Fostering Collaboration between Industry and Academia Trends, Opportunities and Global Regulatory im

1
Fostering Collaboration between Industry and
Academia Trends, Opportunities and Global
Regulatory implications for the Medical Device
Industry
David R. Jones Director Quality Assurance,
Regulatory Affairs, and Philips Business
Excellence Philips Home Healthcare Solutions
AIMBE Session on Translational Research at the
Biomedical Engineering Society Annual Meeting
St. Louis, MO. October 3rd, 2008
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Trends, Opportunities and Global Regulatory
implications for the Medical Device Industry

• Shift Left Personalized Medicine
• Shift Right Moving the cycle of care out of the
  hospital and into the home
• The convergence of IT and Biomedical Engineering
• Starting a New Software based Medical Device or
  Combination Product Company
• Networks of Open Medical Device Networks
• Designing Medical Devices to meet Global
  Regulatory requirements

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Pre -Shift-Left Personalized Medicine
Ref MEDICAMUNDI 47/1 April 2003
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Shift-Left Personalized Medicine (The Paradigm
shift in healthcare due to the advent of
Molecular medicine and Molecular Imaging and
Diagnostics)
Ref MEDICAMUNDI 47/1 April 2003
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Shift Left Personalized Medicine

• Use of molecular imaging diagnostics to screen
• for genetic predisposition of disease processes
  
• Oncological
• Cardiovascular
• Neurological
• Infectious Diseases
• In disease prediction, detection correction
• Business benefits
• Improved early disease discovery predictability
• Predictable disease mitigation
• Reduced long term health care costs
• Improved long term quality of life

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Proposed Cost Vectors of Traditional Medicine vs.
Shift Left Personalized Medicine
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Shift Right Moving the cycle of care out of the
hospital and into the home
Intensive Care unit Monitoring
Operating room Monitoring Imaging
Treatment
Treatment
Diagnostics
Diagnostics
Personal Healthcare
Diagnosis
Rehabilitation
Remote monitoring
Management
Prevention
Diagnostics Imaging
Emergency Response Services
Follow Up
Pre-Hospital/Ambulance Monitoring
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Philips Home Healthcare Solutions portfolio of
products and services addresses the challenges of
chronically ill people living independently
Philips Remote Cardiac Services
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Moving the cycle of care out of the hospital and
into the home

• Multiple Diseases
• Automated Vital Signs
• Weight
• BP
• ECG
• Glucose
• SpO2
• Manual Measurements
• Subjective surveys
• Health Assessment
• Education
• Reminders

• TV-based Patient user interface, on-demand
• Broadband-enabled, on any patients TV
• Real-time, bidirectional communications
  messaging
• Rich multimedia content
• Goal-oriented behavior modification modules
• Care Manager Cockpit
• Workflow-oriented
• Care Plan-based
• Provides patient registry, enrollment tools

Monitoring
Education

• Intelligent flagging
• Comprehensive Health Assessment
• On-demand mailed education

Clinical
Services
Dedicated teams to provide implementation,
technical support, training education, and
account management.
Remote Management
Telemonitoring
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The Convergence of IT and Biomedical Engineering
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The Convergence of IT and Biomedical Engineering

• Different Perspective
• Life-critical vs.mission-critical
• Medical devices vs. Information Systems
• The Biomed links medicine and technology
• Privacy
• Security

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The Convergence of IT and Biomedical Engineering

• Medical Technology intertwined with IT
• Move toward Electronic Medical Record (EMR),
  Clinical Decision Support Systems (CDSS) requires
  information flow
• Devices are an integral part of information flow
• More regulations and protocol requirements (The
  Joint Commission, Leapfrog) drives data movement
• Desire to integrate data from real-time systems
  to achieve smart/predictive alarms
• AAMI, ACCE, and HIMSS recently joined forces to
  develop the new Clinical Engineering/IT community
  (CEIT)
• Develop guidance documents
• Share best practices
• Promote an understanding of the issues
  surrounding the ongoing integration of IT and
  Clinical Engineering

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Starting a New Software based Medical Device or
Combination Product Company

