Independent Verification and Validation

Independent Verification and Validation (IV&V) is an objective, systems-level evaluation of medical devices, embedded and clinical software, algorithms, and integrations to confirm safety, efficacy, reliability, cybersecurity, and interoperability under combat, prolonged-field-care, and austere conditions. IV&V combines laboratory testing, clinical simulation, human factors analysis, and operational stress testing to reduce risk before deployment.

Technical Challenges

  • Ensuring device and software reliability under blast, dust, vibration, and temperature extremes.

  • Validating decision-support algorithms with sparse, heterogeneous battlefield data and high prevalence of polytrauma.

  • Integrating interoperable data streams across tactical networks while maintaining cybersecurity and data integrity.

  • Replicating prolonged and delayed evacuation scenarios, including resource-limited care and shifted vital-sign baselines.

Emerging Opportunities

  • Standardized IV&V protocols tailored to austere and prolonged-field-care clinical endpoints.

  • Comprehensive human factors testing for diverse user cadres (medic, corpsman, surgeon) in noisy, chaotic environments.

  • Repeatable, realistic simulation platforms that reproduce polytrauma, hemorrhage, and blast physiology for system-level testing.

  • Rapid, scalable IV&V pathways that align with regulatory review while preserving operational realism.

Current and Emerging Technologies in Independent Verification and Validation

Hardware-in-the-loop and environmental stress testing

Closed-loop rigs, environmental chambers, and vibration/EMI testing validate device function under battlefield-specific mechanical and electromagnetic stresses.

Clinical simulation and high-fidelity manikins

Simulated polytrauma, hemorrhage, and prolonged care scenarios enable performance validation of devices, workflows, and decision aids with realistic physiology.

Algorithmic IV&V for AI/ML systems

Bias testing, adversarial inputs, model explainability, and validation against diverse combat-relevant datasets ensure clinical reliability of decision-support systems.

Cybersecurity and data-integrity validation

Penetration testing, secure boot validation, and tamper-resistance assessments protect mission-critical medical systems and patient data in contested networks.

Interoperability and standards conformance

Fidelity testing against HL7/FHIR, tactical waveforms, and MEDCOM interfaces ensures seamless integration with electronic health records and tactical medical systems.

Importance to Military Medicine

Reduce battlefield risk

Objective validation prevents device or algorithm failures that could worsen hemorrhage, hypoxia, or shock during tactical care.

Enable prolonged and distributed care

IV&V confirms tools perform reliably when evacuation is delayed and resources are limited, supporting extended enroute and far-forward interventions.

Maintain readiness and interoperability

Validated systems integrate across platforms and services, reducing training burdens and ensuring mission-capable medical support.

Support regulatory and ethical imperatives

IV&V provides documented evidence for safety and performance that informs DoD acceptance, FDA interactions, and clinical governance.

Alignment with the MTEC Mission

Accelerates transition of validated medical innovations from lab to deployed settings, matching MTEC’s goal of faster fielding.

Supports cross-disciplinary projects across trauma, prolonged care, infectious disease, and neurohealth prioritized by MTEC.

Enables evidence-based device acceptance for operational use, reducing field risk and improving force readiness.

Facilitates dual-use outcomes by validating technologies for both military deployment and civilian health-care adoption.

Dual-Use (Military + Civilian) Applications

Civilian trauma centers and emergency medical services benefit from IV&V-tested devices and protocols developed for battlefield hemorrhage control and damage-control resuscitation.

Public health and hospital networks gain hardened, secure telehealth and remote-monitoring systems validated for degraded communications and cyberthreats.

Validated AI triage and diagnostic tools translate to civilian mass-casualty response, improving surge capacity and clinical decision consistency.

Regenerative and reconstructive technologies that pass IV&V in tactical settings are more readily adopted for civilian trauma and reconstructive surgery.

Explore MTEC Members with Independent Verification and Validation Capabilities

MTEC members bring multidisciplinary strengths—clinical subject-matter expertise, accredited simulation centers, systems engineering, cybersecurity, and regulatory experience—to deliver rigorous IV&V tailored to military medicine.

