Medtech Regulation: From Prototype to Approval
How to design evidence-driven clinical trials that satisfy regulators, payers, physicians, and healthcare stakeholders.
What is this course about?
Clinical and regulatory execution is where credibility is built — or lost. The teams that succeed treat evidence as a strategic asset, not a box to check. This 9-week course delivers 17 actionable lessons to guide you from problem definition through post-market evidence generation. You’ll learn how to partner effectively with regulators, design multi-stakeholder trials that satisfy clinical, economic, and reimbursement requirements, select the optimal regulatory pathway, accelerate first-in-human studies, leverage KOLs, and build a continuous evidence engine that drives adoption and reimbursement.
Week 1: Regulators as Partners & Expert Team Building
Regulatory strategy works best when it starts early. This week reframes regulators as collaborators and shows how proactive engagement can de-risk your path. You’ll also learn how to assemble a regulatory and clinical team that brings deep domain knowledge and an adaptable, strategic mindset.
Week 2: Problem-Driven Design & Economic Endpoints
Winning trials start with a defined clinical problem. This week focuses on anchoring development by designing endpoints that resonate with regulators, payers, and physicians. You’ll learn how to prioritize both clinical relevance and economic value.
Week 3: Multi-Stakeholder Trial Design & Learning from Precedents
This week explores how to design trials that balance clinical efficacy with economic value — and how to leverage regulatory precedence to strengthen protocols and streamline approval.
Week 4: Strategic Regulatory Path & Q-Sub Mastery
Choosing the right regulatory path shapes everything that follows. This week, we compare 510(k), de novo, and PMA pathways to balance speed, cost, and evidence requirements. You’ll also learn how to use pre-submission interactions to get real-time guidance and build trust with reviewers.
Week 5: Accelerating to First-in-Human & KOL Advocacy
This week’s lesson shows how to move efficiently from benchtop to first-in-human trials to generate real-world data and refine your design. You’ll learn how to leverage early clinical results to win over key opinion leaders (KOLs) and build rapport with physician champions.
Week 6: Strategic Site Selection & Patient Pipeline
The right sites accelerate everything. This week focuses on selecting investigators and centers that deliver credible data and long-term partnership. You’ll also explore modern patient-recruitment approaches that improve compliance.
Week 7: In-House vs. Outsourced Trials & Data as Leverage
This week breaks down when to run in-house studies and when to partner with a CRO. You’ll learn how high-quality, repeatable data becomes leverage — educating regulators, influencing the market, and enabling category creation.
Week 8: The Perpetual Evidence Engine
Regulatory clearance is the starting line. This week explores how continuous post-launch evidence fuels reimbursement, adoption, and product evolution. You’ll learn how to treat clinical data as a long-term asset, not a one-time milestone.
Week 9: Founder’s Evidence Playbook
The course concludes by tying everything together. This final week distills the core framework: problem-driven strategy, lean and advocate-led execution, and evidence as a compounding advantage — giving founders a repeatable playbook for building durable medtech businesses.
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