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Project Management For Medical Devices

"We've qualified for a huge tax credit by capturing our research and development (R&D) hours. The tax law in California has requirements about tracking R&D hours and—if they meet certain criteria—the company qualifies for a tax credit. With Project Insight, we're able to gather all the data on the hours that are being worked on for R&D projects, submit them, and receive a significant tax break."
- Manager of Program Management
ICU Medical

ABOUT THE CUSTOMER

ICU Medical was founded in 1984 by Dr. George Lopez, a practicing internist who imagined that there must be a better way of securing I.V. lines after tragically losing a patient due to an accidental disconnect. Dr. Lopez conceived a product, later known as the Click Lock, which provided a locking mechanism for these I.V. systems. The Click Lock was composed of a protected needle that would also serve to prevent healthcare workers from being accidentally stuck by the I.V. needles. Today, with a market cap of close to $500 million, ICU has an impressive list of landmark products, including the CLAVE NeedleFree Connector and the CLC2000 Catheter Patency Device. Still led by Dr. Lopez, ICU is solely focused on developing and manufacturing products that not only protect the healthcare worker from accidental needle-sticks, but protect the integrity of the patient's IV system, as well.

MAIN CHALLENGES

  • Cumbersome manual project tracking
  • No visibility between various project teams
  • Redundant projects begun because decisions to start new projects made without context
  • Inability to easily track resource allocation and actual hours worked

The manager's program management department works within research and development (R&D), managing the development of new products from the concept stage all the way through production. He said, "Because we're in the medical device industry, we have to comply with FDA and ISO regulations, so lots of documentation has to get done to ensure that we're following design control and other aspects of those guidelines."

With a team of four project managers in San Clemente, and about 12 engineers in Salt Lake City who also serve as project managers, ICU Medical typically works on a list of 35 to 40 projects at any given time. He said, "Right now, we're bringing in a plan in Ensenada, Mexico, so that will add another 30 to 40 projects."

When the manager began working at ICU Medical, the company managed its projects using a combination of spreadsheets, Access databases, email and "sticky notes." His goal coming in was to help the group enable visibility, "Just to have a complete list of everything going on in the company to make sure we're focused on the right things. Early on, that wasn't there. There was no list at all. A lot of decisions to say, ‘Yes, let's do this one or that one,' were made in a bubble and without context. So we had redundant projects or projects that required new capital equipment, and there was no cross-talk. One department couldn't see what the other department was doing. We needed a common viewpoint so that we could collaborate and make smart choices."

WHY PROJECT INSIGHT

ICU Medical's program management team needed a solution that would:

  • Enable time tracking and resource allocation
  • Provide a central place for visibility into all projects, company-wide
  • Be web accessible and easy to learn
  • Automate many of the tasks involved in project management

Working with a consultant, ICU Medical brought in a variety of vendors to do in-house evaluations, and Project Insight was on the short list, as well as a custom system based on MS Project Server. "One of the things that attracted ICU to Project Insight was the resource allocation and the ability to capture hours. The tax law in California has requirements about tracking R&D hours and—if they meet certain criteria—the company qualifies for a tax credit. With Project Insight, we're able to gather all the data on the hours that are being worked on for R&D projects, submit them, and receive the tax credits."

THE RESULTS

Project Insight Edition

  • Project Insight Enterprise On-Premise Edition
  • 200 users
  • Implementation date: September 2005

What they liked about Project Insight:

  • User-friendly and web-accessible
  • Provides broad and deep visibility into the full spectrum of company projects
  • Automates many repetitive project management and reporting tasks
  • Enables resource allocation
  • Detailed time tracking
  • Easy to customize

Now a long time Project Insight customer, ICU uses Project Insight for all its R&D and program management projects. "One of the things we especially like is the ability to customize things, to tweak and modify," the manager of program management noted. "One thing that we've developed around reporting is a steering team committee that has an update meeting every two weeks. We discuss reports that come from Project Insight, generate custom reports for various projects, then go over it all to see if anything is behind schedule or at risk of falling behind, so we can get the help we need to bring a project back on track."

He continued, "We created a category for projects that are pending approval from the steering team. Every month we print out all that are pending approval, sit down and meeting about those. Then we go through each one and select which projects we're going to activate. It's given us a foundation for building our project selection and approval process."

ICU Medical has developed a productive working relationship with Metafuse, the developers of Project Insight. "I like Metafuse a lot," the manager said. "My support contact is really good about returning calls and being quick to respond. He's connected with our IT guys to do updates after hours or anytime we're available. The company has been really good support-wise and in giving us what we need."


*Customer contact names available upon request.

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