Regulatory, clinical, and policy consulting for the medical device industry to help improve patient lives
Evergreen Strategic Consulting is the consulting practice of Dr. Carrie M. Kuehn who provides consulting services in the areas of regulatory affairs, clinical evidence, patient preference and engagement, and advocacy for patient-centric healthcare policy. Dr. Carrie Kuehn is a talented medical device regulatory and clinical affairs professional with a diverse background and over 25 years of experience in epidemiology, medical devices, regulatory and clinical affairs, and patient-focused policy. In practice, Dr. Kuehn applies her expertise, leadership, strategic remediation skills, and broad medical device regulatory knowledge to address the needs of medical products companies across therapeutic areas.
Dr. Kuehn excels at taking complex, multidisciplinary problems and synthesizing them into a cohesive strategy. She is particularly skilled at stepping into crises, supporting remediation efforts, conducting gap analyses, reorienting strategic plans, and bringing positive results out of fire-drill situations. Dr. Kuehn applies her adaptable skill set to address complex issues in the pre-market and post-market space to enhance compliance, fine tune business practice, and improve patient lives around the world. With the increase in clinical requirements being imposed on medical device companies globally, Dr. Kuehn can provide critical expertise in observational and clinical research methods, execution, and publication of clinical results to achieve and maintain market authorization.
An accomplished researcher, Dr. Kuehn has published in the areas of public health, regulatory affairs, and patient engagement policy. She also maintains a blog covering topics relevant to medical regulatory affairs practice and patient-focused policy.
As part-time faculty with the College of Professional Studies at Northeastern University’s Regulatory Affairs Graduate program, Dr. Kuehn helps to prepare the next generation of patient-focused, medical device regulatory professionals. Please review the service areas to determine if Dr. Kuehn can support your needs.
My Guiding Principles
Integrity
My practice is guided by uncompromising integrity and compliance. I do it right the first time and ensure regulatory compliance from start to finish.
Accountability
I believe in being accountable for my words, my work, and my time. I own my responsibilities and meet my commitments.
Efficiency
I get up to speed quickly and work efficiently. I only bill for the time needed to get the work done right.
Authenticity
What you see is what you get. I am direct, honest, and will tell you what you need to hear - not always what you want to hear.
Introducing Patient by Design, a concept that considers how patient input can be integrated across all phases of the medical product life-cycle. Learn more here…
Dr. Carrie M. Kuehn, Principal Consultant & Founder
Contact
➤ LOCATION
Catonsville, MD
☎ (301) 337-8159
carrie.kuehn@esc-strategic.com
Areas of Practice
Patient engagement
Including the patient voice in medical product development and commercialization is a new area of focus for FDA, medical product sponsors, and patient advocacy groups. I focused on how best to use patient experience data to influence regulatory decision-making. I apply my knowledge and experience to designing qualitative and quantitative studies aimed at rigorously capturing patients’ preferences, treatment priorities and benefit-risk tolerance. I have experience developing patient preference studies, qualitative interviews and focus groups, and survey studies. I am equipped with the knowledge and expertise to achieve regulatory expectations for patient input in pre-market submissions and determine the best patient research strategy for your product.
Medical product sponsors and patient advocacy groups will benefit from my unique training and experience in patient-focused observational research, patient engagement, and patient-focused regulatory policy.
Clinical Evidence
With extensive training and experience in clinical and observational research, I provide expert leadership, direction, and clinical affairs consulting for the life sciences industry. My areas of specialty are prospective and retrospective cohort studies, case-control studies, medical device early feasibility study (EFS) and investigational device (IDE) pivotal study design, execution of clinical research, management of clinical operations, data, and biostatistics resources, CRO engagement, and clinical site relations. I have overseen large, multi-center studies to support regulatory requirements, directed the publication of results, and helped design and engage with regulators on the conduct of medical device RWE, premarket, and post-market research.
Clinical research sponsors will realize more efficient conduct of their clinical research, excellent compliance, positive regulatory engagement, and successful achievement of clinical-regulatory goals.
regulatory affairs
With specific expertise in medical device regulation, I provide regulatory affairs consulting services to the medical products industry. My particular areas of specialty are clinical-regulatory requirements and compliance, pre-market strategy development, submission support, CAPA, quality systems compliance, quality document preparation and remediation, recalls, post-market surveillance, analysis of complaint data and trending, and both written communication and direct engagement with regulatory authorities. I have direct experience with U.S. FDA, EU MDR, and Australia medical device regulations and requirements.
Medical product sponsors will realize more successful and efficient pre- and post-market regulatory activities, positive interactions with regulators, and greater regulatory compliance when they rely on my exceptional communication skills and in-depth knowledge of medical device regulations.
Policy advocacy
Patient advocacy groups, industry organizations, and the medical technology industry are increasingly focused on patient-centered policy development. My policy work is focused on the need to augment the patient’s voice in FDA regulatory decision-making. By participating on public-private and industry policy working groups, I have made significant contributions to patient engagement policy development and advocacy, including providing written comments on proposed regulatory policy, and development of patient-centric legislation. I am passionate about the development of rational regulatory policy that benefits patients by enabling the life sciences industry to incorporate patient input in a cost-effective and meaningful way while maintaining least burdensome principles of regulatory requirements.
Industry sponsors, patient advocacy groups, and public-private organizations will benefit from my passionate focus and deep knowledge of patient-centered regulatory policy.