Presentation on theme: "Donna-Bea Tillman AU/OPM II December 2004"— Presentation transcript:
1 Donna-Bea Tillman AU/OPM II December 2004 Use of Outside Experts in FDA’s Premarket Evaluation of Medical DevicesAn Action Learning ProjectDonna-Bea TillmanAU/OPM IIDecember 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 productsI’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 productsHowever, many of FDA’s most difficult challenges lay in the public health promotion arena.
5 FDA Organizational Chart Department of Healthand Human ServicesCenter for VeterinaryMedicineCenter for Food SafetyAnd Applied NutritionFood and Drug AdministrationOffice of the CommissionerNational Center forToxicological ResearchCenter for BiologicsEvaluation and Research(CBER)Center for Drug EvaluationAnd Research(CDER)Center for Devices andRadiological Health(CDRH)
6 Devices are Different from Drugs Drugs YesterdayDrugs TodayDrugs Tomorrow
8 Challenges Facing CDRH Rapid technological changesIncreasing complexity of devicesPublic demand for more control over healthcareGlobal marketplace and global regulationShrinking staff numbers… and we are being asked to make decisions more quickly than ever.
13 Center for Devices and Radiological Health Office of In Vitro Diagnostic Device Evaluation and SafetyOffice of Device EvaluationOffice of Science & Engineering LaboratoriesOffice ofSurveillance& BiometricsCenter for DevicesandRadiological HealthOffice of Management OperationsOffice of Communication, Education, and Rad HealthOfficeofCompliance
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? AcademiaDevice advisory panelsPracticing clinicians, engineers, othersOther parts of FDAOther government agencies
17 Nature of appointments Short term (3 months) to longer term (2 years)Part-time or full-timeFederal employment or government contractOn-site or off-site
18 Office of Device Evaluation Office DirectorDivision of Anesthesiology General Hospital, Infection Control, and Dental DevicesDivision of Reproductive, Abdominal, & Radiological DevicesOffice of Device EvaluationDivision of General, Restorative & Neurological DevicesDivision of Cardiovascular DevicesDivision of Ophthalmic & ENT Devices
19 The (Initial) ProblemHow can CDRH most effectively use outside scientific resources to improve the premarket evaluation of medical devices?
20 The GroupExamine pilot program in the Division of Cardiovascular Devices (DCD)Team members:BZ – Director of DCDMM – Branch chief in DCDMB – Reviewer in DCDSH – Director of MDFPLD – ODE Program Management Specialist
21 The CoachExplained the principles of action learning at Meeting #1, including the role of the coachOther team members were uncomfortable with assuming the role of CoachLack 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 programTeam members engage in the “questioning process”
24 The Questioning and Reflection Process Team asked to reflect at the end of the meeting on how things had goneAgreed that:Would work harder to keep it friendlyWould build on each others questionsWould refrain from asking “questions” that were opinions in disguise
26 The Questioning and Reflection Process, cont’d Medical Device review process involves lots of questionsBut 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 IssuesHow 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 teamParticularly helpful after first few meetingsRefined questioning processPeople’s behavior changed as a result!Demonstrated Kurt Lewin theory that the group is a powerful shaper of individual behavior
32 The Commitment to Taking Action Taking action is linked to the questioning and reflection processNeed 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* - 15Visiting Scholar – senior level clinicians, surgeonsFellow - physician during fellowship trainingResident – physician during residency trainingEngineers* - 42Visiting Scholar – senior level engineerCo-op studentsInternsPhysicists* - 2Scientists* - 5*includes students
35 The Commitment to Taking Action A number of issues were raised that team did NOT take action onCore Issue: How will we determine if the program is a success?Summative evaluationObjective 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 learnedMy role in the organization changed significantly over the course of this projectDeputy Director, DCDDeputy Director, ODEActing Director, ODEDirector, 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 learnedThe 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