Digital Health Consulting
With a unique background as both an Ivy League treatment research professor and a C-suite executive in digital health, I offer specialized consulting services to companies seeking expert guidance in evidence generation / research strategy, clinical product development, clinical operations, and regulatory readiness.
Whether you're launching a new digital therapeutic, preparing for FDA submission, building a robust evidence base for your product, or are going to market in clinical settings or with clinical / coaching staff, I bring deep experience at the intersection of science, product, clinical operations, and regulatory strategy.
Product Development
Background research in therapeutic area / identification of treatment elements and mechanisms of action for inclusion in a new digital therapeutic
Clinical content generation and/or oversight
Improved collaboration with product, design, engineering, and clinical teams to assure alignment andexpedite execution of engaging and effective products
Design, execution, and analysis of UX research at all stages of product development
Evidence Generation
Design of multi-phase evidence generation plan
Phase 1-3 clinical trial design and/or execution
RWE data collection strategy
Partnership with university-based researchers
CRO selection and oversight
Regulatory Processes
Drafting of FDA pre-submission documents and responses to feedback
Consultation on FDA pathways (e.g., 510k or de novo)
Preparation for meetings with FDA
Clinical Operations
Training, supervision, and/or oversight of behavioral health providers or health and wellness coaches
Provider workflow analysis and implementation planning for digital health products sold to or to be prescribed (or ordered) by healthcare providers
Scientific Writing
Dissemination of evidence and/ or clinical background information in alignment with marketing strategies
Drafting of white papers, blogs, social media posts
Scientific manuscript preparation
Securing Funding
Guidance and/or drafting of grant applications including applications for NIH SBIR, Wellcome Trust and others.
Clinical review of investor meeting decks / clinical voice for investor meetings