The device pathway
Our end-to-end support combines bioengineering expertise, fabrication skills and regulatory know-how to create safe, long-lasting and effective prototypes.
MEDICAL DEVICE IDEA BASED ON UNMET PATIENT NEED
Members of our team developed the cochlear implant to restore lost hearing, the bionic eye to restore vision in people with degenerative eye diseases. Neo-Bionica works with clinicians, researchers, start-ups and established companies who have an idea for a life-changing medical bioelectronic device.
SHOW MOREIDEATION AND PROOF-OF-PRINCIPAL TESTING
We work with clinical collaborators to design a concept that best meets the medical need. Then our interdisciplinary team works with the client to design and develop a prototype. In collaboration with researchers, we validate prototype safety and efficacy in pre-clinical studies in appropriate animal models.
SHOW MOREDETAILED DESIGN AND PROTOTYPING
Our medical device, design and engineering teams optimise the prototype in response to the results of pre-clinical studies. In addition to perfecting the electrode design, we identify the best surgical approach and ensure the long-term manufacturability of the implantable medical device.
SHOW MORECLINICAL INPUT AND TESTING
Working with a broad range of leading clinicians, we take prototypes through to first-in-human studies and clinical trials. We provide clients with clinical and surgical expertise, surgical evaluation and clinical trial support. This includes navigating regulatory approval processes.
SHOW MOREIMPROVED PATIENT OUTCOMES
Neo-Bionica enables clients to turn their ideas into medical technologies that improve patients’ lives. Our engineers and technicians have designed and developed medical bioelectronic device prototypes to restore lost function, assist in diagnosing disease and treat debilitating medical conditions.
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