Non-FDA Regulated Medical Devices

Georgia Southern University is a vibrant institution with over 26,100 students across three campuses in Statesboro, Savannah, and Hinesville. The university offers 132 degree programs at the associate, bachelor’s, master’s, and doctorate levels, emphasizing student success, community impact, and research excellence. With a commitment to inclusivity and engagement, Georgia Southern fosters a supportive environment for diverse learners, including military-affiliated and adult students. The university is dedicated to transforming lives through education and community engagement, aligning its programs with regional needs. Additionally, Georgia Southern provides accelerated pathways for students to fast-track their master's degrees, enhancing educational opportunities. The university also emphasizes career readiness and public impact research, preparing students for successful careers and contributing to community development.

Teleflex is a global provider of medical technologies designed to improve the health and quality of people's lives. The company focuses on purpose-driven innovation to empower healthcare professionals and enhance patient outcomes across various medical fields.

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.

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

The Institute for Integrative & Innovative Research (I3R) at the University of Arkansas is dedicated to pioneering solutions to complex societal challenges through convergence research. With a mission to advance research excellence and stimulate economic development, I3R focuses on deploying innovations at scale through collaboration across various sectors, including academia, industry, and government.

The University of Chicago is a prestigious urban research university committed to rigorous inquiry and intellectual freedom. Founded in 1890, it has produced numerous Nobel laureates and is known for its transformative education and groundbreaking research across various fields. The university fosters an inclusive and diverse learning environment, encouraging participation from all community members.

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.

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.

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.

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.

TRI Medical, Inc. develops and supplies educational simulation models and training services to enhance the diagnostic and manual skills of healthcare professional students and new graduates. The company focuses on providing real-time, psychomotor feedback tools for medical education programs and healthcare organizations, aiming to improve confidence, self-efficacy, and diagnostic accuracy prior to clinical practice.

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.

Smith+Nephew is a portfolio medical technology company focused on the repair, regeneration, and replacement of soft and hard tissue. The company aims to restore people's bodies and their self-belief by using technology to take the limits off living. With a commitment to medical education and improving patient outcomes, Smith+Nephew operates in over 100 countries and is dedicated to sustainability and community health. Their purpose is to promote health and wellbeing, not just through their products but also by ensuring a positive impact on society and the environment. Smith+Nephew is also committed to increasing diversity within the medical device industry through initiatives like the Orthopaedics for All global advisory board.

The University of Maryland, Baltimore (UMB) is Maryland’s public health, law, and human services university. It is dedicated to improving the human condition and serving the public good through education, research, clinical care, and service. UMB is the founding campus of the University System of Maryland and offers a wide range of professional degrees in health care, human services, and law.

The University of North Carolina Wilmington (UNCW) is a top doctoral and research institution located in Wilmington, North Carolina. Established in 1947, UNCW has grown to serve nearly 18,000 students and employs about 2,500 staff. The university is dedicated to providing a powerful academic experience that fosters creative inquiry, critical thinking, and thoughtful expression in a beautiful coastal setting. UNCW is committed to educational excellence, community engagement, and global connections, making it a vibrant part of the southeastern North Carolina community. UNCW also emphasizes the importance of freedom of expression and mutual respect within its diverse community.

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.