Get Free Access to the First Two Modules of Design Input Essentials!
Unlock exclusive access to the first two modules of the Design Input Essentials course—designed to provide practical tools and knowledge to improve your design input process.
Start Learning for Free
Get Free Access to the First Two Modules of Design Input Essentials!
Unlock exclusive access to the first two modules of the Design Input Essentials course—designed to provide practical tools and knowledge to improve your design input process.
Start Learning for Free
Get Free Access to the First Two Modules of Design Input Essentials!
Unlock exclusive access to the first two modules of the Design Input Essentials course—designed to provide practical tools and knowledge to improve your design input process.
Start Learning for FreeWhy Should You Sign Up?
Real Value, Zero Risk
These two modules are packed with actionable lessons that will give you a taste of what our full course offers.
Why Should You Sign Up?
Instant Access to Module 1 & 2
Gain foundational insights and real-world applications without any cost!
Boost Your Skills
Get a head start with expert content on critical thinking and creating high-quality design inputs.
Learn from the best
See for yourself why industry professionals trust this course to level up their skills.
Sign up now for free access to Module 1 & Module 2
and take the first step toward mastering design inputs for medical devices!
Sign up now for free access to Module 1 & Module 2
and take the first step toward mastering design inputs for medical devices!
Sign up now for free access to Module 1 & Module 2
and take the first step toward mastering design inputs for medical devices!
Sign up now for free access to Module 1 & Module 2
and take the first step toward mastering design inputs for medical devices!
What’s Inside
Module 1: Course Introduction and Overview
Lesson 1: Introduction and Course Overview
- In this lesson, you'll be welcomed to the course and introduced to its main focus: Design Inputs for medical devices and combination products. You'll also learn about Ventura Solutions' mission and why this course exists.
Lesson 2: Instructor Background and Company Expertise
- This lesson overviews the instructor’s professional background, including key accomplishments and industry experience. Additionally, you'll learn about Ventura Solutions' areas of expertise and the comprehensive services they offer to the medical device and combination products industry.
Lesson 3: Course Purpose and Learning Objectives
- Here, you'll explore the purpose of the course and understand its objectives. This lesson covers what you'll gain from the course, including practical skills and knowledge. It also clarifies what topics are not covered in this training.
Lesson 4: Disclaimers and Legal Notices
- The final lesson of this module addresses important legal notices, including copyright information and disclaimers about the course content.
Module 2: General Overview
Lesson 1: Regulatory Requirements for Design Inputs
- This lesson covers the FDA and ISO requirements for design inputs. You’ll learn about the specific regulations and standards that dictate how design inputs should be documented, reviewed, and approved.
Lesson 2: Key Terminology and Concepts
- This lesson defines essential terms related to design inputs, such as user needs, stakeholder needs, risk controls, design inputs, design verification, and design validation. Understanding these terms is crucial for effectively managing design inputs throughout the development process.
Lesson 3: Importance of Great Design Inputs
- This lesson highlights the value of creating robust design inputs. You’ll learn how well-defined design inputs can lead to cost savings, accelerated product development, and improved product quality, as well as their impact on regulatory compliance and user experience.
Lesson 4: Design Input Team and Prioritization
- This lesson discusses the composition and responsibilities of the design input team. It also covers prioritizing design inputs based on their importance and impact on device functionality and safety.
Lesson 5: Defining Patient, User, and Use Environments
- This lesson emphasizes the importance of understanding the patient, user, and use environments when defining design inputs. You’ll learn how to tailor design requirements to meet the specific needs of the users and patients.
Lesson 6: Time Management and Development Phases
- This lesson covers the recommended time allocation for design inputs and provides an overview of the medical device product development phases. You’ll understand how to balance time spent on design inputs with other stages of development.
Lesson 7: Practical Examples and Applications
- This lesson provides practical examples of design controls, including a case study on prefilled syringes. It covers design inputs, design outputs, and the verification and validation process, demonstrating how these concepts are applied in real-world scenarios.
Module 3: Sources for Design Inputs
Lesson 1: Introduction to Sources for Design Inputs
- Gain a foundational understanding of the diverse sources that contribute to creating effective design inputs, setting the stage for deeper exploration in subsequent lessons.
Lesson 2: Various Sources for Design Inputs
- Explore an overview of the key sources that inform the creation of design inputs, including both internal and external data sources.
