Public Workshop: The Center for Devices and Radiological Health (CDRH) Health of Women (HoW) Program Launch: Educate, Enable, Enlist and Explore – HoW to Improve the Health of Women, June 24

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Center for Devices and Radiological Health (CDRH) Health of Women (HoW) Program Launch: Educate, Enable, Enlist and Explore – HoW to Improve the Health of Women.”

CDRH is developing a Health of Women (HoW) Program to explore some of the unique issues related to the performance of medical devices in women, and seeks public input on the priority activities.  The workshop is planned as the Health of Women Program launch.

The mission of the HoW program is to improve the health of women by:

• improving the availability, consistency and communication of sex-specific information for the safe and effective use of medical devices in women;
• addressing identified gaps and unmet needs through targeted resources; and
• fostering the development of innovative strategies, technology and clinical study paradigms.

The CDRH HoW program seeks to bring together clinicians, researchers, academia, government agencies, industry, and patient / advocacy groups in an effort to 1) Develop Device-Specific Clinical Study Recruitment Retention Strategies; 2) Improve Analysis and Communication of Sex-Specific Findings to Providers and Patients; 3) Develop a Priority Research Road Map for the HoW Device Ecosystem. The workshop focus will be device- and disease-specific, patient-centered and action-oriented.

The meeting will be held on June 24 and 25, 2013, beginning at 8:00 a.m. at the following location:

FDA White Oak Campus, Building 66
Rooms G512 and G514
10903 New Hampshire Avenue
Silver Spring, MD, 20993

*Please allow sufficient time for security screening.

• FDA Campus Information

The meeting will begin with introductory presentations to outline the 3 primary areas of focus for the CDRH HoW Program:

1. Develop Device-Specific Recruitment Retention Strategies
2. Improve Analysis Communication of Sex-Specific Findings to Providers Patients
3. Develop a Priority Research Road Map for the HoW Device Ecosystem

Agenda Overview
A detailed agenda with times and speakers will be provided in advance of the workshop.

Plenary 1 – Develop Device-Specific Recruitment Retention Strategies

Workshop focus:

• Specific for device industry studies (not all pharmaceutical and NIH/academia approaches may fit; distill those that do and explore new practical device-specific strategies)
• Emphasize patient perspective to understand how to overcome patient barriers to recruitment and retention

Workshop objectives:

1. Identify and understand top 3 or 4 barriers to recruitment and retention of women in device studies
2. Explore device-specific ”success strategies” for addressing top barriers
3. Identify, enlist and partner with key stakeholders to test and adopt practical success strategies  for the top barriers
4. Develop strategy to communicate and broadly disseminate findings from items 1-3  (steps may include: define problem i.e. top barriers, benchmark with current data, show results of tested success strategies)

Plenary 2 – Improve Analysis and Communication of Sex-Specific Findings to Providers Patients

Workshop focus:

• Discuss a potential decision framework for sex-specific analysis (When do we need more data how much?)
• Practitioner audience communication strategy (effective messages vehicles – journals, professional societies, practice guidelines)
• Patient audience communication strategy (effective messages vehicles – advocacy groups and other trusted sources)

Workshop objectives:

1. Explore the utility of a potential decision framework for sex-specific analysis
2. Identify and explore the development of 3 – 4 communication strategies to provide useful information to patients and practitioners
3. Enlist and partner with potential collaborators to test and adopt communication strategies

Plenary 3 – Develop a Priority Research Road Map for the HoW Device Ecosystem

Workshop focus:

• Discuss and solicit stakeholder input on the proposed approach to prioritize research areas related to the health of women
• Showcase example Total Product Life Cycle (TPLC) regulatory science efforts in high priority research areas

Workshop objectives:

1. Discuss proposed approach to gap analysis to prioritize research agendas related to the HoW Device Ecosystem
2. Influence research and device development to incorporate consideration of unique issues related to the health of women
3. Embed device considerations into priority disease research  areas
4. Develop action plan and partnerships to develop research agendas for the HoW priority areas using the TPLC regulatory science approach to focus research efforts and target resources 

If you wish to attend this Workshop, you must register by 5 p.m. on June 14, 2013.

Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online. Early registration is recommended because facilities are limited and, therefore, the FDA may limit the number of participants from each organization. If time and space permits, onsite registration will be provided beginning at 7:30 a.m. on the day of the public workshop.