MEDICAL DEVICE PACKAGING AS TOLD THROUGH DESIGN CONTROL Jenn Goff Associate Packaging Manager, Stryker Instruments
Bio: Jennifer Goff Graduated from MSU School of Packaging in Dec, 2005 Wyeth Consumer Healthcare Intern, 2004 Work History Edwards Lifesciences, 2006-2012 Packaging Engineer I, Operations Packaging Engineer II, R&D Packaging Laboratory Supervisor Sr. Packaging Engineer, R&D Sr. Quality Engineer, Operations Stryker Corporation, 2012 present Staff Engineer, R&D Associate Packaging Manager, Instruments
Agenda Legal Why this presentation? Control Requirements Risk and Sample Size Recommendations/Takeaways Questions
Legal The views and opinions expressed in this presentation are those of the presenter and do not necessarily reflect the official policy or position of Stryker Corporation or its affiliates.
Why is this presentation important? Packaging resource pulled in after device is mostly designed R&D just put it in a pouch and a box Add value to the overall user experience and in some cases, create a competitive advantage in the marketplace. Understand the impact proposed changes can make.
What are Controls? controls are in place to require manufactures of medical devices to maintain procedures to control the design of the device in order to ensure that specified design requirements are met.
Control: FDA CFR21.8.820 and Development Planning Validation Transfer Input Verification Changes Output Review
Control: FDA CFR21.8.820 Reference: Control Guidance for Medical Device Manufacturers, FDA Center for Devices and Radiological Health
Control and Package Development and Development Planning Project Plan (charter) Cost for Packaging development Packaging Roles and Responsibilities Responsible/Accountable/Consulted/Informed Understand scope of project (commodity vs innovative) Understand regulatory strategy and potential impact to device packaging (environmental compliance, timeline strategy, clinical trials) and Development Planning Validation Transfer Input Output Verification Review Changes and Development Planning
Control and Package Development Input User Needs User Needs/Intended Use: Where to get this information? Consider user and the patient. VOC Consider if package is part of the procedure Customer complaints Empathic and Development Planning Input Validation Verification Transfer Changes Input Output Review
Control and Package Development Input User Needs User Need Device to remain protected through expiration date at point of use. Device to remain sterile through expiration date at point of use. Package to allow ease of aseptic transfer. Package to retain and organize used device components during procedure. Device size needs to be clearly identifiable with other sized devices. Package to be stored on hanging rack. Source (Complaints/VOC) Empathic Empathic VOC
Control and Package Development Input Inputs/Requirements Document Device protection Geometric/mass/fragility challenges Sterilization method Biocompatibility Distribution plan Countries Storing/shipping methods Product configuration Labeling requirements and Development Planning Input Validation Verification Transfer Changes Input Output Review
Control and Package Development Input User Need Source Input Device to remain protected through expiration date at point of use. Device to remain sterile through expiration date at point of use. Device to remain functional post transportation and storage testing. Package to allow ease of aseptic transfer by means of picking method. (Complaints/VOC) Package to retain and organize used device components during procedure. Device size needs to be clearly identifiable with other sized devices. Package to be stored on hanging rack. Empathic Empathic VOC
Control and Package Development Input User Need Source Input Device to remain protected through expiration date at point of use. Device to remain sterile through expiration date at point of use. Device to remain functional post transportation and storage testing. Package to generate a sterile barrier around the device for a three year shelf life. Package to allow ease of aseptic transfer by means of picking method. (Complaints/VOC) Package to retain and organize used device components during procedure. Device size needs to be clearly identifiable with other sized devices. Package to be stored on hanging rack. Empathic Empathic VOC
Control and Package Development Input User Need Source Input Device to remain protected through expiration date at point of use. Device to remain sterile through expiration date at point of use. Package to allow ease of aseptic transfer by means of picking method. (Complaints/VOC) Device to remain functional post transportation and storage testing. Package to generate a sterile barrier around the device for a three year shelf life. Package materials must allow device sterilization by means of ETO. Package to retain and organize used device components during procedure. Device size needs to be clearly identifiable with other sized devices. Package to be stored on hanging rack. Empathic Empathic VOC
