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Addressing the Challenges of Medical Content Authoring

Five Recommendations for Combining English Content Development with Localization

A Publication of Lionbridge Life Sciences

CONTENTS

Provide Strong Leadership

Find the Right Partner

Find the Right Reviewers

Address the Automation Question

Analyze Your Process

RECOMMENDATION 1

INTRODUCTION

RECOMMENDATION 2

RECOMMENDATION 3

RECOMMENDATION 4

RECOMMENDATION 5

3Addressing the Challenges of Medical Content Authoring

www.lionbridgelifesciences.com

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Typically, English content developers and localization project managers work in completely different parts of a Life Sciences organization. The two questions that keep them from working together effectively – “Why can’t you translate what I write?” and “Why can’t you write so I can translate?” – can prevent teams from coming together for common outputs. However, the processes for developing source content, and its subsequent target language translation, can and should be meshed to increase speed and quality.

In this eBook, we will explore the challenges, considerations and advantages of combining English content development with the localization process.

INTRODUCTION



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Provide Strong LeadershipIf your content development team and localization project managers are in different parts of your organization, taking the initiative as the leader, and assisting with the integration of these departments, can not only improve your credibility, but also your ability to support product launches more quickly and effectively. As the number of product translations increases, so, too, does the need for process alignment later in the development cycle.

If it‘s not possible to organizationally combine the content development and localization teams to work with R&D, you can start by moving the teams closer to each other. This will help encourage communication and begin the discussions around common processes and key touch points.

RECOMM

ENDATION 1



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If physically moving the teams isn’t possible, setting up recurring team meetings will help to encourage communication. Dialog between content developers and localization project managers can center on topics such as usability, regulatory language constraints, localization challenges, and combined timelines

Although these conversations can be lively, and at times contentious, they can lead to the development of a robust and integrated process.



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When implementing a combined localization and source development process, the core of the work is project management (PM). Any good project manager can work effectively within this structure as long as he or she has two particular skill sets:

1

2A passion for language and culture

The ability to manage through influence and without position power



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When working within a source and target translation process, the candidates for PM must have the ability and desire to work with language, analyze language issues, and be willing to communicate and work with different cultures.

The PM skills for both content development and localization do have similarities, and getting the teams to talk through their approaches helps to develop trust, camaraderie, and a shared vision for meeting product releases.

Through strong leadership, the foundation of strong communication is the first step toward improving the integration of the content development and localization processes.



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Analyze your ProcessesThe key to a successful integration of English content development with localization is process. Many technical communication and localization teams are unaware of the business processes that run their organizations. When asked for a process flowchart, or even to explain the process, they have difficulty articulating the concept. “We just work with the engineers and write the manual,” or “The content developers send us the English source and we translate it.” These may sound like simple explanations of what the task entails, but this process is anything but easy.

The not-so-encouraging news about process analysis is that it does not follow a predefined model. There are not 10 easy steps to miraculously change your process. But it does require team members to creatively analyze the work flow, based on work patterns that already exist in your organization, within a few defined parameters. The analysis can usually be completed in three key stages.

RECOMM

ENDATION 2



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Assess the Current ConditionThe goal of the Assessment stage is to gather and summarize the expectations and requirements of the external and internal customers to the process. Simultaneously, you’ll want to document the current process through flow charts, to better understand its impact on your current operations. It also helps to determine how the process interacts and links with other business units within the organization. Within this flow charting exercise, you should be documenting tasks performed by process participants, resources utilized, and any technology and organizational dependencies. These findings, along with the documented process maps, are used as the framework for the redesign phase. To assess the current condition, you can obtain this information through focus group meetings, interviews, and surveys.

Establishing the boundaries of the process you are analyzing is key to keeping the analysis from spinning out of control. For example, “The process analysis covers receipt of request from external customer to release to Localization PMs.” This type of process boundary allows your team to focus on one particular area and not get sidelined with extraneous conversations that cannot be solved within the parameters of the team.

STAGE 1



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RedesignRedesign is the time when the creative juices really get flowing. In the Redesign stage, you will analyze the results of the Assessment stage to find areas within the process that can be improved. Key areas that can be decreased or eliminated from the process include:

STAGE 2

Number of people in the process

Excessive passing of information

Non-value-added activities

Excessive queue times

During the redesign, you might consider developing a new process to increase throughput, free up or eliminate resources, or move tasks and responsibilities from one business unit to another. When developing the new process, it is critical to engage all of the stakeholders who may be impacted by the process change. The stakeholders can be identified after the boundaries of the process are defined. If you do not have full organizational buy-in for a large process change, structuring the boundaries so they are under your specific control and influence helps make the process analysis and implementation successful.



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ImplementImplementing the results of your process analysis is probably the most difficult part because it involves CHANGE. Therefore, change management becomes the key to success. Change management requires planning and buy-in from those most affected by the process. In order for people to embrace the process change, it must be realistic, measurable, and achievable. “Selling” the change to your organization does not allow for long-term success. There are many resources available to assist with change management and to help your organization succeed in this area.

STAGE 3



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Address the Automation Question

RECOMM

ENDATION 3

•Structured authoring. Controlled English. XML. CMS. TMS. DITA. Workflow.

•FrameMaker is great. FrameMaker is terrible.

•XML is the way to go. XML is so far out of our reach.

•Translation memories. Translation glossaries.

Wrong.There is so much information out there regarding source content creation and translation that it really boggles your mind. And, if you are actually DOING the work, up against deadlines, working with R&D, trying to get your documentation out on time and within budget in 12 languages, you really don’t have time to worry about a new system. A system may be broken for the long term, but who has the energy to think about three years out when you have a deadline tomorrow?

Like sugarplums dancing in your head, right?



