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Perseon Corporation Case Study

Climate, Challenges, Data and Solutions

Rick Gaykowski

VP Global Regulatory Affairs

[email protected]

Cognizant Technology Solutions and Perseon Corporation.

mailto:[email protected]

HEALTHCARE PRODUCTS

Healthcare Environment Interactions

2

Investment Financial Partners Customers

OSHA

FDA

SEC

Governing Agencies

EPA

Clinical & Medical

Specialists

Distribution Partners

Legal Counsel Shareholders

& Employees

Strictly private and confidential

Fluid Environment: Data Dynamics

3 Strictly private and confidential

Global regulatory alignment: FDA & Int’l Partners

• Class I Recalls, MD-SAP, Global FDA training

Higher level of oversight:

• R-T-A, De-Novo, Section 515(i)

Enhanced market expectations:

• Risk-based approach

Increased sophistication:

• FDA Guidance, International Standards (ISO 9001:2015, ISO 13485:2016, IEC 4th Edition)

Emerging market alignment:

• FDASIA, UDI 2013/2016, CFDA Oct 2014, JPAL Nov 2014

Fluid Environment: Data Dynamics (con’t)


FDA 3-Year Strategic Priorities

Item Topic Industry Relevant

1 Regulatory Science √

2 Globalization √

3 Safety & Quality √

4 Smart Regulation √

5 Stewardship √

REGULATORY SCIENCE: “…development of tools, processes, and approaches for

achievement of safety, effectiveness, and quality…” (Paraphrase)

Fluid Environment: Data Dynamics (con’t)


FDA Guidance Documents (CDRH)

Year “Draft” Guidance Final Guidance

2016 9 3

2015 23 7

2014 17 4

2013 6 4

R-T-A: ~37% of 510(k)’s returned for inadequacy

• SI percentage within 60-days: ~97.5%

• 510(k) accepted within 90-days: ~98.5%

• Average review cycles: ~1.6

MDUFA III

(MDUFA IV Proposed – QM

Team)

Food, Drug & Cosmetic (FD&C) Industry Snapshot


0 10 20 30 40 50 60 70

Biologics 14.6%

Cosmetics 0.7%

Device 12.5%

Food 28.5%

Drug 43.7%

INDUSTRY SECTORS

642# WL’s issued in 2015

(54/month, ~3/day)

*FDA Enforcement Report, 2/24/2016

144# Recalls in 2016* 33# 483’s in 2016,

through 3/9/2016

15# WL’s issued in

February 2016


Management Responsibility

Management Review

Quality Policy Management

Representative Quality Manual

Production and Process

Controls Training

Corrective and Preventive

Action Quality Audit

Complaint Files

Device Labeling

Document Control

Inspection and Test

Equipment

Environmental Controls

Purchasing Control

Design Control Identification

and Traceability

Device Packaging

Non-conforming

product

Process Change Control

Distribution Handling Storage Design Review

Device History Record

Servicing Device Master

Record Installation

Supplier Evaluation

Label Storage Supplier

Qualification Label Integrity

Design Verification

Design Inputs Design

Outputs Design History

File

Process Validation

Acceptance Status

Design Transfer

Design Changes

Software Validation

Calibration Acceptance

Activities Quality System

Record Servicing Record

Certification to Foreign Govt.

Preventive Maintenance

Recognized International

Standards Technical File

Essential Requirements

Checklist

Quality Planning

Objective Reference

Evidence of Conformity

Contamination Control

Normative Reference

510 (k) Submission

Adverse Event Product Recall Field

Correction

Quality System Certification

Establishment Distribution

UDI and GUDID

Device Listing

Data Dysphoria


Elements of excellence


• Excellence in everything we do, each time, every time

• Execution and ‘Attention to Detail’ orientation

• Upgrade capability with greater strength & experience

• Utilize leading-edge tools without inhibition

I N E S S E N C E , T H E R E S H O U L D B E A D N A C H A N G E

Regulatory Environment


COMPANY

CUSTOMER

GOVERNMENT AGENCIES

Competent Authority Expectations


Subject to global oversight

Required to investigate complaints

Required to review customer feedback for unanticipated trends

Expected to make improvements to

prevent patient harm

Required to report serious events

A Fluid Regulatory Environment…


Global Perspective


FOR GLOBAL REACH… …EACH OF US MUST WEAR

A ‘GLOBAL FACE’