Access Restricted This content is exclusive to students who have purchased the full course.
Module 4: Adequacy of Design Inputs
Lesson 1: Adequacy of Design Input
- Understand what makes a design input adequate, setting the foundation for developing clear and effective requirements.
Lesson 2: Design Inputs Shall be Verifiable
- Learn the importance of creating design inputs that can be objectively verified.
Access Restricted This content is exclusive to students who have purchased the full course.
Module 5: Types of Requirements
Lesson 1: Overview of Design Input Types
- This lesson provides an overview of the various types of design inputs that will be covered in the module. It introduces the importance of clearly defining design inputs to ensure product safety, performance, and regulatory compliance. The lesson sets the stage for a detailed examination of each type of design input, highlighting the role and significance of each type of design input in the overall design process.
Lesson 2: Physical Design Inputs
- In this lesson, we delve into physical design inputs pertaining to a product's tangible attributes, such as size, shape, weight, and other constraints. Understanding physical design inputs is critical for ensuring that products meet all necessary physical specifications.
Lesson 3: Performance Design Inputs
- Performance design inputs are focused on how well a product functions. This lesson discusses how to define these inputs to ensure that the product performs as expected, addressing criteria such as speed, efficiency, accuracy, and response time.
Access Restricted This content is exclusive to students who have purchased the full course.
Module 6: Tools for Creating Design Inputs
Lesson 1: Overview of Tools
- This introductory lesson provides an overview of the tools and techniques covered in this module. It explains the importance of using structured methods to create design inputs and how these tools can help ensure that all requirements are accurately captured and documented. The lesson sets the stage for a deeper dive into each specific tool, highlighting their relevance in different stages of the design process.
Lesson 2: Trace Matrix
- This lesson explores the Trace Matrix, a critical tool for ensuring traceability throughout the design and development process. The Trace Matrix helps map design inputs to corresponding user needs, regulatory requirements, risk controls, and other relevant criteria, ensuring that nothing is overlooked. This lesson covers how to create and use a Trace Matrix, including best practices for maintaining traceability from initial requirements to final product verification.
Access Restricted This content is exclusive to students who have purchased the full course.
Module 7: Economics of Design Inputs
Lesson 1: Overview of Economic Considerations
- Importance of considering economics in design inputs to balance cost, timeline, and resource use without compromising safety and efficacy.
Lesson 2: Level of Detail in Design Inputs
- Need for precision without over-engineering. Design inputs should be detailed but not overly detailed, avoiding unnecessary resource use and complexity.
Access Restricted This content is exclusive to students who have purchased the full course.
Module 8: How to Get Design Inputs Approved
Lesson 1: Getting Design Inputs Approved
- Learn the key steps and requirements for getting design inputs approved, focusing on understanding the approval process, essential documentation, and stakeholder involvement.
Lesson 2: Importance of Early Engagement
- Explore why early engagement with stakeholders is critical to the success of design input approval. This lesson emphasizes building relationships and gathering feedback early in the process.
Lesson 3: Gain Early Agreement
- Discover the benefits of gaining early agreement on design inputs with all involved parties. Learn techniques for reaching consensus and reducing potential conflicts.
Access Restricted This content is exclusive to students who have purchased the full course.
What’s Inside
Module 1: Course Introduction and Overview
Lesson 1: Introduction and Course Overview
- In this lesson, you'll be welcomed to the course and introduced to its main focus: Design Inputs for medical devices and combination products. You'll also learn about Ventura Solutions' mission and why this course exists.
Lesson 2: Instructor Background and Company Expertise
- This lesson overviews the instructor’s professional background, including key accomplishments and industry experience. Additionally, you'll learn about Ventura Solutions' areas of expertise and the comprehensive services they offer to the medical device and combination products industry.
Lesson 3: Course Purpose and Learning Objectives
- Here, you'll explore the purpose of the course and understand its objectives. This lesson covers what you'll gain from the course, including practical skills and knowledge. It also clarifies what topics are not covered in this training.
Lesson 4: Disclaimers and Legal Notices
- The final lesson of this module addresses important legal notices, including copyright information and disclaimers about the course content.
