LIVE ONLINE COURSE

💡 MedTech Product Strategy & PRDs

⚙️ Usability & Risk Management

🏛️ Regulatory & Clinical Pathways

🚀 Go-to-Market & Product Launch

MEDICAL DEVICE PRODUCT MANAGEMENT

Dates: 25 JUN 2026 - 18 AUG 2026

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

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NIVEDITHA ARUMUGAM
DEXCOM

LIVE ONLINE COURSE

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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 Niveditha Arumugam, who’s leading 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 mirrors how MedTech products are actually built, validated, and launched in the real world. You’ll progress through a structured set of assignments that take you from unmet clinical need all the way to commercialization — building a complete, portfolio-ready product strategy along the way.

CASE STUDIES & WORKSHOPS

Learn through real MedTech scenarios drawn from successful and failed medical device innovations. Each case study breaks down how products move from clinical insight to commercial reality, while workshops give you hands-on practice with industry-grade tools and frameworks.

FINAL PROJECT

Your final deliverable is a professional-grade MedTech product strategy deck — built incrementally throughout the course using your assignments. Instead of a theoretical paper, you’ll assemble a real executive artifact that reflects how product teams operate in the industry.

Niveditha Arumugam LINKEDIN PROFILE

Leads next-generation biosensing and digital biomarker innovation as Head of Product for New Analytes Sensing & Insights Products at Dexcom, defining the company’s future growth opportunities in digital health.
Scaled a $1B digital healthcare platform as Vice President of Product at Becton Dickinson (BD), driving innovation in medication safety, workflow automation, and connected care solutions.
Pioneered emerging medical technologies at Google Life Sciences (Verily), leading the development of 12+ medical devices across remote patient monitoring, chronic disease management, and decentralized clinical trials.
Brings deep expertise in digital health, wearable technologies, clinical software, medical devices, and data-driven healthcare products, with a proven track record of bringing complex innovations to market.
Combines technical excellence with strategic product leadership, holding a Master's degree in Engineering from Stanford University and decades of experience building high-impact healthcare solutions.
Champions inclusive leadership and innovation-driven cultures, fostering diverse teams grounded in intellectual honesty, collaboration, and meaningful patient outcomes.

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

Introduction to the MedTech PM & Stanford Biodesign Framework

Learn what makes MedTech product management different from traditional product roles. Explore the Stanford Biodesign framework and discover how successful medical devices move from unmet need to market adoption.

MedTech product management fundamentals
Stanford Biodesign: Identify, Invent, Implement
What qualifies as a medical device
Upstream vs. downstream product management
Working across clinical, regulatory, & technical teams
Medical device lifecycle overview

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

Clinical Observation & Opportunity Identification

Learn how to uncover valuable product opportunities by observing real clinical environments. Identify unmet needs, workflow inefficiencies, and stakeholder pain points that can become the foundation for innovation.

Clinical observation & ethnographic research
Documenting raw clinical reality
Multi-stakeholder healthcare personas
Voice of Customer (VoC) research
Market research methodologies
Case Study: Clinical unmet need driven medical device

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

Need Screening & Market Sizing

Separate promising ideas from costly distractions. Learn how to validate opportunities, size markets, and transform clinical insights into compelling product strategies.

Building strong need statements
TAM, SAM, SOM fundamentals
Market sizing filters & strategy-infused screening matrix
Sizing & stakeholder persona maps
Product vision development
Case Study: Unmet clinical need & value proposition of a successful medical device

Assignment #1: Clinical Opportunity Assessment
Identify 10 unmet clinical needs, then validate and prioritize your top three opportunities with need statements and initial market sizing.

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

Concept Generation & Value Proposition Matrix

Turn validated needs into viable product concepts. Explore how clinical impact, technical feasibility, and commercial value intersect to create winning MedTech solutions.

MedTech brainstorming techniques
Hardware, software, and hybrid solutions
The MedTech value proposition matrix
User value vs. economic value
Development ROI assessment
Case Study: Deconstructing a business case

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

Product Architecture, Intellectual Property & FTO

Protect innovation before investing in development. Learn how to assess patent landscapes, establish freedom to operate, and design product architectures that create long-term competitive advantage.

MedTech intellectual property fundamentals
Freedom to Operate (FTO) assessments
Building defensible product strategies
Product architecture frameworks
Design for manufacturability & serviceability
Workshop: Patent & architecture tear-down

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

Design Controls & Product Requirements Workshop

Translate clinical needs into engineering-ready specifications. Learn how design controls transform product ideas into compliant, development-ready requirements.

Introduction to design controls
Writing engineering-ready design inputs
Functional vs. non-functional requirements
Workshop: Group PRD writing session

Assignment #2: Product Requirements Document
Develop a complete PRD for your selected product concept, including user needs, design inputs, and technical requirements.

