MDIC 1 George Serafin Deloitte & Touche LLP MDIC Open Forum Quality System Maturity Model Update

MDIC 2 Quality System Maturity Model Project Team

MDIC 3 Background / Objective: Quality System Maturity Model Background In May 2015, MDIC presented research on current Maturity Models established across various industries and provided recommendations regarding how specific options can be adopted by MDIC stakeholders including, but not limited to, industry members and the Food & Drug Administration. Objective As a result of this research, a quality maturity model work stream was formed to develop and implement a Quality System Maturity Model based on the Capability Maturity Model Integration (CMMI) for the medical device industry that is focused on promoting product quality and patient safety.

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 CMMI Pilot Development Connect with Measures Team Maturity Model Development Conduct Pilot Develop Pilot Strategy and Approach Identify pilot participants Present pilot plan at CfQ Forum Kick-off pilot Complete pilot Selection of process areas Adapt CMMI process framework Present adapted CMMI Model at CfQ Forum Selected pilot process areas built out CMMI alignment and identify gaps/enhancements Develop plans and on-board pilot participants Define Maturity levels

‏ Approach

MDIC 6 Our approach focuses on adapting the CMMI process framework to medical devices then developing content for the selected process areas. Approach for adapting CMMI process framework for Medical Devices CMMI Process Framework Alignment to QSR / ISO Identify Gaps Fill in Gaps / Enhance Leverage and combine CMMI process frameworks for Development, Acquisition, and Service constellations to create a process framework for medical devices Align combined CMMI process framework to QSR and ISO Conduct gap analysis and identify any missing elements in the process framework Address identified gaps and enhance process framework; define maturity levels

MDIC 7 The CMMI Framework approximately maps to 80% of Quality System Regulations and ISO requirements Mapping of CMMI Process Framework 30% 40% 20% 50% 10% 80% 90% 60% 100% CMMI Model Medical Device Profile 70% Quality Policy & Practice All three standards align to the following: Management oversight Establishment of organizational standards & practices Monitoring & control Training Medical Device Requirements Both FDA & ISO incorporate requirements specific to Medical Devices which CMMI does not Risk Management FDA and ISO are aligned, but address risk management in separate standards focused on patient impact CMMI focuses only on project risk ‏ Percent Alignment to QSR and ISO 13485

MDIC 8 CMMI, ISO and the QSR all incorporate risk differently, with different emphasis. Risk Management is an area where further alignment will be needed. Risk Management CMMI Project Risk ISO Medical Device Risk FDA Guidance ICH Q9 CMMI Risk management framework is project-centric ISO Medical Devices FDA addresses risk for medical devices mainly through guidance documents. It also references ISO Risk Management ISO addresses risk for medical devices in a separate standard

Level Definitions and Process Area Selection

MDIC 10 Maturity Indicator Levels: Maturity Indicator Levels were defined based on the following areas: Processes and Procedures IT Systems & Information Management Organization Governance Culture Maturity Indicator Level Definitions Monitoring and Auditing Reporting Communications and Training Risk Management Maturity indicator levels (MILs) for the Quality System Maturity model are aligned to the CMMI MILs Level 2 Managed Level 2 Managed Level 3 Defined Level 3 Defined Level 4 Quantitatively Managing Level 4 Quantitatively Managing Level 5 Optimizing Level 5 Optimizing Level 1 Initial Level 1 Initial

MDIC 11 Maturity Indicator Levels - Characterizations

MDIC 12 Selection of focused process area for the pilot study will be based on the following criteria Process Area Selection for Pilot Study Ease of Implementation Process area should be narrow in scope and could easily be implemented in a pilot study Size Agnostic Process area should be relevant to small, medium, and large organizations Alignment to Metrics Team Process area should align with the Metrics and Measures work stream. Value to Business Process area should be of value from a business perspective Well Defined Process area should be holistic in terms of people, process, and technology. Impact on Product Quality Process area should have a significant impact on patient safety and product quality.

‏ Next Steps

MDIC 14 Next Steps – Pilot Study Pilot Study Develop 1-2 process areas (process areas will be determined based off of selection criteria) Identify at least 3 companies that will participate in pilot study FDA will shadow pilot assessment to gain an understanding of how maturity is assessed Develop 1-2 process areas (process areas will be determined based off of selection criteria) Identify at least 3 companies that will participate in pilot study FDA will shadow pilot assessment to gain an understanding of how maturity is assessed In addition to building out the selected process areas for the pilot, planning for the pilot study will the focus for the next quarter.

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