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 session aims to briefly outline the most common globalization issues found in medical devices through visual examples and case studies. By outlining best practices of global product development, participants will 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.

During this presentation, a comparison will be made 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. The session will also 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.

There is no prior knowledge of the subject required to attend. This session is aimed at all those involved or interested in globalizing medical devices to make an efficient and repeatable process.

Ever have a project fail? You met with your project team, you talked with the customer, you reviewed technical requirements. But did you talk to your users? Just as one diagnosis doesn’t fit all patients, one application’s approach doesn’t work for all users. Know who accesses your information and uses your applications. Only then choose your features. Using a case study of a multinational project covering four countries, 10 business units, and tens of thousands of content elements, we’’ll explore personas, scenarios, and other user-centered techniques. We’ll look at identifying users as well as segregating content according to users and regulatory needs.

What was involved in this cases study?

First we analyzed the 10 business units and their approaches and definitions of business goals. Next we analyzed industry standards for medical devices and their usage.

But that wasn’t enough. We interviewed 40 people in 4 countries, and created an information architecture prototype. We then tested this prototype in hospitals, doctors’ offices, and on site where medical devices were in use.

Based on this contextual inquiry, we refined the architecture and our understanding of the users. Decisions were then made on what type of content would be both appropriate and legal for each user and in each country.

Only with a solid understanding of the users and their goals could we define a flexible, extensible, and usable information and content architecture.

Inspired by an open letter blog post by diabetes advocate, Amy Tenderich, asking Steve Jobs to bring his design genius to the medical device industry, Adaptive Path created an experience design concept known as Charmr. The concept was created based on research with diabetics and diabetes experts. Since the project was announced, the video showing Charmr has been seen at diabetes conferences around the world, and has been viewed by nearly 20,000 people on YouTube.

The most important objective of this project was to NOT approach it as an “engineering or technical problem”. As an experience design firm, we wanted to approach it from the users’ perspective: what is it like to live with diabetes? The idea was to show with our user centered design process that it is possible to make devices that fit the lives of their customers more comfortably and naturally.

In this presentation, attendees will learn about the Adaptive Path approach to this challenge and how medical manufactures, technical writers, information architects, and interaction designers might adopt this approach to improve their products, writing and training.