{"id":262,"date":"2017-06-12T03:55:14","date_gmt":"2017-06-12T03:55:14","guid":{"rendered":"http:\/\/tgfrconsulting.com\/blog\/?p=262"},"modified":"2024-01-20T22:30:22","modified_gmt":"2024-01-20T22:30:22","slug":"architecture-requirements","status":"publish","type":"post","link":"https:\/\/www.tgfrconsulting.com\/blog\/archived\/product-definition\/architecture-requirements\/","title":{"rendered":"Architecture and Requirements"},"content":{"rendered":"<div class=\"entry\">\n<p>The development of the final set of requirements closely couples to the development of the architecture.\u00a0 Architecture embodies the breakdown of the system into subsystems, and the final system requirements development should consider the architecture.\u00a0\u00a0 Many approaches to medical device development advocate for design inputs that are \u201cconcept free\u201d, but a concept free approach can lead issues when the design inputs are translated to lower level requirements.\u00a0 Specific areas that can be addressed through consideration of the architecture of the system include<\/p>\n<ul>\n<li><strong>Subsystem Development and Integration<\/strong> \u2013 a system where requirements map more directly to the subsystems lessens the pressure to ensure that subsystems and interfaces are consistent during development. Subsystem development can proceed without the necessity to review and evaluate design through the development cycle.<\/li>\n<li><strong>Subsystem Verification<\/strong> \u2013 Verification at the subsystem level can satisfy the overall system verification, usually with much less cost. As an example, a single drug delivery subsystem with that delivers all of the critical requirements for accuracy may be tested using \u201cwhite box\u201d methods that are much more efficient and accurate.<\/li>\n<\/ul>\n<p>Overall, the careful consideration of the structure of the requirements and the associated architecture results in a system more amenable to parallel subsystem development, cleaner integration and simpler verification.<\/p>\n<h4>Architecture Evaluation Criteria<\/h4>\n<p>The elaboration process begins with identifying the goals for the subsystem decomposition.\u00a0 Manufacturing capability, the development approach (insource\/outsource) and organizational factors drive the development of goals for the subsystem decomposition. Key business elements for consideration include<\/p>\n<ul>\n<li><strong>Voice of the Business <\/strong>\u2013 in some texts this is referred to as \u201cnon-functional requirements\u201d, but represents the product from an institutional view<\/li>\n<li><strong>Manufacturing Capability<\/strong> \u2013 this is the \u201chow\u201d for the production, and needs to consider make\/buy and other critical factors.<\/li>\n<li><strong>Pre-existing Systems<\/strong> \u2013 in almost all system development, pre-existing systems or components exist<\/li>\n<\/ul>\n<p>In addition to the business considerations, design considerations should be established.\u00a0 These should include<\/p>\n<ul>\n<li><strong>Coupling<\/strong> \u2013 the degree to which subsystems depend upon each other<\/li>\n<li><strong>Cohesion<\/strong> \u2013 the degree to which the elements of a subsystem functionally belong together.<\/li>\n<li><strong>Subsystem Structure<\/strong> \u2013 This should consider organizational structure and the alignment of the architecture with the structure of the development group. A old saying, \u201cthe system architecture reflects the organization\u201d should not be ignored.<\/li>\n<\/ul>\n<p>The elements should be formed into a set of \u201cneeds\u201d and given the familiar 1\/3\/9 weighting. Only one or two of the design or business needs should be assigned a 9 weighting.\u00a0\u00a0 The following figure shows the Pugh Matrix for architecture<\/p>\n<figure id=\"attachment_490\" aria-describedby=\"caption-attachment-490\" style=\"width: 3836px\" class=\"wp-caption alignnone\"><a href=\"http:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2017\/06\/Requirements-Elaboration-Pugh-Matrix.png\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-490\" src=\"http:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2017\/06\/Requirements-Elaboration-Pugh-Matrix.png\" alt=\"Requirements Elaboration Pugh Matrix\" width=\"3836\" height=\"2966\" srcset=\"https:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2017\/06\/Requirements-Elaboration-Pugh-Matrix.png 3836w, https:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2017\/06\/Requirements-Elaboration-Pugh-Matrix-300x232.png 300w, https:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2017\/06\/Requirements-Elaboration-Pugh-Matrix-768x594.png 768w, https:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2017\/06\/Requirements-Elaboration-Pugh-Matrix-1024x792.png 1024w\" sizes=\"auto, (max-width: 3836px) 100vw, 3836px\" \/><\/a><figcaption id=\"caption-attachment-490\" class=\"wp-caption-text\">Requirements Elaboration Pugh Matrix<\/figcaption><\/figure>\n<p>The process of developing the system architecture relies on the same iterative techniques used in the development of the concept.\u00a0 At least two passes, with the development of a super concept, should be performed.\u00a0\u00a0 This will drive the development and evaluation of alternatives for the architecture and prevent rushing to an unsuitable partitioning with issues that will only surface during the subsequent stages of development.<\/p>\n<p>Definition of the architecture is best performed prior to the finalization of requirements.\u00a0 As will become apparent, tailoring the final system requirements to the architecture will result in a system that is easier to integrate and verify.\u00a0 The following illustrates the general flow<\/p>\n<figure id=\"attachment_493\" aria-describedby=\"caption-attachment-493\" style=\"width: 5012px\" class=\"wp-caption alignnone\"><a href=\"http:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2017\/06\/Requirements-Elaboration-Workflow.png\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-493\" src=\"http:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2017\/06\/Requirements-Elaboration-Workflow.png\" alt=\"Requirements Elaboration Workflow\" width=\"5012\" height=\"4220\" srcset=\"https:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2017\/06\/Requirements-Elaboration-Workflow.png 5012w, https:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2017\/06\/Requirements-Elaboration-Workflow-300x253.png 300w, https:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2017\/06\/Requirements-Elaboration-Workflow-768x647.png 768w, https:\/\/www.tgfrconsulting.com\/blog\/wp-content\/uploads\/2017\/06\/Requirements-Elaboration-Workflow-1024x862.png 1024w\" sizes=\"auto, (max-width: 5012px) 100vw, 5012px\" \/><\/a><figcaption id=\"caption-attachment-493\" class=\"wp-caption-text\">Requirements Elaboration Workflow<\/figcaption><\/figure>\n<p>This workflow replicates the workflow used in concept <a href=\"http:\/\/tgfrconsulting.com\/blog\/2017\/04\/elaborating-the-concept\/\">development.<\/a>\u00a0 Wherever possible several sub-teams should develop proposed architectures. The whole development team evaluates the proposals and develops the super concept for the iteration.\u00a0 This should continue until the team decides that further iteration will not substantively change the outcome.<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>The development of the final set of requirements closely couples to the development of the architecture.\u00a0 Architecture embodies the breakdown of the system into subsystems, and the final system requirements development should consider the architecture.\u00a0\u00a0 Many approaches to medical device development advocate for design inputs that are \u201cconcept free\u201d, but a concept free approach can &#8230;<\/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":[10,24],"class_list":{"0":"post-262","1":"post","2":"type-post","3":"status-publish","4":"format-standard","6":"category-archived","7":"category-product-definition","8":"tag-architecture","9":"tag-requirements","10":"anons"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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