CDRH Vision - Total Product Life Cycle

2. CDRH Vision - Total Product Life Cycle

5. CDRH Science Review • Planning of Review - Nov 1999 • Internal Review – March 2001 • External Review – • June 21, 2001 (Orientation) • July 24 to 26, 2001 • Science Board Report – Nov 2001 • Science Review Implementation

6. Broad Areas of Focus: CDRH Internal & External Reviews • Review seeks information about the Center’s decision making process • Scientific decision making • Impact of decision made by CDRH • Resources required • Integration of decisions made • Processes and feedback mechanisms to document decisions and enhance organizational learning • Preparedness to address future science issues

7. Internal Review • “Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH • “Top 10 list” of recommendations for science-based regulation at CDRH

8. “Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH • CDRH is not always recognized as a science-based organization by: • parts of CDRH and FDA, • the Department of Health and Human Services, • Congress and • Industry. Recommendation: • CDRH needs to communicate its scientific vision and the scientific basis for its regulatory actions. • CDRH needs advocates for its scientific role in medical devices and radiological health, including the FDA Science Board

9. “Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH • The Center leadership does not always communicate science as a priority. We miss opportunities to creating the time and resources for our scientists to have the training and experiences to stay current and build their scientific expertise. Budget and resource planning is often reactive and short term and not well used to “walk the talk” of the priority of science. Recommendation: • The Center leadership needs to demonstrate the priority of science in how it allocates its human resources, and through strategies to maintain and build science capacity in the Center.

10. “Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH • CDRH’s scientific staff is “graying” and an anticipated wave of retirement will exacerbate the shortages of some types of expertise. Replacement hiring will also create challenging opportunities. Recommendation: • CDRH needs to implement the Magnet for Excellence goal area of its strategic plan which seeks to recruit and retain the type of employees that will help us accomplish our public health mission.

11. “Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH • Budget policies of the last eight years have markedly reduced operating dollars leaving laboratory programs and information technology infrastructure funded at a subsistence level. Recommendation: • Rich or poor, the Center needs to assure that there are enough operating dollars (vs. salary dollars) to provide the funds needed to maintain the effectiveness of our employees.

12. “Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH • New staff is trained largely by apprenticeship with insufficient attention to assuring the development of the core competencies needed for science-based regulation. Recommendation: • CDRH needs to identify core competencies and the types of experiences that will develop them to create a flexible scientific workforce able to meet future challenges.

13. “Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH • Premarket deadlines, acute problems, and “squeaky wheels” dominate resource allocation and leave programs disconnected and sometimes out of balance. Recommendation: • The Center’s strategic vision of assuring the public health throughout the total product life cycle and having meaningful measures of the impact of our efforts are strategies that will allow us to prioritize work better by the impact that it has.

14. “Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH • Scientific communication opportunities are underutilized, whether with scientific peers, medical device users or the general public. This limits our mission effectiveness. Recommendation: • The goal area of Knowledge Management in the Center’s strategic plan provides an approach not only to the acquisition and management of new knowledge, but also to the dissemination to our stakeholders to promote our mission.

15. “Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH • We solve many problems too slowly in a rapidly changing world. While decision making is often timely, implementation is often not. Recommendation: • CDRH should set goals, choose important problems, assess how to measure impact, create the team needed and be accountable for timely results from its efforts.

16. “Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH • Peer review is underutilized as a method for prioritizing efforts and evaluation. Choices are heavily driven by regulatory needs and evaluation is usually done through the organizational hierarchy. Recommendation: • Peer review should be routinely incorporated into the science-based decision making and science-based efforts by peers within and from outside the Center to supplement other methods of assessing scientific quality and effectiveness.

17. “Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH • Scientific partnerships with NIH, NAS, Universities, professional societies exist, but are underdeveloped. Recommendation: • Scientific partnerships with NIH, NAS, Universities, professional societies exist, should be developed as a source of external expertise, as sources of recruitment, and for partnerships in mission related activities.