Control and Package Development Input User Need Source Input Device to remain protected through expiration date at point of use. Device to remain sterile through expiration date at point of use. Package to allow ease of aseptic transfer by means of picking method. (Complaints/VOC) Device to remain functional post transportation and storage testing. Package to generate a sterile barrier around the device for a three year shelf life. Package materials must allow device sterilization by means of ETO. Package to have a double sterile barrier. Package to retain and organize used device components during procedure. Device size needs to be clearly identifiable with other sized devices. Package to be stored on hanging rack. Empathic Empathic VOC
Control and Package Development Input User Need Source Input Device to remain protected through expiration date at point of use. Device to remain sterile through expiration date at point of use. Package to allow ease of aseptic transfer by means of picking method. (Complaints/VOC) Device to remain functional post transportation and storage testing. Package to generate a sterile barrier around the device for a three year shelf life. Package materials must allow device sterilization by means of ETO. Package to have a double sterile barrier. Inner sterile barrier to be a rigid tray with ribbed corners. Package to retain and organize used device components during procedure. Device size needs to be clearly identifiable with other sized devices. Package to be stored on hanging rack. Empathic Empathic VOC
Control and Package Development Input User Need Source Input Device to remain protected through expiration date at point of use. Device to remain sterile through expiration date at point of use. Package to allow ease of aseptic transfer by means of picking method. Package to retain and organize used device components during procedure. Device size needs to be clearly identifiable with other sized devices. Package to be stored on hanging rack. (Complaints/VOC) Empathic Empathic VOC Device to remain functional post transportation and storage testing. Package to generate a sterile barrier around the device for a three year shelf life. Package materials must allow device sterilization by means of ETO. Package to have a double sterile barrier. Inner sterile barrier to be a rigid tray with ribbed corners. Outer sterile barrier to be a flexible pouch with a chevron seal.
Control and Package Development Input User Need Source Input Device to remain protected through expiration date at point of use. Device to remain sterile through expiration date at point of use. Package to allow ease of aseptic transfer by means of picking method. Package to retain and organize used device components during procedure. Device size needs to be clearly identifiable with other sized devices. Package to be stored on hanging rack. (Complaints/VOC) Empathic Empathic VOC Device to remain functional post transportation and storage testing. Package to generate a sterile barrier around the device for a three year shelf life. Package materials must allow device sterilization by means of ETO. Package to have a double sterile barrier. Inner sterile barrier to have ribbed corners for ease of opening. Outer sterile barrier to be a flexible pouch with a chevron seal. Package to be rigid tray design with identifiable cavities for used devices.
Control and Package Development Input User Need Source Input Device to remain protected through expiration date at point of use. Device to remain sterile through expiration date at point of use. Package to allow ease of aseptic transfer by means of picking method. Package to retain and organize used device components during procedure. Device size needs to be clearly identifiable with other sized devices. Package to be stored on hanging rack. (Complaints/VOC) Empathic Empathic VOC Device to remain functional post transportation and storage testing. Package to generate a sterile barrier around the device for a three year shelf life. Package materials must allow device sterilization by means of ETO. Package to have a double sterile barrier. Inner sterile barrier to have ribbed corners for ease of opening. Outer sterile barrier to be a flexible pouch with a chevron seal. Package to be rigid tray design with identifiable cavities for used devices. Package label to have color coding of compatible sized devices used during procedure.
Control and Package Development Input User Need Source Input Device to remain protected through expiration date at point of use. Device to remain sterile through expiration date at point of use. Package to allow ease of aseptic transfer by means of picking method. Package to retain and organize used device components during procedure. Device size needs to be clearly identifiable with other sized devices. (Complaints/VOC) Empathic Empathic Device to remain functional post transportation and storage testing. Package to generate a sterile barrier around the device for a three year shelf life. Package materials must allow device sterilization by means of ETO. Package to have a double sterile barrier. Inner sterile barrier to have ribbed corners for ease of opening. Outer sterile barrier to be a flexible pouch with a chevron seal. Package to be rigid tray design with identifiable cavities for used devices. Package label to have color coding of compatible sized devices used during procedure. Package to be stored on hanging rack. VOC Outer sterile barrier to have hang hole for standard OR racking system.
