{"id":238,"date":"2017-04-02T02:38:16","date_gmt":"2017-04-02T02:38:16","guid":{"rendered":"http:\/\/tgfrconsulting.com\/blog\/?p=238"},"modified":"2024-01-20T22:34:36","modified_gmt":"2024-01-20T22:34:36","slug":"elaborating-the-concept","status":"publish","type":"post","link":"https:\/\/www.tgfrconsulting.com\/blog\/archived\/elaborating-the-concept\/","title":{"rendered":"Elaborating the Concept"},"content":{"rendered":"
\n

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

Elaborating the Concept SIPOC<\/h2>\n\n\n\n\n\t\n\n\t
Inputs<\/th>Key Activities<\/th>Outputs<\/th>\n<\/tr>\n<\/thead>\n
Clinical Use<\/b>
\nClear understanding of the overall therapy, workflow and risks associated with the seminal idea <\/b>
\n
\nRisk Analysis and Essential Requirements<\/b>
\nThe phase, function and mitigations developed as part of the risk analysis step.
\n
\nCTQs <\/b>
\nThe key requirements identified as part of the concept selection process
\n
\nVOB \u2013 Business Requirements <\/b>
\nThe Needs of the business
\n
\nStandards<\/b>
\nRegulatory as well as business standards consistent with the markets for the product
\n
\nManufacturing Capability<\/b>
\nCharacterization of capacity, measurement systems and process capability
\n<\/td>		Use Case Development<\/b>
\nA structured analysis of the clinical application to develop system modes of operations and interactions with other elements
\n
\nArchitecture Elaboration<\/b>
\nBreaking the system down to into subsystems
\n
\n
\nRequirements Elaboration<\/b>
\nTranslation of the Performance Parameters, CTQs and concept into the system definition (use cases, requirements, architecture and interfaces)
\n
\nFinal Concept Confirmation<\/b>
\nThe final confirmation of the concept with the users
\n<\/td>		System Definition (Design Inputs)<\/b>
\n\u2022\tSystem and Subsystem Requirements
\n\u2022\tUse Cases, Risk Control
\n\u2022\tPreliminary Architecture and Interfaces
\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n

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

\"Elaborating
<\/p>\n

Elaborating the Concept<\/figcaption><\/figure>\n

Over the next several weeks we will discuss each of the activities, starting with the use case development<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Elaborating the concept integrates the results of the concept definition into a complete system definition, the design inputs. The overall work flow is as shown in the following Over the next several weeks we will discuss each of the activities, starting with the use case development<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[61,5],"tags":[29,31],"class_list":{"0":"post-238","1":"post","2":"type-post","3":"status-publish","4":"format-standard","6":"category-archived","7":"category-product-definition","8":"tag-system-requirements","9":"tag-use-cases","10":"anons"},"yoast_head":"\nElaborating the Concept - TGFR Consulting LLC<\/title>\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\/elaborating-the-concept\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Elaborating the Concept - TGFR Consulting LLC\" \/>\n<meta property=\"og:description\" content=\"Elaborating the concept integrates the results of the concept definition into a complete system definition, the design inputs. The overall work flow is as shown in the following Over the next several weeks we will discuss each of the activities, starting with the use case development\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/elaborating-the-concept\/\" \/>\n<meta property=\"og:site_name\" content=\"TGFR Consulting LLC\" \/>\n<meta property=\"article:published_time\" content=\"2017-04-02T02:38:16+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-01-20T22:34:36+00:00\" \/>\n<meta property=\"og:image\" content=\"http:\/\/tgfrconsulting.com\/blog\/wp-content\/uploads\/2017\/04\/Elaborating-the-Concept-1024x629.png\" \/>\n<meta name=\"author\" content=\"Timothy Robinson\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Timothy Robinson\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/elaborating-the-concept\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/elaborating-the-concept\/\"},\"author\":{\"name\":\"Timothy Robinson\",\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/#\/schema\/person\/5e055d3bb1c73babd5af6a3d1f31ca05\"},\"headline\":\"Elaborating the Concept\",\"datePublished\":\"2017-04-02T02:38:16+00:00\",\"dateModified\":\"2024-01-20T22:34:36+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/elaborating-the-concept\/\"},\"wordCount\":61,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/elaborating-the-concept\/#primaryimage\"},\"thumbnailUrl\":\"http:\/\/tgfrconsulting.com\/blog\/wp-content\/uploads\/2017\/04\/Elaborating-the-Concept-1024x629.png\",\"keywords\":[\"system requirements\",\"use cases\"],\"articleSection\":[\"Archive\",\"Product Definition\"],\"inLanguage\":\"en\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/elaborating-the-concept\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/elaborating-the-concept\/\",\"url\":\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/elaborating-the-concept\/\",\"name\":\"Elaborating the Concept - 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