David Orbach

David Orbach Email and Phone Number

Biomedical engineer, medical doctor, and clinical researcher @ Thermo Fisher Scientific
New York, NY, US
David Orbach's Location
New York, New York, United States, United States
About David Orbach

MD, MS (in BioMedical Engineering) with 15+ years of experience in caring for patients, teaching college bioscience courses, conducting lab and clinical research, working with EMR/EHRs, and performing quality assurance and quality improvement for oncology diagnostics.I’ve helped five startup teams raise $4 million, $1 million, $30,000, $5,000, and $500 to develop medical products, in vitro diagnostic biosensors, a novel drug delivery platform “Bionaut", & synthetic biology projects.I also analyze data, improve health outcomes and patient satisfaction, advise startups, and consult for several health and wellness companies.Highlights:• Helped validate & optimize the chemistry for a US Govt bioweapon detection system.• Cornell University dual degree & MS in Biomedical Engineering & MD with highest honors.• Further trained in psychiatry, neurology & a Clinical Research Fellowship in emergency medicine and “clinical epidemiology and health service research”.• Successfully multi-tasked 2 full-time post-doctoral fellowships plus 9 Weill Cornell Medicine graduate courses, all concurrently, over two years.• Directed 2 programs and 3 Research & Development projects.• Developed & taught 7 college courses & co-managed 2 biology labs.• Founded an in-vitro diagnostics medical company & advanced in 3 accelerator programs including National Science Foundation (NSF) I-Corps, and “eLab” (at Cornell).• Took 3 MBA courses, learned marketing, and recruiting efforts, & increased student enrollment by 70%.• Trained and supported 34 out of 35 pre-medical students (97% success rate) with 9 of them entering combined MD/PhD programs.• Improved processing rates 20-fold with >99.9% accuracy to improve EMR/EHR interoperability.• Personable, resourceful, and comfortable in the operating room working with everyone.• Functions with a sense of urgency to improve outcomes and data accuracy and completeness.• Experienced with basic and applied research in industry, academia, & government labs and also clinical research in hospitals and clinics.• Familiar with surgery, radiology (especially ultrasound), data analysis, epidemiology, and public health, population health, social determinants of health (SDoH).Key words:* Diagnostics, point of care biosensors.* Immunohistochemistry.* Health Informatics* Medical devices* Quality Improvement & Quality Assurance* Workflow efficiency* Patient satisfaction* Electronic health records (EHR/EMR),* Developing lectures, courses, and use cases* Consulting* Business AnalystUS Citizen. Able to relocate, but prefer NYC or CT

