Pending favorable outcomes of the study, production of the device should begin as soon as possible. A
manufacturer should be selected and manufacturing plans should be rapidly developed. It will be
important to stimulate demand in the short term by investing in medium- to large-scale introductions of
the device in two to four early-adopter countries through broad collaborations with ministries of health,
nongovernmental organizations, and other key stakeholders. It will be useful to simultaneously lay the
foundation for broad, long-term uptake worldwide and to begin cross-cutting activities to achieve quick
results in a few targeted countries.
Global regulatory pathways should also be rigorously pursued. Assuming that study results are favorable,
this includes seeking a strong recommendation in the WHO guidelines for managing prolonged and
obstructed labor and in the organization’s Managing Complications in Pregnancy and Childbirth: A
Guide for Midwives and Doctors. The device should also be included in the Interagency List of Essential
Medical Devices for Reproductive Health.
Regional and national regulatory pathways should also be rigorously pursued. A particular focus should
be placed on national regulatory registration and approval in countries where the burden of maternal
mortality is high and ministries of health are receptive to the introduction of the Odón Device.
Introduction in these countries may be facilitated through existing and future training programs for the
active management of the third stage of labor.
Although the Odón Device will require less specialized training than VEs or forceps, investments in
adequate training for midwives, nurses, and physicians will be essential to ensure improved treatment
outcomes.