standard-title Clients / Projects

Clients / Projects

Coordinated a FDA follow-up consult on-site for a medical device company, Philadelphia, PA (6/15/14 – 7/18/14)

Medical Device Consulting Clients Projects

  • Utilized expertise in Risk Management to review and update FMEAs (Failure Modes and Effective Analysis) as was needed
  • Reported and worked directly with the Research Director and Quality Engineering Personnel
  • Assessed production lines and determined where quality checks and controls were needed to be implemented
  • Reviewed validations and documents their document management system and researched all materials that were applicable to the FMEAs (Failure Modes and Effective Analysis).
  • Utilized statistical process and control and test method validations to support the implementation of the required quality checks and process controls
  • Identified root cause and implemented effective solutions to prevent event recurrence
  • Reviewed adverse medical device reports (MDRs), complaint investigations, corrective and preventive action (CAPA) reports, non-conformances and change controls
  • Analyzed and organized data from multiple sources in support of weekly updates and management review
  • Developed a Final Evaluation Report related to their current validation and verification tasks and provided recommendations as part of their submission to the FDA subsequent to a FDA site visit which had been approved by Therakos Research & Development and Quality Review Divisions

B. H. Barkalow & Associates to consult on orthopedic implant & cardiovascular device liability cases (3/19/14-present-representing the plaintiff)

Medical Device Consulting Clients Projects

  • Utilized expertise in FDA Device Controls and Risk Management for total knee implant systems
  • Reviewed 510(k) related to this specific knee implant system
  • Reviewed adverse medical device reports (MDRs) and other adverse events related to implant device failure
  • Working directly with Barkalow engineering personnel and legal support staff representing plaintiff
  • Assessed Current Good Manufacturing Practices (CGMP) practices used for present implant system failures
  • Reviewed total knee implant and bone cement validation and verification activities and document system and researched all materials that were applicable to liability case issues
  • Utilized statistical process and control and test method validations in investigation root cause of implant failure
  • Reviewed cardiovascular device and surgical system cases
  • Reviewed adverse medical device reports (MDRs), complaint investigations, corrective and preventive action (CAPA) reports, non-conformances and change controls
  • Analyzed and organized data from multiple sources in support of weekly updates and management review

Hospital Health Systems (Pittsburgh, PA)

  • Provided my expertise for a surgical device issue

A Security Systems Firm

  • Provided my expertise with implantable cardiac defibrillators (ICD) and cardiac pacemakers
  • Collaborated with heart failure therapy device firms on the development of testing protocols for both ICDs and cardiac pacing devices
  • Retained by this Security Systems’ firm to ensure the safety of patients who wear these devices and are required to pass through their security systems

Retained as an expert witness for the following medical systems

  • 1 Magnetic resonance Imaging (MRI) System
  • 8 total knee and total shoulder implant system cases
  • 3 implantable cardiac device (ICD) lead issues associated with specific models developed by an lCD manufacturer
  • 1 heart rate monitoring system
  • 1 neonatal monitoring system
  • 1 surgical navigation system for an orthopedic application
  • 1 remote patient monitoring system

Retained as an expert in the R&D and patent related development

  • Diabetic monitoring system being developed by a start-up in the France and the UK

Retained as an expert by GLC

  • Marketing strategist to be used by three start-up companies who had been involved with chronic heart failure device, diabetic monitoring, and atrial fibrillation systems

A Medical Device Start-up Firm (Cleveland, OH) – retained as an Expert on the R&D

  • New electrocardiogram (ECG) electrode system

Retained as a Medical Imaging Consultant by a cardiovascular device company

  • Novel application related to their internal cardiac defibrillator (lCD) device

Projects List

  • Surgical wound care research with Adam Saltman, MD (affiliated with Downstate Health Center, Brooklyn, NY)
  • Collaborated with software engineers affiliated Data Science International with an order to optimize their new software for heart failure therapy research used in preclinical device trials to optimize cardiac pacing (Cleveland Clinic’s Lerner Research Institute)
  • Research and Development of an innovation to optimize cardiac pacing (filed a provisional patent with the US patent office
  • Member of the Scientific Advisory board for Integral ElectroMagnetronic