Drug and Medical Device Development: A Strategic Approach - Online Program

Frontload your knowledge to achieve commercial success

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Course Dates


February 11, 2021

Course Duration


8 weeks, online
5-6 hours per week

Course Duration

What does it take to bring a new medical device or pharmaceutical to life?

Digital disruption in healthcare has opened the market for new products that are data-driven and patient-centered. But bringing a medical device or drug to market is very different from building other kinds of products. Added layers of regulation make it a highly complex process.

Who Should Attend?

The MIT xPRO Drug and Medical Device Development: A Strategic Approach program is designed for individuals and companies that operate in the health product industry as well as those looking to enter this fast-growing industry. Having a background in health sciences is helpful, but not required. The program is ideal for:

  • Engineers involved in the development of new medical device products or pharmaceuticals
  • Executives in the drug and medical device development/product management field
  • Scientists and those who lead teams of scientists in R&D
  • Quality assurance and regulatory affairs professionals
  • Professionals making a horizontal transition into the healthcare industry
  • Entrepreneurs seeking to launch a product in the U.S. healthcare market
  • Companies in need of training employees and new hires on the entire process of developing medical devices and pharmaceuticals

Participants include representatives from companies like:

  • Hoffmann-La Roche
  • BioMarin Pharmaceutical Inc.
  • Cardinal Health
  • Nanoshift LLC
  • Scimitar Inc.
  • BlueAllele
  • Genentech
  • Foundation Patents
  • Innovate Biopharmaceuticals
  • Morgans Financial
  • Proctor & Gamble

Participants hold job functions and titles such as:

  • Owner, Director, CEO, President
  • VP, Scientific Affairs and Technical Services
  • Global Chief Clinical Officer
  • Regulatory Manager
  • Sr. Product Manager
  • Sr. Quality Systems Specialist
  • Management Consultant
  • Postdoctoral Researcher
  • Physician
  • Pharmacist

What Are The Opportunities?

$430 Bn Industry
Global med-tech industry is $430 Bn with 5% growth expected annually.

Source: Statista

73% Job Growth
Jobs related to medical product development grew by 73% in the last year.

Source: Emsi data


  • Gain a “big picture” perspective of the entire drug and medical device development process, from day one strategic planning through product commercialization
  • Understand the critical interplay between strategy and development—and how they affect each other
  • Learn frameworks for assessing both the benefits and the risks associated with developing a new product in the healthcare market
  • Gain clarity around the regulatory requirements in the U.S. market and the process for achieving approval
  • Develop professional networks for career development, industry partnerships or strategic alliances

“This program explodes the notion that there is ‘research’ followed by ‘development’. These forces are intertwined until you launch it.”
- Professor Michael Cima, Program Director and MIT Associate Dean of Innovation

Program Modules

Over eight weeks, including the orientation week, you will learn how to anticipate and address the complexities involved with developing medical products. Each week covers one theme, divided into specific topics.

Week 1:

Strategy, Reimbursement, and Proof of Concept

Week 2:

Intellectual Property, Outcome Measures, Trials and Indications

Week 3:

Quality and Medical Devices

Week 4:

Diagnostics, Biomarkers, and Wearable Devices

Week 5:

Software, Target Selection and Drug Discovery, and Absorption, Distribution and Metabolism

Week 6:

Toxicity, Formulation, and Stability

Week 7:

Parenteral Products and Biologics

Week 1:

Strategy, Reimbursement, and Proof of Concept

Week 5:

Software, Target Selection and Drug Discovery, and Absorption, Distribution and Metabolism

Week 2:

Intellectual Property, Outcome Measures, Trials and Indications

Week 6:

Toxicity, Formulation, and Stability

Week 3:

Quality and Medical Devices

Week 7:

Parenteral Products and Biologics

Week 4:

Diagnostics, Biomarkers, and Wearable Devices

For full details on the program modules, please download the brochure.

Download Brochure

Case Studies and Assignment

Case Study: Corvia Medical Device

You will play the role of a Corvia quality engineer, writing a quality systems summary for your CEO that addresses the quality elements for this market bound product.

