Open Source Community Drives Innovation

The problem of getting complex new systems through regulatory acceptance is severe.

Our approach: sharing architectures, designs and safety data facilitates for all a more thorough understanding of the safety basis of many medical devices being developed.

The outcome: regulators get consistent data for many platforms; developers’ work is eased; interactions between developers and regulators become more collaborative; approvals become faster; devices get to market.

The problem: it costs too much to develop new platforms which may become medical devices from scratch. 

Our platform approach cuts costs for all; minimizing redundancies in component and system design, manufacturing oversight, safety testing, and data collection.

The outcome: Potential important savings in research, development and deployment, modifications and even recalls. The broader our platform’s adoption, the better potential the cost and size reductions for all in trials and use.

The problem - device development is slow and expensive and hard to achieve market ROI when each device addresses one narrow set of indications.

Our approach: each new generation of our platform will have more powerful components and software, enabling more uses. Just like a smartphone.

The outcome: This means new indications can be added without the cost and time of platform design - rather like a phone app. Faster to invent and faster to prove and faster to deploy.

The Problem: not enough safety data, not shared

Our approach: Collaboration in safety data sharing promotes a proactive approach to identifying and mitigating potential risks associated with medical platforms.

The outcome: By collectively addressing safety concerns, developers contribute to a safer healthcare ecosystem, ensuring that patients receive the most reliable and effective medical technologies available. Thus driving cost out of healthcare.

The problem - device trials using different designs, that migrate in uncoordinated ways.

Our approach means a broadly-used platform has system quality manufacture data made open, rigorous and widely understood.

The outcome: Safety and efficacy results from one trial can be easily and rapidly shared and compared with those of other trials. Methodologies will accelerate as researchers see the basic platform technology as a solved problem.

The problem is inconsistent data between uses, regions, indications, devices, and so on.

Our approach: explicitly open-source, enabling open data collaboration and data-sharing.

The outcome: This benefits regulators with faster and more specific actions; it enables researchers and clinicians whose confidence in the breadth of safety and efficacy information is essential,  and benefits patients.