Transforming Processes at Medtronic
Daphne Walmer, CRM Technical Communications Manager at Medtronic, and her colleague, Andre Purnot, Translations Manager, made a proposal to request funding to design and implement a single-sourcing toolset. Upper management found their presentation compelling and agreed that from productivity, accuracy, translation, and regulatory perspectives, this investment in automation and database publishing made sense.
However, they requested that Walmer and Purnot back up a step and inventory their organizations’ processes worldwide. They pointed out that they had funded other projects that had automated processes and added tools where the tools made sense. In some cases, though, the automation or tools were grafted onto poorly understood or inefficient existing processes. Upper management authorized Walmer and Purnot to take an in-depth look at their processes and, as a parallel activity, research tool and automation options.
This investigation is consistent with Medtronic’s reputation for both quality and innovation. Medtronic is one of the world’s leading medical technology companies; they design and manufacture, among other devices, pacemakers, implantable defibrillators, heart valves, cardiac surgery products, angioplasty products, and products used to treat pain and movement disorders. Not only are these products sophisticated, many are programmable in the field-either in surgery or in doctors’ offices. Additionally, many base products are customized for particular hospitals, applications, or techniques. As with all global manufacturers, Medtronic must translate its documentation.
All of these factors contribute to make single-sourcing a good option. Medical product documentation has two other drivers. First, lives are at stake. Second, every word has to be approved (and that approval documented) by the US Food and Drug Administration (FDA) and other regulatory bodies elsewhere in the world. If the FDA changes the wording for a particular procedure for one product, then those changes need to ripple throughout all the product manuals that use this procedure. Without a single-source database tracking changes, even finding where a particular bit of text exists can be a huge undertaking.
In common with many organizations, the writing groups reporting to Walmer had maintained the processes they had originally established to document individual products-even when there were shared warnings or other potentially reusable text. To prepare for her presentation to management, Walmer’s team had already started down the path of defining the processes and finding where they could be combined.
Framing the Problem and the Conditions
The Medtronic Advanced Publishing System (MAPS) team had already framed the problem and the conditions. First, many products are similar, but the documentation may be written by different individuals or teams.
Second, the same customer set may receive manuals for several products, which is an incentive for the wording to be consistent. Differences in wording can also affect how efficiently translation automation programs operate. Slight differences can mean that translation programs won’t find a matching translation even though one already exists.
Third, each manual needs to be translated into up to eleven languages. For regulatory reasons, Medtronic releases products simultaneously throughout Europe before they can be released in the US. If regulatory requirements allow, the company would prefer to release simultaneously world wide; to accommodate this practice, the documents must be translated before the product is complete. This timing means that last-minute changes need to be made in up to thirteen different language versions.
Fourth, Medtronic expects all functional areas to reduce cycle time and improve time to market. And, as with any industry that manufactures products that affect people’s health, these improvements need to occur while maintaining the highest quality and accuracy.
Fifth, because the products (including the manuals) are regulated, the team needs to automate a method of documenting changes. Authors also need to be able to search for all instances of particular blocks of text so that the changes can be made everywhere at one time.
Sixth, Walmer’s team is in the US, Purnot’s in the Netherlands, and other partners reside in many other locations world wide, which adds the complications of time, language, and collaborating across miles.
Calling on Expert Help
When Walmer began creating the investigation team, she decided to ask for help from a professional consulting group: IBM Global Services. Pat Velderman, IBM’s facilitator for the Medtronic project, says that there are three reasons why consultants get called in:
1 Consultants are often granted access to high-level managers and other important employees more readily than in-house teams. Because the consultants’ time is authorized at a high level, management buy in is often stronger, as is management cooperation.
2 Consultants, because they are from outside the organization, are often perceived as respectable sources; they do not operate within the corporate political scheme, so they can be trusted to make objective recommendations.
3 Consultants have experience with many other organizations who have faced the same issues. They have access through their contacts and peers to a much wider view of problem solving than someone inside a particular corporation.
From Walmer’s perspective, she found IBM Global Services consultants helpful because they are professional, polished facilitators. They are not emotionally attached to any of the processes and have no vested interest in any particular solution. They do, however, understand the publishing process so they are able to ask why a particular step or process is necessary.
However, when you call in consultants, Velderman cautions against believing they will give you “the” answer. He says, “I don’t know the intimate details of how the people do the work. My job is to help them to discover-together-a path for them to move forward on. After all, I’m only there for a few weeks; they will need to own the process day after day. We’re here to help clients discover for themselves solutions that work for them.”