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The automation questions…what, how, when…plague all source content creation departments, but finding the answers will be the key to your success.

Determining which system, or even WHAT to automate, can be daunting. Getting your arms around your process is critical. You can’t automate something you don’t understand. Automating a poor process will just lead to automated chaos. Once you have a handle on the process, you can then determine which portions of the process make sense to automate. Your answer may be “none” and that’s ok.

Sometimes what you have in place makes the most sense for your department and for your organization.



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Once you determine which portions of the process can be automated, you can start to examine technology on the market. After going through an extensive analysis of most CMS tools out there, we can tell you they all pretty much accomplish the same thing. Some are better at some parts of the process than others. Some have a strong reviewer component, but a poor workflow. Some have excellent authoring assistance, but the cost is too high. There are pros and cons to every system, and even when you have strict requirements, the tool you select may not accomplish all your goals. Partnering with someone you trust, someone who has been through an implementation at a similar organization, is critical. There is no substitute for experience. Be sure to ask your representatives if they’ve used the system in a particular environment, not just implemented it.

Big difference.



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When is the right time? This is probably the most difficult question to answer for anyone. When. When do I do this? When workloads slow down? When we don’t have another huge release? Well, that will never happen. That “when” is a long way off. Most documentation departments cannot take off 9-12 months to implement a new system. That has to be accomplished while continuing to support product launches, documentation updates, complaints, and new translation requests. The best advice is really whenever you have the money, approval, and energy. The job security you have with updates and endless projects will never go away, and therefore, cannot be a determining factor of when to move forward with an implementation. Most likely, you will need to run parallel systems for a while until you have some successes with the new system. Finding authors and project managers within the department who are willing to work through the processes’ ups and the downs will be critical for long-term success. The other key is understanding when it’s not working. If the system pilot is not a success, that was the point. Don’t try to keep working a system that doesn’t meet the needs.



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Find the Right ReviewersThe review process, both during the creation of the target language and the in-country review, is critical for the success of technical documents. Subject Matter Experts are crucial to ensure accuracy for medical device labeling. But the review process can be painful. There is the learning curve for the technical writer to fully understand the material, and the reviewers need to be coached to look for content issues and not writing or structure problems. This is a tough line to tow, especially since a good review is essential.

This process is typically managed through PDFs and emails. Reviewers receive a complete document and are asked to review updates, but are tempted to, and often do, review the entire deliverable. This creates a ripple effect of additional changes that were unplanned in the timelines, and difficult to manage in the target language documents.

A huge benefit of migrating to an XML, topic-based system is that you can send out only those components that are impacted by changes. The reviewer will see only the topics that are changed, allowing them to focus on subsets of content rather than entire documents.

RECOMM

ENDATION 4



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That’s the theory, anyway.In practice, this can be much, much more difficult, especially with highly-regulated content. Reviewers need to be trained, coached, encouraged, and trained, coached and encouraged again, to understand the benefits of topic-based content. In our experience, reviewers still want to see the entire document. It is difficult to get the reviewers to agree to only review topics. This resistance will stop an implementation in its tracks.

It is critical to identify two or three key reviewers to help influence and make the pilot a success. You need to engage the reviewers early on in the implementation, including adding SMEs to the list of main stakeholders, for the success of the system.

This often overlooked area needs to be even more tightly-examined and managed when implementing an XML topic-based system at a medical device or highly-regulated company.



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Find the Right PartnerDuring a recent discussion regarding CMS implementations, we were shown a very simple graphic

depicting the conceptual utopia of simultaneous content creation, review, edit, release, and translation workflows using XML topics.

This is the baseline premise of XML systems; that you can author in smaller topics, review in smaller topics, translate in smaller topics, and the CMS system manages these topics through a symphonic workflow and produces content topics that fit together in perfect harmony.

For anyone who has attempted, is attempting, or has abandoned an XML implementation in a Life Sciences environment, simultaneous development and review of content is an ideal future state. However, showing such a slide to those new to the process without proper context or explanation is irresponsible. This future state may take years to achieve, and setting unrealistic expectations in the very beginning stages of CMS system evaluations is risky. Implementing an XML-based CMS solution for Life Sciences clients is complicated and has specialized issues that need to be addressed in a responsible and pragmatic manner.

RECOMM

ENDATION 5



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If you are a medical device or pharmaceutical client looking to implement this type of solution, there are some key things to consider as you embark on finding the right partner.

1

2Find a partner who understands it is about process, not technology – Anyone who comes into your company for a discovery meeting and does not discuss the content development process is unaware of the challenges of a successful XML implementation. Knowing how to move from the current condition to a future state is critical.

Ensure the partner you are engaging with understands the complexities of your environment – Simultaneous content creation, review, and translation within a well-defined workflow are conceptually possible. However, implementing these capabilities within a highly-regulated environment has specific concerns that need to be addressed prior to selecting a technology solution. Be sure the partner has someone on staff who can answer specific questions regarding authoring in the Life Sciences industry.



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Ask for references – One of the first questions to ask your partner is to point to a successful implementation within an environment that mimics your own. Seeing a successful process at a software company authoring department doesn’t quite help if you author for medical devices. And since there are few Life Sciences companies working in a fully deployed XML environment, you will most likely be a trailblazer. Just be sure you have access to someone who can address your specific concerns.

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Lionbridge Life Sciences provides process consulting services to evaluate your content authoring and localization processes, making recommendations to increase throughput, improve quality, and better align your efforts with key departments in your organization. Our expert team has over 20 years of experience in medical device manufacturing, managing labeling, translation, and English content development teams, as well as implementing XML content management systems. For more information or to contact us, visit our website at www.lionbridgelifesciences.com

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