CDRH Vision - Total Product Life Cycle

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CDRH Vision - Total Product Life Cycle
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CDRH Science Review

• Planning of Review - Nov 1999
• Internal Review March 2001
• External Review
• June 21, 2001 (Orientation)
• July 24 to 26, 2001
• Science Board Report Nov 2001
• Science Review Implementation

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Broad Areas of Focus CDRH Internal External
Reviews

• Review seeks information about the Centers
  decision making process
• Scientific decision making
• Impact of decision made by CDRH
• Resources required
• Integration of decisions made
• Processes and feedback mechanisms to document
  decisions and enhance organizational learning
• Preparedness to address future science issues

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Internal Review

• Top 10 list of the greatest challenges and
  problems for science-based regulation at CDRH
• Top 10 list of recommendations for
  science-based regulation at CDRH

8
Top 10 list of the greatest challenges and
problems for science-based regulation at CDRH

• CDRH is not always recognized as a science-based
  organization by
• parts of CDRH and FDA,
• the Department of Health and Human Services,
• Congress and
• Industry.
• Recommendation
• CDRH needs to communicate its scientific vision
  and the scientific basis for its regulatory
  actions.
• CDRH needs advocates for its scientific role in
  medical devices and radiological health,
  including the FDA Science Board

9
Top 10 list of the greatest challenges and
problems for science-based regulation at CDRH

• The Center leadership does not always communicate
  science as a priority. We miss opportunities to
  creating the time and resources for our
  scientists to have the training and experiences
  to stay current and build their scientific
  expertise. Budget and resource planning is often
  reactive and short term and not well used to
  walk the talk of the priority of science.
• Recommendation
• The Center leadership needs to demonstrate the
  priority of science in how it allocates its human
  resources, and through strategies to maintain and
  build science capacity in the Center.

10
Top 10 list of the greatest challenges and
problems for science-based regulation at CDRH

• CDRHs scientific staff is graying and an
  anticipated wave of retirement will exacerbate
  the shortages of some types of expertise.
  Replacement hiring will also create challenging
  opportunities.
• Recommendation
• CDRH needs to implement the Magnet for Excellence
  goal area of its strategic plan which seeks to
  recruit and retain the type of employees that
  will help us accomplish our public health
  mission.

11
Top 10 list of the greatest challenges and
problems for science-based regulation at CDRH

• Budget policies of the last eight years have
  markedly reduced operating dollars leaving
  laboratory programs and information technology
  infrastructure funded at a subsistence level.
• Recommendation
• Rich or poor, the Center needs to assure that
  there are enough operating dollars (vs. salary
  dollars) to provide the funds needed to maintain
  the effectiveness of our employees.

12
Top 10 list of the greatest challenges and
problems for science-based regulation at CDRH

• New staff is trained largely by apprenticeship
  with insufficient attention to assuring the
  development of the core competencies needed for
  science-based regulation.
• Recommendation
• CDRH needs to identify core competencies and the
  types of experiences that will develop them to
  create a flexible scientific workforce able to
  meet future challenges.

13
Top 10 list of the greatest challenges and
problems for science-based regulation at CDRH

• Premarket deadlines, acute problems, and squeaky
  wheels dominate resource allocation and leave
  programs disconnected and sometimes out of
  balance.
• Recommendation
• The Centers strategic vision of assuring the
  public health throughout the total product life
  cycle and having meaningful measures of the
  impact of our efforts are strategies that will
  allow us to prioritize work better by the impact
  that it has.

14
Top 10 list of the greatest challenges and
problems for science-based regulation at CDRH

• Scientific communication opportunities are
  underutilized, whether with scientific peers,
  medical device users or the general public. This
  limits our mission effectiveness.
• Recommendation
• The goal area of Knowledge Management in the
  Centers strategic plan provides an approach not
  only to the acquisition and management of new
  knowledge, but also to the dissemination to our
  stakeholders to promote our mission.

15
Top 10 list of the greatest challenges and
problems for science-based regulation at CDRH

• We solve many problems too slowly in a rapidly
  changing world. While decision making is often
  timely, implementation is often not.
• Recommendation
• CDRH should set goals, choose important problems,
  assess how to measure impact, create the team
  needed and be accountable for timely results from
  its efforts.

16
Top 10 list of the greatest challenges and
problems for science-based regulation at CDRH

• Peer review is underutilized as a method for
  prioritizing efforts and evaluation. Choices are
  heavily driven by regulatory needs and evaluation
  is usually done through the organizational
  hierarchy.
• Recommendation
• Peer review should be routinely incorporated into
  the science-based decision making and
  science-based efforts by peers within and from
  outside the Center to supplement other methods of
  assessing scientific quality and effectiveness.

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Top 10 list of the greatest challenges and
problems for science-based regulation at CDRH

• Scientific partnerships with NIH, NAS,
  Universities, professional societies exist, but
  are underdeveloped.
• Recommendation
• Scientific partnerships with NIH, NAS,
  Universities, professional societies exist,
  should be developed as a source of external
  expertise, as sources of recruitment, and for
  partnerships in mission related activities.

