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Services OfferedProduct
Development Capability Assessment
Review
of your product development capabilities includes assessment of product
completion dates, planning tools, financial models, product specifications,
experimental design and analysis tools, problem solving capabilities, field
tracking capabilities. A report will highlight strengths and how to achieve
improvements. Reliability
Planning and Implementation
Reliability
capability will be assessed. Improvements, if required will be made through a
reliability planning template that uses, reliability specification development,
initial reliability estimates and allocation to subsystems, Fault Tree and FMECA
analysis, FRACAS (Failure Review and Corrective Action System), reliability
growth management. Field
Performance and Reliability Tracking
Tracking
systems will be reviewed. Quality improvement systems will be provided using
FRACAS (Failure Review and Corrective Action System) principles and reliability
growth management.
Evaluation
Protocol Development and Analysis
Evaluation
protocols will be reviewed and / or developed based on review and development of
specifications and construction of efficient experimental designs. Experimental
designs will be developed for any part of the product development cycle,
including FDA submissions. Product
Valuation Assessment
Review
of product valuation involves assessment of modeling methods used, quality of
data inputs, review of historical financial predictions vs. outcomes, and review
of how financial models mesh with the product development decision making
process. A report will highlight strengths and how to achieve improvements. Product
Development Schedule Assessment
Review
of a product completion date includes interviews with key participants, review
of historical prediction and completion dates, assessment of specifications, and
technological issues. Modeling methods where appropriate will be used. A report
will provide probabilities for several completion scenarios as well as methods
to improve schedule prediction accuracy. Software
Development
Custom
software solutions will be provided using Excel and Access. Software
solutions include menu driven data retrieval from databases, FRACAS, analysis modules,
and automatic generation of graphs, pivot tables, or other reports. Other
solutions are based on SAS. Expert WitnessExperience in reviewing medical error cases.TrainingTraining
will be provided for a variety of project management and data analysis
techniques. |