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

Frontload your knowledge to achieve commercial success.

Get Your Brochure

Course Dates

STARTS ON

October 27, 2022

Course Duration

DURATION

8 weeks, online
5-6 hours per week

Course Fee

PROGRAM FEE

US$3,500 US$3,115 or get US$350 off with a referral

Course Information Flexible payment available

Application Details

program fee

US$3,500 US$3,115

Pay by
program fee

US$3,500 US$3,220

Pay by

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?

$435.7 Billion

Estimated volume of medical devices in 2022, a segment that accounts for the majority of revenue in the medical technology market

Source: Statista

$644.2 Billion

Estimated market volume of medical technology by 2026, driven by a CAGR of 5.32%

Source: Statista

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.

Week 1:

Strategy, Reimbursement, and Proof of Concept

Recognize and minimize risks. Examine the strategic role of reimbursement. Explore how having a “Proof of Concept” test is vital to development.

Week 2:

Intellectual Property, Outcome Measures, Trials and Indications

Determine the best time to seek IP protection for ideas. Learn the key sections of a patent and outcome measures of products. Discover the intended uses of medical products and how those are tested in clinical trials.

Week 3:

Quality and Medical Devices

Design a quality study. Apply quality systems to clinical trials. Discover important regulatory pathways.

Week 4:

Diagnostics, Biomarkers, and Wearable Devices

Evaluate diagnostics through sensitivity and specificity testing. Discover biomarkers, the molecular or physical indicators of disease. Understand what counts as wearable devices, how they are used, and what is needed to bring them to market.

Week 5:

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

Review of software and hardware regulations including the FDA's General Principles of Software Validation. Identify key elements of drug discovery.

Week 6:

Toxicity, Formulation, and Stability

Validate the therapeutic index of drugs. Understand formulations and how they ensure successful drug delivery. Learn about drug stability: how drugs physically and chemically break down.

Week 7:

Parenteral Products and Biologics

Examine parenteral products - drugs injected directly into the body. Explore biologics - drugs produced from living organisms.

Week 1:

Strategy, Reimbursement, and Proof of Concept

Recognize and minimize risks. Examine the strategic role of reimbursement. Explore how having a “Proof of Concept” test is vital to development.

Week 5:

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

Review of software and hardware regulations including the FDA's General Principles of Software Validation. Identify key elements of drug discovery.

Week 2:

Intellectual Property, Outcome Measures, Trials and Indications

Determine the best time to seek IP protection for ideas. Learn the key sections of a patent and outcome measures of products. Discover the intended uses of medical products and how those are tested in clinical trials.

Week 6:

Toxicity, Formulation, and Stability

Validate the therapeutic index of drugs. Understand formulations and how they ensure successful drug delivery. Learn about drug stability: how drugs physically and chemically break down.

Week 3:

Quality and Medical Devices

Design a quality study. Apply quality systems to clinical trials. Discover important regulatory pathways.

Week 7:

Parenteral Products and Biologics

Examine parenteral products - drugs injected directly into the body. Explore biologics - drugs produced from living organisms.

Week 4:

Diagnostics, Biomarkers, and Wearable Devices

Evaluate diagnostics through sensitivity and specificity testing. Discover biomarkers, the molecular or physical indicators of disease. Understand what counts as wearable devices, how they are used, and what is needed to bring them 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 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.

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:
Faculty Member Noubar Afeyan

