About

Expert Advisors, Medical Device Regulatory Consultants and Clinical Research Organization

There’s been roller coaster changes in the healthcare economy over just the past decade. RCRI has been there providing accurate, efficient, and complex  regulatory and clinical consulting services for decades. Our team continues transforming medical device product concepts into successful, revenue-generating businesses for clients worldwide.

More than 600 companies – from entrepreneurial start-ups to Fortune 100 market leaders – have trusted the proven value of RCRI’s unique Integrated Approach to life science consulting and strategy development delivered by our knowledgeable and insightful experts.

RCRI supports clients through all phases of product development, including:

  • Regulatory and clinical strategy
  • Study design and statistical analyses
  • FDA/regulatory body negotiation
  • Clinical study operations
  • Health economics & reimbursement
  • Quality systems
  • Compliance

From simple modifications of market-released products to novel combination products, RCRI’s deep expertise and proven Integrated Approach removes obstacles thereby expediting regulatory approvals with major regulatory agencies and notified bodies around the globe.

Our Certifications

Expert Advisors

Mary Beth Henderson, PhD, MBA

Vice President of Regulatory Affairs and Quality Systems and Senior Principal Advisor
Mary has worked for over 30 years in medical device and biotechnology industries. She brings experience in strategic regulatory affairs, global submissions (PMAs, IDEs, HUDs/HDEs, 510(k)s, technical files, etc.), regulatory body negotiations, quality systems strategy and support, auditing, research and development and business development. Mary has an MBA from the University of Massachusetts-Lowell and a PhD in Chemistry from Northwestern University.

Peggy Pereda, MS

Vice President of Clinical Sciences and Senior Principal Advisor
Peggy has over 20 years’ experience in clinical research and management with extensive experience in the strategy, design, analysis, and reporting of scientifically sound clinical trials and programs to support early product feasibility, product approval and post-marketing requirements around the globe. She has held positions in Fortune 500 medical device and pharmaceutical manufacturers and has a Master’s degree in Statistics from North Carolina State University.

Lisa M. Olson, MBA

President
With over 20 years industry experience including ISO standards development, preclinical testing, laboratory operations, research and development, service development, market development and executive leadership, Lisa brings a multidimensional viewpoint to leadership and strategic growth. Lisa received her undergraduate degree in Microbiology from the University of Minnesota and her Masters of Business Administration from the University of St. Thomas.

Theresa Carlson, BS

Regulatory Principal Advisor
For over 20 years, Theresa has supported medical device and pharmaceutical research and development, including regulatory affairs, manufacturing, and exempt product support in start-ups to multinational companies. She has supported products from Orphan drugs and Class III implantables to in vitro diagnostics, including electronic submissions and UDI requirements.Theresa graduated from the University of Minnesota with a BS in Biochemistry.

Jill Cernohous, MA

Clinical Sciences Senior Principal Advisor
Jill has over 25 years’ experience supporting the pharmaceutical and medical device industries, including combination products, across the development lifecycle from preclinical studies to studies to support premarket approval applications (PMA) and new drug applications (NDA), post-market surveillance programs, marketing, reimbursement and research and development with extensive experience in clinical compliance and auditing. Jill has a BS in Animal Science from the University of WI, River Falls and a Master’s degree in Management from Saint Mary’s University of Minnesota.

Barb Duerr, MS, CCRA

Clinical Sciences Principal Project Manager
Barb has over 20 years of Clinical Research experience involving clinical project management and oversight, as well as regulatory compliance/quality systems and clinical research training and education. Over the course of her Clinical Research career, Barb has worked in the pharmaceutical division and healthcare business group of a fortune 500 company, as well as the Clinical Quality area of a mid-sized medical device company and consulting roles in Clinical Operations and management. Barb holds a MS in Biochemistry and Molecular Biology from Ohio State University and a BA in Biology and Chemistry from Potsdam College.

David France, BS

Clinical Sciences Principal Advisor
David’s 30 years of experience in the medical device industry encompasses start-ups through multinational corporations. He has been responsible for strategic planning, clinical protocol development, enrollment strategies, report authorship, FDA advisory panel preparation, extensive site and investigator management, and publication strategy development and support. Additionally, David has built and managed numerous clinical study teams both in-house and in the field. David holds an undergraduate degree in Biology from Gannon University.

Thomas Hughes, JD

Health Economics/Reimbursement Senior Principal Advisor
Tom has over 20 years of experience in medical device reimbursement for companies from start-ups to multi-national companies, specializing both in reimbursement strategy and execution. He has built reimbursement teams for medical device companies, negotiated national payer contracts, lobbied federal and state decision makers, advised on reimbursement, government regulations and business development approaches for health economics and reimbursement. Tom holds a BA in Political Science from the University of Minnesota and a JD from the William Mitchell College of Law.

