MEDICAL DEVICE PRODUCT MANAGEMENT

Get oriented to the course, meet your instructor, and understand how the program will guide you through the full lifecycle of a medical device product. You will also explore how MedTech fits into the broader healthcare ecosystem.

• Meet your instructor
• Course structure 
• Assignments & final project overview
• Med device trends

Build a foundational understanding of the medical device product management role within the broader MedTech ecosystem. Examine how product managers balance upstream strategy with downstream commercialization while coordinating with regulatory, clinical, and engineering teams throughout the product lifecycle.

• Introduction to product management 
• Medical device definition
• Medical device PM
• Core responsibilities & stakeholders
• The medical device product lifecycle

Learn how successful medical device products begin with identifying meaningful clinical and market gaps. Explore research methods used to uncover unmet needs, translate insights into user personas, and evaluate competitive landscapes using structured analytical tools.

• Market research, VoC, & competitive analysis
• Case Study: Next Generation product launch

Assignment #1: Product Concept
Define the initial product concept and its value proposition.

Learn how to articulate a compelling vision statement, build a strong value proposition, and develop a business case that considers intellectual property viability, technical feasibility, and organizational resources.

• Translating user needs into product strategy
• Intellectual property & technology assessment
• Case Study: Product vision of a successful medical device

Explore how product managers translate strategic goals into detailed product requirements that guide engineering and design teams. Practice structuring a comprehensive PRD that clearly defines functionality, user stories, and acceptance criteria.

• Writing a clear PRD
• Workshop: PRD writing for the mock product

Navigate the regulatory landscape that governs medical device development and commercialization. Compare major regulatory pathways and learn how clinical evidence requirements shape product timelines, documentation, and market entry strategies.

• Regulatory frameworks & their impact 
• Regulatory team & PMO
• Regulatory pathways
• Role of clinical evidence
• Case Studies: The regulatory journey of a medical device in Health Canada & FDA markets

Assignment #2: Regulatory Path
Create a brief overview of a medical device regulatory pathway.

Understand how clinical strategy supports regulatory approval and product credibility. Examine how clinical trials are structured, how endpoints are defined, and how clinical evidence integrates into regulatory submissions.

• Design of a clinical study
• Integrating clinical strategy 
• Clinical trial phases
• Key clinical endpoints
• Submission to regulatory bodies

Develop the analytical tools required to identify, assess, and mitigate risk in medical device development. Explore formal risk analysis frameworks and the product manager’s role in coordinating mitigation strategies across engineering, quality, and regulatory teams.

• Risk management
• Risk analysis
• Core medical device risks
• Product Manager's role as a risk owner
• Workshop: Risk analysis

Explore the regulatory and scientific principles that ensure medical devices are safe, effective, and user-friendly. Learn how usability engineering and human factors research guide design decisions, compliance processes, and formal design reviews.

• Design controls: Compliance roadmap
• Working with RA for compliance
• Usability engineering & Human factors
• Working with R&D for UE/HF and safety
• Design review
• Workshop: Risk mitigation

Assignment #3: Usability & Risk Analysis
Write a usability & risk analysis report.

Learn how to transition from product development to successful commercialization. Examine how product managers structure go-to-market strategies, define target segments, and coordinate marketing, sales, and service teams during launch planning.

• Go-to-market strategy
• Tactical launch planning

Explore how pricing strategy and reimbursement models shape the commercial success of medical devices. Analyze the economic evidence required to support product adoption and learn how reimbursement frameworks influence pricing decisions.

• Pricing models & product profitability
• Global market access & health economics
• Reimbursement & CPT codes
• Physician fee schedule
• Workshop: Pricing strategy for the mock product

Assignment #4: Commercial Strategy
Define a commercial strategy & financials for your product.

Understand how marketing and sales teams translate product value into market demand. Examine how product managers support commercialization by developing messaging strategies, competitive positioning, and practical tools for field sales teams.

• Product messaging & content strategy
• Marketing & communication
• Sales team: Tools & training materials

Explore how product management continues after launch through monitoring performance, managing compliance, and guiding product improvements. Learn how complaint handling, CAPA processes, and regulatory documentation support safe and effective lifecycle management.

• Managing a product after launch
• Lifecycle management
• Performance monitoring & continuous improvement
• Customer complaints & CAPA
• Post surveillance & documentation retention 
• Case Study: Responding to a post-market issue or a product recall

Assignment #5: Final Project: Medical Device Concept Pitch Deck
Develop a comprehensive product launch proposal that demonstrates your ability to manage a medical device from concept to commercialization.

Examine the leadership skills required to succeed as a product manager in a complex regulatory environment. Develop strategies for influencing stakeholders, resolving cross-functional conflicts, and aligning teams around a shared product vision.

• The PM as a visionary & communicator
• Leading without authority
• Cross-functional conflicts & trade-offs
• Effective stakeholder management

Present a comprehensive product launch strategy developed throughout the course. Practice communicating your product vision, regulatory approach, and commercialization plan while receiving professional feedback from peers and instructors.

• Final presentations
• Peer & instructor feedback

Explore how emerging technologies and healthcare trends are reshaping the MedTech landscape. Develop a professional narrative and portfolio that demonstrates your expertise in medical device product management and prepares you for future career opportunities.

• The future of product management
• Career guidance & portfolio guidelines 
• Interview preparation
• Next steps & PM community