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

Expand your medical device knowledge to achieve commercial success
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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

  • IQVIA

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

Impact

  • 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 the course of seven modules, you will learn how to anticipate and address the complexities involved with developing medical products. Designed to provide a big picture view of initiating a medical drug or product development, this program explains the whole process one concept at a time.

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

Case Studies and Assignment

Corvia Medical Device

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.

Disappearing Polymorphs

Case Study: Disappearing Polymorphs

You will play the role of a Lab Manager for a pharmaceutical company whose drug form 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.

Scoping a Proof of Concept

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.

Osteoporosis and the Failed Drug Trial

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.

Note: These are some of our learning facilitators and may change for upcoming cohorts.

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
Noubar Afeyan

Senior Managing Partner, CEO, Flagship Ventures

Nikolai Begg
Nikolai Begg

PhD, Research Manager, Surgical Innovations at Medtronic

Cheryl Blanchard
Cheryl Blanchard

PhD, President and Chief Executive Officer, Microchips Biotech

Katerine Bosley
Katerine Bosley

CEO, Editas

Michael Elliott
Michael Elliott

VP, Immunology Scientific Innovation at Johnson & Johnson

Colin Gardner
Colin Gardner

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

Todd Armstrong
Todd Armstrong

PhD, JD Partner, Clark+Elbing

Elain Blais
Elain Blais

Partner, Goodwin Proctor

Paolo Bonato
Paolo Bonato

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

Hongming Chen
Hongming Chen

ScD, CSO, Kala Pharmaceuticals

Robert Farra
Robert Farra

Executive VP & CTO, Microchips Biotech

Dennis Giesing
Dennis Giesing

Chief Scientific Officer, Taris Biomedical

Nathaniel Katz
Nathaniel Katz

CEO, Analgesic Solutions

Dave Mantus
Dave Mantus

PhD, Clinical and Technical Operations, Arsanis

Mark McClellan
Prof. Mark McClellan

PhD, MD, Duke University

Steven Paul
Steven Paul

MD, President and Chief Executive Officer, Voyager Therapeutics

Rene Russo
Rene Russo

PharmD, BCPS Chief Development Officer, Arsanis

David Vogel
David Vogel

President, Intertech Engineering

Janet Woodcock
Janet Woodcock

Director, Center for Drug Evaluation and Research, FDA

Mark Levin
Mark Levin

Partner, 3rd Rock Ventures

John Maraganore
John Maraganore

CEO, Alnylam

John McDonough
John McDonough

CEO, T2 Biosystem

Richard Pops
Richard Pops

CEO, Alkermes

Purnanand Sarma
Purnanand Sarma

CEO, Taris Biomedical

Tony Wood
Tony Wood

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

Program Highlights

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Webinars

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Over 40 Interviews with Industry Experts

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Real-world Application

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Byte-Sized Learning

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Earn a certificate and 4 Continuing Education Units (CEUs) from MIT xPRO

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Peer Learning & Feedback

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Mobile Learning App

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Grading & Evaluation

MIT Faculty

MICHAEL CIMA
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 In...

Testimonials

I liked the format and thought that the majority of the videos were short, crisp, and very insightful. There were abundant resources which made it possible for us to go further. I have attended severa...
Manon Boisclair
Founder and CEO, InnovID B2
Both the content and format of the material were exactly what I was looking for in my goal to better understand the industry I serve.
Jonathan Kelly
Senior Software Development Engineer, Amazon Web Services
The best part of the program were the case studies from the instructors in the videos. These are comprehensive cases that include multiple topics and good illustrations to understand the concept.
Miaojun Wang
Senior Process Engineer, Applied Materials
It gave a quick overview of various medical product development and regulatory processes and development. People from various departments of pharma or biotech can use this for training.
Grace Kao
Senior Clinical Trial Physician, Bristol Myers Squibb
I learned from the experience of the interviewees. Their knowledge and professional experience were priceless in understanding the difficulties that can occur in drug and medical product development a...
Isabelle Viellard Pelve
Marketing Manager, DIH Technology Co.
The course was designed very nicely. I understand the great effort and hard work required to prepare this course and appreciate it. Overall, it gave an excellent overview and depth of the pharma indus...
Vikas Gujar
Customer Engineer Lead, Applied Materials
Certificate

Certificate

Get recognized! Upon successful completion of this program, MIT xPRO grants a certificate of completion to participants and 4 Continuing Education Units (CEUs). This program is graded as a pass or fail; participants must receive 75% to pass and obtain the certificate of completion.

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.

FAQs

Financing Options

Climb Credit*

We offer financing options with our partner, Climb Credit*. Click here to learn more.

*Applicable for US Residents

Flexible Payment Options For All

Flexible payment options allow you to pay the program fee in installments. Click here to see payment schedule.

Have Questions?

Email: enterprise.clientsuccess@emeritus.org. We attempt to respond to queries in 24 hours or less. However, over weekends and holidays, our responses may take up to 72 hours.