PRODUCT DEVELOPMENT PROCESS

TECH TRANSFER PROCESS

Project Management

With Biomerics as your product development partner, we take personal responsibility for the success of your project. We assign each new project a project manager who facilitates regular communication as your single point of contact, driving project execution to committed timelines, and assuring project deliverables are met with the shared goal of developing a manufacturable product that achieves your business objective and provides value to your customers.

Our customers can be confident that our systematic product development process integrates consistent progress reports, regular communication, and transparency at all levels of the process. We take your project and our role as your development partner very seriously, and want you to know you are in good hands. We will work with you to ensure projects move forward with speed, accuracy, and efficiency. We take pride in following three critical pillars for project success.

  1. Following the Biomerics Design & Development Process
  2. Incorporating Project Management best practices
  3. Maintaining impeccable ethical values and behavior

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CONCEPT
Purpose

Transform an idea, thought, or sketch into a design with a working and functioning prototype that mimics the intended device and prospective use in the market.

High-Level Outputs
  • Execute agreements and open DHF
  • Concept Development ideas in Place
  • Prototyping & performance testing initiated
  • Project teams assess the manufacturability of a concept device
  • Cost modeling scenarios completed
  • DFMEA assessment in progress
Result

Concept Prototypes are constructed and reviewed before moving on to the next step.

Recurs During Concept & Feasibility

Design For Manufacturing
Purpose

Provides design considerations to determine if the device can be manufactured in low and high volumes, while maintaining high-quality products consistently, with the end goal to make better products at a lower cost.

High-Level Outputs
  • Meets Required Quality and Cost Targets
  • Assembly Line Configured and Prepared
  • Creates a Process for FMEA
  • Update Risk Management Plan
  • Identify High-Risk Design Features, and Proposes Process to Mitigate Risk and Quality Costs
  • Tooling Executed
Result

Reduce the complexity of the product’s design. Satisfy the customer’s requirements for better pricing, clarity in specifications needed materials, and proper scheduling for the product through the manufacturing process.

Recurs During Concept & Feasibility

Design For Manufacturing
Purpose

Provides design considerations to determine if the device can be manufactured in low and high volumes, while maintaining high-quality products consistently, with the end goal to make better products at a lower cost.

High-Level Outputs
  • Meets Required Quality and Cost Targets
  • Assembly Line Configured and Prepared
  • Creates a Process for FMEA
  • Update Risk Management Plan
  • Identify High-Risk Design Features, and Proposes Process to Mitigate Risk and Quality Costs
  • Tooling Executed
Result

Reduce the complexity of the product’s design. Satisfy the customer’s requirements for better pricing, clarity in specifications needed materials, and proper scheduling for the product through the manufacturing process.

FEASIBILITY
Purpose

Establishes “design freeze” that presents a working engineering level sample with initial evidence supporting design feasibility.

High-Level Output
  • Design & Development Plan – Full Optimization
  • Equipment & Process Development
  • Packaging Design Outlined
  • Risk Management Plan Initiated
  • Design Testing
  • Engineering Design Testing
  • Any Included Animal Trials
Results

Design is frozen, and all aspects of the project will follow as described in documented drawings.

DESIGN QUALIFICATION
Purpose

Provide needed data points and information to verify and validate the device. The device should work like, look like and made, as well as meet the customers original design intent (requirements/inputs).

High-Level Outputs
  • Build Production Like Qualification Product
  • Design Verification & Validation Testing & Reports
  • Complete Device Master Record (DMR)
  • Execute Biocompatibility Strategy
  • Full Risk Management Plan is Organized
  • FMEA
  • IFU Review
  • Biocompatibility Testing
  • Packaging and Sterilization Validation
  • Regulatory Submission Preparation
Results

Quality Test Reports Completed, Regulatory Submission of Device (filing).

CLINICAL VALIDATION
Purpose

Establish objective evidence that device specifications conform to user needs and intended uses.

High-Level Outputs
  • Source, Create and Develop relationships with Key Opinion Leaders (KOLs) in Industry
  • Interviews with KOL
  • Product Evaluations
  • Substantiated Evidence Accepted by Authoritative Professionals, with Guidelines, Consensus, or Evidence-Based Sources Received
  • May Involve First in Man Study
  • May Involve Clinical Study
Results

Design Validation Report.

REGULATORY SUBMISSION / APPROVAL
Purpose

Achieve regulatory approval for a medical device project.

