1. Competency-Development Project 08-December-2015

2. MDIC 2 What is the Competency-Development Project? ‏ Purpose: The purpose of this project is to improve medical device Quality by improving overall competency, awareness, and understanding across key stakeholders that have the most influence on device Quality. ‏ Problem Description: Inconsistent understanding of what comprises device Quality, and a lack of clarity of other stakeholder’s perspectives, needs, and constraints, is a contributing factor to inefficiencies and risks across the medical device industry. ‏ Mission Statement: Improve device Quality and patient safety by promoting programs where regulators, payers, providers, and industry professionals learn together in a collaborative environment. Move beyond cost-containment and compliance to a more holistic realization of Quality aligned with stakeholder’s needs.

3. MDIC 3 Status Report: Competency Development 08 Dec 2015 G G Y Y R R = On Time= At Risk= Late C C = Complete G G C C C C C C C C C C C C

4. MDIC 4 Key milestones and overall project timeline July 2015 August 2015 September 2015 October 2015 November 2015 December 2015 January 2016 February 2016 March 2016 Timeline Conduct Survey Survey expected (ideal state) competencies Develop Survey Analysis & Recommendations Define roles & competencies Plan Phase 2 Create high-level suggestions Perform Gap Analysis Prioritize Gaps Create detailed suggestions for low-hanging fruit. Survey current state competencies Phase 2

5. MDIC 5 Progress Part 1 We outlined 24 competencies and their importance in 44 roles covering manufacturers, regulators. patients, payors, and providers We assess the ideal & current state for these competencies (1056 pairs)

6. MDIC 6 Progress Part 2 We compared top gaps from our internal survey to results from the Oct 8 th meeting, and found a good correlation

7. MDIC 7 Progress Part 3 We are recommending to move forward on the topics of Management Review and Understanding the Cost of Poor Quality. We like these topics because Management Review is an area that is very tactical – we could immediately start seeing improvements, and CoPQ is very strategic – very impactful but might take awhile to see improvements.

8. MDIC 8 Next Steps A small group of us met on December 3 rd, and we spent 2 hours brainstorming ideas & prioritizing our results. We will vet these ideas with the larger group on the 17 th and will forward our recommendations to the steering committee, while we work on a plan for Phase 2..

9. MDIC 9 Questions?