18. Evaluation of External Review • Survey of External Panel Members (11/12 responded)

19. CDRH Science Review Evaluation • Opening the scope of the review to include the entire Center, i.e., not limited to a laboratory science review mean = 4.9 • The early planning/kick-off meeting in Atlanta on June 21, 2001 mean = 4.2 • Background materials on CDRH’s Mission and Organization mean = 4.5 No Use Essential

20. CDRH Science Review Evaluation • Case Studies: - the concept mean = 4.1 • - the materials • mean = 3.8- the staff Interviews • mean = 4.8 No Use Essential

21. CDRH Science Review Evaluation • “On the Spot”: - the concept mean = 4.0 • - the materials • mean = 2.7- the staff Interviews • mean = 4.1 No Use Essential

22. CDRH Science Review Evaluation • Role Playing Sessions mean = 3.8 • The Industry Interviews • mean = 4.1 • The callback writing session mean = 4.7 No Use Essential

23. CDRH Science Review Evaluation • Open Ended Questions: • What was the best/most useful activity or component of the Science Review? • What was the worst/least useful activity or component of the Science Review? • Which of the Committee’s recommendations do you believe: CDRH must address in the near term to address a critical flaw? • Which of the Committee’s recommendations do you believe: CDRH must address to assure our place as a scientific leader in the medical device community?

24. case studies and industry interviews the thought that preceded the committees work allowed more substantive activity as did the excellent prepared materials interviews with the management and staff (2) staff interviews – all were great & essential to further our understanding of the issues and way CDRH processes information discussion with staff and case studies the background materials were essential to getting up to speed. The interviews were essential to understanding realities of the Center beyond the public persona or management view staff interviews interfacing with staff discussion of recommendations What was the best/most useful activity or component of the Science Review?

25. role playing sessions (2) “on the spot” was least useful as it was difficult for the review team to know what to ask for. Not really necessary. Would have been better to have more time for discussions with CDRH staff preselection of case studies science review committee was too heavily weighted towards an industry bias. Insufficient “federal” scientific stakeholder representation it was a bit scripted, and some things slipped past before we realized they needed more thoughts What was the worst/least useful activity or component of the Science Review? • “on the spot” • every part was good • the “on the spot” activities were unfocused and for more work than was valuable. This time could have been better spent. • the case studies were good but need to be very carefully selected or they are not useful • “on the spot” binder – lists of documents not helpful • “on the spot” materials • trying to understand the materials and cope with the quantity

26. all of them manpower distribution workload distribution more transparent communication Strong immediate need to re-evaluate OST – structure, if OST exists, must change to reflect current and future science. Recommendation #3 CDRH should consider outsourcing some of its review activities, although it was not contained in the committee’s final recommendations, CDRH should consider charge back for industry “keep current and support staff Rec #13 & 14 – quality metrics and evaluation Assessment of needs (#7) Which of the Committee’s recommendations do you believe: CDRH must address in the near term to address a critical flaw? • develop a strategic staffing plan to accommodate expected turnover/attrition/retirement & fill technical gaps with respect to future technologies • Develop a plan for cross office communication (#4) • Establish an electrtonic database for decisions and inventory (#5) • Add human factors expertise to panels (#10) • Funding which drives workload • Rec #1 & 2 – define and communicate a vision and from that the organization and resources needed to meet that vision. Don’t start with the budget. • Position it’s staff for the next 20 years challenge

27. all of them it’s difficult, but planned ready enrichment must be viewed as a core not supplemental activity staff evaluation is needed to have a clear picture or required hiring to maintain (attain) expertise needed for biological/technological “revolution” (Rec #7) see Rec #7 Be scientific! See Rec #7 develop a strategic staffing plan to accommodate expected turnover/attrition/retirement & fill technical gaps with respect to future technologies Rec #7 & 9 – expertise of staff Improve career path (# Which of the Committee’s recommendations do you believe: CDRH must address to assure our place as a scientific leader in the medical device community? • More outreach (#12) that’s the only way to keep up and connected • Reassess what laboratory programs to support – some are outdated & in other areas critical new fields of science are not covered at all • Vision is extremely important • Identification of those technologies and development of an in-house capability in those technologies that will support approval of future medical devices • Add new staff to cope with new technology

28. Science Review Next Steps • Establishment of CDRH Recommendations Committee

29. Frances Benedict, OCD Bob Cangelosi, OHIP James Dillard, ODE Patricia Dubill, OST Philip Frappaolo, OCD Anita Rayner, OSB Donald Serra, OC Mitchell Shein, ODE Toni Nearing, OCD Kathleen Walker, OSM Cheryll Wells, OC CDRH Science Recommendations Committee Representatives from every Office 2 Quality systems experts

