MedTech Product Development from edX

Have an idea for a Health Technology device, but don't know where to begin? ****

Course 2: Product Development is the second course in the MEDTECH FUNDAMENTALS by NEMIC Virtual Classroom Certificate Program, and serves to take a deep-dive into the highly-regulated MedTech commercial space. Course 2 contains 6 modules:

Product Development 101
Research Usability + Human Factors
Product Development 102
Regulatory Affairs 101
Quality Assurance 101
Clinical Trials + Validation

Researched, developed, and delivered by industry professionals from some of the world's most admired and successful companies in Health Tech, Product Development will both broaden and deepen the learners' knowledge in the space.

In this course, NEMIC Advisors will guide you through a series of activities that will break down barriers to FDA navigation, multi-phase development of a med device, unpack clinical trials, and more.

Come experience the most succinct, comprehensive MedTech education available.

What you'll learn

Product Development 101:

Development lifecycle
Multi-phase development approach
Discovery, engineering + verification

Research Usability + Human Factors:

Human-centered design specifications
Usability research
Risk mitigation, minmize user error
Verification + validation testing concepts

Product Development 102

Multi-phase development approach [continued]
Pilots
Post-market surveillance

Regulatory Affiars:

"Laws" of the MedTech world
Key regulatory concerns and requirements
FDA submission requirements

Quality Assurance 101:

FDA quality requirements navigation
FDA systems navigation
How to avoid costly pitfalls

Clinical Trials + Validation

Various types of clinical trials
How to plan and manage clinical trials
How to partner with clinical research organizations [CROs].

What's inside

Learning objectives

Development lifecycle
Multi-phase development approach
Discovery, engineering + verification
Human-centered design specifications
Usability research
Risk mitigation, minmize user error
Verification + validation testing concepts
Multi-phase development approach [continued]
Pilots
Post-market surveillance

"laws" of the medtech world
Key regulatory concerns and requirements
Fda submission requirements
Fda quality requirements navigation
Fda systems navigation
How to avoid costly pitfalls
Various types of clinical trials
How to plan and manage clinical trials
How to partner with clinical research organizations [cros].

Development lifecycle
Multi-phase development approach
Discovery, engineering + verification
Human-centered design specifications
Usability research
Risk mitigation, minmize user error
Verification + validation testing concepts
Multi-phase development approach [continued]
Pilots
Post-market surveillance
"laws" of the medtech world
Key regulatory concerns and requirements
Fda submission requirements
Fda quality requirements navigation
Fda systems navigation
How to avoid costly pitfalls
Various types of clinical trials
How to plan and manage clinical trials
How to partner with clinical research organizations [cros].

Good to know

Know what's good

, what to watch for

, and possible dealbreakers

Examines development lifecycle and multi-phase development approach, which are standard in the MedTech product development industry

Explores human-centered design specifications, usability research, risk mitigation, and verification and validation testing concepts

Covers multi-phase development approach, pilots, and post-market surveillance, which are key stages in MedTech product development

Examines regulatory affairs, key regulatory concerns, and FDA submission requirements, which are essential for navigating regulatory compliance

Covers FDA quality requirements and FDA systems navigation, which are important for ensuring product quality and compliance

Explores clinical trials and validation, which are key steps in the MedTech product development process

Activities

Be better prepared before your course. Deepen your understanding during and after it. Supplement your coursework and achieve mastery of the topics covered in MedTech Product Development with these activities:

Explore online tutorials on various topics within product development

Show steps

Expand your knowledge and skills by exploring online tutorials on specific topics related to product development in the medical technology industry.

Browse courses on Product Development

Show steps

Identify specific areas or topics within product development that you're interested in learning more about.
Search for online tutorials or courses that cover these topics.
Follow the tutorials and complete the exercises or activities provided.
Take notes or summarize the key takeaways from the tutorials.

Review: terminology and concepts in health tech

Show steps

Sharpen your understanding of health tech vocabulary, including terms related to product design, regulatory affairs, quality assurance, and product trials.

Show steps

Review terms and definitions in course syllabus

Get started by reading 'The Biomedical Engineering Handbook, 6th Edition'

Show steps

Reinforce core concepts and strategies related to product development in the medical technology industry.

