Regulatory

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.

Deloitte is a leading global provider of audit, consulting, tax, and advisory services. The company is committed to improving public outcomes through a focus on people and developing relevant, timely, and sustainable solutions for clients. Deloitte's mission is to lead with purpose and drive positive change for people and communities, with a strong emphasis on social impact, sustainability, equity, and trust. Deloitte is also dedicated to helping the power, utilities, and renewables industry grow to become more sustainable, safe, and efficient, and is a fierce champion of industrials, inspiring optimism for the future.

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.

The Conafay Group specializes in representing life sciences companies, universities, and other organizations in the biomedical space before the federal government and associated stakeholders. Since 2004, they have been helping clients advance their research and policy goals by leveraging federal government resources and building strong coalitions.

Revolution Biomanufacturing Inc. (RBIx) is expanding beyond traditional CDMO Process/Analytical Development and Manufacturing services to pioneer distributed molecular manufacturing. A new class of digital biomanufacturing that enables the autonomous design, manufacture, quality verification, and deployment of Nucleic Acid therapeutics and molecular diagnostics at the point of need. By integrating AI-driven sequence optimization, enzymatic nucleic acid synthesis, Nanoparticle design and manufacturing (LNP & EV), closed-loop quality control, and field-deployable manufacturing platforms, RBIx is creating adaptive biological infrastructure capable of responding to emerging diseases, national security threats, and personalized medicine with unprecedented speed and flexibility.

Booz Allen Hamilton is a leading management and technology consulting firm with over 110 years of experience. The company is dedicated to empowering people to change the world through innovative solutions in various sectors including cybersecurity, artificial intelligence, engineering, and defense. Booz Allen partners with government and commercial clients to tackle their most complex challenges, leveraging a culture of innovation and a commitment to excellence. The firm operates with core values of integrity, courage, service, ingenuity, and a commitment to diversity and inclusion.

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.

Clinical Research Strategies (CRS) is a Pittsburgh-based contract research organization and executive management consultancy dedicated to improving the performance of start-up and mid-size life sciences companies. With a focus on instilling fiscal discipline and reducing risks in clinical development, corporate affairs, and quality assurance programs, CRS provides tailored consulting and staffing solutions to navigate the complexities of regulatory pathways and ensure successful product launches. CRS is also committed to leveraging advancements in artificial intelligence and machine learning to enhance clinical research and regulatory processes.

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.

DLH delivers improved health and national security readiness solutions for federal programs through science research and development, systems engineering and integration, and digital transformation. With over 3,200 employees, DLH is committed to solving complex problems faced by civilian and military customers, leveraging advanced technologies and methodologies to enhance health outcomes and operational readiness.

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.

Kaléo is a global leader in drug-delivery device technology and auto-injector innovation, providing millions of patients with security and peace of mind. Our patented Aerio™ platform, with unmatched capabilities and human factors engineering, powers our portfolio of auto-injector products, as well as products under development for third parties.

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.

Trimaran Medical Technology Systems Inc. is developing an edge-native, high-acuity medical software and devices engineered for continuous physiological telemetry in remote, austere, and prehospital operational environments.