{"id":587,"date":"2020-09-10T21:49:37","date_gmt":"2020-09-10T21:49:37","guid":{"rendered":"http:\/\/www.tgfrconsulting.com\/blog\/?p=587"},"modified":"2024-01-20T22:22:50","modified_gmt":"2024-01-20T22:22:50","slug":"introduction-to-the-2nd-edition-of-the-cascade-building-a-medical-device","status":"publish","type":"post","link":"https:\/\/www.tgfrconsulting.com\/blog\/archived\/general\/introduction-to-the-2nd-edition-of-the-cascade-building-a-medical-device\/","title":{"rendered":"Introduction to the 2nd Edition of the Cascade, Building a Medical Device"},"content":{"rendered":"<div class=\"entry\">\n\n\n<p>The 2nd edition of the Cascade, Building a Medical Device, details a process of developing a medical device, taking the reader from the initial idea through to the realization of the complete medical device.&nbsp;&nbsp; Along the way, the reader will be introduced to a wide range of tools and techniques that will facilitate each of the critical activities.&nbsp; While these tools do not represent the only tools that can be employed, these tools are simple and have been shown to work.&nbsp; With this process outline and proven tools in this blog, the development of a medical device becomes simple, straightforward, and deterministic.<\/p>\n\n\n\n<p>Several things have changed since the 1<sup>st<\/sup> edition of the blog.&nbsp; In most cases regulations have aligned with best practices to make the process clearer.&nbsp; In other areas, experience has led to revised tools that make the process simpler.&nbsp; This edition reflects those changes.&nbsp;<\/p>\n\n\n\n<p>The process described here breaks down into two distinct cycles based upon an old paradigm:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Building the Right Device<\/strong> \u2013 defining the scope of the project and establishing the right requirements for the device<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Building the Device Right<\/strong> \u2013 executing on the development to create a robust design that meets the requirements for the device.<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Building the Device Right<\/strong><\/h3>\n\n\n\n<p>The process of building the right device starts with the Voice of the Customer (VOC) and the Voice of the Business (VOB) and defines the characteristics of a device must meet to satisfy to meet the customer and the business.&nbsp; Concept elaboration creates device concept that meets these characteristics as well as the needs of the medical intended use, regulatory standards.&nbsp; Every concept considers current manufacturing capability, whether internal or external.&nbsp; Finally, the concept is transformed into the system level requirements that define the device at a detail that allows the device to be built right.&nbsp; This is illustrated in the following figure<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"852\" src=\"http:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2020\/08\/Blog-1-Figure-1-1024x852.png\" alt=\"Building the Right Product\" class=\"wp-image-603\" srcset=\"https:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2020\/08\/Blog-1-Figure-1-1024x852.png 1024w, https:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2020\/08\/Blog-1-Figure-1-300x250.png 300w, https:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2020\/08\/Blog-1-Figure-1-768x639.png 768w, https:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2020\/08\/Blog-1-Figure-1.png 1329w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><figcaption>Figure 2 &#8211; Building the Right Product<\/figcaption><\/figure>\n\n\n\n<p>The following table details the tools used to realize the system requirements and use<\/p>\n\n\n\n<figure class=\"wp-block-table is-style-stripes\"><table><tbody><tr><td><strong>Tool<\/strong><\/td><td><strong>Use<\/strong><\/td><\/tr><tr><td>Five Whys and User<br>Needs Statements<\/td><td>Translate the Voice of the Customer into actionable user needs<\/td><\/tr><tr><td>The Spider Chart<\/td><td>Map the current condition, the best in class and device goals for the development against the user needs<\/td><\/tr><tr><td>The QFD<\/td><td>Translate user needs into CTQs, device features that<br>determine the success of the product<\/td><\/tr><tr><td>Risk Analysis<\/td><td>Establishing the risk controls that will ensure a safe and <br>effective product<\/td><\/tr><tr><td>The PUGH Matrix<\/td><td>Drive the objective concept selection<\/td><\/tr><\/tbody><\/table><figcaption> Tools Building the Right Product<\/figcaption><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Building the Device Right<\/strong> <\/h3>\n\n\n\n<p>Building the Device Right takes the concept, architecture and system requirements and translates these documents into a robust design, free of defects.&nbsp; Requirements translate to drawing to components, to assemblies and into the finished device.&nbsp; Verification confirms that the design meets the requirements, and validation confirms that the finished device meet the stated user needs and intended use.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"871\" src=\"http:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2020\/08\/Blog-1-Figure-2-1024x871.png\" alt=\"Building the Product Right\" class=\"wp-image-604\" srcset=\"https:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2020\/08\/Blog-1-Figure-2-1024x871.png 1024w, https:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2020\/08\/Blog-1-Figure-2-300x255.png 300w, https:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2020\/08\/Blog-1-Figure-2-768x654.png 768w, https:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2020\/08\/Blog-1-Figure-2.png 1329w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><figcaption>Figure 2 &#8211; Building the Product Right<\/figcaption><\/figure>\n\n\n\n<p>The following table details the tools used to realize the final device<\/p>\n\n\n\n<figure class=\"wp-block-table is-style-stripes\"><table><thead><tr><th><\/th><th><\/th><\/tr><\/thead><tbody><tr><td><strong>Tool<\/strong><\/td><td><strong>Use<\/strong><\/td><\/tr><tr><td>Requirements Flow<br>down with Transfer<br>Function<\/td><td>Using the concept of a transfer function to map system to subsystem requirements<\/td><\/tr><tr><td>Deployment Worksheet<\/td><td>Ensuring the consistency of the requirements flow down<\/td><\/tr><tr><td>N<sup>2<\/sup> Chart<\/td><td>Identifying the interactions between components of subsystems<\/td><\/tr><tr><td>Use Cases<\/td><td>Defining the user interaction with the design<\/td><\/tr><tr><td>Human Factors Testing<\/td><td>Ensuring the system meets the user needs<\/td><\/tr><\/tbody><\/table><figcaption>Tools &#8211; Building the Product Right<\/figcaption><\/figure>\n\n\n\n<p>Subsequent blogs will explore each of these activities, highlighting the tools and processes that will ensure a positive outcome.&nbsp; Please join us for the journey<\/p>\n\n\n\n<p><\/p>\n\n\n<\/div>","protected":false},"excerpt":{"rendered":"<p>This is the intro to the 2nd Edition of the book &#8220;The Cascade, Building a Medical Device&#8221;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[61,4],"tags":[49,50,51],"class_list":{"0":"post-587","1":"post","2":"type-post","3":"status-publish","4":"format-standard","6":"category-archived","7":"category-general","8":"tag-2nd-edition","9":"tag-cascade","10":"tag-introduction","11":"anons"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Introduction to the 2nd Edition of the Cascade, Building a Medical Device - TGFR Consulting LLC<\/title>\n<meta name=\"description\" content=\"Introducing the 2nd Edition of The Cascade, Developing a Medical Device. 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