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Hire Kimberly K.

United States

15+ Years' Experienced Clinical Research & Medical Writing Consultant

Profile Summary

Clinical research and medical writing consultant with over 15 years’ experience supporting medical device and biologics companies across their full product lifecycle. I have contributed to the development of clinical and regulatory documentation ranging from clinical study protocols, clinical study reports (CSRs), EU MDR focused clinical deliverables (CEP, CER, PMCF and SSCPs), and manuscripts for submission to peer-reviewed journals. With a background in biomedical engineering and applied statistics, I bring a structured, data-driven approach to clinical evidence and strategy helping teams navigate complex regulatory requirements with clear, quantitative and defensible documentation. I support companies through both project-based work and ongoing advisory engagements.

Subject Matter Expertise

• ☆ Biostatistics
• ☆ Data Analysis
• ☆ Big Data Analytics
• ☆ Statistics
• ☆ Applied Statistics
• ☆ R
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 14971
• ☆ Clinical Trials
• ☆ Clinical Trial Design
• ☆ Clinical Trials Data Analysis
• ☆ Regulatory Affairs

Services

• Writing
• Research
• Consulting
• Data & AI

Writing Clinical Trial Documentation, Medical Writing, Technical Writing

Research Scientific and Technical Research, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis, Data Visualization, Data Cleaning

Work Experience

Owner and Consultant

KC Clinical Consulting, LLC

April 2026 - Present

Senior Staff Medical Writer

Stryker

February 2022 - August 2025

Director Project Management

MiMedx Group, Inc.

February 2015 - February 2022

Clinical Research Associate

Integra LifeSciences

September 2011 - February 2015

Education

Master's Applied Statistics

Penn State World Campus

January 2020 - August 2022

Bachelor of Science, Biomedical Engineering

University of Texas at Austin

August 2003 - May 2008

Certifications

• Graduate Certificate, Applied Statistics

  Penn State World Campus

  May 2018 - Present

Publications

JOURNAL ARTICLE

Tettelbach W, Tucker T, Kot K (2025). Real-world outcomes of a placenta-based tissue product versus standard of care for lower extremity diabetic ulcers: a Medicare cohort study . Journal of wound care.

Kimberly Kot, William H Tettelbach, Travis Tucker (2025). Comparative outcomes of a placenta-based tissue product to other LCD covered cellular and matrix-based products for the treatment of lower extremity diabetic ulcers: A Medicare real world evidence study . International Journal of Tissue Repair.

Spector JE, Hubbs B, Kot K, Istwan N, Mason D (2021). Micronized Dehydrated Human Amnion/Chorion Membrane Injection in the Treatment of Chronic Achilles Tendinitis . Journal of the American Podiatric Medical Association.

Alden KJ, Harris S, Hubbs B, Kot K, Istwan NB, Mason D (2019). Micronized Dehydrated Human Amnion Chorion Membrane Injection in the Treatment of Knee Osteoarthritis-A Large Retrospective Case Series . The journal of knee surgery.

Bianchi C, Tettelbach W, Istwan N, Hubbs B, Kot K, Harris S, Fetterolf D (2019). Variations in study outcomes relative to intention-to-treat and per-protocol data analysis techniques in the evaluation of efficacy for treatment of venous leg ulcers with dehydrated human amnion/chorion membrane allograft . International wound journal.