Control and Package Development Input Initial evaluation of Risk As the design evolves, new risks may become evident CAUTION inputs should be specific, but also need to be verified/validated therefore use caution when determining specifications or tolerances Required vs Nice to Have and Development Planning Input Validation Verification Transfer Changes Input Output Review
Control and Package Development Output The results of a design effort The finished design output is the basis for the device master record. 1 and Development Planning Input Validation Verification Transfer Changes Output Output Review 1 Control Guidance for Medical Device Manufacturers, FDA Center for Devices and Radiological Health
Control and Package Development Output Specifications Minimum peel force Critical quality attributes Standards/Test results ASTM Test Methods Internal procedures Drawings and Development Planning Input Validation Verification Transfer Changes Output Output Review
Control and Package Development Output User Need Source Input Output Device to remain protected through expiration date at point of use. Device to remain sterile through expiration date at point of use. Package to allow ease of aseptic transfer by means of picking method. Package to retain and organize used device components during procedure. Device size needs to be clearly identifiable with other sized devices. Package to be stored on hanging rack. (Complaints/V OC) Empathic Empathic VOC Device to remain functional post transportation and storage testing. Package to generate a sterile barrier around the device for a three year shelf life. Package materials must allow device sterilization by means of ETO. Package to have a double sterile barrier. Inner sterile barrier to have ribbed corners for ease of opening. Outer sterile barrier to be a flexible pouch with a chevron seal. Package to be rigid tray design with identifiable cavities for used devices. Package label to have color coding of compatible sized devices used during procedure. Outer sterile barrier to have hang hole for standard OR racking system. Packaging Drawing BOM Packaging Drawing/Specification BOM/Packaging Drawing Packaging Drawing Packaging Drawing Packaging Drawing Labeling Artwork Packaging Drawing
Control and Package Development Review Concept reviews Validation strategy reviews Which method s were chosen and why Sample size rationale Manufacturing strategy reviews Make/buy decisions Testing anomalies/failure and root cause reviews and Development Planning Input Validation Verification Transfer Changes Review Output Review
Control and Package Development Verification Verification: method in which you confirm the specified requirements can be consistently fulfilled Which methods chose and why? and Development Planning Input Validation Verification Transfer Changes Verification Output Review
Control and Package Development Validation Validation: method in which you confirm the design meets the user need/intended use. Partner with Marketing Ask the right questions the right way. Avoid asking open ended questions in this stage and Development Planning Input Validation Verification Transfer Changes Validation Output Review
Control and Package Development Verification User Need Source Input Output Verification/Validation Device to remain protected through expiration date at point of use. Device to remain functional post transportation and storage testing. BOM Verification: Device functionality protocol and report Device to remain sterile through expiration date at point of use. Package to generate a sterile barrier around the device for a three year shelf life. BOM Verification: Packaging protocol and report Package materials must allow device sterilization by means of ETO. Packaging Drawing/Specification Verification: Sterilization protocol and report Package to allow ease of aseptic transfer by means of picking method. (Complaints /VOC) Package to have a double sterile barrier. Inner sterile barrier to have ribbed corners for ease of opening. BOM/Packaging Drawing Packaging Drawing Verification: Packaging protocol and report Verification: Packaging protocol and report Outer sterile barrier to be a flexible pouch with a chevron seal. Packaging Drawing Verification: Packaging protocol and report Package to retain and organize used device components during procedure. Empathic Package to be rigid tray design with identifiable cavities for used devices. Packaging Drawing Verification and Validation Device size needs to be clearly identifiable with other sized devices. Empathic Package label to have color coding of compatible sized devices used during procedure. Labeling Artwork Validation: Marketing survey Package to be stored on hanging rack. VOC Outer sterile barrier to have hang hole for standard OR racking system. Packaging Drawing Validation: Marketing survey
Control and Package Development Transfer Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications 2 Do packaging procedures convey exactly how to package the product? Configuration Photos Clear instructions In process specifications/monitoring and Development Planning Input Validation Verification Transfer Changes Transfer Output Review 2 Control Guidance for Medical Device Manufacturers, FDA Center for Devices and Radiological Health
Control and Package Development Changes and Development Planning Input Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation. 3 control documentation to be rev controlled. Tell the story. Ensure Packaging is evaluating Device changes Understand how proposed changes impact the overall project Time Cost Resource Validation Verification Transfer Changes Changes Output Review 3 Control Guidance for Medical Device Manufacturers, FDA Center for Devices and Radiological Health
Risk and Sample Size Considerations Severity Classification of the device Implant vs disposable Occurrence Rate Risk Management File or FMEA Clinical Expertise Marketing/Sales input
Control Takeaways Get involved with your project teams early Push instead of getting pulled Provide input/review design control documentation Get inspired Articles Other industries Team building
Control and Package Development