He was an outstanding expert before my jury; knowledgeable, yet not the least bit arrogant or patronizing. He makes the complex seem simple.

 

Services

Biomedical Engineering and Clinical Engineering services and consultation

Law Firm / Attorney

Plaintiff or Defense firms for issues related to medical technology

Medical Device Company

FDA regulated medical device and medical technology businesses

 

Federal Food Drug Administration

Central and regional FDA agencies as related to 21 CFR medical device enforcement

 

Insurance Companies

Insurance companies covering diagnostic and therapeutic technology issues in healthcare

Health Care Organizations

Medical Centers, Hospitals, Clinics, Physician Groups or Practices, Health Care Management Firms, Medical Device Rental Agencies, Home Health Care Firms

 

 

Consultation for Law Firms and Attorneys
Expert Assistance and Consultation for Matters Related To Medical Technology and Medical Devices

EXPERTISE: Biomedical and Clinical Engineering Forensic Investigations

Healthcare Organization Related:

  • In-house, shared service, vendor, or other third party medical device support.
  • Analysis of the hospital medical technology profile, identification of problem areas, defining required support resources, compliance with JCAHO medical device related standards, identification of medical technology risk exposure, and case-related technical advice as to the quality and quantity of medical technology support.
  • Medical Device support personnel job descriptions and performance review.
  • JCAHO medical device related compliance.
  • Federal and State compliance with medical technology codes and standards.
  • Medical Device related User Training and Physician Credentialing criteria.

Medical Device Related:

  • Medical Device failure analysis
  • Medical Device incident simulations
  • Medical device labeling including: labels on the device; operator's manuals; and service manuals.
  • Representations of the medical device function and suitability for use.
  • User training.
  • Warranty and after warranty service support.
  • FDA 21 CFR related compliance.

CASE RELATED SUPPORT:

  • Confidential case file review for medical technology and medical device related issues.
  • Incident simulations and expert investigations as required.
  • Expert reports as required.
  • Deposition and Trial Testimony as required

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Consultation for Healthcare Organizations is primarily Clinical Engineering support for Administration and Designated Departments

BIOMEDICAL QUALITY ASSURANCE:
Independent Review of Biomedical or Clinical Engineering

  • In-house, Shared Service, Vendor, or other third party medical device support. The review typically consists of an analysis of the hospital medical technology profile, identification of problem areas, defining existing support resources, compliance with JCAHO medical device related standards, identification of inordinate medical technology risk exposure, and recommendations for short and long term improvement of medical technology support.
  • Staff job descriptions and performance review criteria.
  • JCAHO medical device related compliance.
  • Cost effectiveness and recommendations for improvement.

MEDICAL EQUIPMENT REVIEW AND ACQUISITION:
Consultation for Administration or Selected Departments

  • Medical Equipment Capital Budget Planning.
  • Long Range Medical Technology Planning.
  • Independent review of expressed medical technology needs to determine underlying clinical requirements.
  • Translation of clinical requirements into a set of equipment or technology specifications.2
  • Translating technology specifications to form the basis of a Request for Proposal against which medical device manufacturers may bid.
  • Review of the various responses to determine the advantages and disadvantages of the various choices.
  • Once a manufacturer has been selected, independent monitoring of the purchase, delivery, installation, user training, and follow-up service.

INCIDENT AND ACCIDENT INVESTIGATION: Consultation for Administration and/or Risk Management

  • Working in cooperation with Risk Management, physicians, in-house biomedical staff, and regulatory agencies, perform independent investigation and confidential reporting for medical device related incidents or accidents.
  • Assistance can be provided for proper reporting of the incident according to State and Federal requirements.
  • Quality Control follow up procedures to address the causes of and future prevention of similar or related incidents.

RISK ASSESSMENT RELATED TO MEDICAL TECHNOLOGY:
Consultation for Administration and/or Risk Management

  • Perform a survey of overall hospital technology, concentrating on areas of known high risk and areas where the hospital has experienced inordinate problems.
  • Confidential reporting of the findings to Administration of Risk Management.
  • Confidential assistance to implement corrective measures to eliminate medical technology risk. This may include:
    • Targeted physician, nurse, or other healthcare professional training related to the subject technology.
    • Revision or upgrade of the targeted medical technology.
    • Enhanced biomedical support.