David Orbach's Current Company Details
Thermo Fisher Scientific

Thermo Fisher Scientific

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Biomedical engineer, medical doctor, and clinical researcher
New York, NY, US
Website:
thermofisher.com
Employees:
99360
David Orbach Work Experience Details
  • Thermo Fisher Scientific
    Thermo Fisher Scientific
    New York, Ny, Us
  • Roche
    Senior Design Quality Engineer
    Roche Nov 2021 - Present
    Switzerland 🇨🇭 , Ch
    Roche Tissue Diagnostics.Ventana Medical Systems.• Support “Companion Diagnostics” - oncology biomarker immunohistochemistry (IHC) assay co-development with global pharmaceutical partner(s) including “digital pathology”. • Also help with Clinical Chemistry and Clinical Quality areas 10% of time.• Work with ~7 global pharmaceutical partners, on ~10 tumor biomarkers, spanning ~15 indications via cross-matrixed teams.• Interface with Regulatory Affairs, Assay Development, Clinical Development, Risk Management, Clinical Operations, Clinical Study Manager, Medical Writing, Pathology, Digital Pathology, Business, Manufacturing Operations, Biostatistics, Legal, Project Manager, Project Leaders, IT, etc.• Proofread and approve version-controlled documents (milestone deliverables) before review by FDA & global health authorities.• Maintain Design History File (DHF) in a state of audit readiness; ensure inspection readiness; ensure traceability & completeness.• Support and/or approve technology assessments, design reviews, milestone reviews and/or help colleagues and partner(s).• Helped transition to a new modular Quality Management System (QMS) by presenting plan, steps to implement, guiding teams, managing expectations, training, supporting, coaching, mentoring.• Comply with 21 CFR 820, ISO 13485:2016 (QMS) Quality Management Systems, ISO 14971:2019 (Risk), ISO 20916 (Clinical), Regulation (EU) 2017/746 (IVDR) (Europe), ICH/GDP, GCP, GMP, (GxP), CAP/CLIA, Standard Operating Procedures (SOP), CLSI, etc.• Also review and approve Diagnostic Protocols, Investigator Brochures, Validation Plans and Reports, Summary of Analytical Performance, Performance Evaluation Plan, Clinical Performance Report.• Use SAFe Agile, ServiceNow, SharePoint, Confluence, Jira, Kiteworks, Trello, Veeva, Smartsheet, Monday, Wiki, etc.• Aware of audits (TUV, MDSAP, and pharma partner), and help with FDA pre-sub meetings & responses to FDA feedback and root cause investigations.
  • Northwell Health
    Clinical Analyst - Population Health - Medical Informatics
    Northwell Health Nov 2019 - May 2020
    Lake Success, Ny, Us
    Helped with the initial wave of COVID EHR efforts in the largest private hospital system in NYS. Captured business needs from stakeholders amidst changing regulations, mapped clinical workflow, and documented software improvement requirements.Helped to predict, prioritize, and design EHR changes to meet clinical and business needs in a highly-dynamic environment.Liaised with software developers, beta tested new builds, helped train users, improved health outcomes for Medicaid “Health-Homes” patients.{6-month contract via Starpoint/YOH recruiter}
  • Toxistat (Medical Device Startup)
    Lead Engineer, Cofounder
    Toxistat (Medical Device Startup) Jun 2015 - Dec 2019
    Focused on creating in-vitro diagnostic device to quantify cyanide to help emergency responders treat victims of house-fire smoke inhalation, industrial spills, and military and homeland security incidents.Participated in pre-seed workshop, eLab, and NSF I-Corps NYCRIN program:Spoke to customers to discover true end-users, customers, purchasers, influencers, saboteurs, identify product-market fit, customer segmentation, value propositions, key resources, key partners, etc.Won $30,000 in grant funding from NYSTAR/CCMR/JumpStart, NIH-CTSC, & eLab to develop organic polymer to sensitively and specifically bind and quantify cyanide levels in blood using nanofabricated organic field-effect transistors (OFETs). Gained cleanroom experience at the Cornell Nanoscale Facility (CNF), liaised with IRB, IACUC animal care and use committee, Environmental Health and Safety, Office of Sponsored Programs to ensure all pieces were present before proceeding.Read FDA 21 CFR Part 820 while still focusing on product development and learned about 510(k) and PMA pathways, IDE, de novo, pre-submission inquiry meeting, quality management systems, etc. [Keywords: customer segmentation, value proposition, minimal viable product (MVP), sales channels, marketing, business plan, business model canvas, voice-of-the-customer (VOC), client-facing, stakeholder analysis, point of care, POC, proof of concept.]Also helped students and other startups around Cornell and remotely via InnoCentive platform:1) Health Hackathon Mentor/Advisor at Cornell University and Weill Cornell Medicine (e.g., a 3D printed prosthetic hand and wrist device with proximity and force sensing and LED array indicator).2) NASA Innocentive Challenge: Designed a Compact Aerobic and Resistive Exercise System for Astronauts on long space flights and ventures >3 months.
