medical device innovation consortium - mdicx - q3 …...2018/09/12 · medical device discovery...
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MDICx - Q3 Quarterly update on the CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program
Francisco Vicenty, CDRHKim Kaplan, CMMIKathie Bardwell, Steris CorporationStephanie Fossat-Dominguez, CeloNova Biosciences September 12, 2018
Medical DeviceDiscovery Appraisal Program
MDICx3rd Quarterly update:CDRH Case for Quality Pilot ProgramKim Kaplan [email protected] September 12, 2018
The Capability Maturity Model Integration (CMMI®) is a capability improvement model that can be adapted to solve any performance issue at any level of the organization in any industry.
The Model provides guidelines and recommendations for helping your organization diagnose problems and improve performance.
Used by over 10,000 organizations from more than 100 countries all over the world, CMMI helps you identify and achieve measurable business goals. See Case Studies.
What is CMMI®?
50%DECREASE
non-conformities on project
deliverables
60%DECREASE50%
DECREASE
cost of poor quality defects
Czech Republic
INCREASE
On Budget Performance
INCREASE
On Time Performance
Customer Satisfaction
INCREASE
39% 71% 53%
What is this program?
Reduced defects / rework
Accelerated time to market
Increased Customer Satisfaction
A culture of quality - across the organization.
This pilot program leverages the CMMI framework as the standard maturity model by which medical device organizations may measure their capability to produce high quality devices and increase patient safety. FDA will adjust their engagement activities and submission requirements as a recognition of this independent assessment of quality maturity. The CDRH Voluntary Medical Device Manufacturing and Product Quality pilot was announced in the Federal Register on December 28, 2017.
Reduced costs
Paradigm Shift
• Value to ParticipantsWhat value are stakeholders getting from program?“Program Effectiveness”
• Consistency & Scalability Is the program sustainable?“Program Adoption”
• Elevating IndustryThe long term “next steps”…
• What: Appraisal identifies opportunities for improvement, reduced regulatory burden, increased innovation, faster time to market How: Survey results, participant feedback, appraiser feedback, FDA feedback, lessons learned incorporated into program
• What: Program operations are performed consistently for growing # new participantsHow: Number of appraisals, wait time to appraisal, number of appraisers trained in the program, lessons learned incorporated into program
• What: Industry baseline for organizations to benchmark improvement journeyHow: trend participant results & quality performance metrics over time
Success Components Success Identification
What does success in this pilot look like?
• # of Enrollees17 Organizations | 33 Facilities
• # of Appraisals17 Complete | 7 Scheduled
• Time from scheduling appraisal to appraisal execution (days)Range = 17 - 77 | Average = 43
Program Adoption Metrics to Date
• Did the appraisal identify areas or processes that could improve how work is performed to increase product quality?
88.2% YES | 11.8% NO
• Did the appraisal practice areas conflict with any regulatory compliance assessment areas?
97.8% NO | 2.2% YES
• Did you find the appraisal to be of value? 95.7% YES | 4.3% NO
• Would you recommend this program?100% YES | 0% NO
Program Effectiveness Metrics to Date
Elevating Industry
• Continue to execute the program• target of 30 appraisals for 2018
• Define reappraisal approach• Balancing value-add to participants and FDA’s information needs
• Define a multi-site appraisal approach• How can have a broader view of an organization, ex: TPLC
• Determine use of performance report in appraisal process• Consistent set of information collected, individual vs industry journey
• Create a ‘year end review’ document• Include lessons learned and proposed actions for a 2019 program
Next Steps
• MDIC: Case for Quality
• CMMI Institute: MDDAP
• MedTech Insight Series: Article 1 & Podcast 1, Article 2 & Podcast 2, Article 3 & Podcast 3
• June 5th MDICx Webinar: Slides and Video
• February 27th MDICx Webinar: Slides and Video
• November 15th MDIC Meeting: Presentations
• October 10th FDA Public Meeting: Presentations
Additional Information
CeloNova BioSciences Inc.