Noubar Afeyan

Senior Managing Partner, CEO, Flagship Ventures

Faculty Member Nikolai Begg

Nikolai Begg

PhD, Research Manager, Surgical Innovations at Medtronic

Faculty Member Cheryl Blanchard

Cheryl Blanchard

PhD, President and Chief Executive Officer, Microchips Biotech

Faculty Member Katerine Bosley

Katerine Bosley

CEO, Editas

Faculty Member Michael Elliott

Michael Elliott

VP, Immunology Scientific Innovation at Johnson & Johnson

Faculty Member Colin Gardner

Colin Gardner

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

Faculty Member Todd Armstrong

Todd Armstrong

PhD, JD Partner, Clark+Elbing

Faculty Member Elain Blais

Elain Blais

Partner, Goodwin Proctor

Faculty Member Paolo Bonato

Paolo Bonato

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

Faculty Member Hongming Chen

Hongming Chen

ScD, CSO, Kala Pharmaceuticals

Faculty Member Robert Farra

Robert Farra

Executive VP & CTO, Microchips Biotech

Faculty Member Dennis Giesing

Dennis Giesing

Chief Scientific Officer, Taris Biomedical

Faculty Member Nathaniel Katz

Nathaniel Katz

CEO, Analgesic Solutions

Faculty Member Dave Mantus

Dave Mantus

PhD, Clinical and Technical Operations, Arsanis

Faculty Member Prof. Mark McClellan

Prof. Mark McClellan

PhD, MD, Duke University

Faculty Member Steven Paul

Steven Paul

MD, President and Chief Executive Officer, Voyager Therapeutics

Faculty Member Rene Russo

Rene Russo

PharmD, BCPS Chief Development Officer, Arsanis

Faculty Member David Vogel

David Vogel

President, Intertech Engineering

Faculty Member Janet Woodcock

Janet Woodcock

Director, Center for Drug Evaluation and Research, FDA

Faculty Member Mark Levin

Mark Levin

Partner, 3rd Rock Ventures

Faculty Member John Maraganore

John Maraganore

CEO, Alnylam

Faculty Member John McDonough

John McDonough

CEO, T2 Biosystem

Faculty Member Richard Pops

Richard Pops

CEO, Alkermes

Faculty Member Purnanand Sarma

Purnanand Sarma

CEO, Taris Biomedical

Faculty Member Tony Wood

Tony Wood

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

Program Highlights

Decorative image relating to webinars

Webinars

Decorative image relating to over 40 interviews with industry experts

Over 40 Interviews with Industry Experts

Decorative image relating to real-world application

Real-world Application

Decorative image relating to byte-sized learning

Byte-Sized Learning

Decorative image relating to digital certificate directly from MIT xPRO

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

Decorative image relating to peer learning & feedback

Peer Learning & Feedback

Decorative image relating to the mobile learning app

Mobile Learning App

Decorative image relating to grading & evaluation

Grading & Evaluation

MIT Faculty

Faculty Member 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 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.

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 several ‘open hours’ and appreciated the generosity and depth of the explanations.”

— 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 and how to evaluate the possible strategies.”

— 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 industry.”

— 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.

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

FAQs

  • How do I know if this program is right for me?

    After reviewing the information on the program landing page, we recommend you submit the short form above to gain access to the program brochure, which includes more in-depth information. If you still have questions on whether this program is a good fit for you, please email learner.success@emeritus.org, and a dedicated program advisor will follow-up with you very shortly.


    Are there any prerequisites for this program?

    Some programs do have prerequisites, particularly the more technical ones. This information will be noted on the program landing page, as well as in the program brochure. If you are uncertain about program prerequisites and your capabilities, please email us at learner.success@emeritus.org for assistance.


    Note that, unless otherwise stated on the program web page, all programs are taught in English and proficiency in English is required.


    What is the typical class profile?

    More than 50 percent of our participants are from outside the United States. Class profiles vary from one cohort to the next, but, generally, our online certificates draw a highly diverse audience in terms of professional experience, industry, and geography — leading to a very rich peer learning and networking experience.


    What other dates will this program be offered in the future?

    Check back to this program web page or email us at learner.success@emeritus.org to inquire if future program dates or the timeline for future offerings have been confirmed yet.

  • How much time is required each week?

    Each program includes an estimated learner effort per week. This is referenced at the top of the program landing page under the Duration section, as well as in the program brochure, which you can obtain by submitting the short form at the top of this web page.



    How will my time be spent?

    We have designed this program to fit into your current working life as efficiently as possible. Time will be spent among a variety of activities including:



    • Engaging with recorded video lectures from faculty
    • Attending webinars and office hours, as per the specific program schedule
    • Reading or engaging with examples of core topics
    • Completing knowledge checks/quizzes and required activities
    • Engaging in moderated discussion groups with your peers
    • Completing your final project, if required

    The program is designed to be highly interactive while also allowing time for self-reflection and to demonstrate an understanding of the core topics through various active learning exercises. Please contact us at learner.success@emeritus.org if you need further clarification on program activities.



    What is it like to learn online with the learning collaborator, Emeritus?

    More than 250,000 professionals globally, across 80 countries, have chosen to advance their skills with Emeritus and its educational learning partners. In fact, 90 percent of the respondents of a recent survey across all our programs said that their learning outcomes were met or exceeded.

    A dedicated program support team is available 24/5 (Monday to Friday) to answer questions about the learning platform, technical issues, or anything else that may affect your learning experience.


