Tibor Duliskovich, MD
3535 Fiebrantz Drive,
Brookfield, Wisconsin 53005
(414) 828-0049, tibor@duliskovich.com, www.linkedin.com/in/duliskovich, www.duliskovich.com
2011 - present Medical Director, Patient Safety Center
of Excellence, GE Healthcare (from April 2014)
Previously Medical Director, MICT, DoseWatch
and Advanced Workstation
• Promoting medical consciousness and being the “Voice of the Patient” to the Leadership Team.
• Conducted
700+ post-market medical safety risk assessments, supported MDR reportability
determinations, presented recalls at the Post-Market Safety Review Board
(PSRB).
• Supported Molecular Imaging, CT, PET/CT, MR, PET/MR, Ultrasound, DGS, Surgery, Lunar, Healthcare IT, Advanced Workstation businesses over the tenure at GEHC. Currently covering pre-market design safety, evidence generation and post-market complaints for MR, PET/MR, Ultrasound and Informatics products, including AI (150+ product lines). Interacting with FDA, TGA, MHLW, NMPA, BfArM and other agencies.
• Designed and served as medical monitor for over 40 GE sponsored clinical trials for cardiac, pulmonary, neuro, oncology, pediatric, mammo indications and for radiation dose reduction. Supported close to 90 investigator initiated studies, many resulting publications. Medical monitor for all in-house volunteer scanning and research in ultrasound and MRI.
• Interpreted clinical trial results and communicated to regulatory resulting in FDA 510(K) and CFDA (China) registrations and extension of indications for use for multiple products.
• Served as industry representative and provided medical input into the MDCG (MDR) and IMDRF workgroups concerned with clinical evaluation of medical devices (see details on page 3 under Academic, Clinical and Regulatory Experience).
• Provided
medical risk assessments for post-market complaints, consolidated modality risk
assessment records, wrote multiple white papers to streamline Complaint
Handling Units decisions.
• Guided teams and approved the clinical evaluation plans and reports, and other MDR documents to support safety and performance claims for CE mark.
• Built
a portfolio of medical evidence to support NPIs, marketing claims and
reimbursement strategy, including a first-for-GE eDossier
published on Academy of Managed Care Pharmacy System (http://www.amcp.org/).
• Lead multiple Medical Advisory Boards for lung and breast cancer indications, coronary disease, myocardial viability, and dose management.
• Met in person with KOLs in academia and research institutions to help advance Company’s luminary and research strategy. Presented medical affairs vision, strategies and programs to major customers, for which received a Strategic Initiative Award from Quality-Regulatory and Chief Medical Officers.
• Revised multiple CT and X-Ray reference protocols against the AAPM Dose Check recommendations resulting in 10-15% dose reduction for patients.
• Performed
medico-clinical and risk assessments for acquisition due diligence for projects
totaling $500M+ USD.
• Created a “GE Physicians” group to facilitate interactions amongst 100+ GE doctors in various roles, businesses and geographies.
• Supported multiple initiatives, including HealthImagination, ValueLabs (UPMC CESM), i3 Innovation, London Olympics, PET/CT and PET/MR innovation summits, startup engagements. and others. Supported GEHC Education-As-A-Business strategies.
• Published four articles in CT Clarity magazine on safety and new emerging technologies.
• Continue to serve as medical liaison for medical societies (RSNA, ACR, ESR) and industry advocacy groups (currently COCIR, DITTA and MITA).
2008 – 2011 Sr. Product Manager, Enterprise Imaging Informatics at Philips Healthcare
• Member of Philips Healthcare global Medical Leadership Team, supporting strategic goals of Office of Medical and Health Affairs lead by dr. Eric Silfen CMO.
• Managed complete life-cycle of iSite Enterprise and iSite Radiology product lines and integration with clinical applications, including roadmaps, 3rd partner strategy, sales support, AOP. Delivered 9 releases of iSite PACS product lines that represented 95% of global customer base, all on time and on budget.
