Services Offered

Product 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 Reporting 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.

Expert Witness

Experience in reviewing medical error cases.

Training

Training will be provided for a variety of project management and data analysis techniques.

List of clients

• Abbott

• Advanced Bionics

• Affymetrix

• bioMérieux

• Boston Scientific

• Cellestis

• ESA

• Helicos

• HemoSense

• Hygieia

• IL

• ITC

• KeeJin Science

• LabNow

• Luminex

• PlaCor

• Roche

• SeraCare

• Wiener Laboratorios

• others (will be listed after permission is granted)

Volunteer Work

• NCCLS (now called CLSI)