Use of Outside Experts in FDAs Premarket Evaluation of Medical Devices

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Use of Outside Experts in FDAs Premarket
Evaluation of Medical Devices
An Action Learning Project

• Donna-Bea Tillman
• AU/OPM II
• December 2004

Mans rational life consists in those moments in
which reflection not only occurs but proves
efficacious. George Santayana
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FDA Mission Historical Basis

• Protect the public from unsafe products

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FDA Mission Today
Promote
Protect
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FDA Organizational Chart
Department of Health and Human Services
Center for Veterinary Medicine
Center for Food Safety And Applied Nutrition
Food and Drug Administration Office of the
Commissioner
National Center for Toxicological Research
Center for Biologics Evaluation and Research
(CBER)
Center for Drug Evaluation And Research (CDER)
Center for Devices and Radiological Health
(CDRH)
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Devices are Different from Drugs
Drugs Yesterday
Drugs Today
Drugs Tomorrow
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Devices
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Challenges Facing CDRH

• Rapid technological changes
• Increasing complexity of devices
• Public demand for more control over healthcare
• Global marketplace and global regulation
• Shrinking staff numbers

• and we are being asked to make decisions more
  quickly than ever.

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Medical Device User Fees to the Rescue!
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CDRHs New Challenge

• Turning dollars into shorter review times

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while maintaining our commitment to good
science.
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How are we going to make this happen?
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Office of In Vitro Diagnostic Device Evaluation
and Safety
Office of Device Evaluation
Office of Science Engineering Laboratories
Office of Surveillance Biometrics
Center for Devices and Radiological Health
Office of Management Operations
Office of Communication, Education, and Rad Health
Office of Compliance
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CDRH Medical Device Fellowship Program
CDRH established the Medical Device Fellowship
Program to increase the range and depth of
collaborations between CDRH and the outside
scientific community. The MDFP offers short and
long-term fellowship opportunities for
individuals interested in learning about the
regulatory process and sharing their knowledge
and experience with medical devices.
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Initial MDFP Goals

• Bring in experts in a range of disciplines.
• Develop a cadre of outside experts.
• Incorporate outside expertise into
  decision-making.

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Where do outside experts come from?

• Academia
• Device advisory panels
• Practicing clinicians, engineers, others
• Other parts of FDA
• Other government agencies

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Nature of appointments

• Short term (3 months) to longer term (2 years)
• Part-time or full-time
• Federal employment or government contract
• On-site or off-site

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Office Director
Division of Anesthesiology General Hospital,
Infection Control, and Dental Devices
Division of Reproductive, Abdominal,
Radiological Devices
Office of Device Evaluation
Division of General, Restorative Neurological
Devices
Division of Cardiovascular Devices
Division of Ophthalmic ENT Devices
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The (Initial) Problem

• How can CDRH most effectively use outside
  scientific resources to improve the premarket
  evaluation of medical devices?

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The Group

• Examine pilot program in the Division of
  Cardiovascular Devices (DCD)
• Team members
• BZ Director of DCD
• MM Branch chief in DCD
• MB Reviewer in DCD
• SH Director of MDFP
• LD ODE Program Management Specialist

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The Coach

• Explained the principles of action learning at
  Meeting 1, including the role of the coach
• Other team members were uncomfortable with
  assuming the role of Coach
• Lack of familiarity with principles of AL
• Too touchy/feely
• Donna-Bea agreed to be the permanent Coach

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The Questioning and Reflection Process

• Team meeting 2 SH presents her understanding of
  mission and goals of MDFP program
• Team members engage in the questioning process

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Meeting 2 The Questioning Process
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The Questioning and Reflection Process

• Team asked to reflect at the end of the meeting
  on how things had gone
• Agreed that
• Would work harder to keep it friendly
• Would build on each others questions
• Would refrain from asking questions that were
  opinions in disguise

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Subsequent Meetings The Questioning Process
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The Questioning and Reflection Process, contd

• Medical Device review process involves lots of
  questions
• But the purpose of these questions is to get an
  answer

Science has promised us truth It has never
promised either peace or happiness. Gustave Le
Bon
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The Questioning and Reflection Process, contd

• Action Learning has a different perspective on
  questions
• seeking to go deeper, to understand, to
  respond to what is being asked, to give it
  thought. Asking questions is not only a quest for
  solutions but also an opportunity to explore
  (Marquardt, p.31)

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Core Issues

• How do we identify resource needs that can be
  appropriately filled using outside resources?
• How do we find the appropriate people to fill the
  need?
• What should be our selection criteria?
• How do we address real or apparent conflicts of
  interest?
• How do we determine the appropriate hiring
  mechanism and salary to use in each case?

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Core Issues

• What do we need to do to train outside resource?
• What are the infrastructure needs (e.g.,
  computers, space) required to support the
  program?
• How do we evaluate the impact of the program on
  our decision-making process?
• How do we foster staff acceptance of outside
  experts?
• How do we ensure confidentiality of proprietary
  information obtained by outside experts?

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The Commitment to Learning

• Team spent time at the end of each meeting
  talking about how we had done as a team
• Particularly helpful after first few meetings
• Refined questioning process
• Peoples behavior changed as a result!
• Demonstrated Kurt Lewin theory that the group is
  a powerful shaper of individual behavior

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The Commitment to Learning
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The Commitment to Taking Action

• Taking action is linked to the questioning and
  reflection process
• Need to reframe the question and get at root
  causes in order to determine appropriate action
  to take

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Finding the right people

• Core Issues
• How do we identify resource needs that can be
  appropriately filled using outside resources?
• How do we find the appropriate people to fill the
  need?
• Why are other divisions not interested in MDFP?
• Questioning process lead to root cause and
  development of actions to move forward

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Medical Device Fellowship Program at end of FY04

• Physicians - 15
• Visiting Scholar senior level clinicians,
  surgeons
• Fellow - physician during fellowship training
• Resident physician during residency training
• Engineers - 42
• Visiting Scholar senior level engineer
• Co-op students
• Interns
• Physicists - 2
• Scientists - 5
• includes students

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The Commitment to Taking Action

• A number of issues were raised that team did NOT
  take action on
• Core Issue How will we determine if the program
  is a success?
• Summative evaluation
• Objective of the program will determine the
  evaluation questions

It is the mark of a good action that it appears
inevitable in retrospect. Robert Louis Stevenson
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Outcomes MDFP

• Current Status of MDFP
• Next Steps
• Determine objectives
• Conduct evaluation

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What I learned

• My role in the organization changed significantly
  over the course of this project
• Deputy Director, DCD
• Deputy Director, ODE
• Acting Director, ODE
• Director, ODE

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What I learned

• What you see depends on where you stand
• Leader needs to be able to see things from all
  perspectives

Every man takes the limits of his own field of
vision for the limits of the world. Schopenhauer
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What I learned

• The skills that I needed to be successful in the
  early part of my career were very different from
  the skills I would need to be successful in the
  later stages of my career

We run carelessly to the precipice, after we
have put something before us to prevent us from
seeing it. Pascal
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What I learned
A
B
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Questions?
Man who say it cannot be done should not
interrupt man doing it. Chinese proverb