Medical device company ensures product quality while saving hundreds of thousands of dollars

Transcription

1 Medical device company ensures product quality while saving hundreds of thousands of dollars enables analysts enterprise-wide to easily access and analyze data while automating monitoring and alerting with Statistica s advanced analytics platform Case Study COMPANY PROFILE Company Industry Pharmaceuticals and Healthcare Country United States Employees 1,000 BUSINESS NEED To enhance innovation, quality and regulatory compliance, needed to enable scientists across the company to easily access data and perform advanced analytics. SOLUTION With Statistica s advanced analytics platform, scientists enterprise-wide are saving valuable time with easy, consistent analytics, automated process monitoring and alerting, and the company is saving hundreds of thousands of dollars by avoiding scrap and rework while improving quality. BENEFITS Saved hundreds of thousands of dollars by avoiding scrap and rework Enabled scientists and engineers enterprise-wide to easily access data and perform advanced analytics Helped ensure regulatory compliance by automating process monitoring and alerting Saved engineers hours of work a day, enabling them to focus on innovation Enabled supply chain monitoring to ensure product quality

2 Few technologies are advancing faster than those in the medical field so having the right advanced analytics software can be a game changer. 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 Statistica. ANALYSTS CAN NO LONGER AFFORD TO WAIT FOR IT As a market leader in diagnostic instruments for critical care and hemostasis, 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. To implement and maintain other analytics platforms, you need to know analytics solutions programming. But with Statistica, I can connect to our data, create an analysis and publish it within an hour. - John Young, Business Analyst, 2

3 Like many companies, we were data-rich but analysis-poor, explains John Young, business analyst for. 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. SOPHISTICATED PRODUCTS DEMAND SOPHISTICATED ANALYSIS TOOLS Implementing sophisticated analytics was especially critical for 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. STATISTICA DELIVERS ADVANCED ANALYTICS FOR USERS ENTERPRISE-WIDE 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 Statistica. For, 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. 3

4 EASY TO USE, EASY TO DEPLOY AND EASY ON THE BUDGET 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. What about Minitab? Young reports that some scientists at Instrumentation Laboratory do continue to use Minitab for some purposes, but Young notes that it is not even in the same class as Statistica. Minitab doesn t even come close to Statistica, he says. For example, it does not enable us to publish analysis configurations and schedule analysis to run at specific dates and times, or to key external events using Visual Basic code. 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. - John Young, Business Analyst, 4

5 SAVING HUNDREDS OF THOUSANDS OF DOLLARS WITH QUICK, EFFECTIVE ANALYSIS AND REAL-TIME ALERTS 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. 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 (edhr) 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 s the appropriate people or logs the violations to a database. 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. - John Young, Business Analyst, Instrumentation Laboratory ENSURING REGULATORY COMPLIANCE In addition to saving money, Statistica also helps ensure the company s processes comply with 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. Statistica s automated alerting helps comply with other FDA requirements as well. We re required by the FDA to have established escalation procedures based on statistical evaluation of our data, explains Young. If we did not have Statistica, implementing those escalation procedures would have required custom coding. But with Statistica, it was quick and easy: we simply have the platform evaluate our data and the appropriate people even staff who don t have Statistica installed but who need to be involved. 5

6 Using Statistica, you can discover all sorts of insights about your data that you might not otherwise be able to find. - John Young, Business Analyst, ENSURING CONSISTENCY Creating standardized analysis configurations in Statistica that can be used across the enterprise helps ensure consistency and quality at. 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 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. Before subassemblies are installed in the instrument, they need to be tested to make sure that they meet specifications. For example, when we receive a shipment of boards from a supplier, we test them and record the data in our LabVIEW database, Young says. Statistica can interface to that database and calculate the process capability index (Cpk) on that test data, so we can work with vendors to ensure they are meeting our specifications. SAVING TIME In addition to saving money and improving regulatory compliance for, 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 if and when a factor like glucose slope becomes an issue. 6

7 In addition, Statistica enables to perform batch analyses, and it efficiently organizes the results. Statistica s batch functionality allows me to say I want to do this type of analysis by this area, by this variable and by this variable, Young explains. And it organizes the results into a nice tree structure, which is much better than Minitab s output folder. We can even include other documents in the structure along with the analysis, which is very helpful. THE POSSIBILITIES ARE ENDLESS is excited about the possibilities made possible by the visibility Statistica 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. ABOUT STATISTICA Statistica s advanced analytics, big data and IoT offerings provide you endless possibilities to innovate your enterprise. Whether it s uncovering the genetic basis of a disease, reducing hospital readmissions, mitigating financial risk, or ensuring procedural validation, Statistica enables organizations to transform in new and exciting ways. By embedding analytics everywhere and empowering a wider community of citizen data scientists, you ll accelerate innovation, improve customer experiences, and streamline your enterprise for the future. VIEW MORE CASE STUDIES AT STATISTICA.IO/RESOURCES Statistica and the Quest Software logos and products as identified in this document are registered trademarks of Quest Software, Inc. in the U.S.A. and/or other countries. Other trademarks and trade names may be used in this document to refer to either the entities claiming the marks and names or their products. Quest Software disclaims any proprietary interest in the marks and names of others. Availability and terms of Quest Software, Solutions and Services vary by region. This case study is for informational purposes only. Quest Software makes no warranties express or implied in this case study. March 2017, Quest Software Inc. All Rights Reserved. CASESTUDY-STATISTICAINSTRUMENTATIONLAB-US-AA