Case For Quality Pilot Participation
Stephanie Fossat-Dominguez – VP OperationsNicole Barber- Director Regulatory Affairs
CONFIDENTIAL
About CeloNova BioSciences• CeloNova BioSciences, Inc. is an
innovative global medical device leader transforming the treatment of cardiovascular disease and promoting positive outcomes in patients around the world.
• CeloNova BioSciences develops, manufactures and markets a family of products based upon its novel Polyzene-F (PzF) nanocoating technology.
Founded: 2000
Specialty: Interventional Cardiology
Headquarters:8023 Vantage Dr. Suite 1400 San Antonio, TX 78230
Employees: 50+ FTEs
Manufacturing: 5840 El Camino Real Suite 111 Carlsbad, CA 92008 United States
Web Address: www.celonova.com
CONFIDENTIAL
Enrolled Site OverviewCA Site Employee Count ~ 381 product: COBRA PzFOn site functions: Manufacturing, Demand Planning Distribution and Logistics R&D, Product Development Manufacturing Engineering Purchasing Supply Chain Quality Control Quality Assurance/Engineering Complaint Handling Auditing Regulatory Affairs
CONFIDENTIAL
Case for Quality Timeline
CeloNova accepted in the program January 11,
2018
As a benefit for
enrolling, FDA waived inspection
(Post-Approval
PMA)
MDDAP Appraisal April 9-13.
Quarterly Touch
Points with Lead
Appraiser
Metrics Submitted
to FDA
Next Step preparation
CONFIDENTIAL
Case for Quality- How did we get there?
Late 2017-Awareness of Pilot program thru FDA Website
Information gathered from MDIC page
Attended webinars with peer testimony
Compiled information for Executive management
Presented and convinced Exec.
11Jan2018-CeloNova enrolled in CfQ
Engagement of all executives at CeloNova was immediate real: Saw the value of the program, even for a small
company Supported the enrollment and the appraisal Support follow-ups and next steps
CONFIDENTIAL
Case for Quality- Appraisal Vs Audit
Appraisal• Use a limited pool of
interviewed resources• Discovery Appraisal: no
documented evidence needed
• Interviews with people responsible
• Open conversation• Limited preparation time
Audit• Large amount of resources:
audit room, back room• Documentation preparation
and review• Assigned audit hosts, SME• Guarded conversation• Significant preparation of
documents, rationales, justifications etc…
CONFIDENTIAL
Case for Quality- Preparation and Appraisal Webinars with peers’ experiences Monthly MDIC calls MDIC connected us with other
participants who went through their appraisal
Model discovery and exploration with our Lead Appraiser and access to CMMI website
Most difficult task: translate CMMI language
Preparation meeting with interviewees to explain: What each Practice Area
covers This is not an audit Answer more that just the
question Prepare to explain your
process without supporting documentation
CONFIDENTIAL
Case for Quality- Appraisal Scope, method 2 expert appraisers 5 days on-site Only 10 hours of
interviews, review and result sessions
11 Areas, level 2 Discovery Appraisal
Results detailed per area, with Strength, Weakness and Notes
CONFIDENTIAL
Case for Quality- Appraisal outcomes
Impact on employee morale Validation that we are doing the right thing! Realization that interactions and communication between
processes is critical Program gives time to implement improvement to areas of
weakness. No more rushed and inadequate fixes to a 483! Open conversation with Appraisers regarding next steps: what
will the next appraisal look like? What level for which practice area?
CONFIDENTIAL
Case for Quality- Life after the Appraisal
Quarterly touch points with Lead Appraiser Metrics sent to the FDA Metrics are a work in progress Likely subject to change as conversation evolves
Being a participant gives us an opportunity to influence the pilot direction, help shape the program, have a voice we would otherwise not have.
