Slide 1 of 33 Rob Packard, President [email protected] Combining Product Risk Management & Design...

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Rob Packard, Presidentwww.MedicalDeviceAcademy.com

[email protected]

Combining Product Risk Management &

Design Controls

ISO14971

ISO 13485,

Clause 7.3

http://www.medicaldeviceacademy.com/

mailto:[email protected]

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Design Controls

User Needs

Design Input

DesignProcess

DesignO utput

M edica lDevice

VALIDAT IO N

VERIFICAT IO N

REVIEW

“Waterfall Diagram”

• 820.30h) – Design Transfer• 820.30j) – Design History File (DHF)

QSIT Major Subsystem



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Two Hump Diagram

DHFBegins

ProductLaunch510(k)

DR



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Two Hump Diagram+ Typical Stages of Design

DHFBegins

ProductLaunch510(k)

Design Transfer

ConceptPhase

FeasibilityPhase

DevelopmentPhase

PilotPhase

ReleasePhase

DR



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When to Start a DHF?• After the design plan has been developed

• Upon approval of the design project

• It’s not uncommon to start a DHF late and to retroactively assemble the file from documents that were already created in team meetings.



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DHF Contents• Design Plan• User Needs• Design Inputs• Design Outputs – including labeling• Verification Protocols & Reports• Validation Protocols & Reports• Process Validation & work instructions• Design Review Meeting Minutes• IOVV / Design Requirements Matrix• Risk Management File• Initial PMS Plan• Clinical Data Summary and/or Clinical Evaluation Report• Initial DMR/TF Index• Regulatory Approval

Organize Chronologicall

y



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5 or 6 Phase Gates

1. 7.3.1 – Design Plan Approval

2. 7.3.2 – Design Inputs Approval

3. 7.3.3 – Design Outputs Approval

4. 7.3.5 & 7.3.6 / 1st in Humans Study Approval

5. Pilot Launch Approval

6. Commercial Launch Approval

Each Gate is a Design Review Meeting

Clause 7.4

ISO 13485 Clauses Referenced



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Design Reviews• ISO 13485, Clause 7.3.4• Reviews shall…

– Be systematic and according to design plan– Evaluate ability of design & development to meet

requirements– Identify problems and propose necessary actions– Include participants representing various functions of the

design team from that stage– Results and necessary actions shall be recorded– Include a reviewer not involved in that stage (21 CFR

820.30e)



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Design Planning• ISO 13485, Clause 7.3.1• The plan shall…

– Define stages of design & development– Define the review, verification, validation & transfer

activities for each stage– Define responsibilities & authorities

• Management shall manage interfaces• Document planning output and update as

needed

ConceptPhase



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Design Inputs

User Need Typical Design Input Better Design Input

Biocompatible Material = Teflon ISO 10993-1

Easy to Use Pictorial User Interface IEC 62366-1

Won't Puncture Nylon Reinforced Pouch ISTA 2A

Connects with Monitor RS232 Connection Protocol P123



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Input OutputVerification Validation

item User Needs Design Inputs Design Outputs Verification Test Method Validation Test Method 12345678910

Also called a Design Requirements Matrix



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Risk Management / Design Controls

• Clause 7.3.2e) of ISO 13485 states that Risk management shall be an Input into Design & Development

• Clause 6.3 of ISO 14971 requires verification of effectiveness of risk controls

• Clause 6.7 of ISO 14971 requires verification of completeness of risk controls



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Risk Management FileISO 14971, Clause 3.5 • File for each medical device • The risk management file shall provide

traceability for each identified hazard to:– the risk analysis– the risk evaluation– the implementation and verification of the risk control

measures– the assessment of the acceptability of any residual

risk(s)



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Risk Management Activities Needed

• Risk Management Plan• Hazard Identification• Risk Assessment• Risk Control Option Analysis• Risk Control Effectiveness Verification• Risk / Benefit Analysis• Risk Management Report



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Risk Management PlanISO 14971, Clause 3.4 (See Annex F for Example)• The plan shall include at least the following:

– the scope of the planned risk management activities, identifying and describing the medical device and the life-cycle phases for which each element of the plan is applicable

– assignment of responsibilities and authorities– requirements for review of risk management activities– criteria for risk acceptability, based on the manufacturer's policy for determining acceptable risk,

including criteria for accepting risks when the probability of occurrence of harm cannot be estimated

– verification activities– activities related to collection and review of relevant production and post-production information

• For each risk management plan the manufacturer should choose appropriate risk acceptability criteria

– May implement a matrix indicating which combinations of probability of harm and severity of harm are acceptable or unacceptable

• The risk management plan is part of the risk management file– Record of the changes shall be maintained in the risk management file



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Hazard IdentificationISO 14971, Clause 4.3• Documentation on known and foreseeable

hazards associated with the medical device in both normal and fault conditions

• Maintained in the risk management file• Annex C, Annex E, Previous Risk Analysis & TPLC

Database (http://bit.ly/FDATPLC)



http://bit.ly/FDATPLC

http://bit.ly/FDATPLC

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Risk Assessment ToolsISO 14971, Annex G • Preliminary Hazard Analysis• Fault Tree Analysis (FTA)• Failure Mode & Effects Analysis (FMEA)• Hazard & Operability Study (HAZOP)• Hazard Analysis and Critical Control Point

(HACCP)



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dFMEA

Function / ItemPotential Failure

ModePotential Failure

Effects

Severity

Probability

of Occurrence

Current Risk Controls

Verification Method

RPN

(

SxO

)

Planned Actions Assigned toUpdated Risk

Controls

Updated S

Updated O

Re-

verification

Method

Updated RPN

Cutting / Spring

Internal spring does not product adequate needle set.