• NPI launch responsibilities, positioning, pricing, promotion, sales tools and knowledge transfer, collateral owner, interface to clinical end-users.
• Marketing owner of pre-development projects based on Scrum agile technology.
• Co-authored two patents on user interface and image manipulations by radiologists (http://www.freepatentsonline.com/WO2012001625.pdf, http://www.freepatentsonline.com/WO2012001637.pdf)
• Supported day-to-day quality, regulatory and patient safety activities, including but not limited to PACS, RIS, pathology and cardiology PACS, CT, XRays, PET/CT, MRI and ultrasound. Performed root cause analysis and closed numerous CAPAs.
• Validated a “gold dataset” of images for automated software testing.
• Virtualized entire RSNA demo environment.
• Medical Science Liaison to Field Organization.
• Started "Innovations in Radiology" Philips’ LinkedIn group and grew to 6000+ members before departure from Philips.
• Member of Bay Area Emergency Response Team.
2008 – current Owner
of largest private LinkedIn group dedicated to radiology (33K+ members)
• Diagnostic Imaging Group www.linkedin.com/groups/80424
2009 – 2010 Medical Consultant to Animage, LLC
• Consulted in a clinical trial for veterinary imaging modality. Generated evidence to support the marketing claims. Prepared the team for successful regulatory submission.
2009 Medical Consultant to National Semiconductor, division of Texas Instruments
• Due diligence on a medical technology acquisition deal worth $20M+ USD.
2001 – 2008 Medical Director, Aspyra, Inc.
• Led a team of clinical application specialists and medical writers.
• Developed requirements for PACS software and diagnostic mammography viewing station, redesigned GUI to assist radiologist workflow.
• Personally introduced our products into two international markets, found local integrator companies, formulated contracts and closed the deals.
• Coordinated clinical end-user training, performed on-site trainings. Introduced web-casts and CME-approved CBTs. Maintained demo database. Trained sales representatives.
• Supported major sales deals, dealt with unhappy customer sites.
2000 – 2001 Sr. Manager of Research and Development, Wuestec, Inc.
• Contributed to product definitions and design of digital X-ray detector.
• Transformed a concept into an X-ray film scanning production line and business.
• Participated in revising company’s Quality System in response to an FDA consent decree.
1998-2001 Medical Consultant to Medimon Engineering Service and Trading Co. Ltd.
•
MEDING
(member of IFMBE-CED) postgraduate continuing education program lecturer.
•
Input
into PACS/RIS software development.
1997-2000 Consultant to Medicor Roentgen Corporation, later acquired by GE Healthcare
•
Input
into R&D of medical equipment design, usability testing.
1995-2000 Medical Consultant to Variotrade Co. Ltd (Toshiba)
•
Medical
device testing and input into R&D.
•
Web
design, medical literature translation, education of team.
1994-2000 Consultant to Medicare Trading Co. Ltd. (GE ultrasound dealer)
•
Educating
and training ultrasound demo personnel.
•
Medical
and technical literature translation.
2017 – 2020 Industry expert (COCIR) into the
Medical Devices Coordination Group
I have
represented GE into COCIR as a medical expert, and represented COCIR as an
industry expert into MDCG that developed Guidance on clinical evaluation (MDR)
/ Performance evaluation (IVDR) of medical device software (https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_1_guidance_clinic_eva_md_software_en.pdf).
2015 – 2016 Industry expert (DITTA) into IMDRF
(International Medical Device Regulators Forum)
I represented
GE via DITTA (Diagnostic Imaging, HCIT, and Radiation Therapy Trade
Association, www.globalditta.org) and
worked with global regulators in IMDRF (I www.imdrf.org),
providing feedback into guideline development, clinical examples, and being
voice of industry in the Software as a Medical Device (SaMD, http://www.imdrf.org/workitems/wi-samd.asp)
workgroup.
