meeting regulatory compliance with integrated complaints management … · 2016. 3. 15. · meeting...

Meeting Regulatory Compliance with

Integrated Complaints Management

Solutions For Small Consumer Business

Bobae Kim

Chief Technology Officer

[email protected]

@iluminage

Iluminage Beauty Inc.

mailto:[email protected]

Iluminage Beauty Syneron-Candela & Unilever Ventures

A growing collaboration built upon strong industry foundations

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• Joint venture: Forging experts in consumer branding with professional

aesthetic technology to bring high end, beauty devices and solutions to the

home user

• Recently established (2014): Headquarters at New York with additional

global locations included within the expansion model

• Expanded consumer retail environment: Via department stores, .com

ventures, home shopping and distribution models in smaller global markets

• Internal customer support department: Encourage troubleshooting,

complaints and claims reporting to the Company

• Low risk beauty devices: Burden of regulatory compliance as medical device

under Quality Management Systems

Strictly Private and Confidential

Regulatory Trends in the US

Home Use Devices: Home Health Care Sector

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• Increasing attention on home use devices by regulators

• Increase public awareness regarding home use devices

• New requirements and guidance on design considerations

• Design Considerations for Devices Intended for Home Use: Guidance for Industry and FDA Staff (Nov 24, 2014)

• Labeling Repository: Home Use Device Labeling Pilot Program (April 17, 2015)


• SGS Gateway

• Electronic reporting requirements

• UDIs and Data Analytics – GUDID Database

ELECTRONIC SYSTEMS

Challenges of Managing Consumer Complaints

Impacts customer satisfaction and lack of holistic regulatory compliance

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• Broad regulatory definition of “complaints”

• Over reporting by consumer

• Business complaint and Compensation driven

• High percent of false reporting or lost to follow up

• Convergence of consumer health market with traditional healthcare

• Data explosion from Protected Health Information (PHI) that are arising from a surge in the number of devices

available collecting patient data such as wearable devices

• Burden of collecting, assessing, evaluating, investigating ALL consumers’ and retailer’s complaints as per regulatory

requirements

• Time sensitive reporting and assessments required with limited human resource available

• Wide and diverse range of product offerings

• Reporting requirements to multiple global regulatory authorities

• Cloud based applications focus on security, control, accountability and communication


Complaints Processing

Manual Processing across the workflow

INVESTIGATION AND FOLLOW UP

INCOMING COMPLAINT

TRIAGED FOR QA/RA

EVALUATION OF REPORTABILITY

DOCUMENTATION APPROVALS FILING TRENDING

CRM Database - SalesForce

CRM Database- SalesForce

Manual Report (WORD DOC)



Wet Inked Signatures

Manual Filing Manual Data

Collection (CRM + Logs)

Automation of manual processes

Establish traceability and audit trails at each level

Meet regulatory

requirements

Problem Statements

5 Strictly Private and Confidential

Advantages of electronic complaint management system (eCMS)

Streamlined and seamlessly integrated

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Cost effective/

ROI

Expandable model (global)

Regulatory compliance

Accessible and usable

Customize business needs

SFDC plug in (Cloud/Data/

Analytics)

• Potential to expand to other global sites

• Various modules available: Returns Management, CAPA, etc

• Continues upgrades and patches (eMDR and Device Registration)


Post-implementation

Automated process workflow

INVESTIGATION AND FOLLOW UP

INCOMING COMPLAINT

TRIAGED FOR QA/RA

EVALUATION OF REPORTABILITY

DOCUMENTATION APPROVALS FILING TRENDING

CRM Database - SalesForce

CRM Database- SalesForce

eCMS Automated & Handled Manual Data

Collection (CRM + Logs)

Regulatory compliant, highly productive and improved

business/ process efficiencies

Significant reduction to labor costs through bottleneck elimination of manual reporting,

updating and signing

Improved customer service because of expandable platform along with quick financial savings in

software costs alone


eCMS - Dashboards

Live dashboards: Fast visual representation of data

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By Country

By Status


Complaint Investigation

Complete tracking of the investigation status


Evaluation of the Reportability

Pre-defined workflows based on FDA and EU regulatory requirements


ROI Labor-cost analysis

Significant savings in time and effort

Without eCMS ($) With eCMS ($)

Including Monthly Subscription Costs

Savings ($)

Monthly Annually Monthly Annually Monthly Annually

Complaints Processing: Coordinator Follow Up and Investigation

$ 1666.67 $20000.00 $446.67 $5360.00 $-1220.00 $-14640.00

Complaints Approval: Manager's Review and Approval

$3333.33 $40000.00 $863.33 $10360.00 $-2470.00 $-29640.00

Total Departmental: Labor Costs $5000.00 $60000.00 $1310.00 $15720.00 $-3690.00 $-44280.00

• Average number of complaints/month is 40 cases

• Average processing time is 10 minutes/case without eCMS, 25% of the time with eCMS automation

• Average hourly wage of coordinator and manager is $25 and $50 respectively

• Does not include cost of eCMS SW and Deployment


Considerations and lessons learned

A long term approach in addition to addressing current gaps


UNDERSTAND YOUR CURRENT

AND FUTURE NEEDS

Type of customer, volume of complaints,

level of engagement (internal/

contractors) and business tools IDENTIFY ANY GAPS AND

THEIR COMPLIANCE RISK

Inefficiencies, work method, tools

EVALUATE POTENTIAL SOLUTIONS

eCMS platforms,

processes, personnel

EXECUTE

RE-EVALUATE

Perform in-depth analysis

to optimize matching

business needs and tool

capabilities


Thank You

Bobae Kim Chief Technology Officer [email protected] @iluminage

March 2016

mailto:[email protected]

meeting regulatory compliance with integrated complaints management … · 2016. 3. 15. · meeting...

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