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Tibor Duliskovich, MD
14960
Shamrock Lane, Brookfield, Wisconsin 53005
(262) 391-6852, tibor@duliskovich.com, 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 300+
post-market safety risk assessments, supported MDR reportability
determinations, presented recalls at the Post-Market Safety Review Board
(PSRB).
• Supported Molecular Imaging, CT, MR, PET/MR, Ultrasound, DGS, Surgery, Lunar, Healthcare IT, Advanced Workstation businesses with teams spread all over the globe. Covering pre-market design safety and post-market complaints for 17 product lines in CT, 80+ applications on AW platform, IDI and DoseWatch, 20+ products in HCIT, 4 Lunar, 7 MR and PET/MR and 50+ platforms/product lines in ultrasound businesses and surgery.
• 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 resulting publications.
• Interpreted clinical trial results and communicated to regulatory resulting in FDA 510(K) and CFDA (China) registrations and extension of indications for use for virtual-unenchanced imaging and nephrolith characterization in dual-energy CT, MR MAGIC and SAR, PET/MR SUV MR-based bone correction.
• Continue to provide medical input into the International Medical Device Regulators Forum, Software as a Medical Device: Clinical Evaluation workgroup (SaMD, http://www.imdrf.org/workitems/wi-samd.asp).
•
Worked with
CHU to consolidate modality RACs with the global RAC. Wrote multiple guidelines
to empower CHU.
• Completed clinical literature evaluation summaries (CESR) to support safety and performance claims for CE mark per MEDDEV 2.7/1 of supported products.
• 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.
• Revised multiple CT and X-Ray reference protocols against the AAPM Dose Check recommendations resulting in 10-15% dose reduction for patients.
• Met face-to-face over 200 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.
•
Performed
medico-clinical and risk assessments for acquisition due diligence for projects
totaling $500M+ USD.
• Medical Affairs representative into GE’s Government Relationships team (until April 2014)
• Created a “GE Physicians” group to facilitate interactions amongst 100+ GE doctors in various roles, businesses and geographies. Manage monthly calls.
• Supported HealthImagination, ValueLabs (UPMC CESM), i3 Innovation, London Olympics, PET/CT innovation workshop and PET/MR innovation summit.
• Supported GEHC Education-As-A-Business strategies.
• Published four articles in CT Clarity magazine on topics important for business, all related to radiation safety and diagnostic performance.
• Continue to serve as medical liaison for medical societies (RSNA, ACR, ESR, SHR) and industry advocacy groups (DITTA, MITA, Dose Index Registries, ImageWisely).
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, all on time of iSite PACS product lines that represented 95% of global customer base.
• 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.
• Member of Emergency Response Team.
2008 – current Owner of largest 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.
• Prepared supporting documentation and the team for 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.
• 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 a 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.
2015 – current Industry
expert in IMDRF (International Medical Device Regulators Forum)
I
have the honor to represent GE and the medical devices industry via DITTA
(Diagnostic Imaging, HCIT, and Radiation Therapy Trade Association, http://globalditta.org/about/about-ditta/)
and work with global regulators in IMDRF (International Medical Device
Regulators Forum, http://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 Certified Adult/Child First Aid Provider, American Heart Association.
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 and travel 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 Medimon Corporation and MEDING (member of IFMBE-CED) postgraduate continuing education program lecturer and writer.
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 Several month long healthcare policy project as an external expert in Ministry of Health.
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.
2014 - present Member of Society of Radiologists in Ultrasound
2009 - present Member of American College of Radiology
2008 - 2010 Member of The Association for Medical Imaging Management (AHRA)
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
1998 - present Member of Association of Physicists in Medicine
1995 - present Member of Roland Eotvos Physical Society
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
Native in Russian, Hungarian. Proficient in English (Academic IELTS test score 8.5 out of max. 9) and Ukrainian.
http://www.duliskovich.com/recommendations/index.htm
http://www.linkedin.com/in/duliskovich
Gemstone Spectral Imaging's Role as a Biomarker for Numerous Clinical Conditions. CT Clarity Magazine, November 2013.
How Can Industry Partner with Organizations and Providers to Reduce Patient Dose? CT Clarity magazine, December 2012.
Does My Patient Need a CT Scan? CT Clarity magazine, December 2011.
Photon Counting: A New CT Technology Just Over the Horizon. CT Clarity magazine, December 2011.
Medical Devices: Career Opportunities for Medical Professionals in Healthcare Informatics, Advanced Clinical Applications and Imaging Modalities industry. Presented on May 11th, 2010 at Stanford School of Medicine Career Center, Munzer Auditorum. Watch presentation, download PowerPoint.
The Foreseeable Technological Advancements, Clinical Expectations and Financial Challenges in Diagnostic Imaging. Presented at annual meeting of Association of University Radiologists on March 26th, 2010 http://www.duliskovich.com/publications/Radiology_2030_FULL.ppt.
Teleradiology (clinical and ethical issues). Journal of Healthcare Managers, Volume VI., N3. 2007, April, 39-44 p. http://www.imeonline.hu/article/633/15.pdf
Teleradiology (technical issues). Journal of Healthcare Managers, Volume VI., N2. 2007, March, 43-47 p. http://www.imeonline.hu/article/623/16.pdf
PACS economics. Journal of Healthcare Managers, Volume VI., N1. 2007, February, 37-42 p. http://www.imeonline.hu/article/610/14.pdf
PACS planning, evaluation, selection, configuration, deployment, QA. Journal of Healthcare Managers, Volume V., N10. 2006, December, 41-46 p. http://www.imeonline.hu/article/596/41_46.pdf
Outsourcing imaging library: the Achilles heal for PACS vendors. EuroPACS, Berlin. 2005. CARS 2005 PDF.
PACS/HIS/RIS integration and workflow. Journal of Healthcare Managers, Volume III., N6. 2004, September, 42-50 p. http://www.imeonline.hu/article/271/42_50.pdf
LCD vs. CRT for primary diagnostic reading. Training class syllabus. 2003 February. Download PDF.
Patient Dose-tailoring with Digital X-Ray Detectors. Kando Kalman Electro-Technical College, Budapest, Hungary. 2000 February, Lecture notes for Engineers.
Quality Control in Ultrasound Imaging: Radiological Bulletin, Volume 35 (Suppl.1) 1999, 50-59 p. (JPEG). Download scanned PDF.
Digital X-ray detector technologies: "Where is Digital Radiology in 1999?" symposium syllabus, 30th April 1999, Debrecen. (JPEG). Download scanned PDF.
RIS, PACS. Filmless Radiology in "IT Notes for Radiographers", October 1997. Download scanned PDF.
Up-To-Date Digital Image Archiving Techniques. Radiological Bulletin, Volume 32 (Suppl.1), (HU-ISSN 0133-2791), 1996, 80-89. (JPEG). Download scanned PDF.
Initial Experiences With Three-Dimensional Sonography of the Eye. Hungarian Ophthalmology 1995, 132: 231-236. Download scanned PDF.
CT Scanners Quality Assurance. Radiological Bulletin, Volume 31 (Suppl.1), (HU-ISSN 0133-2791), 1995, 124-134. Download scanned PDF.
Initial Experiences with Color Doppler Ultrasonography of Rectal Tumors. Lege Artis Medicinae 1994/4: 340-345 p. Download scanned PDF.