H.13 FAR 8.4 Limited Sources Justification (V1.4 11-29-2023) BIA Devices - Redacted.pdf

UNITED STATES MARINE CORPS

MARINE CORPS INSTALLATIONS NATIONAL CAPITAL REGION

MARINE CORPS BASE QUANTICO

3250 CATLIN AVENUE

QUANTICO VIRGINIA 22134 5001

J&A No. M00264-25-JA-025 FAR Subpart 8.4 Limited Sources Justification

V 1.4 (29 Nov 2023)

MEMORANDUM TO THE FILE

Subj: FAR SUBPART 8.4 LIMITED SOURCES JUSTIFICATION

I. BACKGROUND:

A. FAR 8.405-6 states that orders placed or BPAs established under Federal Supply Schedules are exempt from the requirements in FAR Part 6. However, an ordering activity must justify its action when restricting consideration. This memorandum documents the justification for limiting sources, in accordance with FAR 8.405-6(c).

B. This acquisition is conducted under the authority of the Multiple-Award Schedule Program (see

FAR 8.401).

C. For a proposed order or BPA exceeding the simplified acquisition threshold (SAT), the requiring activity shall assist the ordering activity contracting officer in preparation of the justification, in accordance with FAR 8.405-6(c)(1).

II. IDENTIFICATION OF THE AGENCY AND CONTRACTING ACTIVITY:

This acquisition is being conducted by the Department of the Navy, under the Headquarters Marine Corps, Installation and Logistics (HQMC, I&L) Head of the Contracting Activity (HCA). The executing contracting office is Marine Corps Installations National Capital Region - Regional Contracting Office (MCINCR-RCO), 2010 Henderson Road, MCB Quantico, VA 22134-5000.

III. NATURE AND/OR DESCRIPTION OF THE ACTION BEING APPROVED

Marine Corps Training and Education Command (TECOM) has a sole source requirement for the following: ninety-two (92) InBody 770 Bioelectrical Impedance Analysis (BIA) devices, ninety-two (92) Laser Printers, one hundred and eighty-four (184) InBody 770 results sheets (500 count), two-hundred and sixty-seven (267) Marketing Posters and ninety-two (92) Extended three (3)-year warranties.

The intent of this action is to issue a Sole Source order under the GSA Schedule 36F79722D0074 BioSpace, Inc.

The required delivery/performance start date is on 30 Nov 2025.

IV. DESCRIPTION OF THE SUPPLIES OR SERVICES REQUIRED TO MEET THE

AGENCY’S NEEDS (INCLUDING THE ESTIMATED VALUE):

The Marine Corps Training and Education Command (TECOM) has identified requirement for the InBody 770 Bioelectrical Impedance Analysis (BIA) devices to support the Marine Corps' evolving approach to physical readiness and personnel assessment. The BIA devices must be able to provide the following: segmental analysis, visceral fat measurement, military validation, and MARADMIN reference.

The InBody 770 is a clinically validated, multi-frequency BIA analyzer designed to deliver 99% reproducibility across segmental readings. It provides high-resolution measurements critical to both individual health monitoring and compliance with Marine Corps standards, including:

• Body Weight

• Lean Body Mass

• Body Fat Mass & Percentage Body Fat

• Visceral Fat Level

• Segmental Fat and Lean Analysis (upper/lower extremities and trunk)

• Total Body Water (TBW)

• Body Mass Index (BMI)

• Multi-frequency Impedance Readings for all body segments

• Integrated scale with precision weight measurement for accurate fat estimation

• Manufacturer-backed warranty and extended service coverage for lifecycle support

In accordance with MARADMIN 423/22, issued 8 August 2022, Marines who exceed height and weight limits must have their body fat verified by an approved BIA device—specifically the InBody 770—or via DEXA scan prior to:

• Assignment to the Body Composition Program (BCP)

• Any formal review or retention proceedings

• Reassessment during BCP monitoring cycles

To meet this directive, the Marine Corps must field InBody 770 devices across commands and installations, ensuring universal access to standardized assessments.