30. Science Review Next Steps • Establishment of CDRH Recommendations Committee • Scheduling of Division Directors Go-Away to address recommendations in light of strategic goal areas (Dec 6, 2001)

31. Science Review Next Steps • Establishment of CDRH Recommendations Committee • Scheduling of Division Directors Go-Away to address recommendations in light of strategic goal areas (Dec 6, 2001) • Internet posting of Final Report • www.fda.gov/cdrh/science

32. CDRH Science Review Committee • CDRH Recommendations Committee • to prioritize the recommendations from the review (long and short term priorities), and • make suggestions to Sr. Staff on how to merge these recommendations into our strategic plan

33. New Technology Scan Horizon

34. New Technology Develop Regulatory Path

35. New Technology Identify External Experts

36. New Technology Build Internal Capacity

37. New Technology ConsolidateTPLC Team

38. Center for Devices and Radiological Health • Strategic Goal Areas • Total Product Life Cycle product management • Magnet for Excellence to attract and develop the staff to accomplish our mission • Knowledge Management • Meaningful Metrics

39. Center for Devices and Radiological Health • Mission: • CDRH promotes and protects the health of the public by ensuring the safety and effectiveness of medical devices and the safety of radiological products.

40. CDRH is not always recognized as a science-based organization by: parts of CDRH and FDA, the Department of Health and Human Services, Congress and Industry. The Center leadership does not always communicate science as a priority. We miss opportunities to creating the time and resources for our scientists to have the training and experiences to stay current and build their scientific expertise. Budget and resource planning is often reactive and short term and not well used to “walk the talk” of the priority of science. CDRH’s scientific staff is “graying” and an anticipated wave of retirement will exacerbate the shortages of some types of expertise. Replacement hiring will also create challenging opportunities. Budget policies of the last eight years have markedly reduced operating dollars leaving laboratory programs and information technology infrastructure funded at a subsistence level. New staff is trained largely by apprenticeship with insufficient attention to assuring the development of the core competencies needed for science-based regulation. Premarket deadlines, acute problems, and “squeaky wheels” dominate resource allocation and leave programs disconnected and sometimes out of balance. Scientific communication opportunities are underutilized, whether with scientific peers, medical device users or the general public. This limits our mission effectiveness. We solve many problems too slowly in a rapidly changing world. While decision making is often timely, implementation is often not. Peer review is underutilized as a method for prioritizing efforts and evaluation. Choices are heavily driven by regulatory needs and evaluation is usually done through the organizational hierarchy. Scientific partnerships with NIH, NAS, Universities, professional societies exist, but are underdeveloped. “Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH

41. CDRH needs to communicate its scientific vision and the scientific basis for its regulatory actions. It needs advocates for its scientific role in medical devices and radiological health, including the FDA Science Board. The Center leadership needs to demonstrate the priority of science in how it allocates its human resources, and through strategies to maintain and build science capacity in the Center. CDRH needs to implement the Magnet for Excellence goal area of its strategic plan which seeks to recruit and retain the type of employees that will help us accomplish our public health mission. Rich or poor, the Center needs to assure that there are enough operating dollars (vs. salary dollars) to provide the funds needed to maintain the effectiveness of our employees. CDRH needs to identify core competencies and the types of experiences that will develop them to create a flexible scientific workforce able to meet future challenges. The Center’s strategic vision of assuring the public health throughout the total product life cycle and having meaningful measures of the impact of our efforts are strategies that will allow us to prioritize work better by the impact that it has. The goal area of Knowledge Management in the Center’s strategic plan provides an approach not only to the acquisition and management of new knowledge, but also to the dissemination to our stakeholders to promote our mission. CDRH should set goals, choose important problems, assess how to measure impact, create the team needed and be accountable for timely results from its efforts. Peer review should be routinely incorporated into the science-based decision making and science-based efforts by peers within and from outside the Center to supplement other methods of assessing scientific quality and effectiveness. Scientific partnerships with NIH, NAS, Universities, professional societies exist, should be developed as a source of external expertise, as sources of recruitment, and for partnerships in mission related activities. “Top 10 list” of recommendations for science-based regulation at CDRH