Introduction
The UDI Submission Challenge Supply Chain Must Solve Today
Supply Chain and Operations teams already manage product data across multiple systems, yet some UDI solutions introduce added complexity and operational bottlenecks. The challenge is not just meeting one-time UDI submission requirements, but doing so consistently with minimal disruption as regulations evolve globally. The right UDI submission solution should leverage existing product data, minimize manual effort, and keep device data submission-ready at all times.
This eBook outlines the key dimensions Supply Chain professionals should evaluate in a UDI submission solution, and how Innovit enables efficient and scalable compliance while minimizing operational disruption.
Table of Contents
This eBook is structured to help you quickly navigate the key areas Supply Chain professionals should evaluate in a UDI submission solution. Each section focuses on a specific capability, outlining what to look for, how Innovit delivers and why it matters.
Use the table of contents to jump directly to the sections most relevant to your priorities or current challenges.
Executive Summary
System Integration & Data Aggregation
System Integration & Data Aggregation
Data Management and Approval Workflows
Ease of Use
Audit Trail & Traceability
Submission Control & Visibility
M2M Data Submission
Compliance Standards and System Validation
Implementation Speed & Cost Efficiency
Support and Ongoing Maintenance
Reliable Partner with Deep Healthcare Expertise
Conclusion
Executive Summary
As UDI requirements evolve globally, Supply Chain teams must ensure their piece of UDI data is consistently ready for submission without added operational burden. Innovit addresses this by integrating with existing systems for device data, simplifying data maintenance & validation, and automating UDI submissions with minimal operational impact to supply chain professionals.
Leverage Existing Product Data
Innovit enables sourcing device data from PIM, MDM, Supply Chain, ERP and other operational systems, eliminating duplicate data entry and reducing manual effort for Supply Chain teams.
Simplify Data Ownership and Workflows
Supply Chain should manage the attributes they own simply and efficiently, with best-practice UDI submission workflows that minimize complexity and eliminate unnecessary process steps.
Validate Device Data Early
Validation must occur at the point of data entry or soon after onboarding existing data, ensuring issues are identified and resolved before they impact UDI submissions.
Automate Submissions
UDI submissions should be automated through M2M connectivity when applicable, eliminating manual uploads and reducing the risk of last-minute disruptions for supply chain resources.
Enable Scalable Operations
A UDI submission solution should support global requirements in a single platform, allowing processes to scale across products and markets without increasing operational complexity.
Stay Compliant with a Trusted Partner
Backed by deep healthcare expertise, Innovit delivers continuous product updates, responsive support, and embedded guidance to help Supply Chain meet evolving UDI requirements seamlessly.
System Integration & Data Aggregation
System Integration & Data Aggregation
Can You Leverage Existing Product Data Without Recreating It?
What Supply Chain Needs
Supply Chain already manages product data across multiple systems. They should not be required to recreate or duplicate that data for UDI. The priority is to efficiently leverage existing systems without adding operational burden.
Key Concerns:
- Duplicate data entry across systems
- Inconsistent product data sources
- Manual data consolidation effort
- Unpredictable data availability
Supply Chain needs a system that:
- Integrates with existing product data systems
- Automates data ingestion and transformation
- Consolidates data into a single view
- Minimizes disruption to current processes
The goal is not to manage more product data. It is to use existing data more effectively.
How Innovit Delivers
Innovit integrates seamlessly with existing systems to eliminate duplicate data entry and streamline UDI data aggregation. This includes:
- Integration with ERP, PIM, MDM, and other product data systems
- File-based and API-based data ingestion in different file formats
- Automated import scheduling for continuous data onboarding
- Data mapping and transformation into UDI data models
- Centralized aggregation stage for data consolidation and cleansing
UDI data is leveraged from existing systems without duplication or process disruption.
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No redundant data entry
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Faster data onboarding
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Process continuity
Product data is first leveraged from existing systems. It is consolidated and prepared for UDI submission without duplication.
