Globalization of Medical Device Embedded Systems
Developing medical devices that run on embedded systems is a regular practice in the life science industry. Very often these embedded platforms are single-purpose, proprietary systems, built from the ground up with little to no dependence on common programming frameworks or operating systems.
For local markets, the product typically works as intended. However, when those devices get into the hands of global users, a said company can be inundated with urgent requests to create versions of the product into various languages in order to comply with international regulatory requirements. Panic quickly ensues once it is realized that the devices, more often than not, fail to completely support the language scripts, formats and conventions for the requester, be it users in Western Europe, Brazil or Japan.
The process of creating "global-ready" medical devices to support languages and conventions outside of one's local norms always seems to inevitably fall into the realm of afterthought, leading to painful, costly and time-consuming efforts to retrofit products to support each subsequent language release. It does not have to be this way.
This presentation outlines the most common globalization issues found in medical devices through visual examples and case studies. By outlining best practices of global product development, you may gain awareness of methods for avoiding - or at least minimizing - globalization issues from the start. With these concepts in mind, design of new "global-ready" product lines or a full revamp of a popular device can allow for faster, more efficient, lower cost and nearly painless global release efforts.
This presentation also draws comparisons with the most recent advances in the IT space for embedded product interfaces, what lessons life science companies can learn, and the common platforms that exist for embedded devices today.
It aims to provide a bigger picture of how localization of embedded products fits into the overall globalization cycle including the testing of localized embedded products. As a take-away, a "Dos and Don'ts" checklist will be provided that developers or technical writers can use to determine how well their devices stack up against existing globalization best practices, and as a guide for future medical device development efforts.
This presentation was delivered at the Documentation & Training Life Sciences 2008 Conference.
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