Hologic Improves Lives, Ensures Regulatory Compliance Using Product Lifecycle Management Solutions in Every Phase of Product Development

Hologic Improves Lives, Ensures Regulatory Compliance Using Product Lifecycle Management Solutions in Every Phase of Product Development

  • Oracle Customer:  Hologic
    Location:  Bedford, Massachusetts
    Industry:  Life Sciences
    Annual Revenue:  $1 to $5 Billion

Hologic, Inc. is known for developing innovative medical technology—like the world’s first 3-D mammogram—that can quickly diagnose women’s health issues and save lives in the process.

“Our goal is to be at the forefront of innovation. At Hologic we believe every life is extraordinary, and, now we are helping our customers provide extraordinarily powerful care,” said Dave Rudzinsky, senior vice president and CIO, Hologic.

Because Hologic operates in a highly regulated industry, standards, controls, and governance are paramount.

The company supports many of its business priorities with Oracle’s Agile Product Lifecycle Management (PLM) applications. Agile PLM solutions support every phase of product development, from the genesis of a new idea, through the retirement of a product.
“The software stores our product record and helps accelerate innovation and time to market,” Rudzinsky said. 

Hologic has grown significantly through acquisition in recent years. It relies on Agile PLM applications to rapidly integrate new products, and associated data, into the organization to support synergy, visibility, and compliance initiatives, and jumpstart return on investment.
Agile PLM solutions also play a critical role in ensuring product quality. “At Hologic, product quality begins with the materials that we purchase from our suppliers, so we work collaboratively with them,” Rudzinsky said. Hologic uses Agile PLM applications and Oracle E-Business Suite applications to manage all supplier information and carefully track and analyze supplier quality.

In addition, Hologic relies on Agile PLM solutions to meet increasingly complex regulatory requirements. Agile’s flexible platform manages all of Hologic’s product data and many aspects of its regulatory needs and requirements. A key is managing all product-related data, design history files, and device master records. All of that information resides in Agile. Keeping this information secure and accessible is critical to meeting stringent regulations. 

“Every time a new regulatory requirement is introduced, we ask ourselves, ‘Is this something we can manage with Agile?’ The applications are user friendly, quick to roll out, and easy to maintain and manage,” Rudzinsky said.

For example, Hologic recently faced new US Food and Drug Administration (FDA) requirements around unique device identifiers (UDIs). Because its product data is already in Agile, Hologic is using the software as the foundation for UDI and adding the additional data elements needed to create these device identifiers. Thanks to Agile, Hologic can easily interface with the FDA’s database to streamline compliance, without devoting additional time and resources towards a new solution.

Hologic collects a growing volume of data directly from its connected equipment at customer locations. This information can be used to automatically create a service request in Oracle E-Business Suite, which flows directly to the Agile Product Quality Management environment, where it enters a workflow to help resolve the problem in a closed-loop, quality system.

The company quickly embraced Agile and continues to explore using this strategic platform to adapt to changing business needs and regulatory requirements. Hologic is using Oracle Product Lifecycle Analytics to gain more information to help the business make decisions, examine product quality, and gain a better understanding of how to improve women’s health.

A word from Hologic

  • “Master product data is one of Hologic’s most important enterprise assets. We trust its management to Oracle’s Agile Product Lifecycle Management solutions.” – Dave Rudzinsky, Senior Vice President and CIO, Hologic, Inc.



Why Oracle

Hologic chose Oracle’s Agile PLM solution because it is easy for employees to use, quick to deploy, and it does not require a lot of overhead to maintain. It also integrates easily with the company’s Oracle E-Business Suite environment. Agile’s flexible platform has offered support to engineering design and quality processes.

 “We need to run our business with extraordinary software. Agile Product Lifecycle Management solution enables us to collaborate better and track critical product information as well as integrate company acquisitions quickly by moving them to our Agile and Oracle E-Business Suite system, so that everything is on one single global enterprise system for our whole business,” Rudzinsky said.