Module 2: General Overview
Lesson 1: Regulatory Requirements for Design Inputs
- This lesson covers the FDA and ISO requirements for design inputs. You’ll learn about the specific regulations and standards that dictate how design inputs should be documented, reviewed, and approved.
Lesson 2: Key Terminology and Concepts
- This lesson defines essential terms related to design inputs, such as user needs, stakeholder needs, risk controls, design inputs, design verification, and design validation. Understanding these terms is crucial for effectively managing design inputs throughout the development process.
Lesson 3: Importance of Great Design Inputs
- This lesson highlights the value of creating robust design inputs. You’ll learn how well-defined design inputs can lead to cost savings, accelerated product development, and improved product quality, as well as their impact on regulatory compliance and user experience.
Lesson 4: Design Input Team and Prioritization
- This lesson discusses the composition and responsibilities of the design input team. It also covers prioritizing design inputs based on their importance and impact on device functionality and safety.
Lesson 5: Defining Patient, User, and Use Environments
- This lesson emphasizes the importance of understanding the patient, user, and use environments when defining design inputs. You’ll learn how to tailor design requirements to meet the specific needs of the users and patients.
Lesson 6: Time Management and Development Phases
- This lesson covers the recommended time allocation for design inputs and provides an overview of the medical device product development phases. You’ll understand how to balance time spent on design inputs with other stages of development.
Lesson 7: Practical Examples and Applications
- This lesson provides practical examples of design controls, including a case study on prefilled syringes. It covers design inputs, design outputs, and the verification and validation process, demonstrating how these concepts are applied in real-world scenarios.
Module 3: Sources for Design Inputs
Lesson 1: Introduction to Sources for Design Inputs
- Gain a foundational understanding of the diverse sources that contribute to creating effective design inputs, setting the stage for deeper exploration in subsequent lessons.
Lesson 2: Various Sources for Design Inputs
- Explore an overview of the key sources that inform the creation of design inputs, including both internal and external data sources.
Access Restricted This content is exclusive to students who have purchased the full course.
Module 4: Adequacy of Design Inputs
Lesson 1: Adequacy of Design Input
- Understand what makes a design input adequate, setting the foundation for developing clear and effective requirements.
Lesson 2: Design Inputs Shall be Verifiable
- Learn the importance of creating design inputs that can be objectively verified.
Access Restricted This content is exclusive to students who have purchased the full course.
Module 5: Types of Requirements
Lesson 1: Overview of Design Input Types
- This lesson provides an overview of the various types of design inputs that will be covered in the module. It introduces the importance of clearly defining design inputs to ensure product safety, performance, and regulatory compliance. The lesson sets the stage for a detailed examination of each type of design input, highlighting the role and significance of each type of design input in the overall design process.
Lesson 2: Physical Design Inputs
- In this lesson, we delve into physical design inputs pertaining to a product's tangible attributes, such as size, shape, weight, and other constraints. Understanding physical design inputs is critical for ensuring that products meet all necessary physical specifications.
Lesson 3: Performance Design Inputs
- Performance design inputs are focused on how well a product functions. This lesson discusses how to define these inputs to ensure that the product performs as expected, addressing criteria such as speed, efficiency, accuracy, and response time.
Access Restricted This content is exclusive to students who have purchased the full course.
Module 6: Tools for Creating Design Inputs
Lesson 1: Overview of Tools
- This introductory lesson provides an overview of the tools and techniques covered in this module. It explains the importance of using structured methods to create design inputs and how these tools can help ensure that all requirements are accurately captured and documented. The lesson sets the stage for a deeper dive into each specific tool, highlighting their relevance in different stages of the design process.
Lesson 2: Trace Matrix
- This lesson explores the Trace Matrix, a critical tool for ensuring traceability throughout the design and development process. The Trace Matrix helps map design inputs to corresponding user needs, regulatory requirements, risk controls, and other relevant criteria, ensuring that nothing is overlooked. This lesson covers how to create and use a Trace Matrix, including best practices for maintaining traceability from initial requirements to final product verification.
Access Restricted This content is exclusive to students who have purchased the full course.
Module 7: Economics of Design Inputs
Lesson 1: Overview of Economic Considerations
- Importance of considering economics in design inputs to balance cost, timeline, and resource use without compromising safety and efficacy.
