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.

59 Members with Class II capabilities.

Member
Volatylix, Inc

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.

Member
FiteBac Pharma

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.

Member
Qidni Labs

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.

Member
STAT Therapeutics

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.

Member
Bessel

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.

Member
Harmac

Harmac is a global contract design and manufacturing organization specializing in single-use medical devices. With over four decades of experience, Harmac provides comprehensive services including product design and development, advanced manufacturing, automation, value engineering, quality assurance, and packaging and sterilization. The company is known for its operational excellence, regulatory compliance, and commitment to sustainability and community engagement. Harmac operates facilities across the United States, Ireland, and Mexico, supporting customers worldwide and across a range of clinical applications. ISO 13485 Certified and FDA Registered.

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
Sana Health

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.

Member
Evimero

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.

Member
ExcelCoat Technologies, Inc.

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.

Member
RBT Resources Inc

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. ​

Member
Ease Healthcare

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.

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
PPD

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.

Member
Simbex

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.

Member
Limax Biosciences, Inc.

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.

Member
Makani Science, Inc.

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.

Member
Via Product Development

Via Product Development (Via PD) helps turn ambitious visions into successful products by providing expert guidance throughout the entire product development lifecycle. We specialize in electronics design and development, helping clients navigate from initial concept through to manufacturing. With a focus on clear communication, strategic planning, and technical excellence, we help teams reduce risk and accelerate timelines. We leverage deep industry expertise and strong partnerships to ensure optimal product-market fit and successful commercialization, particularly in highly regulated and technically complex sectors.

Member
Pneuma Systems Corporation

Pneuma Systems Corporation specializes in designing and licensing closed-loop fluid control systems that precisely manage small fluid volumes without the complexity of traditional pumping mechanisms. The company leverages over 30 inventions and three novel subsystems to revolutionize fluid flow, workflow, information flow, and cash flow, aiming to transform the standard of care in infusion therapy. Pneuma is a small team of experienced medical device professionals working on a new technology platform for precise fluid delivery, with an emphasis on infusion therapy. Armed with a strong IP portfolio, Pneuma’s infusion controller is designed to support all venues of infusion therapy including acute care, standalone infusion centers, and home care. The design offers significant advances in fluid flow, information flow, and work flow. The design has been accepted into an accelerated review program by the U.S. Food and Drug Administration (FDA), known as STeP.

Member
VETRUN LLC

VETRUN LLC is intentionally structured as a lean, project-focused organization designed to deliver complex, regulated medical products with speed, accountability, and cost efficiency. Rather than maintaining large internal departments for legal, regulatory, testing, manufacturing, and specialized engineering functions, VETRUN utilizes a distributed execution model, contracting with best-in-class service providers as required by each program. VETRUN works exclusively on one project at a time, enabling full leadership focus, rapid decision-making, and disciplined execution without competing internal priorities. This model allows VETRUN to assemble a tailored team of subject matter experts for each program, including legal counsel, FDA regulatory consultants, accredited testing laboratories, industry experts, contract manufacturers, and design and development partners. These relationships are not ad hoc. VETRUN has curated a robust network of U.S.-based (“Made in USA”) companies over more than 20 years, selecting partners with demonstrated experience in FDA-regulated medical devices, government programs, and high-reliability manufacturing. This long-standing network enables VETRUN to rapidly mobilize proven resources, scale capabilities as needed, and replace or augment services without disruption. By avoiding fixed overhead associated with large permanent staff and facilities, VETRUN maintains low indirect costs while preserving access to deep technical and regulatory expertise. This structure enhances flexibility, reduces financial risk, and allows resources to be applied directly to execution and milestone achievement rather than administrative burden. This execution model results in a company that is fast-moving, adaptable, and highly responsive, well-suited for time-sensitive programs requiring regulatory rigor, domestic manufacturing, and close coordination with Government stakeholders. VETRUN’s role is to serve as the integrator and accountable authority, ensuring that all partners operate cohesively toward a common objective while maintaining schedule discipline, quality compliance, and mission focus.

Member
CorNeat Vision

CorNeat Vision is dedicated to developing innovative biomimetic medical solutions aimed at addressing unmet medical needs across various therapeutic fields. Their mission is to harness biomimicry to improve health and equality worldwide, focusing on creating permanent, synthetic implants that integrate seamlessly with human tissue.

Member
CellBios

CellBios is a biotechnology company specializing in the design, development, and manufacturing of single-use bioprocessing and medical device solutions for healthcare, biotechnology, and regenerative medicine sectors. The company operates GMP and ISO-certified cleanroom facilities, offering a comprehensive portfolio of cryopreservation products, bioreactors, fluid management systems, advanced packaging, and specialty devices. By leveraging expertise in extrusion, molding, assembly, sterilization, quality control, and regulatory compliance, CellBios provides customized, scalable solutions to support blood transfusion, cell and gene therapy, biologics manufacturing, and clinical workflows.