Paula Kamman, BA, CCRA

Clinical Sciences Principal Advisor
Paula has worked for over 20 years in global trial management and clinical affairs in the Medical Device and Pharmaceutical industries for companies from start-ups to multinational corporations. Paula brings layers of expertise to clinical trials by orchestrating multi-departmental teams, incorporating project management, site management, CEC/DSMB management, efficient clinical operations and quality into every project. Paula has managed projects and advised clients in of support PMAs, 510(k)s, and NDAs. She holds a BA from the University of Wisconsin-Madison.

Rachel Kennedy, BS

Regulatory Senior Principal Advisor
Rachel has over 27 years of experience in the medical device industry, focusing on the areas of research, manufacturing, product development, quality systems and regulatory affairs. Rachel has extensive experience working with development teams in medical device start-ups to guide the generation of data to support product registrations. Rachel holds a BS in Engineering from Marquette University, School of Biomedical Engineering.

Russell Olson, BS

Regulatory Senior Principal Advisor
Russ has over 30 years’ experience in the medical device industry, including time with venture-funded companies, focusing on the areas of research, manufacturing, product development, preclinical studies, regulatory affairs, quality systems and clinical studies. Russ has a degree in Microbiology and Public Health and has additional training in quality system auditing, sterilization validations, sterile packaging testing, and software validation.

Carol Ryerson, PhD

Regulatory Senior Principal Advisor
For 30 years, Carol has developed domestic and international regulatory strategies, drafted submissions, and negotiated their approval by worldwide regulatory agencies for medical device and diagnostic companies. Carol’s experience includes regulatory strategy, regulatory body negotiations, product development, analytical and clinical study design, medical device labeling, and global regulatory submissions. Based in Boston, Massachusetts, Carol holds a Bachelor’s degree in Chemistry from the College of the Holy Cross, and a PhD in Biochemistry from the Massachusetts Institute of Technology.

Mary Kay Sobcinski, RN, BSN, MHA

Clinical Sciences Senior Principal Advisor
Mary Kay’s experience of over 30 years spans the strategic design, development and management of innovative clinical trials including pilot, global IDE, IND and post-market trials for medical devices and pharmaceuticals. She has supported international regulatory initiatives involving negotiations with FDA, Health Canada, Notified Bodies, and the Therapeutic Goods Administration (Australia). Mary Kay is a registered nurse with a BS in Nursing from Loyola University Chicago and a Master’s degree in Healthcare Administration from the University of Minnesota.

Board of Directors

Jennifer Marrone, MBA

Co-founder of RCRI, Inc., Executive Vice President, and an Executive Principal Advisor in worldwide regulatory and clinical affairs.
Jennifer holds an MBA and over 30 years’ experience in the medical device industry, including preclinical, product development, regulatory submissions (PMAs, IDEs, HUDs/HDEs, 510(k)s, dossiers, technical files, etc.), global regulatory, quality and clinical affairs, negotiation with governmental authorities and clinician interaction. She has successfully organized and managed professional staff in regulatory, clinical and quality system/compliance departments for several medical device manufacturers.

Stephan Norsted, PhD, MPH

CEO and Co-founder of RCRI, Inc. and an Executive Principal Advisor in worldwide regulatory and clinical affairs.
Steve holds a PhD and an MPH in Epidemiology and has been responsible for the design, execution and analysis of preclinical and clinical studies since 1980. He joined the medical device industry in 1988 and has held senior-level positions in Regulatory Affairs/Clinical Studies. Steve served as an Epidemiologist for the Washington State Health Department and has served as an instructor of preclinical and clinical studies for the graduate schools of three universities.

Tierney Norsted, PhD, MPH

CEO and Co-founder of RCRI, Inc. and an Executive Principal Advisor in worldwide regulatory and clinical affairs.
Terry holds a PhD and an MPH in Epidemiology and has been responsible for the design, execution and analysis of clinical trials since 1981. Terry has held clinical and regulatory management positions for medical device companies since 1987 where she has been responsible for numerous successful domestic and international regulatory strategies, regulatory product submissions (Pre-IDEs, IDEs, 510(k)s, PMAs, HUDs/HDEs, reclassification petitions), as well as the design, implementation, and analysis of clinical trials of medical devices.

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CASE STUDY:
Innovation can be viewed as the application of better solutions that meet existing market needs 

A start-up medical device manufacturer developed an innovative orthopedic device designed to gain full knee extension following total knee replacement surgery.  The technology was simpler and more effective than existing alternatives, but there was a major problem:  the manufacturer had no billing code.

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