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lecture_5 - Product Documentation S Laguette ME128 Fall...

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Unformatted text preview: Product Documentation S. Laguette ME128 Fall 2007 October 10, 2007 10/10/07 ME128 1 Medical Device Product Documentation Business proposal Product specification Design specification Software Quality Assurance Plan Software Requirements Specification Software Design Description Primary Types of Records 10/10/07 ME128 2 Design of Biomedical Devices Clinical Needs Device Design Regulatory Requirements Customer Needs Company Needs 10/10/07 ME128 3 Business Proposal Market Need and Potential Project Overview Core Project Team Product Proposal Business Proposal Supporting Documentation Strategic Fit Risk Analysis and Research Plan ME128 Economic Analysis 10/10/07 4 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 10/10/07 ME128 5 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 ME128 10/10/07 6 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 10/10/07 ME128 7 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 10/10/07 Where do the pieces fit? ME128 8 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 10/10/07 ME128 9 Economic Analysis Rough estimate of costs and personnel required to specify, design, develop, and launch each product variant into the market place 10/10/07 ME128 10 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 10/10/07 ME128 11 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. 10/10/07 ME128 12 Product Specification First step in transforming product ideas into approved product development efforts Subject to revision level control Joint ownership among all concerned departments 10/10/07 ME128 Product specification helps turn this into reality 13 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 10/10/07 ME128 14 Product Design Specification Establishes the customer wants and needs so that the design concepts may be established Prioritizes customer needs Is evolutionary and will change as the design progresses Finalizes what is intended to manufactured and marketed 10/10/07 ME128 15 Product Design Specification (PDS) Product title Purpose or function the product is to perform Features Competition Intended market Performance Requirements Life-cycle Human Factors Social, Political, Legal, and Ethical Issues 10/10/07 ME128 16 Why is there a need for this product 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 10/10/07 ME128 17 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 10/10/07 ME128 18 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 10/10/07 ME128 19 Primary types of records Design History File (DHF) Device Master Record (DMR) Device History Record (DHR) Technical Documentation File (TDF) 10/10/07 ME128 20 Design History File (DHF) Compilation of records which describes the Design History of a finished device Covers the design activities used to develop the device, accessories, labeling, packaging, and processes Contains or references the records required in accordance with approved design plans and the requirements of the QSR Design Control requires a DHF for each type of device 10/10/07 ME128 21 Device Master Record (DMR) Compilation of containing the complete specifications and procedures for a finished device Drawings, Component specs, software specs Process specs, productions methods, equipment QA procedure and specs including criteria and equipment Packaging and labeling specs Installation, maintenance, and servicing procedures 10/10/07 ME128 22 Device History Record (DHR) Actual production records for a specific device, manufacturing lot or batch Dates of manufacture Quantity manufactured and released for distribution Acceptance records in accordance with the DMR Labels and labeling information Device identification, lot numbers, control numbers 10/10/07 ME128 23 Technical Documentation File (TDF) Contains relevant design data which demonstrates that essential safety requirements per the Medical Device Directives (MDD) 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 MDD for CE approval 10/10/07 ME128 24 10/10/07 ME128 25 References Text, Reference King, P.H. and R.C. Fries, Design of Biomedical Devices and Systems, Marcel Dekker, 2003 King, P.H. lectures series 10/10/07 ME128 26 ...
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