The total estimated value for this procurement is $XXX. Marine Corps Operations and Maintenance (O&M) appropriations will be used to fund this requirement as outline in the table below:

FY25 Total Base

O&M $XXX $XX

Manufacturer Part Number Description Quantity Estimated Unit Price

Estimated Total Unit Price

BioSpace, Inc InBody 770 Bioelectrical Impedance Analysis Device 92

BioSpace, Inc PRINTR Laser Printer 92

BioSpace, Inc InBody Results InBody 770 Results Sheets (500 count) 184

BioSpace, Inc Posters Marketing Posters 276

BioSpace, Inc 3Y-INBODY 770 Three-year Manufacturer Warranty 92

N/A N/A OCONUS Shipping (CONUS Shipping included in the device cost therefore shipping is only for OCONUS devices)

Total

V. THE DETERMINATION TO LIMIT SOURCES IS BASED ON THE FOLLOWING

AUTHORITY AND SUPPORTING RATIONALE (select all that apply):

A. ___ AN URGENT AND COMPELLING NEED EXISTS, AND FOLLOWING THE

PROCEDURES IN FAR 8.405-2 OR 8.405-3 WOULD RESULT IN UNACCEPTABLE

DELAYS (FAR 8.405-6(a)(1)(i)(A)):

The supplies or services are of such unusual and compelling urgency that the Government would be seriously injured unless the agency is permitted to limit the number of sources from which it solicits bids or proposals. Urgent requirements are supplies or services that will result in a work stoppage or are mission critical and the routine processing time would result in injury to the Government. The determination that the procurement for the above item/service is an urgent and compelling requirement is based on the following:

1. Date on which the requirement was first identified:

2. Required delivery date/period of performance:

3. Explanation of why delivery/commencement of services by the date mentioned above is required:

4. Market research:

B. X ONLY ONE SOURCE IS CAPABLE OF PROVIDING THE SUPPLIES OR SERVICES

REQUIRED AT THE LEVEL OF QUALITY REQUIRED BECAUSE THE SUPPLIES OR

SERVICES ARE UNIQUE OR HIGHLY SPECIALIZED (FAR 8.405-6(a)(1)(i)(B)) (select all that apply):

1. ___ RESTRICTIVE RIGHTS. The source has established proprietary rights, limited rights in data, patent rights, copyrights or secret processes in the item or service required.

2. ___ EXCLUSIVE LICENSING AGREEMENTS. The item or service is only available from the Original Equipment Manufacturer (OEM), or there is only one authorized distributor or technical representative for the OEM.

3. X OTHER REASONS.

The Marine Corps’ Training and Education Command (TECOM) is requesting the procurement of InBody 770 Bioelectrical Impedance Analysis (BIA) devices to meet policy-driven modernization of the Marine Corps Body Composition and Military Appearance Program (BCMAP). The BIA devices must be able to provide the following: segmental analysis, visceral fat measurement, military validation, and MARADMIN reference.

As outlined in MARADMIN 423/22 and mandated as of January 1, 2023, Marines who exceed height and weight standards must undergo body fat verification via approved BIA technology or

DEXA scan. The InBody 770 is the sole authorized BIA device for official Marine Corps assessments and is actively fielded across more than 250 Marine Corps installations.

The InBody 770 uses Direct Segmental Multi-Frequency Bioelectrical Impedance Analysis (DSM-MFBIA) to provide high-accuracy, reproducible results with 98.8% comparability to DEXA. Its design enables:

• Segmental analysis of five body zones for precision readings

• Multi-frequency testing to distinguish intracellular vs. extracellular water

• Direct measurement methodology—no reliance on age, gender, or ethnicity

• 99% reproducibility, ensuring standardization across operating units

Its analytical capabilities include:

• Total Body Water (TBW) – segmental analysis

• Intracellular & Extracellular Water

• Skeletal Muscle Mass

• Lean Body Mass & Body Fat Mass

• Visceral Fat & Phase Angle

• Percentage Body Fat & BMI

• Basal Metabolic Rate (BMR)

The InBody 770 is fully integrated into BCMAP protocols:

• Replaces outdated tape methods for verifying body fat

• Required for determining BCP assignment and pre-separation validation

• Enables assessment of Marines’ physical readiness and military appearance

• Ensures equity and data integrity across all units

• Scans may be authorized via inter-command coordination when units are unassigned

Additionally, the InBody 770 is used operationally by:

• Verification Tool: If a Marine fails the tape test, they must receive an InBody scan within 7 calendar days.

• BCP Assignment: Results from the InBody 770 determine whether a Marine is formally placed in the BCP.

• Data Accuracy: The scan provides direct measurements of body fat, muscle mass, and water distribution—no estimations based on age or gender.

• Military Appearance: Commanders may also use the scan to assess Marines who appear to have improper weight distribution, even if they pass the tape test.

• Only certified Force Fitness Instructors (FFIs) or Command Physical Training Representatives (CPTRs) conduct assessments. All results are formally captured within MCTIMS to ensure accountability and recordkeeping.