Member
Predicate AI Labs

Predicate AI Labs is advancing the future of healthcare diagnostics as the developer of OpenDx™, a clinical surveillance platform that anticipates — not just detects — patient deterioration. By fusing wearable sensor data with voice analysis (semantics and vocal biomarkers), Predicate is redefining early warning systems to support earlier intervention, improve outcomes, and extend advanced surveillance capabilities to low-resource, austere, and military care settings.

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
Aerstone

Aerstone is a cybersecurity firm dedicated to elevating businesses beyond the security status quo. With a focus on personalized cybersecurity solutions, Aerstone prioritizes understanding the unique needs and challenges of each client. The company is NSA-certified and boasts over 20 years of experience in the field, offering a boutique approach to cybersecurity that emphasizes quality over quantity. Aerstone's mission is to secure the digital world, one client at a time, by providing tailored strategies that deliver maximum impact. Aerstone's security architecture services are designed to fortify digital landscapes, safeguard assets, and keep organizations ahead of evolving threats, ensuring compliance and business continuity.

Member
Critical Innovations LLC

Critical Innovations LLC is a medical research and development company focused on creating cutting-edge solutions to health threats across pre-hospital, hospital, and military environments. The company focuses on task-shifting evidence-based interventions to earlier echelons of care and more general specialty levels, to simplify management and allow for rapid provision in emergency and combat environments. The company is dedicated to developing innovative medical devices and technologies that enhance emergency care and trauma management, particularly in military settings.

Member
Singletto

Singletto is a biotechnology company revolutionizing antimicrobial protection for healthcare, military, industry, and consumer applications. Their core technology, Oxafence®, leverages Antimicrobial Photodynamic Inactivation (aPDI) using light-activated dyes to generate singlet oxygen, which inactivates viruses and bacteria on treated surfaces. Founded during the COVID-19 pandemic by Drs. James Chen and Thomas Lendvay, Singletto's mission is to deliver ongoing, science-driven Active Protection™ against current and emerging biological threats. The company collaborates with global health leaders, including the WHO and CDC, and partners with manufacturers to develop and commercialize innovative products that actively destroy pathogens during use. Singletto's work is validated by a robust body of peer-reviewed research and ongoing global collaborations.

Member
Citeline

Citeline offers data, analytics, and digital solutions to support clinical trials, drug development, and regulatory compliance. Their capabilities include AI-powered clinical planning, site selection, patient engagement, real-world data integration, regulatory reporting automation, and in-depth industry analysis for the global life sciences sector.

Member
ClearCure Biosciences

ClearCure Biosciences is a clinical-stage biopharmaceutical company focused on developing non-toxic, first-in-class and best-in-class therapies for cancer, infectious diseases, sepsis, neurological diseases, and cardiovascular conditions. The company emphasizes drugging challenging targets, leveraging proprietary small molecules, nanotechnology, new oncology cell therapies, new transdermal drug delivery technology, AI and omics-driven approaches, and digital health solutions to address serious unmet medical needs. The company is currently seeking collaborators and partnerships.

Member
Modulim

Modulim is dedicated to preventing the complications of chronic wounds due to diabetes, peripheral arterial disease, and burns. Mapping tissue health at the point-of-care is key to preventing non-healing chronic wounds. This is made possible only by Modulim's handheld microvascular imaging solution, powered by Spatial Frequency Domain Imaging (SFDI), that empowers healthcare teams with proprietary data and proactive, personalized AI insights.

Member
PyrAmes Inc.

PyrAmes is a digital health company focused on transforming healthcare delivery through advanced sensor measurement. The company is developing a proprietary platform for continuous, accurate, wireless, and non-invasive blood pressure monitoring for patients of all ages, from newborns to seniors. PyrAmes aims to make blood pressure monitoring easy, low-cost, unobtrusive, and painless, ultimately improving patient outcomes.

Member
Cohesys

Cohesys is a clinical-stage company focused on innovating fracture repair solutions. Its product, BoneTape, is the first bone fixation device that does not require drilling into healthy bone. The company aims to disrupt the traditional surgical-repair industry that relies on invasive plates and screws.