High-Level Outputs
  • Preclinical Testing
  • Compliance Management Plans Confirmed (CAPAS)
  • Medical Device Reporting (MDR) Methodology Determined
  • Reports Submitted to Regulatory Bodies as Required
  • Complaint Handling
Results

Authorized documentation clears either FDA or EU governing bodies.

DESIGN TRANSFER PLAN
Purpose

Develop an execution plan to prepare for full-scale manufacturing, while ensuring both yield and quality throughout the project.

High-Level Outputs
  • Create Process Flow Chart
  • Define Manufacturing Cell Layout
  • Transferred to Manufacturing for Review
  • Quality Management System Documentation Begins (Includes: 2-D Prints and Drawings, Bill of Materials (BOM), Test Methods, Labels, Work Instructions, DHR, Suppliers, and Vendors Selected.)
  • Initialize Sterilization Plan
  • Design is Transferred to Process Manufacturing Team for the Production
Results

Plan for manufacturing is created, and adequately assigned to necessary production teams.

PROCESS VALIDATION
Purpose

Consists of the collection and evaluation of data, from the process design stage throughout the production. It establishes scientific evidence that a process is capable of consistently delivering quality products.

High-Level Outputs
  • Process Validation (IQ, OQ, & PQ) Finalized
  • Quality Inspection Plans are in Place
  • Packaging and Labeling Procedures Configured
  • Final Risk Management Plan in Place
Results

Concept Prototypes are constructed and reviewed before moving on to the next step.

REGULATORY APPROVAL / LAUNCH
Purpose

This stage reflects the devices’ compliance with regulatory bodies and the continuous monitoring and management of the device in its reflected market.

High-Level Outputs
  • Complete & Maintain Regulatory Submissions
  • Continuous Improvement
  • Commercialization Plan is Activated
  • Complaint Handling
  • Regular Analysis and Performance Review of Product in the Market
Results

Proper shipment of products to Distributors, Healthcare Providers, Physicians, and Technicians as it relates to market commercialization plan.

REGULATORY APPROVAL / LAUNCH
Purpose

This stage reflects the devices’ compliance with regulatory bodies and the continuous monitoring and management of the device in its reflected market.

High-Level Outputs
  • Complete & Maintain Regulatory Submissions
  • Continuous Improvement
  • Commercialization Plan is Activated
  • Complaint Handling
  • Regular Analysis and Performance Review of Product in the Market
Results

Proper shipment of products to Distributors, Healthcare Providers, Physicians, and Technicians as it relates to market commercialization plan.

PROCESS VALIDATION
Purpose

Consists of the collection and evaluation of data, from the process design stage throughout the production. It establishes scientific evidence that a process is capable of consistently delivering quality products.

High-Level Outputs
  • Process Validation (IQ, OQ, & PQ) Finalized
  • Quality Inspection Plans are in Place
  • Packaging and Labeling Procedures Configured
  • Final Risk Management Plan in Place
Results

Concept Prototypes are constructed and reviewed before moving on to the next step.

REGULATORY APPROVAL / LAUNCH
Purpose

This stage reflects the devices’ compliance with regulatory bodies and the continuous monitoring and management of the device in its reflected market.

High-Level Outputs
  • Complete & Maintain Regulatory Submissions
  • Continuous Improvement
  • Commercialization Plan is Activated
  • Complaint Handling
  • Regular Analysis and Performance Review of Product in the Market
Results

Proper shipment of products to Distributors, Healthcare Providers, Physicians, and Technicians as it relates to market commercialization plan.

DESIGN TRANSFER PLAN
Purpose

Develop an execution plan to prepare for full-scale manufacturing, while ensuring both yield and quality throughout the project.

High-Level Outputs
  • Create Process Flow Chart
  • Define Manufacturing Cell Layout
  • Transferred to Manufacturing for Review
  • Quality Management System Documentation Begins (Includes: 2-D Prints and Drawings, Bill of Materials (BOM), Test Methods, Labels, Work Instructions, DHR, Suppliers, and Vendors Selected.)
  • Initialize Sterilization Plan
  • Design is Transferred to Process Manufacturing Team for the Production
Results

Plan for manufacturing is created, and adequately assigned to necessary production teams.

PROCESS VALIDATION
Purpose

Consists of the collection and evaluation of data, from the process design stage throughout the production. It establishes scientific evidence that a process is capable of consistently delivering quality products.

