Performer provided teleconferences) for all meetings and discussions with the FDA. Whether the Government can or cannot attend, detailed notes will be provided to the Government by the Performer. Copies of notes and regulatory communications from the FDA shall be sent to the COR within three (3) days of occurrence or receipt. The Performer shall provide copies of all communications, to include meeting minutes, emails, and letters, to the FDA within five (5) business days. If submissions have occurred prior to contract award, the Performer shall provide copies of any submissions, to date.

· For any/all clinical trials and/or studies, apply for approval from the Office of Human and Animal Research Oversight (OHARO) to ensure compliance with all protocols; trials or studies shall not commence in advance of formal approval.

· For all GLP studies, apply for approval from the Office of Human and Animal Research Oversight (OHARO) to ensure compliance with all protocols; trials or studies shall not commence in advance of formal approval.

· For any/all clinical trials and/or studies that will include animal studies, apply for approval from the Animal Care and Use Review Office (ACURO) to ensure compliance with all protocols; trials or studies shall not commence in advance of formal approval.

· Plan for and initiate compliance with current Good Manufacturing Practices (cGMP) and Quality System Regulations (QSR) per 21 CFR Part 820, in preparation for eventual production capability

· In the event that data from the GLP animal studies or feedback from the FDA requires additional studies and/or data, the Performer may propose the necessary work.

During Phase II, full execution of the Regulatory Strategy must be completed, including updates to all relevant documents from Phase I, and FDA approval or clearance must be obtained.

4.4 Standards Compliance

Standards Compliance requirements are found in both the “Advanced Medical Monitor (AMM) Consolidated Performance Parameters (CPPs)” and “U.S. Department of Defense Defense Health Agency (DHA) Operational Medicine Care Delivery Platform (OpMed CDP) Hardware / Software Requirements” documents; both are attachments to this solicitation. Note there are hardware and software specifications. Minimum and/or Threshold requirements, as per the documents, define imperative compliance. Additionally, there are Recommended and/or Objective requirements, which should be considered for implementation, but are not mandatory minimums for compliance.

Additionally, the Performer shall “design in” compliance with networking hardware and software standards.

4.5 Cybersecurity Compliance

As part of its cybersecurity assessment, the Government will evaluate device cyber risks. During Phase I, feedback from the assessment will be provided to the performer to allow for any corrections needed. During Phase II, any corrections must be implemented and verified, for the Government to be able to obtain an ATO. If the Government is unable to obtain an ATO, the end items will not be fieldable, and procurement of production quantities will not follow. As such, expertise to provide iterative feedback to the Government, as well as to implement any corrections, must be included as part of both the Phase I and Phase II efforts.

Note, documentation submitted shall include drawings/schematics and data flow diagrams sufficient for cybersecurity assessment, in accordance with the Medical Device and Equipment Risk Assessment (MDERA) (see Appendix X). Reference the MDERA for additional details surrounding expected compliance considerations.

The Performer shall generate and deliver Software Bills of Materials (SBOMs) for all code, software components and subcomponents, and software-based services delivered under this contract, including firmware, operating systems, applications, and application services, including cloud-based software. Full details that include the scope, inventory and reporting, emerging threats and self-attestation can be found in References, Software Bills of Material.

4.6 Logistics and Sustainment Capabilities

Provide logistics and training expertise required to achieve the Scope of Effort as defined in section 3, (A) Phase I. Documentation shall include:

· initial user guide,

· initial quick start guide,

· initial maintenance and repair manual defining maintenance actions and intervals as well as step-by-step trouble-shooting guides, schematics and identification of high-failure parts (if any),

· initial user training development, as train-the-trainer format,

· initial maintainer training development, including any OEM or other certifications needed by Government maintainers, as train-the-trainer format,

· release for Government to duplicate and/or post training materials to Government websites for use by Government users, maintainers and/or repair technicians,

· recommended maintenance and repair kits, including estimated costs and any minimum buys,

· shelf life estimate of any consumables and/or maintenance parts,

· life expectancy of the devices based on wear and tear and/or repair part obsolescence

· summary plan for OEM support, identifying capabilities which will be planned for long-term support (i.e. this planning would include efforts such as repair capability, technical support, etc.),

· initial parts catalog or other ordering methodology for consumables, maintenance and repair parts, including part numbers

· defined software update methodologies, including anticipated intervals for updates,

· release for Government to post software updates on U.S. Army Communications-Electronics Command (CECOM) and/or other Government website, to allow for field updates of software releases,

· Mean Time Between Failure (MTBF) and Mean Time to Repair (MTTR) data, if available,

· initial configuration control board planning, including a provision for Government participation,

· initial user and maintainer manuals, and device quick start guide shall be submitted for review and comment. Updates shall be made to address comments.

