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Quick Facts

Medium Of InstructionsMode Of LearningMode Of Delivery
EnglishSelf Study, Virtual ClassroomVideo and Text Based

Course Overview

The Global Med-Tech industry is worth USD 430 Billion and expected to rise further with diverse roles and employment opportunities. As such, it is a lucrative field to enter. The Drug and Medical Device Development A Strategic Approach - Online Program certification course will equip you with the knowledge and skills necessary to land high-paying jobs in Med-Tech.

There are case studies and assignments in the programme wherein you will have to assume the role of a drug developer, quality engineer, lab manager, etc. and solve real-world problems. With the Drug and Medical Device Development A Strategic Approach - Online Program, you will learn all that and more, in just eight weeks.

Participants of the Drug and Medical Device Development A Strategic Approach - Online Program include representatives from companies like Procter & Gamble, Cardinal Health, Genentech, Innovate Biopharmaceuticals, Pharmaceutical Inc., among others. Besides, you will learn from a highly eminent MIT faculty for a comprehensive understanding of medical equipment development. 

The Highlights

  • Webinars
  • 5-6 hours per week
  • 8-week programme
  • Mobile learning app
  • Real-world application
  • Grading and evaluation
  • Flexible payment options
  • Peer learning and feedback
  • A digital certificate from MIT xPRO
  • Interviews with over 40 industry experts

Programme Offerings

  • Webinars
  • 8-Week course
  • 5-6 Hours Per Week
  • Mobile Learning App
  • Byte-Sized Learning
  • Real-World Application
  • Grading and Evaluation
  • Peer Learning and Feedback
  • Digital Certificate from MIT xPRO
  • Interviews with Over 40 Industry Experts.

Courses and Certificate Fees

Certificate AvailabilityCertificate Providing Authority
yesMIT Cambridge

You can pay the entire fee upfront, or you can pay in two or three instalments. 

The Drug and Medical Device Development A Strategic Approach - Online Program fee structure

Course

Fee

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

USD 3,500


Eligibility Criteria

If you are interested in the Drug and Medical Device Development A Strategic Approach - Online Program, a background in Health Sciences will help, but it is not mandatory. 

Moreover, the candidate must score 80% or above in the assignments to pass and receive the certificate.

What you will learn

Knowledge of medical technology

After completing The Drug and Medical Device Development A Strategic Approach - Online Program, learners should be able to:

  • Look at the bigger picture, i.e., the entire medical device and drug development process, from day one of strategic planning through to product commercialization.
  • Identify the risks and rewards associated with developing a new product in the healthcare market.
  • Understand the relationship between strategy and development and how they affect one another.
  • Understand the regulatory requirements in the US market and the approval process. 
  • Develop professional networks for career development, strategic alliances, or industry partnerships.

Who it is for

The Drug and Medical Device Development A Strategic Approach - Online Program training is best suited for:

  • Regulatory affairs and quality assurance professionals
  • Scientists and leaders of research and development teams
  • Professionals entering the healthcare industry horizontally
  • Entrepreneurs looking to launch a product or service in the US healthcare market
  • Engineers involved in the development of pharmaceuticals and new medical devices.
  • Executives in the medical devices and drug development, product management field.
  • Companies that are looking to train employees and new hires on the entire medical devices and pharmaceuticals development process.

Admission Details

Step 1: Open the course page for ‘The Drug and Medical Device Development A Strategic Approach - Online Program’ here: https://executive-ed.xpro.mit.edu/drug-and-medical-device-dev/success?thank_you=true

Step 2: You will find the ‘Apply Now’ tab located at the bottom of the course webpage, click on it.

Step 3: Use your credentials to log in to your account or create a new account.

Step 4: Complete the application form and pay the programme fee to finish the enrolment process.

Application Details

You will have to provide your personal and professional (work experience) information, contact details, etc. to apply for the Drug and Medical Device Development A Strategic Approach - Online Program certification course.

The Syllabus

  • Recognize and minimize risks
  • Examine the strategic role of reimbursement
  • Explore how having a “Proof of Concept” test is vital to development
  • Explore the intricate dynamics of the pharmaceutical supply chain, including the influence of wholesalers, pharmacy benefit managers (PBMs), and manufacturers
  • Gain insights into risk management, strategic positioning, and navigating the complexities of bringing innovative medicines to market

  • 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
  • Gain further understanding of patent strategies
  • Manage IP assets and navigate the complexities of product development in the pharmaceutical industry

  • Design a quality study
  • Apply quality systems to clinical trials
  • Discover important regulatory pathways
  • Gain deeper understanding of design controls, documentation, and the intricacies of developing medical diagnostics
  • Maintain high-quality standards, adhere to regulatory requirements, and effectively manage medical device development projects

  • 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
  • Understand the challenges and breakthroughs in ovarian cancer screening, innovative colon cancer screening methods, and the complexities of obtaining reimbursement for medical tests
  • Develop a comprehensive understanding of integrating innovative diagnostic technologies into the healthcare system, from development to market adoption

  • 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
  • Explore the evolution and impact of Electronic Health Records (EHRs) on healthcare, as well as the role of Artificial Intelligence (AI) in medicine, offering innovative solutions for patient care and data management
  • Gain a deeper understanding of integrating technology, drug discovery, and pharmacokinetics in pharmaceutical development

  • 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

Instructors

MIT Cambridge Frequently Asked Questions (FAQ's)

1: Do I have to pay the entire fee upfront?

No, if you are unable to pay the entire amount upfront, there are flexible payment options available. You can pay in two or three installments.

2: Do I have to pay additionally for the certificate?

No, the course fee includes the cost of the certificate.

3: Will I receive a physical certificate?

No, you will receive a digital certificate via email.

4: What is the duration of this course?

The Drug and Medical Device Development A Strategic Approach - Online Program is an eight-week course.

5: How much do I need to score to get the certificate?

You need to score 80% or more to pass and receive your certificate. 

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