    How do I interact with other program participants?

    Peer learning adds substantially to the overall learning experience and is an important part of the program. You can connect and communicate with other participants through our learning platform.

  • What are the requirements to earn the certificate?

    Each program includes an estimated learner effort per week, so you can gauge what will be required before you enroll. This is referenced at the top of the program landing page under the Duration section, as well as in the program brochure, which you can obtain by submitting the short form at the top of this web page. All programs are designed to fit into your working life.

    This program is scored as a pass or no-pass; participants must complete the required activities to pass and obtain the certificate of completion. Some programs include a final project submission or other assignments to obtain passing status. This information will be noted in the program brochure. Please contact us at learner.success@emeritus.org if you need further clarification on any specific program requirements.


    What type of certificate will I receive?

    Upon successful completion of the program, you will receive a smart digital certificate. The smart digital certificate can be shared with friends, family, schools, or potential employers. You can use it on your cover letter, resume, and/or display it on your LinkedIn profile.
    The digital certificate will be sent approximately two weeks after the program, once grading is complete.


    Can I get the hard copy of the certificate?

    No, only verified digital certificates will be issued upon successful completion. This allows you to share your credentials on social platforms such as LinkedIn, Facebook, and Twitter.


    Do I receive alumni status after completing this program?

    No, there is no alumni status granted for this program. In some cases, there are credits that count toward a higher level of certification. This information will be clearly noted in the program brochure.


    How long will I have access to the learning materials?

    You will have access to the online learning platform and all the videos and program materials for 12 months following the program start date. Access to the learning platform is restricted to registered participants per the terms of agreement.

  • What equipment or technical requirements are there for this program?

    Participants will need the latest version of their preferred browser to access the learning platform. In addition, Microsoft Office and a PDF viewer are required to access documents, spreadsheets, presentations, PDF files, and transcripts.


    Do I need to be online to access the program content?

    Yes, the learning platform is accessed via the internet, and video content is not available for download. However, you can download files of video transcripts, assignment templates, readings, etc. For maximum flexibility, you can access program content from a desktop, laptop, tablet, or mobile device.

    Video lectures must be streamed via the internet, and any livestream webinars and office hours will require an internet connection. However, these sessions are always recorded, so you may view them later.

  • Can I still register if the registration deadline has passed?

    Yes, you can register up until seven days past the published start date of the program without missing any of the core program material or learnings.


    What is the program fee, and what forms of payment do you accept?

    The program fee is noted at the top of this program web page and usually referenced in the program brochure as well.

    • Flexible payment options are available (see details below as well as at the top of this program web page next to FEE).
    • Tuition assistance is available for participants who qualify. Please email learner.success@emeritus.org.

    What if I don’t have a credit card? Is there another method of payment accepted?

    Yes, you can do the bank remittance in the program currency via wire transfer or debit card. Please contact your program advisor, or email us at learner.success@emeritus.org for details.


    I was not able to use the discount code provided. Can you help?

    Yes! Please email us at learner.success@emeritus.org with the details of the program you are interested in, and we will assist you.


    How can I obtain an invoice for payment?

    Please email learner.success@emeritus.org with your invoicing requirements and the specific program you’re interested in enrolling in.


    Is there an option to make flexible payments for this program?

    Yes, the flexible payment option allows a participant to pay the program fee in installments. This option is made available on the payment page and should be selected before submitting the payment.


    How can I obtain a W9 form?

    Please email us at learner.success@emeritus.org for assistance.

  • What is the policy on refunds and withdrawals?

    You may request a full refund within seven days of your payment or 14 days after the published start date of the program, whichever comes later. If your enrolment had previously been deferred, you will not be entitled to a refund. Partial (or pro-rated) refunds are not offered. All withdrawal and refund requests should be sent to admissions@emeritus.org.



    What is the policy on deferrals?

    After the published start date of the program, you have until the midpoint of the program to request to defer to a future cohort of the same program. A deferral request must be submitted along with a specified reason and explanation. Cohort changes may be made only once per enrolment and are subject to availability of other cohorts scheduled at our discretion. This will not be applicable for deferrals within the refund period, and the limit of one deferral per enrolment remains. All deferral requests should be sent to admissions@emeritus.org.

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.

Apply Now

Early registrations are encouraged. Seats fill up quickly!

Flexible payment options available. Learn more.