VentOS

https://gitlab.com/project-ventos/ventos

1.0 Introduction 

1.1 Problem and Background

Many open-source ventilators were built during 2020 but lacked high quality open-source firmware to run them.

1.2 Solution summary in simple terms

VentOS is open-source firmware for medical devices initially targeting ventilators and could also be used on any electromechanical medical device.

1.3 Solution summary in technical terms

VentOS is C++ firmware written in a modular format using PlatformIO. VentOS conforms to ISO 14971 and IEC 62304 with the goal of developing medical device software that could get CE, FDA etc. approval. This would provide a platform to lower barriers to entry for medical device startups, local manufacture and enable a research platform for open research and testing of new control systems, AI and UI development.

1.4 State of advancement of the project

VentOS has been under continuous development for 8 months and the team has produced a working demonstration of the platform.

1.5 Project Timeline

VentOS is a long term project following an agile development method. Current goals are to implement advanced control algorithms and a UI based on healthcare professionals feedback. We aim to implement this over the next 2 months.

2.0 Project Implementation

2.1 Solution

VentOS is a C++ firmware using PlatformIO software to deploy to native, Arduino UNO and Espressif ESP32.

2.2 Methodology

VentOS follows ISO 14971 and IEC 62303 for the development of medical device software.

2.3 Results/Expected results

VentOS aims to provide a modular platform for ventilators and extend it to other medical devices.

3.0 Safety, quality assurance and regulation 

3.1 What steps have you taken to ensure your solution’s safety? How advanced are you in this process (if applicable)? Please check the Biosafety and Biosecurity guideline of OpenCovid19

VentOS uses test driven development, established code review processes and FMEA.

3.2 Have you planned the conduct of your manufacturing process that ensures quality, what are the steps you have taken? How advanced are you in this (if applicable)?

N/A

3.3 Will you need assistance with the regulation system? If not, which regulatory system do you plan on using to distribute the product?

VentOS will provide documentation for the software but expects partner projects to apply for regulatory approval as a complete medical device.

3.4 Have you talked to medical staff about the feasibility of your project? What did they say? 

VentOS was created by an anesthetist, Dr Erich Schulz, and is surveying medical staff to gather feedback on improving software ergonomics.

3.5 Have you planned the testing, verification and validation of your solution? How advanced are you?

VentOS is at a proof of concept demo stage with aims to user test the solution within the next several months.

4.0 Impact, issues and risks

4.1 What impact do you feel your project could have?

VentOS will provide a high quality medical device software that can be used on a range of medical devices from ventilators to oxygen concentrators. This could lower costs, lower barriers to entry and enable research.

4.2 What do you think would make your project a success?

VentOS would be a success if used in a medical device.

4.3 Please list the known issues, potential risks, grey-areas, etc in your project

VentOS requires further development and requires volunteers to support it.

5.0 Originality

5.1 What other projects on JOGL are like yours?

None.

5.2 Is this an innovative project? What makes this project different if it’s unique on JOGL?

VentOS is innovative in its scope, modularity and focus on documentation in the open source space.

5.3 Is there already an open source version of this project?

There are no open source medical device platforms that we are aware of.

6.0 Team experience

6.1 Team members and labs

Dr Erich Schulz, MD. Project lead. Dr Schulz is an anaesthetist with extensive experience in the use of ventilators.

Dr Robert Read, PhD. Project lead. Dr Read is a computer scientist with extensive industry and research experience. He is the founder and President of Public Invention, and board member of Helpful Engineering.

Ben Coombs

Ben has a Master of Engineering. He is an experienced engineer in electronic, software and mechanical projects.

JD Rudie

JD holds a Computer Science Degree and is a C++ developer for VentOS.

Jacline Contrino

Jacline has a background in UX research and is conducting a study on improving the UX design to improve patient outcomes.

Adrian Maldonado

Adrian has a background in design and is designing the UI.

Rupesh Gujarathi

Rupesh holds a Computer Science Degree and is the front end UI developer.

7.0 Funding and Costs

7.1 How is your project being funded so far?

All development to date has been done at zero cost.

7.2 How much funding do you need and how do you plan to use that funding?

Funding would be used to purchase ISO standards, research papers and web hosting.

• ISO standards: 600
• Research papers: 300
• Web hosting: 150

Total: 1050 Euro

VentOS is a Helpful Engineering project using the MIT license.