CONFIDENTIAL
Case for Quality- Use of Benefits
PMA Post-Approval inspection waived when enrolled 30-day notice: Received 5-day review benefit for 1 out of
2 30-day notices submitted since enrolling The 30-day notice that did not receive 5-day review was due
to the specific nature of the change. The review branch informed us in advance that the streamlined format would not be appropriate for the change.
The review branch requested we discuss 30-day notices with them prior to submitting as they get familiar with the streamlined submission.
CONFIDENTIAL
September 12, 2018
MDIC
Q3 Update
CDRH Quality Pilot
www.yourwebsite.com
Business Segments:
HEALTHCARE PRODUCTSInfection prevention and procedural solutions for healthcare providers worldwide, including consumables, equipment maintenance and installation services and capital equipment.
HEALTHCARE SPECIALTY SERVICES (HSS)A range of specialty services for healthcare providers including hospital sterilization services and instrument and scope repair.
APPLIED STERILIZATION TECHNOLOGIES (AST)Contract sterilization and laboratory services for medical device and pharmaceutical Customers.
LIFE SCIENCESConsumable products, equipment maintenance and specialty services, and capital equipment primarily for pharmaceutical manufacturers.
Customers We Serve:
Hospitals, Surgery and GI Centers
Medical Device andPharmaceuticalManufacturers
Pharmaceutical Production(Biopharma)
About STERIS
About STERIS AST
LABORATORIESProvides microbiological and analytical testing
LOCATIONS:Americas: 2 | EMEAA: 13
COMPATIBILITY:Laboratory testing, sterility testing, validation services
MOIST HEAT (STEAM)High temp, high pressure with vacuum or gravity conditioning
LOCATIONS:Americas: 1 | EMEAA: 0
COMPATIBILITY:Most temperature-stable materials | Packaging must be breathable
VHPLow temp gas process under deep vacuum
LOCATIONS:Americas: 0 | EMEAA: 1*
COMPATIBILITY:Most materials, except cellulose-based | Requires enabling pathways
ETHYLENE OXIDEExposes product to gaseous sterilant
LOCATIONS:Americas: 10 | EMEAA: 10
COMPATIBILITY:Most materials, liquids not recommended | Packaging must be breathable
X-RAYUses ionizing energy from electron beams
LOCATIONS:Americas: 0 | EMEAA: 1
COMPATIBILITY:Most materials | Excellent penetration on dense products
GAMMAExposes product to Cobalt 60 radiation
LOCATIONS:Americas: 13 | EMEAA: 16
COMPATIBILITY:Most materials | Good penetration on dense products
ELECTRON BEAMExposes product to high-energy electrons
LOCATIONS:Americas: 7 | EMEAA: 7
COMPATIBILITY:Most materials | Mid-low penetration on dense products
Disclaimer
This presentation contains simulated data for illustrative purposes concerning headcount, production volumes, financial estimates, dosimeter results and non-conformance/ CAPA levels as it relates to STERIS AST’s production and quality systems. The information is provided as an aid in today’s presentation on STERIS’ Case for Quality Performance Metrics.
