How Guidant Corporation Gained Support for their Content Management Project
Manager and Project Sponsor, Technical Communications
Guidant, located in St. Paul, Minnesota, is a world leader in the design and development of cardiovascular medical products. In a highly regulated environment, Guidant provides physicians with leading-edge technologies for improved patient management and clinical outcomes. The Technical Communications group produces product documentation for Guidant products, such as physician's manuals, operator's manuals, and technical manuals. Product documentation must meet stringent regulatory requirements. Because of issues in authoring and reviewing content, Guidant's Technical Communications group identified a need to move to content management.
The Technical Communications group was experiencing several issues in authoring, including:
- Authors created many files using a desktop publishing application, then stored them on a shared drive
- Copy and paste was common but it was difficult for authors to know which document to use as the source file
- Authors wrote in silos, resulting in content being inconsistent from product to product
- Authors typically managed numerous product complexities, with variations from product to product
The review process was also problematic with:
- Last minute change requests from reviewers, resulting in errors
- Authors having difficulty identifying which documents were affected by product updates
- A high volume of product reviews, which at same time resulted in limited quality review time
- No overlap between product teams, resulting in inconsistent reviews
- No formal process to track reviewer comments
In addition to issues in authoring and reviewing, Guidant was facing a number of ongoing challenges, including:
- Managing more complex products
- Adhering to accelerated schedules
- Meeting increasing regulatory requirements
Guidant had a number of goals including:
- Improve productivity
- Increase consistency in content and minimize errors, omissions, and recalls
- Write and review content across products (single source) and track reviewer comments
- Reduce translation costs and reduce the burden on "in-country" reviewers
- Eliminate redundant content
- Improve production, tracking, and storage of content
- Assemble common content rather than copy and paste
- Make it possible for other functional groups (e.g., clinical, regulatory) to reuse content from product labeling
What we did and why
To address our issues, we decided to adopt a unified content strategy supported by XML-based authoring and content management. Our first step was to build a solid business case, which we approached from two directions. The first direction is from the viewpoint of compliance mitigation (e.g., mitigating compliance risk) and the other is from the perspective of making quantifiable returns (e.g., saving money).
The compliance mitigation proved to be the most powerful argument for our business case. We built a "story" around what would happen if there were a labeling issue. People expect the information to be right and regulatory agencies exact a high price if it isn't, such as fines, product withdrawal, lost support for a product in a specific country.
To support the case for compliance mitigation we looked at the costs of:
- Millions in a litigation case
- Correcting an error internally
- Lost revenue if we had a recall
And we determined how we could minimize or avoid some of these costs.
In addition to the compliance mitigation case, we identified a number of cost savings benefits that would result from adopting this strategy, including:
- Reduced cost of translation through content reuse. This reuse includes:
- 70% reuse between therapies described in the system guides
- 70% reuse between patient guides
- 90% reuse in warranty information
- 100% reuse between the physician's guide and technical manual
- Increased consistency in product labeling
- Reduced review time of at least 50% for labels. We currently have 50 models that result in 1200 labels and are translated into six languages, resulting in a review/proof time of 37.5 days. We wanted to cut that time in half.
- Significant reduction or complete elimination of desktop publishing costs due to the use of XML (e.g., desktop publishing is no longer required, because it is controlled by style sheets). Current costs are $50,000 per product.
We were surprised to find that we had very few challenges to the business case. Management was very conscious of risk in content and the gains they could realize from the compliance issues. In addition we had:
- Done our homework so that we clearly understood what Guidant would be getting from the system
- Laid out the business case very clearly by:
- Telling the story
- Identifying what they needed to purchase (technology and consulting)
- Tying the story to current events
- Tying the solution to real measurable benefits
- Making it clear how the solution would be beneficial in the years to come
Management insisted on the development of criteria for success that we would have to report back on annually. The development of the success factors really helped to focus us on the winning business case.
We decided to test the content management strategy on a brand new product. This was beneficial as there was no legacy content to convert, but because content creation and review were for new material, we are projecting ongoing savings rather than current savings. However, there is a commonality between the new product and the existing products that has already resulted in a savings of 20% in translation costs.
- Talk informally to groups that will be affected by the initiative in advance of the formal business case presentation to gain insight and feedback on what to include and not include in the business case
Before we presented the business case through a formal presentation we talked to a number of functional groups (IS, engineering, regulatory) to provide them with an understanding what we wanted to do, what would be the impact and benefits. They provided us with a lot of good feedback on what to include or not include in the business case.
- Develop criteria for success
Develop your criteria for success so that you can point to positive measurable outcomes. The criteria for success have enabled us to go back for second phase funding.
- Always plan on spending more money than you think
Don't be too conservative; err on the side of the high end. It is better to come in under budget then have to go back for more money part way through.