Application Case 2.1

Medical Device Company Ensures Product Quality While Saving Money

  Few technologies are advancing faster than those in the medical field—so having the right advanced analytics software can be a game changer. Instrumentation Laboratory is a leader in the development, manufacturing, and distribution of medical devices and related technologies, including technology that is revolutionizing whole blood and hemostasis testing. To help ensure its continued growth and success, the company relies on data analytics and Dell Statistica.


  As a market leader in diagnostic instruments for critical care and hemostasis, Instrumentation Laboratory must take advantage of rapidly evolving technologies while maintaining both quality and efficiency in its product development, manufacturing, and distribution processes. In particular, the company needed to enable its research and development (R&D) scientists and engineers to easily access and analyze the wealth of test data it collects, as well as efficiently monitor its manufacturing processes and supply chains.

  “Like many companies, we were data-rich but analysis-poor,” explains John Young, Business Analyst for Instrumentation Laboratory. “It’s no longer viable to have R&D analysts running off to IT every time they need access to test data and then doing one-off analyses in Minitab. They need to be able to access data quickly and perform complex analyses consistently and accurately.”

  Implementing sophisticated analytics was especially critical for Instrumentation Laboratory because of the volume and complexity of its products. For example, every year, the company manufactures hundreds of thousands of cartridges containing a card with a variety of sensors that measure the electrical signals of the blood being tested.

  “Those sensors are affected by a wide range of factors, from environmental changes like heat and humidity to inconsistencies in materials from suppliers, so we’re constantly monitoring their performance,” says Young. “We collect millions of records of data, most of which is stored in SQL Server databases. We needed an analytics platform that would enable our R&D teams to quickly access that data and troubleshoot any problems. Plus, because there are so many factors in play, we also needed a platform that could intelligently monitor the test data and alert us to emerging issues automatically.”


  Instrumentation Laboratory began looking for an analytics solution to meet its needs. The company quickly eliminated most tools on the market because they failed to deliver the statistical functionality and level of trust required for the healthcare environment. That left only two contenders: another analytics solution and Dell Statistica. For Instrumentation Laboratory, the clear winner was Statistica.

  “Choosing Statistica was an easy decision,” recalls Young. “With Statistica, I was able to quickly build a wide range of analysis configurations on top of our data for use by analysts enterprise-wide. Now, when they want to understand specific things, they can simply run a canned analysis from that central store instead of having to ask IT for access to the data or remember how to do a particular test.”

  Moreover, Statistica was far easier to deploy and use than legacy analytics solutions. “To implement and maintain other analytics solutions, you need to know analytics solutions programming,” Young notes. “But with Statistica, I can connect to our data, create an analysis and publish it within an hour—even though I’m not a great programmer.”

  Finally, in addition to its advanced functionality and ease of use, Statistica delivered world-class support and an attractive price point. “The people who helped us implement Statistica were simply awesome,” says Young. “And the price was far below what another analytics solution was quoting.”


  With Statistica in place, analysts across the enterprise now have easy access to both the data and the analyses they need to continue the twin traditions of innovation and quality at Instrumentation Laboratory. In fact, Statistica’s quick, effective analysis and automated alerting is saving the company hundreds of thousands of dollars.

  “During cartridge manufacturing, we occasionally experience problems, such as an inaccuracy in a chemical formulation that goes on one of the sensors,” Young notes. “Scrapping a single batch of cards would cost us hundreds of thousands of dollars. Statistica helps us quickly figure out what went wrong and fix it so we can avoid those costs. For example, we can marry the test data with electronic device history record data from our SAP environment and perform all sorts of correlations to determine which particular changes—such as changes in temperature and humidity—might be driving a particular issue.”

  Manual quality checks are, of course, valuable, but Statistica runs a variety of analyses automatically for the company as well, helping to ensure that nothing is missed and issues are identified quickly. “Many analysis configurations are scheduled to run periodically to check different things,” Young says. “If there is an issue, the system automatically emails the appropriate people or logs the violations to a database.”

  Some of the major benefits of advanced data analytics with Dell Statistica included the following:

  • Regulatory compliance. In addition to saving Instrumentation Laboratory money, Statistica also helps ensure the company’s processes comply with Food and Drug Administration (FDA) regulations for quality and consistency. “Because we manufacture medical devices, we’re regulated by the FDA,” explains Young. “Statistica helps us perform the statistical validations required by the FDA—for example, we can easily demonstrate that two batches of product made using different chemicals are statistically the same.”

  • Ensuring consistency. Creating standardized analysis configurations in Statistica that can be used across the enterprise helps ensure consistency and quality at Instrumentation Laboratory. “You get different results depending on the way you go about analyzing your data. For example, different scientists might use different trims on the data, or not trim it at all—so they would all get different results,” explains Young. “With Statistica, we can ensure that all the scientists across the enterprise are performing the analyses in the same way, so we get consistent results.”

  • Supply chain monitoring. Instrumentation Laboratory manufactures not just the card with the sensors but the whole medical instrument, and therefore it relies on suppliers to provide parts. To further ensure quality, the company is planning to extend its use of Statistica to supply chain monitoring.

  • Saving time. In addition to saving money and improving regulatory compliance for Instrumentation Laboratory, Statistica is also saving the company’s engineers and scientists valuable time, enabling them to focus more on innovation and less on routine matters. “Statistica’s proactive alerting saves engineers a lot of time because they don’t have to remember to check various factors, such as glucose slope, all the time. Just that one test would take half a day,” notes Young. “With Statistica monitoring our test data, our engineers can focus on other matters, knowing they will get an email if and when a factor like glucose slope becomes an issue.”

  Future Possibilities

  Instrumentation Laboratory is excited about the opportunities made possible by the visibility Statistica advanced analytics software has provided into its data stores. “Using Statistica, you can discover all sorts of insights about your data that you might not otherwise be able to find,” says Young. “There might be hidden pockets of money out there that you’re just not seeing because you’re not analyzing your data to the extent you could. Using the tool, we’ve discovered some interesting things in our data that have saved us a tremendous amount of money, and we look forward to finding even more.”

1. What were the main challenges for the medical device company? Were they market or technology driven? Explain.
2. What was the proposed solution?
3. What were the results? What do you think was the real return on investment (ROI)?