Employee Health & Safety
0.84
1.08
0.84
0.72
0.35 0.32
1.371.32
1.161.05
0.93
1.02
0.00
0.20
0.40
0.60
0.80
1.00
1.20
1.40
1.60
FY16 FY17 FY18
Recordable Case Incident Rates | FY16 - FY18
Recordable Rate for AST GloballyRecordable Rate for Libertyville NorthWorld Class Recordable Rate for Medical Equipment ManufacturersOSHA Average Recordable Rate for Medical Equipment Manufacturers
World Class Recordable Rate - AST
YearRecordable
CasesEmployees Incident Rate
FY16 57 6814 0.84
FY17 77 7158 1.08
FY18 54 6460 0.84
World Class Recordable Rate - Libertyville North
YearRecordable
CasesEmployees Incident Rate
FY16 2 278 0.72
FY17 1 287 0.35
FY18 1 310 0.32
Simulated data for illustrative purposes only
Reliability – First Pass Yield | Year over Year
First Pass Yield - Irradiation Global (FY16 - FY18)Year
Production Runs
Rereads First Pass Yield Target Rate
FY16 153,799 1,846 98.8% 99%
FY17 186,266 1,868 99.0% 99%
FY18 223,145 1,785 99.2% 99%
First Pass Yield - Libertyville North (FY16 - FY18)Year
Production Runs
Rereads First Pass Yield Target Rate
FY16 4,610 42 99.1% 99%
FY17 4,630 37 99.2% 99%
FY18 5,094 26 99.5% 99%
153,799
186,266
223,145
FY16 FY17 FY18
Production Runs - Irradiation Global FY16 - FY18
Production Runs Rereads
1,846 1,868 1,785
98.8%
99.0%
99.2%99.1%
99.2%
99.5%
98.6%
98.9%
99.2%
99.5%
99.8%
FY16 FY17 FY18
First Pass Yield - Irradiation Global FY16 - FY18
First Pass Yield Libertyville Target Rate
Simulated data for illustrative purposes only
Target 99%
Reliability – First Pass YieldQuarterly Comparison
First Pass Yield - Irradiation Global (FY18)Quarter Production Runs Rereads First Pass Yield Target Rate
Q1 56,087 457 99.2% 99%
Q2 55,567 476 99.2% 99%
Q3 55,585 455 99.2% 99%
Q4 55,906 398 99.3% 99%
First Pass Yield - Irradiation Global (FY19)Quarter Production Runs Rereads First Pass Yield Target Rate
Q1 66,221 568 99.1% 99%
First Pass Yield - Libertyville North (FY18)Quarter Production Runs Rereads First Pass Yield Target Rate
Q1 1,329 4 99.7% 99%
Q2 1,215 7 99.5% 99%
Q3 1,300 9 99.3% 99%
Q4 1,250 7 99.5% 99%
First Pass Yield - Libertyville North (FY19)Quarter Production Runs Rereads First Pass Yield Target Rate
Q1 1,607 11 99.3% 99%
66,221
56,087 55,567 55,585 55,906
Q1 Q2 Q3 Q4
Production Runs and Rereads – Irradiation Global FY19 vs. FY18
FY19 Production Runs FY19 Rereads FY18 Production Runs FY18 Rereads
98.8%
98.9%
99.0%
99.1%
99.2%
99.3%
First Pass Yield - Irradiation Global FY19 vs. FY18
FY19 First Pass Yield FY19 Libertyville FY18 First Pass Yield Target Rate
Q4 Q1 Q2 Q3
Target Q1 = 99.1%
99%
Simulated data for illustrative purposes only
568 457 476 455 398
Availability – Damages
Financial Damages - Global (FY16 - FY18)Year Customers Affected Americas EMEAA Global
FY16 129 $246,913 $175,685 $422,598
FY17 110 $257,314 $183,534 $440,848
FY18 116 $233,100 $211,380 $444,480
129
110
116
100
105
110
115
120
125
130
135
FY16 FY17 FY18
Customers Affected – Global FY16 - FY18
Customers Affected
$175,685 $183,534 $211,380
$246,913 $257,314 $233,100
0
100,000
200,000
300,000
400,000
500,000
FY16 FY17 FY18
Financial Damages – Global FY16 - FY18
EMEAA Americas Target
Target$300K
Simulated data for illustrative purposes only
Availability – Customer Feedback
