Product Documentation

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Product Documentation

• Chapter 5

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Title 21 of the Code of Federal Regulations

• Volume 1 Parts 1-99 (FDA, General)
• Volume 2 Parts 100-169 (FDA, Food for Human
  Consumption)
• Volume 3 Parts 170-199 (FDA, Food for Human
  Consumption)
• Volume 4 Parts 200-299 (FDA, Drugs General)
• Volume 5 Parts 300-499 (FDA, Drugs for Human
  Use)
• Volume 6 Parts 500-599 (FDA, Animal Drugs, Feeds
  and Related Products)
• Volume 7 Parts 600-799 (FDA, Biologics
  Cosmetics)
• Volume 8 Parts 800-1299 (FDA, Medical Devices)
• Volume 9 Parts 1300-End (DEA and Office of
  National Drug Control Policy)

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21CFR part 820 requires

• Business proposal
• Product specification
• Design specification
• Software Quality Assurance Plan
• Software Requirements Specification
• Software Design Description
• if /where applicable

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Primary types of records

• Design History File (DHF)
• Device Master Record (DMR)
• Device History Record (DHR)
• Technical Documentation File (TDF)

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Business Proposal
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Project Overview, Objectives, Major Milestones,
and Schedule

• Statement of overall project objectives and major
  milestones
• Objectives clearly define project scope and
  provide specific direction
• Schedule anticipates key decision points and
  completion of primary deliverables
• Events contingent upon achievements of estimated
  dates should be stated

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Example Timeline (Gantt)
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Market Need/ Potential

• Defines customer and clinical need for product or
  service
• Identifies potential territories to be served

• Examine market size and trends
• Compare product with competitors,

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Product Proposal

• Proposes the product idea that fulfills the
  market need
• Differentiates product features
• Explains user and/or clinical value
• Several alternatives product ideas should be
  evaluated against base case idea

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Strategic Fit

• Discusses how the proposed product conforms with
  (or departs from) stated technology with respect
  to
• Product
• Market
• Clinical setting
• Technology
• Design
• Manufacturing
• Service

Where do the pieces fit?
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Risk Analysis and Research Plan

• Assessment of risks and unknowns
• Estimate of resources needed to reduce risks to a
  level with a reasonably high level of confidence
• Risk categories
• Technical
• Market
• Financial
• Regulatory
• Available resources
• Schedule

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Economic Analysis

• Rough estimate of costs and personnel required to
  specify, design, develop, and launch each product
  variant into the market place

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Core Project Team

• Formation of core project team to perform
  research to reduce risks, develop user
  specification, and prepare project plan
• Outline requisite skills of proposed team members
• Estimate approximate time required of each
  participant
• Estimate incremental expenses

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NCIIA Example follows
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Proposal
Requirements

• Project and feature descriptions
• Projects market potential
• Social and environmental impact
• Team members, skills, roles, resumes
• All advisors
• Work plan and timeline
• Necessary equipment and resources
• Budget in tabular format

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Proposal Evaluation
Project Aspect

• Technical feasibility.
• Technology that is appropriate, achievable, and
  commercially sustainable.
• A plan and budget are reasonable and achievable.
• Likelihood of development of a licensable or
  marketable product or service.
• Demonstrated knowledge of market and evidence of
  consumer interest.

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Proposal Evaluation
-Team Aspect

• Appropriate student and advisor skills
• Team membership
• Balance of business, technical, and other
  specialists. External mentors. Diversity
  reflecting the institutions population.
• Team (faculty, students, mentors, and
  institution) commitment.
• Strong faculty recommendations. 

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Product Specification

• First step in transforming product ideas into
  approved product development efforts
• Subject to revision level control
• Joint ownership among all concerned departments

Product specification helps turn this into
reality
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Design Specification

• Derived from product specification
• Requirements are reduced to specific design
  requirements
• Addresses each subsystem
• Each performance specification should be listed
  with nominal worst case requirements

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Software Quality Assurance Plan (SQAP)

• Assures that procedures, tools and techniques
  used during software development and modification
  are adequate to provide desired level of
  confidence in final product
• Assures that software does not reduce reliability
  of device
• Detailed listing of requirements

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Software Requirements Specification (SRS)

• Specification for a particular software product
  or programs that perform certain functions
• Correctly defines software requirements
• Each software requirement is a statement of some
  essential capability of the software to be
  developed

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Software Design Description (SDD)

• Specifies necessary information content and
  recommended organization for a software design
  description
• Detailed blueprint for implementation activity
• Each requirement must be traceable to one or more
  design entities

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Records Mandated
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Design History File (DHF)

• Compilation of records which describes the design
  history of a finished device
• Contains or references the records necessary to
  prove that the design was developed in accordance
  with approved design plans
• Contains institutional memory of previous
  design activities
• Contains verification and validation protocols

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Device Master Record

• Design specifications
• Production specifications
• QA procedures
• Packaging/labeling specifications
• Install/maintenance/service methods

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Device History Record

• Date(s) of manufacture
• Quantities manufactured
• Quantities released
• Acceptance records (DMR proof)
• ID labeling information
• Device ID/control numbers
• MDRs

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Technical Documentation File (TDF)

• Contains relevant design data which demonstrates
  that essential safety requirements are satisfied
• File must be kept for 10 years after production
  stops in case of liability proceedings
• Allows assessment of the conformity of the
  product with requirements of the Medical Device
  Directives

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