LIVE ONLINE COURSE

MEDICAL DEVICE PRODUCT MANAGEMENT

Dates: 16 JUN 2026 - 4 AUG 2026

Duration: 8 WEEKS
TUESDAYS & THURSDAYS
5 PM PT / 8 PM ET

APPLY

TROY STEARNS
ABBOTT

LIVE ONLINE COURSE

Healthcare innovation meets product strategy. Learn how medical devices move from concept to clinic — and how product managers make it happen.

Build the roadmap behind life-saving technology under the guidance of Troy Stearns, who’s leading global product strategy in one of the world’s top healthcare companies.

THIS COURSE IS FOR YOU, IF...

YOU ARE A HEALTHCARE PROFESSIONAL MOVING INTO MEDTECH

You understand clinical workflows and patient needs — but turning those insights into real medical devices requires a new toolkit. We’ll show you how clinical problems become product opportunities, guiding you through device development, regulatory approval, and launch.
YOU ARE A PRODUCT MANAGER FROM TECH OR ANOTHER INDUSTRY

You know agile, roadmaps, and product frameworks, but MedTech plays by different rules. This course helps you adapt your product mindset to regulated environments, understand frameworks, and learn how PMs coordinate engineering, clinical, regulatory, and commercial teams in medical device development.
YOU ARE A MEDTECH ENGINEER OR TECHNICAL SPECIALIST MOVING INTO PRODUCT

Engineers often drive execution but rarely define the vision. You build the technology — now learn how to shape the product. This is medical device risk management training in action — and it helps you translate technical capabilities into real product value and working across multi-functional teams to guide products from concept to market.
YOU WORK IN COMMERCIAL, REGULATORY, OR CONSULTING ROLES IN HEALTHCARE

You see customer needs and innovation opportunities every day — but influencing product direction isn’t always part of the job. Learn how pricing, positioning, regulatory planning, and clinical evidence shape the medical device roadmap — and gain the frameworks needed to step into more strategic product leadership roles.

REAL-WORLD PRODUCT LIFECYCLE

This course walks you through the real work of a Global PM. You’ll tackle five practical assignments that mirror the industry process: defining a product concept, mapping regulatory pathways, conducting usability and risk analysis, shaping commercial strategy, and pitching a full product launch.

CASE STUDIES & WORKSHOPS

Learn through scenarios drawn from the medical device industry. Case studies explore next-generation launches, product vision analysis, regulatory journeys through FDA and Health Canada. Hands-on workshops guide you through writing a PRD, running risk analysis, and developing pricing strategies.

FINAL PROJECT

Your final project is a mock medical device launch pitch deck — the kind of work product managers present in real companies. You’ll define the brief, outline the regulatory pathway, and develop a marketing and launch plan, turning your concept into a clear, portfolio-ready product strategy.

TROY STEARNS LINKEDIN PROFILE

Leads global product strategy for infectious disease diagnostics at Abbott, one of the world’s leading medical device and healthcare companies.
Drives product leadership across major medtech brands, including Abbott, Healgen Scientific, and Thermo Fisher Scientific.
Built and scaled the Molecular Diagnostics business unit at Healgen Scientific, helping expand a fast-growing diagnostics segment.
Navigates complex regulatory landscapes, leading initiatives aligned with IVDR and global compliance standards.
Oversees the full product lifecycle — from portfolio strategy to commercialization and global launch execution.
Combines deep expertise in medical devices, molecular diagnostics, and global product management.

THU (6/11), 5 PM PT/8 PM ET

Welcome Class

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

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TUE (6/16), 5 PM PT/8 PM ET

Introduction to the Medical Device PM

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

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THU (6/18), 5 PM PT/8 PM ET

Uncovering Unmet Needs

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.

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TUE (6/23), 5 PM PT/8 PM ET

Defining the Product Vision

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

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THU (6/25), 5 PM PT/8 PM ET

Product Requirements Document (PRD)

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

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TUE (6/30), 5 PM PT/8 PM ET

Regulatory Strategy & Pathways

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.

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THU (7/2), 5 PM PT/8 PM ET

Clinical Development & Regulatory Affairs

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

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TUE (7/7), 5 PM PT/8 PM ET

Strategic Risk Management & Decision-Making

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

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THU (7/9), 5 PM PT/8 PM ET

Design Controls, Usability Engineering & Human Factors + Guest Speaker

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.

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TUE (7/14), 5 PM PT/8 PM ET

Go-to-Market Strategy & Tactical Launch Planning

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

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THU (7/16), 5 PM PT/8 PM ET

Pricing, Profitability, & Reimbursement

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.

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TUE (7/21), 5 PM PT/8 PM ET

Sales & Marketing: Driving Commercial Success + Guest Speaker

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

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THU (7/23), 5 PM PT/8 PM ET

Post-Market Surveillance & Lifecycle Management

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.

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TUE (7/28), 5 PM PT/8 PM ET

Product Manager as a Leader & Cross-Functional Collaborator

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

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TUE (8/4), 5 PM PT/8 PM ET

Future-Ready Product Manager: Trends, Career & Next Steps

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.