Discovering and Documenting Current Processes
Together, Velderman and the process-redesigning (MAPS) team created a plan to gather information about how the processes work today and what business needs had to be solved by the proposed system.
The methodology required several all-day meetings with teams doing the work in the US and in Europe. Velderman facilitated these meetings, helping the participants stay on track. From their earlier investigation, the participants knew the top-level process. At first glance, it looked as though each team used the same process.
However, as the teams in the various locations began charting their work, it became apparent that different groups and individuals had different methods of getting the job done. Velderman worked with teams in each location for three days, and they documented the results in Visio. When the project team compiled the results from all locations, the steps of the process took 20 pages to document.
With Velderman’s facilitation, the teams began considering how to remove steps, automate repetitive or error-prone steps, and make the process consistent across all groups. At the end of the investigation, they reduced the number of steps needed to create English manuals by one-half and translated manuals by two-thirds. By reducing the number of steps, the teams were able to both reduce cycle time and remove opportunities to introduce error. Walmer says that even if the department did nothing more to automate the process, they made progress toward company goals in terms of shorter cycle time, reduced translation costs, and text reuse.
Looking at the Human Equation
Both Walmer and Velderman were encouraged by the constructive participation of the teams in all locations. Velderman interviewed managers in several peer organizations, including product development, marketing, legal, translation, and engineering. He used the results of these interviews to probe into each step further, to help the participants identify where the process really was different from person to person or group to group. He then helped facilitate a consolidation process by encouraging open discussion about which differences were necessary and which were not.
Obviously, these discussions were sometimes tough. After all, people are attached to processes in which they have invested time, creativity, and trouble. Furthermore, people are naturally anxious about how changes in the process will change or eliminate their work. Walmer encouraged people to voice these fears.
When possible, she explained how the work and the skill sets for the work in the future were evolving. The technical communication management team is working with individuals to explore training and career changes before the redesign becomes a threat. While this type of proactive and honest management cannot eliminate the fears about change, it can mitigate some of the destructive rumor-mill activity that can sidetrack process redesign efforts.
Velderman made a point of getting the most vocal people into the redesign process. He says, “When you put skeptical and vocal people, who are also good thinkers, in the room together, you can make real progress by getting them to chart their processes. When they write everything down-every minor variation-and then step back, they are amazed. That’s when the team pulls together to redesign pretty much on their own.” They can see clearly the non-value-added tasks and will, therefore, own the new process when it is complete.
As Julie Bradbury noted in the February case study, changes only work when they are institutionalized and well communicated. The MAPS team created a communication and action plan. The plan included monthly brown bag lunches with small groups to discuss changes and problems. Project team members also attend staff meetings to provide status and answer questions. As they choose tools, the authors are invited to product demos and, as tools are purchased, they will go to training classes.
Walmer notes that the human side in technical projects is often overlooked because it is the hardest part. She says, “The technology piece is relatively easy, so people focus on it. However, if you don’t try to focus on the people side, if you haven’t explained why change is needed, and where the changes are taking you, then the project is likely to fail. Because, of course, people are the variable piece of the puzzle-they can either embrace the changes and work with the technology, or they can resist it.”
The report Velderman, Walmer, and Purnot made on behalf of the team to Medtronic’s upper management endorsed the course that Walmer and Purnot had originally presented: move to a single-sourcing approach using SGML and focus on reusable pieces of text. The team further recommended that some of the authors become specialists; for example, one person might learn about one pacemaker feature that doctors might activate in their offices. This person would work inside the company with engineering and field consultants and outside with customers to understand everything about the process for the entire product line. The author would, in effect, become a subject-matter expert, one on whom the rest of the authoring team could rely for writing or editing text on a narrow, but deep area.
Walmer and the MAPS team believe this structural change will help people share responsibility and retain ownership. The development of accurate information that is faster and less expensive to maintain and translate becomes the shared responsibility of the whole team. The opportunity to own a subject or process will enhance the technical knowledge of and, therefore, the career prospects and visibility of individual team members.
After hearing the team’s report and reviewing the information, Medtronic’s management approved funding for designing and prototyping the new system. While this design phase goes on, Walmer’s and Purnot’s teams are already reaping some benefits from the process redesign. Walmer should have a follow-up report next year on how adding the single-sourcing tools works within the new framework.