Course Content

Regulatory and Reimbursement

Course Overview

Needs and Markets

Intellectual Property

• Regulatory and Reimbursement

Video
Slides
Questions
Example
Worksheet

Company Formation

Funding

Financials

Summary

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This section discusses the regulatory laws enforced by the U.S. FDA with respect to medical technologies, and describes the procedures required for regulatory approval in the United States. In addition, reimbursement policies of Medicare and private insurers are discussed, and procedures are discussed for obtaining adequate reimbursement for a medical technology.

Upon completion of this section, you should understand the regulatory pathway that will be required for your project to gain approval. You should also understand the current status of reimbursement for your technology. Based on these assessments, you should be able to estimate the size and duration of the clinical trial required for regulatory approval and adequate reimbursement.

Content

Play video [Username: sfbip@stanford.edu; Password: 16pin35]

1. Sara Toyloy on U.S. regulatory law
2. Howard Holstein on regulatory strategies
3. Judith Hickey on medical reimbursement

Slides (PDF)

Speakers Biographies

Sara Toyloy

Howard Holstein

Judith Hickey

Additional Materials

Assesment Questions - Regulatory and reimbursement

Example - Regulatory and reimbursement (PDF)

Worksheet - Developing clinical and regulatory strategy

Worksheet - Developing clinical and regulatory strategy (PDF)