{"id":626,"date":"2021-02-19T02:02:09","date_gmt":"2021-02-19T02:02:09","guid":{"rendered":"http:\/\/www.tgfrconsulting.com\/blog\/?p=626"},"modified":"2024-01-20T22:44:14","modified_gmt":"2024-01-20T22:44:14","slug":"concept-elaboration","status":"publish","type":"post","link":"https:\/\/www.tgfrconsulting.com\/blog\/archived\/concept-elaboration\/","title":{"rendered":"Concept Elaboration"},"content":{"rendered":"
\n\n\n

Elaborating the concept integrates the results of the concept definition into a complete system definition, the design inputs.<\/p>\n\n\n\n

Concept Elaboration SIPOC<\/p>\n\n\n\n

\n
\n
\n
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Inputs<\/td>Key Activities<\/td>Outputs<\/td><\/tr>
Clinical Use<\/strong>
Clear understanding of the overall therapy, workflow and risks associated with the seminal idea

Selected Concept<\/strong>
The concept output, including the CTQs from the concept selection process

Standards<\/strong>
Regulatory as well as business standards consistent with the markets for the product

Manufacturing Capability<\/strong>
Characterization of capacity, measurement systems and process capability<\/td>		Task and Preliminary Hazard Analysis<\/strong>
a structured analysis of the clinical application to develop system modes of operations and the hazards associated with the use of the system.


Architecture Elaboration<\/strong>
Breaking the system down to into subsystems


Requirements Elaboration<\/strong>
Translation of the Performance Parameters, CTQs and concept into the system definition (use cases, requirements, architecture and interfaces)

Final Concept Confirmation<\/strong>
The final confirmation of the concept with the users<\/td>		System Definition (Design Inputs)
\u00b7         Task Analysis
\u00b7         Preliminary Hazard Analysis
\u00b7         System Architecture
\u00b7         Use Specifications
\u00b7         System Requirements
\u00b7         Interface Requirements<\/td><\/tr><\/tbody><\/table>
Concept Elaboration SIPOC<\/figcaption><\/figure>\n<\/div>\n<\/div>\n<\/div><\/div>\n<\/div>\n<\/div>\n<\/div><\/div>\n\n\n\n

The overall workflow is as shown in the following<\/p>\n\n\n\n

\"\"
Concept Elaboration Workflow
<\/figcaption><\/figure>\n\n\n\n

Architecture and Elaboration translates the inputs into requirements, integrating the selected concept with regulatory standards, the VOB and Manufacturing Capability as well as the tasks and risk controls defined by the intended use.  The finished requirements define the device and will serve as the basis for all other design and development activities.<\/p>\n\n\n\n

<\/p>\n\n\n<\/div>","protected":false},"excerpt":{"rendered":"

Elaborating the concept integrates the results of the concept definition into a complete system definition, the design inputs.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[61,3],"tags":[58,23],"class_list":{"0":"post-626","1":"post","2":"type-post","3":"status-publish","4":"format-standard","6":"category-archived","7":"category-concept-creation","8":"tag-concept-elaboration","9":"tag-qfd-medical-device-development","10":"anons"},"yoast_head":"\nConcept Elaboration - TGFR Consulting LLC<\/title>\n<meta name=\"description\" content=\"Concept elaboration integrates the results of the concept definition into a complete system definition, the design inputs.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/concept-elaboration\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Concept Elaboration - TGFR Consulting LLC\" \/>\n<meta property=\"og:description\" content=\"Concept elaboration integrates the results of the concept definition into a complete system definition, the design inputs.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/concept-elaboration\/\" \/>\n<meta property=\"og:site_name\" content=\"TGFR Consulting LLC\" \/>\n<meta property=\"article:published_time\" content=\"2021-02-19T02:02:09+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-01-20T22:44:14+00:00\" \/>\n<meta property=\"og:image\" content=\"http:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2020\/08\/Blog-7-Figure-10-1024x669.png\" \/>\n<meta name=\"author\" content=\"John Howells\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"John Howells\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/concept-elaboration\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/concept-elaboration\/\"},\"author\":{\"name\":\"John Howells\",\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/#\/schema\/person\/c95f178c9706582822ab93f4699a1bf8\"},\"headline\":\"Concept Elaboration\",\"datePublished\":\"2021-02-19T02:02:09+00:00\",\"dateModified\":\"2024-01-20T22:44:14+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/concept-elaboration\/\"},\"wordCount\":282,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/concept-elaboration\/#primaryimage\"},\"thumbnailUrl\":\"http:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2020\/08\/Blog-7-Figure-10-1024x669.png\",\"keywords\":[\"Concept Elaboration\",\"QFD. 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