Case Study: Disappearing Polymorphs

You will play the role of a Lab Manager for a pharmaceutical company whose drug form, ritonavir, has inexplicably changed, impacting the drug’s efficacy and numerous patients’ lives. Your task is to provide a causal factor analysis of why this drug has changed and a recommendation to this problem.

Assignment: Scoping a Proof of Concept

You will play the role of a drug developer working on a new pain relief drug. Your task is to identify the surrogate endpoints and the patient population for your Proof of Concept test to ensure your drug has its desired effects.

Case Study: Osteoporosis and the Failed Drug Trial

You will play the role of a drug developer for an osteoporosis drug that has failed its clinical trial. Your task is to determine why the trial failed.

Industry Leaders

You will learn from industry experts from a wide variety of backgrounds, including leaders in healthcare, pharmaceuticals, venture capital, insurance, intellectual property law, and regulatory agencies. Featured experts include:

Noubar Afeyan

Senior Managing Partner, CEO, Flagship Ventures

Nikolai Begg

PhD, Research Manager, Surgical Innovations at Medtronic

Cheryl Blanchard

PhD, President and Chief Executive Officer, Microchips Biotech

Katerine Bosley

CEO, Editas

Michael Elliott

VP, Immunology Scientific Innovation at Johnson & Johnson

Colin Gardner

PhD, Consultant, Formerly the VP of Global Pharmacology Development, Merck

Todd Armstrong

PhD, JD Partner, Clark+Elbing

Elain Blais

Partner, Goodwin Proctor

Paolo Bonato

PhD, Director of the Motion Analysis Laboratory, Spaulding Rehabilitation Hospital

Hongming Chen

ScD, CSO, Kala Pharmaceuticals

Robert Farra

Executive VP & CTO, Microchips Biotech

Dennis Giesing

Chief Scientific Officer, Taris Biomedical

Nathaniel Katz

CEO, Analgesic Solutions

Dave Mantus

PhD, Clinical and Technical Operations, Arsanis

Prof. Mark McClellan

PhD, MD, Duke University

Steven Paul

MD, President and Chief Executive Officer, Voyager Therapeutics

Rene Russo

PharmD, BCPS Chief Development Officer, Arsanis

David Vogel

President, Intertech Engineering

Janet Woodcock

Director, Center for Drug Evaluation and Research, FDA

Mark Levin

Partner, 3rd Rock Ventures

John Maraganore

CEO, Alnylam

John McDonough

CEO, T2 Biosystem

Richard Pops

CEO, Alkermes

Purnanand Sarma

CEO, Taris Biomedical

Tony Wood

VP, Head of Worldwide Medicinal Chemistry Pfizer (Now SVP, Medicinal Science & Technology, GlaxoSmithKline)

Program Highlights


Over 40 Interviews with Industry Experts

Real-world Application

Byte-Sized Learning

Digital Certificate Directly from MIT xPRO

Peer Learning & Feedback

Mobile Learning App

Grading & Evaluation

MIT Faculty

Michael Cima

David H. Koch Professor of Engineering

Michael is the David H. Koch Professor of Engineering and a Professor of Materials Science and Engineering at the Massachusetts Institute of Technology at the David H. Koch Institute for Integrative Cancer Research. He has a B.S. in chemistry and a Ph.D. in chemical engineering from the University of California at Berkeley.

He is the faculty director of the Lemelson-MIT Program, a U.S.-based program aimed at inspiring youth to be inventive. Michael is also co-director of MIT’s Innovation Initiative and the Associate Dean of Innovation for the School of Engineering. He has also started three successful pharmaceutical and three medical device companies.



Get recognized! Upon successful completion of this program, MIT xPRO grants a certificate of completion to participants. This program is graded as a pass or fail; participants must receive 80% to pass and obtain the certificate of completion.

Download Brochure

After successful completion of the program, your verified digital certificate will be emailed to you, at no additional cost, in the name you used when registering for the program. All certificate images are for illustrative purposes only and may be subject to change at the discretion of MIT.

Registration for this program is done through Emeritus. You can contact us at mit@emeritus.org
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