Class II
Class II encompasses moderate-risk medical devices and systems—diagnostics, physiological monitors, ventilators, portable imaging, drug-delivery and hemorrhage adjuncts—requiring special controls. In military medicine, Class II tech must be rugged, interoperable, and maintain accuracy for combat casualty care, prolonged field care, and austere settings.
Technical Challenges
Environmental ruggedness: devices must tolerate temperature extremes, dust, moisture, and shock.
Power and portability: limited battery life and weight constraints impede prolonged use during delayed evacuation.
Interoperability and data security: integration with tactical networks and secure electronic health records is complex.
Rapid, accurate diagnostics in-field: detecting sepsis, AMR, and polytrauma biomarkers under resource constraints.
Emerging Opportunities
Low-power, durable monitoring platforms with validated clinical accuracy across operational conditions.
Point-of-injury diagnostics that identify hemorrhage sources, infection, and coagulopathy rapidly.
Compact respiratory support and drug-delivery systems optimized for prolonged field care and mass-casualty scenarios.
Sterile, biofilm-resistant consumables and affordable disposables that simplify infection control in austere environments.
Current and Emerging Technologies in Class II
Portable point-of-care diagnostics
Multiplex PCR, isothermal amplification, and microfluidic immunoassays for rapid pathogen detection, coagulation profiling, and biomarker measurement at the point of injury.
Wearable and transport physiological monitoring
Low-power ECG, noninvasive hemoglobin, continuous lactate proxies, and multi-parameter wearables that enable remote triage and longitudinal tracking during prolonged evacuation.
Compact respiratory and circulatory support
Field-capable ventilators, transport infusion pumps, and adjuncts for hemorrhage control and stabilized perfusion designed for rugged, portable use.
Telemedicine, AI, and decision-support
Secure teleconsultation, AI-assisted triage, imaging interpretation, and algorithms that augment medics’ decision-making during prolonged or distributed care.
Materials, manufacturing and consumables
Antimicrobial coatings, sterile single-use kits, and on-demand 3D printing of parts to support logistic resilience in austere supply chains.
Importance to Military Medicine
Combat casualty care
Rapid diagnostics and reliable therapeutic devices reduce time-to-treatment for hemorrhage, respiratory failure, and shock on the battlefield.
Prolonged and delayed evacuation
Portable Class II systems sustain higher-acuity care when evacuation is delayed, preserving function and survival during prolonged field care.
Austere environment resilience
Ruggedized devices withstand environmental stressors and reduce mission risk by delivering consistent clinical performance outdoors and afloat.
Force readiness and surge capacity
Class II technologies expand point-of-care capability across units, improving readiness and enabling civilian-military surge response.
Alignment with the MTEC Mission
Accelerates transition of validated medical technologies from lab to battlefield, shortening timelines from prototype to deployed capability.
Supports multidisciplinary consortia and DoD partnerships to address regulatory, clinical validation, and field-evaluation requirements for Class II devices.
Promotes dual-use innovations that deliver civilian public-health benefit while meeting military operational requirements.
Dual-Use (Military + Civilian) Applications
Civilian emergency medicine and EMS—rapid diagnostics, durable monitors, and transport ventilators improve prehospital outcomes and mass-casualty response.
Disaster and humanitarian response—portable, self-contained systems support clinical care when infrastructure is compromised.
Hospital surge and rural health—scalable point-of-care platforms expand capacity and reduce reliance on centralized labs.
Explore MTEC Members with Class II Capabilities
MTEC members bring clinical trial infrastructure, DoD engagement pathways, and regulatory expertise to validate Class II devices under operationally relevant conditions.
Consortium partners offer engineering, materials science, and manufacturing scale-up that accelerate ruggedization and supply-chain resilience.
Explore member profiles to find collaborators with combat-casualty expertise, telehealth integration experience, and proven regulatory pathways for Class II technologies.
57 Members with Class II capabilities.

Volatylix, a Cambridge, MA based startup, is dedicated to early diagnosis enabling timely and appropriate treatment benefiting the patient, physician, provider and payor. Our patent pending platform – DECIPHER – and unique detection sensor technology – OFIS - combine to identify various disease states and conditions via proprietary breath biomarkers, volatile organic compounds (VOC’s). DECIPHER is disease agnostic and will speed diagnosis, while improving accuracy over currently available diagnostic methods. The tests use a noninvasive 4-minute breath sample with analysis taking ~15 minutes on our portable, battery powered platform. Initial products include fungal pneumonias, lung cancer (staging, monitoring, differential diagnosis and screening) and C. difficile.

