1. Use of Outside Experts in FDA’s
Premarket Evaluation of Medical Devices
Donna-Bea Tillman
AU/OPM II
December 2004
An Action Learning Project
“Man’s rational life consists in those moments in which
reflection not only occurs but proves efficacious.”
George Santayana

2. FDA Mission:
Historical Basis
 Protect the
public from
unsafe
products

4. FDA Mission Today
Protect
Promote

5. Department of Health
and Human Services
Food and Drug Administration
Office of the Commissioner
Center for Devices and
Radiological Health
(CDRH)
Center for Drug Evaluation
And Research
(CDER)
Center for Biologics
Evaluation and Research
(CBER)
Center for Veterinary
Medicine
Center for Food Safety
And Applied Nutrition
National Center for
Toxicological Research
FDA Organizational Chart

6. Devices are Different from Drugs
Drugs Yesterday
Drugs Today
Drugs Tomorrow

7. HHS/FDA/CDRH
Devices

8. 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.

9. Medical Device User Fees to
the Rescue!

10. CDRH’s New Challenge:
Turning dollars
into shorter
review times…

11. …while
maintaining
our
commitment
to good
science.

12. How are we going
to make this
happen?

13. Center for Devices
and
Radiological Health
Office of
Device
Evaluation
Office of
Surveillance
& Biometrics
Office of
Science &
Engineering
Laboratories
Office
of
Compliance
Office of
Communication,
Education, and
Rad Health
Office of In Vitro
Diagnostic Device
Evaluation and
Safety
Office of
Management
Operations

14. 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.
CDRH Medical Device
Fellowship Program

15.  Bring in experts in a range of disciplines.
 Develop a cadre of outside experts.
 Incorporate outside expertise into decision-
making.
Initial MDFP Goals

16.  Academia
 Device advisory panels
 Practicing clinicians, engineers, others
 Other parts of FDA
 Other government agencies
Where do outside experts
come from?

17.  Short term (3 months) to longer term (2 years)
 Part-time or full-time
 Federal employment or government contract
 On-site or off-site
Nature of appointments

18. Division of
Anesthesiology
General Hospital,
Infection Control,
and Dental Devices
Division of General,
Restorative &
Neurological Devices
Division of Ophthalmic
& ENT Devices
Division of
Reproductive,
Abdominal, &
Radiological Devices
Division of
Cardiovascular
Devices
Office of Device
Evaluation
Office Director

19. The (Initial) Problem
How can CDRH most
effectively use outside
scientific resources to improve
the premarket evaluation of
medical devices?

20. 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

21. 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

22. 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”

23. Meeting #2: The Questioning Process

24. 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

25. Subsequent Meetings: The Questioning Process

26. The Questioning and Reflection
Process, cont’d
 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

27. The Questioning and
Reflection Process, cont’d
 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)

28. 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?

29. 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?

30. 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
 People’s behavior changed as a result!
 Demonstrated Kurt Lewin theory that the group
is a powerful shaper of individual behavior

31. The Commitment to Learning

32. 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

33. 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

34.  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
Medical Device Fellowship Program at
end of FY04

35. 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

36. Outcomes:
MDFP
 Current Status of MDFP
 Next Steps
 Determine objectives
 Conduct evaluation

37. 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

38. 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

39. 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

42. What I learned

43. Man who say it cannot be done should
not interrupt man doing it.
Chinese proverb
Questions?