Medical device design.
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.
Medical device design.
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.
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.
The unique difficulties with medical devices
The unique difficulties with medical devices
The unique difficulties with medical devices
As an early stage medtech startup, there are many pitfalls that can be experienced when developing connected medical devices:
As an early stage medtech startup, there are many pitfalls that can be experienced when developing connected medical devices:
The hardware, firmware and app come from different suppliers, and the faults land in the gaps between them
The hardware, firmware and app come from different suppliers, and the faults land in the gaps between them
The hardware, firmware and app come from different suppliers, and the faults land in the gaps between them
The software quietly turns the product into regulated software without anyone noticing until submission
The software quietly turns the product into regulated software without anyone noticing until submission
The software quietly turns the product into regulated software without anyone noticing until submission
Readings that hold on the bench start drifting when in use on a real patient
Readings that hold on the bench start drifting when in use on a real patient
Readings that hold on the bench start drifting when in use on a real patient
Each of those sits where disciplines meet. Our electronics, firmware, mechanical and app engineers work as one team, under one ISO 13485 system, so the whole device, including the data it produces, is designed and documented together.
Each of those sits where disciplines meet. Our electronics, firmware, mechanical and app engineers work as one team, under one ISO 13485 system, so the whole device, including the data it produces, is designed and documented together.
Medical Device Development Framework
Medical Device Development Framework
An end-to end process for developing capable and compliant medical devices.
Step 1
Clinical & Connectivity Requirements
Clinical needs, users and the regulatory pathway are defined, along with what data the device must capture, where it goes and who needs to see it.
Step 1
Clinical & Connectivity Requirements
Clinical needs, users and the regulatory pathway are defined, along with what data the device must capture, where it goes and who needs to see it.
Step 2
System Architecture & Risk
Electronics, firmware, sensing, power and connectivity are architected together. Early feasibility work and risk analysis catch technical and safety problems while they are still cheap to fix.
Step 2
System Architecture & Risk
Electronics, firmware, sensing, power and connectivity are architected together. Early feasibility work and risk analysis catch technical and safety problems while they are still cheap to fix.
Step 3
Integrated Device & App Design
Custom PCBs, embedded firmware and the companion app are developed side by side, so the device, the data link and the interface work as one system.
Step 3
Integrated Device & App Design
Custom PCBs, embedded firmware and the companion app are developed side by side, so the device, the data link and the interface work as one system.
Step 4
Prototype & Connected Validation
Working prototypes are tested for performance, safety and usability, including how the device behaves when the connection drops, the battery runs low or data arrives late.
Step 4
Prototype & Connected Validation
Working prototypes are tested for performance, safety and usability, including how the device behaves when the connection drops, the battery runs low or data arrives late.
Step 5
Optimisation, Security & DFM
The design is refined for size, battery life, cost and assembly. Data security and over-the-air updates are hardened so the device stays safe after it ships.
Step 5
Optimisation, Security & DFM
The design is refined for size, battery life, cost and assembly. Data security and over-the-air updates are hardened so the device stays safe after it ships.
Step 6
Verification & Clinical Readiness
Verification is completed and technical documentation prepared for clinical evaluation, with the software's safety classification settled rather than assumed.
Step 6
Verification & Clinical Readiness
Verification is completed and technical documentation prepared for clinical evaluation, with the software's safety classification settled rather than assumed.
The power behind our framework.
The power behind our framework.
Our framework is only possible due to our capability to cover every aspect of medical device development. Click the cards below to explore exactly what we can do.
Our framework is only possible due to our capability to cover every aspect of medical device development. Click the cards below to explore exactly what we can do.
Built inside an ISO 13485 quality system
Built inside an ISO 13485 quality system
IMME has been certified to ISO 13485:2016 since 2024. It covers how we work, not your device, which is approved through your own submission. What it gives you is design work ready for that submission:
Design controls recorded as the project runs, not reconstructed later
A design history that goes straight into your technical file
Risk management built in from the start
Every hardware, firmware and enclosure change traceable
A certified supplier that's simpler to qualify
We also design to the standards your device will likely be assessed against: IEC 62304, ISO 14971, and IEC 60601-1 and 60601-1-2.
IMME has been certified to ISO 13485:2016 since 2024. It covers how we work, not your device, which is approved through your own submission. What it gives you is design work ready for that submission:
Design controls recorded as the project runs, not reconstructed later
A design history that goes straight into your technical file
Risk management built in from the start
Every hardware, firmware and enclosure change traceable
A certified supplier that's simpler to qualify
We also design to the standards your device will likely be assessed against: IEC 62304, ISO 14971, and IEC 60601-1 and 60601-1-2.
See one of our health/medical device projects.
See one of our health/medical device projects.
Sub-bandage pressure, measured for the first time rather than guessed.
Health/medical
Feeltect
Meet the health platform device that is revolutionising how we view bandage application
Meet the health platform device that is revolutionising how we view bandage application
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