Manufacturing

Manufacturing capability enables rapid, quality-controlled fabrication and distribution of devices, implants, biologics, PPE and sterile disposables. It spans design-for-manufacture, GMP/commercial scale-up, regulatory pathways, and surge retooling to maintain medical readiness during combat, prolonged-field care, and public-health emergencies.

Technical Challenges

  • Supply-chain fragility causing shortages of critical consumables and reagents in theater

  • Scaling GMP-compliant biologics and cell therapies from lab to deployable production

  • Rapid qualification and verification of novel devices for austere and expeditionary use

  • Maintaining sterility, packaging, and cold-chain integrity under prolonged-field conditions

Emerging Opportunities

  • Distributed, point-of-care manufacturing capability to replenish stocks near the point of need

  • Portable, modular GMP platforms for small-batch biologics and autologous cell products

  • Standardized rapid-validation pathways bridging DoD operational requirements and FDA standards

  • Resilient logistics solutions integrating digital traceability, packaging, and sterilization for austere transport

Current and Emerging Technologies in Manufacturing

Additive manufacturing (3D printing)

Rapid fabrication of patient-specific implants, surgical guides, and on-demand parts; enables low-volume, high-complexity production at or near point-of-care with reduced lead times.

Modular GMP biomanufacturing

Single-use, containerized bioreactors and automated downstream processing for rapid scale-up of vaccines, monoclonal antibodies, and autologous cell therapies suitable for expeditionary deployment.

Flexible, automated assembly and QA

Robotic and automated production lines with inline inspection, digital twins, and AI-driven quality control to maintain throughput and traceability under variable demand.

Sterilization, packaging, and cold-chain innovations

Advanced low-temperature sterilization, barrier packaging, and portable cold-chain systems preserve sterility and biologic potency during extended transport in austere conditions.

On-demand reagent microfactories

Microfluidic and lyophilization platforms for producing diagnostics reagents, point-of-care therapeutics, and stable biologics near deployment sites to reduce dependency on long supply lines.

Importance to Military Medicine

Sustain combat casualty care

Ensures uninterrupted access to hemostatic devices, implants, and sterile disposables during mass-casualty and polytrauma scenarios.

Enable prolonged and distributed care

Portable production reduces evacuation dependence by delivering therapies and supplies where delayed transport or austere timelines exist.

Maintain readiness and surge capacity

Rapid retooling and distributed manufacturing mitigate shortages during outbreaks, supply disruptions, or high-tempo operations.

Support austere operational logistics

Design-for-manufacture and ruggedized production systems reduce failure rates and simplify maintenance in expeditionary environments.

Alignment with the MTEC Mission

Accelerates translation of technologies from prototype to deployable product, aligned with MTEC’s DoD-focused mission to field force-multiplying medical solutions.

Supports multidisciplinary collaboration—engineering, clinical, regulatory, and manufacturing partners—central to MTEC consortium projects.

Enables dual-use outcomes where military readiness improvements translate to civilian surge capacity and public-health benefits.

Leverages MTEC contracting and programmatic support to shorten development timelines and reduce acquisition friction for the DoD.

Dual-Use (Military + Civilian) Applications

Trauma and surgical devices: on-demand production of implants, fixation devices, and sterilized surgical kits optimized for battlefield orthopedics and damage-control surgery.

Biologics and cell therapies: modular GMP platforms for small-batch autologous cell products, emergency vaccines, and therapeutic proteins tailored to operational needs.

Diagnostics and reagents: microfactories producing stable reagents and rapid-test components to preserve force health and enable early outbreak detection.

Consumables and PPE: scalable manufacturing and surge strategies for hemostatic agents, dressings, masks, and sterile disposables to avoid operational shortages.

Explore MTEC Members with Manufacturing Capabilities

MTEC members bring complementary strengths—industrial manufacturing capacity, clinical and regulatory expertise, GMP process development, and logistics integration—accelerating maturation of deployable solutions.

Explore member profiles to identify partners with rapid-prototype facilities, biomanufacturing suites, sterile-packaging capabilities, and experience in DoD and FDA pathways for fast, field-ready production.

31 Members with Manufacturing capabilities.

Member
Advanced Regenerative Manufacturing Institute (ARMI)

The Advanced Regenerative Manufacturing Institute (ARMI) is a member-based, nonprofit organization dedicated to advancing the bioeconomy of the United States. Its mission encompasses enhancing manufacturing, healthcare, and education and workforce development, aiming to create a scalable and effective manufacturing ecosystem for engineered cells, tissues, and organs.

Member
Auburn University

Auburn University Research & Economic Development is dedicated to advancing research and economic growth through a collaborative effort among its various colleges and departments. The organization focuses on fostering innovation, supporting faculty and student research, and facilitating partnerships with industry and government to address societal challenges and enhance the quality of life. Recent initiatives include the launch of the Team Science Series to promote interdisciplinary collaboration and the development of the Gulf Coast Engineering Research Station to address coastal environmental challenges.