  • Nyc Surgical Associates
    Director Of Research
    Nyc Surgical Associates Jun 2018 - Dec 2018
    New York, Ny, Us
    * Aggregated and analyzed data for 500+ patients with pelvic congestion syndrome (a.k.a. pelvic venous hypertension), nutcracker phenomena, lymphedema, lipedema, hernia, etc.* Streamlined clinical data collection mechanisms and digitized surveys.* Recommended IRB oversight for several novel clinical studies involving venous angiography, fluoroscopy, embolization, balloon angioplasty, venous stenting, intravascular ultrasound (IVUS), laser ablation, sclerotherapy, mesh removal, liposuction, etc.* Collaborated with colleagues in four surgical sites around NYC/NJ.[Keywords: interventional, endovascular, endovenous, chronic venous obstruction, Gelfoam, coil, WALLSTENT, renal vein, IVC, greater saphenous vein, uterus, bladder, varicose veins.]
  • Bionaut Labs
    Contractor (Pre-Clinical Development Scientist & Engineer)
    Bionaut Labs Mar 2017 - Mar 2018
    Los Angeles, Ca, Us
    * Helped team win $4 million in Series A funding round from Khosla Ventures.* Worked collaboratively at the junction of clinical trials, oncology, and novel drug-delivery device research and development at the Max Planck Institutes for Intelligent Systems in Stuttgart, Germany.* Reviewed literature and recommended clinical treatment endpoints for a novel therapeutic delivery system for three oncology indications.* Evaluated contract research organizations (CROs), designed international animal trials, and selected optimal animal models and solid tumors for evaluation.* Experimented with animals ex-vivo using ultrasound imaging, tracking, and external magnetic targeting/maneuvering/guidance system and planned in-vivo animal test protocols to investigate the efficacy, safety, and toxicology with CRO in Germany.* Innovated technical solutions to novel problems, captured images, analyzed data, and wrote reports to benefit interdisciplinary teams.[Keywords: In vivo imaging system (IVIS), IACUC animal care and use committee, rabbits, rats, animal trials, pre-clinical, clinical trial design, histology, ultrasound, high-intensity focused ultrasound (HIFU), fibroids, solid tumors, brain cancer, liver cancer, literature summarization.](Company emerged from stealth mode on 3/3/2021)
  • Cornell University
    Director Of Masters Program In Biological Engineering / Lecturer
    Cornell University Nov 2014 - Nov 2015
    Ithaca, Ny, Us
    Directed and marketed the MEng Program in Biological and Environmental Engineering.Taught “Professional Development and Industry Survival Skills”. Mentored graduate students in design projects.Started medical device company based on Cornell-owned technology.Developed polymer-based sensors to solve emergency problems (cyanide toxicity)Collaborated with industry, faculty, and hospitals to develop projects and gained laboratory funding.Recruited, oriented, and advised students toward successful careers.Tutored and counseled students in need.
  • Intelligent Medical Objects
    Subject Matter Expert - Health Informatics
    Intelligent Medical Objects Jun 2013 - Jan 2014
    Rosemont, Il, Us
    * Helped build a concept-based database to streamline and facilitate patient care and research via controlled vocabulary and easier population of structured data fields ("Semantic interoperability").* Served as subject matter expert for procedures involving surgery, radiology, microbiology, pathology, and laboratory domains. Used clinical terminology to optimize EMRs for 3500+ hospitals using SNOMED CT, medical terminology, etc.* Increased processing efficiency 20-fold using engineering and medical backgrounds.* Training in "Health Informatics" via online courses ever since.[Keywords: HL7, ICD9, ICD10, migrating, ontology, EHR, EMR, IMO, data abstraction, accuracy, procedures, orthopedic surgery, gynecological procedures, interventional radiology, blood bank, biobank, antibiotic susceptibility testing (AST), clinical, research.]
  • The Cooper Union For The Advancement Of Science And Art
    Assistant Director - Center For Biomedical Engineering & Visiting Assistant Professor
    The Cooper Union For The Advancement Of Science And Art Aug 2010 - Jul 2013
    New York, Ny, Us
    * Developed and taught four additional biology and bioengineering courses: -Pharmacology -Microbiology/Immunology -Pathogen Reduction Engineering. -Special Topics in Bioengineering -Genetic Engineering/Synthetic Biology.* Pre-Medical Advisor:Taught, advised, mentored, and wrote letters of recommendation resulting in 34 of 35 students getting accepted into medical school, with 9 students getting into MSTP or combined MD/PhD programs.* Co-managed the Center for Biomedical Engineering.* Co-instructed award winning multi-centered student teams with Columbia University and GenSpace. (IGEM gold medal 2011 and bronze medal in 2012.)* Gained over $5000 in grants from private donors for research.
  • The Cooper Union For The Advancement Of Science And Art
