INTERNSHIP PROJECT: FDA Regulatory Compliance & Market Entry Strategy for Health Technology Devices
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No skills listed📋 PROJECT OVERVIEW
Project Title: "Regulatory Pathway Development for Health Technology Market Entry"
Duration: 12-16 weeks (flexible semester scheduling)
Format: Remote with structured mentorship and real-world application
Industry Focus: Health Technology, Regulatory Affairs, Digital Marketing for Healthcare
🎯 LEARNING OBJECTIVES & MCPHS MISSION ALIGNMENT
Real-World Application:
- Navigate actual FDA regulatory requirements for health technology devices
- Develop market entry strategies for FDA/Health Canada-approved products
- Create compliance documentation for health tech marketing campaigns
Career Preparation:
- Hands-on experience with regulatory submission processes
- Professional mentorship in healthcare business development
- Portfolio development for regulatory affairs careers
Interprofessional Collaboration:
- Work with marketing, business development, and regulatory teams
- Cross-functional project management experience
- Healthcare industry networking opportunities
💼 PROJECT SCOPE: ClearAirDevice.ca Case Study
Company Background:
ClearAirDevice.ca - a Canadian health technology company specializing in:
- FDA and Health Canada approved cleantech sanitization devices
- Ozone-based air purification technology (99.99% sanitization efficacy)
- Chemical-free, sustainable health solutions for families and healthcare settings
Student Challenge:
Develop comprehensive regulatory compliance and market entry strategy for expanding into US healthcare markets.
📚 CORE PROJECT COMPONENTS
Phase 1: Regulatory Framework Analysis (Weeks 1-4)
Deliverables:
- FDA device classification analysis for ozone sanitization technology
- Regulatory pathway mapping (510(k) vs. PMA requirements)
- Comparative analysis: FDA vs. Health Canada approval processes
- Compliance gap analysis and recommendations
Learning Outcomes:
- Master FDA device classification systems
- Understand international regulatory harmonization
- Develop a regulatory strategy, thinking
Phase 2: Clinical Evidence & Documentation (Weeks 5-8)
Deliverables:
- Clinical evidence review for 99.99% efficacy claims
- Draft regulatory submission documents (IND/510(k) components)
- Risk assessment and mitigation strategies
- Post-market surveillance planning
Learning Outcomes:
- Apply clinical development knowledge
- Practice regulatory writing skills
- Understand evidence-based marketing compliance
Phase 3: Market Entry Strategy (Weeks 9-12)
Deliverables:
- Healthcare market segmentation analysis
- Regulatory-compliant marketing strategy
- Distribution channel recommendations
- Competitive landscape assessment
Learning Outcomes:
- Integrate regulatory knowledge with business strategy
- Develop healthcare marketing expertise
- Practice strategic thinking and presentation skills
Phase 4: Implementation & Presentation (Weeks 13-16)
Deliverables:
- Final regulatory strategy presentation
- Implementation timeline and budget
- Risk mitigation protocols
- Professional portfolio piece
Learning Outcomes:
- Executive-level presentation skills
- Project management experience
- Professional network development
📊 ASSESSMENT & OUTCOMES
Evaluation Criteria:
- Technical Competency (40%): Regulatory knowledge application
- Strategic Thinking (30%): Business development insights
- Professional Skills (20%): Communication and presentation
- Innovation (10%): Creative problem-solving approaches
Career Outcomes:
- Portfolio Development: Professional case study for regulatory affairs roles
- Industry Connections: Healthcare business development network
- Skill Certification: Digital marketing for healthcare compliance
🌟 UNIQUE VALUE PROPOSITION
For MCPHS Students:
- Real FDA regulatory experience with actual health technology products
- Mentorship from experienced healthcare business development professionals
- Portfolio piece demonstrating regulatory and business acumen
- Potential pathway to continued employment in the growing digital health sector
For ClearAir Device Ltd:
- Access to top-tier regulatory affairs talent
- Fresh perspectives on FDA compliance strategies
- Support for the health technology market expansion
- Pipeline for future regulatory affairs team members
About the company
In light of current environmental challenges, numerous studies have revealed alarming levels of contaminants in our soil, food, and water, posing significant threats to our health. Motivated by this, our journey to reduce toxic loads and promote sustainability took root.
While scientific and clinical documents highlight over 100 benefits and uses for ozone technology, the existing machines are often expensive, bulky, and primarily tailored for agricultural, industrial, and clinical settings. This limitation left us feeling both frustrated and concerned.
The pivotal question arose: "How can we effectively eliminate contaminants and toxic loads from our daily essentials, such as food and water?" The answer emerged in the form of Aqueous Ozone – a safe, daily-use ozone water solution that can be applied in occupied spaces. Not only does it showcase remarkable efficiency in water and food sanitization, but medical and FDA reviews have also underscored its effectiveness in eradicating and controlling SARV-CV19.
In response to this need for accessible and sustainable solutions, ClearAir Device was established in October 2021. Our primary goal is to empower everyday individuals to harness the cost-saving benefits of ozone purification (O3) as a powerful tool to combat contamination in their health and living spaces. Join us on our journey towards a healthier, more sustainable future. Company is rebranding to CLEANDEVICES.CA
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