Evergreen Strategic Consulting
Evergreen Strategic Consulting, led by Dr. Carrie M. Kuehn, specializes in patient-centric regulatory affairs, clinical evidence, patient engagement, and policy advocacy for the medical device industry. With over 25 years of experience, the company aims to improve patient lives by providing expert consulting services that address complex regulatory, clinical, and policy challenges across therapeutic areas. The firm emphasizes integrity, accountability, efficiency, and authenticity in its practice, and promotes patient involvement throughout the entire medical product life-cycle through innovative concepts like Patient by Design. It also actively participates in policy development, advocacy, and educational initiatives to ensure the patient voice is integrated into regulatory decision-making and product development.
Industries
Nr. of Employees
small (1-50)
Evergreen Strategic Consulting
Snohomish, Washington, United States, North America
Products
Patient-centered policy infographic
Infographic summarizing patient-centered policy concepts and guidance intended to support stakeholder discussions and planning.
Patient by Design
A comprehensive strategic consulting framework integrating patient input and experience across all phases of the medical product life-cycle, including development, clinical trials, regulatory submissions, and post-market surveillance.
Patient-centered policy infographic
Infographic summarizing patient-centered policy concepts and guidance intended to support stakeholder discussions and planning.
Patient by Design
A comprehensive strategic consulting framework integrating patient input and experience across all phases of the medical product life-cycle, including development, clinical trials, regulatory submissions, and post-market surveillance.
Services
Advisory and hands-on support for regulatory strategy, pre-market pathway selection, regulatory submissions, regulator engagement, and regulatory intelligence for medical products.
Design and execution support for clinical trials, observational studies, RWE projects, clinical operations oversight, CRO engagement, protocol development, and publication strategy.
Design and conduct of patient engagement activities and patient preference studies including interviews, focus groups, surveys, recruitment strategies, and analysis to inform development and regulatory decisions.
Policy review, position development, submission of written comments on regulatory proposals, stakeholder coordination, and participation in public-private policy working groups to advance patient-centric regulatory policy.
Advisory on integrating patient input across the full product lifecycle, including design input, clinical trial design, regulatory strategy, and post-market surveillance.
Advisory and hands-on support for regulatory strategy, pre-market pathway selection, regulatory submissions, regulator engagement, and regulatory intelligence for medical products.
Design and execution support for clinical trials, observational studies, RWE projects, clinical operations oversight, CRO engagement, protocol development, and publication strategy.
Design and conduct of patient engagement activities and patient preference studies including interviews, focus groups, surveys, recruitment strategies, and analysis to inform development and regulatory decisions.
Policy review, position development, submission of written comments on regulatory proposals, stakeholder coordination, and participation in public-private policy working groups to advance patient-centric regulatory policy.
Advisory on integrating patient input across the full product lifecycle, including design input, clinical trial design, regulatory strategy, and post-market surveillance.
Expertise Areas
- Medical device regulatory strategy
- Clinical trial design and management (medical devices)
- Real-world evidence (RWE) and observational research
- Patient preference and patient engagement research
Key Technologies
- Real-world data / Real-world evidence (RWD/RWE)
- Observational study methodologies (prospective and retrospective cohorts, case-control)
- Clinical trial design for medical devices (EFS, IDE, pivotal)
- Patient preference research methodologies (qualitative interviews, focus groups, surveys, discrete-choice approaches)
News & Updates
Certified as a LGBT Business Enterprise (LGBTBE) by the NGLCC.
Certified as a LGBT Business Enterprise (LGBTBE) by the NGLCC.