Focus on Medical Device: A conversation about Case for Quality. September 22, 2017

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1 Focus on Medical Device: A conversation about Case for Quality September 22, 2017

Today's speakers George Serafin Francisco Vicenty Doug Grindstaff

Life Sciences Grant Thornton Program Manager - Case for Quality

Program Director Medical Device Innovation Consortium (MDIC)

gov dgrindstaff@cmmiinstitute.com SChristopher@mdic.

3 Today's speakers George Serafin Francisco Vicenty Doug Grindstaff Stephanie Christopher National Managing Principal, Health Care & Life Sciences Grant Thornton Program Manager - Case for Quality FDA Global New Business and Market Development CMMI Institute Program Director Medical Device Innovation Consortium (MDIC) George.Serafin@us.gt.com Francisco.Vicenty@fda.hhs.gov dgrindstaff@cmmiinstitute.com SChristopher@mdic.org 2017 Grant Thornton LLP All rights reserved U.S. member firm of Grant Thornton International Ltd 3

4 Why create a Voluntary Program? CDRH Vision Where do we want to be? Patients have access to high quality, safe, effective medical devices, of public health importance, first in the world Grant Thornton LLP All rights reserved U.S. member firm of Grant Thornton International Ltd 4

5 Why create a Voluntary Program? Current State Actions and decisions driven by regulatory requirement Firms expend resources trying to satisfy FDA and not pursue quality Information and data is limited by what is permitted by regulations Interactions with industry are defensive and lacking trust Patient preference not considered Compliance focused actions serve as proxy for patient safety & quality Perspectives & Reality 2017 Grant Thornton LLP All rights reserved U.S. member firm of Grant Thornton International Ltd 5

6 Why create a Voluntary Program? Where do we need to be Quality focused Patient centric Value driven Work for solutions Accelerate Innovation Enhanced data Proactive/Predictive Transparent Collaborative Adaptive It is all about the patients! 2017 Grant Thornton LLP All rights reserved U.S. member firm of Grant Thornton International Ltd 6

8 Why create a Voluntary Program? Benefits Implementing a standard, recognized maturity model across the medical device industry, can produce a wide range of benefits Grant Thornton LLP All rights reserved U.S. member firm of Grant Thornton International Ltd 8

9 Why create a Voluntary Program? Regulatory Benefits Regulatory Activity Modifications Pilot Phase Inspections Remove from routine surveillance Waive pre-approval inspections where appropriate Issues Engagement Rapid resolution Manufacturing submissions Reduce submission for 30-Day Notices, Site Changes, and PMA Originals Program Expansion Development submissions 510(k) and PMA Original Accelerate approval path Comparative metrics and data Faster, more indicative way of assessing performance Benefits Industry Tangible value Faster time to market Improve resource deployment FDA Redeployed resources Estimated Average FTEs Redeployed Faster and more effective data Focused reviews Where does FDA add value Patients Increased responsiveness to issues Proactive improvements Faster access to products and improvements 2017 Grant Thornton LLP All rights reserved U.S. member firm of Grant Thornton International Ltd 9

FDA Manufacturers Patients Healthcare Providers Direct value across stakeholders 30-Day Notices consumed 15-22 FTEs Site Changes

2M/year savings 1 facility based on optimized processes and resource allocation (69 30-Day Notices) FDA audit cost (10 Days) - $140K

11 product quality improvements at one facility to patients 60- days sooner Increase product improvements Faster implementation of

10 FDA Manufacturers Patients Healthcare Providers Direct value across stakeholders 30-Day Notices consumed FTEs Site Changes consumed 5 FTEs $30M/month top line. $1.2M/year savings 1 facility based on optimized processes and resource allocation (69 30-Day Notices) FDA audit cost (10 Days) - $140K Limited submissions and improvements due to regulatory resources European product lines optimized faster/better than US. 11 product quality improvements at one facility to patients 60- days sooner Increase product improvements Faster implementation of corrections to safety issues Product performance transparency Safety Effectiveness Reliability Usability Availability Compatibility Patient Experience 2017 Grant Thornton LLP All rights reserved U.S. member firm of Grant Thornton International Ltd 10