FiteBac Technology/FiteBac Pharma's K21 uniquely targets the underlying disease state, given that most diseases involve microbial-associated inflammation and mitochondrial dysfunction. FiteBac Technology innovations stem from the work of numerous international academic research scientists. FiteBac Pharma K21 is the blockbuster antimicrobial small molecule designed to modulate biological, immunological, and metabolic systems for treating a wide range of infectious and inflammatory diseases. This patented drug substance has demonstrated the ability to safely eliminate bacterial, fungal, and viral infections, enhance innate immunity, induce mitophagy while improving mitochondrial and cellular metabolism, accelerate wound healing, and even promote the development of zebrafish and chickens, leading to increased adult mass. Rigorous research from Dr. Bhupesh Prusty's laboratory and Dr Christopher Rongo's laboratory is focused on various aspects of mitochondrial remodeling and reprograming, as well as mitochondrial-to-nuclear signaling with K21.

Qidni Labs is a NATO DIANA company recognized by Fast Company as a 2025 World Changing Idea. The company has developed a portable, nearly waterless hemodialysis system that will make treatment accessible for over 10 million patients every year.

STAT Therapeutics is focused on developing a drug- device combination for easy, rapid administration of intramuscular, life-saving medications by users in any setting, aiming to improve access and usability for acute emergency treatments such as pain, anaphylaxis, and seizures.

From Rapid Innovation to Breakthrough Impact, Bessel Helps Startups and Scaling Teams Move Faster, Smarter, and Together with Fewer Missteps. Experience Bessel Rapid Innovation: We embed with your team to rescue stalled projects or fill critical gaps. From R&D to Quality Systems to Regulatory Affairs, we drive rapid progress to reduce your burn rate and improve profitability. We help your team deliver measurable results: reduced COGS, decreased complaints, improved performance. Our Powered by Bessel™ Accelerator is an Intensive, fixed-duration programs to refine your technology strategy, align teams, and prepare for fundraising—perfect for startups seeking clarity and velocity. Save months in development, find your sweet spot with investors, build and support your team. The Bessel Origin™ workforce development program, born in the classroom, trains emerging medtech teams in design thinking and agile teamwork, fueling innovation. Boost team performance and identify, develop, and retain your emerging leaders.

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.

Military Operational Medicine funded for PTSD, Adjustment Disorder and Pain and Sleep (over $5m). 3 trials in progress. Sana Health is an FDA Breakthrough Designated Device, currently in front of the FDA for Neuropathic Pain as a de novo - expecting to be on market Q4 2025. Sana is a wearable audiovisual neuromodulation device, that provides anxiety and pain relief, and sleep on demand. $25m raised to date, and in the middle of a Series A extension SAFE note round.

Evimero is an interdisciplinary company focused on understanding the interactions between microorganisms and human health, agriculture, and the environment, utilizing Systems Biology and AI/ML. Evimero applies molecular principles to infectious disease and microbiome science to improve health outcomes and environmental sustainability through targeted interventions in dysbiotic microbiomes and in people with infectious disorders. Evimero has an infectious disease product pipeline including both prophylactic and diagnostic assets against common causes of Travelers' Diarrhea, including a unique approach to preventing infection with human Norovirus, enterotoxigenic E. coli (ETEC) and others. Evimero's pipeline of drugs targeting human and animal microbiomes includes early-stage assets aimed at generalized microbiome-driven inflammation and gut leak, and specific disease-targeted disorders including Parkinson Disease and Inflammatory Bowel Diseases. Evimero's platform also makes possible a suite of point-of-care diagnostics that can be used for patient cohorting (infectious diseases), risk stratification, and ultimately informing therapeutic decision-making. The nature of Evimero's platform assures a steady stream of novel assets targeting both infectious diseases and chronic disorders with roots in microbiome dysfunction.

ExcelCoat Technologies, Inc., based in Frederick, Maryland, is an emerging biotechnology company. It is developing novel medical devices to improve wound healing with proprietary atmospheric non-thermal plasma technology. The reactive plasma species generated in the non-thermal plasma can be optimized to effectively disinfect bacteria to prevent delayed healing, and at the same time stimulate epithelial cell migration and proliferation. This novel device will be used by care providers in clinic settings to treat wounds without causing pain to the patient. The company also holds a US patent on biocompatible nanocoating, which can be applied onto cardiovascular stents to prevent both in-stent restenosis and thrombosis.

