Neurotech Implantables: 7 Ways to Get to First-in-Human Clinical Trials as Quickly and Efficiently as Possible

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What we do

neo-bionica is the world’s only CDMO focused exclusively on implantable and wearable electronics and electrodes for neuromonitoring and neuromodulation devices. From first concept to First-in-Human, we bring together the clinical, technical, and commercial expertise to help global innovators build clinical-grade devices that push the boundaries of what's medically possible.

Who we help

Medical device startups

University spinouts

Research hospitals and clinician-researchers

Growth-stage neurotech companies

Global medtech leaders

The devices we help create

We specialise in building cutting-edge neurotechnologies, including:

Bioelectronic implants and AIMDs

Neurostimulation and monitoring devices

Wearables and body-worn therapies

Surgical tooling

Custom Class II and III systems

With deep expertise in a range of components, including:

Hermetic enclosures

Silicone leads

Custom neural interfaces

IPG/EPG units

Custom PCB layouts

Telemetry coils & magnetic systems

For devices targeting a range of clinical applications, including: 

Chronic pain and neurological disorders, including spinal cord stimulation (SCS), peripheral nerve stimulation (PNS) for epilepsy, Parkinson's disease, and stroke

Sleep and respiratory health including obstructive sleep apnea (OSA)

Pelvic health, overactive bladder (OAB), underactive bladder (UAB)

Advanced brain monitoring and brain-computer interfaces (BCI)

Regenerative and restorative therapies such as nerve regrowth, hearing loss, vision loss, and spasticity

Additional specialized applications, including: fetal health monitoring, hydrocephalus, head & neck pain, and mood disorders

“neo-bionica had specific expertise we couldn’t find anywhere else — particularly in cochlear-style and skull-based implants. That’s what made them stand out.”

CTO, early-stage neuroelectronics therapy developer

“neo-bionica was the most technically capable and cost-effective of all the potential suppliers we looked at. I’d recommend them without hesitation.”

Phil Eggers, VP of R&D at Neurotech Stealth Startup

How it works

We pair our scientific and technical knowledge with unique clinical insights to help you develop a device that’s fit for purpose and applicable in a real-world setting. Supported by our capabilities in systems engineering, neural device fabrication, testing and manufacturing, we offer the end-to-end expertise you need to turn innovative ideas into clinical reality.

Design and develop

Our team provides end-to-end engineering, from early concept to design transfer:


  • Electronic circuit design and miniaturisation

  • Mechanical design for implants and wearables 

  • Embedded firmware and software development

  • Systems engineering and integration

  • Automated testing systems and tooling 

  • Functional, performance, and lifetime testing

Build and assemble

We offer precision fabrication and cleanroom assembly with:


  • ISO 7 cleanroom environments

  • Microelectronics and SMT assembly

  • Wire bonding (ball and wedge)

  • Laser welding and laser marking

  • UV, epoxy, and Parylene encapsulation

  • Potting, sealing, and micro soldering

  • Custom fixtures, tooling, and integration of medical-grade materials

Test and validate

We operate in-house testing for:


  • Optical, electrical, and wireless (RF) performance

  • Thermal cycling, humidity, and mechanical fatigue

  • Biocompatibility and environmental resilience

  • Test method development, design verification, and traceability  

  • Hermitization and hermeticity testing

Commercialise

We help get your product to market with:


  • An ISO 13485:2016 certified quality management system

  • Regulatory support for TGA, FDA, and MDR

  • Technical documentation, risk assessment, DHF, and DMR 

  • Clinical trial and ethics support

  • IP alignment and technology transfer to manufacturing partners

Prototype and manufacture

We support every stage from concept to clinical:


  • Rapid prototyping and fast-paced iteration

  • Pre-clinical and clinical trial builds and pilot production

  • Traceable small-batch production in controlled environments

Close-up of engineer working on a neurotech prototype using wired components and a custom acrylic test enclosure
Close-up of engineer working on a neurotech prototype using wired components and a custom acrylic test enclosure

“A significant draw for us was the potential to work with neo-bionica throughout our commercialisation journey. Their ability to not only design and develop our prototype, but also manufacture the device once we get to the clinical trial phase is a huge benefit. It mitigates the risk of knowledge loss and delays due to knowledge transfer.”

Matthew Hoskin, CEO Nirtek

Go from first concept to first-in-human

Whether you need deep technical guidance, a trusted clinical build partner, or a fast, compliant path to First-in-Human trials – neo-bionica can get you there.

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