MDIC Open Forum Quality System Maturity Model Update

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

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

Quality System Maturity Model Project Team 2 Team Members Company Pat Baird Baxter Jodie

Quality System Maturity Model Project Team 2 Team Members Company Pat Baird Baxter Jodie Bastian Stryker Sarah Deegan Johnson & Johnson Jeff Fecho (Adva. Med Rep) St. Jude Medical Bob Kenney Veeva Bill Murray (Co-Lead) Nick Premnath MDIC Deloitte Tim Rew Terumo Nicole Schumacher Deloitte George Serafin (Co-Lead) Deloitte Jason Spiegler (ASQ Rep) Camstar Dan Torrens CMMI Francisco Vicenty FDA Rusty Young CMMI MDIC

Background / Objective: Quality System Maturity Model Background In May 2015, MDIC presented research

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. 3 MDIC

Key milestones and overall project timeline July 2015 August 2015 September 2015 October 2015

Key milestones and overall project timeline July 2015 August 2015 September 2015 October 2015 November 2015 December 2015 January 2016 February 2016 March 2016 Maturity Model Development Develop Pilot Strategy and Approach Connect with Measures Team Define Maturity levels CMMI alignment and identify gaps/enhancements Timeline Adapt CMMI process framework Present adapted CMMI Model at Cf. Q Forum CMMI Pilot Development Selection of process areas Selected pilot process areas built out Identify pilot participants Present pilot plan at Cf. Q Forum Develop plans and on-board pilot participants Conduct Pilot Kick-off pilot Complete pilot 4 MDIC

Approach

Approach

Approach for adapting CMMI process framework for Medical Devices Our approach focuses on adapting

Approach for adapting CMMI process framework for Medical Devices Our approach focuses on adapting the CMMI process framework to medical devices then developing content for the selected process areas. Fill in Gaps / Enhance Identify Gaps Alignment to QSR / ISO CMMI Process Framework Address identified gaps and enhance process framework; define maturity levels Conduct gap analysis and identify any missing elements in the process framework Align combined CMMI process framework to QSR and ISO 13485 Leverage and combine CMMI process frameworks for Development, Acquisition, and Service constellations to create a process framework for medical devices 6 MDIC

Mapping of CMMI Process Framework The CMMI Framework approximately maps to 80% of Quality

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

Risk Management CMMI, ISO and the QSR all incorporate risk differently, with different emphasis.

Risk Management 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 framework CMMI is project-centric CMMI Project Risk Management ISO 14971 Medical Devices 8 ISO addresses risk for medical devices in a separate standard ISO 14971 Medical Device Risk FDA Guidance ICH Q 9 FDA addresses risk for medical devices mainly through guidance documents. It also references ISO 14971 MDIC

Level Definitions and Process Area Selection

Level Definitions and Process Area Selection

Maturity Indicator Level Definitions Maturity indicator levels (MILs) for the Quality System Maturity model

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

Maturity Indicator Levels - Characterizations Maturity Indicator Levels (MILs) Level 1 Initial • Inconsistent

Maturity Indicator Levels - Characterizations Maturity Indicator Levels (MILs) Level 1 Initial • Inconsistent application & results • Project or unit specific • Execution dependent on individuals • No formal training program • Sporadic or non-existent • Qualitative • No RM framework • Focus on testing & meeting specs • Lagging metrics • Ad hoc reporting • No management review • Inconsistent problem resolution Level 2 Managed • Defined locally • Governance structure Improved application & results • Enforcement inconsistent • Developed of SMEs or project teams • Selective training • Formal risk methodologies applied • Project/unit specific • No RM Framework • Often pro-forma • Lagging metrics • Internally focused • QA/compliance driven • Reporting internal to local units • Limited or ad hoc Management Review • Inconsistent problem resolution Level 3 Defined • Defined & consistent for regulated activities • Consistent inputs/outputs • Quality by Design • Formal training program by roles & responsibilities • Beginning RM framework • Risk integrated into processes • Quantitative/semiquantitative • Well-defined toolbox & procedures • Analytics • Two-way communication with management • Improved problem resolution Level 4 Quantitatively Managing • Processes defined & “institutionalized” • Consistently applied with consistent results • Automation • Formal training syllabi by roles & responsibilities • Active tracking & reporting • RM framework “institutionalized” • Risk fully integrated & specialized to processes • Quantitative/predictive/proa ctive • Complete toolbox • Implementation of methodologies (e. g. Lean/Six-Sigma) • Proactive Analytics Level 5 Optimizing • Integrated Automation • Fully life cycle management framework • Change management • Centers of excellence • Fully trained, highly skilled • Focus on professional & personal development • Predictive risk used strategically • Drives business opportunities • Patient focus • Analytics driven, predictive • Incorporate business metrics • Cost of Quality • Continuous Improvement • Analytics-based quantitative reporting • Proactive management involvement • Strategic preventative action 11 MDIC

Process Area Selection for Pilot Study Selection of focused process area for the pilot

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

Next Steps

Next Steps

Next Steps – Pilot Study In addition to building out the selected process areas

Next Steps – Pilot Study In addition to building out the selected process areas for the pilot, planning for the pilot study will the focus for the next quarter. Pilot Study ü Develop 1 -2 process areas (process areas will be determined based off of selection criteria) ü Identify at least 3 companies that will participate in pilot study ü FDA will shadow pilot assessment to gain an understanding of how maturity is assessed Next Steps Process Area q Identification of potential process areas Model Development q Incorporate measures work stream output into maturity model q Analysis and selection of 1 q Determine resources required -2 process area q Frame out incentives 14 Company Identification Execution q Reach out to companies to q Develop execution plan / determine interest in pilot schedule for assessors study and FDA members q Selection of at least 3 companies q Perform maturity model assessment MDIC

Questions?

Questions?