• When is your product a medical device or
  combination product versus not?
• Each Country with elaborate submission
  requirements has a definition of what constitutes
  a Medical Device and its Intended Use
• Fundamentally it relates to the treatment of a
  patient
• You cure X
• You fix Y
• You supply information necessary for diagnosing
  Z
• You provide a device used for the compensation or
  alleviation of disease, injury, or disability
• Classes of devices
• Organized by device risk
• Determining if a device is a medical device or
  not requires careful evaluation of its written
  and verbal claims i.e. its Intended Use
• Claiming you can enhance patient safety by
  providing alarms to alert facility staff to clean
  up spills, which could cause falls, does not make
  your device a medical device
• Generally if you associate a device with a
  disease it will be a medical device

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Starting a New Software based Medical Device or
Combination Product Company

• If you claim to track a patient parameter but
  give no specific medical reason you could just be
  a data gathering device until you say that
  someone can use that information to monitor,
  treat, or diagnose
• If you link the data to the better treatment or
  diagnosing of a disease then you will be a
  medical device
• Will your Medical Device deliver biotherapeutics
  (drugs, proteins, nucleic acids, or cells) and be
  a Combination Product? (1)
• How do you decide which molecules to put on your
  devices?
• How can you test and manufacture multiple
  combination products?
• Registering to ISO 134852003
• How it differs from FDA GMPs
• Choosing an Authorized Representative and your
  Notified Body
• (1) Combination Products Devices, Drugs, and
  Genes. mdrues_at_vascularsci.com

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Software Development Validation Practices That
Drive Predictable Results at your new Medical
Device company
Ref Real-world benchmarks for PSP, Carnegie
Mellon University Software Engineering
Institute (a) Capability Maturity Model
Integrated
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Networks of Open Medical Device Networks Today

• Alarm, Trending, Retrospective review data is
  currently transmitted on secure closed private
  networks
• Network protocols used are similar to the
  Computer Industry in the mid 1980s
• Patient data privacy is required to meet HIPAA
  requirements
• ISO TC210 (focus process control related to
  medical device design and manufacture) and IEC
  SC62A (focus safety of electromedical systems)
  proposed a formal standards initiative study
  group to focus on "safety requirements relating
  to installation, configuration and maintenance of
  networkable medical devices

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Networks of Open Medical Device Networks Today
(cont.)

• Currently neither IEC nor ISO has ventured beyond
  the point of sale of medical devices (this has
  traditionally been the borderline of the risk
  model used in this regulated industry)
• Manufacturers and consumers of medical devices
  will need to establish systematic protocols for
  the transfer of safety related information,
  requirements and support across the veil of
  commerce (1)
• Proposed FDA reclassification of Medical Device
  Data Systems (FDA Docket 2007N-0484 Devices
  General Hospital and Personal Use Devices)
• Devices that function as a technical conduit of
  medical data IT equipment, router, or a medical
  device
• A clinical user focused device, archives and/or
  dispays medical device data, and with which a
  user interacts. This device is at the end of a
  medical system chain
• Relationship to IEC 60601-1-8, the standard for
  alarm systems
• Impact on general purpose IT devices which form
  the backbone of hospital network infrastructure
  systems
• (1) Brian Fitzgerald, Deputy Director Division
  of Electrical and Software Engineering, CDRH,
  FDA, December 2005.

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Networks of Open Medical Device Networks - Future

• Alarm and patient data sent as secure packets on
  wired/wireless networks of open Medical Device
  networks
• Heterogeneous vendor interoperability
• The CIO owns the network not the Biomedical
  Engineering Department

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Designing Medical Devices to meet Global
Regulatory requirements

• Which Regulatory requirements should you focus
  on
• FDA U.S.
• Medical Device Directive (MDD) - Europe
• Other Authorities with Jurisdiction
• Worldwide Competent Authorities e.g. SFDA,
  Japans PAL
• Worldwide Notified Bodies
• Generally speaking you should follow the EU MDD
  utilizing applicable Harmonized EN Standards
• This allows you to meet 95 of any other
  Countries Requirements for Product Approvals
• Variations are typically related to labeling and
  in a few instances defined Country differences in
  safety and performance tests
• Pay attention to U.S. label and reduced leakage
  current requirements
• Establish a Master matrix for verification and
  validation requirements
• Audit for differences between the FDA and MDD
  requirements
• Note the FDA focuses on the Product, the MDD
  focuses on the System

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Designing Medical Devices to meet Global
Regulatory requirements

