It is with great pride that we share mOm Incubators’ recent announcement that their first product – the mOm Essential Incubator – has been granted regulatory approval (CE Mark).
First deployments of the innovative, lightweight Incubator, created by mOm Founder & CEO, James Roberts, and developed by mOm & the engineering team at eg technology, are to commence in the NHS as part of a series of pilots to help reduce the need for short-term admission to Special Care and to help maintain the core temperature of babies being moved around hospital sites.
mOm is also working with outside partners on the deployment of the mOm Essential Incubator overseas.
The mOm Essential Incubator is designed and approved to be used across a variety of settings and is able to run off multiple power sources to vastly increase the opportunities for vital care to be administered.
eg technology undertook the entire end-to-end development of the incubator, from initial concept to transfer to manufacture. We were able to provide mOm with a fully integrated engineering resource, across software, electronics, mechanical engineering and industrial design, working to a clearly defined, phased development programme to meet the clinical and business goals of the client. As with all medical device development, safety and efficacy were central to the programme and eg technology engineers were able to use their expertise to ensure that the product was developed in accordance with IEC 60601, IEC 62304, ISO 14971, all within eg’s own ISO 13485 quality management system.
”It has been an incredible journey turning a university project into a fully approved and regulated medical device that is now helping to sustain life in the NHS. The original inspiration was built on the idea of giving clinicians a more flexible solution that can expand access to neonatal care. I am thrilled and humbled that we are able to help in the UK now and overseas in the near future.
James RobertsFounder, mOm
”We would like to extend our congratulations to James and his team at mOm. It has been a privilege to be part of this pioneering project. The regulations around incubator development are, quite rightly, stringent, so to develop a product which met the exacting regulations both from the point of view of device safety and ISO 60601, as well as medical device software to IEC 62304 Class C, and to now achieve CE Marking is testament to the skill of our engineers.
Andrew EdeDirector & Co-Founder, EG Technology
Please see the full mOm Incubators case study for further information on the design and development of this device.
For more information on getting your technology or ideas to market, or to chat with one of the eg team about your product design and development requirements, please get in touch.
Via email on design@egtechnology.co.uk, by giving us a call on +44 01223 813184, or by clicking here.
About eg technology
eg technology are a product engineering design and development specialist based in Cambridge. We have extensive experience within the MedTech sector, ranging from microfluidics and diagnostics to surgical instruments and lateral flow. Our engineers are highly skilled in taking devices from concept through to transfer to manufacture. Specialising in electronics, software and mechanical engineering, industrial design, human factors, project management and quality assurance, eg technology is ISO 13485 accredited. We provide our clients with the compliance to standards for safety, quality, risk management and traceability. Our team is able to provide an integrated solution for those who require the expertise to bridge the gap between innovation and a market-ready product.
About mOm
mOm is a MedTech start-up on a mission to provide global access to high-quality healthcare by providing accessible technology solutions that can operate anywhere in the world. The concept for the mOm incubator came to CEO & Founder, James Roberts, in reaction to the appalling infant mortality statistics in low/middle-income countries. In 2014, he won the Sir James Dyson Global Prize for Innovation for his design. The mOm Incubator is a cost-effective, fold-away and lightweight neonatal incubator offering a safe, thermoregulated environment for neonates. It will help reduce the thousands of newborn deaths that occur every day due to a lack of basic medical equipment.