About

15Lucisano_Joe051fxwb Lucisano Consulting’s Founder and President, Joseph Lucisano, PhD, has deep experience in medical device research, product development, regulatory navigation, clinical affairs, and business strategy and operations. Dr. Lucisano’s background in medical devices includes a long-standing focus in medical sensors, with an emphasis on implantable medical monitoring products. Lucisano Consulting was formed to deliver medical device R&D and business expertise to a wide range of clients in the medical and health technology field.

Dr. Lucisano has an extensive history of success securing awards and serving as principal investigator for competitive targeted R&D projects. Program awards include numerous grants and contracts from peer-reviewed programs at the National Institutes of Health, the National Institute of Standards and Technology, the U.S. Department of Defense, Breakthrough T1D (JDRF), and others.

Past service in medtech organizations includes roles such as Bioengineer, Scientist, Principal Engineer, Program Director, CTO, Founder/President/CEO, and Board Member. Consulting clients have spanned the gamut of size/stage, from small startups to Fortune 500 companies. Dr. Lucisano is a Senior Member of the Institute of Electrical and Electronics Engineers, a Fellow of the American Institute of Medical and Biological Engineering, and a Founding Member, Board of Trustees for the UCSD Jacobs School of Engineering, Department of Bioengineering.

Education

PhD Bioengineering · University of California San Diego
MS Aeronautics/Astronautics · Stanford University
BS Bioengineering · University of California San Diego

Selected Publications and Presentations

Lucisano, J, K Bertsch, P Gupta, L Kurbanyan, JT Lin, and S Martha, “Artifact Suppression Algorithm in a Second-Generation Long Term Implantable Continuous Glucose Monitoring System,” 11th International Conference on Advanced Technologies & Treatments for Diabetes (2018).
Paldus, B, DN O’Neal, AJ Jenkins, H Jones, SL Martha, SA McAuley, AT Butler, and JY Lucisano, “Patient Tolerance of a Long Term Fully-Implanted Continuous Glucose Monitoring (CGM) System in People with Type 1 Diabetes,” 11th International Conference on Advanced Technologies & Treatments for Diabetes (2018).
Engler, RL, JY Lucisano, and TL Routh, “Adoption Barriers for Continuous Glucose Monitoring and their Potential Reduction with a Fully Implanted System: Results from Patient Preference Surveys,” Clinical Diabetes, 36(1): 50-58, https://doi.org/10.2337/cd17-0053 (2018).
Lucisano, J, T Bailey, K Bertsch, P Gupta, L Kurbanyan, S Martha, L Morrow, and J Wilensky, “User Acceptability of a Long Term Fully-Implanted CGM System – Interim Clinical Results,” American Diabetes Association 77th Scientific Sessions (2017).
Lucisano, J, L Kurbanyan, S Martha, and T Routh, “Clinical Update with a Long Term, Unobtrusive, Fully-Implanted Continuous Glucose Monitoring System,” 10th International Conference on Advanced Technologies & Treatments for Diabetes (2017).
Lucisano, JY, TL Routh, JT Lin, and DA Gough, “Glucose Monitoring in Individuals with Diabetes using a Long-Term Implanted Sensor/Telemetry System and Model.” IEEE Transactions on Biomedical Eng, 64(9): 1982-1993, 10.1109/TBME.2016.2619333 http://ieeexplore.ieee.org/document/7600444/ (2017).
Lucisano, JY “Update of Clinical Experience with a Long Term Fully-Implanted Continuous Glucose Monitoring System.” Sixteenth Annual Diabetes Technology Meeting (2016).
Lucisano, JY and DA Gough, “Continuous, Long-term, Fully Implanted Glucose Sensor.” NIH Fourth Artificial Pancreas Workshop: Testing and Adoption of Current and Emerging Technologies, Bethesda, MD (2016).
Lucisano, JY, TL Routh, JE Lucisano, E Watkins, “Late-Breaking Human Clinical Results from a Second-Generation Long Term Fully-Implanted Continuous Glucose Monitoring System.” Fifteenth Annual Diabetes Technology Meeting (2015).
Lucisano, JY, TL Routh, and RL Engler, “Patient Preference Assessment of a Long Term Fully-Implantable Continuous Glucose Monitoring System,” Fourteenth Annual Diabetes Technology Meeting (2014), A69.
Kumosa, LS, TL Routh, JT Lin, JY Lucisano, and DA Gough. “Permeability of subcutaneous tissues surrounding long-term implants to oxygen.” Biomaterials 35 (2014) 8287-8296.
Gough, DA, LS Kumosa, MM Tong, TL Routh, JT Lin, and JY Lucisano. “Fully Implanted Sensors: Demise of the ‘Impermeable Tissue’ Hypothesis,” The Tissue Response to Implanted Active Medical Devices Meeting, Herndon, Virginia (2014).
Lucisano, JY, DA Gough, TL Routh, JE Lucisano, and JT Lin, “Long Term, Fully-Implanted, Self-Contained Subcutaneous Glucose Sensor: Results from Clinical Evaluation and Applicability for Closed Loop Systems,” NIH Workshop on Innovation towards an Artificial Pancreas (2013).
Gough, DA, P Kaveh, T. Routh, JT Lin, and JY Lucisano, “Long-Term Implanted Glucose Monitor for Diabetes: Unique Challenges and Recent Results,” The Pittsburgh Conference (Pittcon) (2013).
Lucisano, JY, TL Routh, M Hompesch, and JE Lucisano, “Application of the Long Term Implantable Continuous Glucose Monitoring (ICGM) System in a Human Subject,” Twelfth Annual Diabetes Technology Meeting (2012) S37.
Gough, DA, LS Kumosa, TL Routh, JT Lin, and JY Lucisano, “Function of an Implanted Tissue Glucose Sensor for More than 1 Year in Animals,” Science Translational Medicine 2 42 (28 July 2010) p42ra53.

