5
min read
Taking a Practical Approach to DHF Modernization with Orcanos
Medical Device
ALM
Powell, Tennessee
Overview
Global Medical Manufacturer Founded in 1973 DeRoyal Industries is committed to improve the clinical quality and economic health of its customers. For over 50 years, our worldwide team has brought value to our customers in several distinct markets with product and business solutions that include patient care products, orthopedic supports & bracing, surgical & safety devices, wound care products, and Continuum® integrated inventory management technologies. Our broad and deep workforce of 1,900 employees within 2.5 million square feet under roof, operates collectively between 20 facility locations in 5 countries, with manufacturing assets on 2 continents.
“Orcanos has provided DeRoyal Industries with greater documentation transparency, accessibility, and a more streamlined approach to document management and design and development.” Dhanvin Desai, Director of Engineering & Innovation, DeRoyal Industries, Inc.
Managing a Design History File (DHF) becomes increasingly complex as years of documentation accumulate. For organizations with deep product histories, modernizing DHF processes must be done thoughtfully—without disrupting ongoing work.
To address this challenge, DeRoyal Industries, Inc. began adopting Orcanos to manage the DHF of its next-generation products, taking a pragmatic, phased approach that aligns with real-world constraints.
The Challenge: Managing a Large Volume of Legacy Documentation
Over the years, DeRoyal has accumulated a substantial amount of legacy DHF documentation. Fully restructuring that content into a new system all at once was neither practical nor efficient. At the same time, the organization recognized the need for a more structured and scalable approach to support future product development.
The Approach: Start Simple and Avoid Disruption
Rather than attempting a complete transformation, DeRoyal took a measured approach by migrating legacy DHF documentation into Orcanos as static PDF records. This strategy allowed the team to:
- Centralize all DHF documentation within a single system
- Maintain accessibility to historical records
- Avoid time-consuming and unnecessary restructuring
One of the most impactful benefits has been permission-based document access, giving the R&D team confidence that critical documents cannot be inadvertently moved or deleted. As documents are updated over time, working files such as Word and Excel are gradually introduced into Orcanos—allowing modernization to occur naturally as part of normal workflows.
Where the Value Begins: New Product Development
DeRoyal focused Orcanos adoption on new product development, ensuring future efforts start with structure from day one. For new projects:
- DHFs are created and managed directly within Orcanos
- Development activities begin in a structured environment
- Traceability is built incrementally throughout the lifecycle
This approach enables DeRoyal to move forward without reworking legacy products while establishing a foundation for long-term scalability. The company is currently implementing Application Lifecycle Management (ALM) in Orcanos for all future development projects. Teams are enthusiastic about the intuitive user interface, streamlined workflows, and end-to-end traceability—capabilities expected to significantly improve the efficiency and consistency of the design and development process.
The Result: Controlled Progress Without Overload
By:
- Centralizing legacy DHF documentation
- Introducing structure gradually
- Prioritizing new product development
DeRoyal has created a clear, sustainable path toward a more structured and scalable DHF environment—without disrupting active projects or overwhelming teams.
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