Bring your medical device to market — solving the right problem.
Rohmo is an end-to-end medical device development partner for inventors and clinicians. We start with market discovery and customer insight, then carry your device through design, regulatory approval and manufacturing.
Discovery first. Then build.
Most device projects fail on the problem, not the engineering. We invest early in understanding the market, the users and the clinical workflow, so every design decision downstream is made for a reason.
Discover
Market landscape, competitor analysis, clinical and customer interviews, unmet-needs mapping.
Define
User needs, intended use, product requirements and a regulatory strategy that fits the business case.
Develop
Concept, prototype and verification under design controls — electronics, firmware, mechanical, software.
Deliver
Validation, regulatory submission, design transfer and manufacturing support through launch.
Everything between the idea and the market.
Engage us for the whole journey or for the stage you need most.
Discovery & Insights
Market discovery, customer needs and clinical insight, so we build the product that solves the right problem.
Learn moreDesign & Development
Concept, engineering and prototyping — electronics, firmware, mechanical and software — under a design-controlled process.
Learn moreRegulatory & Quality
Regulatory strategy, risk management, usability and a quality system that gets you through TGA, FDA and CE.
Learn moreManufacturing & Launch
Design transfer, validated production and the support you need to put a device in clinicians’ hands.
Learn moreInventors and clinicians with a problem worth solving.
Clinicians
You see the problem every day and know what a better device would look like. We turn that insight into a product without taking you away from your practice.
- Validate the need beyond your own department
- Protect and structure the idea
- Navigate hospital, regulatory and reimbursement pathways
Inventors & founders
You have a concept, maybe a prototype, and need a partner who has taken devices through the whole process before.
- De-risk the idea before heavy engineering spend
- A regulatory and quality pathway from day one
- Investor-ready evidence and documentation
Built by people who have shipped devices.
Insight-led
We don't start with CAD. We start with customers, clinicians and the market, so you build once.
Regulatory-native
ISO 13485, ISO 14971, IEC 62304, IEC 60601 and TGA/FDA pathways are how we work, not an afterthought.
End to end
One team from discovery to manufacturing, so nothing is lost in hand-offs between vendors.
Have a device idea? Let's talk.
Tell us about the problem you're trying to solve. A short conversation is usually enough to work out whether — and how — we can help.
Sydney, Australia