Bambi Medical, a Dutch medtech startup company and former winner of a Gerard & Anton Award, has completed CE marking for the Bambi Belt, a skin-friendly and wireless neonatal vital sign monitoring system. The third and final part of this solution that received the CE mark is the Bambi Interface.
“I am excited about this achievement that completes the three required CE markings of our Bambi Belt solution”, says the company’s CEO, Fabio Bambang Oetomo. The regulatory process to be admitted to the European market took the company much longer than expected, due to the European medical device regulation (MDR). “It tested the patience of both the Bambi team and all of our stakeholders – investors, suppliers, and hospital staff. Now that we have reached this significant milestone, I look forward to seeing the Bambi Belt in action standalone without any adhesive electrodes, dramatically improving the quality of care for premature babies. We look forward to seeing the smiles on the faces of parents, nurses, and last but certainly not least, the babies in the hospital.”
The complete CE marking of the Bambi Belt solution paves the way for Bambi Medical to commercialize its device in the European market. The first countries where the Bambi Belt will be introduced are the Netherlands, Germany, and Sweden.
Belt, Bridge, and Interface
Founded in 2016, Bambi Medical has developed its first product – a wireless neonatal vital sign monitoring system called the Bambi Belt. The Bambi Belt consists of a disposable Bambi Belt, a reusable Bambi Bridge, and the Bambi Interface. The Bambi Belt functions by being wrapped around the baby’s chest. Sensors integrated inside the belt measure the ECG and dEMG of the baby in a non-intrusive way while the Bambi Bridge sends the captured data to the Bambi Interface. The Bambi Interface transmits this data to the bedside patient monitor. The system works in combination with existing patient monitors within the hospital infrastructure. The non-sticky and skin-friendly texture of the Bambi Belt eliminates the pain and stress experienced by the babies when using the current monitoring system with adhesive electrodes. Its wireless features allow parents to take the baby out of the incubator and perform Kangaroo Mother Care, which, according to the World Health Organization (WHO), is essential for babies’ development.
Now-retired Pediatrician-Neonatologist and Chief Medical Officer of Bambi Medical, Professor Sidarto Bambang Oetomo, created the original concept for the system at the Department of Industrial Design at the Eindhoven University of Technology (TU/e). Bambi Medical received a Gerard & Anton Award in 2017.
Bambi Medical has collaborated with Benchmark Electronics, an electronics company based in Almelo, The Netherlands, for product development. Benchmark is also the manufacturing partner of the Bambi Bridge. The company’s manufacturing partner for the Bambi Belt is Freudenberg Medical, a silicone injection molding company based in Kaiserslautern, Germany. The Bambi Interface is manufactured by Sioux Technology Assembly, an electronics company based in Eindhoven, The Netherlands. Bambi Medical closely collaborates with the Maxima Medical Center in Veldhoven and the Amsterdam University Medical Center.
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