Maternal Newborn Health Innovations (MNHI) is a mission-driven Public Benefit Corporation focused on enabling a gentle and safe way for obstetricians to assist the birth of newborns during circumstances of prolonged, complicated labour. The company is committed to operating in a responsible, ethical and sustainable manner to develop innovations that help reduce avoidable death, pain and harm to mothers and newborns caused by childbirth-related complications. Over the last several months Health Tech Enterprise (HTE) has helped MNHI conduct a health economic analysis to simulate the real-life impact that its OdonAssist™ inflatable obstetric device for assisted vaginal birth could have in the maternity space. Read the interview with Charlie Fuller, Director UK, Ireland and Nordics to find out more.
Our technology
In January 2022 Maternal Newborn Health Innovations (MNHI) was incorporated in the U.S. as a public benefit corporation for the purpose of developing new medical devices designed to address unmet maternal and newborn health needs. MNHI is presently in the process of seeking regulatory approval in Europe (CE Mark) for the OdonAssist™ inflatable obstetric device for assisted vaginal birth. OdonAssist is designed to provide a gentler and safer method to perform assisted vaginal birth procedures in circumstances of prolonged, difficult labour. It is intended to offer an alternative to forceps and vacuum extraction, both originally invented hundreds of years ago, and both known to cause adverse patient reactions, particularly to the newborn.
OdonAssist benefits from over ten years of development and an investment of over US$25 million by Becton, Dickinson and Company before MNHI acquired the rights to the device. Following extensive simulated clinical testing, OdonAssist was utilized in human clinical studies at the University of Bristol, UK and Besancon Regional University Hospital, France. Results from these studies have been published in the American Journal of Obstetrics and Gynecology.
The human clinical studies demonstrated up to 88.5% successful assisted birth (efficacy) with no device related serious adverse reactions (safety) to mothers or newborns. The safety profile for newborns was particularly noteworthy, with no typical patterns of marks, bruising or injury caused by the birthing device that are commonly associated with use of forceps or vacuum extraction devices.
The operative components of OdonAssist are an inserter and a clear sleeve with an air cuff that is filled with air to form gentle and secure 360-degree contact around the head of the fetus, enabling traction to assist birth. Unlike forceps and vacuum, the insertion technique utilized for OdonAssist during the clinical studies was the same regardless of fetal head position, providing an additional potential safety benefit to newborns (improper placement of forceps and vacuum devices can result in serious harm to the newborn).
Results from the clinical studies indicate that OdonAssist was regarded as being easy to use by obstetricians. Additionally, participants responded very favorably to OdonAssist, regarding it to be a kinder method to assist birth compared with forceps and vacuum extraction.
OdonAssist™ is currently in the process of CE-marking and not yet available for sale in any markets.
Impacts
MNHI recognises the importance of financial evidence and impact when bringing a new innovation to market. Collaborating with the Health Tech Enterprise team we were able to conduct a thorough health economic analysis to simulate the real-life impact that OdonAssist could have in the maternity space. From the outset, HTE demonstrated a deep understanding of our needs and goals. Their team worked closely with us, ensuring that every aspect of the model accurately reflected an understanding of clinical pathways and usage procedures. Their collaborative approach fostered a strong partnership, enabling us to seamlessly integrate our insights and feedback throughout the model development process.
HTE’s proficiency in health economics is noteworthy. They meticulously crafted a model that not only met but exceeded our expectations. Their attention to detail and rigorous methodology ensured the accuracy and reliability of the model, which will be important for how the model may influence decision-making processes.
The support and communication from HTE were exceptional. Their team were always available to address our questions and concerns, providing clear and concise explanations. This level of engagement gave us confidence in the project’s progress and outcomes.
In summary, Health Tech Enterprise has been an invaluable partner in efforts to bring an entirely new medical device innovation to market. Their expertise and dedication have resulted in a health economic model that is both sophisticated and user-friendly. We highly recommend HTE to any organization seeking top-tier health economic modelling services.
