Pharmaceutical and Medical Device Innovations

  • 4.4
Approx. 13 hours to complete

Course Summary

This course covers the fundamentals of pharmaceutical and medical device innovation, including the development process, regulations, and commercialization strategies.

Key Learning Points

  • Learn about the entire process of developing and commercializing pharmaceutical and medical device products
  • Understand the regulatory and legal requirements for these products
  • Explore the various strategies for successful commercialization

Related Topics for further study


Learning Outcomes

  • Understand the key stages of pharmaceutical and medical device development
  • Identify the regulatory and legal requirements for these products
  • Develop strategies for successful commercialization

Prerequisites or good to have knowledge before taking this course

  • Basic knowledge of science and healthcare industries
  • Access to a computer and internet

Course Difficulty Level

Intermediate

Course Format

  • Online
  • Self-paced
  • Video lectures
  • Quizzes

Similar Courses

  • Drug Development
  • Medical Device Innovation

Related Education Paths


Related Books

Description

This course in the Healthcare Marketplace specialization gives the learner an in-depth view of the intellectual property creation that is vital to creating breakthrough technologies. Included is an understanding of the strategy deployed for pricing drugs and new technologies as well as the market sizing exercise to identify where future research and development investments should be made.

Outline

  • The Pharmaceutical Industry: Bench Science to Bedside
  • Recap of Healthcare Marketplace Specialization
  • Meet Steve Parente (or "My Five Hats")
  • 1.1.0 Overview; Pharmaceutical Industry: Trends in Drug Development
  • 1.1.1 Pharmaceuticals: From Bench to Bedside
  • 1.1.2 Pharmaceutical Industry: Drug Development Challenges
  • 1.1.3 Pharmaceutical Industry: Intellectual Property
  • 1.2.1 Pharmaceutical Industry: Food & Drug Administration
  • 1.2.2 Pharmaceutical Industry: Investigational New Drug / Phase 1 to Phase 4
  • 1.2.3 Pharmaceutical Industry: Global Regulatory & Harmonization
  • 1.3.1 Pharmaceutical Reimbursement: US Market
  • 1.3.2 Pharmaceutical Reimbursement: Public Insurance Market
  • 1.3.3 Pharmaceutical Reimbursement: Overseas US Market
  • Pharma Bench Science
  • Pharma Regulatory
  • Pharma Reimbursement
  • The Pharmaceutical Industry: Bench Science to Bedside
  • Pharmaceutical Market Deployment & Management
  • 2.1.1 Defining a Market Space
  • 2.1.2 Who are your Customers?
  • 2.1.3 Who or what Influences your Customer?
  • 2.2.1 Early Competitors in Brand Space
  • 2.2.2 Global Space Competitors
  • 2.2.3 Generic and Over the Counter (OTC)
  • 2.3.1 Trends in Cancer Drugs
  • 2.3.2 British Criteria for Cancer Drug Payment
  • 2.3.3 U.S. Criteria for Cancer Drug Payment
  • Pharma Marketing Plan
  • Pharma Competitor Analysis
  • UK vs. US Policy for Cancer Drugs
  • The Medical Device Industry: Bench Science to Bedside
  • 3.1.1 Medical Device Industry: Regulatory Basics
  • 3.1.2 Device Failure
  • 3.1.3 Medical Device and Pharma Convergence
  • 3.2.1 Reimbursement Coding
  • 3.2.2 Payment to Healthcare Providers
  • 3.2.3 Medical Device Industry: Reimbursement Strategy
  • 3.3.1 U.S. Device Public Reimbursement
  • 3.3.2 U.S. Device Private Insurer Reimbursement
  • 3.3.3 Medical Device Reimbursement Outside U.S.
  • Medical Device Innovation
  • Medical Device Regulatory
  • Device Reimbursement
  • Medical Device Bench Science to Bedside
  • Medical Device Market Deployment & Management
  • Medical Device Market Deployment & Management Overview
  • 4.1.1 Medical Device Industry: Market Space
  • 4.1.2 Medical Device Industry: Innovation Pipeline & Valuation
  • 4.1.3 Medical Device Industry: Global Partnerships
  • 4.2.1 Medical Device: Device Competitor Analysis
  • 4.2.2 Medical Device: Global Competitor Analysis
  • 4.2.3 The 510k: Friend or Foe?
  • 4.3.1 Go to Market
  • 4.3.2 Managing Market Share
  • 4.3.3 Keeping the Product Fresh and Safe in the Long Run
  • Device Market Plan
  • Device Competitor Analysis
  • Device Sales & Risk
  • Device Market Deployment & Management

Summary of User Reviews

The Pharma & Medical Device Innovations course on Coursera has received high ratings from users. Many users have praised the course for its comprehensive coverage and practical insights into the pharma and medical device industry.

Key Aspect Users Liked About This Course

Comprehensive coverage and practical insights into the pharma and medical device industry

Pros from User Reviews

  • The course provides a thorough understanding of the pharma and medical device industry
  • The course covers a range of topics including regulatory processes, product development and commercialization
  • The course is taught by industry experts and provides practical insights into the industry

Cons from User Reviews

  • Some users found the course to be too technical
  • The course is quite intensive and may require a significant time commitment
  • Some users found the course to be too focused on the US market and regulations
English
Available now
Approx. 13 hours to complete
Stephen T Parente
University of Minnesota
Coursera

Instructor

Stephen T Parente

  • 4.4 Raiting
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