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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 BrochureYou 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, 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.
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.
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.