Presentation is loading. Please wait.

Presentation is loading. Please wait.

Use of Outside Experts in FDAs Premarket Evaluation of Medical Devices Donna-Bea Tillman AU/OPM II AU/OPM II December 2004 An Action Learning Project Mans.

Similar presentations


Presentation on theme: "Use of Outside Experts in FDAs Premarket Evaluation of Medical Devices Donna-Bea Tillman AU/OPM II AU/OPM II December 2004 An Action Learning Project Mans."— Presentation transcript:

1 Use of Outside Experts in FDAs Premarket Evaluation of Medical Devices Donna-Bea Tillman AU/OPM II AU/OPM II December 2004 An Action Learning Project Mans 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 Protect the public from unsafe products

3

4 FDA Mission Today Protect Promote

5 Department of Health and Human Services 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 Rapid technological changes Increasing complexity of devices Increasing complexity of devices Public demand for more control over healthcare Public demand for more control over healthcare Global marketplace and global regulation Global marketplace and global regulation Shrinking staff numbers Shrinking staff numbers … and we are being asked to make decisions more quickly than ever.

9 Medical Device User Fees to the Rescue!

10 CDRHs New Challenge: Turning dollars into shorter review times… Turning dollars into shorter review times…

11 …while maintaining our commitment to good science. …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 Surveillance & Biometrics Office of Science & Engineering Laboratories OfficeofCompliance 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. Bring in experts in a range of disciplines. Develop a cadre of outside experts. Develop a cadre of outside experts. Incorporate outside expertise into decision- making. Incorporate outside expertise into decision- making. Initial MDFP Goals

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

17 Short term (3 months) to longer term (2 years) Part-time or full-time Part-time or full-time Federal employment or government contract Federal employment or government contract On-site or off-site 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? 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) Examine pilot program in the Division of Cardiovascular Devices (DCD) Team members: Team members: BZ – Director of DCD BZ – Director of DCD MM – Branch chief in DCD MM – Branch chief in DCD MB – Reviewer in DCD MB – Reviewer in DCD SH – Director of MDFP SH – Director of MDFP LD – ODE Program Management Specialist LD – ODE Program Management Specialist

21 The Coach Explained the principles of action learning at Meeting #1, including the role of 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 Other team members were uncomfortable with assuming the role of Coach Lack of familiarity with principles of AL Lack of familiarity with principles of AL Too touchy/feely Too touchy/feely Donna-Bea agreed to be the permanent Coach 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 meeting #2: SH presents her understanding of mission and goals of MDFP program Team members engage in the questioning process 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 Team asked to reflect at the end of the meeting on how things had gone Agreed that: Agreed that: Would work harder to keep it friendly Would work harder to keep it friendly Would build on each others questions Would build on each others questions Would refrain from asking questions that were opinions in disguise Would refrain from asking questions that were opinions in disguise

25 Subsequent Meetings: The Questioning Process

26 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

27 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)

28 Core Issues How do we identify resource needs that can be appropriately filled using outside resources? 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? How do we find the appropriate people to fill the need? What should be our selection criteria? What should be our selection criteria? How do we address real or apparent conflicts of interest? 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? 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 do we need to do to train outside resource? What are the infrastructure needs (e.g., computers, space) required to support the program? 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 evaluate the impact of the program on our decision-making process? How do we foster staff acceptance of outside experts? How do we foster staff acceptance of outside experts? How do we ensure confidentiality of proprietary information obtained by 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 Team spent time at the end of each meeting talking about how we had done as a team Particularly helpful after first few meetings Particularly helpful after first few meetings Refined questioning process Refined questioning process Peoples behavior changed as a result! Peoples behavior changed as a result! Demonstrated Kurt Lewin theory that the group is a powerful shaper of individual behavior 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 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 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: Core Issues: How do we identify resource needs that can be appropriately filled using outside resources? 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? How do we find the appropriate people to fill the need? Why are other divisions not interested in MDFP? Why are other divisions not interested in MDFP? Questioning process lead to root cause and development of actions to move forward Questioning process lead to root cause and development of actions to move forward

34 Physicians* - 15 Physicians* - 15 Visiting Scholar – senior level clinicians, surgeons Visiting Scholar – senior level clinicians, surgeons Fellow - physician during fellowship training Fellow - physician during fellowship training Resident – physician during residency training Resident – physician during residency training Engineers* - 42 Engineers* - 42 Visiting Scholar – senior level engineer Visiting Scholar – senior level engineer Co-op students Co-op students Interns Interns Physicists* - 2 Physicists* - 2 Scientists* - 5 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 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? Core Issue: How will we determine if the program is a success? Summative evaluation Summative evaluation Objective of the program will determine the evaluation questions 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 Current Status of MDFP Next Steps Next Steps Determine objectives Determine objectives Conduct evaluation Conduct evaluation

37 What I learned My role in the organization changed significantly over the course of this project My role in the organization changed significantly over the course of this project Deputy Director, DCD Deputy Director, DCD Deputy Director, ODE Deputy Director, ODE Acting Director, ODE Acting Director, ODE Director, ODE Director, ODE

38 What I learned What you see depends on where you stand What you see depends on where you stand Leader needs to be able to see things from all perspectives 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 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

40

41

42 What I learned

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


Download ppt "Use of Outside Experts in FDAs Premarket Evaluation of Medical Devices Donna-Bea Tillman AU/OPM II AU/OPM II December 2004 An Action Learning Project Mans."

Similar presentations


Ads by Google