1. Competency-Development Project 08-October-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 8 Oct 2015 G G Y Y R R = On Time= At Risk= Late C C = Complete G G 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 Competency List Established Regulatory Awareness Understanding of applicable regulations and how to comply. Understanding applicable laws (e.g. US Food & Drug Law, Health Canada, EU MDD, etc.) Understanding the major technologies (software, plastics, etc.), including what can go wrong, and how to apply the regulations to those technologies, and current state of practice Understanding applicable standards Understanding relevant therapies Understand appropriate implementation of Quality Systems Understanding of what a nonconformity means, what a recall means, etc Understanding significance of regulatory communication (e.g. understand some observations are worse than others; severity more important than quantity.) What makes a good management review? We developed 24 competencies across categories of Regulatory Awareness, Execution, Understanding Value, and Soft Skills.

6. MDIC 6 Roles List Established Regulators Investigator/Auditor (FDA/NB/HC/..) Perform facility inspections, consumer complaint investigations, collect physical and documentary samples. Field Management (first line supervisors) Provide training, perform first line of review of reports from Investigators (e.g. review for completeness, accuracy, appropriate evidence), review potentially violative conditions, preliminary assessment of potential 483, make first recommendation (e.g. is this OAI) and forwards to Compliance Officer if appropriate. Compliance Officer Review Inspection Reports, exhibits, 483s, samples, etc., that were noted as potentially violatives. Review 483 information and confirms that is supportable by evidence that is collected and confirms regulatory citations. Makes preliminary assessments of other potentially violative information such as website materials, labeling, need for 510(k) submission. Determines next step in process (e.g. administrative action vs judicial action) District Management Determines if issues need to be escalated to the Center vs. handling locally. Understanding local firms inside of the District and use this information to prioritize where resources are best spent. Center Management Establish device policy, set strategic priorities for Center, (e.g. provide excellent customer service, striking right balance between preMarket/postMarket.) Develop enforcement strategies, respond to Congressional inquiries. Receives escalations from District and takes appropriate actions. "Sets the tone for how the Center is going to do business." Reviewers (510(k), PMA) Receive submissions and evaluate performance. Determination of substantial equivalence (510(k)), review testing / data in the application, review clinical information, make requests for additional information to support regulatory decision. We developed 44 roles across categories of Regulator, Manufacturer, Provider, Patient, Payor, etc.

7. MDIC 7 Ideal-State Survey Complete There are 24 competencies and ~44 roles; this equates to a survey of 1056 pairs!

8. MDIC 8 Please assign a value for each competency-role pairing using numeric values Key: 3 = high importance 2 = medium importance 1 = low importance 0 = no or insignificant importance blank = no opinion Are there any major differences between scores? If so, how many times is there a difference? Investigator/Auditor (FDA/NB/HC/..) Resp 1Resp 2Resp 3Resp 4Resp 5Resp 6Resp 7Resp 8Resp 9# RespSumAvgMaxMin Difference ? Regulatory Awareness 3 Understanding of applicable regulations and how to comply. N/A 32333 5142.832 Understanding applicable laws (e.g. US Food & Drug Law, Health Canada, EU MDD, etc.) N/A 33233 5142.832 Understanding the major technologies (software, plastics, etc.), including what can go wrong, and how to apply the regulations to those technologies, and current state of practice 2N/A 22333 5132.632 Understanding applicable standards N/A 33233 5142.832 Understanding relevant therapies 1N/A 22223 5112.232 Understand appropriate implementation of Quality Systems 1N/A 32333 5142.832 C-Suite understanding of what a nonconformity means, what a recall means, etc (current phrasing is scary) N/A 3333 412333 Understanding significance of regulatory communication (e.g. understand some observations are worse than others; severity more important than quantity.) N/A 32333 5142.832 What makes a good management review? (focus on causes not symptoms) (look at updated 13485) 1N/A 32233 5132.632

9. MDIC 9 Interesting Discoveries As we were reviewing, we looked at places where there were significantly different ratings (e.g. one respondent rated High Importance, another rated No Importance.) Sometimes, a single viewpoint was an outlier. Other times, different interpretations or different visions of an ideal world drove the differences. Examples are: - Key Opinion Leaders – that role is used in 2 ways, one which requires a high-level of competency, another which does not. - Trainers – do they need to be masters of their material, or are they a delivery mechanism? - HR – to successfully build Quality into organizational culture, need a strong understanding of the Quality principles.

10. MDIC 10 Next Steps The next steps is to perform a gap analysis and prioritization steps. Note that the survey will not be the only source used to determine gaps & priorities; this is a talented team with lots of experience, and the survey results will be supplemented with personal experience and published analyses.

11. MDIC 11 Questions?