{"id":27,"date":"2014-12-07T20:41:38","date_gmt":"2014-12-07T20:41:38","guid":{"rendered":"http:\/\/dawilson.co.uk\/blog\/?p=27"},"modified":"2014-12-11T21:54:35","modified_gmt":"2014-12-11T21:54:35","slug":"the-roundup-week-49","status":"publish","type":"post","link":"https:\/\/dawilson.co.uk\/blog\/the-roundup-week-49\/","title":{"rendered":"The roundup – week 49"},"content":{"rendered":"

A summary of\u00a0two online articles that I have found interesting in the past week.<\/em><\/p>\n

Software as a medical device<\/h1>\n

The background behind this story is one which already feels very familiar to me: software is becoming increasingly\u00a0common and increasingly complex in a certain safety related industry, and there is now a need\u00a0to create a standardised set of guidelines to be adopted when developing these systems. Similar rationale was given during the introduction of IEC 61508<\/a>, which\u00a0covers the\u00a0functional safety of industrial control systems, and also ISO 26262<\/a>, which covers the\u00a0functional safety of road vehicles.<\/p>\n

This particular article\u00a0by Rick Merritt discusses the concept of\u00a0Software as a Medical Device (SaMD), which is a type of software used in the diagnosis and treatment of patients, but which is independent of any particular\u00a0hardware platform. Examples of SaMD could be software which is installed on a desktop PC to perform diagnostic analysis of images that leads to treatment decisions; or software that analyses fluid samples in order to detect illnesses.<\/p>\n

SaMD poses several interesting challenges not\u00a0typically found in\u00a0more traditional medical devices. Firstly, the software may perform differently when deployed on different types of hardware; secondly, in-the-field\u00a0updates are\u00a0often carried out by healthcare professionals (i.e. the users), rather than a trained\u00a0engineer or technician; and finally, insecure licensing may lead to unauthorised copies of the software being circulated\u00a0outside of the manufacturer’s control.<\/p>\n

In order to address these issues, the\u00a0International Medical Device Regulators Forum have issued a\u00a0document that offers guidance on how to assess the risk category of a SaMD based on the criticality of the situation or condition being treated and the intended use for the information provided by the system. Relevant considerations for each category are then described.<\/p>\n

http:\/\/www.eetimes.com\/document.asp?doc_id=1324861<\/a><\/p>\n

Safety critical RTOS certification kit<\/h1>\n

Developing safety critical software is hard.\u00a0More specifically, it is both time and cost intensive due to the rigorous verification and validation activities that are required, along with\u00a0the need for\u00a0meticulous documentation. These are\u00a0facts that\u00a0could easily\u00a0be overlooked by an\u00a0organisation new to software development in general, but who are\u00a0keen to produce the next major innovation in their industry.<\/p>\n

I have heard of an\u00a0example of this myself, where a company*\u00a0that created primarily mechanical safety systems invested a great deal of time and money in the development of a new software intensive vision system. This system\u00a0was intended to place industrial machinery into a safe state when the presence of an operator was detected by a video camera. The device was however developed as a ‘normal’ product with no special consideration given to its safety aspects and, as a result\u00a0of this, the company were unable to achieve the required level of certification.<\/p>\n

This type of problem could be eliminated if organisations opt to\u00a0base their\u00a0development around\u00a0a pre-certified real-time operating system (RTOS), such as the newly released Micrium uC\/OS-II ‘cert-kits’\u00a0described in this article by Bernard Cole. These kits contain a RTOS kernel, complete with verification evidence and user manuals, which\u00a0comes with T\u00dcV type approval.<\/p>\n

Although this approach will\u00a0not completely eliminate the\u00a0work required\u00a0for final product approval, it promises to greatly streamline the process.<\/p>\n

* Thankfully not a company that I worked for!<\/em><\/p>\n

http:\/\/www.embedded.com\/electronics-news\/4437842\/Micrium–Embedded-Office-GmbH-team-on-safety-critical-Cert-Kits<\/a><\/p>\n

Conclusion<\/h1>\n

Both of this week’s articles highlight\u00a0an important point in that as software becomes more prevalent in\u00a0systems that may be considered to have some safety\u00a0related functionality, there is an increasing need to treat its development as an engineering activity and not simply a ‘hack-a-thon’.<\/p>\n

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

A summary of\u00a0two online articles that I have found interesting in the past week. Software as a medical device The background behind this story is one which already feels very familiar to me: software is becoming increasingly\u00a0common and increasingly complex in a certain safety related industry, and there is now a need\u00a0to create a standardised … <\/p>\n

Continue reading “The roundup – week 49”<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[3],"tags":[4,10,9],"class_list":["post-27","post","type-post","status-publish","format-standard","hentry","category-roundups","tag-roundup","tag-rtos","tag-safety-critical-systems"],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/dawilson.co.uk\/blog\/wp-json\/wp\/v2\/posts\/27","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dawilson.co.uk\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dawilson.co.uk\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dawilson.co.uk\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dawilson.co.uk\/blog\/wp-json\/wp\/v2\/comments?post=27"}],"version-history":[{"count":18,"href":"https:\/\/dawilson.co.uk\/blog\/wp-json\/wp\/v2\/posts\/27\/revisions"}],"predecessor-version":[{"id":57,"href":"https:\/\/dawilson.co.uk\/blog\/wp-json\/wp\/v2\/posts\/27\/revisions\/57"}],"wp:attachment":[{"href":"https:\/\/dawilson.co.uk\/blog\/wp-json\/wp\/v2\/media?parent=27"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dawilson.co.uk\/blog\/wp-json\/wp\/v2\/categories?post=27"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dawilson.co.uk\/blog\/wp-json\/wp\/v2\/tags?post=27"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}