SLT workshop Jan.18, 2022 by https://padlet.com/SLTworkshopJan182022/Bookmarks Made with a quick smile en-us 2021-11-16 12:49:20 UTC 2022-01-18 20:30:20 UTC hello@padlet.com Instructions - How to add sticky note SLTworkshopJan182022 https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1992116674 Add sticky note by clicking the icon in bottom right corner with "+"

Add heading + text

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Edit sticky note by clicking the three dots in the upper right corner]]> 2022-01-14 11:07:46 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1992116674 Instruction Exercise #1 SLTworkshopJan182022 https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1992119414 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
]]> 2022-01-14 11:10:27 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1992119414 GS - EU MDR issues https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998839995 Availability of resources

]]> 2022-01-18 19:35:32 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998839995 Major Issue - QE Resources over allocated to various projects (cc) https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998840030 2022-01-18 19:35:34 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998840030 Bienkiewicz https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998840170 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]]> 2022-01-18 19:35:38 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998840170 SLH - Resource vs Activity https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998840488 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.]]> 2022-01-18 19:35:42 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998840488 PB - Stent validation process and unanticipated issues have taken resource time and hindered timeline targets https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998841411 2022-01-18 19:36:08 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998841411 JMB https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998841585 Resourcing - too many projects competing for resources. Particularly regarding covered stents.]]> 2022-01-18 19:36:15 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998841585 CC Major remediation activities for Endovascular products (validations) https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998841785

]]> 2022-01-18 19:36:20 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998841785 #1 Not enough resources are available at the site. SLTworkshopJan182022 https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998841820 2022-01-18 19:36:21 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998841820 GS - EU MDR issues https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998842183 Duplication of Resources Stents vs Drains ]]> 2022-01-18 19:36:32 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998842183 SB https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998842326 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]]> 2022-01-18 19:36:37 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998842326 #2 Spreading available resources too thin SLTworkshopJan182022 https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998842414 2022-01-18 19:36:40 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998842414 #3 Too complex processes SLTworkshopJan182022 https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998842994 2022-01-18 19:36:57 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998842994 #4 Dependency on Compliance Activities SLTworkshopJan182022 https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998843563 2022-01-18 19:37:10 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998843563 #5 Notified Body resources/ NB availability SLTworkshopJan182022 https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998844119 2022-01-18 19:37:22 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998844119 HS - Standard Assessment Conformity required prior to proceeding with EuMDR implementation (Risk, labeling, etc) https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998844349 2022-01-18 19:37:30 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998844349 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). https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998844610 2022-01-18 19:37:37 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998844610 CC - Major Delays in Risk, Labeling CAPAs due to heavy involved process https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998844777 2022-01-18 19:37:42 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998844777 SB https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998844790 Not enough resources/conflicting priorities going through a single funnel on Drains]]> 2022-01-18 19:37:42 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998844790 GS - EU MDR Issues https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998844834 Cost of completing the project prior to the deadline

]]> 2022-01-18 19:37:43 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998844834 SLH - Review/Approval https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998845349 Identify what processes require specific roles for approval so that these actions can be focused and executed by the specific role.]]> 2022-01-18 19:37:57 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998845349 SB https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998847140 Processes that have changed since they were completed for grafts, affecting ability to use what has been done as a template]]> 2022-01-18 19:38:39 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998847140 PB - Lack of discussion about financial implications of missing targets. https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998847582 2022-01-18 19:38:51 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998847582 CC - Conflicting views of project timeline and critical path items https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998848380 2022-01-18 19:39:14 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998848380 CC - Extended timeframe of review by TUV - 18 months? https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998849794 2022-01-18 19:39:58 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998849794 LD - 1) Handling too many projects at the same time; 2) Time lapse due to a different priority shift; 3) Lack of communication https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998850407 2022-01-18 19:40:17 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998850407 #6 Lack of understanding of financial impact of delay of EU MDR uplift SLTworkshopJan182022 https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998852210 2022-01-18 19:41:12 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998852210 HS - TUV SUD limited resources to review TD at end of Q3 2023 and Q4 2024 https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998852577 2022-01-18 19:41:24 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998852577 PB Stent documentation changing due to multiple stent programs. https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998852923 2022-01-18 19:41:34 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998852923 #7 Inconcistent project tracking. SLTworkshopJan182022 https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998853012 2022-01-18 19:41:37 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998853012 #8 Lack of accountability/empowerment among PMs/teams. SLTworkshopJan182022 https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998853809 2022-01-18 19:42:01 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998853809 SLH - Detailed Project Cascade https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998854299 Definition of element relationships is unclear, cascade of precursor activities not apparent. ]]> 2022-01-18 19:42:17 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998854299 EB - Competing resources/priorities https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998855956 Teams dedicated to EU MDR also have other priorities. Documents for EU MDR rely on other projects that are also resource-constrained.]]> 2022-01-18 19:43:05 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998855956 EB - Inconsistent project tracking https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998860303 Project tracking inconsistent with other sites. Not quite aware of current project status overall, for a given project team member. ]]> 2022-01-18 19:45:19 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998860303 JMB https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998890336 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.]]> 2022-01-18 19:59:59 UTC https://padlet.com/SLTworkshopJan182022/Bookmarks/wish/1998890336