Justification_Notice_PR16192578_Butterfly_Burundi_Signed.pdf

RESTRICTING COMPETITION NOT EXCEEDING THE SIMPLIFIED

ACQUISTION THRESHOLD

SECTION 1: IDENTIFICATION OF THE AGENCY AND THE CONTRACTING

ACTIVITY

Department of State Contracting Activity

Acquisition Management

Requiring Activity United States Military Group – Burundi Office

SECTION 2: NATURE AND/OR DESCRIPTION OF THE ACTION BEING

APPROVED

Approval is requested to award on a sole source basis to Butterfly Operations, Inc at 1600 District Avenue, Burlington, Massachusetts, USA for the supplies and/or services described in Section 3 on behalf of the Requiring Activity.

SECTION 3: DESCRIPTION OF SUPPLIES/SERVICES REQUIRED TO MEET THE

AGENCY’S NEEDS

The requirement is to provide Butterfly iQ3 Ultrasound System and Butterfly iQ3 Charger Kits (Type C) at the US MILGP - Burundi. The estimated value for the entire period of performance is $262,580, including options. These supplies/services require that Butterfly delivers 50 Ultrasound Systems and 50 Charger Kits. Butterfly will also provide Individual Global Health Memberships, as well as training workshops. There will be onsite training workshops for thirty (30) learners to achieve the intended learning outcomes. This will allow the Office of US MILGP – Burundi to accomplish their mission of providing ultrasound capability to local hospitals in need of this technology. The purchase of this equipment strengthens the nation's health services and the partnership between the United States and Burundi.

Each Butterfly iQ3 System is a single-probe, whole-body ultrasound device that includes a 1.5-meter Lightning® and USB-C 2.0 cable, along with a three-year manufacturer's warranty. The accompanying Individual Global Health Ultrasound Memberships provide each user with a single-user license, customized archive storage, and anonymized study-sharing capability, allowing clinicians to store and access ultrasound studies via mobile and web platforms.

The training component, delivered through the Global Ultrasound Institute (GUSI), consists of a six-week Train-the-Trainer program for the thirty (30) learners referenced above. This includes two weeks of in-person, hands-on didactic instruction in obstetric point-of-care ultrasound (POCUS) fundamentals—covering fetal anatomy, biometry, gestational age assessment, and report writing—followed by four weeks of longitudinal, precepted mentorship at antenatal clinics in Bujumbura. The program concludes with a structured clinical examination and certification of competency, and includes twelve months of access to the GUSI OB Essentials online learning platform.

Together, these supplies and services will equip Burundian midwives and clinicians with the devices, software, and clinical proficiency necessary to deliver improved maternal and fetal ultrasound diagnostic care in resource-limited settings, directly supporting USMILGP Burundi's public health and capacity-building mission and the broader U.S.-Burundi partnership.

SECTION 4: IDENTIFICATION OF THE STATUTORY AUTHORITY PERMITTING

OTHER THAN FULL AND OPEN COMPETITION

In accordance with Federal Acquisition Regulation (FAR) 12.102(a), the Contracting Officer has deemed only one source reasonably available based on the following:

Brand-name

SECTION 5: DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S

UNIQUE QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES

USE OF THE AUTHORITY CITED

The nature of this acquisition requires the strict restriction of competition to the brand-name Butterfly iQ3 Ultrasound System, engineered and manufactured exclusively by Butterfly Network, Inc. This specific platform possesses unique technical features, proprietary hardware architecture, and integrated cloud-based software capabilities that are essential to the mission requirements of US MILGP – Burundi. No other commercial alternative can be substituted without causing substantial duplication of costs and unresolvable capability gaps.

Proprietary Ultrasound-on-a-Chip™ Technology: Traditional, legacy ultrasound systems require multiple fragile, expensive, and separate transducers (probes) to conduct different anatomical scans (e.g., cardiac, abdominal, pediatric, vascular). The Butterfly iQ3 utilizes proprietary semiconductor technology that integrates a micro-machined matrix of sensors onto a single silicon chip. This unique engineering allows a single, highly ruggedized probe to emulate 20+ distinct clinical applications. Restricting procurement to this brand name eliminates the extreme logistical burden, high replacement costs, and operational vulnerability of managing multiple delicate probes in a resource-constrained environment.

Infrastructure-Independent Portability: Recipient hospitals in Burundi operate under severe infrastructural deficits, including frequent grid failures, daily rolling blackouts, and limited clinical space. The Butterfly iQ3 is an ultra-portable, handheld device powered by highly resilient internal battery architectures compatible with standard Type-C charging setups. This ensures full bedside and field-level diagnostic operations entirely independent of consistent alternating current (AC) power—a field capability that larger, laptop-style or cart-based commercial systems cannot match.

Closed Ecosystem and Global Health Subscription Integration: The Butterfly iQ3 functions within a secure software architecture supported by the mandated Individual Memberships – Global Health. This subscription delivers artificial intelligence (AI)-guided diagnostic imagery overlays, secure local cloud storage, and remote peer-to-peer clinical consultation capabilities.

Competing commercial off-the-shelf (COTS) devices lack the cross-platform compatibility required to interface with this proprietary digital ecosystem, which is mandatory for maintaining the continuity of data, quality control, and clinical tracking across the recipient hospitals.

Turnkey Educational Infrastructure and Dedicated Training Cadre: Device deployment in this region is entirely dependent on the specialized, vendor-proprietary curriculum delivered by the thirty (30) certified onsite trainers. The curriculum, user interfaces, and remote educational modules are deeply integrated into the Butterfly ecosystem. Introducing an alternative brand would render the pre-planned training curriculum entirely obsolete, delay the period of performance, and require costly, extensive curriculum redesign that the government cannot justify.

Accordingly, Butterfly Network, Inc. is the only source capable of providing the specific hardware, software, and highly tailored training required to meet the agency's minimum requirements without causing unacceptable operational delays, duplication of costs, and mission failure.

SECTION 6. DETERMINATION BY THE CONTRACTING OFFICER THAT THE

ANTICIPATED COST TO THE GOVERNMENT IS FAIR AND REASONABLE

By signing the justification, the Contracting Officer makes a determination that the price to the Government is anticipated to be fair and reasonable.