4.7 Configuration Control Board (CCB) Planning

Following completion of all RDTE activities, the Government intends to field equipment items (note – procurement and fielding are not included in scope of this solicitation.) Over the duration of long-term equipment item usage, configuration changes may result from parts obsolescence, safety considerations, software updates, performance improvements, materials changes, or any number of reasons for engineering change proposals (ECPs). Class I ECPs are those which would change form, fit or function of the end items. Class II ECPs are all other changes. The Government shall have the following authorities with respect to ECPs:

· Concur / non-concur with designation as Class I or Class II

· Approval authority for all Class I changes During the RDTE phase, the Performer shall submit its plan for the CCB.

4.8 T&E – Performer Activities

Test and evaluation summary reports shall be included with monthly reports. Performer format is acceptable.

4.9 Government T&E

Government T&E activities will include environmental testing (ET), an early operational assessment (OA), an initial logistics evaluation and initial cybersecurity or Risk Management Framework (RMF) evaluation. The Government will not share the detailed reports with the Perfomer. However, information from the reports will be summarized and provided to the Performer to the extent needed for the Performer to understand any shortfalls with respect to expected compliance for this effort.

4.10 Meetings and Reports

A) The Performer shall provide monthly reports and monthly program update meetings for the Government. Performer format is acceptable, however, note minimum content shall include:

· Technical status and plans

· Regulatory status and plans

· Integrated master schedule, to a level sufficient for demonstrating feasibility of achieving required delivery dates

· Financial status and monthly billing estimate to the end of the PoP

· Summary of all deliverables, including actual or estimated delivery dates and documented Government acceptance dates

· Summary of new inventions or intellectual property (IP) claimed

· Summary of issues and mitigation plans Monthly meetings shall generally be via MS Teams or alternate application which allows remote verbal, video and screen-sharing capability, and which is accessible by Government participants. The Performer shall be available to host Government monthly meetings at its site a minimum of two times per year.

Read-ahead monthly reports shall be provided to the Government a minimum of two work days prior to the scheduled meetings. Following all monthly meetings, the Performer shall provide draft minutes to the Government within five work days after the meetings. Performer format is acceptable, however, content shall include an agenda of topics covered, a summary of attendees including organization and functional role for each, a summary of discussions, and action items. The minutes shall not be considered final until approved by the Government.

B) Preliminary Design Review (PDR) A one-time PDR shall be conducted, as an in-person meeting at the Performer’s facility, to evaluate the feasibility of the design, and to identify any potential issues or challenges that may need to be addressed. The Performer shall provide draft minutes to the Government within five work days after the meetings. Performer format is acceptable, however, content shall include an agenda of topics covered, a summary of attendees including organization and functional role for each, a summary of discussions, and action items. The minutes shall not be considered final until approved by the Government.

4.11 TAA Compliance

All end items must be TAA Compliant/Comply with Trade Agreements Act. Reference DFARS 252.225-7021 Trade Agreements/federal government procure only “U.S.-made or designated country end products.” To be TAA compliant, a product or service must be made or “substantially transformed” in the U.S. or a designated/approved country. Link: DFARS 252.225-7021

4.12 Inventions / Intellectual Property (IP) Reporting

Any inventions and/or IP claimed under this contract must be reported via iEdison, at https://www.nist.gov/iedison. Also provide a brief summary of any submittals in the Monthly Report.

4.13 Rough Order Magnitude (ROM) Production Unit Costs

Following delivery of Prototype devices, Performer shall submit estimated ROM costs for production of NGMM and/or EMM devices as well as any subcomponents or parts requiring replacement as part of regular maintenance (ex. batteries). Estimates should be provided in current year dollars, with a fidelity of +/- 20%.

4.14 Additional Tasking

Should additional in-scope tasking be identified as needed to successfully perform Phase I efforts, the Government and Performer shall incorporate updates to the resulting contract, per mutually agreeable terms. Examples include efforts to address FDA-driven incremental efforts to achieve clearance/approval, or incremental efforts to address technology-driven modifications to end item compliance with Government network compatibility.

NGMM Deliverables – TMRR Phase I

(electronic)

* Unless otherwise indicated, Contractor Format Acceptable ** Due dates are approximations for purpose of solicitation, and will be updated in the resulting contract, if needed, based on Offeror’s proposal.

*** Prototype NGMM Device includes (i.e. configuration for each item):

- fully configured monitor capable of operation for medical purposes

- reusable, ruggedized shipping container

- twelve-month supply of any consumables required for use

- cables, power cords and other such equipment items necessary for power, network connectivity, recharging batteries, and any proprietary cables or connectors needed to perform patient monitoring

- equipment quick-start guide

- proprietary equipment or tools, if any, required to maintain or repair device

EMM Deliverables – TMRR Phase I

(electronic)

** Due dates are approximations for purpose of solicitation, and will be updated in the resulting contract, if needed, based on Offeror’s proposal.