Lesson 2: Level of Detail in Design Inputs
- Need for precision without over-engineering. Design inputs should be detailed but not overly detailed, avoiding unnecessary resource use and complexity.
Access Restricted This content is exclusive to students who have purchased the full course.
Module 8: How to Get Design Inputs Approved
Lesson 1: Getting Design Inputs Approved
- Learn the key steps and requirements for getting design inputs approved, focusing on understanding the approval process, essential documentation, and stakeholder involvement.
Lesson 2: Importance of Early Engagement
- Explore why early engagement with stakeholders is critical to the success of design input approval. This lesson emphasizes building relationships and gathering feedback early in the process.
Lesson 3: Gain Early Agreement
- Discover the benefits of gaining early agreement on design inputs with all involved parties. Learn techniques for reaching consensus and reducing potential conflicts.
Access Restricted This content is exclusive to students who have purchased the full course.
About Your Instructor
-
Extensive experience in:
-
Product development, design controls, risk management, manufacturing, project management, quality, regulatory, sales, marketing, and commercialization.
-
Building high-performing teams
-
Leading and implementing the creation of countless Design History and Risk Management Files.
-
Prior employment experience at Baxter Healthcare, Hospira, Pfizer, and many other consulting clients.
-
R&D Combination Products Systems Engineering manager. Responsible for all DHF’s, Risk Management Files and Product Development.
-
Created a Medical Device company from a napkin sketch and brought it to a commercial deal.
-
One of the Inventors of the V Needle, cost-effective integrated solution to Venous Needle Dislodgement (VND). VND is one of the biggest patient risks associated with hemodialysis. Multiple global patents issued.
-
Raised capital, built a team, implemented an ISO 13485 electronic quality system, and led all product development. Also led all regulatory submissions and FDA interactions.
-
Bachelor’s degree in Biomedical Engineering with a minor in Electrical Engineering from the University of Illinois at Chicago. Master’s degree in Mechanical and Aerospace Engineering from the Illinois Institute of Technology.
About Your Instructor
-
Extensive experience in:
-
Product development, design controls, risk management, manufacturing, project management, quality, regulatory, sales, marketing, and commercialization.
-
Building high-performing teams
-
Leading and implementing the creation of countless Design History and Risk Management Files.
-
Prior employment experience at Baxter Healthcare, Hospira, Pfizer, and many other consulting clients.
-
R&D Combination Products Systems Engineering manager. Responsible for all DHF’s, Risk Management Files and Product Development.
-
Created a Medical Device company from a napkin sketch and brought it to a commercial deal.
-
One of the Inventors of the V Needle, cost-effective integrated solution to Venous Needle Dislodgement (VND). VND is one of the biggest patient risks associated with hemodialysis. Multiple global patents issued.
-
Raised capital, built a team, implemented an ISO 13485 electronic quality system, and led all product development. Also led all regulatory submissions and FDA interactions.
-
Bachelor’s degree in Biomedical Engineering with a minor in Electrical Engineering from the University of Illinois at Chicago. Master’s degree in Mechanical and Aerospace Engineering from the Illinois Institute of Technology.
FAQS
What is included in the mini-course?
The mini-course offers a curated selection of lessons from the full Design Input Essentials course. You’ll get a sneak peek into key concepts and strategies to help you define and manage design inputs effectively.
How long does the mini-course take to complete?
The mini-course is designed to be concise and impactful, taking approximately 2 hours to complete at your own pace.
What if I want more content after completing the mini-course?
If you enjoy the mini-course, you can upgrade to the full Design Input Essentials course for access to in-depth lessons, additional resources, and templates.
What will I learn in the mini-course?
The mini-course covers essential concepts of design inputs, giving you a foundation in defining and managing inputs for product development.
What is the Design Input Essentials course about?
This course equips you with the knowledge and tools to define and manage design inputs, ensuring compliance with industry regulations and supporting the development of safe and effective medical devices or combination products.
How much does the mini-course cost?
The mini-course is completely free and serves as an introduction to the full Design Input Essentials course.
Can I upgrade to the full course after completing the mini-course?
Yes! You can upgrade anytime to unlock the full course’s comprehensive lessons, resources, and templates.
Do I get any resources or materials with the mini-course?
Yes, the mini-course includes select resources and examples to help you apply the concepts covered. For full access to all templates and tools, consider upgrading to the complete course.
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