Race to a sub-$1000, Health-Canada approved ventilator production package for the Code Life Ventilator Finalist Designs
We must vastly reduce manufacturing costs of the ventilators that we so critically need right now, in order to save lives worldwide.
The COVID-19 pandemic has revealed the worldwide ventilation shortage and healthcare disparity between countries.
Medical devices, like pharmaceuticals, must be affordable, to uphold the quality of human lives across the planet: this is a McGill Third Century Challenge. Engine is McGill’s technology and innovation hub, pushing technological innovation for the greater social good. Teaming up with Code Life Ventilator partners, Engine launches the Made for AllManufacturing Challenge to produce low-cost ventilators that can be manufactured locally around the world.
Respiratory illnesses, including COVID-19, but also Acute respiratory distress syndrome (ARDS) and viral pneumonia, sometimes necessitate respiratory assistance with ventilators. Long before the pandemic hit, many lives in developing countries have been lost due to shortages of ventilators needed to treat a variety of respiratory ailments. The Code Life Ventilator Challengecatalyzed three low-cost, easy-to-build and easy-to-use ventilator designs. Now what is needed is to finalize and ready those designs for manufacture worldwide.
How it works
The Made for All challenge will run in two phases—Team Formation, and The Sprint.
Team Formation phase—global teams of manufacturing and compliance experts get together—to include an industrial engineer, design engineer, medical device expert, technical writer, and a clinical respiratory expert. Each formed team pitches the Finalists of the Code Life Ventilator Challenge, to be selected as the Made for All Team to work on their design. At the end of this phase there will be three Made for All Teams.
The Sprint—all three Made for All Teams race to be the first to obtain Health Canada approval for their device and make a final manufacturing package for a ventilator costing less than $1000 CAD.
Up to $300,000 will be awarded in compensation to the first Made for All Sprint Team to cross the finish line, in exchange for the final manufacturing package and license to share worldwide with competent manufacturers. $100,000 has generously been donated by the Montreal General Hospital Foundation already, and McGill Engine, the Faculty of Engineering Innovation and Entrepreneurship centre, seeks to raise$200,000 to support this important initiative.
Call for Expertise. McGill Engine needs your expertise for the manufacturing and regulatory panels that will evaluate the project. If you are interested please contact us.
Ventilators for the World
The Made for All Sprint participants will join their Code Life Ventilator Challenge Finalist colleagues to grant a low-cost license to their manufacturing package so that these safe, low-cost, optimized-for-manufacturing designs can be shared worldwide with manufacturers that are committed to low-cost manufacturing for the next 18 months.
Time is of the essence: join McGill Engine in completing the next phase of the vital and life-saving Code Life Ventilator Challenge by greatly reducing ventilator manufacturing costs.
Dr. Peter Goldberg - Director, Clinical Care Centre, McGill University Health Centre (MUHC)
Professor Reza Farivar - Canada Research Chair in Integrative Neuroscience
Professor Benoit Boulet - Director, McGill Engine
Vivian Diniz - Business Development Officer, McGill Engine
Katya Marc - Associate Director, McGill Engine
Elise Monaghan Joubert - Associate Director, McGill Faculty of Engineering University Advancement
PLEASE CHECK BACK FREQUENTLY FOR UPDATES/CHANGES TO THE GUIDELINES
Teams must have the technical and financial means to produce the manufacturing prototype of the proposed design(s) and obtain regulatory approval from Health Canada or the FDA.
Teams must also be composed of at least 5 people and include, but not limited to:
an independent expert physician or respiratory therapist capable of signing off on the clinical adequacy and performance
a subject matter expert, able to guide and attest to the compliance of the device with ISO standards
an industrial engineer, to direct the preparation of a professional, optimized manufacturing package
an industrial designer, to direct the optimization of the final device and its usability
a technical writer, to prepare compliant documentation for installation, use, etc, of the device
a software engineer with medical device programming experience, to guide and attest to certifiable software for the devices
1. Pitching phase
Each candidate team must select a design among the three design teams: Haply, IFPR Brazil or Lung Carburetor. The candidate team will then prepare a pitch for the respective design team.
The pitch should be as concise as possible and must outline the team’s capabilities and expertise and the reasons why the team should be selected to optimize the chosen design to manufacture a ventilator for less than $1,000 CAD while still complying with the Health Canada or FDA regulatory requirements (under COVID-related or interim-authorization accelerated review process, for example)
Each design team will have two weeks to review all the corresponding design pitches and select one candidate team to move on to the design optimization phase.
2. Design Optimization Race
Once the candidate teams are selected by the design teams, they must notify the sponsors and submit a formal agreement between them, showing agreement on items such as IP and licensing. They will then have until Dec. 1st, 2020 (approximately 90 days) to produce a manufacturing package for the corresponding ventilator design and obtain approval for human use from either Health Canada or the FDA, or have at least interim approval for COVID Ventilators.
Candidate teams will then work to optimize the chosen ventilator design to allow the production of a ventilator for $1000 CAD or less. Teams must produce a manufacturing package that will be reviewed and judged by experts based on defined manufacturability and financial criteria. Candidate teams will also have ongoing access to consultants (e.g. aPriori) to assist the cost optimization process.
The manufacturing package must comprise a full package composed of any documents or other materials such as prototypes, designs and design histories, instructions, procedures, methods of construction, compositions of matter, models, specially designed tools, communications, texts, presentations or videos relating to the Challenge, and as needed by other manufacturers to adopt the design for production at their facility and obtain regulatory approval for that device.
In addition to the manufacturing package, the teams must provide access to the full dossier of test results and other information relevant to the regulatory approval process--essentially all material needed for another manufacturer to be able to file for rapid authorization to produce the device.
3. Winner Announcement
The first candidate team to successfully complete a Financial Assessment and obtain Regulatory Approval by Health Canada or FDA will win the challenge and receive compensation up to $300,000 CAD.
Information on the design teams
Information on the Ventilator Designs will be made available by material and documents provided by the Design Teams to the Candidate Teams. Some of these will be shared on this site.