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The FDA’s Case for Quality: Promoting Operational Excellence, Collaboration, and Simplification Cisco Vicenty Office of Compliance Center for Devices and Radiological Health April 3, 2018 1
The FDA’s Case for Quality: Promoting Operational Excellence, Collaboration, and Simplification
Cisco Vicenty
Office of Compliance
Center for Devices and Radiological Health
April 3, 2018
1
www.fda.gov
Agenda
• CDRH Vision
• Why it matters?
• How do we get there?
• Voluntary Pilot Details
• Next Steps
2
www.fda.gov
Where do we want to
be?
Patients in the U.S. have access to high quality, safe, effective medical devices, of public health importance, first in the world.
CDRH Vision
3
www.fda.gov
It is all about the patients!
What does it take?
• Focus on quality • Patient centric
perspective • Value • Collaboratively seek
solutions • Speed
• Accelerate Innovation
• Enhanced data and capability
• Proactive/Predictive
• Adaptive regulatory framework 4
www.fda.gov
Why does it matter?
5
www.fda.gov
Case for Quality
6
Why
Risk to patients from quality issues and hampered innovation in manufacturing and product
development practices
High industry focus on meeting
regulatory requirements over focusing on adopting best quality
practices
Low investment in automation and digital
technologies to improve
manufacturing
and design
No competitive
market around medical device
quality
What
Collaborative effort that focuses on organizational excellence and
product quality
New ways of assessing
organizational performance and focusing
on quality
Adapting regulatory
oversight to increase agility,
responsiveness, and enable continuous
improvement
Increasing visibility into
product quality to
inform purchasing
decisions and market choice
www.fda.gov
What does a focus on quality mean for the medical device ecosystem?
Increased manufacturing and product confidence
Faster time to markets, better information to drive regulatory
decisions, improved resource allocation
Improved patient outcomes, reduced costs, and informed users
www.fda.gov
How do we get there?
8
www.fda.gov
Move to operational excellence
Shift away from inspect and control
Drive connections within quality systems and organizations
Move to rapid learning and continuous improvement
Enable simplification and error-proofing
9
www.fda.gov
Voluntary Medical Device Manufacturing and Product Quality Pilot
10
Pilot Program
• Third-party maturity appraisal that leverages the Capability Maturity Model Integration (CMMI) framework to assess a medical device organizations capability to produce high quality devices and increase patient safety
• Pilot was announced on December 28, 2017 and will run from January 2, 2018 and continue through December 28, 2018
FDA Adjustments
• Forgo surveillance, appropriate post-approval, and risk-based inspections
• Manufacturing change notice submissions
• Streamlined submission
• Accelerated acceptance 48 hours vs 30 days
• Manufacturing site changes
• Streamlined submission
• Accelerated approval – 1 week Target
• Original PMA Manufacturing Section
• Streamlined submission
• Forgo pre-approval inspection
These changes reduce the burden and disruption of audits, accelerate the
review and approval process for changes, and shift resources to innovation and improvement.
www.fda.gov
Value across stakeholders
FDA
• 30-Day Notices consumed 15-22 FTEs
• Site Changes consumed 5 FTEs
• *Resource estimates are based on
number of 30-Days received in 2016. For the 69 30 Days it is the equivalent of 1 FTE dedicated to that site for the year.
Man
ufa
ctu
rers
• $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. Pa
tien
ts/P
rovi
der
s • 11 product quality improvements at one facility to patients 60-days sooner
• Increase product improvements
• Faster implementation of corrections to safety issues
11
Value analysis considered the submissions received at FDA in 2016 and the 30-dDy Changes submitted by one location of one manufacturer, the FTEs used during previous FDA audits, and estimated monthly revenue impact of approval delays for a recently released product.
www.fda.gov
Voluntary Pilot Details
12
www.fda.gov
www.fda.gov
Mechanics of an appraisal
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• Process area results & overall result for an organization
• Aggregate metrics of issues, resolutions, and responsiveness
• High level view into organization’s risks and issues
• Aggregate of all products at facility and not for individual products (instructions provided)
• Specific to organization depending on how they manage that data, tools, and function of the organization
• Discovery appraisal conducted by a 3rd party, including
– interviews
– document review as able
– crafting of findings
– verification of findings
– presentation of readout
– heat map
On-site Measurements Report out
www.fda.gov
What information is collected?
