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.

38 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
ATCC (American Type Culture Collection)

ATCC is a nonprofit biological resource center, with a nearly century-long legacy supporting public health, biodefense, and global health security. ATCC provides critical infrastructure for infectious disease research and CBR threat response. Our biorepository operations support federal agencies, academia, and industry through secure specimen handling, reagent authentication, and global distribution. ATCC manages over 22 million vials under federal contracts, including repositories for NIAID, CDC, BARDA, NCI, FDA, and USDA. These programs enable rapid deployment of validated biological materials for vaccine development, diagnostic assay verification, and therapeutic screening against high-consequence pathogens such as SARS-CoV-2. Certified under ISO 9001, 13485, 17025, and 17034, ATCC ensures quality, traceability, and regulatory compliance across its operations. Our high-containment laboratories (BSL-2 and BSL-3, with access to BSL-4 through partners) and Select Agent license position us to support MTEC-aligned efforts in emerging infectious diseases and medical countermeasure development for CBRN threats.

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
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.

Member
Metis Foundation

The Metis Foundation is a 501(c)(3) non-profit organization dedicated to advancing military medicine through scientific, educational, financial, and project management support for federally and privately sponsored research, clinical trials, and education. Their mission is to innovate and transform defense health research to save and enhance the lives of service members, their families, and the communities they serve.

Member
Key Tech

Key Tech is a multidisciplinary product development firm specializing in medical, industrial, and consumer products. With over 20 years of experience, the company focuses on transforming complex technologies into intuitive products, ensuring compliance with regulatory standards while enhancing user experience. Key Tech's team of engineers, designers, and scientists work collaboratively to deliver innovative solutions across various sectors, including drug delivery, medical devices, and in vitro diagnostics. The company is also committed to environmental sustainability, integrating eco-friendly practices into its design and development processes.

Member
Wireless Research Center (WRC)

The Wireless Research Center (WRC) is an independent, private nonprofit research center based in North Carolina’s Research Triangle region. Since 2010, WRC has advanced global innovation in wireless connectivity through applied research, engineering, and certified testing. WRC supports clients worldwide, helping develop and commercialize wireless products from concept to high-volume production. The organization is recognized for its unique intellectual property policy, allowing clients to retain full ownership of jointly developed IP. WRC’s core initiatives—WRC Technologies, RIoT, Connected Communities, and the Advanced Mobility Collective—focus on improving wireless technologies, accelerating startups, supporting entrepreneurs, and fostering technology-led economic development. WRC is a catalyst for collaboration among local governments, schools, companies, and global partners, integrating technology and innovation into communities to improve lives and bridge the digital divide.

Member
Viscus Biologics LLC

Viscus Biologics LLC specializes in product realization from ideation to high volume production, manufacturing components, devices, and products with natural polymer and extracellular matrix materials. The company aims to fulfill patient and market needs, improve quality of life, and restore tissue to a healthy state.

Member
Leidos

Leidos is a leading systems integrator in science, technology, and engineering, dedicated to solving some of the world's toughest challenges. The company emphasizes a commitment to integrity, diversity, and sustainability while delivering innovative solutions across various sectors including defense, healthcare, and energy.

Member
Military & Health Research Foundation

The Military & Health Research Foundation is a non-profit organization dedicated to advancing military technology and medical research. It serves as a communication bridge between innovative researchers and funding sources, focusing on delivering effective solutions for medical capability gaps. The foundation fosters collaboration among industry, academia, and military entities to enhance healthcare for American military personnel.

Member
Digital Infuzion

Digital Infuzion is a CMMI level 3-appraised information technology firm that specializes in innovative computer services, informatics, and enterprise solutions. With a strong focus on healthcare, the company aims to help clients manage, mine, and make sense of data, driving digital transformations across various sectors. The company prides itself on creativity, openness, and growth, fostering a culture that encourages innovative problem-solving and collaboration.

Member
SoarTech

SoarTech is an industry leader in the application of innovative, context-informed AI solutions for Department of Defense (DoD) research and development problems. The company focuses on developing intelligent software that reasons like humans, automating complex tasks, simplifying human-machine interactions, and modeling human behaviors. SoarTech emphasizes a human-centered approach to AI, aiming to enhance human capabilities rather than replace them, and is committed to transparency and explainability in AI systems.

Member
Knowesis, Inc.

Founded in 2007, Knowesis is a Woman Owned and Service Disabled Small Business providing health research solutions to the Federal Government. We are experts in Military Health System and Veterans Affairs data to predict health outcomes, evaluate health and medical programs and determine efficacy of interventions.

Member
Reliable Systems Engineering, LLC

Reliable Systems Engineering, LLC is a consulting firm specializing in systems engineering for the medical device industry. The company supports clients—particularly startups, contract developers, OEMs, and CMOs—through expertise in system architecture, requirements development, risk management, verification, and cross-functional coordination. Its mission is to bring clarity, structure, and guidance to complex device development, ensuring regulatory compliance and efficient progress through disciplined engineering practices, all rooted in recognized industry standards and decades of experience.

Member
MRIGlobal

MRIGlobal is a renowned Midwest research institute based in Kansas City, dedicated to improving the overall health, safety, and well-being of people everywhere. With over 80 years of experience, MRIGlobal specializes in diagnostics, pharmaceutical sciences, vaccines and therapeutics, global health surveillance, infectious disease, public health, warfighter protection, agriculture, and management and operations. The organization is committed to using science and technology to create solutions for a safer, healthier, and more sustainable world.