Patents (additional pending)

US #11,278,668 “Analyte sensor and medicant delivery data evaluation and error reduction apparatus and methods,” with P Gupta.
US #11,255,839 “Apparatus and methods for analyte sensor mismatch correction,” with P Gupta.
US #10,736,553 “Method of manufacturing an analyte detector element,” with B Javidi, L Kurbanyan, J Lin, T Routh, and B Walker.
US #10,660,550 “Implantable sensor apparatus and methods,” with J Wilensky and R Engler.
US #10,638,979 “Analyte sensor data evaluation and error reduction apparatus and methods,” with P Gupta.
US #10,638,962 “Bio-adaptable implantable sensor apparatus and methods,” with T Routh and J Lin.
US #10,561,353 “Biocompatible implantable sensor apparatus and methods,” with B Javidi, L Kurbanyan, J Lin, T Routh, and B Walker.
US #10,561,351 “Tissue implantable sensor with hermetically sealed housing,” with MB Catlin, WJ Choi, PC Chu, JT Lin, TL Routh, and TG Wallner.
US #10,041,897 “Hermetic Implantable Sensor,” with MB Catlin.
US #9,782,111 “Hermetic Feedthrough Assembly for Ceramic Body,” with RE Calou, MB Catlin, JT Lin, and TL Routh.
US #8,763,245 “Hermetic Feedthrough Assembly for Ceramic Body,” with RE Calou, MB Catlin, JT Lin, and TL Routh.
US #7,894,870 “Hermetic Implantable Sensor,” with MB Catlin.
US #7,871,456 “Membranes with Controlled Permeability to Polar and Apolar Molecules in Solution and Methods of Making Same,” with DA Gough, JT Lin, HM Tsay, and D Lim.
US #7,336,984 “Membrane and Electrode Structure for Implantable Sensor,” with DA Gough.
US #7,248,912 “Tissue Implantable Sensors for Measurement of Blood Solutes,” with DA Gough, MC Jablecki, and MB Catlin.
US #7,235,350 “Alumina Insulation for Coating Implantable Components and Other Microminiature Devices,” with JH Schulman, R Shah, CL Byers, and SM Pendo.
US #7,160,672 “Alumina Insulation for Coating Implantable Components and Other Microminiature Devices,” with JH Schulman, R Shah, CL Byers, and SM Pendo.
US #6,844,023 “Alumina Insulation for Coating Implantable Components and Other Microminiature Devices,” with JH Schulman, R Shah, CL Byers, and SM Pendo.
US #6,721,587 “Membrane and electrode structure for implantable sensor,” with DA Gough.
US #6,472,122 “Method of Applying Insulation for Coating Implantable Components and Other Microminiature Devices,” with JH Schulman, R Shah, CL Byers, and SM Pendo.
US #6,043,437 “Alumina Insulation for Coating Implantable Components and Other Microminiature Devices,” with JH Schulman, R Shah, CL Byers, and SM Pendo.
US #6,027,479 “Medical Apparatus Incorporating Pressurized Supply of Storage Liquid,” with PE Alei, DK Wong, D Glazerman, and D Buse.
WO 99/43259 “Medical Apparatus Incorporating Pressurized Supply of Storage Liquid,” with PE Alei, DK Wong, D Glazerman, and D Buse.
US #5,985,129 “Method for Increasing the Service Life of an Implantable Sensor,” with DA Gough.
US #5,932,175 “Sensor Apparatus for use in Measuring a Parameter of a Fluid Sample,” with WL Knute, DK Wong, TJ Carlisle, and A Del Toro.
US #5,804,048 “Electrode Assembly for Assaying Glucose,” with DK Wong.
US #5,791,344 “Patient Monitoring System,” with JS Schulman, RL Lebel, AE Mann, OR Rule, and DI Whitmoyer.
US #5,660,163 “Glucose Sensor Assembly,” with JS Schulman, OR Rule, DI Whitmoyer, RJ Lebel, and A. E. Mann.
EPO #0505442 “Method for Increasing the Service Life of an Implantable Sensor,” with DA Gough.
US #5,497,772 “Glucose Monitoring System,” with JS Schulman, OR Rule, DI Whitmoyer, RJ Lebel, and AE Mann.
US #4,703,756 “Complete Glucose Monitoring System with an Implantable, Telemetered Sensor Module,” with DA Gough, JC Armour, and BD McKean.