High-Level Outputs
  • Process Validation (IQ, OQ, & PQ) Finalized
  • Quality Inspection Plans are in Place
  • Packaging and Labeling Procedures Configured
  • Final Risk Management Plan in Place
Results

Concept Prototypes are constructed and reviewed before moving on to the next step.

REGULATORY APPROVAL / LAUNCH
Purpose

This stage reflects the devices’ compliance with regulatory bodies and the continuous monitoring and management of the device in its reflected market.

High-Level Outputs
  • Complete & Maintain Regulatory Submissions
  • Continuous Improvement
  • Commercialization Plan is Activated
  • Complaint Handling
  • Regular Analysis and Performance Review of Product in the Market
Results

Proper shipment of products to Distributors, Healthcare Providers, Physicians, and Technicians as it relates to market commercialization plan.

REGULATORY SUBMISSION / APPROVAL
Purpose

Achieve regulatory approval for a medical device project.

High-Level Outputs
  • Preclinical Testing
  • Compliance Management Plans Confirmed (CAPAS)
  • Medical Device Reporting (MDR) Methodology Determined
  • Reports Submitted to Regulatory Bodies as Required
  • Complaint Handling
Results

Authorized documentation clears either FDA or EU governing bodies.

DESIGN TRANSFER PLAN
Purpose

Develop an execution plan to prepare for full-scale manufacturing, while ensuring both yield and quality throughout the project.

High-Level Outputs
  • Create Process Flow Chart
  • Define Manufacturing Cell Layout
  • Transferred to Manufacturing for Review
  • Quality Management System Documentation Begins (Includes: 2-D Prints and Drawings, Bill of Materials (BOM), Test Methods, Labels, Work Instructions, DHR, Suppliers, and Vendors Selected.)
  • Initialize Sterilization Plan
  • Design is Transferred to Process Manufacturing Team for the Production
Results

Plan for manufacturing is created, and adequately assigned to necessary production teams.

PROCESS VALIDATION
Purpose

Consists of the collection and evaluation of data, from the process design stage throughout the production. It establishes scientific evidence that a process is capable of consistently delivering quality products.

High-Level Outputs
  • Process Validation (IQ, OQ, & PQ) Finalized
  • Quality Inspection Plans are in Place
  • Packaging and Labeling Procedures Configured
  • Final Risk Management Plan in Place
Results

Concept Prototypes are constructed and reviewed before moving on to the next step.

REGULATORY APPROVAL / LAUNCH
Purpose

This stage reflects the devices’ compliance with regulatory bodies and the continuous monitoring and management of the device in its reflected market.

High-Level Outputs
  • Complete & Maintain Regulatory Submissions
  • Continuous Improvement
  • Commercialization Plan is Activated
  • Complaint Handling
  • Regular Analysis and Performance Review of Product in the Market
Results

Proper shipment of products to Distributors, Healthcare Providers, Physicians, and Technicians as it relates to market commercialization plan.

CLINICAL VALIDATION
Purpose

Establish objective evidence that device specifications conform to user needs and intended uses.

High-Level Outputs
  • Source, Create and Develop relationships with Key Opinion Leaders (KOLs) in Industry
  • Interviews with KOL
  • Product Evaluations
  • Substantiated Evidence Accepted by Authoritative Professionals, with Guidelines, Consensus, or Evidence-Based Sources Received
  • May Involve First in Man Study
  • May Involve Clinical Study
Results

Design Validation Report.

REGULATORY SUBMISSION / APPROVAL
Purpose

Achieve regulatory approval for a medical device project.

High-Level Outputs
  • Preclinical Testing
  • Compliance Management Plans Confirmed (CAPAS)
  • Medical Device Reporting (MDR) Methodology Determined
  • Reports Submitted to Regulatory Bodies as Required
  • Complaint Handling
Results

Authorized documentation clears either FDA or EU governing bodies.

DESIGN TRANSFER PLAN
Purpose

Develop an execution plan to prepare for full-scale manufacturing, while ensuring both yield and quality throughout the project.

High-Level Outputs
  • Create Process Flow Chart
  • Define Manufacturing Cell Layout
  • Transferred to Manufacturing for Review
  • Quality Management System Documentation Begins (Includes: 2-D Prints and Drawings, Bill of Materials (BOM), Test Methods, Labels, Work Instructions, DHR, Suppliers, and Vendors Selected.)
  • Initialize Sterilization Plan
  • Design is Transferred to Process Manufacturing Team for the Production
Results

Plan for manufacturing is created, and adequately assigned to necessary production teams.

