Case Studies

Developing a neonatal incubator for medical device ce marking

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BACKGROUND

mOm Incubators

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 globally. In 2014, he won the Sir James Dyson Global Prize for Innovation for his design. We worked with mOm to develop the mOm Incubator; a cost-effective, fold-away and lightweight neonatal incubator offering a safe, thermoregulated environment for neonates. The mOm incubator will help reduce the thousands of newborn deaths that occur every day due to a lack of basic medical equipment. 

  

THE CHALLENGE

mOm approached us following a recommendation from a medical partner in order to develop and engineer their concept for a neonatal incubator. mOm wished to address the shortcomings of current incubation systems and save the lives of premature babies in challenging, low/middle-income settings; as well as provide more options for standard neonatal care in the UK and the developed world. They, therefore, specified that the unit should be designed with accessibility in mind; it should be compact, fold-away & lightweight to facilitate effective storage and shipping via air freight, and suitable for use with all major international power voltages. 

As the device is designed for neonates, the safety and efficacy of the device were paramount. mOm naturally required the device to be fully compliant to all of the required standards - tested to IEC 60601, IEC 62304, developed in accordance with ISO 13485 and ISO 14971 and finally, CE marked. 

 

Cost-effective, fold-away, lightweight device with rechargeable battery & mains power | Certified to IEC 60601, IEC 62304, ISO 14971 & ISO 13485 | Fully managed & integrated, end-to-end, multi-discipline project with emphasis on Software engineering 

 

OUR APPROACH

mOm Incubators

eg technology undertook the entire end-to-end development of the incubator, from initial concept design to transfer to manufacture. Acting as a fully integrated engineering resource, our Software, Electronics, Mechanical Engineering and Industrial Design teams worked concurrently across a clearly defined phased development programme to meet the clinical and business goals of the client. As Covid-19 hit, our team were able to not only expedite the development but also adapt to shifting requirements in response to the pandemic, with teams working remotely under Covid-working conditions.

Using formative usability studies to drive the detailed design of the device, we provided concept designs in accordance with their IP and created Alpha and Beta Prototypes to ensure that the required specifications were implemented and any risks were mitigated, whilst enabling the client to facilitate further investment. We carried out the design for manufacture and verification testing in house, ensuring all safety-critical elements were maintained in the software in accordance with harmonised standards, prior to submission to the notified body. In providing life-saving thermoregulation for neonates, the software was developed in accordance with IEC 62304 software safety class C.

 

"It has been a privilege to be part of this pioneering project. The complexity of the programme, coupled with the development taking place during a global pandemic meant the team had to draw on their extremely broad experience and multi-disciplinary expertise to ensure the project maintained momentum. 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, is testament to the skill of our engineers." - Andrew Ede, Director & Founder | eg technology

 

mOm incubators

results

As a start-up, mOm was able to leverage our extensive design and development engineering expertise and experience within the medical sector. We worked closely with their team to create a product that not only meets specifications but is now certified by a Nationally Recognised Testing Laboratory (NRTL). Our expertise and thorough understanding of the product development process and applicable standards, specifically the regulations surrounding neonatal incubators, ensured the product was developed in accordance with IEC 60601, IEC 62304, ISO 14971, as well as within our own ISO 13485 framework.

The innovative British-Manufactured lightweight, neonatal incubator achieved its first clinical use in the UK in November 2021, as it helped to sustain a premature baby’s life at St Peters Hospital, Chertsey.  

"The incredible team at eg technology were pivotal in the development of this device and despite the complications brought about by a global pandemic, their engineers remained flexible, agile and steadfast in their dedication to achieving results. Their experience of bringing medical devices to market within a highly regulated framework was reassuring during this complex development and instrumental as we approach achieving certification. An idea that started as my vision now has the potential to impact many lives and I thank the great team at eg technology for helping to turn this dream into a reality" - James Roberts FRSA | CEO | mOm

 

For further information on how eg technology can support in 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

 

Image credits:
Incubator images: mOm Incubators
Image of infant in Incubator: St Peters Hospital Chertsey with grateful thanks to the parents for their permission to share