Surgeon not able to cut and remove vitreous in order to allow proper access to retina for repair.

2 3

Specifiction for internal spring force.

Bench testing of parts outside design specification.

6 0

Cutting / Spring

Spring does not allow full closure of cutting port.


2 3

Specification for intenral spring maximum length.


6 0

Cutting / Spring

Spring does not fully open cutting port.


2 3

Specification for intenral spring minimum length.


6 0

Aspiration / Tubing

Vitreous is pulled into cutting port too quickly.

Elevated aspiration rate.

2 3

Specification for aspiration tubing inner diameter.


6 0

Aspiration / O-ring and Tubing

Interface

O-ring does not seal propertly.

Insufficient aspiration rate.

2 3

Specification o-ring and tubing outer diameter.


6 0



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Problems with dFMEA• Bottom-up approach doesn’t facilitate complaint

investigations• RPN scores encourage prioritization of risk

controls that deviates from MDD (EN ISO 14971:2012)

• No traceability to specific IFU Warnings & Precautions



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Traceability of Risks

http://imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n15r8-risk-management-principles-qms-050520.pdf






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Integration ofRisk Activities with Design Phases

DHFBegins

ProductLaunch510(k)

Design Transfer

ConceptPhase

FeasibilityPhase

DevelopmentPhase

PilotPhase

ReleasePhase

HazardIdentification

Risk ControlOption Analysis

RiskAssessment

Risk ControlEffectivenessVerification

RiskManagement

Plan

Risk / BenefitAnalysis

Risk ManagementReport

DR



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Starting the Lifecycle Loop

ClinicalEvaluation

Post-Market Surveillance

RiskAnalysis

Initial Risk Analysis Estimates Frequency of Occurrence for Hazards

Post-Market Surveillance (PMS) Report Estimates

Frequency of Harm

Clinical Evaluation Report (CER) Assesses

the Clinical Risk/Benefit of the New Product



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Combined IOVV & Risk Traceability

Item No.

User NeedHazard Identified

Design Input

Risk Control Method(s)

Severity of Harm

Probability of Occurrence (P1)

Design Output

Verification Reference (Protocol/Report)

Validation Reference (Protocol/Report)

Probability of Occurrence Resulting in Harm (P2)

Residual Risk in IFU

PMCF Study (Protocol/Report)

123456789101112

http://medicaldeviceacademy.com/design-control-proceduresforms/





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Initiating Combined Matrix• Perform Hazard Identification• Work Backward to User Needs• Fill in 1st Two Columns• These are the first steps of the design process

that often lead up to creating a Regulatory Pathway Summary Document & Design / Risk Management Plan



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Preparation forApproval of Design Inputs

• Identify Applicable Harmonized Standards• Identify Performance Testing

– Predicate Devices 510(k) Summary– Special Controls Guidance Documents– Search ISO Standards– Are their internal specifications?



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Perform Risk Assessment• Identify Possible Risk Control Methods• Severity of Harm• Probability of Occurrence (P1)• Preliminary Screening against Design Inputs• Reiterate Risk Controls & Design Specifications• Finalize Design Specifications (Approve Outputs)



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V&V• Verification of Risk Control Effectiveness• Preliminary Estimation of P2 based upon

literature (Need to perform literature search…Clinical Evaluation Report)

• Results of Clinical Evaluation and Risk / Benefit Analysis should determine:– if Clinical Study is Needed– If Post-Market Clinical Follow-up Study is Needed



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Draft IFU• Identify Residual Risks

– Warnings– Precautions– Contraindications

• This is critical for Adverse Events, Investigator Brochures and Litigation of Injuries or Death



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Draft PMS Plan• Post-Market Surveillance (PMS) Plan

– Needs to collect data for any residual risks– Should verify estimated risks– Should identify any missing hazards– Should identify incorrect severity of harm– Should include justification of no PMCF Study or…

• PMCF Protocol• PMCF Report

– Should include updated Risk Management Plan



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Risk Management Report• This is a Summary Technical Document (STED)

that summarizes all the risk management activities and references the document control numbers for the Risk Management Documents

• This should also include the dates of activities and personnel involved

• The frequency of review and update of the risk management documentation should be included



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Other Training Webinars

http://medicaldeviceacademy.com/implementing-risk-management-process-compliant-iso-149712007-address-seven-deviations-identified-en-iso-149712012/

http://medicaldeviceacademy.com/design-controls-implementation-21-cfr-820-30/

User Needs

Design Input

DesignProcess

DesignO utput

M edica lDevice

VALIDAT IO N

VERIFICAT IO N

REVIEW












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Q & A

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Do You Need Help with Design Controls or Risk Management?

Rob Packard

[email protected]

+1.802.281.4381

rob13485



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