Financial Damages - Global (FY18)Year
Customers Affected
GlobalAverage Damages
FY18 116 $444,480 $3,832
Financial Damages - Top 15 Customer Damages (FY18)Year Customer Occurrences Damages
FY18 Customer 1 4 $53,345
FY18 Customer 2 3 $44,048
FY18 Customer 3 2 $34,659
FY18 Customer 4 11 $34,813
FY18 Customer 5 5 $28,853
FY18 Customer 6 2 $23,714
FY18 Customer 7 1 $21,558
FY18 Customer 8 4 $21,555
FY18 Customer 9 1 $19,839
FY18 Customer 10 1 $15,381
FY18 Customer 11 2 $12,283
FY18 Customer 12 1 $11,936
FY18 Customer 13 1 $10,144
FY18 Customer 14 2 $10,000
FY18 Customer 15 2 $10,000
$53,
345
$44,
048
$34,
659
$34,
813
$28,
853
$23,
714
$21,
558
$21,
555
$19,
839
$15,
381
$12,
283
$11,
936
$10,
144
$10,
000
$10,
000
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
0
10,000
20,000
30,000
40,000
50,000
60,000
Financial Damages - Top 15 Customer Damages (FY18)
Damages Customer Satisfaction
Simulated data for illustrative purposes only
Effectiveness – CAPA ManagementYear Over Year
CAPA Management - Global (FY16 - FY18)Year Complaints
Non-conformances
Total Events CAPAs CAPA Rate Target Rate
FY16 547 1,205 1,752 571 32.6% 30%
FY17 961 1,642 2,603 574 22.0% 30%
FY18 896 1,059 1,955 570 29.2% 30%
CAPA Management - Libertyville North (FY16 - FY18)
Year ComplaintsNon-
conformancesTotal Events CAPAs CAPA Rate Target Rate
FY16 31 40 71 21 29.9% 30%FY17 24 29 53 8 14.8% 30%FY18 30 35 65 11 16.3% 30%
1,752
2,603
1,955
571 574 570
0
500
1,000
1,500
2,000
2,500
3,000
FY16 FY17 FY18
CAPA Management - Global FY16 - FY18
Total Events CAPAs
32.6%
22.0% 29.2%29.9%
14.8% 16.3%
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
30.0%
35.0%
FY16 FY17 FY18
CAPA Rate – Global FY16 - FY18
CAPA Rate Libertyville Target Rate
Target30%
Simulated data for illustrative purposes only
Operational Effectiveness – Year over Year
Operational Effectiveness - Irradiation Global (FY16 - FY18)Year
Production Runs
Non-conformances Damages Rereads Complaints
Operational Effectiveness
Target Rate
FY16 153,799 1,205 1,424 1,846 547 96.7% 96%FY17 186,266 1,642 2,407 1,868 961 96.3% 96%FY18 223,145 1,059 3,607 1,785 896 96.7% 96%
Operational Effectiveness - Libertyville North (FY16 - FY18)Year
Production Runs
Non-conformances Damages Rereads Complaints
Operational Effectiveness
Target Rate
FY16 4,610 40 19 42 31 97.1% 96%FY17 4,630 29 12 37 24 97.8% 96%FY18 5,094 35 32 26 30 97.6% 96%
153,799
186,266
223,145
0
50,000
100,000
150,000
200,000
250,000
FY16 FY17 FY18
Production Runs - Irradiation Global FY16 - FY18
Production Runs
96.7% 96.3%96.7%
97.1%
97.8%97.6%
95.0%
95.5%
96.0%
96.5%
97.0%
97.5%
98.0%
98.5%
99.0%
FY16 FY17 FY18
Operational Effectiveness - Irradiation Global FY16 - FY18
Operational Effectiveness Libertyville Target Rate
Simulated data for illustrative purposes only
Target 96%
Performance Reporting Summary
Safety
Reliability
Availability
Effectiveness
CMMI Recommended: STERIS AST Metric:
• Environmental Health & Safety• Employee Health & Safety
• First Pass Yield
• Damages• Customer Feedback
• Operational Effectiveness
Case for Quality
Program PilotCisco Vicenty
Program Manager, Case for Quality
Office of Compliance, CDRH
September 12, 2018
42
www.fda.gov
For Discussion
What’s happening now?
What are we learning?
