Understanding the Needs of the Medical Device Client...

Understanding the Needs of theMedical Device Client Bonnie Norman, Director

Quality Assurance & Regulatory Affairs

© Intel-GE Care Innovations LLC. All rights reserved. *All other third-party trademarks referenced herein belong to their respective owners.

21 CFR Part 820

820.1 Scope

Governs the methods, facilities and controls used for:• design• manufacture• packaging• labeling• storage• installation• service

of all finished devices intended for human use.

Safe & efficaciousproduct


Regulatory Landscape

• Class I, II, III Devices

• FDA Authority• Inspections• Warning Letters• Civil Penalties• Injunctions• Consent Decrees

• Are you supplying a Critical Component?

• Agreements


Things to consider – putting those customer requests into context:

• The device manufacturer is responsible for determining risk associated with component failure.

• Objective evidence must be on file of appropriate level of testing.

• The device manufacturer is responsible for determining intended use of the product and placing on the market - they cannot ‘not know’ what is in that product.

• Doesn’t mean you lose IP rights.• It DOES mean your applicable processes and controls will likely

be audited by the device manufacturer.

• Records and evidence.


Understanding the Medical Device Client Needs

• Risk, Verification, and Validation• Audits, What to Expect• Records & Evidence

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DEFINEDUSER NEEDS

SPECIFICATION

PRODUCT

Translation of RequirementsClinicalData

MarketData

UserStudies

MDRsComplaints


“Status of device may be determined from 20’ under normal

hospital lighting.”

DEFINED USER NEEDS

SPECIFICATION

“LED capable of displaying2 lines of characters, 1/2”high, 12 characters/line.”

OUTPUT (Component/Product)

“Acme MedicalPN 231A”


VERIFICATION examines the subsystems of a design for robustness and correctness against the specification.

“Status of device may be determined from 20’ under normal hospital lighting.”

DEFINED USER NEEDS

SPECIFICATION“LED capable of displaying2 lines of characters, 1/2”high, 12 characters/line.”




DESIGN VALIDATION measures the correctness of the finished device for its intended use, including the interactions between the verified subsystems.

“Status of device may be determined from 20’ under normal hospital lighting.”

DEFINED USER NEEDS

SPECIFICATION“LED capable of displaying2 lines of characters, 1/2”high, 12 characters/line.”



© Intel-GE Care Innovations LLC. All rights reserved. *All other third-party trademarks referenced herein belong to their respective owners. 5/9/2011

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Verification Requirements

• Establish and maintain procedures• Verify the device design• Confirm that design output meets design input requirements• Document result in Design History File

• Identification• Date• Methods• Individual(s)

© Intel-GE Care Innovations LLC. All rights reserved. *All other third-party trademarks referenced herein belong to their respective owners. 5/9/2011

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Design Validation Requirements

• Establish and maintain procedures• Validate the device design• Perform under defined operating conditions• Ensure conformance to user needs

• Test production units (or equivalent) under actual or simulated use conditions

• Include software validation and risk analysis, where appropriate• Document result in Design History File

• Identification• Date• Methods• Individual(s)


Basing V&V Activities on Risk

Power supply for a home ventilator, Class III device (Risk of serious injury or death)

Low risk = verification: review of manufacturer’s specificationvalidation: functionality confirmed during other

validation tests

In addition to design response,High risk = verification: confirm backup, reliability data,

boundary condition testing, environmental testing, etc.

validation: long-term reliability, clinical trials, etc.

- Validate that power supply meets requirements- Same requirement (supply continuous power)- Risk level identifies “how much” objective evidence is required

Power supply for diagnostic lab equipment, Class II device (Risk of lost test)


Winning the Business:

• Verification Package• Specification• Sample test protocols• Expected performance results

• You should not supply final verification• Intended use is in hands of manufacturer• You cannot predict interaction with other components

• Understand historical adverse events related to similar components


Adverse event reporting

• FDA maintains a searchable database of adverse events

• Manufacturer and User Facility Device Experience (MAUDE)

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm



• Risk, Verification, and Validation• Audits, What to Expect• Records & Evidence


Supplier Audits

• 21 CFR 820.50: Each manufacturer shall …

• Ensure product and services conform to specified requirements,• Maintain the quality requirements that must be met• Evaluate and select suppliers on their ability to meet quality

requirements

• This does NOT mean you must meet all quality system requirements• Supplier evaluation may or may not require an on-site visit

• Criticality of component• Quality history• Custom component


Audits – Expectations

• Client should define audit scope prior to visit• If available, send in advance

• Quality Manual• SOPs related to areas they will be auditing• Org chart

• Audit should typically be one day and not exceed 2 days for most component suppliers

What YOU should ask for:• Identified risk associated with your component• Finished device description


What if I don’t have requested quality documentation?

• Put together a quality plan for the client, demonstrating how you meet the quality requirements:

• Description of quality requirement (such as training)• Owner• Your process• Where evidence of meeting requirement will be kept


Winning the business:

• Professional interaction prior to audit (show how prepared you are)• Ask for clarification of terms – don’t assume their definition is the

same• Don’t throw out terminology like ‘FDA-approved components’• Consider further education in this area (AAMI supplies recognized

quality training in this area)• Join local groups, such as RAPS• Respond to any audit findings promptly with information regarding

finding closure – including preventive action



• Risk, Verification, and Validation• Audits, What to Expect• Records & evidence


Summary

• Medical device manufacturers are regulated both in the US and internationally

• You are not selling just a component, you are selling a component that is part of a regulated system

• Anything you can do to lessen their overhead will be a competitive differentiator

Helpful Links:• Medical Devices: http://www.fda.gov/MedicalDevices/default.htm

• Device Advice: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm

• Warning Letters: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

• Adverse Events database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

Understanding the Needs of the Medical Device Client...

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