*** Prototype EMM Device includes (i.e. configuration for each item):

- fully configured monitor capable of operation for medical purposes

- reusable, ruggedized shipping container

- twelve-month supply of any consumables required for use

- cables, power cords and other such equipment items necessary for power, network connectivity, recharging batteries, and any proprietary cables or connectors needed to perform patient monitoring

- equipment quick-start guide

- proprietary equipment or tools, if any, required to maintain or repair device

5. PERFORMANCE OBJECTIVES – OPTIONAL TASKING – EMD PHASE II

5.1 Developmental Effort

Provide program management, engineering, quality management, regulatory and other expertise required to achieve the Scope of Effort as defined in section 3, (B) Phase II, including device capabilities, additional efforts and supporting documentation. Ensure adequate time is planned for expertise in providing detailed support and iterative responses related to documentation requirements. Estimates for expertise should pay particular attention not only to engineering developmental activities for design and test of items, but should also include focus on cybersecurity / RMF documentation and FDA and/or other regulatory documentation.

Note – If the Performer had been awarded Phase I tasking for both the NGMM and EMM capabilities, the Government may choose to exercise optional tasking for the EMD Phase II for either or both the NGMM and/or the EMM. Additionally, the Government may choose to not award Phase II.

5.2 Performance Parameters

Reference document titled, “Advanced Medical Monitor (AMM) Consolidated Performance Parameters (CPPs)” for detailed, critical, and desired performance parameters. Note, the overarching AMM parameters apply to both NGMM and EMM. Additionally, for the NGMM and EMM, each has its own set of parameters. This referenced document is part of the solicitation package.

5.3 Regulatory Concerns

FDA approval / clearance is a critical parameter and must be achieved. During Phase II, all efforts begun under Phase I must be successfully completed, resulting in FDA clearance / approval. Reporting that must be completed includes:

· A final Indication for Use

· Documented completion of all items within the Regulatory Strategy

· A finalized FDA Submission package, in accordance with Data Item Description (DID) # DI-TCSP-82040, Title: RESEARCH AND DEVELOPMENT OF MEDICAL PRODUCTS REGULATED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA). Regulatory activities should ensure accomplishment of approval/clearance no later than 2030.

· The Performer shall include the DHA COR or his/her designee in all meetings both formal and informal with the FDA. It is the intention of the Government to be present (physically whenever possible or via Performer provided teleconferences) for all meetings and discussions with the FDA. Whether the Government can or cannot attend, detailed notes will be provided to the Government by the Performer. Copies of notes and regulatory communications from the FDA shall be sent to the COR within three (3) days of occurrence or receipt. The Performer shall provide copies of all communications, to include meeting minutes, emails, and letters, to the FDA within five (5) business days (Deliverable 13). If submissions have occurred prior to contract award, the Performer shall provide copies of any submissions, to date.

· Provide copies of formal minutes from all FDA meetings or calls.

· For any/all clinical trials and/or studies, any updates to protocols or plans must be approved by the Office of Human and Animal Research Oversight (OHARO) in advance of commencement.

· For any/all clinical trials and/or studies that will include animal studies, apply for approval from the Animal Care and Use Review Office (ACURO) to ensure compliance with all protocols; trials or studies shall not commence in advance of formal approval. Documented compliance with current Good Manufacturing Practices (cGMP) and Quality System Regulations (QSR) per21 CFR Part 820, in preparation for eventual production capability

· In the event that data from the GLP animal studies or feedback from the FDA requires additional studies/data, the Performer may propose the necessary work.

During Phase II, full execution of the Regulatory Strategy must be completed, including updates to all relevant documents from Phase I, and FDA approval or clearance must be obtained.

5.4 Standards Compliance

Standards Compliance requirements are found in both the “Advanced Medical Monitor (AMM) Consolidated Performance Parameters (CPPs)” and “U.S. Department of Defense Defense Health Agency (DHA) Operational Medicine Care Delivery Platform (OpMed CDP) Hardware / Software Requirements” documents; both are attachments to this solicitation. Note there are both hardware and software specifications. Minimum and/or Threshold requirements, as per the documents, define imperative compliance. Additionally, there are Recommended and/or Objective requirements, which should be considered for implementation, but are not mandatory minimums for compliance.

Additionally, the Performer shall finalize compliance with networking hardware and software standards.

5.5 Cybersecurity Compliance

As part of its cybersecurity assessment, the Government will evaluate device cyber risks. During Phase I, feedback from the assessment will be provided to the performer to allow for any corrections needed. During Phase II, any corrections must be implemented and verified, for the Government to be able to obtain an ATO. If the Government is unable to obtain an ATO, the end items will not be fieldable, and procurement of production quantities will not follow. As such, expertise to provide iterative feedback to the Government, as well as to implement any corrections, must be included as part of both the Phase I and Phase II efforts.

