Industrial IoT & Remote Monitoring.

Medical device design requires a more structured approach than most product development. Every decision must consider patient safety, risk management, and regulatory compliance from the start. We help startups build with verification and clinical readiness in mind, so innovation can move forward confidently toward approval and real-world use.

A docotor taking note of critical patient information on their tablet device.
A stressed founder has their head in their hands as they are working on their laptop.
A stressed founder has their head in their hands as they are working on their laptop.

Where early stage startups can get stuck

Where early stage startups can get stuck

Where early stage startups can get stuck

As an early stage medtech startup, there are many uncertanties that can make make the process seem daunting:

As an early stage medtech startup, there are many uncertanties that can make make the process seem daunting:

Understanding complex FDA/ CE regulatory guidlines

Understanding complex FDA/ CE regulatory guidlines

Understanding complex FDA/ CE regulatory guidlines

Struggling to produce realistic and effective MVPs

Overlooking manufacturability and cost early on

Struggling to produce realistic and effective MVPs

Overlooking manufacturability and cost early on

At IMME we offer a structured, six-step development framework which takes you from idea to manufacturable prototype, while considering cost, time to market and regulatory compliance from the outset.


At IMME we offer a structured, six-step development framework which takes you from idea to manufacturable prototype, while considering cost, time to market and regulatory compliance from the outset.


Medical Device Development Framework


An end-to end process for developing capable and compliant medical devices.
Six-step medical device development process: discovery and clinical requirements; system architecture and feasibility; integrated hardware and firmware design; prototype build and engineering validation; design optimisation and DFM; verification, compliance and clinical readiness.

Medical Device Development Framework


An end-to end process for developing capable and compliant medical devices.

Six-step medical device development process: discovery and clinical requirements; system architecture and feasibility; integrated hardware and firmware design; prototype build and engineering validation; design optimisation and DFM; verification, compliance and clinical readiness.
Six-step medical device development process: discovery and clinical requirements; system architecture and feasibility; integrated hardware and firmware design; prototype build and engineering validation; design optimisation and DFM; verification, compliance and clinical readiness.

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A render of the Onawave device, sitting on a table and the case in focus.
The printed circuit board of the Onawave device, held over a table.

Do you have questions about our services?


GET IN

TOUCH

Do you have questions about our services?


GET IN

TOUCH

A render of the Onawave device, sitting on a table and the case in focus.
The printed circuit board of the Onawave device, held over a table.