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

Regulatory Strategy & Market Pathways

Navigate global regulatory pathways with confidence. Learn how regulatory strategy influences product timelines, market access, and competitive positioning from day one.

Global regulatory frameworks
FDA, MDR, and Health Canada pathways
510(k), De Novo, and PMA submissions
Strategic regulatory positioning

Assignment #3: Regulatory Pathway Briefing
Create a regulatory pathway brief outlining the optimal approval strategy for your mock product concept.

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TUE (7/20), 5 PM PT/8 PM ET

Clinical Evidence Strategy & Endpoint Design

Design evidence-generation strategies that satisfy regulators, payers, and healthcare providers alike. Learn how clinical trials become both approval and commercialization tools.

Clinical trial lifecycle overview
Early feasibility & pivotal studies
Safety & efficacy endpoints
HEOR integration
Designing commercially relevant studies

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

Global Market Access, Reimbursement & HEOR

Understand how products get paid for, not just approved. Learn how reimbursement, pricing, and health economics drive adoption and long-term commercial success.

Coding, coverage, payment fundamentals
Reimbursement pathways
Selling to the Hospital Value Analysis Committee (VAC)
Pricing models: Capital purchase vs. SaaS subscription vs. single-use disposables
Workshop: Pricing strategy & financial modeling

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

Strategic Risk Management & ISO 14971

Learn how to identify, assess, and mitigate product risks before they become costly failures. Build a risk-first mindset while balancing innovation, usability, and patient safety.

Application of risk management to medical devices
Hazard identification & FMEA basics
The PM as risk owner
Balancing product feature utility with clinical risk profiles
Workshop: Collaborative risk analysis & mitigation mapping

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THU (7/30), 5 PM PT/8 PM ET

Usability Engineering & Human Factors (UE/HF)

Design products that fit seamlessly into real clinical workflows. Discover how human factors engineering reduces use errors, improves adoption, and strengthens regulatory success.

IEC 62366 & FDA guidance
Human Factors Engineering (HFE)
Formative vs. summative usability testing
Anatomy of a design review: Engineering/QA approval
Guest Speaker: Human Factors Engineer/MedTech Industrial Designer

Assignment #4: Usability Strategy & Risk Mitigation Report
Develop a usability testing and risk mitigation plan that identifies key user interactions, potential use errors, and mitigation approaches.

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

Go-to-Market Strategy & Phase-Gate Execution

Build a launch strategy that bridges product development and commercial success. Learn how to align product readiness, market demand, and organizational execution.

The commercial phase-gate process
Targeting & segmentation
Distribution & channel strategy
Setting product OKRs vs. commercial launch KPIs

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

Sales Playbooks, Messaging & Field Enablement

Transform clinical evidence into compelling commercial stories. Learn how to equip sales teams with compliant messaging, competitive positioning, and tools that accelerate adoption.

Translating clinical data into marketing claims
Competitive positioning & objection handling
Creating field-ready collateral: ROI calculators, value briefs, clinical case summaries
Guest Speaker: Downstream Marketing Director/MedTech Sales Executive

Assignment #5: Commercial Strategy & Launch Plan
Develop a commercialization strategy covering pricing, positioning, launch execution, and financial viability. Begin building your final launch presentation.

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TUE (8/11), 5 PM PT/8 PM ET

Post-Market Surveillance & Continuous Improvement

Discover what happens after launch and how successful MedTech products evolve over time. Learn how post-market data drives compliance, product improvements, and long-term growth.

Post-market surveillance under FDA & MDR frameworks
Complaint handling, MDR, and CAPA processing
Product lifecycle management (PLM)

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TUE (8/18), 5 PM PT/8 PM ET

The Future-Ready MedTech PM & Career Blueprint

Prepare for the next generation of healthcare innovation while building a career strategy that sets you apart. Learn how to position yourself for opportunities across MedTech, digital health, AI, and Software as a Medical Device (SaMD).

Emerging horizons: SaMD, AI/ML, cybersecurity
Converting course assignments into a professional MedTech PM portfolio
Interview mastery: Technical, clinical, & regulatory interview loops
Next steps & the PM community

Final Project: Executive MedTech Product Strategy Deck
Present your complete MedTech product strategy to a mock executive board, demonstrating how you would take a medical device from unmet clinical need to successful market adoption.

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MEDICAL DEVICE PRODUCT MANAGEMENT

THIS COURSE IS FOR YOU, IF...

YOU ARE A HEALTHCARE PROFESSIONAL MOVING INTO MEDTECH

YOU ARE A PRODUCT MANAGER FROM TECH OR ANOTHER INDUSTRY

YOU ARE A MEDTECH ENGINEER OR TECHNICAL SPECIALIST MOVING INTO PRODUCT

YOU WORK IN COMMERCIAL, REGULATORY, OR CONSULTING ROLES IN HEALTHCARE

Our students work in 1600+ companies worldwide

What our students say