Use of Outside Experts in FDA’s Use of Outside Experts in FDA’s Premarket Evaluation of Medical Premarket Evaluation of Medical

DevicesDevices

Donna-Bea TillmanDonna-Bea Tillman AU/OPM IIAU/OPM II

December 2004 December 2004

An Action Learning ProjectAn Action Learning Project

“Man’s rational life consists in those moments in which reflection not only occurs but proves efficacious.”

George Santayana

FDA Mission: FDA Mission: Historical BasisHistorical Basis

Protect Protect the the public from public from unsafe unsafe productsproducts

FDA Mission TodayFDA Mission Today

ProtectPromote

Department of HealthDepartment of Health and Human Servicesand Human Services

Food and Drug AdministrationOffice of the Commissioner

Center for Devices and Radiological Health

(CDRH)

Center for Drug EvaluationAnd Research

(CDER)

Center for Biologics Evaluation and Research

(CBER)

Center for VeterinaryMedicine

Center for Food SafetyAnd Applied Nutrition

National Center for Toxicological Research

FDA Organizational Chart

Devices are Different from Devices are Different from DrugsDrugs

Drugs Yesterday

Drugs Today

Drugs Tomorrow

HHS/FDA/CDRH

DevicesDevices

Challenges Facing Challenges Facing CDRHCDRH

Rapid technological changesRapid technological changes Increasing complexity of devicesIncreasing complexity of devices Public demand for more control over Public demand for more control over

healthcarehealthcare Global marketplace and global regulationGlobal marketplace and global regulation Shrinking staff numbersShrinking staff numbers

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

Medical Device User Medical Device User Fees to the Rescue!Fees to the Rescue!

CDRH’s New Challenge:CDRH’s New Challenge:

Turning dollars Turning dollars into shorter into shorter review times…review times…

……while while maintaininmaintaining our g our commitmecommitment to good nt to good science.science.

How are we How are we going to make going to make this happen?this happen?

Center for Devices Center for Devices

and and

Radiological HealthRadiological Health

Office of Office of Device Device

EvaluationEvaluation

Office ofOffice of

Surveillance Surveillance & Biometrics& Biometrics

Office of Office of Science & Science &

Engineering Engineering LaboratoriesLaboratories

Office Office of of

ComplianceCompliance

Office of Office of Communication, Communication, Education, and Education, and

Rad HealthRad Health

Office of In Vitro Office of In Vitro Diagnostic Device Diagnostic Device

Evaluation and Evaluation and SafetySafety

Office of Office of Management Management

OperationsOperations

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 CDRH Medical Device Fellowship ProgramFellowship Program

Bring in experts in a range of disciplines.Bring in experts in a range of disciplines. Develop a cadre of outside experts. Develop a cadre of outside experts. Incorporate outside expertise into Incorporate outside expertise into

decision-making.decision-making.

Initial MDFPInitial MDFP GoalsGoals

Academia Academia

Device advisory panelsDevice advisory panels

Practicing clinicians, engineers, Practicing clinicians, engineers, othersothers

Other parts of FDAOther parts of FDA

Other government agenciesOther government agencies

Where do outside Where do outside experts come from?experts come from?

Short term (3 months) to longer term (2 Short term (3 months) to longer term (2

years)years)

Part-time or full-timePart-time or full-time

Federal employment or government Federal employment or government

contractcontract

On-site or off-siteOn-site or off-site

Nature of appointmentsNature of appointments

Division of Anesthesiology

General Hospital, Infection

Control, and Dental Devices

Division of General,

Restorative & Neurological

DevicesDivision of

Ophthalmic & ENT Devices

Division of Reproductive, Abdominal, & Radiological

Devices

Division of Cardiovascular

Devices

Office of Device Evaluation

Office DirectorOffice Director

The (Initial) ProblemThe (Initial) Problem

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

The GroupThe Group

Examine pilot program in the Division Examine pilot program in the Division of Cardiovascular Devices (DCD)of Cardiovascular Devices (DCD)

Team members:Team members: BZ – Director of DCDBZ – Director of DCD MM – Branch chief in DCDMM – Branch chief in DCD MB – Reviewer in DCDMB – Reviewer in DCD SH – Director of MDFPSH – Director of MDFP LD – ODE Program Management LD – ODE Program Management

SpecialistSpecialist

The CoachThe Coach

Explained the principles of action learning Explained the principles of action learning at Meeting #1, including the role of the at Meeting #1, including the role of the coachcoach

Other team members were uncomfortable Other team members were uncomfortable with assuming the role of Coachwith assuming the role of Coach Lack of familiarity with principles of ALLack of familiarity with principles of AL ““Too touchy/feely”Too touchy/feely”

Donna-Bea agreed to be the permanent Donna-Bea agreed to be the permanent Coach Coach

The Questioning and Reflection The Questioning and Reflection ProcessProcess

Team meeting #2: SH presents her Team meeting #2: SH presents her understanding of mission and goals understanding of mission and goals of MDFP programof MDFP program

Team members engage in the Team members engage in the “questioning process”“questioning process”