InBody faces competition from several companies in the body composition analysis space, each with different technologies and use cases. Here's a breakdown of key competitors and how their capabilities compare to the government's requirement:

Vendor Device Segmental Analysis

Visceral Fat Measurement

Military Validation

MARADMIN

Reference Notes

BioSpace DBA InBody 770 Yes Yes Yes Yes

Meets all criteria;

widely deployed across USMC

Styku S100 No No No No 3D body scanner;

lacks clinical BIA capabilities

SELVAS

Healthcare

ACCUNIQ

BC380 Yes Yes No No

Commercial grade;

not validated for military use

Tanita MC-980U Yes Yes No No Clinical use; lacks

MARADMIN

reference

Evolt 360 Evolt 360 Yes Yes No No Fitness-focused; lacks clinical/military validation

Brand Technology Strengths Limitations

InBody 770 Direct Segmental Multi-Frequency BIA

Clinical-grade accuracy; no empirical assumptions; military-approved Premium pricing

Styku 3D Infrared Body Scanning

Visual 3D modeling; circumference tracking; goal setting

Does not measure body water or muscle mass directly

SELVAS

Healthcare

Bioelectrical Impedance Analysis

(BIA)

Medical-grade analyzers; assistive tech integration

Smaller global footprint compared to InBody

Tanita BIA Widely available; suitable for home use

Relies on empirical data (age/gender) for body composition

Evolt 360 BIA Fitness-focused; strong app integration

Similar tech to InBody but lacks clinical/military validation

Based off the market research above, only InBody 770 meets all the required criteria: segmental analysis, visceral fat measurement, military validation, and MARADMIN reference. All other vendors lack either clinical validation for military use or are not referenced in official Marine Corps guidance. Use of alternative devices would compromise compliance and operational consistency.

While alternative vendors offer features suitable for fitness tracking or visual modeling, only the InBody 770 meets the clinical, operational, and policy-driven requirements for military body composition assessment. It is the sole device referenced in MARADMIN 423/22 and remains the only platform validated for use in medical and military contexts.

The InBody 770 was the designated analyzer during the Marine Corps’ comprehensive study to evaluate and restructure the Body Composition Program. This study, which included data from 2,173 Marines, formed the empirical basis for updated standards and policy revisions. Any deviation from the specific brand and model used in this foundational research would compromise data integrity and invalidate future comparative assessments.

Moreover, the InBody 770 has been adopted across multiple branches of the U.S. military including the Marine Corps, Navy, Air Force, Army, and Special Operations Commands ensuring cross-service interoperability and consistency in health metrics. Continued use of this platform supports standardized assessments, facilitates unified data analysis, and reinforces alignment with Department of Defense health and readiness objectives. Therefore, the InBody 770 is the only responsible source for meeting the Marine Corps’ body composition assessment requirements.

C. ___ IN THE INTEREST OF ECONOMY AND EFFICIENCY, THE NEW WORK IS A LOGICAL

FOLLOW-ON TO AN ORIGINAL FEDERAL SUPPLY SCHEDULE ORDER (FAR 8.405-

6(a)(1)(i)(C)):

The original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order or BPA was not issued under sole-source or limited-sources procedures.

D. ___ ITEMS PECULIAR TO ONE MANUFACTURER (FAR 8.405-6(b)):

An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer. A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer.

VI. DETERMINATION THAT THE ORDER OR BPA REPRESENTS THE BEST VALUE:

The Contracting Officer has determined that the order or BPA covered by this justification will represent the best value to the Government. Fair and reasonable pricing will be determined in accordance with DoD Class Deviation 2014-O0011 using the proposal analysis techniques at FAR 15.404-1.

VII. DESCRIPTION OF THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS:

A discussion of the market research conducted among schedule holders and the results, or a reason market research was not conducted, is included in Section V, above.

VIII. ACTIONS TAKEN TO REMOVE OR OVERCOME BARRIERS:

DFARS 208.405-6 and PGI 208.405-6 REQUIREMENTS: The subject order or BPA exceeds the simplified acquisition threshold and is a follow-on to an order or BPA for the same supply or services previously issued based on a limiting sources justification citing the authority at FAR 8.405-6(a)(1)(i)(B) or (C). In accordance with DFARS 208.405-6 and PGI 208.405-6, this limited source justification includes a copy of the previous justification.

Additionally, Training and Education Command, in collaboration with the U.S. Army Research Institute of Environmental Medicine, will continue to explore the efficacy and effectiveness of the BIA machines while developing a long-term plan to transition all body composition evaluation from height/weight tables and circumference method to viable alternatives.