15
In scope process areas
Estimating
Planning
Monitor & Control
Configuration Management
Requirements Development and Management
Process Quality Assurance
Implementation Infrastructure
Technical Solution
Product Integration
• Baseline collection: Heat map of performance within a practice area against a model
• Allows for quick visualization to understand where the organization has met the intent of the practice descriptions
• Organization and PMO receive a copy of the full appraisal
Organization's Results
• The FDA receives process area average results & overall result for each participating organization:
Results reported to FDA
• Organizations will have an opportunity to re-baseline
Governance
Managing performance & Measurement
www.fda.gov
Optimizing
Quantitatively Managed
Defined
Managed
Initial
How is a maturity appraisal different?
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• Focus is on actual capabilities and activities of value add for the organization
• Interviews / data collection from people who perform work which provides an atmosphere for actual inspection to improve from
• Drives a conversation of how to actually improve in a way that makes sense to the business
Medical Device Discovery Appraisal
• Looks beyond the 820 CFR, and not just strict compliance
• Interviews / data collection are not from just those in the “front room” or those who manage audits
• Does not focus on just a corrective action list to “get into compliance”
The Difference
www.fda.gov
What can it show?
• Strengths among participants • Strong capability and focus on design solutions
to meet well established customer requirements, in a cost effective manner, and a focus on reducing rework
• Strong emphasis on manufacturing and assembling product to address functionality and quality characteristics
• Opportunities among participants • Opportunity to improve the assessing,
planning, and estimation of the size, effort, duration, and cost of the work and resources needed to develop, acquire, or deliver solutions
• Opportunity to improve how organizations ensure that the processes important to the organization are habitually and persistently improved
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0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
EST
PLAN
MC
CM
MPM
RDMPQA
GOV
II
PI
TS
Benchmark Performance
Manufacturer A Manufacturer B Manufacturer C Manufacturer D
This data is not actual data but a representative demonstration. Results scores were randomly generated.
www.fda.gov
Current Pilot Applicant Update
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Applicants
Total: 19 Qualified: 17 Withdrawn: 2
US: 13 OUS: 4
0
1
2
3
4
5
6
7
8
9
10
1-25 26-50 51-100 101-200
Count of Products Manufactured
Sites by Product Manufactured Range
0
1
2
3
4
5
6
1-25 26-50 51-100 101-500 501-2000 2001+
Employee Ranges
Breakout of Applicant Site By Employees
0
1
2
3
4
5
6
7
8
9
Class II Class III Class I and Class II Class II and Class III All Classes
Product Class Categories
Product Class Distribution
Appraisals:
Completed: 6 Scheduled: 4 In Scoping: 7
Inspection modifications started
Two instances where inspection occurred despite application
Modified change submissions started
One received. - Accepted in 48 hours
19 Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally
CMMI Appraisal vs. FDA Inspection
CMMI Appraisal
FDA Inspection
• Capability maturity model appraisal of business practices and processes.
• Be open in answering questions.
• Talk about improvements made over time and where we’re going.
• Appraisers conduct group interviews of ‘doers’ responsible for work products.
• Appraisers engage in discussions to truly understand how the
business operates relative to best practices.
• Many participants outside of QA. • Minimal disruption to site resources and no need for Back
Room / Front Room • Weaknesses are opportunities to improve business process.
• Inspection of quality system procedures and records. • Only answer questions asked.
• Don’t discuss improvement opportunities or future
plans.
• Inspectors interrogate Quality leaders, process experts, and record owners.
• Inspectors review procedures, records, storyboards
looking for evidence of noncompliance to regulations. • Few participants outside of QA.
