1. Donna-Bea Tillman AU/OPM II December 2004
Use of Outside Experts in FDA’s Premarket Evaluation of Medical Devices
An Action Learning Project
Donna-Bea Tillman
AU/OPM II
December 2004
“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
I’d like to start my talk by looking back at the historical roots of FDA, which trace back to a public health protection problem.
107 people, mostly children, died when sulfanilamide, the first “wonder drug” was formulated into an elixr containing the toxin ethylene oxide. Exisiting laws did not require the drugs manufacturer to test the formulation for safety before it was sold.
Congress corrected this weakness in the law the next year when it passed the Federal Food, Drug, and Cosmetic Act. This law, for the first time, required companies to prove the safety of new drugs before putting them on the market.

4. FDA Mission Today Promote Protect
Today, FDA’s mission has broadened beyond public health protection to also include public health promotion – ensuring the availability of new products that promote the health of the American people.
When most people think of FDA, they think of our public health protection role:
-Historical roots of FDA
-Methods well understood
-Good business – basis of public confidence in medical products
However, many of FDA’s most difficult challenges lay in the public health promotion arena.

5. 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)

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

7. Devices
HHS/FDA/CDRH

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 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

14. 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.

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

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

17. 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

18. Office of Device Evaluation
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

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. 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

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 A B

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