Gore’s Strategic IT Approach Connects Clinical, Quality, and Regulatory
"This independence and ability to focus on our medical team stakeholders is the foundation for building an end-to-end ecosystem that supports clinical, regulatory, and quality."
W. L. Gore & Associates (Gore) is a privately held company with over 13,000 Associates globally. Operating across highly diverse industries—including aerospace, mobile electronics, consumer fabrics, and medical products—the company historically relied on a centralized enterprise IT model to support all business units.
Gore’s medical business, being in a highly regulated industry, had more stringent IT requirements than the other business units. To eliminate operational friction and align technology requirements with business value, they transitioned to individualized IT operations across business units. Within the medical business, Gore introduced dedicated IT leaders for product and innovation, supply chain, and commercial.
Steve Speranza, global IT leader of product and innovation, shared how Gore transitioned to dedicated IT operations for different business units and the impact to compliance and the business.
Standardizing tools to align with industry best practices
By decentralizing their IT model, Gore was able to take a medtech focused approach and start introducing purpose-built solutions across clinical, regulatory, and quality. Speranza wanted to ensure that the organization implemented out-of-the-box solutions that aligned with industry requirements and enabled scale.
“When you have heavily customized systems with extensive integrations, it builds tech debt and makes data more difficult to access. We want to ensure that all of our systems are easy to build upon and allow us to integrate innovative technology to expand our capabilities,” said Speranza.
The process has enabled the medical business to reevaluate its core systems and create a long-term adoption roadmap that is tailored to its unique needs. Speranza added, “this independence and ability to focus on our medical team stakeholders is the foundation for building an end-to-end ecosystem that supports clinical, regulatory, and quality.” To date, Gore has implemented Veeva eTMF, CTMS, EDC, QualityDocs, Validation Management, and PromoMats to standardize across the organization. The company intends to evaluate additional systems to build out the ecosystem with clear priorities that balance the immediate business impact with long-term scalability.
Developing a market-access ecosystem
Aligning IT to distinct business units created autonomy, but the challenge of aligning clinical, regulatory, and quality remained. Gore was intentional in their change management strategy with a comprehensive roadmap that included the business impact of each new solution.
In an effort to not overwhelm the organization, Speranza took a crawl, walk, run approach. He views optimization as a journey, in which the role of IT is to identify the solutions that can address an immediate need while also allowing for scale as the business grows. He shared an example on their QMS journey, “instead of trying to do a big bang, we started with quality docs, pushed for NCR and CAPA, and then we can implement the full eQMS system. We want to take it slow at first, and then when we gain momentum we accelerate to the end goal.”
This step-by-step approach helped improve adoption with the end-users, while demonstrating incremental value to leadership. Speranza added, “outlining the value of each individual piece is important, but sometimes we might not see ROI until the entire implementation is complete.” Until ROI can be attributed to the system, demonstrating ongoing process improvements helps prove qualitative value.
Continuous optimization
Proving the business value of a technological investment extends beyond obtaining buy-in from leadership and showing ROI. Gore’s medical business currently has implemented Veeva in clinical and quality, with hopes of bringing on Veeva RIM for the regulatory team.
“Optimization is not a destination, it is a journey. It is important for us to follow the phased approach to demonstrate the value that each new implementation will bring and ensure that we are fully prepared to move to the next phase.” said Speranza. This approach helped the IT team stay focused on the task at hand, while showing sustainable success and growth of the organization as they progress through their roadmap and can eventually show ROI.
Because a single platform structure is utilized, a robust foundation is prepared to seamlessly support future innovations, such as AI and automated reporting. Gore’s operational agility is also enhanced and they are positioned to adapt swiftly to evolving patient needs, continued business growth, and industry shifts.
Key Learnings
Drawing from Gore’s digital transformation journey, Speranza shares several key principles for navigating complex technology migrations:
- Crawl, walk, run – In an effort to not overwhelm the organization, the technical rollouts are strategically phased so that user adoption is fully secured and early business value is demonstrated.
- Prioritize data readiness – By ensuring data readiness early in the modernization lifecycle, compliance risks are minimized, decision-making confidence is elevated, and a clear path is paved for advanced data analytics and future initiatives.
- Partner with IT – When IT is a strategic partner, roadblocks are avoided and there is better alignment with the business, ensuring growth and revenue goals are met.
- Continuously optimize – Realizing ROI takes time and go-live is not the finish line. Continuous, collaborative optimization is important to keep systems aligned with evolving regulations and business needs.
Learn more about Gore Improved Data Architecture and Operational Efficiency Across Clinical.