BD will invest in R&D, manufacturing, marketing and distribution of the Odon device. BD will build the necessary technical and advocacy capabilities with the goal of deploying this product at a market appropriate price, especially for low-income countries which have a high burden of maternal and neonatal deaths. BD will seek support from the Economic Development Board (EDB) of Singapore to carry out the development and commercialization of the product from Singapore.
BD is currently in discussion with WHO to develop an access pricing agreement. BD will work with international health agencies such as WHO, USAID, and other Grand Challenge partners to implement a collaborative model for conducting clinical trials, funding procurement, and expanding patient access with a goal of reaching the most vulnerable populations in emerging and developing countries. Collectively, these organizations are working as collaborative partners to achieve the goal of reducing maternal and newborn mortality associated with prolonged and obstructed labor.
BD's core competencies in medical device design, quality systems, process design and low?cost manufacturing, and its global organizational reach, will be instrumental in successful global deployment of the Odon Device. By partnering with the WHO and Odon to advance the safety of childbirth for mothers and newborns, BD is also committing to a broader strategy to address maternal and newborn mortality consistent with Millennium Development Goals 4 and 5.
BD is initially targeting the Countdown to 2015 developing and emerging countries for deployment of the Odon Device. The market will be segmented by facilities that have skilled birth attendants. BD will work with local implementing partners as part of a distribution plan to utilize country-level personnel to reach women in remote, rural areas of developing countries.
The key next step for the Odon device is to establish the product development process, including hiring the product development team. This will be accomplished by BD in Asia. BD will advance the commitment plans with external organizations such as WHO and USAID to support clinical trials and launch of the device. This latter activity is being led by BD's Global Health function, building on its established competencies in cross-sector collaboration.
WHO has agreed to fund and conduct the clinical studies for the Odon device and to support regulatory processes, including product registration at country-level. Agencies that have selected this device as the winner of the Grand Challenge for Saving Lives at Birth competition such as USAID and Grand Challenge-Canada have expressed preliminary interest in providing procurement funding for Odon.
BD also held preliminary discussions with CARE International, a global NGO who is deeply involved in the maternal and child health, about utilizing their country-level personnel to reach women in remote, rural areas of developing countries. We anticipate engaging in similar discussions with other NGO's prior to the launch of the Odon Device.
The three year milestone plan is as follows:
Definition Phase (06/01/2013 - 02/01/2014): Develop integrated project plans and business strategies
This includes the development of a project plan, business plan, design plan and IP strategy. Specifically, this involves defining product requirement and configurations, designing procurement and operations strategies and developing medical affairs and regulatory affairs strategies. This phase also includes technology development and the design of manufacturing and process strategy.
Development Phase (02/01/2014 - 09/30/2014): Product design and concept testing
This phase includes process development and testing and the development of product specifications, as well as the verification of design and process. Other activities will include the development of an integrated operations plan, clinical evaluations, development of an approved regulatory plan and clinical trial protocols, and the development of a quality assurance plan.
Qualification Phase (07/01/2014 - 09/01/2015): Product validation and qualification
Validation studies will be designed and pilot samples will be built. Process validations and clinical trials will also be conducted. Clinical trials are conducted with direct involvement of WHO and FIGO (International Federation of Obstetrics and Gynecology), the leading worldwide professional association in Obstetrics and Gynecology. WHO and FIGO have set up a steering committee that includes world experts and opinion leaders in obstetrics and gynecology and neonatology. WHO and FIGO experts, principal investigators at study sites and health professionals (OB/GYNs and midwives) involved in the trial constantly provide information and feedback on the use of the device contributing to its development towards a final instrument. If clinical trials will prove the device effective and safe, WHO and FIGO will include it in clinical guidelines for management of labor and delivery. Those guidelines will form the basis for training packages. It is envisaged that potential users of the device will have to be certified to be proficient both in applying the device and in assessing the clinical conditions for safe and effective use of the device.
Launch Phase (09/01/2015 - 02/29/2016): Data review and market registration
A statistical data review will be conducted, and the product will be subject to regulatory CE submission (a legal requirement). From a clinical trial perspective, the CE marking will facilitate approval at national level to conduct the trial. After the CE mark is received, market registration and listing will be undertaken in countries around the world.
Obstructed or prolonged labor are two of the most common causes of maternal and child mortality in developing countries. Each day, approximately 1,000 women die in childbirth, and 20 times more experience a serious medical complication such as bleeding, infection, fistula and incontinence. Ninety?nine percent of these maternal deaths and complications from childbirth occur in the less?developed world, particularly in poor, rural locations where there is limited access to skilled birth attendants. In addition, three million newborn babies die each year, and an additional three million are stillborn, in part due to complications from obstructed labor during childbirth. Addressing death and serious injury to women and children from childbirth?related complications is a major priority for the United Nations, and is reflected in the Millennium Development Goals (MDGs) numbers four and five.
Currently available devices to deal with prolonged labor, such as forceps and vacuum extractors, are known to cause injury and complications in both mother and newborn. Alternatively, in situations of prolonged labor, doctors will often perform a caesarian section (C?section). In developing countries, C?section procedures are rarely performed due to lack of access to doctors and adequate medical facilities. In many industrialized countries, C-sections are performed in excess due to lack of alternative procedures, and concerns about patient injury and associated liabilities.
The Odon Device was invented by an automotive technician from Argentina, Jorge Odon. He came up with the idea based on a trick he used to perform at cocktail parties, removing a cork embedded in an empty wine bottle using plastic bags to develop negative pressure. The Odon Device is designed to replace forceps or vacuum?assist devices in circumstances of prolonged labor, which occur in approximately ten percent of all labors. Supported by positive preliminary results, Odon and WHO presented the Device to the Grand Challenge - Saving Lives at Birth competition, funded by the World Bank, Bill and Melinda Gates Foundation and the governments of the U.S., Canada, UK and Norway. The Odon Device was selected as a winner in this competition and was particularly recognized as a breakthrough by WHO. WHO approached BD at the January 2012 World Economic Forum in Davos, Switzerland as this agency believes BD possesses the core competencies and commitment to global health necessary to achieve success in reducing maternal mortality with the Odon Device.