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.
EXECUTIVE EDUCATION
EXECUTIVE EDUCATION
Frontload your knowledge to achieve commercial success
April 28, 2021
8 weeks, online
5-6 hours per week
US$3,500 or get US$350 off with a referral
Special pricing up to 20% discount is available if you enroll with your colleagues. Please send an email to group-enrollments@emeritus.org for more information.
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 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 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. Recognize the target validation process for drug development. Understand the essential processes of absorption, metabolism, transportation, and development in drug development and delivery.
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. Recognize the target validation process for drug development. Understand the essential processes of absorption, metabolism, transportation, and development in drug development and delivery.
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 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.
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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.
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Webinars
Over 40 Interviews with Industry Experts
Real-world Application
Byte-Sized Learning
Digital Certificate Directly 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. This program is graded as a pass or fail; participants must receive 80% 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.
Flexible payment options available.