11 Why does this matter to FDA? It is all about the patient People and resources Creating a learning regulatory system Flexibility and responsiveness 2017 Grant Thornton LLP All rights reserved U.S. member firm of Grant Thornton International Ltd 11

12 12 MDIC Strategies to Advance Regulatory Science MDIC strategies facilitate stakeholder collaboration to expedite regulatory science innovation and ensure broad-based benefits Create A Forum For Collaboration & Dialogue Flexible governance structure Multi-stakeholder involvement Focus on patient benefit Make Strategic Investments In Regulatory Science Improve efficiency & costeffectiveness Focus on unmet needs Improve innovation cycle time Provide Tools To Drive Innovation Evidence generation Patient engagement & access Quality & patient safety

13 13 MDIC and the Case for Quality FDA launched the Case for Quality in 2011 after a series of reports identified how a culture of compliance in medical device manufacturers was not producing a culture of quality In 2015, MDIC was awarded a contract from FDA to advance the Case for Quality by: Researching and piloting a maturity model that could be applied to medical device manufacturers Convening Forums to get industry, hospital, physician regulator support and contributions to the Case for Quality In 2017, MDIC has continued to advance the Case for Quality by continuing to advance the Maturity Model and to provide operational support as CDRH prepare to launch their voluntary quality review program

14 14 MDIC trusted Medical Device Ecosystem

program which leverages CMMI as the standard maturity model by

produce high quality devices and improve patient safety.

requirements as a recognition of this independent assessment of

Reduced defects / rework Reduced costs Accelerated time to market

15 What is the Voluntary Program? Background Quality System Maturity Model Team Charter Develop a program which leverages CMMI as the standard maturity model by which medical device organizations may measure their capability to produce high quality devices and improve patient safety. FDA will adjust their engagement activities and submission requirements as a recognition of this independent assessment of quality maturity. Reduced defects / rework Reduced costs Accelerated time to market Increased Customer Satisfaction A culture of quality across the organization 2017 Grant Thornton LLP All rights reserved U.S. member firm of Grant Thornton International Ltd 15

program available to a broad spectrum of organizations within the Medical Device Industry. B. Braun Baxter C.R. Bard, Inc.

16 What is the Voluntary Program? Background The Maturity Model Working Group is comprised of a blend of small, medium, and large-sized companies as well as professional services firms that will enable the development of a viable program available to a broad spectrum of organizations within the Medical Device Industry. B. Braun Baxter C.R. Bard, Inc. Booz Allen Hamilton Boston Scientific Carver Global Health Group CMMI Institute CVRx Deloitte Double Play Process Diagnostics Edwards FDA, Health and Human Services (6) General Electric Grant Thornton Innovize Johnson & Johnson Medical Device Innovation Consortium Medtronic Regulatory and Quality Solutions LLC Siemens Spectranetics St. Jude Medical Stryker Two Harbors Consulting Veeva Systems 2017 Grant Thornton LLP All rights reserved U.S. member firm of Grant Thornton International Ltd 16

17 Why Does Capability Matter? A capability is anything an organization does well that drives meaningful business results. Source: Building Organizational Capability, McKinsey Global Survey Results, March Defects/Rework - Cost - Time to Market - Risk Capabilities + Quality + Productivity Quality + Productivity Customer + Satisfaction Customer + Satisfaction + Performance + New & Repeat Business Repeat Business This presentation contains proprietary information and may not be distributed without the express written permission of the CMMI Institute CMMI Institute.

certification, appraisals, and public benchmarks Models Public Benchmark Training and

18 What is CMMI? CMMI consists of a framework of best practices that are presented through models, training and certification, appraisals, and public benchmarks Models Public Benchmark Training and Certification Appraisal Methods This presentation contains proprietary information and may not be distributed without the express written permission of the CMMI Institute CMMI Institute.