Member
BioPharma Connections

BioPharma Connections is an independent, woman-owned consulting firm founded in San Francisco in 2007, providing strategic business development, technical operations, regulatory, product development, and commercialization support to the life sciences industry. Serving pharmaceutical, biotechnology, medical device, and diagnostic companies globally, the firm specializes in facilitating connections between organizations, service providers, CROs, CDMOs, and investors—guiding clients from concept to commercialization, with deep expertise in regulatory compliance, emerging technologies, and diverse therapeutic areas.

Member
Boston University

Boston University is a major research institution committed to leading breakthroughs across various disciplines. The Office of Research supports and advances research excellence, fostering collaboration among researchers, industry partners, and government leaders to address significant societal challenges.

Member
Sunflower Therapeutics

Sunflower Therapeutics is a women-owned and led biotechnology public benefit corporation founded in 2018, dedicated to democratizing access to protein manufacturing worldwide. The company develops next-generation, automated, and fully-integrated protein manufacturing solutions that simplify the process from discovery to full-scale biomanufacturing. Their mission is to make high-quality, cost-effective therapeutics, vaccines, and protein-based products accessible globally, especially in low- and middle-income countries, by leveraging innovative technologies, sustainable practices, and intuitive equipment. Sunflower’s vision is to transform the global health landscape by enabling more medicines and protein products to reach patients and consumers everywhere. Their core technologies include efficient microbial hosts, data-driven process development, and modular manufacturing facilities, supporting agile, rapid, and cost-effective production cycles for a wide range of protein-based products.

Member
Baylor University

Baylor University is a preeminent Christian research university committed to addressing the world's most meaningful challenges through top-tier research and scholarship. Recognized as an R1 research institution, Baylor focuses on infusing its distinct Christian mission into its research initiatives, fostering a commitment to excellence and innovation.

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
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
Blood Centers of America

Blood Centers of America (BCA) is the largest blood supply network in the United States, comprising over 60 independent community blood centers that collectively distribute approximately 50% of the nation's blood supply. BCA supports member organizations through supply chain solutions, donor recruitment, advocacy, disaster response, and purchasing power. In addition to providing whole blood, red blood cells, platelets, plasma, cells, and tissues for therapeutic, diagnostic, research, and advanced therapy applications, BCA and its network are engaged in the development and delivery of advanced therapies including cell and gene therapy starting materials, processing, and manufacturing. BCA actively mobilizes resources in response to national emergencies, pandemics, and technological advances in donor experience and biotherapeutics.

Member
Solventum

Solventum is a healthcare company dedicated to enabling better, smarter, and safer healthcare solutions. With a legacy of innovation, Solventum focuses on improving patient outcomes through advanced medical technologies, oral care solutions, health information technology, and purification and filtration systems.

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
Michigan Engineering (University of Michigan College of Engineering)

Michigan Engineering combines top-tier engineering education with advanced research and state-of-the-art facilities, supporting both undergraduate and graduate students. The college emphasizes hands-on and experiential learning, interdisciplinary collaboration, and research strengths in areas such as robotics, energy, sustainability, precision medicine, cybersecurity, space systems, and computational science. Advanced laboratories are available for internal and external users, reflecting a commitment to innovation, industry partnerships, and technology transfer.

Member
Draper

Draper is an independent nonprofit engineering innovation company with a legacy spanning over 90 years, dedicated to delivering transformative solutions for national security, prosperity, and global challenges. Renowned for its pioneering work in guidance, navigation, and control (GN&C) systems, Draper partners with government, industry, and academia to engineer advanced technologies in space, defense, biotechnology, and electronic systems. The company leverages multidisciplinary expertise, digital engineering, and a collaborative approach to provide field-ready prototypes, mission-critical systems, and innovative research. Draper’s mission is to ensure the nation's security and prosperity by delivering sustainable, cutting-edge solutions that address the toughest problems of today and tomorrow, while fostering an inclusive and diverse workforce. Draper also invests in the next generation of innovators through robust educational programs, including internships, co-ops, and the Draper Scholars Program, integrating academic research with real-world problem-solving.

Member
NTx Bio

NTx Bio (Nature’s Toolbox, Inc.) is revolutionizing biomanufacturing by enabling on-demand, decentralized, and scalable production of high-quality RNA and proteins. Our mission is to democratize access to medicines by overcoming the bottlenecks of traditional, centralized manufacturing. Through proprietary, synthetic biology platforms like NTxscribe® (mRNA production) and NTxpress® (cell free protein production), NTx empowers researchers and companies to accelerate the development and delivery of personalized and mass-scale therapeutics, making next-generation medicine more accessible, sustainable, and efficient, while eliminating supply chain concerns by using 100% domestic inputs and production capabilities.