Risk

iden

tifi

cati

on

Management avo

idan

ce

index

resource

analysis

knowledge

event

monitor

imp

lem

enta

tio

n

project re

du

ctio

n

method

con

tro

l

residual

severity

cost

remediation

usability

risk/benefit

Anticipation and Preparation


PLAN

ACT

REVIEW

ASSESS

Time Is Money


Total of Open Complaints Aging

Owner Regulatory Review 0-29 Days New 30-59 Days at Risk Grand Total

Fiber 1 1

OPS QA SLC OBQ 1 1 2

Fiber 4 4

OPS QA YOK Review in Progress 2 2

OBQ 2 1 3

Fiber 27 27

RA Review in Progress 1 1

Safety Complaint 25 42 67

Service Review in Progress 138 2 140

Fiber 2 2

Grand Total 173 76 249

Lumenis Fiscal Week #45 33 34 35 36 37 38 39 40 41 42 43 44 45

Report Week Beginning Date 11-Aug 18-Aug 25-Aug 1-Sep 8-Sep 15-Sep 22-Sep 29-Sep 6-Oct 13-Oct 20-Oct 27-Oct 3-Nov

Report Week Ending Date 17-Aug 24-Aug 31-Aug 7-Sep 14-Sep 21-Sep 28-Sep 5-Oct 12-Oct 19-Oct 26-Oct 2-Nov 9-Nov

13-wk

Average

New Service Complaints 68 60 57 51 65 50 74 64 65 73 60 78 65 64

73.91% 74.07% 59.38% 68.00% 66.33% 67.57% 70.48% 59.81% 63.73% 73.74% 63.16% 71.56% 59.09% 72.93%

New Fiber Complaints 0 6 2 6 4 3 3 9 4 2 2 3 0 3

0.00% 7.41% 2.08% 8.00% 4.08% 4.05% 2.86% 8.41% 3.92% 2.02% 2.11% 2.75% 0.00% 3.87%

New LightSheer Duet Service Complaints 17 8 20 16 20 16 17 15 19 14 26 20 23 18

18.48% 9.88% 20.83% 21.33% 20.41% 21.62% 16.19% 14.02% 18.63% 14.14% 27.37% 18.35% 20.91% 20.30%

New Out of Box Quality Issues 3 0 0 0 0 0 2 3 5 0 2 1 1 1

3.26% 0.00% 0.00% 0.00% 0.00% 0.00% 1.90% 2.80% 4.90% 0.00% 2.11% 0.92% 0.91% 1.49%

New LightSheer Duet Adverse Events 0 0 1 1 4 0 0 0 1 1 0 0 1 1

0.00% 0.00% 1.04% 1.33% 4.08% 0.00% 0.00% 0.00% 0.98% 1.01% 0.00% 0.00% 0.91% 0.79%

New Array LaserLink Complaints 0 0 0 0 0 0 2 4 1 0 0 0 0 1

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 1.90% 3.74% 0.98% 0.00% 0.00% 0.00% 0.00% 0.62%

New LightSheer Desire Complaints 0 1 0 0 2 1 0 0 0 0 0 2 6 6

0.00% 1.23% 0.00% 0.00% 2.04% 1.35% 0.00% 0.00% 0.00% 0.00% 0.00% 1.83% 5.45% 6.85%

New LightSheer Infinity Complaintss 0 2 1 0 0 1 2 0 1 2 1 0 2 1

0.00% 2.47% 1.04% 0.00% 0.00% 1.35% 1.90% 0.00% 0.98% 2.02% 1.05% 0.00% 1.82% 1.05%

New M22 Complaints 4 2 15 0 3 3 5 11 6 7 4 4 11 6

4.35% 2.47% 15.63% 0.00% 3.06% 4.05% 4.76% 10.28% 5.88% 7.07% 4.21% 3.67% 10.00% 6.59%

New ReSurFX Complaints 0 2 0 1 0 0 0 1 0 0 0 1 1 0

0.00% 2.47% 0.00% 1.33% 0.00% 0.00% 0.00% 0.93% 0.00% 0.00% 0.00% 0.92% 0.91% 0.53%

Total New Complaints Received 92 81 96 75 98 74 105 107 102 99 95 109 110 88

96% 91% 83% 99% 95% 93% 93% 89% 93% 91% 95% 94% 82% 100%

Closed Complaints Total 0 0 200 251 396 75 50 128 159 73 93 101 113 126

Remaining Total Open (WIP) 681 729 650 491 217 227 299 279 228 250 256 266 249 371

