MIT xPRO Drug and Medical Device Development | Online Certificate Program

EXECUTIVE EDUCATION

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STARTS ON

April 28, 2021

DURATION

8 weeks, online
5-6 hours per week

PROGRAM FEE

US$3,500 or get US$350 off with a referral

Flexible payment available

Special group enrollment pricing

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

What Are The Opportunities?

Image showcasing how global med-tech industry is worth $430 Bn with 5% growth expected annually

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

Source: Statista

Image showcasing how jobs related to medical product development grew by 73% in the last year

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

Source: Emsi data

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 the whole process one concept at a time.

Week 1:

Strategy, Reimbursement, and Proof of Concept

Identify the strategic objectives required for launching any medical product development program; learn how medical reimbursement factors into the strategic analysis of drug and medical product development; explore how proof of concept informs strategy.

Week 2:

Intellectual Property, Outcome Measures, Trials and Indications

Learn about protecting intellectual property in drug and device development; explore the key sections of a patent and outcome measures of products; understand best practices for studying subjective endpoints; and discover how clinical trials are conducted.

Week 3:

Quality and Medical Devices

Identify elements of a quality system required for creating medical products, applying it to all aspects of a project, including clinical testing; understand validation and verification; and examine quality systems in specific device development use cases.

Week 4:

Diagnostics, Biomarkers, and Wearable Devices

Evaluate diagnostics and medical devices through sensitivity and specificity testing; explore the importance, uses, and limitations of biomarkers in the drug development process; and identify what it takes to bring wearable devices to market.

Week 5:

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

Review software regulation, including the FDA’s General Principles of Software Validation; examine the role of molecular compounds and target validation in drug development; and understand absorption, distribution, and metabolism in drug development and delivery.

Week 6:

Toxicity, Formulation, and Stability

Validate the therapeutic index of drugs; evaluate how formulations are made to ensure effective drug delivery; explore the usefulness of extended-release drugs; construct a solution to a drug manufacturing problem; determine drug stability.

Week 7:

Parenteral Products and Biologics

Explore the function and administration of parenteral products and the importance of sterilization in their manufacture; examine bioburdens; learn how biologics function; and identify optimal and suboptimal practice in drug development.

Week 1:

Strategy, Reimbursement, and Proof of Concept

Identify the strategic objectives required for launching any medical product development program; learn how medical reimbursement factors into the strategic analysis of drug and medical product development; explore how proof of concept informs strategy.

Week 5:

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

Review software regulation, including the FDA’s General Principles of Software Validation; examine the role of molecular compounds and target validation in drug development; and understand absorption, distribution, and metabolism in drug development and delivery.

Week 2:

Intellectual Property, Outcome Measures, Trials and Indications

Learn about protecting intellectual property in drug and device development; explore the key sections of a patent and outcome measures of products; understand best practices for studying subjective endpoints; and discover how clinical trials are conducted.

Week 6:

Toxicity, Formulation, and Stability

Validate the therapeutic index of drugs; evaluate how formulations are made to ensure effective drug delivery; explore the usefulness of extended-release drugs; construct a solution to a drug manufacturing problem; determine drug stability.

Week 3:

Quality and Medical Devices

Identify elements of a quality system required for creating medical products, applying it to all aspects of a project, including clinical testing; understand validation and verification; and examine quality systems in specific device development use cases.

Week 7:

Parenteral Products and Biologics

Explore the function and administration of parenteral products and the importance of sterilization in their manufacture; examine bioburdens; learn how biologics function; and identify optimal and suboptimal practice in drug development.

Week 4:

Diagnostics, Biomarkers, and Wearable Devices

Evaluate diagnostics and medical devices through sensitivity and specificity testing; explore the importance, uses, and limitations of biomarkers in the drug development process; and identify what it takes to bring wearable devices to market.

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: 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

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

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

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.

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Program Highlights

Decorative image relating to webinars

Decorative image relating to over 40 interviews with industry experts

Decorative image relating to real-world application

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Decorative image relating to digital certificate directly from MIT xPRO

Decorative image relating to peer learning & feedback

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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.

Certificate

Certificate

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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Early registrations are encouraged. Seats fill up quickly!

Flexible payment options available. Learn more.