Member
Prospect Life Sciences

Prospect Life Sciences is a medical device development and manufacturing partner offering integrated, end-to-end solutions from concept through global market fulfillment. The company provides comprehensive capabilities in research and design, product development, manufacturing transfer, scalable production, and regulatory compliance, leveraging ISO 13485:2016-certified and FDA-registered quality management systems. With facilities in the USA and Costa Rica, the company serves as a strategic partner for both early-stage and established organizations, enabling efficient, compliant, and scalable innovation in the medical device sector.

Member
BioMojo LLC

BioMojo LLC is a biomedical performance solutions company based in Research Triangle Park, North Carolina. It creates integrated software and hardware solutions to improve human performance, decision-making, knowledge management, resilience, and mission-critical task execution for complex, high-consequence environments. The company leverages advancements in various technologies to enhance the speed, safety, and efficiency of human operators in high-stakes situations.

Member
nou Systems

nou Systems is dedicated to transforming defense systems through innovative, mission-driven technology. With expertise in systems engineering, modeling and simulation, and real-time open systems development, the company delivers powerful, data-driven insights that enhance system capabilities across various complex defense systems.

Member
Corscience

Corscience is a German-based medical technology development and manufacturing provider specializing in advanced solutions for defibrillation, patient monitoring, and vital sign acquisition. The company supports OEMs and medtech startups internationally with expertise across R&D, regulatory affairs (including MDR and FDA compliance), quality management, lifecycle management, and technical consulting. Their track record includes the delivery of complex, safety-critical systems and robust integration of electronic, software, and mechanical components in medical devices.

Member
Triple Ring Technologies

Triple Ring accelerates the pace of innovation allowing our partner companies to drive growth, start new businesses, launch breakthrough products, improve health, and change lives. We are a healthcare-focused Corporate Growth Lab headquartered in Silicon Valley, with offices in Boston, Toronto, and Copenhagen. Our services span three key business lines: Technology translation for US government programs, Corporate Growth Labs, and Technology and product development services. Founded in 2005, Triple Ring has an unparalleled track record supporting clients from startups to many of the world’s largest MedTech and Life Sciences companies.

Member
Medtrade Products Limited

Medtrade is a global medical device company based in the UK, dedicated to saving and improving lives through innovative solutions in wound care, trauma, and hemostasis. With a focus on tackling global health challenges, Medtrade provides advanced manufacturing, regulatory, and marketing support to distribution partners worldwide.

Member
Reed Integration, Inc.

Reed Integration, Inc. is a woman-owned small business that specializes in providing innovative consulting and training services to federal and commercial clients. With over two decades of experience, the company focuses on delivering superior business results through a unique combination of expertise in systems engineering, project management, and advanced analytics. Their mission is to ensure client success while enriching the lives of their team and the communities they serve.

Member
SIMMEC Training Solutions

SIMMEC Training Solutions is a woman-owned, service-disabled veteran-owned small business (WOSB/SDVOSB) providing high-fidelity Tactical Combat Casualty Care (TCCC) training using advanced live models. We specialize in delivering immersive, operationally relevant training environments that replicate battlefield trauma conditions under stress, time pressure, and environmental chaos. Our cadre includes former Special Operations medics and trauma clinicians with real-world deployment experience. All courses align with DoD and CoTCCC standards, supporting combat medics, deploying providers, and allied partner forces. Our training incorporates high-fidelity manikins and cadavers where appropriate, but centers on biologically responsive live tissue models to deliver the highest level of realism and decision-making complexity. SIMMEC is committed to ensuring that live tissue training remains the foundational standard for validating emerging trauma technologies and enhancing military medical readiness. As a Non-Traditional Defense Contractor, SIMMEC is uniquely positioned to support MTEC-funded research through: access to validated, biologically responsive training platforms; benchmark data for simulation and wearable validation; performance observation to support AI and Autonomous Casualty Care (AC2) development; and collaboration in hybrid training model innovation (sim-to-live). We are actively seeking partners involved in trauma simulation, AI/ML triage systems, wearable tech, and data-integrated battlefield medical solutions.

Member
Proxima CRO

Proxima CRO is a leading Contract Research Organization (CRO) that specializes in providing innovative solutions for medical devices, drugs, and diagnostics. With a focus on agility and efficiency, Proxima aims to de-risk biotech and MedTech programs, enhance regulatory clearance chances, and optimize capital efficiency. The company is dedicated to supporting clients through every stage of clinical development, ensuring timely and cost-effective results.

Member
Tensentric

Tensentric is a contract design and manufacturing firm focused solely on medical device, in vitro diagnostic, and advanced therapy markets. We're ISO13485 certified and FDA registered to help our clients bring their new technology and products to market.

Member
Axiom Management Solutions

Axiom Management Solutions is a veteran-owned business offering consulting and service support across all stages of medical device development. Axiom's core philosophy: Early-stage medtech innovators deserve to own their development journey without the burden of heavy overhead or restrictive partnerships. Axiom empowers developers to bring their vision to life with precision, flexibility and expert support. The company specializes in helping innovators navigate regulatory requirements, develop prototypes, establish quality management systems, and take medical devices from concept to commercialization.

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University of California San Francisco

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Arizona State University

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University of Pittsburgh

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