Member
Frontier Bio

Frontier Bio creates lab-grown human tissues to reduce the worldwide organ shortage. Their first clinical product is a tissue-engineered vascular graft made from the patient's own cells.

Member
RelīOx Corporation

ReliOx Corporation is a U.S.-based advanced materials and medical technology company with a clean oxidation platform for on-demand generation of pH-neutral aqueous chlorine dioxide. The ReliOx platform enables safe, controlled oxidation at the point of use without acids, electricity, or hazardous intermediates—addressing long-standing limitations that have historically prevented chlorine dioxide from being used routinely in medical and operational environments. ReliOx directly supports the important core objectives aligned with MTEC members: improving trauma care, reducing infection risk, enabling care in austere and resource-constrained settings, and accelerating transition of dual-use technologies from non-regulated markets into regulated medical and defense applications. The platform’s defining feature is not a new chemical agent, but a novel generation method that produces true chlorine dioxide only at the moment of use, in a neutral pH aqueous form compatible with tissue, metals, polymers, elastomers, and sensitive electronics. ReliOx is advancing an initial wound cleansing and irrigation use case that aligns closely with military and emergency medicine needs, including contaminated wounds, blast injuries, and prolonged field care. The system’s on-demand architecture eliminates the need to store reactive disinfectants, reduces logistical burden, and supports distributed medical operations, a priority across DoD, BARDA, and ONR programs. This makes the platform particularly relevant for battlefield medicine, forward surgical teams, and humanitarian or disaster response scenarios. In parallel, ReliOx operates VetiOx, a veterinary-focused pathway that applies the same platform to animal wound care (including equine). This strategy generates early operational data and clinician familiarity while remaining aligned with long-term human medical translation—an approach consistent with MTEC’s emphasis on de-risking technologies prior to advanced development. The ReliOx platform is inherently dual-use. All commercial, veterinary, food safety, and medical applications share the same resin-based generation mechanism, enabling efficient manufacturing, rapid scaling, and consistent safety characteristics across use cases. This platform approach allows ReliOx to support incremental transition from non-regulated and veterinary markets into FDA-regulated medical devices and DoD-relevant medical countermeasures without fundamental redesign. ReliOx represents a strong MTEC-aligned opportunity at the intersection of advanced chemistry, trauma care, infectious disease mitigation, and distributed manufacturing. The company offers a defensible intellectual property position, a clear regulatory strategy, and a near-term path to operational relevance for military medicine and biodefense stakeholders .

Member
ATD Emolda

ATD Emolda has been delivering innovative solutions for 40 years, specializing in the conversion and manufacturing of components and assemblies for industrial, medical, and pharmaceutical applications. The company has become a thought leader in advanced wound care materials, focusing on developing high-performance polyurethane foams and silicone adhesives.

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
Ceres Nanosciences, Inc.

Ceres Nanosciences, Inc. is a privately held company based in Northern Virginia, specializing in the development and commercialization of Nanotrap® hydrogel particle technology. Their mission is to deliver innovative products powered by Nanotrap Technology to address life science needs and provide better patient outcomes. Ceres' products enable the capture, concentration, and preservation of low-abundance analytes from diverse biological and environmental samples, supporting applications in diagnostics, research, and public health surveillance. The company is ISO 9001:2015 certified and collaborates with leading research institutions, public health agencies, and industry partners to advance global health security and biosecurity. Ceres has established a national network of Wastewater-based Epidemiology Centers of Excellence and has received significant funding from the NIH RADx initiative and other organizations to expand its impact in underserved communities. Their technology is widely adopted for wastewater-based epidemiology, proteomics, and nucleic acid analysis, with a strong focus on supporting public health monitoring, early detection of infectious diseases, and environmental bio-surveillance.

Member
Gel4Med

Gel4Med is a commercial-stage company pioneering the use of smart, bioinspired materials to address major challenges in medicine. Founded out of Harvard Innovation Labs, Gel4Med leverages its proprietary Smart Materials Platform™ (SMP™) to develop advanced therapeutics and devices, with a mission to enhance health outcomes and access for all patients. The company is committed to creating novel biomaterials that improve regenerative medicine and surgical solutions, and has achieved significant milestones including FDA clearance for its lead wound care product, G4Derm™ Plus.

Member
Instant Systems

Instant Systems specializes in the design and manufacture of single-use sterile systems for cell and gene therapy, regenerative medicine, tissue banking, and related bioprocessing applications. The company offers a wide range of customizable solutions for cell culturing, fluid management, media and waste containment, magnetic cell separation, and sterile filtration, with a focus on maintaining process integrity from production through delivery. Their products support closed-system workflows, scalability, and integration into existing manufacturing and research environments.