19 The Global Impact of CMMI 10,000+ organizations 98 countries 12 national governments 10 languages 400+ partners 2,200+ appraisals in 2016

20 What is the Voluntary Program? CMMI Overview Companies that have been appraised by CMMI: Information Technology Healthcare Electrical & Automotive Gov/Defense/Space 2017 Grant Thornton LLP All rights reserved U.S. member firm of Grant Thornton International Ltd 20

management and program updates to Steering Committee Provides participant status and supporting data to FDA (quarterly)

SC approval) as new learnings are acquired Provides benchmarking data (anonymized) to industry to support continuous

24 What is the Voluntary Program? Medical Device Discovery Appraisal (MDDA) High Level activities Description Program subscription provides: Program management and program updates to Steering Committee Provides participant status and supporting data to FDA (quarterly) Delivers training to appraisers Provides quality reviews of appraiser and appraisal submissions Updates program (following SC approval) as new learnings are acquired Provides benchmarking data (anonymized) to industry to support continuous improvement Supports expansion of program Manages enrollment, appraisal scheduling, and reporting to appraised companies and FDA 2017 Grant Thornton LLP All rights reserved U.S. member firm of Grant Thornton International Ltd 24

25 What is the Voluntary Program? MDDA High Level activities Description Planning Detailed scoping with exec sponsor Scheduling with site coordinator and appropriate logistics planning Appraisal plan creation submission On-site Discovery appraisal including interviews, document review as able, crafting of findings, verification of findings, presentation of readout, Brick chart creation Post Activity Report finalization, submission of data to appropriate groups, improvement planning, checkpoint follow ups Checkpoints Performed remotely via phone call on 90 day intervals. 90 day / 270 day checkpoint addresses progress against findings, updates back to appropriate groups 180 day checkpoint addresses progress to findings and updates to discovery appraisal scores as able, submission of data to appropriate groups 2017 Grant Thornton LLP All rights reserved U.S. member firm of Grant Thornton International Ltd 25

26 What is the Voluntary Program? Cost of Participation Current cost considerations Costs are estimated based on the following assumptions: Model areas appraised Number of product lines appraised Size of appraisal team Geographic location Planning, execution, and post appraisal activity Appraisal duration Program management Scope would be following process practice areas from CMM DEV PP, PMC, MA, SAM, PPQA, REQM, CM, RD, TS, PI, VER, VAL Discovery appraisal performed annually 1 geographic location Two appraisers for most appraisals No longer than 1 week for on-site activity Follow up checkpoint activities performed on 90 day cycle 2017 Grant Thornton LLP All rights reserved U.S. member firm of Grant Thornton International Ltd 26

27 What is the Voluntary Program? Cost of Participation Single product line / project 3 product lines / project 7 product lines / project 2.5 day on site appraisal ~10 hours planning, 15 hours post activities $10k appraisal / $5K subscription fee (Total -$15k) 5 day on site appraisal ~20 hours planning, 20 hours post activities $15k appraisal / $5K subscription fee (Total - $20k 5 day on site appraisal 3 person appraisal team 25 hours planning, 40 hours post activities $30k appraisal / $5K subscription fee (Total - $35k) 2017 Grant Thornton LLP All rights reserved U.S. member firm of Grant Thornton International Ltd 27

29 Upcoming meetings MedTech Conference panel on Case for Quality Sept. 25, 2:30pm MDIC Annual Public Forum October 3 CDRH public meeting on Case for Quality October htm MDIC/AdvaMed joint workshop on Quality November 14 Final 2017 Case for Quality Forum November Grant Thornton LLP All rights reserved U.S. member firm of Grant Thornton International Ltd 29

Questions 2017 Grant Thornton LLP All rights reserved

MDUFA Performance Goals and Procedures Process Improvements Pre-Submissions Submission Acceptance Criteria Interactive Review

Page 1 MDUFA Performance Goals and Procedures... 3 I. Process Improvements... 3 A. Pre-Submissions... 3 B. Submission Acceptance Criteria... 4 C. Interactive Review... 5 D. Guidance Document Development...