Innovative product and service design for sustainable environmental and commercial outcomes
MEDTECH ENGINEERING PARTNER
Engineering MedTech
Innovation for Scale
We partner with scientists and MedTech founders from the earliest stages - accelerating your path from discovery to clinical-ready product.
25+
years in operation
3
global markets served
Trusted By
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Our mission is to halve the time for MedTech innovation to get to scale.
Building, prototyping, refining innovation - secure early funding, prepare for clinical & real-world testing
01
NEW PRODUCT CREATION
•
Scientific problem definition
•
Stakeholder insights
•
Requirements planning
•
Concept architecture
•
In-principle prototyping
•
Value and unique selling proposition
•
Risk assessment
•
Device classification
02
DESIGN & DEVELOPMENT
•
Design and prototyping
•
Iterative testing and development
•
Full-stack system design
•
Service model development
•
Manufacturing for research use
•
Pre-clinical trials and refinement
•
Regulatory pathway definition
•
Reimbursement pathway definition
03
MARKET READINESS
•
Go-to-market strategy
•
Design for manufacture
•
Data systems development
•
Quality management systems
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Clinical trial support
•
Health technology assessment
•
Risk assessment
•
Regulatory support
04
SUPPORT & SCALE-UP
•
New poroduct introduction
•
Manufacturing implementation
•
Quality management systems
•
Control systems
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Data system integrations
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Go-to-market support
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Intellectual property support
•
Investment support
Underpinned By
Clinical Evidence & Adoption Readiness
Reimbursement & Regulatory
Supply Chain & Manufacture
— MEDTECH PROJECTS
Translational engineering
in MedTech applications
Multidisciplinary MedTech projects spanning diagnostics, emergency medicine, and reproductive technology.
StatOS
Translating oxidative stress research into a clinician‑ready bedside diagnostic - enabling real‑time, low‑cost measurement in critical care.
Shark Wheelchair System
Reliable wheelchair control that helps people move with confidence, every day.
Formthotics V20 Heater
Improving orthotic fitting with a purpose‑built heating system.
— OUR EXPERTISE
Multi-disciplinary
MedTech engineering
From first clinical insight through to production - every capability you need to bring a medical device to market, under one roof.
1
Product Design
We design medical devices around real patient and clinician needs - form, usability, and engineering working together. Prototypes get tested early so issues show up before they’re expensive or risky.
1
Product Design
We design medical devices around real patient and clinician needs - form, usability, and engineering working together. Prototypes get tested early so issues show up before they’re expensive or risky.
2
Embedded Firmware
We define how the whole device fits together - electronics, firmware, and connectivity - so nothing behaves unpredictably later. Clear system boundaries help avoid last‑minute surprises during testing or approval.
2
Embedded Firmware
We define how the whole device fits together - electronics, firmware, and connectivity - so nothing behaves unpredictably later. Clear system boundaries help avoid last‑minute surprises during testing or approval.
3
Electronics Hardware
We design electronics that are safe, buildable, and realistic to manufacture. Schematics, PCB layout, and early prototypes help surface compliance or reliability issues before certification and tooling.
3
Electronics Hardware
We design electronics that are safe, buildable, and realistic to manufacture. Schematics, PCB layout, and early prototypes help surface compliance or reliability issues before certification and tooling.
4
Cloud and App
We build apps and cloud systems that clinicians actually want to use: clear screens, reliable data, and sensible permissions. The focus is day‑to‑day use, not flashy features no one needs.
4
Cloud and App
We build apps and cloud systems that clinicians actually want to use: clear screens, reliable data, and sensible permissions. The focus is day‑to‑day use, not flashy features no one needs.
5
New Product Introduction
We help move devices into production - working with suppliers, sorting tolerances, and setting up end‑of‑line testing. The goal is fewer factory issues and smoother first builds.
5
New Product Introduction
We help move devices into production - working with suppliers, sorting tolerances, and setting up end‑of‑line testing. The goal is fewer factory issues and smoother first builds.
6
Product Compliance
We handle risk and compliance as the design evolves, not at the end. Hazard analysis, verification planning, and documentation are built alongside development to support regulatory review and market entry.
6
Product Compliance
We handle risk and compliance as the design evolves, not at the end. Hazard analysis, verification planning, and documentation are built alongside development to support regulatory review and market entry.
— WHY INFACT
Deep experience where
science meets scale
inFact has provided advanced engineering design services to commercialise science and research for Medical, Deeptech and industrial applications.
01
Competitive Rates, Global Reach
A favourable NZ exchange rate means your development budget goes further - without compromising on capability or global ambition.
02
Specialist Supply Chain
Extensive design and manufacturing networks across EU, USA, and Asia - from specialist materials to precision prototyping and full production runs.
03
Regulatory Confidence
ISO 13485 and ISO 98211 QMS pathway focus, with reimbursement expertise to establish the optimal pathway for your device classification and market entry.
— TESTIMONIALS
Don’t take our word for it.
Hear from our clients
InFact likes to understand the why as much as the how of bringing science to reality.
Anthony Phillips
Professor (University of Auckland)
Eliminating manual level monitoring and providing low-level tank alerts … has allowed the clinics to refine their processes and provide stakeholders with more confidence.
Fertility Associates
Client Feedback
InFact’s support was invaluable… It got us from zero to one in a timeframe that was unachievable otherwise.
Mathieu Sellier
Professor (University of Canterbury)