Course Description
Design and development of digital health solutions including mobile health apps, wearables, telehealth platforms, and AI-powered diagnostics. Covers the full product lifecycle from ideation through FDA clearance, launch, and scaling. Students work in teams to develop digital health prototypes addressing real clinical problems.
Credit Hours
3 credits (3 lecture/lab)
Prerequisites
ENT 601 or instructor permission
Student Learning Outcomes
- Apply human-centered design principles to digital health product development
- Navigate FDA regulatory pathways for digital health products (SaMD, SiMD)
- Develop product requirements and technical specifications
- Design clinical validation studies for digital health solutions
- Create go-to-market strategies for digital health products
- Evaluate emerging technologies (AI/ML, blockchain, IoT) for healthcare applications
Course Topics
- Digital Health Landscape: Market Trends, Success Factors
- Human-Centered Design for Healthcare
- Product Development: Agile, MVP, User Testing
- FDA Digital Health Regulations: SaMD Framework, Pre-Cert
- Clinical Evidence Generation: RWE, Pragmatic Trials
- Interoperability: FHIR, HL7, API Design
- Reimbursement for Digital Health: CPT Codes, DTx Pathways
- Cybersecurity and HIPAA Compliance
Deliverables
- Digital Health Product Proposal (15%)
- Prototype Development (25%)
- Regulatory Strategy Document (15%)
- Clinical Validation Plan (15%)
- Final Pitch and Demo (30%)
Required Textbooks
- Steinhubl & Topol: Digital Medicine
- FDA Digital Health Guidance Documents (provided)