# Open Complaint-Related CAPA's in TrackWise 0 0 0 0 0 0 0 0 0 0 0 0 0 0

# Complaint Open >60 days 31 31 31 31 31 31 31 34 50 51 53 54 72 41

# Complaints at ACCEPT >30 Days 0 0 0 0 0 0 0 3 0 1 4 10 1 1

# New Adverse Events 2 1 3 3 6 10 1 7 4 6 8 8 8 5

# Open Adverse Event Cases 22 17 13 7 9 19 18 20 16 12 19 19 23 16

# Closed Adverse Event Cases 2 6 7 9 4 0 2 5 8 10 1 8 4 5

Average Age of Open Complaints (Days) 40 54 43 44 60 71 52 56 66 64 65 66 69 58

Average Age of Closed Complaints (Days) 0 0 49 45 25 26 22 17 12 11 13 12 12 19


TRAILBLAZERS NOT REQUIRED!

Basic Fundamental Rules


Stay in-bounds

Use proper and tested equipment

Apply discretion and good judgement

Buddy-system (don’t do it alone)

Proper provisions

Implementation Case Experiences


Different Needs and Expectations


• Notable global complaint activity >750/week

• Interfaces: SAP, Enovia PLM, S-Max, SFDCom

• Significant data migration (>5,000 complaint

records imported)

• Active IT Department oversight

LASER COMPANY Complaint PMS Centric

MW ABLATION COMPANY Business Overview Need

• Small global installed base

• Low complaint rates

• Sales/Installed Base/Trunk Stock/PMS tracking

expectations

• Incorporating Quality Metrics

1

2

Situational Analysis


LASER COMPANY 1 • Cap. Eq/Dispos, large install base

• Class I/II/III portfolio, multiple sectors

• M&A conglomerate, six Notified Bodies

• SW linkage (SAP, Enovia, S-MAX, SFDCom)

• US-only data, moderate growth

• Global compliance sensitivity

• Portfolio expansion

• Data capture, application, utilization

• Establish “Agility-Risk-Compliance” balance

Deployment Highlights


LASER COMPANY 1

Complaints CAPA Reports and

Documentation

FUNCTIONALITIES IMPLEMENTED

• Non-Safety

Complaints

• Safety

Complaints

• Manual & Fiber

Complaints

• Reportability

• Product CAPA

• Process CAPA

• Supplier CAPA

• SCAR/NCMR

• Product

Investigations

• Service

Documentation

• Integrations built with ServiceMax Cases and Work Orders

• MedVantageTM configuration & customization completed

within stipulated timelines

• Minimal to no issues identified during UAT

• Validated the entire instance including IQ and OQ

documentation

• 24x7 Product Support and Assistance is being provided

DEVELOPMENT AND SUPPORT

User Adoption


LASER COMPANY 1

• Over 9,500 complaint records as of December 2015

• Complaints are entered by Communications Centers

in the EU, UK, USA and Japan

• Data sliced by product family, region, with drill down

to specific customers & installed product

• Audit trail documentation of all decisions and

actions

• Electronic storage of all related event documentation

• Valuable global trend data helped improve

product performance across markets

• Accurate picture of unique customer

experiences

• Sales advantage with additional resources

• Compendium of clinical experience data

• Eliminated e-mail table-tennis

BUSINESS BENEFITS

USER ADOPTED PROCESSES

Complaints Count Reports


LASER COMPANY 1

Complaints Status Reports


LASER COMPANY 1

Complaints by Reported Problem Code


LASER COMPANY 1

Complaints Documentation


LASER COMPANY 1

Results


LASER COMPANY 1

Time savings Global complaint database Product performance data

Immediate data availability (cloud-based)

