Patient-Centric Regulatory Affairs & Policy
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Carrie M. Kuehn, MA, MPH, LPD, RAC

Regulatory Consulting Services

 

Consulting for the medical products 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 FDA regulatory affairs, patient engagement, and advocacy for patient-centric healthcare policy. Dr. Kuehn has over 20 years experience in research epidemiology, statistical analysis, FDA regulatory affairs and policy advocacy. With a diverse and adaptable skill set, Dr. Kuehn applies her strong, patient-focused work ethic to address a variety of client issues. Please review the service areas to determine if Dr. Kuehn can support your needs.

Introducing Patient x Design, a concept by which patient input is necessary across all phases of the medical product life-cycle. Learn more here…

 
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Dr. Carrie M. Kuehn, Principal Consultant

Dr. Carrie M. Kuehn, Principal Consultant

Contact

➤ LOCATION

Snohomish, WA

Elkridge, MD

☎ (425) 241-6510

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. My patient engagement work is focused on how best to use patient experience data to influence regulatory policy and 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.

Medical product sponsors and patient advocacy groups will benefit from my unique training and experience in observational research, patient engagement, and patient-focused regulatory policy.


FDA regulatory affairs

With specific expertise in medical device regulation, I provide FDA regulatory affairs consulting services to the medical products industry. My particular areas of specialty are compliance, CAPA, quality systems, post-market surveillance, analysis of complaint data and trending, pre-market strategy development, FDA submission support, and both written communication and direct engagement with FDA.

Medical product sponsors will realize more successful and efficient interactions with FDA when they rely on my exceptional communication skills and in-depth knowledge of FDA 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.

Industry sponsors, patient advocacy groups, and public-private organizations will benefit from my deep knowledge ad expertise in patient-centered regulatory policy.


Litigation support

Medical device litigation can be complex and require review of large volumes of historical documentation. I have extensive experience supporting discovery and case strategy for medical device-related litigation with a focus on FDA required medical product documentation. My litigation support work has included both consulting and testifying expertise in state and federal court as a FDA regulatory expert. Prior case work has included tort, insurance, and fiduciary duty cases.

Medical device industry counsel will achieve a thorough understanding of their client’s regulatory compliance situation, and experience a more efficient discovery process and clearer context within which to develop a defense strategy.