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Evaluation of External Review

• Survey of External Panel Members
• (11/12 responded)

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CDRH Science Review Evaluation
No Use
Essential

1. Opening the scope of the review to include the
   entire Center, i.e., not limited to a laboratory
   science review mean 4.9
2. The early planning/kick-off meeting in Atlanta
   on June 21, 2001 mean 4.2
3. Background materials on CDRHs Mission and
   Organization mean 4.5

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CDRH Science Review Evaluation
No Use
Essential

• Case Studies - the concept mean 4.1
• - the materials
• mean 3.8 - the staff Interviews
• mean 4.8

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CDRH Science Review Evaluation
No Use
Essential

• On the Spot - the concept mean 4.0
• - the materials
• mean 2.7 - the staff Interviews
• mean 4.1

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CDRH Science Review Evaluation
No Use
Essential

• Role Playing Sessions mean 3.8
• The Industry Interviews
• mean 4.1
• The callback writing session mean 4.7

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CDRH Science Review Evaluation

• Open Ended Questions
• What was the best/most useful activity or
  component of the Science Review?
• What was the worst/least useful activity or
  component of the Science Review?
• Which of the Committees recommendations do you
  believe CDRH must address in the near term to
  address a critical flaw?
• Which of the Committees recommendations do you
  believe CDRH must address to assure our place
  as a scientific leader in the medical device
  community?

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What was the best/most useful activity or
component of the Science Review?

• case studies and industry interviews
• the thought that preceded the committees work
  allowed more substantive activity as did the
  excellent prepared materials
• interviews with the management and staff (2)
• staff interviews all were great essential to
  further our understanding of the issues and way
  CDRH processes information discussion with staff
  and case studies

• the background materials were essential to
  getting up to speed. The interviews were
  essential to understanding realities of the
  Center beyond the public persona or management
  view
• staff interviews
• interfacing with staff
• discussion of recommendations

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What was the worst/least useful activity or
component of the Science Review?

• role playing sessions (2)
• on the spot was least useful as it was
  difficult for the review team to know what to ask
  for. Not really necessary. Would have been
  better to have more time for discussions with
  CDRH staff
• preselection of case studies
• science review committee was too heavily
  weighted towards an industry bias. Insufficient
  federal scientific stakeholder representation
• it was a bit scripted, and some things slipped
  past before we realized they needed more thoughts

• on the spot
• every part was good
• the on the spot activities were unfocused and
  for more work than was valuable. This time could
  have been better spent.
• the case studies were good but need to be very
  carefully selected or they are not useful
• on the spot binder lists of documents not
  helpful
• on the spot materials
• trying to understand the materials and cope with
  the quantity

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Which of the Committees recommendations do you
believe CDRH must address in the near term to
address a critical flaw?

• all of them
• manpower distribution
• workload distribution
• more transparent communication
• Strong immediate need to re-evaluate OST
  structure, if OST exists, must change to reflect
  current and future science. Recommendation 3
• CDRH should consider outsourcing some of its
  review activities,
• although it was not contained in the committees
  final recommendations, CDRH should consider
  charge back for industry
• keep current and support staff
• Rec 13 14 quality metrics and evaluation
• Assessment of needs (7)

• develop a strategic staffing plan to accommodate
  expected turnover/attrition/retirement fill
  technical gaps with respect to future
  technologies
• Develop a plan for cross office communication
  (4)
• Establish an electrtonic database for decisions
  and inventory (5)
• Add human factors expertise to panels (10)
• Funding which drives workload
• Rec 1 2 define and communicate a vision and
  from that the organization and resources needed
  to meet that vision. Dont start with the
  budget.
• Position its staff for the next 20 years
  challenge

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Which of the Committees recommendations do you
believe CDRH must address to assure our place
as a scientific leader in the medical device
community?

• all of them
• its difficult, but planned ready enrichment must
  be viewed as a core not supplemental activity
• staff evaluation is needed to have a clear
  picture or required hiring to maintain (attain)
  expertise needed for biological/technological
  revolution (Rec 7)
• see Rec 7
• Be scientific! See Rec 7
• develop a strategic staffing plan to accommodate
  expected turnover/attrition/retirement fill
  technical gaps with respect to future
  technologies
• Rec 7 9 expertise of staff
• Improve career path (

• More outreach (12) thats the only way to keep
  up and connected
• Reassess what laboratory programs to support
  some are outdated in other areas critical new
  fields of science are not covered at all
• Vision is extremely important
• Identification of those technologies and
  development of an in-house capability in those
  technologies that will support approval of future
  medical devices
• Add new staff to cope with new technology

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Science Review Next Steps

• Establishment of CDRH Recommendations Committee

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CDRH Science Recommendations Committee

• Frances Benedict, OCD
• Bob Cangelosi, OHIP
• James Dillard, ODE
• Patricia Dubill, OST
• Philip Frappaolo, OCD
• Anita Rayner, OSB