View Molecular, Cellular, and Tissue Engineering on Amazon

Show steps

Read the preface and introduction of the book.
Focus on the sections that are directly related to the specific modules you're covering in course 2.
Take notes and highlight important details during your reading sessions.
Refer back to the book as you progress through the course for further clarification or support.

Six other activities

Expand to see all activities and additional details

Show all nine activities

Tutorial: Product Development Lifecycle (PDLC)

Show steps

Delve into the stages of the PDLC, from ideation to commercialization, to gain a comprehensive understanding of the product development process in the health tech industry.

Browse courses on Product Development Lifecycle

Show steps

Complete module 1: PDLC 101 in the NEMIC Virtual Classroom
Follow tutorial on PDLC by [Insert Tutorial Link]

Develop a concept for a health technology product

Show steps

Foster creativity and innovation by challenging you to generate ideas and develop a concept for a health technology product.

Browse courses on Product Development

Show steps

Identify a specific healthcare need or problem that you want to address.
Research existing solutions and technologies related to your identified need.
Brainstorm a range of potential product concepts that could fulfill the identified need.
Evaluate and refine your product concept based on market research and feedback.
Create a brief product description or presentation outlining your concept.

Write a summary of the key concepts and steps involved in the product development lifecycle

Show steps

Enhance your understanding and retention of the product development lifecycle by writing a comprehensive summary of the key concepts and steps involved.

Browse courses on Product Development

Show steps

Review the course materials and identify the key concepts and steps of the product development lifecycle.
Organize and structure your summary in a logical and coherent manner.
Use clear and concise language to explain the concepts and steps.
Provide examples or illustrations to support your explanations.

Compile a resource list of tools, frameworks, and guidelines for product development in health technology

Show steps

Enhance your toolkit by compiling a comprehensive resource list of tools, frameworks, and guidelines that can support your product development efforts in the medical technology industry.

Browse courses on Product Development

Show steps

Research and identify reputable sources that provide information on tools, frameworks, and guidelines for product development in health technology.
Evaluate and select the most relevant and useful resources.
Organize and categorize the resources in a clear and accessible manner.
Share your resource list with your fellow learners or industry professionals.

Solve practice questions and case studies related to product development

Show steps

Test your understanding and problem-solving skills by solving practice questions and case studies related to product development in the medical technology industry.

Browse courses on Product Development

Show steps

Find online resources or textbooks that provide practice questions or case studies.
Attempt to solve the questions or case studies on your own.
Review the solutions or answers provided.
Identify areas where you need further clarification or practice.

Conduct a mock FDA submission for a health technology product

Show steps

Gain practical experience in navigating the FDA regulatory process by conducting a mock submission for a health technology product.

Browse courses on Regulatory Affairs

Show steps

Choose a specific health technology product concept or idea.
Research and gather the necessary information and data to support your submission.
Follow the FDA guidelines and requirements for the type of submission you're preparing.
Prepare the necessary documentation, including a cover letter, executive summary, and technical sections.
Submit your mock submission and review the feedback or critique you receive.

Career center

Learners who complete MedTech Product Development will develop knowledge and skills that may be useful to these careers:

Medical Device Product Manager

Medical Device Product Managers are responsible for the development and launch of new medical devices. They work with engineers, designers, and marketing professionals to bring new products to market. This course will help you learn about the product development process, including the regulatory requirements and the clinical trials process.

See salaries and explore the career path for Medical Device Product Manager

Medical Device Engineer

Medical Device Engineers are responsible for the design and development of new medical devices. They work with product managers, regulatory affairs specialists, and quality assurance managers to ensure that medical devices are safe and effective. This course will help you learn about the medical device engineering process, including the different types of medical devices and the regulatory requirements.

See salaries and explore the career path for Medical Device Engineer

Medical Device Regulatory Affairs Specialist

Medical Device Regulatory Affairs Specialists are responsible for ensuring that medical devices comply with all applicable regulations. They work with the FDA and other regulatory agencies to ensure that medical devices are safe and effective. This course will help you learn about the regulatory requirements for medical devices, including the FDA submission process.

