Slovenian company offers innovative corrective helmet for treating babies with flat head syndrome under outsourcing agreement

A Slovenian company has a 25-year experience working as a provider of custom made prosthetic and orthotic medical devices. The company started as a small family business but is now growing fast and becoming a serious player in the industry. The company manufactures the most demanding orthopedic devices using 3D scanning and 3D printing technology. They are one of the first centres in Europe that treats flat head syndrome with a non-invasive method. The company is in procedure of getting the ISO 13485: 2016 certification. They offer innovative highly effective custom made orthosis – corrective helmet for treating flat head syndrome. The concept is based on applying pressure on particular points to gently guide the head to grow and develop in the right shape. First they make a 3D scan, then using a software they design a helmet model and apply a robot to make a helmet. Helmets are made out of plastic and on the inside filed with correction “drivers” made out of soft foam material. The materials are lightweight and hypoallergenic. The orthosis is made individually according to the head model and depends on the deformations. It is suitable for application on babies between the age of 4th and 18th months and should be worn 23 hours per day. Corrective helmet is suitable for the treatment of: • Positional plagiocephaly (front&back) • Positional brachycephaly • Positional scaphocephaly • Mixed craniocephalic positional deformations • Post-surgical treatment of classical craniosynostosis • Post-surgical treatment of early endoscopic surgery of craniosynostosis The company wants to boost its sales and is therefore interested in cooperation with medical institutions under outsourcing agreement. The company will provide partner with know-how for 3D model scanning. Partner will take care of 3D scanning. The company will 3D print the products based on received measurements and send it to partner who will take care of orthosis application on the patient.