Over the past decade, Romar has positioned itself as an industry leader in the design and manufacture of medical devices and aids, thanks to the skill of its in-house biomedical engineers and world class clean room facilities –
one of the largest of its kind in Australia and the Asia Pacific region.
So what can Romar do, that others can’t?
‘Our level of expertise in the medical industry puts us in a unique position, and there are very few companies that offer the complete and scalable service we offer.
Our hugely experienced team of over 20 engineers, including biomedical engineers, ensure we meet all the regulatory requirements to obtain TGA and FDA approval.
You come in with the idea and we’ll apply the science.’ ~ Alan Lipman, CEO
Clients often come to us with an idea for a medical device, but have no idea how to scale for manufacture.
And because of current legislation and the lengthy approval process, once you create a device, have it validated and registered, and you’re ready to start making more, the way you made them is no longer suitable.
Clients often report they are:
- unsure how to manufacture in a commercially viable way
- unsure how to design for manufacture
- certain the device is functional, but not commercially viable
- unsure how to reduce costs through materials and method
- unsure how to make it easier to manufacture
Put simply, they just don’t have experience or expertise to create a scalable manufacturing process.
So how to scale your process?
The first step is to take the complexity out – that’s what we’re good at.
Our end-to-end design and manufacturing solutions work because:
- Romar has an intimate understanding of the design and manufacture of medical devices, both nationally and internationally
- Romar understands the materials that can and can’t be used
- Romar has a certified clean room and we are specialists in packing for sterilisation
- Romar thoroughly understands the FDA case studies approval process
We build in scalability at the very beginning.
Find more about the medical devices we have manufactured here.
If you’re ready to collaborate with a team of biomedical engineers and experts who have access to world-class facilities in Australia and South East Asia, contact Romar for a complete and scalable medical device solution today. Contact Romar.