PROCESS VALIDATION
Purpose

Consists of the collection and evaluation of data, from the process design stage throughout the production. It establishes scientific evidence that a process is capable of consistently delivering quality products.

High-Level Outputs
  • Process Validation (IQ, OQ, & PQ) Finalized
  • Quality Inspection Plans are in Place
  • Packaging and Labeling Procedures Configured
  • Final Risk Management Plan in Place
Results

Concept Prototypes are constructed and reviewed before moving on to the next step.

REGULATORY APPROVAL / LAUNCH
Purpose

This stage reflects the devices’ compliance with regulatory bodies and the continuous monitoring and management of the device in its reflected market.

High-Level Outputs
  • Complete & Maintain Regulatory Submissions
  • Continuous Improvement
  • Commercialization Plan is Activated
  • Complaint Handling
  • Regular Analysis and Performance Review of Product in the Market
Results

Proper shipment of products to Distributors, Healthcare Providers, Physicians, and Technicians as it relates to market commercialization plan.

DESIGN QUALIFICATION
Purpose

Provide needed data points and information to verify and validate the device. The device should work like, look like and made, as well as meet the customers original design intent (requirements/inputs).

High-Level Outputs
  • Build Production Like Qualification Product
  • Design Verification & Validation Testing & Reports
  • Complete Device Master Record (DMR)
  • Execute Biocompatibility Strategy
  • Full Risk Management Plan is Organized
  • FMEA
  • IFU Review
  • Biocompatibility Testing
  • Packaging and Sterilization Validation
  • Regulatory Submission Preparation
Results

Quality Test Reports Completed, Regulatory Submission of Device (filing).

CLINICAL VALIDATION
Purpose

Establish objective evidence that device specifications conform to user needs and intended uses.

High-Level Outputs
  • Source, Create and Develop relationships with Key Opinion Leaders (KOLs) in Industry
  • Interviews with KOL
  • Product Evaluations
  • Substantiated Evidence Accepted by Authoritative Professionals, with Guidelines, Consensus, or Evidence-Based Sources Received
  • May Involve First in Man Study
  • May Involve Clinical Study
Results

Design Validation Report.

REGULATORY SUBMISSION / APPROVAL
Purpose

Achieve regulatory approval for a medical device project.

High-Level Outputs
  • Preclinical Testing
  • Compliance Management Plans Confirmed (CAPAS)
  • Medical Device Reporting (MDR) Methodology Determined
  • Reports Submitted to Regulatory Bodies as Required
  • Complaint Handling
Results

Authorized documentation clears either FDA or EU governing bodies.

DESIGN TRANSFER PLAN
Purpose

Develop an execution plan to prepare for full-scale manufacturing, while ensuring both yield and quality throughout the project.

High-Level Outputs
  • Create Process Flow Chart
  • Define Manufacturing Cell Layout
  • Transferred to Manufacturing for Review
  • Quality Management System Documentation Begins (Includes: 2-D Prints and Drawings, Bill of Materials (BOM), Test Methods, Labels, Work Instructions, DHR, Suppliers, and Vendors Selected.)
  • Initialize Sterilization Plan
  • Design is Transferred to Process Manufacturing Team for the Production
Results

Plan for manufacturing is created, and adequately assigned to necessary production teams.

PROCESS VALIDATION
Purpose

Consists of the collection and evaluation of data, from the process design stage throughout the production. It establishes scientific evidence that a process is capable of consistently delivering quality products.

High-Level Outputs
  • Process Validation (IQ, OQ, & PQ) Finalized
  • Quality Inspection Plans are in Place
  • Packaging and Labeling Procedures Configured
  • Final Risk Management Plan in Place
Results

Concept Prototypes are constructed and reviewed before moving on to the next step.

REGULATORY APPROVAL / LAUNCH
Purpose

This stage reflects the devices’ compliance with regulatory bodies and the continuous monitoring and management of the device in its reflected market.

High-Level Outputs
  • Complete & Maintain Regulatory Submissions
  • Continuous Improvement
  • Commercialization Plan is Activated
  • Complaint Handling
  • Regular Analysis and Performance Review of Product in the Market
Results

Proper shipment of products to Distributors, Healthcare Providers, Physicians, and Technicians as it relates to market commercialization plan.

