WEBINAR
UDI: Medical Device value chain
Speaker: Jim Petragnani
Step 1. Developing the UDI compliance plan
- Brief senior management on project scope and provide resource requirements with cost
- Receive senior management project approval
- Build the right team members who are dedicated and have the right complement of product/process knowledge
- Define clear roles, accountabilities and responsibilities
- Understand the requirements of the Medical Device Regulation
- Engage in an approach that will confirm assumptions early and allow for joint agreed adjustment to the plan
- Evaluate the supply chain business processes
- Produce gap assessment and generate gap findings and conclusions
- Prepare for innovative and sustainable change to the go-forward environment – monitor publications
- Plan and provide that product experts enable knowledge transfer
- Develop a plan for Change Management
Step 2. Understanding the Machine Readable Technology
- That number on the medical device, It’s not just a number….It means something
- Standard product identifier
- Reach out to the global community
- Benefit to the medical community
- Better traceability
- Expedite recalls
Step 3. Change Management
- Create compelling story or business case
- Build a team who are fully committed to the change initiative
- Create the vision
- Communication, Communication, Communication
- Start with “short term” wins
Step 4. Risk Assessment keeping the system agile for future changes
- Proactively identify and manage risks
- Assess Labeling changes – Global Packaging
- Supply Chain continuity planning
Step 5. Implementation of UDI plan across the value chain
- Review with project team key points of requirement
- Identify the representative products for assessments
- Build implementation road map, resourcing including cost
- Identify low impact product device for implementation as pilot project
- Present implementation recommendations and validate with stakeholders
- Parallel process low impact product device
- Evaluate and communicate results of “pilot” product
Step 6. Identifying the data sources for FDA reporting
- Develop UDI data source map
- Develop UDI database for FDA Reporting
- Submit information to FDA which will be used to populate the Unique Device Identification Database (GUDID)