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Journal and Conference Publications: Pietzsch JB, Liu S, Garner AM, Kezirian EJ, Strollo PJ. “Long-Term Cost-Effectiveness of Upper Airway Stimulation for the Treatment of Obstructive Sleep Apnea: A Model-Based Projection Based on the STAR Trial.” SLEEP Journal, Article first published online: 05 OCT 2014 (online ahead of print). Pietzsch JB, Garner AM, Herth FJ. “Cost-Effectiveness of Endobronchial Valve Therapy for Severe Emphysema: A Model-Based Projection Based on the VENT Study.” Respiration, Article first published online: 30 SEPT 2014 (online ahead of print; DOI:10.1159/000368088). Pietzsch JB, Geisler BP, Garner AM, Zeller T, Jaff MR. “Economic analysis of endovascular interventions for femoropopliteal arterial disease: A systematic review and budget impact model for the United States and Germany.” Catheterization and Cardiovascular Interventions (CCI) 84(4): 546-554. DOI: 10.1002/ccd.25536. Pietzsch JB, Liu S, Kezirian EJ, Strollo P. “Long-term cost-effectiveness of Upper Airway Stimulation for the treatment of obstructive sleep apnea – A model-based projection based on the STAR Trial. SLEEP 2014, Minneapolis, MN, June 2, 2014. Geisler BP, Egan BM, Cohen JT, Garner AM, Akehurst RL, Esler MD, Pietzsch JB. “Cost-Effectiveness and Clinical Effectiveness of Catheter-Based Renal Denervation for Resistant Hypertension.” JACC, Vol. 16, No. 14, 2012. October 2, 2012:1271–7. Pietzsch JB; Zanchi MG, Linehan JH. “Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience – Part 2: Medical Device Ecosystem and Policy”. J. Med. Devices 7(2), June 2013, doi:10.1115/1.4023131. Pietzsch JB; Zanchi MG, Linehan JH. “Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience”. Journal of Medical Devices, Vol.6, pp. 021015-021023, June 2012. Pietzsch JB; Garner A; Cipriano LE; Linehan JH. “An integrated health-economic analysis of diagnostic and therapeutic strategies in the treatment of moderate-to-severe obstructive sleep apnea.” SLEEP 2011;34(6):695-709. Pietzsch JB, Shluzas LA, Paté-Cornell ME, Yock PG, Linehan JH. "Stage-Gate Process for the Development of Medical Devices." Journal of Medical Devices, 3:2 (2009).Rao SK, Pietzsch JB. "Policy-Induced Constraints in the Design and Commercialization of Monitoring Devices." Journal of Medical Devices, 3:2 (2009). Arrow K, Auerbach A, et al. "Toward a 21st-Century Health Care System: Recommendations for Health Care Reform." Ann Intern Med; 493-495 (2009). DiDomenico PB, Pietzsch JB, Paté-Cornell ME. "Bayesian Assessment of Overtriage and Undertriage at a Level I Trauma Centre." Philosophical Transactions of the Royal Society A - Theme Issue 'Mathematical and statistical methods for diagnoses and therapies.' Phil. Trans. R. Soc. A, 366:1874 (2008), pp. 2265-2277. Pietzsch JB, Paté-Cornell ME. "Early technology assessment of new medical devices". International Journal of Technology Assessment in Health Care, 24:1 (2008), pp. 37–45. Pietzsch JB, Aquino LM, Yock PG, Paté-Cornell ME, Linehan JH. "Review of U.S. Medical Device Regulation." Journal of Medical Devices Vol. 1, December 2007, pp. 283-292. Pietzsch J.B., "Early-stage technology assessment: methods and opportunities", in: “Bringing HTA into practice – 2nd Annual HTAi Meeting, Rome, 20th-22nd June 2005”: Italian Journal of Public Health, Vol.2, No.2, Summer 2005, Supplement 1, pp.74-75. Pietzsch J.B., Paté-Cornell M.E., Krummel T.M., "A Framework for Probabilistic Assessment of New Medical Technologies," in: Spitzer C, Schmocker U, Dang VN. (eds.). “Probabilistic Safety Assessment and Management (PSAM7-ESREL’04): Proceedings of the 7th International Conference on Probabilistic Safety Assessment and Management, 14-18 June 2004, Berlin Germany.” Springer-Verlag , London UK (2004), pp.2224-2229. Pietzsch J.B., Paté-Cornell M.E., Krummel T.M., "Methods for Early Assessment of New Medical Technologies: An Overview of Relevant Quantitative Modeling Tools," Proceedings of the 19th Annual Meeting of the International Society of Technology Assessment in Health Care, Canmore, Canada, June 2003. Haberland C.A., Benitz W.E., Sanders G.D., Pietzsch J.B., Yamada S., Nguyen L., Garber A.M., “Perinatal screening for group B streptococci: cost-benefit analysis of rapid polymerase chain reaction,“ Pediatrics, Vol. 110, No.3, September 2002, pp.471-80. Pietzsch J.B., Krummel T.M., Paté-Cornell M.E., “Early Technology Assessment of New Medical Devices and Procedures: A Systems Analysis Approach using Probabilistic Modeling,” Proceedings of the 18th Annual Meeting of the International Society of Technology Assessment in Health Care, Berlin, Germany, June 2002. Pietzsch J.B., DiPentino F.R., DiDomenico P., et al., “A Systems Analysis of Santa Clara County’s Trauma System,” Report to the Santa Clara County Trauma Audit Committee, Santa Clara CA, June 2001. Pietzsch J.B., Gemuenden H.G., Bolz A., “General Conditions and Success Factors of Telemedical Innovations,” Biomedizinische Technik - Biomedical Engineering, Vol. 46, Issue 4, 2001, pp. 96-100, Apr. 2001. Pietzsch J.B., Gemuenden H.G., Bolz
A., “Erfolgsfaktoren bundesdeutscher Telemedizinprojekte,” in: Telemedizinfuehrer
Deutschland, A. Jaeckel, Ed., Ober-Moerlen: Medizin Forum AG, 2000, (Chapter
2, pp. 49-52). [in German]. Patents: Kanthi Kiran, James M. Lovette, Nicholas Mourlas, Jan B. Pietzsch, “Methods and Devices for Modulating Atrial Configuration," patent application filed with the U.S. Patent and Trademark Office (PTO Reg. No. 10/388,606) through Stanford Office of Technology Licensing, March 2003. Kanthi Kiran, James M. Lovette, Jan B. Pietzsch, Nicholas Mourlas, “Methods and Devices for Modulating Atrial Configuration,” provisional application filed with the U.S. Patent and Trademark Office (PTO Reg. No. 60/384,633) through Stanford Office of Technology Licensing, May 2002. Kanthi Kiran, James M. Lovette, Jan
B. Pietzsch, “Catheter-Based Delivery of RF-Energy to Modify the Left Atrium
to Prevent Clot Formation in Chronic Atrial Fibrillation Patients,” provisional
patent application filed with the U.S. Patent and Trademark Office (PTO Reg.