FEASIBILITY
Purpose

Establishes “design freeze” that presents a working engineering level sample with initial evidence supporting design feasibility.

High-Level Output
  • Design & Development Plan – Full Optimization
  • Equipment & Process Development
  • Packaging Design Outlined
  • Risk Management Plan Initiated
  • Design Testing
  • Engineering Design Testing
  • Any Included Animal Trials
Results

Design is frozen, and all aspects of the project will follow as described in documented drawings.

DESIGN QUALIFICATION
Purpose

Provide needed data points and information to verify and validate the device. The device should work like, look like and made, as well as meet the customers original design intent (requirements/inputs).

High-Level Outputs
  • Build Production Like Qualification Product
  • Design Verification & Validation Testing & Reports
  • Complete Device Master Record (DMR)
  • Execute Biocompatibility Strategy
  • Full Risk Management Plan is Organized
  • FMEA
  • IFU Review
  • Biocompatibility Testing
  • Packaging and Sterilization Validation
  • Regulatory Submission Preparation
Results

Quality Test Reports Completed, Regulatory Submission of Device (filing).

CLINICAL VALIDATION
Purpose

Establish objective evidence that device specifications conform to user needs and intended uses.

High-Level Outputs
  • Source, Create and Develop relationships with Key Opinion Leaders (KOLs) in Industry
  • Interviews with KOL
  • Product Evaluations
  • Substantiated Evidence Accepted by Authoritative Professionals, with Guidelines, Consensus, or Evidence-Based Sources Received
  • May Involve First in Man Study
  • May Involve Clinical Study
Results

Design Validation Report.

REGULATORY SUBMISSION / APPROVAL
Purpose

Achieve regulatory approval for a medical device project.

High-Level Outputs
  • Preclinical Testing
  • Compliance Management Plans Confirmed (CAPAS)
  • Medical Device Reporting (MDR) Methodology Determined
  • Reports Submitted to Regulatory Bodies as Required
  • Complaint Handling
Results

Authorized documentation clears either FDA or EU governing bodies.

DESIGN TRANSFER PLAN
Purpose

Develop an execution plan to prepare for full-scale manufacturing, while ensuring both yield and quality throughout the project.

High-Level Outputs
  • Create Process Flow Chart
  • Define Manufacturing Cell Layout
  • Transferred to Manufacturing for Review
  • Quality Management System Documentation Begins (Includes: 2-D Prints and Drawings, Bill of Materials (BOM), Test Methods, Labels, Work Instructions, DHR, Suppliers, and Vendors Selected.)
  • Initialize Sterilization Plan
  • Design is Transferred to Process Manufacturing Team for the Production
Results

Plan for manufacturing is created, and adequately assigned to necessary production teams.

PROCESS VALIDATION
Purpose

Consists of the collection and evaluation of data, from the process design stage throughout the production. It establishes scientific evidence that a process is capable of consistently delivering quality products.

High-Level Outputs
  • Process Validation (IQ, OQ, & PQ) Finalized
  • Quality Inspection Plans are in Place
  • Packaging and Labeling Procedures Configured
  • Final Risk Management Plan in Place
Results

Concept Prototypes are constructed and reviewed before moving on to the next step.

REGULATORY APPROVAL / LAUNCH
Purpose

This stage reflects the devices’ compliance with regulatory bodies and the continuous monitoring and management of the device in its reflected market.

High-Level Outputs
  • Complete & Maintain Regulatory Submissions
  • Continuous Improvement
  • Commercialization Plan is Activated
  • Complaint Handling
  • Regular Analysis and Performance Review of Product in the Market
Results

Proper shipment of products to Distributors, Healthcare Providers, Physicians, and Technicians as it relates to market commercialization plan.

Recurs During Concept & Feasibility

Design For Manufacturing
Purpose

Provides design considerations to determine if the device can be manufactured in low and high volumes, while maintaining high-quality products consistently, with the end goal to make better products at a lower cost.

High-Level Outputs
  • Meets Required Quality and Cost Targets
  • Assembly Line Configured and Prepared
  • Creates a Process for FMEA
  • Update Risk Management Plan
  • Identify High-Risk Design Features, and Proposes Process to Mitigate Risk and Quality Costs
  • Tooling Executed
Result

Reduce the complexity of the product’s design. Satisfy the customer’s requirements for better pricing, clarity in specifications needed materials, and proper scheduling for the product through the manufacturing process.