    Post Doctoral Fellow, Adjunct Faculty
    The Cooper Union For The Advancement Of Science And Art Aug 2008 - Jul 2010
    New York, Ny, Us
    * Developed and taught biology and bioengineering courses with labs (Cell & Molecular Biology, Anatomy & Physiology) * Served as Pre-Medical Advisor:* Mentored students in several research projects (Cardiac cell sheet tissue engineering education modules, redesign urinary catheters etc.)* Helped bring in $1,000,000 in grant funding via a presentation to the Board of Trustees* Promoted to a 3-year position for excellence in teaching, mentoring, research, innovation, and budgeting.
  • Newyork-Presbyterian Brooklyn Methodist Hospital
    Emergency Medicine "Ecrip" Fellow (Empire State Clinical Research Investigator Program)
    Newyork-Presbyterian Brooklyn Methodist Hospital Aug 2008 - Jan 2010
    New York, New York, Us
    * Designed and conducted a quality improvement study to analyze the process of patient care and patient throughput.* Directly evaluated emergency room, lab, pharmacy, CT Suite, transporters, radiology, admitting, nurses, doctors, and consult services to verify automated time stamps and sought staff input.* Engaged staff to identify root causes of delays and compiled ideas.* Automated the data extraction and collection process collaboration with the IT department and quality assurance division. Used Cerner, PACS, Excel, STATA, ACCESS.* Analyzed big data sets to identify bottlenecks in the process of care.* Recommended changes to hospital administration to streamline workflow and patient satisfaction.* Funded by NYS-DOH Empire State Clinical Research Investigator Program ("ECRIP") training grant.
  • Stony Brook University
    Intern / Resident Physician
    Stony Brook University Jul 2007 - Jun 2008
    Stony Brook, Ny, Us
    * Diagnosed, treated, and managed the care of patients with mental, neurological, medical, and surgical issues.* Collaborated with 100 different colleagues from different service teams (e.g., cardiology, neurology, obstetrics, endocrine, oncology, nephrology, etc.) to ensure best care for my patients.* Passed all USMLE’s.* Merit award winner.* Worked 80 hours per week as a physician supervised by a different attending each month.Used Cerner, PowerChart, PACS, VA hospital system. Also familiar with Aprima, STATA, Excel, Access, PowerPoint.
  • Lawrence Livermore National Laboratory
    Summer Technical Scholar - Medical Technology Program - Physics Directorate
    Lawrence Livermore National Laboratory Jun 2001 - Aug 2001
    Livermore, Ca, Us
    * Assisted development of a rapid, sensitive, specific pathogen detection system with multiplex capability for detecting food-borne illness pathogens, select agents (bioweapons), and point-of-care biomarkers for diagnosis.* Gained public trust security clearance.
  • The National Institutes Of Health
    Summer Researcher
    The National Institutes Of Health Jun 2000 - Aug 2000
    Bethesda, Md, Us
    * Used advanced analytical equipment to help elucidate the causes and treatments for seizures and epilepsy. * Used combined Gas Chromatography - Mass Spectroscopy to measure neurosteroid concentrations in blood samples of animals with decreased seizure thresholds just before their menstrual cycles.
  • W.L. Gore & Associates
    Summer Assay Intern - Medical Products Division - Technology Development Group
    W.L. Gore & Associates Jun 1998 - Aug 1998
    Newark, Delaware, Us
    * Designed and developed an assay to measure permeability / protein transport across walls of ePTFE (GoreTex) vascular grafts.* Tested various parameters & samples; * Wrote a computer program to analyze results; * Optimized novel graft designs;* Presented finding to colleagues and published an internal report.

David Orbach Education Details

  • Joan & Sanford I. Weill Medical College Of Cornell University
    Joan & Sanford I. Weill Medical College Of Cornell University
    Clinical Epidemiology & Health Service Research ("Summer Intensive Program" Of 9 Graduate Courses)
  • Ross University School Of Medicine
    Ross University School Of Medicine
    Medical Doctor
  • University Of Rochester
    University Of Rochester
    Biomedical Engineering
  • Cornell University
    Cornell University
    Biological/Biosystems Engineering

Frequently Asked Questions about David Orbach

What company does David Orbach work for?

David Orbach works for Thermo Fisher Scientific

What is David Orbach's role at the current company?

David Orbach's current role is Biomedical engineer, medical doctor, and clinical researcher.

What schools did David Orbach attend?

David Orbach attended Joan & Sanford I. Weill Medical College Of Cornell University, Ross University School Of Medicine, University Of Rochester, Cornell University.

Who are David Orbach's colleagues?

David Orbach's colleagues are Gary Lewis, Alex Tattersall, Annamária Csukás, Jeremy Welsh-Kavan, Marianne Zanetakos, Selene Espino, Isidro Garza.

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