www.medical-devices.tech
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Rockwell Automation & Kalypso unify product & regulatory management at CooperSurgical
Integrated PLM and RIM platform reduces ERP deployment risk and centralizes product and regulatory data for medical device compliance.
www.rockwellautomation.com
Application Area: Product Lifecycle Management, Regulatory Information Management
Industry Sector: Medical Device Manufacturing
CooperSurgical, a global medical device company specializing in fertility and female reproductive health technologies, prepared for a major enterprise resource planning deployment in North America. To mitigate rollout risks and address data fragmentation, the company initiated a project to deploy a unified product lifecycle management and regulatory information management platform across its operations.
Fragmented Data and Implementation Risks
Prior to the enterprise resource planning deployment, CooperSurgical encountered complications stemming from legacy decisions made during previous regional software implementations. Resolving these complications through a full system redeployment would have introduced significant costs, extensive timelines, and operational disruptions. Furthermore, the company managed its product, manufacturing, and regulatory information across multiple disconnected tools and spreadsheets. This fragmented data architecture complicated the management of global registrations and the oversight of multiple simultaneous product revisions. Given the strict regulatory requirements and short product shelf lives inherent to the medical device manufacturing industry, the company required a centralized approach to avoid delaying the existing enterprise rollout.
Integrating Lifecycle and Regulatory Management
To establish a reliable source of truth for global compliance, CooperSurgical partnered with Kalypso and Rockwell Automation to implement a unified digital transformation solution. The company selected a combined product lifecycle management system and regulatory information platform to address the immediate structural risks without interrupting the ongoing enterprise program. Implementing both functions on a single platform eliminated the need for complex software integrations and kept product and regulatory data tightly connected. The chosen solution emphasized out-of-the-box functionality to minimize structural disruption while delivering a validated system capable of integrating directly with the enterprise architecture.
Accelerated Deployment Process
Operating with a small team and defined budget parameters, CooperSurgical initiated the deployment utilizing established implementation accelerators and domain expertise provided by the solution partners. This methodology provided an existing structural framework rather than requiring the team to build the architecture from scratch. Discussing the technical deployment, Michelle Taub, Director of Product Systems at CooperSurgical, explained, "PLM usually means starting with a blank spreadsheet. Having a starting point meant we could solve the problem faster and with far less risk." The project prioritized core functionality to ensure the systems were operational in time to support the broader corporate rollout.
Improved Control and Operational Scalability
The deployment enabled the North American enterprise resource planning program to launch on schedule, avoiding the financial and operational penalties associated with regional system redeployments. By consolidating product and regulatory information into a single system of record, CooperSurgical replaced manual data management procedures with shared visibility across engineering, manufacturing, quality, and regulatory departments. Data duplication decreased, cross-departmental handoffs were clarified, and the unified architecture increased operational confidence in handling global registrations. The initial implementation established a scalable digital framework that the company plans to expand into change management, document control, and supplier quality initiatives to maintain long-term medical device compliance.
Edited by Natania Lyngdoh, Induportals Editor, with AI assistance.
www.rockwellautomation.com
Industry Sector: Medical Device Manufacturing
CooperSurgical, a global medical device company specializing in fertility and female reproductive health technologies, prepared for a major enterprise resource planning deployment in North America. To mitigate rollout risks and address data fragmentation, the company initiated a project to deploy a unified product lifecycle management and regulatory information management platform across its operations.
Fragmented Data and Implementation Risks
Prior to the enterprise resource planning deployment, CooperSurgical encountered complications stemming from legacy decisions made during previous regional software implementations. Resolving these complications through a full system redeployment would have introduced significant costs, extensive timelines, and operational disruptions. Furthermore, the company managed its product, manufacturing, and regulatory information across multiple disconnected tools and spreadsheets. This fragmented data architecture complicated the management of global registrations and the oversight of multiple simultaneous product revisions. Given the strict regulatory requirements and short product shelf lives inherent to the medical device manufacturing industry, the company required a centralized approach to avoid delaying the existing enterprise rollout.
Integrating Lifecycle and Regulatory Management
To establish a reliable source of truth for global compliance, CooperSurgical partnered with Kalypso and Rockwell Automation to implement a unified digital transformation solution. The company selected a combined product lifecycle management system and regulatory information platform to address the immediate structural risks without interrupting the ongoing enterprise program. Implementing both functions on a single platform eliminated the need for complex software integrations and kept product and regulatory data tightly connected. The chosen solution emphasized out-of-the-box functionality to minimize structural disruption while delivering a validated system capable of integrating directly with the enterprise architecture.
Accelerated Deployment Process
Operating with a small team and defined budget parameters, CooperSurgical initiated the deployment utilizing established implementation accelerators and domain expertise provided by the solution partners. This methodology provided an existing structural framework rather than requiring the team to build the architecture from scratch. Discussing the technical deployment, Michelle Taub, Director of Product Systems at CooperSurgical, explained, "PLM usually means starting with a blank spreadsheet. Having a starting point meant we could solve the problem faster and with far less risk." The project prioritized core functionality to ensure the systems were operational in time to support the broader corporate rollout.
Improved Control and Operational Scalability
The deployment enabled the North American enterprise resource planning program to launch on schedule, avoiding the financial and operational penalties associated with regional system redeployments. By consolidating product and regulatory information into a single system of record, CooperSurgical replaced manual data management procedures with shared visibility across engineering, manufacturing, quality, and regulatory departments. Data duplication decreased, cross-departmental handoffs were clarified, and the unified architecture increased operational confidence in handling global registrations. The initial implementation established a scalable digital framework that the company plans to expand into change management, document control, and supplier quality initiatives to maintain long-term medical device compliance.
Edited by Natania Lyngdoh, Induportals Editor, with AI assistance.
www.rockwellautomation.com
