The benefit of learning together with your friend is that you keep each other accountable and have meaningful discussions about what you're learning.
Courtlyn
Promotion and Events Specialist
Frontload your knowledge to achieve commercial success.
August 25, 2022
8 weeks, online
5-6 hours per week
US$3,500 or get US$350 off with a referral
Our participants tell us that taking this program together with their colleagues helps to share common language and accelerate impact.
We hope you find the same. Special pricing is available for groups.
The benefit of learning together with your friend is that you keep each other accountable and have meaningful discussions about what you're learning.
Courtlyn
Promotion and Events SpecialistBased on the information you provided, your team is eligible for a special discount, for Drug and Medical Device Development : A Strategic Approach starting on August 25, 2022 .
We’ve sent you an email with enrollment next steps. If you’re ready to enroll now, click the button below.
Have questions? Email us at group-enrollments@emeritus.org.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.
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:
Participants include representatives from companies like:
Participants hold job functions and titles such as:
$430 Bn Industry
Global med-tech industry is $430 Bn with 5% growth expected annually.
73% Job Growth
Jobs related to medical product development grew by 73% in the last year.
“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
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.
Recognize and minimize risks. Examine the strategic role of reimbursement. Explore how having a “Proof of Concept” test is vital to development.
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.
Design a quality study. Apply quality systems to clinical trials. Discover important regulatory pathways.
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.
Review of software and hardware regulations including the FDA's General Principles of Software Validation. Identify key elements of drug discovery.
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.
Examine parenteral products - drugs injected directly into the body. Explore biologics - drugs produced from living organisms.
Recognize and minimize risks. Examine the strategic role of reimbursement. Explore how having a “Proof of Concept” test is vital to development.
Review of software and hardware regulations including the FDA's General Principles of Software Validation. Identify key elements of drug discovery.
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.
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.
Design a quality study. Apply quality systems to clinical trials. Discover important regulatory pathways.
Examine parenteral products - drugs injected directly into the body. Explore biologics - drugs produced from living organisms.
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
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.
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.
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.
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.
Senior Managing Partner, CEO, Flagship Ventures
PhD, Research Manager, Surgical Innovations at Medtronic
PhD, President and Chief Executive Officer, Microchips Biotech
CEO, Editas
VP, Immunology Scientific Innovation at Johnson & Johnson
PhD, Consultant, Formerly the VP of Global Pharmacology Development, Merck
PhD, JD Partner, Clark+Elbing
Partner, Goodwin Proctor
PhD, Director of the Motion Analysis Laboratory, Spaulding Rehabilitation Hospital
ScD, CSO, Kala Pharmaceuticals
Executive VP & CTO, Microchips Biotech
Chief Scientific Officer, Taris Biomedical
CEO, Analgesic Solutions
PhD, Clinical and Technical Operations, Arsanis
PhD, MD, Duke University
MD, 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
VP, Head of Worldwide Medicinal Chemistry Pfizer (Now SVP, Medicinal Science & Technology, GlaxoSmithKline)
Webinars
Over 40 Interviews with Industry Experts
Real-world Application
Byte-Sized Learning
Earn a certificate and 4 Continuing Education Units (CEUs) from MIT xPRO
Peer Learning & Feedback
Mobile Learning App
Grading & Evaluation
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 BrochureAfter 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.
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.
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.
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.
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.
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.
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:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
The program fee is noted at the top of this program web page and usually referenced in the program brochure as well.
Yes, you can do the bank remittance in USD via wire transfer or debit card. Please contact your program advisor, or email us at learner.success@emeritus.org for details.
Yes! Please email us at learner.success@emeritus.org with the details of the program you are interested in, and we will assist you.
Please email learner.success@emeritus.org with your invoicing requirements and the specific program you’re interested in enrolling in.
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.
Yes, the program fee is inclusive of any taxes, except for GST for Singapore residents.
Please email us at learner.success@emeritus.org for assistance.
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.
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.
Flexible payment options available.