{"id":4314,"date":"2015-11-12T09:09:31","date_gmt":"2015-11-12T09:09:31","guid":{"rendered":"https:\/\/lorit-consultancy.com\/2015\/11\/case-study-inside-biometrics\/"},"modified":"2022-09-26T15:52:05","modified_gmt":"2022-09-26T13:52:05","slug":"case-study-inside-biometrics","status":"publish","type":"post","link":"https:\/\/lorit-consultancy.com\/de\/2015\/11\/case-study-inside-biometrics\/","title":{"rendered":"Case study \u2013 Inside Biometrics"},"content":{"rendered":"

The customer<\/strong><\/p>\n

Inside Biometrics<\/strong> is a healthcare medical technology company that operates in the expanding global\u00a0markets of diabetes self-testing devices and personal fitness tracking devices for performance and\u00a0weight management. Based in Dingwall, near Inverness, Scotland, it was founded in 2013 by Dr Selly\u00a0Saini and a team with extensive experience in the development of healthcare medical technology,\u00a0personal self-monitoring devices and medical device manufacture. Before setting up Inside\u00a0Biometrics Saini worked for Johnson & Johnson Inc. as VP Global Strategic Marketing, VP Research &\u00a0Development and Worldwide Director for the Diabetes Care business.<\/p>\n

The challenge<\/strong><\/p>\n

Inside Biometrics\u2019 first product to market is a blood glucose meter that is set to launch in early 2016\u00a0in Europe. The product enables diabetic patients to self-measure the level of glucose in their blood,\u00a0in order to make decisions about medication and food intake. The user obtains a minute drop of\u00a0blood and applies it to a disposable test strip, which is attached to an electronic meter that displays\u00a0the test result. While there are many blood glucose meters on the market, the Inside Biometrics\u00a0product is highly innovative in its ability to collect and analyse the sample, giving users more\u00a0relevant and valuable information that can be used to avoid short and long term health\u00a0complications from diabetes. That ability comes from a combination of new strip technology and\u00a0software within the meter.<\/p>\n

The product will be made available through healthcare providers, such as the NHS. However to bring\u00a0it to market, Inside Biometrics needed to be sure that its product complies with relevant\u00a0international regulatory requirements for this type of medical device.\u00a0This required Inside Biometrics to establish, practice and monitor a well-defined quality\u00a0management system which is subject to continuous improvement. This was implemented using a\u00a0combination of internal experts and specialist external organisations providing skills and experience\u00a0in specific areas for the project.<\/p>\n

\u201cIt was about bringing in the right people with the right knowledge and experience, who could\u00a0advise us and put all the pieces together,\u201d says Dr Selly Saini. \u201cAlastair and the Lorit team had the\u00a0right experience to advise us on medical device software. It was a very good fit that proved to be\u00a0catalytic in achieving our objectives.\u201d<\/em><\/p>\n

How Lorit Consultancy helped<\/strong><\/p>\n

Inside Biometrics picked Lorit Consultancy from a range of providers, based on Lorit\u2019s breadth of\u00a0experience. \u201cAlastair\u2019s broad background gives him the right perspective to bring these kinds of\u00a0programmes to fruition,\u201d says Saini.<\/p>\n

Lorit Consultancy ensured that Inside Biometrics followed the regulations it needed to that sit\u00a0behind the relevant standards.<\/p>\n

The two main standards involved were BS EN 62304 and ISO 13485:2003.BS EN 62304 is a harmonised international standard that specifies life cycle requirements for the\u00a0development of medical software and software within medical devices. ISO 13485:2003 specifies\u00a0requirements for a quality management system where an organisation needs to demonstrate its\u00a0ability to provide medical devices and related services that consistently meet customer\u00a0requirements and regulatory requirements applicable to medical devices and related services.<\/p>\n

Lorit\u2019s role was to take an in depth look at the software controlling the device. The task involved\u00a0making sure that all the correct documentation was in place, that the design history was\u00a0appropriate, that the correct risk analysis measures were taken and that appropriate system testing\u00a0was carried out.<\/p>\n

Specifically, Lorit Consultancy carried out the following actions:<\/p>\n

    \n
  1. Defined a documentation structure for the BS EN 62304 Class B software implementation.<\/li>\n
  2. Defined actions and the nature of activities for the software implementation.<\/li>\n
  3. Restructured requirements for the blood glucose meter implementing V models for both\u00a0software and hardware.<\/li>\n
  4. Linked system, software and hardware requirements to top level product requirements,\u00a0ensuring all requirements are unique, traceable and verifiable.<\/li>\n
  5. Generated architectural requirements for both hardware and software.<\/li>\n
  6. Generated software unit and detailed hardware requirements.<\/li>\n
  7. Defined supporting documentation for the BE EN 62304 implementation.<\/li>\n
  8. Successfully presented the documentation to BSI in the ISO13485 audit.<\/li>\n
  9. Ran checks on requirement traceability.<\/li>\n<\/ol>\n

    Lorit\u2019s range of experience meant that the company was well placed to provide the expertise needed\u00a0for the project. \u201cAlastair was able to being a wealth of experience from other projects, sometimes in\u00a0other industries, and bring them to bear on this particular one we are looking at. That broad experience helped to accelerate the pathway,\u201d explains Saini.<\/p>\n

    \u201cMy background in hardware and software development was particularly useful in this project,\u201d says\u00a0Alastair Walker. \u201cI know the demands placed on development teams and that put me in a good\u00a0position to support Inside Biometrics in what was a fairly time critical project.\u201d<\/p>\n

    The outcome<\/strong><\/p>\n

    For Inside Biometrics, one of the biggest measurable benefits was how efficiently Lorit was able to\u00a0proceed through the project. With a projected UK product launch date of early 2016 , it was\u00a0important to hit milestones promptly. \u201cAlastair was able to put in place all the required systems and\u00a0work synergistically with the internal development and quality teams in preparing the\u00a0documentation within the quality management system, allowing our organisation to move to the\u00a0next development milestone,\u201d says Saini.<\/p>\n","protected":false},"excerpt":{"rendered":"

    The customer Inside Biometrics is a healthcare medical technology company that operates in the expanding global\u00a0markets of diabetes self-testing devices and personal fitness tracking devices for performance and\u00a0weight management. Based in Dingwall, near Inverness, Scotland, it was founded in 2013 by Dr Selly\u00a0Saini and a team with extensive experience in the development of healthcare medical […]<\/p>\n","protected":false},"author":5,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[92,141],"tags":[],"class_list":["post-4314","post","type-post","status-publish","format-standard","hentry","category-medical-devices","category-case-studies"],"acf":[],"_links":{"self":[{"href":"https:\/\/lorit-consultancy.com\/de\/wp-json\/wp\/v2\/posts\/4314","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lorit-consultancy.com\/de\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lorit-consultancy.com\/de\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lorit-consultancy.com\/de\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/lorit-consultancy.com\/de\/wp-json\/wp\/v2\/comments?post=4314"}],"version-history":[{"count":2,"href":"https:\/\/lorit-consultancy.com\/de\/wp-json\/wp\/v2\/posts\/4314\/revisions"}],"predecessor-version":[{"id":4945,"href":"https:\/\/lorit-consultancy.com\/de\/wp-json\/wp\/v2\/posts\/4314\/revisions\/4945"}],"wp:attachment":[{"href":"https:\/\/lorit-consultancy.com\/de\/wp-json\/wp\/v2\/media?parent=4314"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lorit-consultancy.com\/de\/wp-json\/wp\/v2\/categories?post=4314"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lorit-consultancy.com\/de\/wp-json\/wp\/v2\/tags?post=4314"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}