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OCD FY2004: Part 6. Improving Business Practices - CDRH Strategic Goal: Total Product Life Cycle and Magnet for Excellence

Managing Priorities

Strategic Planning and Organizational Scorecards

In FY 04, CDRH implemented organizational scorecards for the Center and for each Office. Organizational scorecards, a CDRH Strategic Plan Phase II initiative, are intended to align work processes in each Office by measuring performance in key result areas. Continued monitoring enables the Center to take corrective action, if needed.

Implementation of MDUFMA presents major performance management challenges. FY 04 organizational scorecards included MDUFMA indicators. Quarterly scorecard reports provided important assistance and information for the Center’s quarterly FY 04 MDUFMA reports.

The CDRH Measurement Team reports performance on key indicators regularly throughout the year. During FY 04, scorecard data was quarterly reported on twelve active indicators in the Center scorecard. Third and fourth FY 04 quarter CDRH scorecard reports are posted on the strategic planning site,  http://www.FDA.Gov/CDRH/strategic/.

CDRH Alignment with Department Goals and President Management Agenda

The President’s Management Agenda and the Department’s One HHS Management Objectives have given departments and agencies the mandate to seek out ways to improve the public health while increasing the linkage between dollars and performance. The Center for Devices and Radiological Health has responded to this by evaluating and ensuring alignment between Center goals and the priorities of the Commissioner, Secretary and the President. This included efforts to identify and communicate the Center’s role in presidential, department, and agency initiatives, which resulted in higher scores on the OMB PART Evaluation, exceptional ratings on agency yearly organizational assessment with the department, and positive performance evaluations with the Commissioner. It has also resulted in greater understanding among Center employees of agency and department initiatives.

CDRH regularly reviews its goals to ensure alignment with the following initiatives:

  • Presidents Management Agenda  http://www.whitehouse.gov/omb/budget/fy2002/mgmt and  http://www.results.gov/
  • Government Performance & Results Act-  http://www.FDA.Gov/ope/fy04plan/2004pp-mainpage.html
  • HHS Strategic Plan -  http://aspe.hhs.gov/hhsplan/
  • OMB Long Term Outcome Goals -  http://www.FDA.Gov/ope/fy04plan/2004pp-mainpage.html
  • FDA Strategic Plan -  http://www.FDA.Gov/oc/mcclellan/strategic.html and  http://www.FDA.Gov/oc/initiatives/reports/priorities2004.html
  • CDRH Strategic Plan -  http://www.fda.gov/cdrh/strategic/

For more information on HHS, FDA, and CDRH Program Initiatives, please visit the following link: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm126359.htm.

CDRH Communication Plan

In FY 04, a Communication Plan was developed and piloted in CDRH. The Plan outlines processes to:

  • plan, prioritize, and budget for CDRH communication activities;
  • help employees communicate across CDRH and share expertise on outreach projects; and
  • provide consistent and coordinated messages to the public.

Magnet for Excellence

CDRH continued to build effective and efficient operations and a highly skilled and diverse workforce needed to carry out the agency’s goal of more effective regulation through a stronger workforce.

Medical Device Fellowship Program

The CDRH Medical Device Fellowship Program (MDFP) provides opportunities for health professionals to participate in the regulatory process for medical devices. MDFP participants are experts in their fields. They perform a variety of duties in CDRH, including:

  • reviewing and consulting on premarket submissions, especially in specialized areas, such as vascular grafts and stents, spinal implants, software, etc.;
  • addressing human factors issues;
  • performing analysis of device failure modes; and
  • developing standards and guidance.

In FY 04 the MDFP had 64 participants. Information about MDFP is available at http://www.fda.gov/AboutFDA/WorkingatFDA/ FellowshipInternshipGraduateFacultyPrograms/MedicalDeviceFellowshipProgramCDRH/default.htm.

Mentoring for Excellence Program

CDRH completed the “Mentoring for Excellence Program” pilot for new managers. The program is intended to develop management competencies which top managers have identified as crucial in CDRH’s culture. The results are being reviewed and CDRH is exploring ways to integrate this tool into the diverse leadership enhancing programs offered within the Center.

Continuing Science Education Program

CDRH created the Continuing Science Education Program, or CSEP, which offers joint educational programs with selected colleges and universities. CSEP has two different programs for targeted audiences: the Basic Science Education Program, also known as BSEP, and the Science Leadership Education Program, known as SLEP. These programs are designed to encourage continual learning and provide employees with an opportunity to enhance their overall scientific knowledge.

Competency Model

The development of a Competency Model that will identify the essential core, science, and functional or job category competencies for CDRH employees was initiated. The model is intended to guide employees’ professional development and ultimately enhance job performance and meet organizational goals.