{"id":3679,"date":"2023-01-18T12:49:03","date_gmt":"2023-01-18T12:49:03","guid":{"rendered":"https:\/\/www.springboard.pro\/?p=3679"},"modified":"2026-09-02T13:53:13","modified_gmt":"2026-09-02T13:53:13","slug":"how-to-plan-better-medical-device-developments","status":"publish","type":"blog","link":"https:\/\/www.sanner-group.com\/insights\/blog\/how-to-plan-better-medical-device-developments\/","title":{"rendered":"How to Plan Better Medical Device Developments – Part Two"},"content":{"rendered":"\n
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In a previous p<\/a>ost<\/a>, we discussed common issues in medical device developments which lead to delays in getting the product to market.\u00a0 This blog covers some strategies on how to spot those issues and how to resolve them.<\/p>\n

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  1. Poorly formulated inputs. <\/strong>Ensure user needs are well understood. For new products significant work should be carried out to understand the users, whilst next generation devices can make use of feedback from existing users of the current device. Invest time in translating user needs into logical product requirements and reviewing requirements for suitability and completeness.<\/li>\n
  2. Loosely defined technical requirements<\/strong>. A good way to spot this is if the technical requirements read like the top level user requirements.\u00a0 For example, if the product is a clamp to occlude blood flow then the technical requirements should have specific numerical force requirements rather than a sentence such as \u00ab\u00a0force shall be sufficient to occlude flow.\u00a0\u00bb Another good technique is to draft verification protocol tests at the time of writing requirements which will ensure each statement is testable.<\/li>\n
  3. Requirements driven by technical ambition rather than user need<\/strong>. Formative user studies should establish the minimum required performance and this should form the basis of the must-have, \u00ab\u00a0shall\u00a0\u00bb requirements. If a user indicates that improved performance would be desirable these can be captured as nice-to-have, \u00ab\u00a0should\u00a0\u00bb requirements. Improved performance for the sake of it should not be captured.<\/li>\n
  4. Underestimation of the time required for quality<\/strong>. Include the quality team early in project planning and then throughout the project. \u00a0Understand their expectations and provide them with ample review opportunities prior to formal sign off.<\/li>\n
  5. System integration<\/strong>. Write interface specifications so each discipline understands the requirements and interactions with other disciplines. Plan staged integration testing which can build up system functionality.\u00a0 Allow time to find problems and fix them.<\/li>\n
  6. A plan for the best case.<\/strong> When planning get multiple viewpoints from a range of team members.\u00a0 Remember the most pessimistic estimate may be the most accurate.\u00a0 It is almost always easier to plan for a pessimistic time and then deliver early than the opposite way round.\u00a0 If there is a large technical issue then don\u2019t be afraid to revisit the plan and update. One potential technique is to use a pre-mortem, where the team brainstorms things that could potentially go wrong ahead of time.<\/li>\n
  7. Insufficient review. <\/strong>Schedule regular reviews within the project team and foster a culture of constructive feedback. A separate and independent review team should also be established to review the design and project at key milestones.<\/li>\n<\/ol>\n

    Don’t hesitate to contact us<\/a> if you have any further questions.<\/p>\n <\/div>\n <\/div>\n <\/div>\n<\/section>","protected":false},"featured_media":3543,"template":"","blog_category":[],"class_list":["post-3679","blog","type-blog","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"\nHow to Plan Better Medical Device Developments - Part Two - Sanner Group<\/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.sanner-group.com\/fr\/insights\/blog\/how-to-plan-better-medical-device-developments\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How to Plan Better Medical Device Developments - Part Two - Sanner Group\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.sanner-group.com\/insights\/blog\/how-to-plan-better-medical-device-developments\/\" \/>\n<meta property=\"og:site_name\" content=\"Sanner Group\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-02T13:53:13+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.sanner-group.com\/wp-content\/uploads\/2022\/12\/P1230259-scaled-1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1922\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.sanner-group.com\\\/insights\\\/blog\\\/how-to-plan-better-medical-device-developments\\\/\",\"url\":\"https:\\\/\\\/www.sanner-group.com\\\/insights\\\/blog\\\/how-to-plan-better-medical-device-developments\\\/\",\"name\":\"How to Plan Better Medical Device Developments - 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