Why This Matters
Leveraging existing systems reduces manual effort and eliminates redundant product data entry. This ensures Supply Chain teams can manage product data efficiently without changing how they already operate.
Data Management and Approval Workflows
Data Management and Approval Workflows
Can Supply Chain Teams Efficiently Manage the Product Attributes They Own?
What Supply Chain Needs
Supply Chain is responsible for specific product attributes, not managing complex workflows. They need simple and guided interactions that allow them to update and contribute data efficiently without delays or unnecessary process complexity.
Key Concerns:
- Unclear data ownership
- Complex workflow navigation
- Delays in approvals
- Excessive process steps
Supply Chain needs a system that:
- Defines clear ownership of product attributes
- Simplifies required user interactions
- Minimizes approval steps and delays
- Provides visibility into pending actions
If workflows aren’t streamlined, they become operational bottlenecks.
How Innovit Delivers
Innovit simplifies UDI data management and approval workflows so Supply Chain teams can focus on the tasks they own. This includes:
- Role-based access to UDI data maintenance & approval
- Defined stages for data aggregation, maintenance and submission
- Configurable checkpoints for data review and approval at each stage
- Visibility into pending tasks and workflow status
- eSignature support with full approval history
Supply chain users can perform their tasks with no process complexity to ensure their UDI data is captured and approved for submission.
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Clear data ownership
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Streamlined approvals
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Reduced friction
Workflows are structured and simplified. UDI data is updated and approved efficiently without unnecessary process overhead.
Why This Matters
Simplified workflows reduce delays and unnecessary coordination overhead. This ensures UDI data progresses efficiently without slowing operations.
Ease of Use
Ease of Use
Can Teams Contribute Without Friction?
What Supply Chain Needs
Supply Chain teams must contribute to UDI data but cannot spend time learning complex systems. The system must be intuitive, efficient, and easy to adopt to ensure consistent usage across teams.
Key Concerns:
- Complex user interfaces
- High training requirements
- Slow task execution
- Inconsistent system adoption
Supply Chain needs a system that:
- Provides intuitive and simple user interfaces
- Requires minimal training to get started
- Enables fast and efficient task completion
- Supports consistent usage across teams
Ease of use is not just about convenience. It is essential to ensuring that Supply Chain teams can contribute accurately, efficiently, and consistently without disrupting operations.
How Innovit Delivers
Innovit is designed for immediate usability, minimizing training and enabling fast adoption across teams. This includes:
- Modern UI/UX optimized for UDI submission processes
- Configurable web forms for simplified data entry
- Native data validation and bulk edit capabilities
- On-screen tooltips and contextual explanations
- Embedded knowledge center for user support
With these capabilities, users can complete tasks quickly and reliably without reliance on extensive training.
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Easier adoption
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Increased productivity
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Fewer errors
Innovit’s system is intuitive and easy to use. Tasks are completed quickly and consistently without extensive training.
Why This Matters
When systems are easy to use, execution becomes streamlined. This reduces UDI submission bottlenecks and improves overall operational efficiency.
Data Integrity & Reliability
Data Integrity & Reliability
Is Your UDI Data Ready Before Submission?
What Supply Chain Needs
Supply Chain teams must ensure the device data they own complies with UDI requirements. Data issues discovered late create delays and rework. UDI data must be validated early to avoid last-minute disruptions.
Key Concerns:
- Late discovery of data issues
- Manual data corrections
- Compliance risk
- Disrupted operational timelines
Supply Chain needs a system that:
- Validates UDI data early and consistently
- Prevents invalid device data from progressing
- Provides clear error identification
- Enables fast and efficient corrections
Supply Chain needs UDI data to be correct early before it becomes a compliance and operational risk.
How Innovit Delivers
Innovit enforces data quality early to prevent downstream issues and last-minute corrections. This includes:
- Built-in data validation rules aligned with UDI database requirements
- Prevention of invalid or incomplete data from submission
- Data validation results at an attribute, record and catalog level
- Easy navigation to erroneous data for bulk remediation
- Automated data validation reports sent upstream to source systems
UDI data is validated early and consistently, ensuring valid device records before submission.