1991 - 2000 Head of Organizational and Methodological Department at National Institute of Radiology and Radiation Physics, Budapest, Hungary
The role of NIRRP was similar to the role of FDA’s Center for Devices and Radiological Health.
• Responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary human exposure to man-made radiation from imaging devices.
• Made financial decisions up to 30-40% of the Institute’s annual budget. Built outstanding attrition record. Started with a team of 5 and grew it to 16.
• Validated and certified imaging equipment and software in clinical environment on patients (ultrasound and CT, bone densitometers, X-ray film scanners, RIS and PACS).
• Coordinated activities with national and international regulatory bodies. As part of a team, revised Hungarian medical devices regulations to harmonize with European ISO 9001 and EN 46001 prior to Hungary joining European Union.
• Pursued funding opportunities (grant applications, industrial contributions).
1996 Visiting Consultant Radiologist at Health
Center, Godollo
1995 Radiology Fellow at Haynal Imre Medical University, Budapest
1994 -
2000 Co-founder of Medirex 2000 Corp., a small primary care provider in Tura,
Hungary serving several thousand patients.
1991 - 1995 Radiology Resident at Haynal Imre Medical University, Budapest
• Residency training necessary for radiologist qualification.
• Research in the field of transrectal Color Doppler sonography and in 3D sonography technical solutions, particularly in examinations of human eye.
• Performed various forms of professional training, graduate and resident teaching.
2016 USA certified by the Board of Regulatory Affairs Professionals Society, http://raps.org/
2016 Certified
Magnetic Resonance Medical Director/Physician (MRMD) by the American Board of
Magnetic
Resonance Safety (http://www.abmrs.org)
1991 - 1995 Board Certified Diagnostic Radiologist, Haynal Imra Medical University, Budapest
1985 - 1991 Medical Doctor, Semmelweis Medical University, Budapest
1990 Paramedic Doctor, Semmelweis Medical University, Budapest
2013 Strategic Excellence Award of GE Healthcare QRM business.
2010 American Heart Association Certified Adult/Child First Aid Provider.
2006 Certified PACS Associate (PACS Administrator Registry and Certification Association).
2000 European Computer Driver License (ECDL) certification.
1999 Nycomed research award.
1998 The Society of Hungarian Radiologists ultrasound school educational grant.
1997 European Federation of Organisations for Medical Physics summer physics school grant.
1995 The Royal College of Radiologists research grant.
1993 Medicom-Glaxo research award.
1985 Gold Medal of USSR Government for excellence in education (first in my school in 20 years).
2000 Nominated for board member position in The Society of Hungarian Radiologists (declined due to relocation to Canada).
1998 - 2000 MEDING (member of IFMBE-CED) postgraduate continuing education program lecturer.
1996 - 2000 Member of several governmental grant review committees.
1998 - 2000 Served via NIRRP as independent expert in law suits.
1994 - 2000 Editor of Radiological Bulletin (HU-ISSN 0133-2791)
2000 Lectured at Kandó Kálmán College of Electrical Engineering, Budapest
1999 Established internet website for Society of Hungarian Radiologists.
1998 Healthcare policy project as an external expert in Ministry of Health, Hungary.
1994 - 1995 Educational activities (principal investigator, student dissertation discussant).
1992 - 1994 Launched lecture tours on digital radiology for countryside hospitals in Hungary together with two other radiologists, visited over a dozen rural hospitals.
2015 - present Member of Regulatory Affairs Professionals Society
2009 - present Member of American College of Radiology
2007 - present Member of Radiological Society of North America
2006 - 2008 Member of PACS Administrator Registry and Certification Association
2004 - present Member of Medical Industry Technology Alliance
1994 - present Fellow of the Hungarian Medical Chamber
1994 - present Fellow of the The Society of Hungarian Radiologists
1994 - present Member of European Society of Radiologists
http://www.linkedin.com/in/duliskovich