Improved & broadened QMS Analytics

B E T T E R Q U A L I T Y D E C I S I O N S , B E T T E R B U S I N E S S D E C I S I O N S

Situational Analysis


MW ABLATION COMPANY 2 • Operating history of 35-years

• Class III, PMA legacy technology

• Flat/negative growth

• ‘Institutionalized’ QMS – Class III

• Emerging Class II technology for cancer

• Asset divestiture, team-rebuild, QMS re-cast,

• Agility-oriented, data-centric, risk-based,

compliance-driven

Inefficient Data Management


MW ABLATION COMPANY 2

Streamlined Customer Interactions through MedVantageTM



ASSETS

SERVICE

COMPLAINT

TREATMENT

CAPA

MATERIAL BOM

SALES ORDERS

ACCOUNT

Data connectivity


MW ABLATION COMPANY 2 • Customer/User Facility database

• Disposable-accessory sales mix

• Procedure/Case details

• Trunk stock movement

• Install base solidification

• Serialized component BOM data

• Complaints/Investigations/Vigilance

• Service Work Orders

• Product updates based on ECO changes

• CAPA

Performance based data


MW ABLATION COMPANY 2 • Procedures by anatomical area

• Customer adoption, utilization, trends

• Patient outcomes, product performance

• By device

• Complaints by type, product group, Country, severity

• Sales by Region, Country, Rep

• Case planning, inventory allocation & tracking

I N S T A N T L Y S C A L A B L E A N A L Y T I C S

Sales dashboards from MedVantageTM (SFDC)



Product Flow by Territory Region



Disposable Complaints by Reported Problem



Capital Equipment Global Install Base



Sales by Account, Value, Type and Month



Results



Product movement overview Product Quality Performance Sales Rep Performance

Complaint, PMS data Immediately Available

Reporting

B E T T E R Q U A L I T Y D E C I S I O N S , B E T T E R B U S I N E S S D E C I S I O N S

Lessons Learned


Lesson: Share the Vision of “Regulatory Science”


• Ensure key decision-makers understand the reason behind change

• Assure end-users are included in the planning and implementation

• Describe the expectations for improvement

• Process improvement requires change

• Embrace constructive change

Lesson: Document Existing Processes


• Identify areas for improvement and focus on them

• Create a ‘safe environment’, for openness, honesty and creativity

• Capture entire in-situ work flow from start to end

• Broken processes are still processes, they should not be ignored

• Inter-functional connections are essential (OPS-Sales-Cust Service-

QA-Finance-R&D-Adm)

Lesson: Benefits of Proper Codes


• A well designed reported event, cause and remediation codes is essential

• Reported problem codes

• Identified cause codes (HVPS, attenuator, Use Error etc.)

• Action codes (repair, replace, dispose)

• Granularity results in fact based decisions

A N A L Y T I C S P O W E R C O M E S F R O M B E T T E R U S A G E O F C O D E S

Lesson: Horizontal – Vertical Data Application


• Use ‘cockpit/dashboard’ reports to create routine visibility

• Integrate data into leadership meetings for early awareness to avoid surprises

• Efficient feeder into meaningful Management Review

• QSIT/cGMP-QSR/ISO Oriented

• Snapshot, SME development, audit team training

• Effective ‘school-yard’ tool for compliance audits

• Audit-Ready Posture: Unannounced, pre-announced, directed, ad hoc, etc.

• Planning, Inventory flow, traceability, PMS advantages

Legacy Management Review


4 Panel Orientation Approach (Sample)


Issues

Actions/Decisions Risks

Analysis

This section includes facility based metrics such as complaint rates or

audit based metrics such as number non-conformances. Section changes

depending on quality system element being discussed.

This section is typically populated by trends noted from the analysis

section or other business areas of concern.

• Description of Issue #1

• Description of Issue #2

• Actions recommended or implemented to address Issue #1.

• Actions recommended or implemented to address Issue #2.

Risk of Issue #1

Patient Risk, Business Risk, Compliance Risk

Risk of Issue #2

Patient Risk, Business Risk, Compliance Risk

Overall criticality of the parameter

Internal Audits


Issues


Analysis

No issues identified

• All essential elements audited

• Process review & streamlining where applicable

No risks identified

Low Criticality

Goal Result Trend

Total Audits Scheduled 5 5

Total Open Audits 1 1

Total Closed Audits 5 5

% Completed vs Scheduled 100% 100%

Number of Nonconformances 0 0

2015 Post Market Complaints


Issues


Analysis

• Significant Distributor response time for return

• Complaints open over 90 days.

• Proactive Customer Service follow-up

• Improve existing database and trending capability

• Software enhancement initiative

• Regulatory compliance risk

• Lack of data for product improvement

Medium Criticality

Complaint Management Center Goal Result Trend

Aware to Close (Days) 30 Days 77

Number Open Complaints 3 3

Avg Age of Open Compl. <30 Days 55

Adverse Events Received N/A 0

# MDRs Filed Late 0 0

Purchasing Controls/Logistics


Issues


Analysis

• Vendors: Delays resulted from changes in customer expectations.