FEASIBILITY
Purpose

Establishes “design freeze” that presents a working engineering level sample with initial evidence supporting design feasibility.

High-Level Output
  • Design & Development Plan – Full Optimization
  • Equipment & Process Development
  • Packaging Design Outlined
  • Risk Management Plan Initiated
  • Design Testing
  • Engineering Design Testing
  • Any Included Animal Trials
Results

Design is frozen, and all aspects of the project will follow as described in documented drawings.

DESIGN QUALIFICATION
Purpose

Provide needed data points and information to verify and validate the device. The device should work like, look like and made, as well as meet the customers original design intent (requirements/inputs).

High-Level Outputs
  • Build Production Like Qualification Product
  • Design Verification & Validation Testing & Reports
  • Complete Device Master Record (DMR)
  • Execute Biocompatibility Strategy
  • Full Risk Management Plan is Organized
  • FMEA
  • IFU Review
  • Biocompatibility Testing
  • Packaging and Sterilization Validation
  • Regulatory Submission Preparation
Results

Quality Test Reports Completed, Regulatory Submission of Device (filing).

CLINICAL VALIDATION
Purpose

Establish objective evidence that device specifications conform to user needs and intended uses.

High-Level Outputs
  • Source, Create and Develop relationships with Key Opinion Leaders (KOLs) in Industry
  • Interviews with KOL
  • Product Evaluations
  • Substantiated Evidence Accepted by Authoritative Professionals, with Guidelines, Consensus, or Evidence-Based Sources Received
  • May Involve First in Man Study
  • May Involve Clinical Study
Results

Design Validation Report.

REGULATORY SUBMISSION / APPROVAL
Purpose

Achieve regulatory approval for a medical device project.

High-Level Outputs
  • Preclinical Testing
  • Compliance Management Plans Confirmed (CAPAS)
  • Medical Device Reporting (MDR) Methodology Determined
  • Reports Submitted to Regulatory Bodies as Required
  • Complaint Handling
Results

Authorized documentation clears either FDA or EU governing bodies.

DESIGN TRANSFER PLAN
Purpose

Develop an execution plan to prepare for full-scale manufacturing, while ensuring both yield and quality throughout the project.

High-Level Outputs
  • Create Process Flow Chart
  • Define Manufacturing Cell Layout
  • Transferred to Manufacturing for Review
  • Quality Management System Documentation Begins (Includes: 2-D Prints and Drawings, Bill of Materials (BOM), Test Methods, Labels, Work Instructions, DHR, Suppliers, and Vendors Selected.)
  • Initialize Sterilization Plan
  • Design is Transferred to Process Manufacturing Team for the Production
Results

Plan for manufacturing is created, and adequately assigned to necessary production teams.

PROCESS VALIDATION
Purpose

Consists of the collection and evaluation of data, from the process design stage throughout the production. It establishes scientific evidence that a process is capable of consistently delivering quality products.

High-Level Outputs
  • Process Validation (IQ, OQ, & PQ) Finalized
  • Quality Inspection Plans are in Place
  • Packaging and Labeling Procedures Configured
  • Final Risk Management Plan in Place
Results

Concept Prototypes are constructed and reviewed before moving on to the next step.

REGULATORY APPROVAL / LAUNCH
Purpose

This stage reflects the devices’ compliance with regulatory bodies and the continuous monitoring and management of the device in its reflected market.

High-Level Outputs
  • Complete & Maintain Regulatory Submissions
  • Continuous Improvement
  • Commercialization Plan is Activated
  • Complaint Handling
  • Regular Analysis and Performance Review of Product in the Market
Results

Proper shipment of products to Distributors, Healthcare Providers, Physicians, and Technicians as it relates to market commercialization plan.

Recurs During Concept & Feasibility

Design For Manufacturing
Purpose

Provides design considerations to determine if the device can be manufactured in low and high volumes, while maintaining high-quality products consistently, with the end goal to make better products at a lower cost.

High-Level Outputs
  • Meets Required Quality and Cost Targets
  • Assembly Line Configured and Prepared
  • Creates a Process for FMEA
  • Update Risk Management Plan
  • Identify High-Risk Design Features, and Proposes Process to Mitigate Risk and Quality Costs
  • Tooling Executed
Result

Reduce the complexity of the product’s design. Satisfy the customer’s requirements for better pricing, clarity in specifications needed materials, and proper scheduling for the product through the manufacturing process.

