Freudenberg Medical manufactures silicone baby monitoring belt

Pre-term babies can spend up to 42 days in a neonatal ICU where their vital signs can be kept under strict medical observation. Since monitoring electrodes and a separation from the mother can lead to discomfort and stress, half of all pre-terms go on to develop cognitive impairments.

In 2008, paediatrician and neonatologist, Sidarto Bambang Oetomo, came up with an idea for a skin-friendly monitoring belt. Today, he runs the Bambi Belt enterprise in Eindhoven, the Netherlands, with his son, Fabio.

To create the first prototypes, Freudenberg Medical supported the belt’s manufacture with material expertise as well as process and product knowledge.

Being cable-free, the Bambi belt allows parents to remove their premature baby from an incubator without causing injury. The belt is formed from a narrow band placed around the baby’s chest. Sensors send signals to a portable monitor.

For premature babies whose skin is too sensitive for adhesive electrodes, the band makes it possible to easily monitor the heart muscle’s electrical activity and measures respiration activity. Prior to this, in the absence of adhesive-free electrodes on the market or electrodes specifically developed for sensitive skin, a patch on the baby’s foot had to be used to monitor the heart rate and oxygen content in the blood of such babies while in the hospital – often leading to injury or infection.

Bambang Oetomo clarified: “The belt is made of skin-friendly silicone and uses dry electrodes. Developing the product was a challenge, since when it comes to materials, process technology and production, medical technology product specifications are demanding. The Freudenberg Medical team in Kaiserslautern supported us with ideas, material know-how and modern production technology.”

Rudolf Dering, project engineer at Freudenberg Medical, added: “When it came to the prototypes and first samples, we built special tools for the belts and tested different silicones which we can produce in four sizes. A special manual production process is used in their manufacture.”

Thirteen years passed from the initial idea for a skin-friendly monitoring belt in 2008 to the present day. During this time, the enterprise was founded in 2016, Fabio Bambang Oetomo who, as a young family man, had left his job at a large company, joined the enterprise, several years of development work were undertaken, employees were hired, and the first clinical studies and the search for manufacturing partners conducted.

The European Union co-financed the project through the Horizon 2020 SME programme. At the prototype’s presentation, parents, hospital staff, and clinics were said to have been ‘thrilled’ and, after two successful trials, the product is expected to be launched next year with certification pending.

The Bambi Belt has been tested in two studies in Dutch hospitals, including at Amsterdam University Hospital. The study monitored premature babies simultaneously using the market’s current monitoring device with conventional adhesive electrodes and the wireless Bambi Belt. The results showed reduced stress for and reliable monitoring of the babies.