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Manufacturer consultation is a combination of Clinical Engineering and Biomedical Engineering Support

INDEPENDENT PRODUCT EVALUATIONS: Independent Review of

  • New or contemplated medical devices for:
    • Clinical user considerations
    • Associated user training
    • Risk assessment for equipment malfunction scenarios
    • User manuals
    • Device labeling
    • Marketing considerations
    • Product comparisons

INDEPENDENT PRODUCT TESTING ASSISTANCE WITH CLINICAL TESTING OPTIONS:

Independent laboratory and/or clinical testing

  • Medical device performance assessments using physiological simulators.
  • Medical device performance assessments using environmental testing (heat, cold, humidity, EMI)
  • Medical device performance using veterinarian supervised animal studies.
  • Medical device clinical trials and/or testing with cooperating healthcare facilities and physicians.

INCIDENT AND ACCIDENT INVESTIGATION: Consultation for Management and/or Quality Assurance

  • Working in cooperation with designated company staff, affected physicians, hospital biomedical staff, and regulatory agencies, perform independent investigation and confidential reporting for medical device related incidents or accidents.
  • Assistance can be provided for proper reporting of the incident according to State and Federal requirements.
  • Quality Control follow up procedures to address the causes of and future prevention of similar or related incidents.

RISK ASSESSMENT RELATED TO MEDICAL TECHNOLOGY: Consultation for Management and/or Quality Assurance

  • Perform an independent confidential audit of designated complaint files to search out patterns of equipment reported problems.
  • Recommend changes and/or actions to reduce medical device liability risks. For example:
    • Targeted physician, nurse, or other healthcare professional training programs related to the subject technology.
    • Revision or upgrade of the targeted medical technology.
    • Enhanced biomedical support for the user facility.
    • Revised and upgraded manuals and device labeling.
  • Confidential review of FDA 483 inspection reports for potential medical device liability issues.
  • Independent assessment and assistance for voluntary and involuntary medical device warnings, "Dear Doctor" letters, and recalls.

ASSISTANCE WITH 510(k) CLEARANCES: Consultation for Management and/or Quality Assurance

  • Work cooperatively with company designated staff to draft the 510(k) application.
  • Coordinate product testing (if needed) to support the 510(k) application.
  • Interface with FDA representatives regarding product questions.
  • Interface with attorneys specialized in FDA 510(k) application procedures.

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Services for the Federal Food and Drug Administration

INDEPENDENT REGULATORY EVALUATIONS:

Independent Review of

  • Medical Device as related to:
    • Inspector noted GMP (483) infractions
      • GMP infraction related to clinical user factors
      • Patient injury or adverse outcome risks
      • Independent product integrity testing
      • Clinical implications of product recalls
      • Alternate or substitute devices
      • "Doing without" scenarios
    • Risk assessment for equipment malfunction scenarios
    • User manual review
    • Device labeling review
  • Product comparisons

INDEPENDENT PRODUCT TESTING ASSISTANCE WITH CLINICAL TESTING OPTIONS: Independent laboratory and/or clinical testing

  • Medical device performance assessments using physiological simulators.
  • Medical device performance assessments using environmental testing (heat, cold, humidity, EMI).
  • Medical device performance using veterinarian supervised animal studies.
  • Medical device clinical trials and/or testing evaluations for 510(k) or PMA applications.

INCIDENT AND ACCIDENT INVESTIGATION: Consultation for

  • Working in cooperation with designated company staff, affected physicians, hospital biomedical staff, and regulatory agencies, perform independent investigation and confidential reporting for medical device related incidents or accidents.
  • Assistance can be provided for proper reporting of the incident according to State and Federal requirements.
  • Quality Control follow-up procedures to address the causes of and future prevention of similar or related incidents.

RISK ASSESSMENT RELATED TO MEDICAL TECHNOLOGY: Consultation for:

  • Independent confidential audit of designated complaint files to search out patterns of equipment reported problems.
  • Recommend changes and/or actions to reduce medical device liability risks. For example:
    • Targeted physician, nurse, or other healthcare professional training programs related to the subject technology.
    • Revision or upgrade of the targeted medical technology.
    • Enhanced biomedical support for the user facility.
    • Revised and upgraded manuals and device labeling.
  • Confidential review of FDA 483 inspection reports for potential medical device liability issues.
  • Independent assessment and assistance for voluntary and involuntary medical device warnings, "Dear Doctor" letters, and recalls.

ASSISTANCE WITH 510(k) EVALUATIONS: Consultation for

  • FDA designated review staff as needed for 510(k) medical device questions.
  • Interface with FDA representatives regarding product comparison questions.
  • Interface with attorneys specialized in FDA 510(k) application procedures for medical device related technical issues.

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Insurance Firm Consultation is a Combination of Clinical Engineering and Biomedical Engineering Support

INCIDENT AND ACCIDENT INVESTIGATION: Biomedical and Clinical Engineering Forensic Investigations

  • Working in cooperation with designated medical device manufacturer representatives, affected physicians, hospital biomedical staff, and regulatory agents, perform independent investigation and confidential reporting for medical device related incidents or accidents.
  • Assistance can be provided for proper reporting of the incident according to State and Federal requirements.
  • Quality Control follow up procedures to address the causes of and future prevention of similar or related incidents.

