Lisa Damhof
Associate Attorney
O: 651.430.7150
M: 651.300.2912
Lisa Damhof advises medtech, pharma, biotech, and life sciences companies on regulatory, compliance, and commercial contracting matters across the product life cycle. She works with clients navigating clinical development, commercialization, and ongoing operations, with a focus on structuring agreements and business practices that align with FDA requirements and healthcare fraud and abuse laws. Clients rely on her to translate complex regulatory and compliance frameworks into practical, business-oriented solutions that support growth while managing risk.
Lisa’s perspective is shaped by her in-house experience at Coloplast, where she worked closely with commercial, legal, and compliance teams in a global medical device environment. That experience informs her understanding of how legal guidance is operationalized within organizations, including the realities of sales, marketing, and market access functions. She brings that practical lens to her work with clients, focusing on solutions that are implementable within real-world business structures.
She regularly partners with executives, in-house counsel, and cross-functional teams, including commercial, marketing, clinical, and product stakeholders. Lisa is known for providing clear, actionable guidance that supports decision-making without slowing down business momentum. She focuses on aligning legal strategy with business objectives, helping teams anticipate risk while maintaining flexibility.
Lisa’s work includes drafting and negotiating a wide range of agreements, including clinical trial agreements, commercial sales and distribution agreements, SaaS and digital health agreements, and supplier agreements. She also advises on advertising and promotional practices, including review of marketing materials and related compliance considerations, as well as broader healthcare compliance issues that arise in commercialization and pricing strategies.
Her practice reflects a combination of regulatory, compliance, and transactional experience, allowing her to support clients across disciplines. Lisa brings a pragmatic approach to complex issues, grounded in both legal analysis and operational insight.
Focus Areas
- Clinical and commercial contracting for medtech, biotech, and pharma companies
- Advertising and promotional review and compliance counseling
- Healthcare compliance, including Anti-Kickback Statute considerations
- Regulatory and compliance support across the product life cycle
- Data privacy considerations in clinical and commercial operations
- Structuring and negotiating commercial sales, distribution, and supplier agreements
Representative Experience
- Drafts and negotiates clinical trial agreements, and commercial sales, distribution, and supplier agreements for medical device, pharma, and digital health companies
- Advises on advertising and promotional materials, including compliance with FDA and healthcare fraud and abuse requirements
- Counsels cross-functional teams on regulatory and compliance considerations in commercial and marketing activities
- Supports clinical-stage and commercial companies in structuring contracting frameworks aligned with product development and commercialization strategies
- Assists with transactional matters, including due diligence and contract review in regulated industry transactions
Differentiators
- Former in-house counsel at Coloplast, with direct experience supporting commercial and compliance functions within a global medical device company
- Deep experience in commercial contracting across clinical, digital health, and product sales and distribution contexts
- Practical, business-oriented approach informed by working within operational teams
- Ability to bridge regulatory, compliance, and transactional considerations in a single advisory framework
Thought Leadership, Teaching, & Ventures
- Contributes to client advisories and internal training on regulatory and compliance topics affecting medical device, pharma, and digital health companies
- Participates in discussions and presentations on healthcare compliance and contracting considerations
Education
- J.D., Law, Mitchell Hamline School of Law
- B.S., Paralegal, Minnesota State University Moorhead
Admissions & Affiliations
- Minnesota
- Member, Minnesota State Bar Association - Food, Drug and Device Law Section
- Minnesota State Bar Association - Health Law Section
Personal
Lisa lives in Minnesota. She enjoys spending time with her family and friends, hiking, playing piano, and making the most of Minnesota summers on the lake.
Articles, Presentations & Press
- OIG Reaffirms: Fair Market Value Alone Does Not Eliminate Anti-Kickback Statute Risk
- OIG Advisory Opinion 26‑10 Signals Scrutiny of Royalty‑Based HCP Consulting Arrangements
- OIG Advisory Opinion 25-11: Key Compliance Insights for Manufacturers
- Event Recap: Negotiating Medical Device, Pharmaceutical, and Biotechnology Product Sales Contracts
- Sunshine Reporting Season Has Begun: Are You Meeting the Requirements?
- Clarity in Complexity: The Benefits of a Business Stance Playbook