Benefits of dynamic product information delivery for life sciences

I was fortunate enough to reconnect to an old friend. I reached out to Greg Johnson from Medtronic and had an amazing conversation about their dynamic information delivery system and the benefits it has to Medical Devices and Life Sciences companies. Over the years, Medtronic has increased their investment in their dynamic information delivery system. They have continued to develop it and they have seen their ROI returned again and again.

Medtronic implemented Arbortext in 1999. They have been the subject of a case study and a customer success story. I've seen them present at the Arbortext user conferences (AUGI) over the years. In fact, I never missed one of Greg's AUGI presentations. I learned a lot from them in the early days and I still have his slides on my computer.

It wasn't so much that I wanted to do what they did—I had to do what was best for my situation—but I could see what was possible, where I could go, and at least one way to get there. I always left inspired by the possibility and exhausted by the prospect of the work ahead.

Greg still presents at conferences world wide. And he will be the first to tell you not to do what they did. Technology has changed, your goals are your goals, your capabilities are your own as well. But definitely join the conversation. The payoffs really are this great. The implications of moving to this kind of system are way bigger than you can imagine.

It was great to catch up with Greg. Over the years, Medtronic has increased their investment, continued to develop, and seen the ROI returned again and again. It was great to see that the payoff is definitely there—and that it continues to be there if you keep at it.  It was also humbling because this is not a short path, it is a long, long journey to get there. It's good to know that if you keep at it, your ROI build upon itself every step of the way.

After 10 years, their project has started to reach out to:

• software objects and applications
• specifications that need to be published
• technical services
• training and education

They're still driving toward cradle to grave information development. As a medical device company, they chose to take their project down a difficult road: they wanted to have their dynamic information development system validated as if it were, itself, a Class 3 Medical Device. They wanted to validate the content coming out of the tool so that their information development would pass FDA audits.

He said that XML publishing addresses three main points essential for Life Sciences companies and anyone interested in producing efficient technical publications:

• The Quality Driver
• The Time to Market Driver
• The Cost Savings Factor

Greg says, "You don't want to do how/what we did. It's 10 yrs later. But I want to encourage you. There are vast savings and vast reductions in cycle time and vast improvements to do in this field, if you do it smart, build your vision, and go be passionate about it."

The Quality Driver

When the FDA audits, they audit manufacturing processes. They want to see the records that you followed those processes. They can go deeper and deeper. They don't do it often, but they have the right to. Every medtech company lives in fear that the FDA will show up at the door one day and want to see everything. Everything needs to be clean. If you don't pass, there are triggers that can shut down a business unit or an entire company. The FDA can padlock the front door if they want to.

Medtronic decided that they wanted a system that provided a level of control for information creation and delivery.  They wanted the system itself validated: They wanted to validated the tool so they wouldn't have to validate the content coming out of the tool. They decided that the best way to get that validation on the input side, so they certified the input. They wanted their documentation to be able to pass FDA audit for every change they ever made. They implemented a system that would meet those requirements. They made sure the system itself was covered, that development was covered, and that staff was properly trained.

Today, their system is Part 11 compliant for system security. The documentation team goes through all the same hoops when testing and preparing for audits that the rest of the company goes through.  It's fair to say that their documentation is being held to a software standard. Medtronic can prove that information coming out of their dynamic information development system:

• has a documented, approved, assigned, scope
• has defined requirements
• cannot exceed the scope
• has traceability and validation to the defined requirements
• documents produced by the system are held to standard of class 3 device

Although their main driver was quality, they've proven that they got that and more. In fact, because they left traditional publishing tools like Word and FrameMaker, they got all of the big three benefits in one package: increased quality, reduced cycle time, and reduced cost. As far as I know, there's no one like them in all of Medtech.

The Time to Market Driver

Cycle time is critical unless you want to miss market ship dates.

Greg told me a story about a time when there was $300 M in new product on shipping doc waiting on the FDA approval of the documentation. They took a chance and preprinted the documentation—at risk—and they were standing by, ready to stuff the boxes and move the product across the line, so they could take the inventory in the quarter. Everything was waiting on the call from FDA.

He tells me that docs are always the last thing approved and that The FDA can require any change (the moving of a comma, for example) before giving the approval required to ship. Documentation can make or break a quarter.

When you add translation to the mix, it's not uncommon for a translation center to tell you that they need the content before the specs are written in order to make the target market release dates they've been given.  These are frantic publishing schedules with $100s of millions of dollars at stake.

At Medtronic, because they've validated the content and can trace every change ever made, they've achieved 90% content reuse. They can assemble existing content, in english and other languages, reducing the risk factor to new content and changed content. They've drastically reduced cycle time in order to pull document release time in closer to product release time in their home market and in the international ones.

The Cost Savings Factor

Even after proving to management that he would increase quality, address the audit issue, and reduce cycle time, management said, 'yeah, but how much money can you save me in this project.'

So he told them about the benefits of reuse, automating composition, and source control.

Greg and one of the MBAs at Medtronic did formal business case model together to show how much money would be saved. The results they predicted were unbelievable. They were too stellar.  So they put in two lines:

1. the numbers they believed in were labeled "optimistic" and
2. numbers they made up and labeled "conservative"

The 2nd line were numbers they thought that management would believe. For example, although they believed the could get 90% reuse, they scaled it down to 50%.

And, for the record, they did reach 90% reuse. They reached every single one of the "optimistic" goals. In 2005, they had exceeded optimistic line and met or exceeded all other commitments. Greg's team received the Star of Excellence for their business unit as well as the Medtronic Star of Excellence. A executive told Greg that they got a higher ROI than if they had put the money into another product and that his project was the "most successful project ever seen at Medtronic".

All thanks to a dynamic information delivery system that solved the audit problem, the cycle time problem, and saved money.

And it all started when Arbortext took them to see what Caterpillar had done (starting 10 years earlier still). Greg said when they came away, he didn't know whether they were more exhilarated or exausted at the proposition and how far they had to go.

Now they're the inspiration for others.

Greg says, "You don't want to do how/what we did. It's 10 yrs later. But I want to encourage you. There are vast savings and vast reductions in cycle time and vast improvements to do in this field, if you do it smart, build your vision, and go be passionate about it."

See also

1. Dynamic information delivery systems reduce translation costs