RISK ASSESSMENT RELATED TO MEDICAL TECHNOLOGY: Consultation for Insurance Firm Management

  • Perform an independent confidential audit of designated clients related to product incidents or claims to search out patterns of equipment related problems.
  • Recommend changes and/or actions to reduce medical device liability risks. For example:
    • Targeted physician, nurse, or other healthcare professional training programs related to the subject technology.
    • Revision or upgrade of the targeted medical technology.
    • Enhanced biomedical support for the user facility.
    • Revised and upgraded manuals and device labeling.
  • Confidential review of FDA 483 inspection reports for potential medical device liability issues.
  • Independent assessment and assistance for voluntary and involuntary medical device warnings, "Dear Doctor" letters, and recalls.

INDEPENDENT PRODUCT TESTING ASSISTANCE WITH CLINICAL TESTING OPTIONS: Independent laboratory and/or clinical testing

  • Medical device performance assessments using physiological simulators.
  • Medical device performance assessments using environmental testing (heat, cold, humidity, EMI).
  • Medical device performance using veterinarian supervised animal studies.
  • Medical device clinical trials and/or testing with cooperating healthcare facilities and physicians.

CLOSED CASE REVIEW: For those closed cases involving medical technology and for which relevant public information is available, seminar presentations are available.

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Clinical Engineering: Clinical Engineers are professionally trained persons who apply electrical, mechanical, optical, and other engineering principles to understand application of medical technology in the clinical environment. Clinical Engineers usually work with physicians, nurses, respiratory therapists, radiology technicians, clinical laboratory technologists, and other health care professionals in the function and use of medical devices. The education level is usually a Bachelor of Science but also may be a Master of Science or Ph.D. level.

Examples of Clinical Engineering work include:

  • Management and supervision of Biomedical Equipment Technicians in a hospital based service department so as to provide maintenance and preventive maintenance of medical devices.
  • Joint Commission on Accreditation for Healthcare Organization standard interpretation and healthcare organization compliance for medical technology
  • Healthcare Organization quality management for medical technology
  • Documented, targeted medical device user education programs for physicians, nurses, and other healthcare professionals on device operation, use, and safety

 

 

  • Investigation of medical device related incidents in the delivery of healthcare
  • Federal Safe Medical Device Act, CFR 21, code compliance for Healthcare Organizations
  • Quality management to avoid repeated medical device incidents
  • Technical evaluation for new medical device purchases
  • Capital budget planning for medical technology acquisition
  • Upgrading and extending the useful life of present medical technology
  • Working as part of a healthcare team where high technology is involved for example:
    • Assist in setting up or upgrading cardiac surgery programs
    • Assist in setting up and operating complex medical information systems
    • Establish or upgrade surgical laser program
  • Team member to work with Architects and Administration to plan and implement new health care facilities

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Biomedical Engineering: Biomedical Engineers are professionally trained persons who apply electrical, mechanical, optical, and other engineering principles to understand, modify, or control biologic, (i.e., human, and animal) systems, as well as design and manufacture products that can monitor physiologic functions and assist in the diagnosis and treatment of patients

Examples of Biomedical Engineering include:

  • Physiological modeling, simulation, and control theory applications
  • Detection, measurement, and monitoring of physiological signals including:
    • Development of Biosensors
    • Development of Biomedical Instrumentation
  • Engineering analysis and interpretation of biological signals such as:
    • Magnetic resonance imaging
    • Electrocardiogram (ECG) analysis for arrhythmia detection
    • Electroencephalogram (EEG) analysis for brain activities
    • Therapeutic and rehabilitation procedures and devices
  • Development of replacement organs and devices to augment bodily function such as:
    • Artificial hearts 
    • Pacemakers
    • Kidney dialysis machines
  • Computer analysis of patient-related data and clinical decision making by means of:
    • Application of artificial intelligence
    • Analysis of medical information
  • Medical imaging for the graphic display of anatomic detail such as:
    • CT scanners
    • MRI units
    • Nuclear medicine imaging
    • Portable x-ray units as mobile C-arm systems
  • Creation of new biological products such as:
    • Artificial skin
    • Tissue engineering
  • Development of medical devices such as:
    • Heart-lung machines
    • Dialysis machines
    • Pacemakers
    • Defibrillators
    • Prosthetic and 2 devices
    • Noninvasive monitors
    • Anesthesia Machines

 

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