Innovation for success Success in medical technology Back training device with high-precision sensors Hocoma AG, Switzerland “Hocoma has set itself the goal of developing and manufacturing highquality products. For our products, quality means: Benefits for patients and therapists, safety and user-friendliness. Cicor is a partner with a broadbased technical expertise in medical technology and accompanies us professionally across the entire development and production process, through to after-sales service.” Hocoma AG, Switzerland Functional medical technology with high motivational factor Cicor develops and produces the Valedo therapeutic back training device for the Swiss company Hocoma. Hocoma is a global market leader in the development, manufacture and marketing of robotic and sensor-based devices for functional movement therapy. The innovative solutions come into use in the rehabilitation of patients with neurological movement disorders and in therapy for back pain both in the clinic and at home. Electronic Solutions The latest technology standards for therapeutic exercises with playful flair The Valedo mobile back training device transmits and records the movements of the trunk using two Bluetooth sensors and thus allows the patient and therapist real time feedback and immediate training evaluation. The clinical exercises are didactically structured and have been specially developed for movement therapy of the lower back. The softwarecontrolled exercises support and encourage stepwise learning of complex and multi-dimensional movements. Valedo was especially developed for long-term promotion of back health and helps prevent back pain. Therapeutic exercises developed for functional movement therapy of the lower back, in combination with motivating and entertaining games, train the back muscles, mobilize the spine and contribute to improved movement awareness. The sensors of the registered medical device include the latest Bluetooth Smart Technology (low energy) and therefore set new technology standards. Each sensor contains a 3D gyroscope, a 3D accelerometer and a 3D magnetometer and so can record full 360 degree movements. The innovative, high precision sensor technology and the motivating power of video games strengthen the back in a playful way. “As an outsourcing partner, we support our customers in the development of the product, in mechanical design, in making an optimum choice of material, through to production and selection of the right packaging and supply chain management.” Cicor Electronic Solutions Innovative outsourcing partner for revolutionary products Cicor supports the customer from the idea through to the realized product. We see ourselves as the partner across the entire supply chain. The demands placed on an outsourcing partner in the manufacture of electronic medical devices and systems are extremely high. Trust is an important prerequisite for successful cooperation. As we hold the relevant ISO certifications, we ensure compliance with all quality standards. The development process and production are ISO 9001 and ISO 13485 certified, the hardware concepts are designed according to the 93/42/EEC directive. The mechanical design of the Valedo product was the key focus of our collaboration. Cicor was responsible for the complete development of the mechanical layout. Here the special challenges were International Protection (IP protection), biocompatibility, as well as product safety (drop test) according to IEC 60601. The use of the latest technology, in this case Bluetooth Smart Technology and the 3D functions (3-axis gyro sensors), led to the development of customerspecific test concepts. Product development Layout Mechanical design Test development Redesign Cicor has developed efficient test concepts for parallel testing of the product functions. For instance, each interface of the Bluetooth sensor is tested through the active movement. As an outsourcing partner, Cicor supports Hocoma across the entire supply chain. Cicor undertakes final assembly, labeling and packaging, as well as shipping to the customer-specific sites. Hocoma can therefore fully concentrate on its core competences. Test concepts Validation NPI Logistic model Procurement cle managemen Life cy t Development strialization Indu A ft er-s ale s Warranty Repair services Maintenance Modification Obsolescence Management P ro d u c ti o n Q u a lit y m anage m e nt Prototyping Board assembly System assembly Plastic injection molding Toolmaking Electronic Solutions Specific expertise and longstanding experience in medical technology Services and products in the field of medical technology demand a high degree of reliability and trust. Thanks to its technical expertise and longstanding experience in medical technology, Cicor offers innovative solutions that meet all requirements for sophisticated development and production of medical devices. Certification of development and production to ISO 13485 ensures the customer‘s requirements and the applicable regulatory requirements are taken into consideration. Longstanding experience in the development and production of medical devices. The hardware and software concepts are aligned with IEC 60601 (Medical electrical equipment – General requirements for basic safety and essential performance). Quality data management ensures safety and traceability The traceability of components and system configurations is pivotal in being able to guarantee that quality requirements, such as functional safety and system stability, can be met. This key factor must be ascertained on the basis of legal requirements and the customer‘s specifications. Quality data management systems provide complete transparency in all manufacturing and after-sales processes. Cicor‘s verified quality data management system extends far beyond the legal requirements. It encompasses numerous functions that we configure according to the customer’s specific needs. Electronic Solutions Developing innovative solutions The challenge Expertise in medical device manufacturing (Risk class 1 according to 93/42/EWG and ISO 13485) Documented Traceability thanks to quality data management Global component purchasing power Compliancy in the latest technology standards (e.g. Bluetooth Low Energy) Reliable and certified manufacturing processes Logistics & manufacturing in multiple locations The requirements Developer expertise In-depth knowledge of standards Mechanical design ISO 13485 certification and longstandingexperience In-house production Prototype and series production Test engineering Industrialization Logistics Local partner with a global reach The Cicor solution Superior technology solutions for medical technology EMC (electromagnetic compatibility) Low-energy rechargeable battery State-of-the-art hardware design 9-axis sensors Biocompatibility Drop and impact test according to IEC 60601 Firmware/Software upload Ports Micro-USB Bluetooth 4.0 LE Test concept for 3D sensors Logistics concept Management Packaging Benefits for Hocoma Dependable partner throughout the entire product lifecycle Reliable and certified manufacturing processes Complete traceability thanks to QDM for the therapist Higher patient compliancy Relevant exercises extend therapy Tool to analyze patient progress and performance Registered and certified medical product for the patient Independence with a product to enable self-guided therapy Motivating therapeutic exercises for back health Immediate performance evaluation and reporting Promotion of movement awareness and specific therapy goals Safe, reliable, portable technology Contacts Cicor Europe Advanced Microelectronics & Substrates Cicorel SA Route de l’Europe 8 2017 Boudry I Switzerland Tel. +41 32 843 05 00 Fax +41 32 843 05 99 [email protected] America Cicor Americas Inc. 185 Alewife Brook Parkway, Suite #410 Cambridge MA 02138 | USA Tel. +1 617 576 2005 Fax +1 617 576 2001 [email protected] Asia Cicor Asia Pte Ltd. 45 Changi South Avenue 2 #04-01 Singapore 486133 Singapore Tel. +65 6546 16 60 Fax +65 6546 65 76 [email protected] Head office Cicor Management AG Leutschenbachstrasse 95 8050 Zurich I Switzerland Tel.+41 43 811 44 05 Fax +41 43 811 44 09 [email protected] cicor.com
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