研究领域
Medical device innovation process; health technology assessment; FDA regulation of medical devices
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Pietzsch, J. B., Aquino, L. M., Yock, P. G., Pate-Cornell, M. E., Linehan, J. H., Review of U.S. Medical Device Regulation, J. Med. Devices 1: 283-292, 2007.
Pietzsch, J. B., Pate-Cornell, M. E., Yock, P. G., Aquino, L. M., Linehan, J. H., Stage-Gate Process for the Development of Medical Devices, J. Med. Devices, 3: 021004-1 to 021004-15, 2009
Shluzas, L. A., Pietzsch, J.B., Paté-Cornell, M.E., Yock, P.G. Linehan, J.H. The Iterative Nature of Medical Device Design. In: Proceedings of the 17th International Conference on Engineering Design (ICED), Volume 1: Design Processes, 2009 Aug 24-27; Stanford, CA. Glasgow: The Design Society; p. 85-96, 2009
Shluzas, Lauren A., John H. Linehan and Larry J. Leifer. A Case Study of Physician Interaction in the Medical Device Development Process. J. Med. Devices, 4(2), 2010
Linehan, J.H., Chaney, A., Academic/Industry Challenges for Medical Device Development. Sci. Transl. Med. 2: 63mr6, 2010
Pietzsch, J. B., Garner, A., Cipriano, L.E., Linehan, J.H., An Integrated Health-Economic Analysis of Diagnostic and Therapeutic Strategies in the Treatment of Moderate-to-Severe Obstructive Sleep Apnea. SLEEP; 34: 695-709, 2011
Pietzsch, J. B., Zanchi, M. G., Linehan, J. H. Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience, J,J. Med. Devices, 6:021015 to 021023, 2012