Marie Rigley is a Regulatory Affairs Certified (RAC) professional with more than 15 years of medical device industry experience and a deep specialization in FDA regulatory strategy and market authorization. She serves as a strategic regulatory resource for portfolio companies and emerging MedTech entrepreneurs navigating the FDA regulatory landscape, helping translate early-stage innovation into compliant, submission-ready programs. A Senior Consultant through MedTech Impact Partners, she brings experience spanning all FDA submission types and Agency interactions, with particular strength in AI/NL-enabled devices, digital health, diagnostics, and combination products. Her regulatory expertise is further informed by a substantive background in Quality Management Systems and R&D, spanning design control, V&V, and risk management from feasibility through design transfer. She is recognized as a trusted regulatory authority by medical device companies seeking strategic, high-impact regulatory guidance.

Julie is a scientist, C-level executive, and entrepreneur with more than 30 years of experience advancing MedTech innovations through FDA clearance and GMP manufacturing across medical devices, digital health, and in vitro diagnostics. She brings a practical combination of scientific depth, operating experience, product development strategy, and commercialization insight to her work with innovators and early-stage companies.

Julie has led R&D efforts at major health technology companies, including Abbott, Beckman Coulter, and Agilent. She also founded and grew a life science service company from launch to $10 million before a successful exit, giving her firsthand experience building and scaling a business in the life sciences sector.

Her expertise includes developing and executing FDA pathways, assessing MedTech technology readiness, supporting investor diligence, and guiding companies through early-stage activities such as need identification, value proposition development, business model design, and product-market fit. She is especially interested in technologies, products, and services that make healthcare more accessible and shift care into the home.

Julie was a member of the $2 billion RADx Tech NIBIB initiative, which helped create U.S. manufacturing capacity for COVID-19 tests. In that role, she led multiple company teams through successful FDA authorization and manufacturing scale-up for new diagnostics in record-breaking time.

Her background also includes leading R&D teams through successful 510(k), de novo, Class I, II, and III FDA diagnostics product development across technologies involving nucleic acids, proteins, cells, viruses, bacteria, and fungi. She has supported digital health companies focused on mental health and evidence-based behavior-modifying apps, developed FDA-cleared clinical lab diagnostic platforms and reagents with significant global sales, and led ISO-9001 and ISO-13485 certification efforts for international medical device technology providers.

Caroline is a business leader, physician, and lawyer with more than 30 years of experience across medical technology, diagnostics, life sciences, commercialization strategy, and healthcare innovation. With training as an internist and pathologist, she brings a rare combination of clinical insight, business leadership, legal perspective, and market strategy to her work with emerging companies and technology-enabled healthcare organizations.

Caroline has advised and built healthcare, diagnostics, and life science tools companies from early financing through exit, supporting team formation, facility development, intellectual property strategy, financing, partnership development, regulatory planning, and commercialization. She works with founders and leadership teams to evaluate technologies in the context of clinical need, market dynamics, policy shifts, competitive trends, and global commercialization opportunities.

Her experience includes operational and strategic roles at BD, where she helped create the BD QIAGEN joint venture and molecular diagnostics business unit, as well as leadership roles at bioMérieux and MDS Proteomics. She later founded Popper and Company, a strategy consulting firm, and co-founded The Sherpanis with Julie Wilkinson.

Caroline has also served as Chief Commercial Officer of Johns Hopkins Precision Medicine, where she worked closely with clinicians, data scientists, and collaborators on issues related to privacy, cloud storage, data federation, and commercialization. She also led commercialization activities for the Johns Hopkins Applied Physics Lab Healthcare Mission Area.

Her expertise spans technology assessment, commercialization strategy, global market development, data strategy, privacy, compliance, corporate governance, regulatory considerations, and the translation of academic innovation into market-ready products and services. She currently serves as co-chair of the American Bar Association Healthcare Section AI Task Force, reflecting her continued focus on the intersection of healthcare, biology, technology, and artificial intelligence.

Todd is a distinguished intellectual property attorney with over 20 years of experience advising startups, academic institutions, and multinational corporations in the pharmaceutical, biotechnology, regenerative medicine, cell and gene therapy and medical device industries. With a Ph.D. in Pharmacology and Toxicology from the University of Georgia and a J.D. from The George Washington University School of Law, Todd brings a unique blend of scientific expertise and legal acumen to his practice.

