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

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From idea to implant.
We build what’s next
in neurotech.

Realise your device’s potential with specialised engineering support for neurotechnology innovators—from early-stage concepts to First-in-Human trials.

DISCUSS YOUR DEVICE

“I’ve worked with a lot of vendors in this space and Neo-Bionica stands out. They brought deep expertise, moved fast, and delivered what they promised. That’s rare in this field.”

Steve Goetz, former VP of Technology and Platform Innovation at Medtronic

Neurotechnology innovation involves many types of challenges

“I’m always impressed by startups that bring Neo-Bionica in early. It shows they’ve done the work, thought through their milestones, and know how to build something real.”

JoJo Platt, Neurotech Strategist & Advisor

Neurotechnology innovation involves many types of challenges

Progress slows or stops because experienced staff are scarce


Neurotechnology expertise remains hard to source. Finding the right people can even require a worldwide search.

Contract manufacturers require large production volumes


Most early-stage innovators don't yet meet large manufacturers' minimum quantity requirements.

Time and capital

are valuable


Development delays reduce investor confidence, potentially compromising future funding access.

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From idea to implant.We build what’s next in neurotech.

Realise your device’s potential with specialised engineering support for neurotechnology innovators—from early-stage concepts to First-in-Human trials.

DISCUSS YOUR DEVICE

“I’ve worked with a lot of vendors in this space and Neo-Bionica stands out. They brought deep expertise, moved fast, and delivered what they promised. That’s rare in this field.”

Steve Goetz, former VP of Technology and Platform Innovation at Medtronic

Neurotechnology innovation involves many types of challenges

“I’m always impressed by startups that bring Neo-Bionica in early. It shows they’ve done the work, thought through their milestones, and know how to build something real.”

JoJo Platt, Neurotech Strategist & Advisor

Neurotechnology innovation involves many types of challenges

Progress slows or stops because experienced staff are scarce


Neurotechnology expertise remains hard to source. Finding the right people can even require a worldwide search.

Contract manufacturers require large production volumes


Most early-stage innovators don't yet meet large manufacturers' minimum quantity requirements.

Time and capital

are valuable


Development delays reduce investor confidence, potentially compromising future funding access.

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“We didn’t want to build a big internal team. It’s expensive and too slow. Neo-Bionica gave us access to experts without the hiring risk. If one person leaves, we don’t lose 30% of the project.”

Pawel Soluch, CEO at Spinally

Gloved hands assembling a neurotech microelectronic component under a microscope in a cleanroom environment
Gloved hands assembling a neurotech microelectronic component under a microscope in a cleanroom environment
Gloved hands assembling a neurotech microelectronic component under a microscope in a cleanroom environment
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The only CDMO focused exclusively on neurotech

We specialise in the design, engineering, and clinical-grade manufacturing of active implantable neurotechnologies. We advance innovations from functional prototypes to First-in-Human devices, and on to scalable production. 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.

Extensive implantable
device expertise


Our team brings deep experience from industry leaders such as Cochlear, Medtronic, Synchron and Advanced Bionics, with proven capabilities in the design and deployment of clinically approved, commercially viable neural interfaces.

Specifically structured for early-stage neurotechnology ventures


Our organisation is designed to support early-phase innovation and small production runs. We offer flexible, fit-for-purpose scopes without volume requirements or long-term commitments.

Strategic milestone-oriented development


We synchronize our phased development protocols with your critical inflection points for milestone achievement and enhanced fundraising credibility.

Advanced

infrastructure


Our facilities include ISO 7 cleanroom environments, capabilities for hermeticity assessment, and equipment to support ISO 14708 testing standards.

Hospital-integrated for clinical collaboration


Our operational headquarters within St. Vincent's Hospital provides immediate access to the clinical practitioners and surgical professionals who represent your device's ultimate end-users.

Comprehensive

ISO 13485 QMS


Our certified quality management infrastructure supports all developmental phases with robust design control mechanisms and traceability that satisfy regulatory requirements.

Close-up of gloved hands assembling a microelectronic implant under a precision tool, used as a background for customer testimonials in a neurotechnology lab
Close-up of gloved hands assembling a microelectronic implant under a precision tool, used as a background for customer testimonials in a neurotechnology lab
Close-up of gloved hands assembling a microelectronic implant under a precision tool, used as a background for customer testimonials in a neurotechnology lab

“I trusted the team. I knew they could pull it off because of the quality of their people and the level of investment in their infrastructure.”

Phil Eggers, VP of R&D at Neurotech Startup

“I’m always impressed by startups that bring Neo-Bionica in early. It shows they’ve done the work, thought through their milestones, and know how to build something real.”