Member
Reinvent Health LLC

Reinvent Health LLC is a U.S.-based medtech company focused on early-stage R&D of scalable, clinically impactful solutions that improve patient care, streamline clinician workflows, and enhance long-term outcomes. At the intersection of clinical insight, engineering design, and translational science, Reinvent Health rapidly prototypes and tests novel technologies to address unmet needs. The company specializes in platform-oriented innovation, technology transfer, and commercial translation through licensing, spinouts, and strategic partnerships. As part of the Tettron Holdings portfolio, Reinvent Health emphasizes device-agnostic, software-driven systems with real-world usability across both hospital and field environments.

Member
Vitls

Vitls is dedicated to transforming patient care through continuous, wireless monitoring technology. Their mission is to provide peace of mind to patients, nurses, and physicians by enabling 24/7 monitoring of vital signs with unobtrusive, wearable medical devices. By pairing their devices with cloud-based data analysis, Vitls empowers healthcare professionals to make quick, informed decisions, improving patient outcomes and reducing delays in care.

Member
Hemerus Medical, LLC

Hemerus Medical, LLC specializes in designing and developing innovative blood collection, processing, preservation, and storage technologies. Our mission is to improve patient transfusion outcomes and ensure the availability of high-quality, life-saving blood products. Hemerus aims to extend the shelf life of blood products and enhance transfusion safety through advanced technologies like leukocyte reduction filters and novel anticoagulant and additive solutions.

Member
Surgical Magic LLC

Surgical Magic develops real-time, AI-driven prediction systems for stroke risk. Using advanced algorithms and standard monitoring inputs, the technology predicts stroke events potentially minutes before they occur, enabling physicians to take preventative actions and improve patient outcomes. The company emphasizes validation and regulatory compliance through multi-site clinical trials and aims to advance operating rooms from reactive to predictive care.

Member
Osteolyse

Osteolyse is a medical device company that develops materials to enhance bone growth at implant sites.

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
Radiatric Inc.

Radiatric Inc. is dedicated to developing and commercializing innovative technologies to improve outcomes for patients with blood stream infections that can lead to sepsis, and septic shock. Antimicrobial resistance is a serious global health threat. Our flagship medical device, our RAD-01 system, is an extracorporeal non-antibiotic device designed to treat blood stream infections by targeting and killing pathogens even multi drug-resistant organisms. The company's focus is on non-pharmacological methods of killing pathogens, aiming to reduce the mortality and long-term effects associated with sepsis.

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
Brinter Inc

Brinter is a pioneering US-based MedTech firm focused on revolutionizing tissue engineering through the development of 3D bioprinted biocomposite regenerative implants, known as BioMods™, which aim to restore damaged tissue and replace conventional implants, launching in orthopedics/tendons and ligaments. The company driven by a team of visionary entrepreneurs and leading bioscientists and engineers.

Member
Opticyte, Inc.

Opticyte is a medical device company dedicated to transforming the standard of care for hemorrhage, sepsis, and other leading causes of organ failure. Their mission is to save lives through early detection and real-time measurement of cellular and blood oxygen levels, providing accurate diagnostics for all skin tones and addressing critical health equity issues. Founded in 2016 as a spinout from the University of Washington, Opticyte is pioneering the first device to measure oxygen inside cells in real time, aiming to reduce organ failure and death associated with hemorrhage, sepsis, and other critical illnesses. The company is recognized for its innovative approach, commitment to health equity, and strong leadership in medical technology.

Member
Calla Lily Clinical Care

Calla Lily Clinical Care develops patented medical device technologies engineered to improve intravaginal drug delivery for women's health, focusing on clinical needs such as fertility support, pregnancy management, prevention of recurrent miscarriage, and restoration of the vaginal microbiome. Recognized for innovation, the company maintains collaborative partnerships with clinical and academic institutions and secures funding to advance clinical trials and R&D. Their technology is designed for leak prevention, convenience, and dosing confidence, with a strong commitment to sustainability and social impact as a certified B-Corporation.

Member
NeuEsse Inc.

NeuEsse Inc. is dedicated to advancing skin health through innovative plant-based technologies. Their mission is to provide effective solutions for skin repair, addressing challenges such as severe burns, wounds, and trauma. Their flagship product, OmegaSkin™, is a human skin substitute made from soy protein, designed to enhance healing outcomes with minimal scarring. NeuEsse aims to meet the unmet needs in wound treatment, offering products that are sustainable, vegan-friendly, and require no special handling.

Member
Hemanext

Hemanext is a privately held medical technology company specializing in oxygen-controlled red blood cell processing and storage systems for transfusion medicine. The company develops, manufactures, and commercializes innovative storage solutions that preserve the quality and function of red blood cells by limiting oxygen and carbon dioxide exposure, with the goal of improving transfusion outcomes for patients with chronic and acute conditions. Hemanext's products have received FDA De Novo marketing authorization and CE Mark certification, enabling global distribution. The company is recognized for its focus on scientific evidence, operational compatibility, and strategic partnerships with blood establishments and clinical researchers.