Recurs During Concept & Feasibility

Design For Manufacturing
Purpose

Provides design considerations to determine if the device can be manufactured in low and high volumes, while maintaining high-quality products consistently, with the end goal to make better products at a lower cost.

High-Level Outputs
  • Meets Required Quality and Cost Targets
  • Assembly Line Configured and Prepared
  • Creates a Process for FMEA
  • Update Risk Management Plan
  • Identify High-Risk Design Features, and Proposes Process to Mitigate Risk and Quality Costs
  • Tooling Executed
Result

Reduce the complexity of the product’s design. Satisfy the customer’s requirements for better pricing, clarity in specifications needed materials, and proper scheduling for the product through the manufacturing process.

FEASIBILITY
Purpose

Establishes “design freeze” that presents a working engineering level sample with initial evidence supporting design feasibility.

High-Level Output
  • Design & Development Plan – Full Optimization
  • Equipment & Process Development
  • Packaging Design Outlined
  • Risk Management Plan Initiated
  • Design Testing
  • Engineering Design Testing
  • Any Included Animal Trials
Results

Design is frozen, and all aspects of the project will follow as described in documented drawings.

DESIGN QUALIFICATION
Purpose

Provide needed data points and information to verify and validate the device. The device should work like, look like and made, as well as meet the customers original design intent (requirements/inputs).

High-Level Outputs
  • Build Production Like Qualification Product
  • Design Verification & Validation Testing & Reports
  • Complete Device Master Record (DMR)
  • Execute Biocompatibility Strategy
  • Full Risk Management Plan is Organized
  • FMEA
  • IFU Review
  • Biocompatibility Testing
  • Packaging and Sterilization Validation
  • Regulatory Submission Preparation
Results

Quality Test Reports Completed, Regulatory Submission of Device (filing).

CLINICAL VALIDATION
Purpose

Establish objective evidence that device specifications conform to user needs and intended uses.

High-Level Outputs
  • Source, Create and Develop relationships with Key Opinion Leaders (KOLs) in Industry
  • Interviews with KOL
  • Product Evaluations
  • Substantiated Evidence Accepted by Authoritative Professionals, with Guidelines, Consensus, or Evidence-Based Sources Received
  • May Involve First in Man Study
  • May Involve Clinical Study
Results

Design Validation Report.

REGULATORY SUBMISSION / APPROVAL
Purpose

Achieve regulatory approval for a medical device project.

High-Level Outputs
  • Preclinical Testing
  • Compliance Management Plans Confirmed (CAPAS)
  • Medical Device Reporting (MDR) Methodology Determined
  • Reports Submitted to Regulatory Bodies as Required
  • Complaint Handling
Results

Authorized documentation clears either FDA or EU governing bodies.

DESIGN TRANSFER PLAN
Purpose

Develop an execution plan to prepare for full-scale manufacturing, while ensuring both yield and quality throughout the project.

High-Level Outputs
  • Create Process Flow Chart
  • Define Manufacturing Cell Layout
  • Transferred to Manufacturing for Review
  • Quality Management System Documentation Begins (Includes: 2-D Prints and Drawings, Bill of Materials (BOM), Test Methods, Labels, Work Instructions, DHR, Suppliers, and Vendors Selected.)
  • Initialize Sterilization Plan
  • Design is Transferred to Process Manufacturing Team for the Production
Results

Plan for manufacturing is created, and adequately assigned to necessary production teams.

PROCESS VALIDATION
Purpose

Consists of the collection and evaluation of data, from the process design stage throughout the production. It establishes scientific evidence that a process is capable of consistently delivering quality products.

High-Level Outputs
  • Process Validation (IQ, OQ, & PQ) Finalized
  • Quality Inspection Plans are in Place
  • Packaging and Labeling Procedures Configured
  • Final Risk Management Plan in Place
Results

Concept Prototypes are constructed and reviewed before moving on to the next step.

REGULATORY APPROVAL / LAUNCH
Purpose

This stage reflects the devices’ compliance with regulatory bodies and the continuous monitoring and management of the device in its reflected market.

High-Level Outputs
  • Complete & Maintain Regulatory Submissions
  • Continuous Improvement
  • Commercialization Plan is Activated
  • Complaint Handling
  • Regular Analysis and Performance Review of Product in the Market
Results

Proper shipment of products to Distributors, Healthcare Providers, Physicians, and Technicians as it relates to market commercialization plan.

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