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Amanda Johnston
Partner

ajohnston@gardner.law
O: 651.364.7484
M: 763.639.6951

Amanda Johnston advises companies across the medtech, biotech, and pharma industries on FDA regulatory strategy and healthcare compliance. Clients turn to her for practical guidance on complex issues involving product commercialization, reimbursement support, interactions with healthcare professionals, compliance investigations, and risk management under federal and state fraud and abuse laws. She focuses on helping companies build compliant, scalable programs that align with business objectives while withstanding regulatory scrutiny.

Amanda’s practice is shaped by her experience working closely with commercial, market access, medical affairs, and regulatory teams. She understands how legal and compliance considerations intersect with real-world business pressures, including product launches, reimbursement challenges, and growth strategies. This perspective allows her to translate regulatory requirements into actionable frameworks that business teams can implement.

She works as an embedded advisor to in-house counsel and executive leadership, often serving in an outsourced compliance leadership role. Amanda helps clients design and operationalize compliance programs, assess risk across business activities, and develop policies, training, and controls that are tailored to their products and organizational structure.

Her work spans a range of matters, including structuring reimbursement support programs, evaluating arrangements with healthcare professionals, advising on promotional and educational activities, supporting DMEPOS compliance, and guiding internal reviews and compliance investigations. She is frequently engaged to assess high-risk or novel business models and provide clear, defensible paths forward.

Amanda is particularly focused on the intersection of FDA regulatory requirements and fraud and abuse risk, including areas where reimbursement, distribution, and patient support activities create heightened scrutiny. She brings a practical, solutions-oriented approach to helping clients move forward with confidence.

Focus Areas

  • FDA regulatory strategy for medtech, biotech, and pharma products, including devices, diagnostics, and digital health technologies
  • Healthcare compliance, including Anti-Kickback Statute, False Claims Act, and related state laws
  • Compliance investigations and internal reviews
  • DMEPOS compliance and reimbursement-related risk management
  • Reimbursement support programs, including prior authorization and patient support services
  • Interactions with healthcare professionals, including consulting, speaker programs, and training
  • Promotional and educational activities, including reimbursement communications
  • Compliance program design, implementation, and auditing

Representative Experience

  • Advises medtech, biotech, and pharma companies on structuring reimbursement support programs to mitigate fraud and abuse risk while supporting patient access
  • Leads and supports compliance investigations and internal reviews related to reimbursement practices, HCP interactions, and commercial activities
  • Develops and implements compliance programs, including policies, procedures, and training for commercial and market access teams
  • Evaluates consulting, speaker, and other financial arrangements with healthcare professionals for compliance with applicable laws and industry codes
  • Provides regulatory and compliance guidance for product launches, including promotional and reimbursement-related considerations
  • Conducts risk assessments and compliance audits aligned with industry standards and enforcement trends
  • Serves as outsourced Compliance Officer for companies across the medtech, biotech, and pharma industries, supporting ongoing compliance operations and governance
  • Advises on DMEPOS compliance obligations, including billing, reimbursement support, and distribution models

Differentiators

  • Prior in-house experience across the healthcare ecosystem, including Medicare operations compliance at UnitedHealth Care, regulatory at Medtronic, and compliance at Coloplast 
  • Deep integration with client business teams, providing guidance that aligns with commercial and operational realities
  • Experience advising on the intersection of FDA regulatory requirements and fraud and abuse risk, including reimbursement and DMEPOS-related considerations 
  • Regularly serves in embedded or outsourced compliance leadership roles 
  • Experience leading compliance investigations and translating findings into actionable remediation strategies

Education

  • J.D., University of Minnesota Law School—Concentration in Health Law & Bioethics
  • B.A., Criminology, University of Minnesota Duluth

Thought Leadership, Teaching, & Ventures

  • Adjunct Professor of Law, Mitchell Hamline School of Law - Drug and Device Law
  • Speaker at medtech and healthcare compliance conferences on topics including reimbursement support, FDA regulatory strategy, fraud and abuse risk, and compliance investigations
  • Develops and delivers compliance training programs for companies across the medtech, biotech, and pharma industries
  • Regularly advises clients on emerging enforcement trends and regulatory developments

Admissions & Affiliations

  • Minnesota
  • Former Council Member, Minnesota State Bar Association - Food, Drug and Device Law Section
  • Member, Minnesota State Bar Association - Health Law Section

Honors & Awards

  • 2024 Super Lawyer
  • 2023 Rising Star, Super Lawyers
  • 2023 Women in Business Honoree, Minneapolis-St. Paul Business Journal
  • Star of Excellence, Medtronic

Personal

Amanda lives in northern Minnesota with her husband and two sons. Outside of her practice, she enjoys lake life, fishing, and traveling, along with spending time with family and friends and cheering on her boys at their sporting events, especially hockey.