Drug and Medical Device Development: A Strategic Approach
Program Overview: Drug and Medical Device Development
The Drug and Medical Device Development: A Strategic Approach online program from MIT xPRO equips you with a complete roadmap for creating, testing, approving, and launching new health products globally. In eight weeks, you will learn what shapes risks, quality, IP protection, clinical development, and ultimately, commercial success.
While healthcare technology is expanding rapidly, bringing a product to market demands more than technical excellence. Added layers of regulation, quality controls, and reimbursement pressures make each decision pivotal. This program equips you with the fluency to anticipate roadblocks, align clinical strategy, and design for adoption. Through real-world case studies and self-paced learning with leading experts, you will gain frameworks that strengthen product viability, accelerate pathways to approval, and position innovations for commercial success.
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Who Is the Drug and Medical Device Development Program For?
This MIT xPRO program is for professionals in the pharmaceutical and biotechnology industries who seek a clear blueprint of the development process for medical devices and drugs, encompassing preclinical testing, clinical trials, regulatory approval, and commercialization.
A background in health sciences is beneficial for the learning journey, but not a requirement.
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
Industry professionals making a horizontal transition into the healthcare industry
Entrepreneurs seeking to launch a product in the US healthcare market
Organizations in need of training employees and new hires on the entire process of developing medical devices and pharmaceuticals
Where Past Learners Come From
Past participants have held job functions and titles including:
Disclaimer: All product and company names are trademarks or registered trademarks of their respective holders. Use of product and company names does not imply any affiliation with or endorsement by the holders.
The list of companies is only indicative and not exhaustive.
Key Takeaways
Gain a “big picture” perspective of the entire drug and medical device development process, from 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 US market and the process for achieving approval
Develop professional networks for career development, industry partnerships, or strategic alliances
What You Will Learn in the Drug and Medical Device Development Program
The program curriculum features seven modules that build practical expertise in the complete drug discovery and medical device development lifecycle, including proof of concept, intellectual property, preclinical testing, diagnostics, software and AI regulation, formulation, and biologics. Through self-paced video lectures, led by renowned MIT faculty, you will learn how pharmaceutical research translates into safe, effective products that meet regulatory approval standards and market needs.
Note: For full details on the program modules, please download the brochure.
Case Studies and Assignment
Osteoporosis and the Failed Drug Trial
Play the role of a drug developer for an osteoporosis drug that has failed its clinical trial and determine why the trial failed.
Corvia Medical Device
Assume the role of a Corvia quality engineer, and write a quality systems summary for your CEO that addresses the quality elements for this market-bound product.
Disappearing Polymorphs
Imagine the role of a lab manager for a pharmaceutical company whose drug form, Ritonavir, has inexplicably changed, impacting the drug’s efficacy and the lives of numerous patients. Provide a causal factor analysis of why this drug has changed and a recommendation for this problem.
Scoping a Proof of Concept
Play the role of a drug developer working on a new pain relief drug. Identify the surrogate endpoints and the patient population for your proof of concept test to ensure your drug has its desired effects.
Sensitivity and Specificity in Action — an AI Colonoscopy Diagnostic
Design an AI application to recognize at-risk polyps during a colonoscopy. Identify the important diagnostic tools to include in the criteria for designing an AI application.
Death by 1000 Clicks - Where Electronic Health Records Went Wrong
Electronic health records are vital to the medical community, enabling physicians to collaborate by utilizing a patient's medical history and current symptoms. Review related software failures and hypothesize on resolving errors that might have resulted in success.
Compounding Pharmacies and Sterile Parenteral Products
Discuss how quality systems are imperative for drugs that require intravenous administration. Provide insights on designing a sterile environment for such drugs.
Note: These are some of our learning facilitators and may change for upcoming cohorts.
Learn from Industry Experts
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:
Senior Managing Partner, CEO, Flagship Ventures
Research Manager, Surgical Innovations at Medtronic
President and Chief Executive Officer, Microchips Biotech
CEO, Editas
Vice President, Immunology Scientific Innovation, Johnson & Johnson
Consultant, Formerly the VP of Global Pharmacology Development, Merck
JD Partner, Clark+Elbing
Partner, Goodwin Procter
Director of the Motion Analysis Laboratory, Spaulding Rehabilitation Hospital
CSO, Kala Pharmaceuticals
Executive VP & CTO, Microchips Biotech
Chief Scientific Officer, Taris Biomedical
CEO, Analgesic Solutions
Clinical and Technical Operations, Arsanis
Director, Duke-Margolis Institute for Health Policy, Duke University
President and Chief Executive Officer, Voyager Therapeutics
PharmD, BCPS Chief Development Officer, Arsanis
President, Intertech Engineering
Director, Center for Drug Evaluation and Research, FDA
Partner, 3rd Rock Ventures
CEO, Alnylam
CEO, T2 Biosystem
CEO, Alkermes
CEO, Taris Biomedical
Chief Scientific Officer, R&D, GlaxoSmithKline
Note: Learning facilitators are subject to change for upcoming cohorts.
Program Highlights
Live webinars with faculty and industry experts
40+ interviews with industry leaders
Real-world case studies and practical exercises
Byte-sized content for flexible learning
Certificate of completion and 4.8 CEUs from MIT xPRO
Networking opportunities and personalized feedback
Mobile-optimized learning for anytime access
Structured grading and evaluation to track progress
Meet the Faculty
David H. Koch Professor of Engineering; Professor of Materials Science and Engineering, MIT David H. Koch Institute for Integrative Cancer Research; Faculty Director, Lemelson-MIT Program
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...
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Certificate
Get recognized! Upon successful completion of this program, you receive 4.8 Continuing Education Units (CEUs), a globally recognized measure of professional learning that reflects compliance with international quality standards, and a certificate of completion from MIT xPRO.
This program is graded as a pass or fail; participants must receive 75 percent 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.
Didn't find what you were looking for? Write to us at learner.success@emeritus.org or Schedule a call with one of our Program Advisors or call us at +1 401 443 9591 (US) / + 44 189 236 2347 (UK) / +65 3129 7174 (SG)
Flexible payment options available.
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