Big Ideas

Regulatory Compliance: Hologic First To Meet New Affordable Care Act Requirement

CIO explains the value of a steady approach and trusted partners

by Aaron Lazenby

September 2014

How do you handle new regulations in your industry?


Last year, as part of the Affordable Care Act, the Federal Drug Administration (FDA) implemented the Unique Device Identifier (UDI) requirement to improve the quality of information on medical devices, identify problems more quickly, and ultimately improve patient safety.

This meant there were new challenges for Hologic, a Bedford, MA company that develops, manufactures, and supplies premium diagnostic products, medical imaging systems, and surgical products to improve patients’ lives. But, says Dave Rudzinsky, senior vice president of information services and chief information officer at Hologic, a strong Oracle foundation and a steady approach helped Hologic become the first medical device team to meet the FDA’s UDI requirement.

Profit spoke to Rudzinsky about how Hologic uses Oracle solutions to keep up with regulatory compliance such as the Affordable Care Act. Rudzinsky also discussed how Hologic’s newest health care developments help people everywhere, and how Oracle provides the foundation for the company’s mission to deliver “the science of sure.”

When I look at the technology that we’re bringing to the marketplace, technology that will help improve outcomes and help people, we're doing it with Oracle as a partner.”

Profit: How is Hologic using technology to improve patient outcomes?

Rudzinsky: October is Breast Cancer Awareness month and for the past nine years, our executives have rung the opening bell for NASDAQ to mark the month. One of the most important things we can do is educate people about breast cancer, in the hopes that women will get screened.

Currently, we are the first company offering 3-D mammography, and the Journal of American Medicine just published an article about 3-D mammography’s superiority to 2-D mammography. A technology called tomosynthesis was in development at Hologic for a long time. The idea is that if you look at digital images that show 3D slices of the breast, you’ll have a better chance of finding something hiding in the tissue.

JAMA found that when tomosynthesis was used with 3-D mammograms, not only was there increased detection of breast cancer, but there was a decrease in false positives. That reduces anxiety—and also reduces health care costs, which is something that’s big and important in the world today, with the government trying to make sure that we can provide health care to more people.

Profit: How does Oracle support Hologic’s work?

Rudzinsky: Oracle’s the foundational platform for Hologic’s IT infrastructure. The science side of the house runs Oracle E-Business Suite, Oracle Business Intelligence, Oracle Agile PLM. And our financial systems are Oracle Hyperion-based. For the last couple of years, we have run our enterprise application platforms on Oracle Exadata, so they're bigger, faster, stronger solutions now. We also have Oracle Fusion Middleware connecting and integrating our solutions together. When I look at the technology that we’re bringing to the marketplace, technology that will help improve outcomes and help people, we're doing it with Oracle as a partner.


For example, we use Agile as a workflow and a collaboration tool for engineers, manufacturers and designers across all different locations and geographies. Because they have a centralized system, they can collaborate and work on products together. With Agile, our engineers and R&D folks can manage the design and development process, creating the structures for these products that they're developing in the labs. We also use Agile for capturing our design history files, and it’s the home for what we call the device master record, which is part of our regulatory requirements from the FDA.

Profit: Speaking of regulatory requirements, with the passing of the Affordable Care Act, you had to make some changes. How did you manage these new requirements?

Rudzinsky: There are some folks in some companies that might panic every time a new regulation comes out. At Hologic we don't panic. The first step for us is to really sift through the hype and make sure we understand the regulation. Then we look at what technology we are already using to run our business that can help us satisfy the new requirement.

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Dave Rudzinsky is senior vice president of information services and chief information officer at Hologic.

Since we already use Oracle and specifically Agile to run our business, that’s what we are using to track the information needed to meet the UDI requirement. We worked with Oracle Platinum Partner, Inspirage, and they teamed up with Oracle to develop a solution together that allows us to be able to transmit the data to the FDA’s Global Unique Device Identification Database.

It’s still a lot of work, because we have to track all of these attributes about our products, and we might store it in Agile, and we might print the labels out of Agile and Oracle, but we still have to gather and collect that content. No one tool can do it for us.

But ultimately, the database is designed to improve the quality of health care, so the FDA understands more about the quality of the devices, and if there is an issue, they have all the information they need to address it. And even with the heavy lifting, we were the first ones to transmit our data to the FDA.

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