Name

Neo-Bionica

Legal name

Neo-Bionica

Website

https://neo-bionica.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

11–50 employees

Ownership category

akta.pro rank

Product category

Medical Device Contract Manufacturing

NAICS

Medical Equipment and Supplies Manufacturing (3391), Surgical Appliance and Supplies Manufacturing (339113), Pharmaceutical and Medicine Manufacturing (3254), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Drug Substance–Drug Product Integrated CDMO (HLAGABAG)

akta.pro secondary industry

Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK)

Keywords

• Neurotechnology CDMO
• Implantable medical devices
• Contract development manufacturing
• Active implantable devices
• Clinical-grade prototyping

Headquarters

HQ city

Melbourne

HQ country

Australia

HQ region

Oceania

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Infrastructure, Operations, Marketing or Sales, Supply Chain

Revenue model

1. CDMO Design & Engineering Services: Fee-for-service revenue from end-to-end design, engineering, and clinical-grade manufacturing engagements spanning conceptual feasibility through First-in-Human devices and scalable production. Engagement models are flexible and fit-for-purpose with no volume requirements or long-term commitments.
2. Pre-Clinical and Clinical Trial Build Services: Traceable small-batch production in controlled environments for preclinical and clinical trial builds, pilot production, and clinical-grade pilot manufacturing runs.
3. Regulatory and Commercialisation Support Services: Regulatory support for TGA, FDA, and MDR pathways, technical documentation, risk assessment, DHF/DMR development, clinical trial and ethics support, and IP/technology transfer to manufacturing partners.

Pricing tiers

Go-to-market motion3 records

Distribution channels2 records

Marketing channels5 records

Core offering

Neo-Bionica is a contract development and manufacturing organization (CDMO) that provides end-to-end design, engineering, prototyping, and clinical-grade manufacturing services for active implantable and wearable neurotechnology medical devices, taking clients from early-stage concept through First-in-Human clinical trials. Its service platform is organized into five interlocking modules: Design and Develop, Build and Assemble, Test and Validate, Commercialise, and Prototype and Manufacture, all delivered from an ISO 13485-certified, hospital-integrated facility at St. Vincent's Hospital Melbourne.

Product overview

Neo-Bionica offers a single unified CDMO service platform (marketed as "the world's only CDMO focused exclusively on implantable and wearable electronics and electrodes for neuromonitoring and neuromodulation devices") organized into five interlocking service modules — Design and Develop, Build and Assemble, Test and Validate, Commercialise, and Prototype and Manufacture — which together operationalize their three-phase Pathway Definition → Iterative Development and Risk Mitigation → First-in-Human Manufacturing methodology, with the published Neurotech Implantables White Paper serving as a thought-leadership asset supporting client acquisition.

Differentiator

Problem solved

Functional benefit

Products and services

• Implantable Neurotechnology CDMO Services (unified platform) End-to-end contract development and manufacturing services for active implantable and wearable neurotechnology medical devices, organised into five interlocking service modules (Design and Develop, Build and Assemble, Test and Validate, Commercialise, and Prototype and Manufacture) that take clients from early-stage concept through First-in-Human clinical trials and scalable production. Specifically structured for early-phase innovation and small production runs with no volume requirements or long-term commitments.
• Design and Develop End-to-end engineering design services from early concept through design transfer, covering electronic circuit design and miniaturisation, mechanical design for implants and wearables, embedded firmware and software development, systems engineering and integration, automated testing systems, and functional, performance, and lifetime testing.
• Build and Assemble Precision fabrication and ISO 7 cleanroom assembly for neurotech devices, including microelectronics and SMT assembly, wire bonding (ball and wedge), laser welding and laser marking, UV/epoxy/Parylene encapsulation, potting, sealing, micro soldering, and custom fixtures, tooling, and integration of medical-grade materials.
• Test and Validate In-house verification testing covering optical, electrical, and wireless (RF) performance; thermal cycling, humidity, and mechanical fatigue; biocompatibility and environmental resilience; test method development, design verification, and traceability; and hermetization and hermeticity testing using a Pfeiffer PRISMAPro mass spectrometer.
• Commercialise Regulatory and market-readiness services including an ISO 13485:2016 certified quality management system, regulatory support for TGA, FDA, and MDR pathways, technical documentation, risk assessment, DHF and DMR compilation, clinical trial and ethics support, IP alignment, and technology transfer to manufacturing partners.
• Prototype and Manufacture Manufacturing services spanning rapid prototyping and fast-paced iteration, pre-clinical and clinical trial builds, pilot production, and traceable small-batch production in controlled environments, from first concept through First-in-Human device builds.