Changing the status quo
Compliance vs Quality Indicators
Future state
43
www.fda.gov
I appreciated the nonchalant nature of the interviews. I felt that we actually got to discuss how we perform to our processes and this drove discussion on improvements.
What’s happening now?
ApplicationsDiverse product classification mix
Participant results
Qualified32
OUS9
Appraisals
Completed14
US23 In scoping
9
Withdrawn2 Scheduled
8
7Class II
3Class III
5Class I and Class II
12Class II and Class III
2All classes
• Improved clinical trial enrollment
• Improved capability performance
• Improved employee engagement
• Quantifiable value and process improvements
44
Multi-site 3
1Class I
www.fda.gov
What is FDA learning from the data?
45
0%10%20%30%40%50%60%70%80%90%
EST
PLAN
MC
CM
MPM
RDMPQA
GOV
II
PI
TS
Improving the system• New collaborative projects
• Simplify CAPA System• “Safe-space” – solve problems, learn, improve
• Improving measurement and responsiveness
www.fda.gov
Changing the status quo
46
7 Changes10 Days
1 Change28 Days
2 Changes1 Day
1 Change30 Days
• Hesitancy Engagement• Problem solving mindset• New opportunities, collaborative learning, and ideas• Assumptions and reactiveness Understanding and insight
Compliance Audit Maturity Appraisal
DEFENSE VALUE
Least burdensome
Learn
Apply
www.fda.gov
Compliance indicators vs. Quality indicators
47
Early participant indicators
Quality Indicators Details Submitted First Pass Yield • Details of what is monitored
• Three year trends• Annual quality target• Quarterly trend
Financial Damages
Safety • Device and procedure related adverse events in commercial and clinical compared to literature search meta- analysis for similar products and procedures
• Quarterly comparison rates
• NCR– NCR trends– NCR resolution timelines
• CAPAs– Counts open vs. closed vs.
overdue• Field actions open per site• ECO#/turn time• Scrap rate trends (positive
vs. negative trend events)• Projects exceeding planned
timeline• Yield trends (positive vs.
negative trend events)
CAPA ManagementOperational Effectiveness
Quality Domains
Effectiveness • Clinical and registry data compared to hypotheses identified in study plans
• Procedure related adverse events compared to literature search meta-analysis for similar products and procedures for training and IFU effectiveness
• At least annually
Reliability • Accelerated voltage life test• Run down testing on devices returned with remaining battery life• Device adverse events benchmarked against similar product
Availability • Inventory and sales volume by geography• Quarterly with management review
Recent performance indictors submitted
www.fda.gov
On the horizon
Expand appraisal focus to include design and supplier management
Expand streamlined review strategy to design reviews
Enable faster responsiveness and product quality (continuous product quality improvement in 510(k) products)
Year two and beyondStreamline with operational and product quality performance metricsExpand practice areas and capability levelsIntegrate with Product Quality Outcome Analytics
Establish full FDA program
48
www.fda.gov
Information, Engagement, and Collaboration
49• For additional information, enrollment, or
feedback• http://mdic.org/cfq/• http://mdic.org/cfq/enroll/• [email protected]
• Program Updates• http://mdic.org/mdicx/
• Public Workshop• https://www.fda.gov/MedicalDevices/N
ewsEvents/WorkshopsConferences/ucm568069.htm
• Pilot FR Notice• https://www.federalregister.gov/docum
ents/2017/12/28/2017-28044/fostering-medical-innovation-case-for-quality-voluntary-medical-device-manufacturing-and-product
• For any issues or concerns contact• [email protected] or
www.fda.gov
Questions?
50
51www.fda.gov
Thank you
Q&APlease use the chat box feature on Zoom to ask your question
53
Connect with the MDIC Case for Quality
• Upcoming Forums – September 27 http://mdic.org/cfq/register/
• Interested in the pilot? Learn more at: http://mdic.org/cfq/enroll/