Explore member profiles to connect with partners who provide high-fidelity testing, clinical trial design, and operational validation pathways that accelerate safe fielding and civilian translation.

39 Members with Independent Verification and Validation capabilities.

Member
Nanohmics Inc.

Nanohmics Inc. is a Texas-based research and development company founded in 2002, specializing in the applied sciences of light, molecule, and advanced material interactions. The company focuses on designing and developing smart technology solutions that enhance product, technology, or system performance across various industries. With a multidisciplinary team of scientists and engineers, Nanohmics integrates advanced materials and state-of-the-art instrumentation engineering to create custom-engineered sensing technologies and platforms. Their mission is to accelerate client success through innovative product development, providing solutions for detection, surveillance, electro-optic imaging, performance characterization, environment awareness, and energy conversion applications.

Member
Ethos Solutions LLC

Ethos Solutions specializes in rapid problem solving in dynamic environments through the Ethos IDEALs (Identification, Define, Engagement, Alignment, and Leveraging). Ethos leverages module working groups (or cells) consisting of Subject Matter Expert (SMEs) clinicians, training cadre, warriors, academics, and researchers able to rapidly identify and solve problem sets that require a grounded approach forged in austere and dynamic environments.

Member
Persistent Technology, Inc.

Persistent Technology, Inc. (PTI) is dedicated to delivering transformative, human-centered solutions that improve patient care. With a focus on digital transformation and emerging technologies, PTI offers innovative solutions that enhance user adoption, improve data quality, and foster interoperability. The company is committed to supporting military and veterans' health, leveraging its expertise to provide cutting-edge healthcare technology solutions.

Member
PinMed, Inc.

PinMed, Inc., is a National Innovation Award-winning bioinformatics/medical-device company that develops high-fidelity cardiovascular monitoring systems, personalized (adaptive) software, and integrated systems and custom solutions for tracking cardiovascular data in the most challenging environments (e.g., intensive activity, extreme electromagnetic interference, and interventional cardiovascular procedures) and identifying subtle but clinically important indicators of cardiovascular events. PinMed’s award-winning solutions include versatile, multisensor, high-fidelity monitoring systems for various hospital and ambulatory settings. The company has extensive experience in electronic and mechanical engineering, development of software and firmware for various processors, computational modeling, and cardiovascular physiology. PinMed’s flagship mobile platform, PELEX, provides unparalleled versatility in physiological monitoring and has been cleared by the FDA for diagnostic 12-lead ECG testing and various types of ambulatory monitoring.

Member
DLH Holdings Corp.

DLH delivers improved health and national security readiness solutions for federal programs through science research and development, systems engineering and integration, and digital transformation. With over 3,200 employees, DLH is committed to solving complex problems faced by civilian and military customers, leveraging advanced technologies and methodologies to enhance health outcomes and operational readiness.

Member
Tietronix Software, Inc.

Tietronix Software, Inc. is a minority-owned small business founded in 1999, located in Houston, Texas, near NASA Johnson Space Center. The company specializes in providing innovative software solutions and services across various sectors including medical, aerospace, and renewable energy. Tietronix is committed to high quality, reliability, and customer satisfaction, leveraging a diverse workforce and a strong project management team to deliver complex, mission-critical systems.

Member
Planned Systems International

Planned Systems International (PSI) is dedicated to delivering innovative solutions that empower clients across various sectors, including national security, health, and federal civilian operations. With a commitment to integrity, service, and excellence, PSI leverages cutting-edge technologies to address complex challenges and enhance operational efficiency. Founded in 1988, PSI has built a reputation for exceeding expectations and fostering a collaborative culture that nurtures employee growth and development.