Member
Luna Labs

Luna Labs is a world-class technology and product development resource for the defense and healthcare industries. Collaborating across our core capabilities in Advanced Materials, Engineered Systems, and Biotechnology, our teams generate solutions for the most demanding environments and customers to save time, save money, and save lives. We partner with universities, government labs, and other world class companies to explore technological feasibility of new ideas, align technologies with customer needs, and generate solutions. Working with a robust global network of manufacturers, suppliers, licensees, and distributors, Luna Labs develops everything from small-scale prototypes up to market-ready products.

Member
Life Protect

Life Protect specializes in the design and manufacture of novel personal protective equipment (PPE), such as face masks and N95 and N99 respirators in the United States with a focus on scientific development, clinical integration, supply chain reliability, and regulatory compliance for healthcare and emergency use.

Member
SutureTech

SutureTech is a surgeon-founded medical device company based in Durham, North Carolina, specializing in the development of innovative internal fixation implants and surgical instruments for soft tissue and tendon repair. The company is dedicated to advancing orthopedic procedures by delivering clinically informed, surgeon-driven solutions that streamline surgical steps, enhance repair strength, and improve patient outcomes. SutureTech's flagship product, RapidFix™, is an all-suture dual anchor system designed for efficient, reliable fixation of soft tissue to bone, and has received FDA 510(k) clearance.

Member
Altrazeal Life Sciences Inc.

Altrazeal Life Sciences Inc. is a specialty medical technology company dedicated to developing and commercializing innovative drug delivery systems. Their mission is to improve patient outcomes by providing comprehensive solutions for patients, providers, and payers. The company is known for its patented Altrazeal® Transforming Powder Dressing, which optimizes the wound healing environment and supports tissue repair.

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.

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Genomind

Genomind is a leader in precision medicine for mental health, dedicated to helping healthcare providers and patients make better prescribing decisions by leveraging genetic, lifestyle, and environmental data. Their mission is to personalize mental health treatment and improve outcomes for individuals, providers, and healthcare systems. Genomind supports a wide range of stakeholders, including individuals, providers, long-term care facilities, ACOs, employers, health plans, and international partners. Through innovative pharmacogenetic testing, precision medicine software, consultative services, and educational resources, Genomind aims to advance mental health care and empower both patients and professionals.

Member
Rx Bandz

Rx Bandz is dedicated to developing innovative, next-generation auto-injectors and life-saving formulations that provide simple solutions for patients, first responders, and the military. Their mission is to enhance the delivery of injectable medications, ensuring accessibility and ease of use for anyone, anytime, anywhere.

Member
LifeBoard Medical

LifeBoard Medical is a healthcare-focused company, led by experienced trauma surgeons and experts in software and solution development, aimed at creating technological improvements in trauma care, with an emphasis on advancing situational awareness for improved team dynamics, improving patient outcomes and improved QI reviews. The company demonstrates a strong commitment to research objectivity and regulatory compliance, particularly in managing financial conflicts of interest in publicly funded research.

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
Exactics, Inc.

Exactics specializes in the development of rapid, affordable, and accurate at-home diagnostic tests for infectious diseases. The company employs a consumer-oriented design and scalable technology platforms to provide point-of-need diagnostics that aim to increase early disease detection and convenience, with a focus on lowering costs and minimizing development timelines.

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Inertia

Inertia is an innovation-driven firm delivering end-to-end design, engineering, prototyping, and manufacturing for medical, clean tech, industrial, safety, and advanced hardware industries. Distinguished by their tightly integrated evidence-based approach—including strategy, human factors, regulatory and advanced manufacturing—they execute at every phase: from early startup product validation through SMB innovation acceleration, to full-scale manufacturing for startup and large enterprises. Their unique differentiator lies in the seamless integration of product strategy, development, and manufacturing under one roof—enabling clients to optimize quality, achieve rapid speed-to-market, and realize measurable cost and risk reductions. With robust quality systems, client-centered project management, and a reputation for transparency, Inertia consistently sets new standards for product innovation and commercialization.

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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
Metro Preclinical Consulting, LLC

Metro Preclinical Consulting, LLC, founded in 2024 and based in New Jersey, USA, provides comprehensive support to medtech companies in the strategy and execution of preclinical evidence generation. The company offers a tailored approach to maximize data while minimizing animal use in preclinical development programs, supporting product research and regulatory filings. Metro Preclinical is committed to being a responsive, diligent, and candid partner, guiding products from concept to clinic.

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Projects

Technology Showcase

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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

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