A trusted advisor to startups, Todd serves as de facto Chief IP Counsel for many early-stage companies, offering comprehensive guidance on patent strategy, trade secret protection, and regulatory compliance. He works closely with founders, boards, and R&D teams to build and manage intellectual property portfolios that protect critical innovations and support business growth. His counsel has helped startups secure funding, navigate partnerships, and prepare for successful acquisitions and IPOs.

His expertise includes drafting and prosecuting complex patent applications, conducting freedom-to-operate analyses, and leading due diligence for financing and acquisition transactions. He is also experienced in negotiating and managing licenses, joint development agreements, and other critical partnerships that support innovation.

A seasoned litigator, Todd has represented clients, including Nobel Laureates, in USPTO inter partes proceedings, Federal District Court cases as well as appeals in front of the Court of Appeals for the Federal Circuit, achieving successful outcomes that have safeguarded startup assets and market positions. His strategic insights and hands-on approach make him an invaluable partner for life sciences companies navigating the competitive and highly regulated landscape of innovation.

Todd is a member of the Georgia, North Carolina, Virginia and District of Columbia Bars, and he is a registered attorney with the United States Patent and Trademark Office. He is an active participant in the Court of Appeals for the Federal Circuit Bar and the American Intellectual Property Law Association.

Victoria Manax Rutson M.D. is a medical oncologist with over two decades of expertise in the pharmaceutical/biotech industry with a focus on global drug/device/diagnostic development, nanomedicines, novel immunotherapies, and product launch/commercialization.  Dr. Manax has made indelible contributions to the field with her expertise in shaping clinical trial landscapes, particularly in adaptive platform designs with biomarker integration from Phase I-IV.   She has most recently joined Eckuity Capital as a partner.

Dr. Manax has played a pivotal role in the development, approval, and launch of billion-dollar products, including the standards of care for breast cancer, lung cancer, and most recently, pancreatic cancer.  She has held multiple executive medical positions in companies including Abraxis Bioscience and Celgene (BMS).  In addition to her pharmaceutical expertise, she was the inaugural Chief Medical Officer for the Pancreatic Cancer Action Network. She has effectively overseen numerous multimillion-dollar global clinical trial programs, holds multiple clinical advisories, chair positions, and patents, exemplifying her commitment to advancing medical science and patient well-being.

She is an internationally recognized speaker from programs through Harvard Business School and is a proud Belfast Ambassador recipient. Dr. Manax has received multiple distinguished honors including Who’s Who in Healthcare and was recently named as a government advisor to Northern Ireland for Health and Life Sciences.

Quan Nguyen is a Partner at Nguyen Tarbet Intellectual Property Law, representing inventors and organizations with impactful, cutting-edge technologies. Quan has a great passion for the process of commercializing new inventions. He works closely with his clients to build winning patent portfolios and helps identify strategic partners, screen for potential business deals, and analyze market opportunities. Quan is also an active member of the Tech Coast Angels (TCA), Desert Angels, and Life Science Angels, where he leads a number of investment deals.

As a seasoned patent attorney, Quan concentrates his practice in patent procurement, opinion work (patentability and freedom to operate analysis), and intellectual property management of inventions in biotechnology, chemistry, medical devices, microfluidics, bioinformatics, and artificial intelligence. His clients include publicly traded companies, major corporations, universities, investors, and entrepreneurs. Prior to founding Nguyen Tarbet LLC, Quan was a Partner at Cozen O’Connor, an international law firm based in Philadelphia. Earlier in his career, Quan also worked in-house as an Assistant Director of Patents at Ionis Pharmaceuticals in San Diego, a leader in RNA-targeted therapeutics.

Quan firmly believes in public service and works tirelessly to advance innovation and entrepreneurship. He is an active Member of the College of Science Dean’s Board of Advisors (University of Arizona), School of Pharmacy and Pharmaceutical Sciences Dean’s Leadership Council (University of California, Irvine) and Beall Applied Innovation (University of California Irvine), where he leads various university initiatives to promote innovation through industry partnerships. As Chairman Emeritus of the Advisory Board of the Chemistry and BioChemistry Board of Advisors (University of Arizona), he helped the department develop strategic industry relationships to advance faculty research. Quan regularly speaks at seminars about innovation, technology investments, and trends in patent law.