Meeting #2: The Questioning ProcessMeeting #2: The Questioning Process

The Questioning and Reflection The Questioning and Reflection ProcessProcess

Team asked to reflect at the end of the Team asked to reflect at the end of the meeting on how things had gonemeeting on how things had gone

Agreed that:Agreed that: Would work harder to keep it friendlyWould work harder to keep it friendly Would build on each others questionsWould build on each others questions Would refrain from asking “questions” that Would refrain from asking “questions” that

were opinions in disguisewere opinions in disguise

Subsequent Meetings: The Questioning Subsequent Meetings: The Questioning ProcessProcess

The Questioning and The Questioning and Reflection Process, cont’dReflection 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

The Questioning and The Questioning and Reflection Process, cont’dReflection 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)

Core IssuesCore Issues

How do we identify resource needs that can be How do we identify resource needs that can be appropriately filled using outside resources?appropriately filled using outside resources?

How do we find the appropriate people to fill How do we find the appropriate people to fill the need?the need?

What should be our selection criteria?What should be our selection criteria? How do we address real or apparent conflicts How do we address real or apparent conflicts

of interest?of interest? How do we determine the appropriate hiring How do we determine the appropriate hiring

mechanism and salary to use in each case?mechanism and salary to use in each case?

Core IssuesCore Issues

What do we need to do to train outside What do we need to do to train outside resource? resource?

What are the infrastructure needs (e.g., What are the infrastructure needs (e.g., computers, space) required to support the computers, space) required to support the program?program?

How do we evaluate the impact of the How do we evaluate the impact of the program on our decision-making process?program on our decision-making process?

How do we foster staff acceptance of outside How do we foster staff acceptance of outside experts?experts?

How do we ensure confidentiality of How do we ensure confidentiality of proprietary information obtained by outside proprietary information obtained by outside experts?experts?

The Commitment to The Commitment to LearningLearning

Team spent time at the end of each Team spent time at the end of each meeting talking about how we had done as meeting talking about how we had done as a teama team Particularly helpful after first few meetingsParticularly helpful after first few meetings Refined questioning processRefined questioning process People’s behavior changed as a result!People’s behavior changed as a result!

Demonstrated Kurt Lewin theory that the Demonstrated Kurt Lewin theory that the group is a powerful shaper of individual group is a powerful shaper of individual behaviorbehavior

The Commitment to The Commitment to LearningLearning

The Commitment to Taking The Commitment to Taking ActionAction

Taking action is linked to the Taking action is linked to the questioning and reflection questioning and reflection processprocess

Need to reframe the Need to reframe the question and get at root question and get at root causes in order to determine causes in order to determine appropriate action to takeappropriate action to take

Finding the right peopleFinding the right people

Core Issues:Core Issues: How do we identify resource needs that can How do we identify resource needs that can

be appropriately filled using outside be appropriately filled using outside resources?resources?

How do we find the appropriate people to fill How do we find the appropriate people to fill the need?the need?

Why are other divisions not interested in Why are other divisions not interested in MDFP?MDFP? Questioning process lead to root cause and Questioning process lead to root cause and

development of actions to move forwarddevelopment of actions to move forward

Physicians* - 15Physicians* - 15 Visiting Scholar – senior level clinicians, surgeonsVisiting Scholar – senior level clinicians, surgeons Fellow - physician during fellowship trainingFellow - physician during fellowship training Resident – physician during residency trainingResident – physician during residency training

Engineers* - 42Engineers* - 42 Visiting Scholar – senior level engineerVisiting Scholar – senior level engineer Co-op studentsCo-op students InternsInterns

Physicists* - 2Physicists* - 2 Scientists* - 5Scientists* - 5

*includes students*includes students

Medical Device Fellowship Medical Device Fellowship Program at end of FY04Program at end of FY04

The Commitment to Taking The Commitment to Taking ActionAction

A number of issues were raised A number of issues were raised that team did NOT take action onthat team did NOT take action on

Core Issue: How will we determine Core Issue: How will we determine if the program is a success?if the program is a success? Summative evaluationSummative evaluation Objective of the program will Objective of the program will

determine the evaluation questionsdetermine the evaluation questions

“It is the mark of a good action that it appears inevitable in retrospect.”

Robert Louis Stevenson

Outcomes: Outcomes: MDFPMDFP

Current Status of MDFPCurrent Status of MDFP Next StepsNext Steps

Determine objectivesDetermine objectives Conduct evaluationConduct evaluation

What I learnedWhat I learned

My role in the organization changed My role in the organization changed significantly over the course of this significantly over the course of this project project Deputy Director, DCDDeputy Director, DCD Deputy Director, ODEDeputy Director, ODE Acting Director, ODEActing Director, ODE Director, ODEDirector, ODE

What I learnedWhat I learned

What you see What you see depends on where depends on where you standyou stand

Leader needs to be Leader needs to be able to see things able to see things from all from all perspectivesperspectives “Every man takes the limits of his own field of vision

for the limits of the world.”

Schopenhauer

What I learnedWhat I learned

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

Man who say it cannot be done should not interrupt man doing it.

Chinese proverb

Questions?