• Shipments: Customs delays resulting from customer communication issues

• Failure to use customer’s shipping account with carrier.

• Vendors: Better account for time required for approvals and

communication between issuance of PO and delivery date.

• Shipments: Establish better communication channels to clearly

communicate requirements by Custom Offices.

• Retrain personnel to review orders for shipping instructions and

communicate with customer when questions exist.

• Customer satisfaction risk

• Financial risk

Medium Criticality

On-Time Delivery/Issues Goal Result Trend

Vendors 95% 94.8%

Shipments 95% 99%

Issues 95% 98.5%

CAPA


Issues


Analysis

• Timely CAPA completion

• Management Changes

• Resources

• Quarterly CAPA Committee review

• Emphasize Cross-functional review of CAPA’s by CAPA Committee

• Process review & streamlining

• External Audit visibility

• Regulatory Noncompliance Vulnerability

2015 Goal Result Trend

Total Open CAPAs 0 1

CAPA Extension Requests 0 1

CAPA Extensions Closed 0 2

Overdue CAPAs 0 0

CAPAs Deemed Ineffective 0 0

Aging CAPAs (Avg Days @ Phase

Investigative Phase 30 Days 30

CAPA Phase 90 Days 164

Verification Phase 14 Days 14

Low Criticality

QMS Effectiveness


QMS Area Internal Audit Findings External Audit Findings Findings/Open

Design Control 0 0 Risk Management

Internal Audit 0 0 On-Schedule

CAPA 1 0 Closure consistency

Records, Documents, Change Control 1 0 SOP consistency, Comprehensive review

Infrastructure 2 0 Calibration, Pest Control

Work Environment 1 0 No impact on product.

Purchasing 1 0 Drawing consistency

Vendor Control 0 0 Rating & Outsourcing audit frequency

Post-Market Surveillance 0 0 Annual product review, Competition,

Complaint Handling 0 0 Trend details, Regional breakout for EU

Labeling 0 0 Expiry Date: Bar-coding vs. print gaps

Training 0 0 SOP refinement, process overhaul

Perseon Project Dashboard (Illustrative)


Metric Goal

Approved Supplier Listing 100% Cleared

On-Time Delivery per production schedule ≥ 95%

IQA Acceptance Rate ≥92.5%

First Pass Yield (CEA – Probes) ≥ 85%

First Pass Yield (Perseon – Generators) ≥ 80%

Complaint/MDR Rate 2%/0.2%

ECO Incorporation Efficiency < 1 week

Notification of NCMR/CAR issues in CEA Production Within 72 hours

Re-occurrence of closed CAR/SCAR/NCMR issues <5%

SCARS reported for workmanship issues 0

Failure to follow MPI’s/ training 0 Occurrences

Adherence to Quality Plan requirements 100% Compliance

Employee Retention Rate 90%

Summary Scoring Indicators


SECTOR PERSEON - SLC

IQA

Production

Complaints

Internal Audits

External Audits

Supplier Audits

CAPA

Design Control

Staffing/Resources

ECO's

Training

New RA Issues

Calibration

Environmental Control

Preventive Maintenance CEA

Regulatory Submissions

A Real Life Incident…


Air France Flight 4590: Turbojet-powered supersonic jet


World class, cutting edge design…


Heavily researched and intricately developed…


Purported to be the fastest and the safest…


But what happens when things go wrong?


What were the circumstances?


What was the root cause?


• Flight 4590 was loaded 810 kg over limit

• Flight 4590 fuel was unbalanced

• Competitor Airline Mechanic cut corners

• Titanium Strap; not approved for temporary repairs

• Strap not installed properly

• Competitor plane loses strap during take-off

• No FOD walk as required by SOP’s

Summary…


EMPHASIS ON QMS CHECKS

GATHER, ANALYZE AND APPLY MEANINGFUL DATA

USE PROPER AND TESTED TOOL/ EQUIPMENT

APPLY DISCRETION & GOOD JUDGEMENT

BUILD & DEVELOP YOUR TEAM

REQUIREMENT VS. PRUDENT BUSINESS CONDUCT

1 2 3

6 5 4

Thank You
