A silicone mask that saves babies’ lives – how Romar’s innovation and expertise really make a difference
Midwife Debbie Ritz was working at a new facility in Bella Vista, Sydney, when she found a major problem with the resuscitation masks used on premature and newborn babies. The design was flawed; they weren’t secure, and too much oxygen was escaping as the masks were poorly fitted.
In other words, they really weren’t doing what they were supposed to be doing – helping babies to breathe.
So what to do? It helps when you’re married to an engineer. Debbie asked her problem-solving, challenge-driven husband Gavin to come in and see if he could find a solution.
He did, and he found one. ResusiSure.
Design, Develop and Prototype
Gavin knew he had the talent and ability to produce something better than the current approved masks – something that could make a real difference to these babies.
So he designed and developed moulds and a prototype of a new silicone mask.
He ascertained the models were working and produced detailed engineering drawings.
The final piece of the puzzle
He knew he needed a contract manufacturer in the medical device space – one that knew silicone inside and out. And so he contacted Romar.
A Silicone Specialist in the Medical Device Space
‘There aren’t many medical device manufacturers that can do silicone injection moulding.
Romar have ISO 13845, and I had a great connection with Neil. He’s a very honest operator.
The Romar technical team are really clever and efficient. The engineers are very good and know what they’re talking about.
The QC and standards systems are impeccable.
I provide detailed design files which they convert and make tools from. Much of the skill in manufacturing is making the tool.’
It comes down to control, quality and delivery
‘The other key to the success is relationships between people. I’ve done this a number of times and working with people you don’t like or don’t trust is a real problem.’
Gavin has a close working relationship with engineers Medhi, Sean and Rita. He gives them working samples which he has handcast, and they work within a particular standard and produce the product to that standard.
That’s the key – the quality standards required.
‘There are always quality control problems when you initially produce a product but we solved any issues we came across. We redesigned the mask a few times, used different processes and we worked it out together.
Together we have been able to design and manufacture a class 1 product, which is TGA, WAND and FDA approved.’
Manufacturing Locally = Quality Control
Despite plenty of options to manufacture in Asia, Gavin had some very clear and specific quality driven reasons why he chose to manufacture locally.
‘I could have chosen to go to Hong Kong or Chinese companies but felt it wasn’t good control. Romar has been in the medical device space for a long time and knows what it takes to produce the quality required.’
And Romar’s award winning world class facilities meant they had the ability to produce commercial volumes …within the conformity required by regulation standards.
No baby should miss a breath
The ResusiSure masks are produced for a global market. Gavin and Debbie Ritz are passionate about the future of ResusiSure, and the importance of its success.
‘10 – 20% of newborn babies require airway intervention. The way to ventilate a baby is through a mask and resuscitation machine. Most masks don’t seal very well, and it’s critical to get accurate pressure to the baby’s lungs. We’ve designed a bunch of different masks that have solved that problem.
No baby should miss a breath.’
Onwards and Upwards
‘We have a second generation design in clinical trials at the moment around the world. The newly designed second generation mask can be used for resuscitation of newborns, premmies and full term babies, as well as for anesthetics for babies less than two months old.’
Driving the design and production of the ResuSisure masks gives Debbie and Gavin Ritz a real sense of place.
‘We save babies’ lives and that gives us immense pride and satisfaction.‘
If you have an idea for a medical device, or are looking for innovative and scalable manufacturing solutions and a world class facility, contact Romar today.