# data[].attributes.body
SLT does not hold PM's/teams accountable when project items are missed/slip; SLT does not often take action to help project teams back on task. Experienced specifically in production when time is held in the production schedule and teams do not execute per the schedule. Teams are not held accountable to hold to schedule/SLT doesn't expect accountability to the project schedule.

# data[].attributes.body
Project tracking inconsistent with other sites. Not quite aware of current project status overall, for a given project team member.

# data[].attributes.body
Teams dedicated to EU MDR also have other priorities. Documents for EU MDR rely on other projects that are also resource-constrained.

# data[].attributes.body
Definition of element relationships is unclear, cascade of precursor activities not apparent.

# data[].attributes.headline
#8 Lack of accountability/empowerment among PMs/teams.

# data[].attributes.subject
#8 Lack of accountability/empowerment among PMs/teams.

# data[].attributes.headline
PB Stent documentation changing due to multiple stent programs. 

# data[].attributes.subject
PB Stent documentation changing due to multiple stent programs. 

# data[].attributes.headline
HS - TUV SUD limited resources to review TD at end of Q3 2023 and Q4 2024

# data[].attributes.subject
HS - TUV SUD limited resources to review TD at end of Q3 2023 and Q4 2024

# data[].attributes.headline
#6 Lack of understanding of financial impact of delay of EU MDR uplift

# data[].attributes.subject
#6 Lack of understanding of financial impact of delay of EU MDR uplift

# data[].attributes.headline
LD - 1) Handling too many projects at the same time; 2) Time lapse due to a different priority shift; 3) Lack of communication 

# data[].attributes.subject
LD - 1) Handling too many projects at the same time; 2) Time lapse due to a different priority shift; 3) Lack of communication 

# data[].attributes.headline
CC - Extended timeframe of review by TUV - 18 months?

# data[].attributes.subject
CC - Extended timeframe of review by TUV - 18 months?

# data[].attributes.headline
CC - Conflicting views of project timeline and critical path items

# data[].attributes.subject
CC - Conflicting views of project timeline and critical path items

# data[].attributes.headline
PB - Lack of discussion about financial implications of missing targets. 

# data[].attributes.subject
PB - Lack of discussion about financial implications of missing targets. 

# data[].attributes.body
Processes that have changed since they were completed for grafts, affecting ability to use what has been done as a template

# data[].attributes.body
Identify what processes require specific roles for approval so that these actions can be focused and executed by the specific role.

# data[].attributes.body
Cost of completing the project prior to the deadline

# data[].attributes.body
Not enough resources/conflicting priorities going through a single funnel on Drains

# data[].attributes.headline
CC - Major Delays in Risk, Labeling CAPAs due to heavy involved process

# data[].attributes.subject
CC - Major Delays in Risk, Labeling CAPAs due to heavy involved process

# data[].attributes.headline
PB - Hiring and replacing the appropriate resources for funded projects has not occurred.  Impact of moving resources to priority projects is not followed by assessment of the projects impacted (timelines, budgets, FTEs).

# data[].attributes.subject
PB - Hiring and replacing the appropriate resources for funded projects has not occurred.  Impact of moving resources to priority projects is not followed by assessment of the projects impacted (timelines, budgets, FTEs).

# data[].attributes.headline
HS - Standard Assessment Conformity required prior to proceeding with EuMDR implementation (Risk, labeling, etc)

# data[].attributes.subject
HS - Standard Assessment Conformity required prior to proceeding with EuMDR implementation (Risk, labeling, etc)

# data[].attributes.headline
#5 Notified Body resources/ NB availability 

# data[].attributes.subject
#5 Notified Body resources/ NB availability 

# data[].attributes.headline
#2 Spreading available resources too thin

# data[].attributes.subject
#2 Spreading available resources too thin

# data[].attributes.body
Endovascular - Engineering resources are inexperienced and require a lot of oversight and guidance that has been being offered by QE.

This takes longer for completion of tasks, and consumes a lot of QE time

# data[].attributes.body
Duplication of Resources Stents vs Drains

# data[].attributes.headline
#1 Not enough resources are available at the site.

# data[].attributes.subject
#1 Not enough resources are available at the site.

# data[].attributes.headline
CC Major remediation activities for Endovascular products (validations)

# data[].attributes.subject
CC Major remediation activities for Endovascular products (validations)

# data[].attributes.body
Resourcing - too many projects competing for resources. Particularly regarding covered stents.

# data[].attributes.headline
PB - Stent validation process and unanticipated issues have taken resource time and hindered timeline targets

# data[].attributes.subject
PB - Stent validation process and unanticipated issues have taken resource time and hindered timeline targets

# data[].attributes.body
Focus on activities needed to be completed, not on the type of resource. Elements like FMEA or FMECA are generic processes that are performed by all types of engineers.

# data[].attributes.body
Major issue: resources are spread too thin due to constant addition of new projects.

Also, technical teams need some recalibration on timely delivery

Overdependence on cross-functional teams

# data[].attributes.headline
Major Issue - QE Resources over allocated to various projects (cc)

# data[].attributes.subject
Major Issue - QE Resources over allocated to various projects (cc)

# data[].attributes.body
Availability of resources

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What is the major issues hindering the EU MDR uplift of Stents and Drains?

-5 min: Individual reflection, write down 3-5 major issues on post-its in Padlet. One major issue per post-it. Include your initials in the heading and a brief sentence to describe the issue.

See instruction to the right on how to create post-it in padlet.

-15 min: Share your thoughts (avoid debating the issues)

-5 min: Grouping and prioritization done in full group

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