Introduction and Purpose
Ethiopia is the second most populated country in Africa and the twelfth poorest country globally, thereby creating high demand and extreme shortages of medical supplies. In sub-Saharan Africa 27% of babies are born with asphyxia, which results in 4% of deaths. According to the Saving Newborns Lives foundation, basic neonatal resuscitation using a bag-valve-mask (BVM) device could prevent 30% of deaths of full-term babies, and 5-10% of preterm deaths. In Ethiopia, 100% of all medical devices are imported resulting in 23% of hospitals lacking the necessary BVM supplies, and extreme shortages of supplies throughout the country. More than 80% of the births are performed at home by Health Extension Workers (HEW’s) and midwives. The Federal Ministry of Health recognizes the need for trained health workers and to make BVM’s available at every delivery. Local manufacturing of neonatal BVM can improve health and economy for the base of the pyramid population, by increasing access to the BVM device and offering employment.
Design and Methods
Raechelon, a U.S. medical device consulting company, partnered with local entrepreneurs and biomedical engineers to create Echelon Medical Device Manufacturing in Ethiopia. We collaborated with University of Wisconsin Madison, Ethiopian physicians, and nurses to design a BVM device specifically for manufacture in Ethiopia. Design team meetings and prototype reviews were held with Ethiopian physicians and nurses to ensure clinical considerations specific to Ethiopia were included. Partnerships with a local water bottle company was established to injection molding Meetings with the Ethiopia Ministry of Health were held to determine suitable price points, annual product demands, and the BID process.
We have commercialized and actively sold the NeoBVM device. The product sells for $10 - $14 U.S. dollars (UDS) and can be reused at least 20 times, resulting in a per use cost of less than $0.50 USD. Ministry of Health (FMHACA) approval for the company was obtained in 1 year, device approval was obtained 15 months from point of inception. The NeoBVM device has been distributed to 10 hospitals and clinics throughout Ethiopia and successfully used to treat over 100 infants to date. The device has been sold to a large public hospital in Addis Ababa. A local supplier for injection molded parts has been established. Investment laws and limitation of hard currency makes it difficult to purchase necessary material, equipment and raise international investment for scaling the business. Lack of business and technical understanding of medical device industry in government, healthcare sector and resource pool creates challenges to large scale purchasing.
Co-creation of product development and testing has demonstrated success. Creating a partnership with a private sector business in the U.S. mitigated initial local currency challenges in Ethiopia but is not sustainable. Using parallel U.S. and Ethiopian development enables us to identify developing country challenges without sacrificing supply of product. Breaking the development and manufacturing processes into smaller manageable stets has allowed for achievement of realistic milestones, manufacture of product, and testing of not only the NeoBVM but the local infrastructure.
"Development and Manufacture
of a Bag-Valve Mask Device in Ethiopia"
A presentation by Tiffini Diage