RBT Resources is a service-disabled veteran-owned medical device company focused on rapidly improving damage-control resuscitation and blood delivery in austere, prehospital, and mass-casualty environments. The company is developing a next-generation rapid blood transfusion platform that leverages a compact, reusable pump and mission-configurable disposables to enable faster, more controlled administration of whole blood and blood products at the point of injury. Founded by former U.S. Special Operations Forces operators, RBT Resources is dedicated to closing critical medical capability gaps observed in combat through user-driven design and close collaboration with military medical teams.

Ease Healthcare (a registered DBA of MPS Medical, Inc.) is committed to advancing next-generation military medicine by accelerating access to clinically validated diagnostic tools, monitoring devices, and health and wellness technologies. As a trusted commercialization partner and distributor, the company empowers providers, organizations, and individuals with advanced solutions that support early detection, timely intervention, and improved health outcomes in both civilian and military settings. With a mission to make cutting-edge science and technology accessible to all, Ease Healthcare focuses on addressing critical health challenges such as 02 delivery, cancer, and cardiovascular disease —areas that directly impact force readiness and resilience. The company’s vision is to break barriers in healthcare by delivering innovative medical solutions that are affordable, accessible, and simple to use, regardless of economic or geographic limitations. In addition to bringing transformative technologies to market, Ease Healthcare provides turnkey services for medical device manufacturing and distribution, guiding partners from product development through regulatory compliance and successful deployment. By combining technical expertise with a dedication to accessibility, Ease Healthcare supports the Department of Defense’s priorities in preparing and protecting service members with next-generation healthcare solutions.

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.

PPD, a clinical research business of Thermo Fisher Scientific, is a leading provider of global contract research organization (CRO) solutions. The company is dedicated to helping clients accelerate the development of life-changing therapies through comprehensive drug development, laboratory, and lifecycle services. With a commitment to operational excellence and innovative technology, PPD empowers its customers to bring therapies to market faster and improve patient health. PPD has been recognized as an industry leader in clinical development digital transformation services and patient engagement digital transformation. With over 30 years of clinical leadership and a workforce of more than 30,000 employees globally, PPD has conducted over 2,100 trials in the past five years.

Simbex is a leading partner in medical device and consumer health product design and development, recognized for transforming complex ideas into commercially successful solutions. With a multidisciplinary team, Simbex excels in engineering, product design, software, data analytics, and commercialization strategy, supporting innovators from concept to market. Their mission is to deliver impactful medical devices and consumer health products that improve health outcomes and quality of life. Simbex is known for its holistic approach, deep regulatory expertise, and commitment to innovation and excellence in the health technology sector. The company is also active in thought leadership, regularly publishing regulatory and reimbursement updates, and hosting educational webinars for the MedTech community. Simbex maintains a robust Quality Management System compliant with ISO 13485 and FDA 21 CFR 820, ensuring high standards in product development. The company is also committed to supporting diversity in MedTech, including initiatives for women in the sector. Simbex's leadership and advisory team bring decades of experience in biomedical engineering, commercialization, regulatory affairs, and technology innovation, further strengthening its position as a trusted partner in the MedTech ecosystem.

Limax Biosciences is dedicated to revolutionizing tissue healing through innovative biomaterials inspired by the natural slime of slugs. Their hydrogels provide superior adhesion and healing capabilities, addressing unmet medical needs both inside and outside the body.

Makani Science, Inc. is dedicated to transforming respiratory care by making respiratory monitoring more accessible, accurate, and comfortable. Originating from over a decade of research at the University of California, Irvine, the company was founded to address the critical need for reliable breathing monitoring in clinical and home settings. Their mission is to improve patient health by providing healthcare professionals and patients with better data, enabling earlier detection of respiratory issues, and enhancing quality of life through advanced biofeedback and wellness applications.

Arizona State University
ASU Crosscutting Technologies to Enhance Military Medical Readiness and Resilience
Dr. Rachel Cassalia leads MTEC-supported efforts at ASU to shift military health from reactive care to proactive readiness through data-driven prevention.
University of Pittsburgh
Topical Metformin Lotion for Tendinopathy Prevention
University of Pittsburgh study shows topical metformin prevents overuse tendon injury. This work was sponsored through MTEC project 22-02-MPAI-014.
Theradaptive
Theradaptive’s RESTORE Trial Initiation for OsteoAdapt™ DE
Theradaptive launches RESTORE Phase I/II trial of OsteoAdapt™ DE for faster, precision bone healing in craniofacial injuries. MTEC-funded study targets improved recovery for military and civilian patients.
Altec
Autonomous Rehabilitation Device for Improved Recovery in Warfighters
The OSCIR platform—developed by Altec Inc in collaboration with the Naval Health Research Center—is bringing clinical-grade, real-time movement analysis to the front lines. Funded under MTEC-22-02-MPAI