• Large support team with Back Room / Front Room,
streams, scribes, etc.
• 483s require escalation to CAPA and formal agency response.
Evolution of behaviors
20 Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally
CMMI Appraisal Impressions
Positives
• Appraiser Accessibility • Appraiser Competency • Valuable Participant Briefing • Structured & Organized • Valuable use of Participants Time • Conversational, Engaging and Positive Group Interviews • High-Level Questions Drove Good Discussion • Valuable verification sessions ensured site ownership
Improvements
• Initial / immediate definition / understanding of approach would be helpful
• Expand Practice Area briefing to better define what will be covered
• High-Level questions seemed vague. More up-front education on the level of detail.
• Terminology at times was difficult, but rephrasing helped. • Pilot metrics may be difficult to define and implement.
CMMI Appraisal – 5 Days
Prep Appraisal Total
Site Coordinator
80 Hrs 20 Hrs 100 Hrs
Participants 60 Hrs 180 Hrs 240 Hrs
Total 140 Hrs
200 Hrs 340 Hrs
2 Day FDA Inspection 1370 Hrs
www.fda.gov
Metrics collected to date
• Wide variability in the metrics received
• High focus on traditional quality system metrics (# CAPAs, CAPA Closure Times, Adverse events)
• Concerns on sharing more depth or detail with FDA
• FDA is looking for how quality is monitored and trended more proactively to demonstrate sustained or improving performance in the process areas
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www.fda.gov
Next Steps
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www.fda.gov
On the horizon
Expand appraisal from manufacturing focus to design
Bring the same type of acceleration to continuous improvement of designs (drive improved quality in 510(k) products)
New Strategic Focus Area Simplification
Increase adoption of technologies
Leaning out validation effort
Enabling simplified processes
Current Effort
Non-Product Computer Systems Validation
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www.fda.gov
Streamline Non-Product Computer System Validations
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• Lag in the medical device industry in implementation of automated systems, data analysis systems, and manufacturing technologies due to lack of clarity, outdated auditing activities, and perceived regulatory burden. This reduces a manufacturers capability to learn, react to issues, and improve product quality.
Why
• Drive a paradigm shift in applying value- driven and patient-focused approaches to streamline non-product software CSV.
• Focus on critical thinking and risk-based, agile approaches to validation and streamlined documentation.
What
• Applying streamlined approaches and practices
• Piloting modified Computer System Validation protocols with industry participants
• Guidance development centered around assurance activities for this category How
www.fda.gov
Non-Product CSV Modification Impact
Activity Current Approach Modified Approach Impact
Streamlined Analytics Reporting:
Consumes 43 hours per report
Reduced to 10.5 hours per report
• $90 per hour average cost • $3870 per report vs $945 • Drives reduced use of analytics and
operational research
Risk-based software vendor qualification:
Approx. 2000 hours of labor
80% reduction in labor
• $100 per hour average cost • $200,000 $40,000
Ad-hoc/Unscripted Testing (AGILE):
14 hours per test script
2 hours • A $10B firm with 100 systems could save $1.62M annually, which can be reinvested into innovation and product quality improvement
• More robust software (Safer Product)
Piloted Risk-Based CSV Validation Process:
CSV does not account for risk or application
Risk-based and patient focused
• Culture change and staff engagement • 30 Day qualification 2 days • 25+ CSV Backlog 6 Closing/5 in process
25 Impact and hour estimates provided by medical device manufacturers
www.fda.gov
Information, Engagement, and Collaboration
26 • For additional information, enrollment, or
feedback
• http://mdic.org/cfq/
• http://mdic.org/cfq/enroll/
• Program Updates
• http://mdic.org/mdicx/
• Public Workshop
• https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm568069.htm
• Pilot FR Notice
• https://www.federalregister.gov/documents/2017/12/28/2017-28044/fostering-medical-innovation-case-for-quality-voluntary-medical-device-manufacturing-and-product
• For any issues or concerns contact
www.fda.gov
Questions?
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28 www.fda.gov
Thank You