Member
Clemson University Research Foundation

The Clemson University Research Foundation (CURF) is dedicated to advancing the research enterprise at Clemson University by connecting faculty and students with industry partners. CURF facilitates the commercialization of university technologies, supports research collaboration, and promotes innovation through various funding and support programs.

Member
Louisiana State University Health Sciences Center New Orleans

LSU Health Sciences Center New Orleans is dedicated to educating future health professionals and scientists, advancing research, and providing exceptional healthcare. With six professional schools and numerous affiliated hospitals, LSUHSC-NO aims to improve health outcomes and address health equity challenges in Louisiana.

Member
Vira Regen Inc.

Vira Regen Inc. is at the forefront of biotech innovation, focusing on regenerative medicine to address the root causes of diseases and injuries. The company is pioneering the development of novel, gene-specific electroceuticals that stimulate the body's bioelectric network and genetic code, promoting accelerated healing through the body's natural self-repair processes.

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
Cook MyoSite

Cook MyoSite, a subsidiary of Cook Group, has been advancing human muscle cell technology since 2002. Operating under ISO 9001:2015-certified quality standards, we specialize in primary human skeletal muscle-derived cells and fibro-adipogenic progenitors sourced from healthy donors and individuals with neuromuscular, metabolic, and rare disorders. Our offerings include custom cell procurement, specialized media formulations, and contract manufacturing services—supporting both academic research and clinical development in regenerative medicine. Beyond research tools, Cook MyoSite is pioneering autologous muscle-derived cell therapies. Our investigational product, iltamiocel, is currently in a Phase III clinical trial for fecal incontinence, demonstrating our commitment to translating cell-based science into real-world solutions. With expertise in GMP manufacturing, analytical testing, and tailored partnerships, we empower collaborators to accelerate innovation in musculoskeletal and neuromuscular health worldwide.

Member
Imperial College London

Imperial College London is a world-leading university focused on science, technology, engineering, medicine, and business. It is dedicated to addressing global challenges through innovative research and education, fostering a diverse and inclusive community of students and staff.

Member
Houston Methodist Academic Institute

Houston Methodist Academic Institute integrates advanced clinical research, education, and healthcare innovation with a focus on translating scientific discoveries into improved patient outcomes. The institute offers accredited graduate and postgraduate medical education, supports interdisciplinary research in major areas such as cancer, cardiology, neuroscience, transplant medicine, and regenerative medicine, and provides extensive infrastructure for digital health and medical technology development. Training and fellowship programs span from medical residencies and fellowships to doctoral and research-oriented positions, supported by collaborations with leading academic and industry partners. The institute leverages core technology platforms, simulation centers, and comprehensive educational pathways to foster future leaders in medicine and biomedical research.

Member
SereNeuro Therapeutics

SereNeuro Therapeutics is focused on discovering and developing advanced therapies for pain relief, emphasizing non-opioid solutions. The company is committed to pioneering innovative treatments to address unmet medical needs in pain management.

Member
Icahn School of Medicine at Mount Sinai

The Icahn School of Medicine at Mount Sinai, located in New York City, is an international leader in biomedical education, research, and patient care. As the academic partner of the Mount Sinai Health System, the school is renowned for its innovative education, groundbreaking research, and commitment to health equity. With over 7,000 faculty, 1,200 students, and 2,500 residents and fellows, the institution fosters a culture of bold thinking, multidisciplinary teamwork, and a willingness to challenge conventional wisdom. Its mission is to radically advance the art and science of medical care through collaborative learning, scholarly inquiry, and a deep respect for diversity, preparing the next generation of healthcare leaders to revolutionize medicine and biomedical science.

Member
Signature Science, LLC

Signature Science, LLC is a multidisciplinary applied science and technology company dedicated to solving the toughest forensic, biosecurity, and public health challenges. Serving both government and commercial clients, Signature Science combines scientific rigor with proven quality assurance to enhance the credibility and defensibility of programs in national security, public safety, and health security. The company is recognized for its innovation, technical excellence, and commitment to advancing the state-of-the-art in forensic science, genomics, and biosecurity technologies. Signature Science also offers advanced bioinformatics and microbiome analysis services, empowering clients with data-driven insights to address emerging threats, pandemics, and bioterrorism. The company is a subsidiary of Southwest Research Institute and is committed to community engagement and workforce development.

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Moberg Analytics

Moberg Analytics – Advanced Brain Monitoring & Critical Care Informatic

Moberg’s platform unifies brain monitoring data for faster, precise treatment of severe brain injuries in military and civilian care.

University of California San Francisco

TemPredict: AI-Driven Wearable Monitoring for Early Illness Detection and Warfighter Readiness

TemPredict: AI wearables detect early illness and health risks to support warfighter readiness.

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.

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