This is the second post in a 4-post series reporting on an interview I did with Greg Johnson from Medtronic. 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.
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.
- Benefits of dynamic information delivery for life sciences
- The Quality Driver
- The Time to Market Driver
- The Cost Savings Factor