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

FDA Mission:
Historical Basis

Protect the
public from
unsafe
products

FDA Mission Today

Protect

Promote

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 Drug Evaluation

And Research
(CDER)

Center for Biologics

Evaluation and Research
(CBER)

Center for Devices and

Radiological Health
(CDRH)

Devices are Different from

Drugs
Drugs Yesterday

Drugs Today

Drugs Tomorrow

Devices

HHS/FDA/CDRH

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.

Medical Device User

Fees to the Rescue!

CDRHs New Challenge:

Turning dollars
into shorter
review times

while
maintainin
g our
commitme
nt to good
science.

How are we
going to make
this happen?

Office of In Vitro
Diagnostic Device
Evaluation and
Safety

Office of
Surveillance
& Biometrics

Office
of
Compliance

Office of
Device
Evaluation

Center for Devices

and
Radiological Health

Office of
Management
Operations

Office of
Science &
Engineering
Laboratories

Office of
Communication,
Education, and
Rad Health

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.

Initial MDFP Goals

Bring in experts in a range of disciplines.

Develop a cadre of outside experts.

Incorporate outside expertise into

decision-making.

Where do outside experts

come from?

Academia

Device advisory panels

Practicing clinicians, engineers,

others

Other parts of FDA

Other government agencies

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

Office Director

Division of
Anesthesiology
General
Hospital,
Infection
Control, and
Dental Devices
Division of
General,
Restorative &
Neurological
Devices

Office of Device
Evaluation

Division of
Reproductive,
Abdominal, &
Radiological
Devices

Division of
Cardiovascular
Devices
Division of
Ophthalmic &
ENT Devices

The (Initial) Problem

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

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

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

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

Meeting #2: The Questioning Process

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

Subsequent Meetings: The Questioning

Process

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

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)

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?

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

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

The Commitment to
Learning

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

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

Medical Device Fellowship Program

at end of FY04

Physicians* - 15

Engineers* - 42

Visiting Scholar senior level clinicians, surgeons

Fellow - physician during fellowship training
Resident physician during residency training
Visiting Scholar senior level engineer
Co-op students
Interns

Physicists* - 2
Scientists* - 5
*includes students

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

Outcomes:
MDFP

Current Status of MDFP

Next Steps

Determine objectives
Conduct evaluation

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

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

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

What I learned

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