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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)