Note, documentation submitted shall include drawings/schematics and data flow diagrams sufficient for cybersecurity assessment, in accordance with the Medical Device and Equipment Risk Assessment (MDERA) (see Appendix X). Reference the MDERA for additional details surrounding expected compliance considerations.

The Performer shall generate and deliver Software Bills of Materials (SBOMs) for all code, software components and subcomponents, and software-based services delivered under this contract, including firmware, operating systems, applications, and application services, including cloud-based software. Full details that include the scope, inventory and reporting, emerging threats and self-attestation can be found in References, Software Bills of Material.

5.6 Logistics and Sustainment Capabilities

Provide logistics and training expertise required to achieve the Scope of Effort as defined in section 3, (B) Phase II. Documentation shall include:

· finalized user guide,

· finalized quick start guide,

· finalized maintenance and repair manual defining maintenance actions and intervals as well as step-by-step trouble-shooting guidelines, schematics and identification of high-failure parts (if any),

· To obtain finalized versions of user and maintainer manuals, and device quick start guide, documents shall be submitted to the Government for review and comment. Updates shall be made to address comments.

· finalized user training development, as train-the-trainer format,

· finalized maintainer training development, including any OEM or other certifications needed by Government maintainers, as train-the-trainer format,

· release for Government to duplicate and/or post training materials to Government websites for use by Government users, maintainers and/or repair technicians,

· recommended maintenance and repair kits, including estimated costs and any minimum buys,

· shelf life of any consumables and/or maintenance parts,

· life expectancy of the devices based on wear and tear and/or repair part obsolescence

· finalized summary plan for OEM support, identifying capabilities that will be planned for long-term support (i.e. this planning would include efforts such as repair capability, technical support, etc.),

· parts catalog or other ordering methodology for consumables, maintenance and repair parts, including part numbers

· defined software update methodologies, including anticipated intervals for updates,

· release for Government to post software updates on CECOM and/or other Government website, to allow for field updates of software releases,

· Mean Time Between Failure (MTBF), Mean Time to Repair (MTTR) and Failure Modes, Effects and Criticality Analysis (FMECA) data, if available,

· finalized configuration control board planning, including a provision for Government participation

5.7 Configuration Control Board (CCB) Planning

Following completion of all RDTE activities, the Government intends to field equipment items (note – procurement and fielding are not included in scope of this solicitation.) Over the duration of long-term equipment item usage, configuration changes may result from parts obsolescence, safety considerations, software updates, performance improvements, materials changes, or any number of reasons for engineering change proposals (ECPs). Class I ECPs are those which would change form, fit or function of the end items. Class II ECPs are all other changes. The Government shall have the following authorities with respect to ECPs:

· Concur / non-concur with designation as Class I or Class II

· Approval authority for all Class I changes During the RDTE phase, the Performer shall submit its finalized plan for the CCB.

5.8 T&E – Performer Activities

Test and evaluation summary reports shall be included with monthly reports. Performer format is acceptable.

5.9 Government T&E

Government T&E activities will include environmental testing (ET), an operational assessment (OA), a logistics evaluation and cybersecurity or Risk Management Framework (RMF) evaluations. The Government will not share the detailed reports with the Performer. However, information from the reports will be summarized and provided to the Performer to the extent needed for the Performer to understand any shortfalls with respect to expected compliance for this effort. All efforts required to achieve compliance with required system performance are considered in scope.

5.10 Meetings and Reports

A) The Performer shall provide monthly reports and monthly program update meetings for the Government. Performer format is acceptable, however, note minimum content shall include:

· Technical status and plans

· Regulatory status and plans

· Integrated master schedule, to a level sufficient for demonstrating feasibility of achieving required delivery dates

· Financial status and monthly billing estimate to the end of the PoP

· Summary of all deliverables, including actual or estimated delivery dates and documented Government acceptance dates

· Summary of issues and mitigation plans Monthly meetings shall generally be via MS Teams or alternate application that allows remote verbal, video and screen-sharing capability, and which is accessible by Government participants. The Performer shall be available to host Government monthly meetings at its site a minimum of two times per year.

Read-ahead monthly reports shall be provided to the Government a minimum of two work days prior to the scheduled meetings. Following all monthly meetings, the Performer shall provide draft minutes to the Government within five work days after the meetings. Performer format is acceptable, however, content shall include an agenda of topics covered, a summary of attendees including organization and functional role for each, a summary of discussions, and action items. The minutes shall not be considered final until approved by the Government.

B) Critical Design Review (CDR) A one-time CDR shall be conducted, as an in-person meeting at the Performer’s facility, prior to finalization of design files. The Performer shall provide draft minutes to the Government within five work days after the meetings.