WEBINAR

UDI: Medical Device value chain

Speaker: Jim Petragnani

Step 1. Developing the UDI compliance plan

  • Bullet Brief senior management on project scope and provide resource requirements with cost
  • Bullet Receive senior management project approval
  • Bullet Build the right team members who are dedicated and have the right complement of product/process knowledge
  • Bullet Define clear roles, accountabilities and responsibilities
  • Bullet Understand the requirements of the Medical Device Regulation
  • Bullet Engage in an approach that will confirm assumptions early and allow for joint agreed adjustment to the plan
  • Bullet Evaluate the supply chain business processes
  • Bullet Produce gap assessment and generate gap findings and conclusions
  • Bullet Prepare for innovative and sustainable change to the go-forward environment – monitor publications
  • Bullet Plan and provide that product experts enable knowledge transfer
  • Bullet Develop a plan for Change Management

Step 2. Understanding the Machine Readable Technology

  • Bullet That number on the medical device, It’s not just a number….It means something
  • Bullet Standard product identifier
  • Bullet Reach out to the global community
  • Bullet Benefit to the medical community
  • Bullet Better traceability
  • Bullet Expedite recalls

Step 3. Change Management

  • Bullet Create compelling story or business case
  • Bullet Build a team who are fully committed to the change initiative
  • Bullet Create the vision
  • Bullet Communication, Communication, Communication
  • Bullet Start with “short term” wins

Step 4. Risk Assessment keeping the system agile for future changes

  • Bullet Proactively identify and manage risks
  • Bullet Assess Labeling changes – Global Packaging
  • Bullet Supply Chain continuity planning

Step 5. Implementation of UDI plan across the value chain

  • Bullet Review with project team key points of requirement
  • Bullet Identify the representative products for assessments
  • Bullet Build implementation road map, resourcing including cost
  • Bullet Identify low impact product device for implementation as pilot project
  • Bullet Present implementation recommendations and validate with stakeholders
  • Bullet Parallel process low impact product device
  • Evaluate and communicate results of “pilot” product

Step 6. Identifying the data sources for FDA reporting

  • Bullet Develop UDI data source map
  • Bullet Develop UDI database for FDA Reporting
  • Bullet Submit information to FDA which will be used to populate the Unique Device Identification Database (GUDID)