• Global Time-to-Market requirements
• Dynamic balance between Central Teams Product
  Teams Geographic Teams Consultants
• Central Teams
• Regulatory Engineering with product and
  regulatory expertise partnered with Research and
  Development
• Country Regulatory Teams
• Experts located in the geography with rapidly
  changing Regulatory Requirements
• Relationship building
• Intelligence gathering and sharing
• Regulatory Roadmap and approvals lessons learned
• Key Future Regulatory Engineering skills
• Risk Management, Software, Useability

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Designing Medical Devices to meet Global
Regulatory requirements Challenges in setting up
a Global Regulatory Strategy

• Global Harmonization Task Force (GHTF)
• In theory the goals of the GHTF are supposed to
  allow for the creation of one Regulatory
  submission file that will be accepted by
  supporting or member Countries
• Primarily a harmonized submission package made to
  a FDA like organization
• Focus on safety, innovation and trade
• Action Plan 2007-2010 focuses on guidance
  implementation, organizational logistics,
  expansion and new topics for GHTF attention
• Based on the EU MDD philosophy
• Allows for specific Country deviations
• However
• Long term this is an excellent solution
• Other aspects are not harmonized such as how to
  deal with other US agencies
• FCC, CDRH, NFPA etc.
• Asian Working Party (AWP) is extending the work
  of the GHTF
• One limitation is that it is based on the EU
  system
• If a Country does not have the supporting
  Government and regulations in place it gets
  customized

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Designing Medical Devices to meet Global
Regulatory requirements Example of Regulatory
differences between the U.S. and the E.U.

• Reporting requirements when there is a Serious
  Injury or Death with your Medical Device
  (Postmarket Surveillance)
• US law requires reporting of problems that arise
  once a device is on the market
• When the failure of a device or the use of a
  device resulted in harm to, or a threat to
  patient safety
• EU reporting obligations are more decentralized
  than in the US
• Incidents must be reported to the national
  authority where the incident has occurred
• Company needs to talk to the Notified Body to
  determine if previous assessment of the device is
  impacted
• Company and the Competent Authority need to
  determine problem root cause and corrective
  action measures
• Member state Competent Authorities share
  information

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Vision Statement for a Future World

• .. provides software based wireless
  controlled nano-drug delivery and monitoring
  Medical Devices, which operate autonomously, and
  execute remedial and maintenance functions in the
  blood distribution systems in the human body.
  Patients are able to routinely live a pain free
  life with identified critically ill chronic
  symptoms with their family and friends and are
  capable and winning finalists in local athletic
  events.

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Shift-Left Personalized Medicine realized (The
Paradigm shift in healthcare due to the advent of
Nanotechnology Combination Products)
Ref Nanotech RD, Commercialization Come Front
and Center. ieee-usa Todays engineer digest
March 2006. Barton Reppert
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• Contact
• david.r.jones_at_philips.com
• Philips Home Healthcare Solutions
• 3000 Minuteman Road
• Andover, Massachusetts 01810
• Tel [phone]

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Acronyms

• AWP Asian Working Party
• AAMI Association for the Advancement of Medical
  Instrumentation
• ACCE American College of Clinical Engineering
• AIMBE American Institute for Medical and
  Biological Engineering
• BP Blood Pressure
• CDRH Center for Devices and Radiological Health
• CDSS Clinical Decision Support Systems
• CEIT Clinical Engineering/IT community
• CFR Code of Federal Register
• CIO Chief Information Officer
• CMMI Capability Maturity Model Integrated
• DNA Deoxyribonucleic Acid
• ECG Electrocardiogram
• EMR Electronic Medical Record
• EN European Norm
• EU European Union
• FCC Federal Communication Commission
• FDA Food and Drug Administration
• GHTF Global Harmonization Task Force

• IEC International Electrotechnical Commission
• IEEE Institute of Electrical and Electronic
  Engineers
• ISO International Organization for
  Standardization
• IT Information Technology
• KLOC Thousand Lines Of Code
• Leapfrog The Leapfrog Group for Patient Safety
• MDD Medical Devices Directive
• MDx Molecular Diagnostics
• NFPA National Fire Prevention Association
• PAL Pharmaceutical Affairs Law
• POC Point Of Care
• PSP Personal Software Process
• RD Research and Development
• SC Sub Committee
• SFDA China Food and Drug Administration
• SPO2 Pulse Oximetry
• TC Technical Committee
• TJC The Joint Commission
• TV Television