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Early validation insights
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Less manual rework
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Confident submissions
UDI data is validated against the latest UDI specifications for reliable submissions.
Why This Matters
Validating UDI data early and consistently prevents errors from surfacing during submission. This ensures Supply Chain avoids last-minute corrections and operational disruptions.
Audit Trail & Traceability
Audit Trail & Traceability
Do You Have Full Visibility into UDI Data Changes?
What Supply Chain Needs
As data owners of key UDI attributes, Supply Chain teams need clear visibility into how product data changes over time. They must quickly understand what changed, who made the change, and when it occurred.
Key Concerns:
- Lack of visibility into changes
- Unclear accountability for updates
- Difficulty tracing data history
- Slow root cause analysis
Supply Chain needs a system that:
- Tracks all data changes automatically
- Shows who changed what and when
- Provides searchable change history
- Enables easy access to past records
Supply Chain needs clear visibility into UDI data changes to establish transparency and accountability.
How Innovit Delivers
Innovit provides complete visibility into all data changes to ensure traceability and accountability. This includes:
- Attribute-level versioning for all product data
- Visibility into who changed what and when
- Searchable and filterable change history
- Exportable audit logs for reporting and review
- Configurable version tracking across data elements
Every data change is captured and easily traceable.
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Full visibility
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Clear accountability
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Easy traceability
UDI data changes are visible, traceable, and controlled.
Why This Matters
Clear visibility into UDI data changes ensures Supply Chain can establish transparency and accountability for their data.
M2M Data Submission
M2M Data Submission
Can UDI Submissions Happen Without Manual Effort?
What Supply Chain Needs
Supply Chain may not submit UDI data, but they are impacted when submissions fail. Manual processes surface data issues late, forcing last-minute corrections and disrupting operations.
Key Concerns:
- Late discovery of data issues
- Manual submission processes
- Last-minute data corrections
- Operational disruptions
Supply Chain needs a system that:
- Automates UDI data submission processes
- Reduces reliance on manual uploads
- Prevents late-stage data issues
- Provides visibility into submission outcomes
Supply Chain needs to avoid last-minute data scrambles caused by manual and error-prone processes.
How Innovit Delivers
Innovit automates UDI submissions and minimizes late-stage efforts to identify and correct data issues across large volume of records. This includes:
- Out-of-the-box M2M connectivity to global UDI databases
- Generation of required XML format for each database
- Automated re-validation of device records during submission
- Real-time tracking of submission status and responses
- Complete message logs for all outbound and inbound exchanges
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Scalable submissions
2
Fewer surprise
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Reduced manual
rework
UDI submissions are automated through M2M connectivity. Device data is submitted without last-minute risk and operational burden.
Why This Matters
Automated submissions eliminate manual effort and reduce the risk of late-stage data issues. This ensures Supply Chain avoids last-minute disruptions and maintains predictable execution.
Scalability & Global Readiness
Scalability & Global Readiness
Can Your UDI Submission Process Scale with Your Operations?
What Supply Chain Needs
As product portfolios grow and new markets are added, Supply Chain must support increasing data volume and regulatory requirements. Scaling UDI processes should not require additional manual effort, new workflows, or system complexity.
Key Concerns:
- Increasing product data volumes
- Multiple regional UDI requirements
- Inconsistent processes across markets
- Rising manual workload
Supply Chain needs a system that:
- Supports global UDI requirements in one platform
- Scales with product and market growth
- Standardizes processes across all regions
- Minimizes manual effort as volume increases
Supply Chain needs scalable UDI processes without added complexity or workload.
How Innovit Delivers
Innovit supports global scale through standardized processes and built-in product capabilities to cover expanding UDI requirements. This includes:
- A single solution for UDI submissions globally
- Pre-packaged attributes, code lists, and data validation rules
- Standardized workflows and submission processes across regions
- Continuous updates aligned with evolving UDI requirements
- Reuse of your core device data across regional requirements
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Global scalability
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Process consistency
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Reduced complexity
Innovit’s solution supports global UDI requirements. Processes scale consistently across products, markets, and regulatory environments.
