CASE STUDY | LIFE SCIENCES

CooperSurgical Streamlines Product & Regulatory Control

CooperSurgical transforms product and regulatory control with Rockwell Automation and Kalypso using a unified PLM and RIM platform.

surgical gloved hands handling petri dish

CooperSurgical has been innovating in the fertility and women’s health field for over 30 years. As leaders in the industry, the company has pioneered new technologies that are changing the landscape of how women, babies, and families are cared for.

Michelle Taub

Director, Product Systems, CooperSurgical

Challenge

High‑risk ERP rollout without a formal PLM system in place
Potential need for costly ERP redeployment due to legacy product setup decisions
Fragmented product and regulatory data spread across spreadsheets and platforms
Requirement to manage multiple product revisions simultaneously for global compliance
Limited business bandwidth as teams focused on ERP implementation

Solution

Kalypso digital transformation services to implement a unified Product Lifecycle Management (PLM) and Regulatory Information Management (RIM) solution

Result

Avoided ERP redeployment and launched ERP on time in North America
Reduced cost and resource requirements compared to traditional PLM programs
Improved visibility, control, and compliance across product and regulatory data
Established source of truth for enterprise decision‑making
Built a scalable foundation for change management and supplier quality initiatives

Challenge

Managing ERP Risk in a Highly Regulated Environment

As a global medical device company focused on female reproductive health, CooperSurgical prepared to launch a major ERP program in North America. But legacy decisions from an earlier regional deployment created unanticipated complications. Addressing the issue through ERP redeployment would have been costly, time‑consuming, and disruptive.

At the same time, product, manufacturing, and regulatory information lived in disconnected tools and spreadsheets. This fragmentation made it difficult to manage global registrations and support multiple product revisions, challenges compounded by short product shelf lives and strict regulatory requirements.

Michelle Taub, Director, Product Systems, was new to CooperSurgical, having been on board for just a few weeks. She recognized an opportunity to solve the problem differently. Based on her prior experience in IT and quality at medical device organizations, she proposed a Product Lifecycle Management (PLM)-approach. A PLM could address the immediate risk without interrupting the ERP program already in place.

“I knew we could solve this faster and cheaper than redeploying ERP. But more importantly, I knew who I could trust to help,” she says.

Solution

A Unified PLM and Regulatory Platform with Kalypso

Michelle contacted Kalypso, a team she had partnered with successfully in previous roles. That trust, and Kalypso’s ability to respond quickly with proven accelerators and deep domain expertise, gave CooperSurgical confidence to move forward. With a small team and limited budget, the group began work immediately, laying the foundation for what would become a broader partnership with Rockwell Automation and Kalypso.

“PLM usually means starting with a blank spreadsheet,” Taub explained. “Having a starting point meant we could solve the problem faster and with far less risk.”

By deploying PLM and regulatory management on the same platform, CooperSurgical eliminated the need for complex integrations and kept product and regulatory data tightly connected. The approach prioritized out‑of‑the‑box functionality to minimize disruption while creating a compliant, validated system integrated directly with ERP.

Result

Improved Control, Lower Risk, Scalable Digital Foundation

The new platform enabled CooperSurgical to launch ERP on time without redeploying systems across regions, avoiding significant cost and disruption to operations. By consolidating product and regulatory data into a single, validated system of record, the organization replaced manual, disparate processes with shared visibility and control across teams.

“We went from spreadsheets and text messages to a system where everyone can see the same information. That visibility alone has been a huge improvement."

Michelle Taub - Director, Product Systems, CooperSurgical

The solution also changed how teams across engineering, manufacturing, quality, and regulatory worked together. With product and regulatory data tightly connected, CooperSurgical gained greater confidence in global registrations, product revisions, and downstream decision-making.

Duplication was reduced, handoffs became clearer, and teams could spend less time reconciling data and more time focusing on execution.

The early success of the program also helped build organizational trust. What began as a small, fast-moving initiative led by a newly onboarded leader quickly demonstrated value, earning broader buy-in across the business. That trust, established through tangible results, allowed CooperSurgical to take a phased, methodical approach to expansion rather than a large-scale transformation.

As a result, the company laid a scalable digital foundation that continues to grow. CooperSurgical is now positioned to extend the platform into change management, document control, and supplier quality, supporting long-term compliance, operational resilience, and future innovation.

Published August 25, 2026