No. 60/364,165) through Stanford Office of Technology Licensing, March 2002. Invited
Lectures and Other Presentations (selection): Northwestern University, Chicago, Jan. 29, 2010. BME
Department Seminar. Lecture Title: "Thinking ahead
- Value-based assessment of medical technology innovations in an era of health
care reform."
World Health Summit 2009, Berlin/Germany, Oct. 15, 2009. Presentation and participation in Panel "How to Reimburse Innovations in Regenerative Medicine?" Presentation Title: "Health Technology Assessment and Reimbursement of Innovative Technologies in the International Context - Overview and Implications." BSRT International Summer School on Regenerative Therapies, Berlin, Germany, July 29, 2009, Keynote Lecture, Title: "Health-economic concepts for tissue regeneration." American Thoracic Society ATS 2009 International Meeting, San Diego, CA, May 18, 2009, Poster Presentation, Title: "An end-to-end analytical model of OSA diagnosis and therapy – Assessing the impact of technology and policy choices on patient outcomes." (Pietzsch JB, Garner A, Cipriano LE, Linehan JH). Advamed 2009 Emerging Growth Company Conference, Newport Beach, CA, May 5, 2009, Invited Talk, Presentation Title: "What is the best model for device development? - Final results of a study based on 80+ device experts (industry & government)." MEDTEC Conferences, Session Chair of day-long industry
workshops, Session Title: "Effective
Medical Device and Diagnostics Development". Medtec Europe, Stuttgart, Germany, March 3, 2009;
Medtec UK, Birmingham, UK, March 24, 2009; Medtec Japan, Yokohama, Japan,
April 7, 2009.
Stanford Center for Professional Development, Stanford, CA, March 10, 2009, Webinar, Title: "Focus on Innovation: New Trends in Technology Assessment and Regulation of Medical Devices." Medical Design & Manufacturing MD&M Conferences, Session Co-Chair of day-long industry workshops, Session Title: "Effective Medical Device and Diagnostics Development" (together with John Linehan, Ph.D.). MD&M East Conference, New York City, June 4, 2008; MD&M Minneapolis, Oct. 22, 2008; MD&M West Anaheim, Feb. 10, 2009. Symposium "Principles and Applications of Adoptive T-Cell Therapy", Berlin, Germany, May 28, 2008, Title: “Challenges of Translating T cell Therapy from Bench to Bedside – Health-economic Considerations and Reimbursement” InHealth Conference 'A Road Map for Device and Diagnostic Innovation: Opportunities for Industry and Regulators', Washington DC, April 30, 2008, Title: "The Medical Dervice Innovation Process" (together with John Linehan, Ph.D.). NHS "World Leaders in Medical Innovations" Conference, London (UK), April 23, 2008, Global Trends & Innovations in Medical Devices, Title: "The evidence does not lie: What's happening to the medical device industry" BIOMEDevice Forum, San Jose, CA, October 3, 2007,
IP and Technology Development Session, Title: “Defining
the Product Development Process” (together with John Linehan, Ph.D.).
AdvaMed 2007 Medical Technology Conference, Washington, D.C. October 2, 2007, Title: “Device and Diagnostic Development: The Bridge Bench to Bedside” (together with John Linehan, Ph.D., and M. Elisabeth Paté-Cornell, Ph.D.). AdvaMed 2007 Medical Technology Conference, Washington D.C. October 1, 2007, Title: “The Challenges for Innovation Facing Emerging Growth Companies” InHealth Annual Symposium 2007 – Accelerating Technological Change – Value and Health Care Reform, Washington DC, July 16, 2007, Title “The Course of Device Development Never Did Run Smooth” (together with John Linehan, Ph.D.) Workshop 'Unternehmerische Charité', Berlin, Germany, July 7, 2007, Title: "Abschätzung von Marktpotentialen" [in German] INFORMS Annual Meeting, Applied Decision-Making in Health Care session, Pittsburgh, P.A. November 6, 2006, Title: "Strategic Decision-Support for Medical Technology Commercialization - Methods and Case Application" FDA Staff College 'Meet the Experts' Seminar Series, Title: “Early Technology Assessment of New Medical Devices", Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Rockville MD, November 1, 2004. FDA Regulatory Rounds Presentation, Title: “Methods of Systems Analysis and Probabilistic Modeling for Early Assessment of Medical Technologies - An Overview and Discussion,” Office of Device Evaluation, Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, October 14, 2003. |
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