JoJo Platt, Neurotech Strategist & Advisor

Transform ideas into clinical-ready systems

Transform ideas into clinical-ready systems

Demonstrate tangible progress to stakeholders with a team experienced in guiding neurotechnology companies through the critical transition from concept to clinical readiness.

Demonstrate tangible progress to stakeholders with a team experienced in guiding neurotechnology companies through the critical transition from concept to clinical readiness.

Before Neo-Bionica

Before Neo-Bionica

After Neo-Bionica

After Neo-Bionica

Handmade benchtop prototypes

Handmade benchtop prototypes

Manufacturing-ready devices engineered for human clinical trials with validated production processes

Manufacturing-ready devices engineered for human clinical trials with validated production processes

Resource-constrained internal

technical teams

Resource-constrained internal

technical teams

Strategic development partner providing accelerated de-risked execution and specialised neurotechnology expertise

Strategic development partner providing accelerated de-risked execution and specialised neurotechnology expertise

Regulatory compliance uncertainty

Regulatory compliance uncertainty

Comprehensive documentation with defensible design history files that meet regulatory scrutiny

Comprehensive documentation with defensible design history files that meet regulatory scrutiny

At-risk development timelines

At-risk development timelines

Strategic milestone achievement with enhanced investor-ready credibility and timeline assurance

Strategic milestone achievement with enhanced investor-ready credibility and timeline assurance

Specialised neurotech talent who understand your requirements

Deliver optimized devices on schedule with expert engineering professionals who understand the unique challenges of your position.

Deliver optimized devices on schedule with expert engineering professionals who understand the unique challenges of your position.

Startup CEO


Your investors expect demonstrable progress. Neo-Bionica understand your next inflection points and deliver.

CTO / Head of R&D


Your product development involves complex engineering challenges. Neo-Bionica’s multidisciplinary expertise ensures functionality, manufacturability, and safety compliance.

Clinical Innovator


Demonstrating clinical efficacy is paramount to your startup’s success. Neo-Bionica translates your idea from proof-of-concept to a clinically-viable device that meets regulatory standards and scalability requirements.

Scientist using a microscope in a lab with holographic medical data overlay, representing innovation in neurotechnology development
Scientist using a microscope in a lab with holographic medical data overlay, representing innovation in neurotechnology development
Scientist using a microscope in a lab with holographic medical data overlay, representing innovation in neurotechnology development

“With Neo-Bionica, we weren’t just buying time from engineers. They really worked to understand what we needed and collaborated as part of our team. They helped us answer early feasibility questions quickly and de-risk our concept before committing to a final design. That work was critical to securing investment and internal buy-in.”

Steve Goetz, former VP of Technology and Platform Innovation at Medtronic

Steve Goetz, former VP of Technology and Platform Innovation at Medtronic

A methodology aligned to your critical milestones

A methodology aligned to your critical milestones

Our development framework precisely coordinates with your critical inflection points and funding cycles—beginning with targeted deliverables, validating functional performance, and scaling with evidence-based confidence.

Our development framework precisely coordinates with your critical inflection points and funding cycles—beginning with targeted deliverables, validating functional performance, and scaling with evidence-based confidence.

1

1

Pathway Definition


We identify your clinical endpoints and regulatory constraints, then formulate a tailored and structured development protocol progressing from conceptual feasibility to first-in-human implementation.

2

2

Iterative Development and

Risk Mitigation


Working collaboratively and iteratively with your development team, we engineer, evaluate, mitigate for risks, and refine functional prototypes.

3

3

Deep Expertise in First-in-Human Manufacturing


Leverage our deep experience and expertise in First-in-Human device manufacture to confidently accelerate your progress.

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Neurotech Implantables White Paper

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

READ WHITE PAPER

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“We started with a small project to test the fit. Neo-Bionica brought expertise, flexibility, and openness to feedback, and delivered what we needed.”

CTO, early-stage neuroelectronics therapy developer

"Neo-Bionica's agility was a great fit for us as a small medtech company looking to innovate quickly. Their depth and breadth of expertise has been instrumental in the creation of a working prototype of our innovation.”

Matthew Hoskin, CEO Nirtek

“Everyone we worked with was excellent. They had a solid science foundation and a really solid engineering team. The people are all extremely qualified.”

Phil Eggers, VP of R&D at Neurotech Startup

Ready for clinical translation?

If your neurotechnology development initiative requires a strategic implementation partner with expertise in first-in-human neural interface systems, we're the next step.

If your neurotechnology development initiative requires a strategic implementation partner
with expertise in First-in-Human neural interface systems, we’re the next step.

DISCUSS YOUR DEVICE