Quantifiable outcome

• Secured $1 million in funding for client Kali Healthcare through prototype development support
• +2 more outcomes

Named customers6 records

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability1 record

Feature8 records

Partnerships

Two partnerships are on record, tiered flagship and core.

• St. Vincent's Hospital MelbourneflagshipStrategic or Co-development PartnerNeo-Bionica's operational headquarters is housed within St. Vincent's Hospital Melbourne, providing immediate access to clinical practitioners and surgical professionals who represent the device's ultimate end-users. This hospital-integrated model enables direct clinical collaboration and is positioned as a key speed-to-First-in-Human advantage. Facilities including ISO 7 cleanrooms, hermeticity testing, laser seam welding, and microfabrication are co-located inside the hospital.
• University of MelbournecoreStrategic or Co-development PartnerDr. Robert Crombie, Head of Enterprise Partnerships & Innovation Initiatives at the University of Melbourne, represents the University on the Neo-Bionica Board, bringing extensive experience in biotech strategy and business development. The partnership provides access to academic research, talent, and innovation pipelines from one of Australia's leading biomedical research institutions.

Scale indicators8 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Cirtec Medical: US-based CDMO specializing in active implantable medical devices, neuromodulation, and minimally invasive surgical devices. Closest direct peer to Neo-Bionica in terms of active implantable electronics manufacturing and Class III device engineering depth.
• Minnetronix Medical: Medical device CDMO with strong active implantable and neuro/neuromodulation capabilities, providing design, manufacturing, and regulatory services. Direct peer in the neurotech-focused contract development and manufacturing niche.
• StarFish Medical: Canadian medical device design, development, and contract manufacturing organization serving startups through commercial-stage medtech. Direct peer in early-stage medical device CDMO services, including neurotech and Class III programs.

Regional players

• Planet Innovation: Australian medical device and life sciences product development and manufacturing company, including Class III implantable work. Direct regional peer with overlapping capabilities in neurotech-adjacent implantable engineering.

Broad incumbents

• Integer Holdings: Large US-listed medical device outsource manufacturer with significant active implantable and neuromodulation manufacturing capacity. Broad incumbent competing in the same end-markets from a much larger scale.
• Resonetics: Global medical device contract manufacturer with capabilities in nitinol, laser processing, and complex implantable components. Broad incumbent serving overlapping neurotech and implantable customer bases.
• Nordson Medical: Medical device component and contract manufacturing business of Nordson, including precision engineered components for neuro and other implantables. Broad incumbent with overlapping manufacturing capabilities.

Emerging players

• Cambridge Consultants: Deep-tech product development and engineering consultancy with active neurotechnology and brain-computer interface practices. Emerging player providing adjacent design and development services to the same neurotech startup segment.
• TTP plc: UK-based technology and product development consultancy with deep neurotech, drug delivery, and implantable device capabilities. Emerging player offering competing design and engineering services to neurotech innovators.
• Helbling Group: Swiss engineering services and product development firm with a dedicated medical devices and neurotechnology practice. Emerging player providing comparable design and development services to early-stage neurotech clients.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/neo-bionica

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Funding overview

Funding rounds2 records

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Neo-Bionica