Medical Device Innovation Consortium - MDICx - Q3 …...2018/09/12  · Medical Device Discovery Appraisal Program MDICx 3 rd Quarterly update: CDRH Case for Quality Pilot Program

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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

[email protected].

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/