Product Product DocumentationDocumentationChapter 5Chapter 5

Title 21 of the Code of Title 21 of the Code of Federal Regulations Federal Regulations

Volume 1: Parts 1-99 (FDA, General) Volume 1: Parts 1-99 (FDA, General) Volume 2: Parts 100-169 (FDA, Food for Human Consumption) Volume 2: Parts 100-169 (FDA, Food for Human Consumption) Volume 3: Parts 170-199 (FDA, Food for Human Consumption) Volume 3: Parts 170-199 (FDA, Food for Human Consumption) Volume 4: Parts 200-299 (FDA, Drugs: General) Volume 4: Parts 200-299 (FDA, Drugs: General) Volume 5: Parts 300-499 (FDA, Drugs for Human Use) Volume 5: Parts 300-499 (FDA, Drugs for Human Use) Volume 6: Parts 500-599 (FDA, Animal Drugs, Feeds and Related Volume 6: Parts 500-599 (FDA, Animal Drugs, Feeds and Related

Products) Products) Volume 7: Parts 600-799 (FDA, Biologics; Cosmetics) Volume 7: Parts 600-799 (FDA, Biologics; Cosmetics) Volume 8: Parts 800-1299 (FDA, Medical Devices) Volume 8: Parts 800-1299 (FDA, Medical Devices) Volume 9: Parts 1300-End (DEA and Office of National Drug Volume 9: Parts 1300-End (DEA and Office of National Drug

Control Policy) Control Policy)

21CFR part 820 requires:21CFR part 820 requires: Business proposalBusiness proposal Product specificationProduct specification Design specificationDesign specification Software Quality Assurance Plan*Software Quality Assurance Plan* Software Requirements Specification*Software Requirements Specification* Software Design Description*Software Design Description* * = if /where applicable* = if /where applicable

Primary types of recordsPrimary types of records Design History File Design History File

(DHF)(DHF) Device Master Record Device Master Record

(DMR)(DMR) Device History Record Device History Record

(DHR)(DHR) Technical Technical

Documentation File Documentation File (TDF)(TDF)

Business ProposalBusiness Proposal

Project Overview, Objectives, Project Overview, Objectives, Major Milestones, and Major Milestones, and ScheduleSchedule

Statement of overall project objectives Statement of overall project objectives and major milestonesand major milestones

Objectives clearly define project scope Objectives clearly define project scope and provide specific directionand provide specific direction

Schedule anticipates key decision Schedule anticipates key decision points and completion of primary points and completion of primary deliverablesdeliverables

Events contingent upon achievements Events contingent upon achievements of estimated dates should be statedof estimated dates should be stated

Example Timeline (Gantt)Example Timeline (Gantt)

Market Need/ PotentialMarket Need/ Potential Defines customer and Defines customer and

clinical need for clinical need for product or serviceproduct or service

Identifies potential Identifies potential territories to be servedterritories to be served

Examine market size Examine market size and trendsand trends

Compare product Compare product with competitors, …with competitors, …

Product ProposalProduct Proposal Proposes the product idea Proposes the product idea

that fulfills the market needthat fulfills the market need Differentiates product Differentiates product

featuresfeatures Explains user and/or Explains user and/or

clinical valueclinical value Several alternatives Several alternatives

product ideas should be product ideas should be evaluated against ‘base evaluated against ‘base case’ ideacase’ idea

Strategic FitStrategic Fit Discusses how the proposed product conforms Discusses how the proposed product conforms

with (or departs from) stated technology with with (or departs from) stated technology with respect to:respect to: ProductProduct MarketMarket Clinical settingClinical setting TechnologyTechnology DesignDesign ManufacturingManufacturing ServiceService

Where do the pieces fit?

Risk Analysis and Risk Analysis and Research PlanResearch Plan

Assessment of risks and unknownsAssessment of risks and unknowns Estimate of resources needed to reduce risks Estimate of resources needed to reduce risks

to a level with a reasonably high level of to a level with a reasonably high level of confidenceconfidence

Risk categories:Risk categories: TechnicalTechnical MarketMarket FinancialFinancial RegulatoryRegulatory Available resourcesAvailable resources ScheduleSchedule

Economic AnalysisEconomic Analysis Rough estimate of Rough estimate of

costs and personnel costs and personnel required to specify, required to specify, design, develop, and design, develop, and launch each product launch each product variant into the variant into the market placemarket place

Core Project TeamCore Project Team Formation of core project team to perform Formation of core project team to perform

research to reduce risks, develop user research to reduce risks, develop user specification, and prepare project planspecification, and prepare project plan

Outline requisite skills of proposed team Outline requisite skills of proposed team membersmembers

Estimate approximate time required of Estimate approximate time required of each participanteach participant

Estimate incremental expensesEstimate incremental expenses

NCIIA Example follows:NCIIA Example follows:

ProposalProposal RequirementsRequirements

Project and feature descriptionsProject and feature descriptions Project’s market potentialProject’s market potential Social and environmental impactSocial and environmental impact Team members, skills, roles, resumesTeam members, skills, roles, resumes All advisorsAll advisors Work plan and timelineWork plan and timeline Necessary equipment and resourcesNecessary equipment and resources Budget in tabular formatBudget in tabular format

Proposal Proposal EvaluationEvaluation – Project Aspect – Project Aspect

Technical feasibility.Technical feasibility. Technology that is appropriate, achievable, Technology that is appropriate, achievable,

and commercially sustainable.and commercially sustainable. A plan and budget are reasonable and A plan and budget are reasonable and

achievable.achievable. Likelihood of development of a licensable or Likelihood of development of a licensable or

marketable product or service.marketable product or service. Demonstrated knowledge of market and Demonstrated knowledge of market and

evidence of consumer interest.evidence of consumer interest.

Proposal Proposal Evaluation Evaluation -Team Aspect -Team Aspect

Appropriate student and advisor skillsAppropriate student and advisor skills Team membership: Team membership: • • Balance of business, technical, and other Balance of business, technical, and other

specialists. specialists. • External mentors. • External mentors. • Diversity reflecting the institution’s population.• Diversity reflecting the institution’s population.

Team (faculty, students, mentors, and Team (faculty, students, mentors, and institution) commitment.institution) commitment.

Strong faculty recommendations. Strong faculty recommendations. 

Product SpecificationProduct Specification First step in First step in

transforming product transforming product ideas into approved ideas into approved product development product development effortsefforts

Subject to revision level Subject to revision level controlcontrol

Joint ownership among Joint ownership among all concerned all concerned departmentsdepartments

Product specification helps turn this into reality

Design SpecificationDesign Specification Derived from product specificationDerived from product specification Requirements are reduced to specific Requirements are reduced to specific

design requirementsdesign requirements Addresses each subsystemAddresses each subsystem Each performance specification should Each performance specification should

be listed with nominal worst case be listed with nominal worst case requirementsrequirements

Software Quality Software Quality Assurance Plan (SQAP)Assurance Plan (SQAP)

Assures that procedures, tools Assures that procedures, tools and techniques used during and techniques used during software development and software development and modification are adequate to modification are adequate to provide desired level of provide desired level of confidence in final productconfidence in final product

Assures that software does not Assures that software does not reduce reliability of devicereduce reliability of device

Detailed listing of requirementsDetailed listing of requirements

Software Requirements Software Requirements Specification (SRS)Specification (SRS)

Specification for a particular Specification for a particular software product or software product or programs that perform programs that perform certain functionscertain functions

Correctly defines software Correctly defines software requirementsrequirements

Each software requirement Each software requirement is a statement of some is a statement of some essential capability of the essential capability of the software to be developedsoftware to be developed

Software Design Software Design Description (SDD)Description (SDD)

Specifies necessary information content Specifies necessary information content and recommended organization for a and recommended organization for a software design descriptionsoftware design description

Detailed blueprint for implementation Detailed blueprint for implementation activityactivity

Each requirement must be traceable to Each requirement must be traceable to one or more design entitiesone or more design entities

Records Mandated:Records Mandated:

Design History File (DHF)Design History File (DHF) Compilation of records which describes the Compilation of records which describes the

design history of a finished devicedesign history of a finished device Contains or references the records necessary Contains or references the records necessary

to prove that the design was developed in to prove that the design was developed in accordance with approved design plansaccordance with approved design plans

Contains ‘institutional’ memory of previous Contains ‘institutional’ memory of previous design activitiesdesign activities

Contains verification and validation protocolsContains verification and validation protocols

Device Master RecordDevice Master Record Design specificationsDesign specifications Production specificationsProduction specifications QA proceduresQA procedures Packaging/labeling specificationsPackaging/labeling specifications Install/maintenance/service methodsInstall/maintenance/service methods

Device History RecordDevice History Record Date(s) of manufactureDate(s) of manufacture Quantities manufacturedQuantities manufactured Quantities released Quantities released Acceptance records (DMR proof)Acceptance records (DMR proof) ID & labeling informationID & labeling information Device ID/control numbersDevice ID/control numbers MDRsMDRs

Technical Documentation Technical Documentation File (TDF)File (TDF)

Contains relevant design data which Contains relevant design data which demonstrates that essential safety demonstrates that essential safety requirements are satisfiedrequirements are satisfied

File must be kept for 10 years after production File must be kept for 10 years after production stops in case of liability proceedingsstops in case of liability proceedings

Allows assessment of the conformity of the Allows assessment of the conformity of the product with requirements of the Medical product with requirements of the Medical Device DirectivesDevice Directives