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Publications and Presentations
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Featured Publication:
"A Study and Model of the Device Development Process - Conducted by Researchers at Stanford University Biodesign" (co-authored by J. B. Pietzsch)
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Journal and Conference Publications:
Pietzsch JB, Garner A, Cipriano LE, Linehan JH. "An Integrated Health-Economic Analysis of Diagnostic and Therapeutic Strategies in the Treatment of Obstructive Sleep Apnea." Submitted to SLEEP (Feb. 2010).
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.' April 2008.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.
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Invited Lectures and Other Presentations (selection):
IMD International Medical Devices Expo and Conference, San Jose, CA, Sept. 29, 2010. Presentation and Participation in Session "Global Opportunities & Challenges in Medical Device Development". Presentation Title: "Europe: The New Proving Ground for Innovation in Medical Devices."
Health Technology Assessment International Annual Meeting, Dublin/Ireland, June 7, 2010. Panel Participation – Panel Title: “Demand forecasting and early modeling in medical technology development - from theory to maximized value of HTA in practice.”
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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 | | SPOTLIGHT | | | Feb. 2010: Ardian Inc. retains Wing Tech to develop comprehensive health-economic model for it's Symplicity® Catheter System™. Ardian is a leading venture-funded medtech company developing a novel catheter-based treatment for hypertension. Read More |
|  | | SPOTLIGHT | | | Jan. 29, 2010: BME Seminar presentation by Jan Pietzsch at NU Chicago: "Thinking ahead - Value-based assessment of medical technology innovations in an era of health-care reform" Read More |
|  | | SPOTLIGHT | | | Oct. 15, 2009: World Health Summit Berlin - Wing Tech participates in Panel Discussion "How to Reimburse Innovations in Regenerative Medicine" Read More |
|  | | SPOTLIGHT | | | June 29, 2009: Best-practice model on medical device development published - Effort to support successful execution of bench-to-bedside process of technology commercialization Read More |
|  | | SPOTLIGHT | | | Apr. 7, 2009 "Effective Medical Device and Diagnostics Development" session at Medtec Japan in Yokohama chaired by Wing Tech Inc. Read More |
|  | | SPOTLIGHT | | | April 3, 2009: Stanford University Course "Technology Assessment and Regulation of Medical Devices" given Spring Quarter 2009 by Jan B. Pietzsch Read More |
|  | | SPOTLIGHT | | | Dec. 2008: Wing Tech Inc./ Wingtec GmbH provide risk management tools to BCRT to efficiently advance novel therapeutic concepts from R&D into the clinic. Read More |
|  | | SPOTLIGHT | | | Oct. 2008: Wing Tech Inc. participates in Northwestern University study assessing impact of technology in diagnosis and treatment of sleep apnea Read More |
|  | | SPOTLIGHT | | | May 2008 Workshop "Challenges for Translating T-Cell Therapy from Bench to Bedside" at Charité Berlin with Wing Tech participation. Read More |
|  | | SPOTLIGHT | | | "A Road Map for Device and Diagnostic Innovation:
Opportunities for Industry and Regulators," April 30, 2008 Washington D.C., with Wing Tech participation. Read More |
|  | | SPOTLIGHT | | | Jan Pietzsch to speak at World Leaders in Medical Innovations Conference on April 23, 2008 in London (UK) -- Global trends in the medical device industry Read More |
|  | | SPOTLIGHT | | | Wing Tech particiaptes in Stanford InHealth Research study on "Medical Device Development Models" Read More |
|  | | SPOTLIGHT | | | Independent Panel of Guidant Corporation cites Early Tech Assessment Work by Wing Tech Inc. Executive and Advisors Read More |
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