selected publications
-
academic article
- Supporting Medical Device Development: A Standard Product Design Process Model. Journal of Engineering Design. 24:83-119. 2013
-
conference paper
- Design for FDA: A Predictive Model for FDA Decision Time. Proceedings of the ASME International Design Engineering Technical Conference, Portland, OR. 2013
- An Analysis of Critical Factors in Medical Device Development to Design for FDA. Proceedings of the ASME International Design Engineering Technical Conference, Chicago, IL. 2012
- Validation Methods for Conceptual Modeling: A Study on Medical Devices. Proceedings of the Industrial and Systems Engineering Research Conference, Orlando, FL. 2012
- A Model-Based Framework for NPD in a Highly Regulated Environment. Proceedings of the Industrial Engineering Research Conference, Reno, NV. 2011
- A Review of Design for X Methods for Medical Devices: The Introduction of a Design for FDA Approach. Proceedings of the ASME International Design Engineering Technical Conference, Washington, DC. 2011
- A Review of Success Factors in NPD: Medical Device Domain. Proceedings of the Industrial Engineering Research Conference, Reno, NV. 2011
- An Ontology Model for the Medical Device Product Development Process and Environment. Proceedings of the 2011 Design of Medical Devices Conference, Minneapolis, MN. 2011
- Validation Issues for a Complex Simulation Model of a DC. Proceedings of the Industrial Engineering Research Conference, Cancun, Mexico. 2010