Why This Matters
Standardized processes reduce complexity as product volumes and UDI regulatory requirements increase. This ensures Supply Chain can scale seamlessly without adding significant manual effort for UDI compliance.
Support and Ongoing Maintenance
Support and Ongoing Maintenance
Can You Stay Compliant Without Interruption?
What Supply Chain Needs
Supply Chain operations depend on systems that are reliable, up to date, and supported. Lack of timely product updates and unreliable support directly impact execution and compliance timelines.
Key Concerns:
- Evolving UDI requirements
- System not keeping pace with UDI regulations
- Slow issue resolution
- Lack of support and user guidance
Supply Chain needs a system that:
- Keeps pace with evolving UDI regulatory requirements
- Delivers continuous updates aligned with UDI changes
- Provides fast and responsive issue resolution
- Offers timely and proactive guidance for users
Supply Chain needs a UDI submission solution that stays current, supported, and reliable.
How Innovit Delivers
Innovit removes the burden of ongoing UDI compliance by continuously managing product updates, support, and performance in the background. This includes:
- Timely product updates aligned with UDI regulatory changes
- Ongoing maintenance ensuring system performance, stability, and security
- Responsive support trained on the most recent UDI developments
- Embedded knowledge center with relevant and timely guidance
- Access to experts with deep system and regulatory knowledge
Innovit’s system stays current, supported, and aligned with evolving UDI regulations to ensure ongoing compliance.
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Ongoing compliance
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Dependable support
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Reliable performance
Innovit’s solution is continuously updated and maintained. Users are supported with timely guidance and responsive expertise.
Why This Matters
Continuous updates and responsive support reduce downtime and prevent gaps in regulatory alignment. This ensures Supply Chain can operate without disruption or additional manual effort.
Trusted Partner with Deep Healthcare Expertise
Trusted Partner with Deep Healthcare Expertise
Do You Have a Partner That Understands Operational Reality?
What Supply Chain Needs
Supply Chain needs a partner that understands healthcare operations and product data complexities. The right partner reduces operational burden and supports long-term scalability.
Key Concerns:
- Lack of domain expertise
- Inefficient implementation experience
- Limited scalability support
- Poor understanding of operations
Supply Chain needs a system that:
- Is backed by deep healthcare expertise
- Supports large-scale enterprise operations
- Provides ongoing operational guidance
- Reduces complexity over time
The right partner reduces compliance and operational risk over time. The wrong one compounds it.
How Innovit Delivers
Innovit combines deep healthcare expertise with proven solutions to support long-term success. This includes:
- 25+ years of healthcare and life sciences experience
- Strategic partnerships with MedTech Europe, GS1 and USDM
- Proven enterprise-grade solution used by global organizations
- Active participation in UDI regulatory initiatives and testing
- First to successfully test EUDAMED M2M device submissions
Innovit provides expertise and partnership that supports long-term operational success.
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Proven expertise
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Trusted partner
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Long-term support
Deep healthcare expertise is built into Innovit’s UDI solution. Customers are supported with proven experience and ongoing partnership.
Why This Matters
Deep expertise from a solution partner reduces the burden of navigating complex UDI requirements globally. This ensures Supply Chain teams can rely on consistent performance and long-term scalability.
Conclusion
Final Takeaways for Supply Chain Professionals
UDI compliance is not a one-time activity – it is an ongoing operational requirement. Innovit enables Supply Chain teams to keep device data ready for ongoing UDI compliance by integrating with existing product data source systems, enforcing early data validation, and automating device submissions to UDI registries to support scalable and reliable compliance over time.
Supply Chain Teams must be able to:
- Leverage existing product data
- Simplify data ownership & maintenance
- Validate UDI data early & consistently
- Automate device submissions
- Scale with confidence
Innovit simplifies UDI compliance by onboarding device data, validating early, and automating submissions, so Supply Chain stays efficient as requirements evolve globally.