Stephanie E. Toney is a highly accomplished Global Market Access & Health Economics executive with over two decades of experience delivering revenue and market share growth for leading medical device and diagnostics companies. Currently serving as an Independent Consultant through her firm Wide Horizons Consulting, LLC, she specializes in market access and reimbursement strategies for healthcare innovation companies.

Stephanie holds a Master of Business Administration with a concentration in Marketing from the University of Wisconsin-Madison (2004) and a Bachelor of Science in Management with a concentration in Finance from Tulane University (1995). She was also a Consortium for Graduate Study in Management Fellow at the University of Wisconsin-Madison.

Her expertise spans global market access, medical device and diagnostics expertise, global reimbursement and payment policy, coverage and coding strategies, and health economics outcomes research. She has established herself as a subject-matter expert consistently called upon by sales, marketing, senior leadership, and advocate groups for her deep knowledge of clinical matters, policies, procedures, and regulations.

Michael J. Thomas is a distinguished healthcare executive and venture capital investor with over three decades of experience achieving remarkable successes in strategic and corporate venture capital investments, turnarounds, IPOs, startup operations, and commercialization of innovative healthcare products and services. As an operating executive, he has achieved investor returns ranging from 3x to 80x, establishing himself as a proven value creator in the healthcare technology sector.

Michael earned his Bachelor’s Degree in Microbiology from Cornell University in 1989, where he was a varsity baseball player and served as House Manager for the Phi Kappa Psi fraternity. His career began in pharmaceutical sales at Merck & Co. (1989-1992) and Glaxo Inc. (now GlaxoSmithKline, 1992-1995), where he demonstrated exceptional performance, earning President’s Club Awards and transforming underperforming territories into top revenue generators.

Susan Solinsky is an Entrepreneur in Residence at BHI, where she leverages her expertise in commercialization, go-to-market strategy, and fundraising to help healthcare organizations successfully navigate market entry. With a track record of scaling technology-driven healthcare startups, Susan specializes in revenue growth, payer and provider relationships, operational efficiency, and building world-class teams. Her leadership has propelled companies from early-stage development to over $120 million in revenue, particularly ones pioneering new care models. She is passionate about harnessing AI, machine learning, and innovative health technologies to expand access, improve outcomes, and drive systemic change—especially in behavioral and women’s health.

As a Strategic Operator with Kayne Anderson and Composition Capital, Susan supports the growth and innovation of healthcare-focused portfolio companies. She serves on the boards of TeleMed2U, Carium, and MDisrupt, organizations advancing virtual care and healthtech validation, and advises women’s health startups, including LunaJoy and Lovu.

Previously, Susan was Co-Founder of Ellipsis Health (Series A+), where she played a pivotal role in commercializing AI-powered voice technology that established a clinically validated vital sign for mental health. She also led enterprise sales at Phreesia (IPO 2019) and co-founded Vital Score, a behavioral health technology company acquired by Phreesia. Her experience includes serving as Managing Partner at Reditus Revenue Solutions, scaling revenue cycle strategies, and holding key leadership roles as part of the founding team at The Advisory Board Company (IPO) and The Corporate Executive Board (IPO).

A champion for female entrepreneurs, Susan has directed the Women’s Health Tech Initiative at HITLAB for five years, connecting startups with funders and industry leaders to drive innovation. She is a founding LP of the How Women Invest Fund, an investor in venture funds such as Swizzle Ventures, Emmeline Ventures, Scrub Capital, and DigitalDx, and also an angel investor in women-led healthcare disruptors, including Avanlee Care, Gabbi, C-Plan.ai and MDisrupt.

Recognized as one of Becker’s Hospital Review’s “Women in Health IT to Know” for the past four years, Susan frequently speaks at industry events and serves on the board of Synapse School, fostering the next generation of changemakers. She holds an A.B. from Princeton University and remains committed to advancing healthcare, technology, and education through leadership and innovation.