See salaries and explore the career path for Medical Device Regulatory Affairs Specialist

Medical Device Quality Assurance Manager

Medical Device Quality Assurance Managers are responsible for ensuring that medical devices are manufactured in accordance with all applicable quality standards. They work with engineers, production staff, and quality control personnel to ensure that medical devices are safe and effective. This course will help you learn about the quality assurance process for medical devices, including the FDA quality requirements.

See salaries and explore the career path for Medical Device Quality Assurance Manager

Regulatory Affairs Manager

Regulatory Affairs Managers are responsible for ensuring that medical devices comply with all applicable regulations. They work with product managers, quality assurance managers, and sales representatives to ensure that medical devices are safe and effective. This course will help you learn about the regulatory affairs process, including the different types of regulations and the regulatory requirements.

See salaries and explore the career path for Regulatory Affairs Manager

Medical Device Sales Representative

As a Medical Device Sales Representative, you will be responsible for selling medical devices and equipment to hospitals, clinics, and other healthcare providers. This course will help you learn about the medical device industry, including the regulatory environment and the different types of medical devices available. You will also learn about sales techniques and how to build relationships with healthcare providers.

See salaries and explore the career path for Medical Device Sales Representative

Quality Assurance Manager

Quality Assurance Managers are responsible for ensuring that medical devices are manufactured in accordance with all applicable quality standards. They work with engineers, production staff, and quality control personnel to ensure that medical devices are safe and effective. This course will help you learn about the quality assurance process, including the different types of quality standards and the regulatory requirements.

See salaries and explore the career path for Quality Assurance Manager

Medical Device Marketer

Medical Device Marketers are responsible for developing and implementing marketing campaigns for new medical devices. They work with sales representatives, product managers, and regulatory affairs specialists to ensure that marketing materials are accurate and compliant with all applicable regulations. This course will help you learn about the medical device marketing process, including the different types of marketing materials and the regulatory requirements.

See salaries and explore the career path for Medical Device Marketer

Clinical Research Associate

Clinical Research Associates are responsible for conducting clinical trials for new medical devices. They work with investigators, patients, and regulatory agencies to ensure that clinical trials are conducted in accordance with all applicable regulations. This course will help you learn about the clinical trials process, including the different types of clinical trials and the regulatory requirements.

See salaries and explore the career path for Clinical Research Associate

Medical Device Distributor

Medical Device Distributors sell and distribute medical devices to hospitals, clinics, and other healthcare providers. They work with manufacturers, sales representatives, and product managers to ensure that medical devices are available to patients. This course will help you learn about the medical device distribution process, including the different types of medical devices and the regulatory requirements.

See salaries and explore the career path for Medical Device Distributor

Healthcare Consultant

Healthcare Consultants provide advice to healthcare organizations on a variety of topics, including medical device development and clinical trials. They work with hospitals, clinics, and other healthcare providers to help them improve their operations and outcomes. This course will help you learn about the healthcare consulting process, including the different types of consulting services and the regulatory requirements.

See salaries and explore the career path for Healthcare Consultant

Patent Attorney

Patent Attorneys are responsible for drafting and prosecuting patent applications for new medical devices. They work with inventors, engineers, and product managers to ensure that patent applications are accurate and compliant with all applicable laws. This course will help you learn about the patent process, including the different types of patents and the regulatory requirements.

See salaries and explore the career path for Patent Attorney

Biostatistician

Biostatisticians are responsible for designing and analyzing clinical trials. They work with researchers to ensure that clinical trials are conducted in accordance with all applicable regulations and that the data collected is accurate and reliable. This course will help you learn about the biostatistics process, including the different types of statistical analyses and the regulatory requirements.

See salaries and explore the career path for Biostatistician

Venture Capitalist

Venture Capitalists invest in new businesses, including medical device companies. They work with entrepreneurs to help them develop their business plans and raise capital. This course will help you learn about the venture capital process, including the different types of venture capital funds and the regulatory requirements.

See salaries and explore the career path for Venture Capitalist

Medical Writer

Medical Writers are responsible for writing a variety of documents, including clinical trial protocols, regulatory submissions, and marketing materials. They work with medical experts to ensure that the information they write is accurate and up-to-date. This course will help you learn about the medical writing process, including the different types of medical writing and the regulatory requirements.

See salaries and explore the career path for Medical Writer