• Donald Serra, OC
• Mitchell Shein, ODE
• Toni Nearing, OCD
• Kathleen Walker, OSM
• Cheryll Wells, OC

Representatives from every Office 2 Quality
systems experts
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Science Review Next Steps

• Establishment of CDRH Recommendations Committee
• Scheduling of Division Directors Go-Away to
  address recommendations in light of strategic
  goal areas (Dec 6, 2001)

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Science Review Next Steps

• Establishment of CDRH Recommendations Committee
• Scheduling of Division Directors Go-Away to
  address recommendations in light of strategic
  goal areas (Dec 6, 2001)
• Internet posting of Final Report
• www.fda.gov/cdrh/science

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CDRH Science Review Committee

• CDRH Recommendations Committee
• to prioritize the recommendations from the review
  (long and short term priorities), and
• make suggestions to Sr. Staff on how to merge
  these recommendations into our strategic plan

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New Technology
Scan Horizon
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New Technology
Develop Regulatory Path
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New Technology
Identify External Experts
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New Technology
Build Internal Capacity
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New Technology
ConsolidateTPLC Team
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Center for Devices and Radiological Health

• Strategic Goal Areas
• Total Product Life Cycle product management
• Magnet for Excellence to attract and develop the
  staff to accomplish our mission
• Knowledge Management
• Meaningful Metrics

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Center for Devices and Radiological Health

• Mission
• CDRH promotes and protects the health of the
  public by ensuring the safety and effectiveness
  of medical devices and the safety of radiological
  products.

40
Top 10 list of the greatest challenges and
problems for science-based regulation at CDRH

1. CDRH is not always recognized as a science-based
   organization by parts of CDRH and FDA, the
   Department of Health and Human Services, Congress
   and Industry.
2. The Center leadership does not always communicate
   science as a priority. We miss opportunities to
   creating the time and resources for our
   scientists to have the training and experiences
   to stay current and build their scientific
   expertise. Budget and resource planning is often
   reactive and short term and not well used to
   walk the talk of the priority of science.
3. CDRHs scientific staff is graying and an
   anticipated wave of retirement will exacerbate
   the shortages of some types of expertise.
   Replacement hiring will also create challenging
   opportunities.
4. Budget policies of the last eight years have
   markedly reduced operating dollars leaving
   laboratory programs and information technology
   infrastructure funded at a subsistence level.
5. New staff is trained largely by apprenticeship
   with insufficient attention to assuring the
   development of the core competencies needed for
   science-based regulation.

• Premarket deadlines, acute problems, and squeaky
  wheels dominate resource allocation and leave
  programs disconnected and sometimes out of
  balance.
• Scientific communication opportunities are
  underutilized, whether with scientific peers,
  medical device users or the general public. This
  limits our mission effectiveness.
• We solve many problems too slowly in a rapidly
  changing world. While decision making is often
  timely, implementation is often not.
• Peer review is underutilized as a method for
  prioritizing efforts and evaluation. Choices are
  heavily driven by regulatory needs and evaluation
  is usually done through the organizational
  hierarchy.
• Scientific partnerships with NIH, NAS,
  Universities, professional societies exist, but
  are underdeveloped.

41
Top 10 list of recommendations for
science-based regulation at CDRH

• CDRH needs to communicate its scientific vision
  and the scientific basis for its regulatory
  actions. It needs advocates for its scientific
  role in medical devices and radiological health,
  including the FDA Science Board.
• The Center leadership needs to demonstrate the
  priority of science in how it allocates its human
  resources, and through strategies to maintain and
  build science capacity in the Center.
• CDRH needs to implement the Magnet for Excellence
  goal area of its strategic plan which seeks to
  recruit and retain the type of employees that
  will help us accomplish our public health
  mission.
• Rich or poor, the Center needs to assure that
  there are enough operating dollars (vs. salary
  dollars) to provide the funds needed to maintain
  the effectiveness of our employees.
• CDRH needs to identify core competencies and the
  types of experiences that will develop them to
  create a flexible scientific workforce able to
  meet future challenges.

• The Centers strategic vision of assuring the
  public health throughout the total product life
  cycle and having meaningful measures of the
  impact of our efforts are strategies that will
  allow us to prioritize work better by the impact
  that it has.
• The goal area of Knowledge Management in the
  Centers strategic plan provides an approach not
  only to the acquisition and management of new
  knowledge, but also to the dissemination to our
  stakeholders to promote our mission.
• CDRH should set goals, choose important problems,
  assess how to measure impact, create the team
  needed and be accountable for timely results from
  its efforts.
• Peer review should be routinely incorporated into
  the science-based decision making and
  science-based efforts by peers within and from
  outside the Center to supplement other methods of
  assessing scientific quality and effectiveness.
• Scientific partnerships with NIH, NAS,
  Universities, professional societies exist,
  should be developed as a source of external
  expertise, as sources of recruitment, and for
  partnerships in mission related activities.