Member
Exponent

Exponent is a multidisciplinary science and engineering consulting firm serving sectors including healthcare, energy, manufacturing, and consumer products. From medical devices, pharmaceuticals, and supplements to digital health and wearables, we deliver rigorous science that quantifies impacts on human health. Exponent helps you push the envelope on the development, deployment, safety, and effectiveness of cutting-edge drugs, devices, and diagnostics — concomitantly balancing benefits and risks. Count on our multidisciplinary, data-driven, evidence-based assessments to give you clarity on your most complex product needs and challenges. With lives on the line, innovations that support healthcare demand the highest levels of scientific rigor. Whether you’re developing a novel drug, a sturdier stent, or a faster flu test, you need clear answers to complex questions, quickly. Exponent supports our life sciences clients across the total product lifecycle by solving critical design, regulatory, safety, and market access challenges. We can collaborate with you throughout your journey, helping you navigate risks and opportunities — and optimize outcomes — with science-based strategies and specialized expertise.

Member
EmergingDx

EmergingDx is dedicated to inventing, developing, and commercializing emerging technologies and products aimed at improving the quality of the human condition while positively impacting the environment and society. The company comprises a diverse team of world-class scientists, engineers, product designers, and business leaders with a proven track record of innovation and successful technology transition.

Member
CUBRC

CUBRC is an independent, not-for-profit company dedicated to research, development, testing, and systems integration, focusing on high-stakes challenges in defense, intelligence, and homeland security. With a legacy of technical excellence, CUBRC combines innovative ideas and state-of-the-art technology to address critical problems facing the nation.

Member
Kitware

Kitware is dedicated to delivering innovation through advanced technical computing, state-of-the-art AI, and tailored software solutions. Founded in 1998, the company emphasizes an open-source philosophy, fostering collaboration and transparency to solve complex scientific challenges. Kitware is committed to advancing scientific understanding and improving technology through its extensive expertise in various domains, including AI and deep learning.

Member
Alira Health

Alira Health is a global consulting and clinical services company that aims to humanize healthcare and life sciences through innovative technologies and expert guidance. They focus on improving patient outcomes by integrating patient voices into the development of treatments and enhancing care quality across the healthcare ecosystem.

Member
Areté

Areté, founded in 1976, is a leading science and engineering company dedicated to providing innovative solutions for national and global security challenges. The company excels in developing advanced sensing products and software, operating from the seafloor to space. Areté's mission is to harness world-class talent to deliver superior solutions, while its vision focuses on using leading-edge science and engineering to protect the nation and the world. The company is known for its creativity, integrity, passion, responsiveness, and collaboration, fostering a unique company culture that emphasizes employee growth and innovation.

Member
Stephenson and Stephenson Research and Consulting (SASRAC)

SASRAC provides trusted, authoritative research and consulting services focused on occupational and environmental safety and health challenges. With expertise in developing hearing damage risk criteria, measuring impulsive noises, evaluating hearing protector performance, and creating wireless audiometric testing technologies, SASRAC has been at the forefront of applied research since the 1970s. Founded by experienced professionals from the USAF and CDC/NIOSH, SASRAC is dedicated to advancing technologies in audiology, bioacoustics, and hearing conservation.

Member
Southwest Research Institute (SwRI)

Southwest Research Institute (SwRI) is a nonprofit research and development organization that provides independent, premier services to government and industry clients. Founded in 1947, SwRI is committed to advancing science and technology to benefit humanity, focusing on innovative solutions that improve human health and safety. With a diverse range of technical divisions, SwRI addresses complex challenges in various fields including mechanical engineering, materials, aerospace, automotive, biomedical, and more.

Member
GenVault

GenVault operates a secure, large-scale biorepository specializing in the storage, management, and logistics of biological and sensitive materials. Serving the life sciences, healthcare, government, and research sectors, GenVault offers robust, regulatory-compliant infrastructure engineered for resilience. The facility supports a comprehensive range of temperature-controlled storage and provides integrated sample management, cold chain logistics, and laboratory relocation services. Quality is maintained through internationally recognized certifications, advanced security systems, and a mature governance structure that emphasizes continuous compliance and operational transparency.

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University of California San Francisco

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