Medical Device Manufacturing
Romar has built its reputation as Australia’s leading medical device manufacturer by driving unparalleled standards and investing in the best people and technology.
Scalable medical device manufacturing
Romar has positioned itself as an industry leader in design and medical advanced manufacturing of medical devices and aids. Our biomedical engineering team works with the very best technology and materials using our advanced manufacturing facilities, including Romar’s world-class clean room facility. Our Class 8 clean room is the largest in Australia and the Asia Pacific region.
Romar is a scalability expert with an intimate understanding of the design and manufacture of medical devices, both nationally and internationally.
We are an authority on material selection and thoroughly understand the FDA case studies approval process. We build in scalability at the very beginning.
Our team works to ensure the highest quality scalable solutions and our international partnerships make innovative medical devices a reality.
“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 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
Experts in medical grade material selection
Romar’s highly qualified material scientists are the most respected in the medical device manufacturing sector. We leverage our unique partnerships with the world’s leading research and development institutions to continually refine and upgrade skills, research and material knowledge. Romar’s pedigree in medical grade silicone manufacturing, including restricted and non-restricted grades, is globally recognised.
Our broad portfolio of silicones and elastomers for application in the healthcare industry has been tested against USPIV and ISO 10993 biocompatibility standards. The distinctive properties of silicone elastomers – the purity, clarity and strength – coupled with ease of processability, have resulted in their use in a broad range of medical device applications.
Our silicone materials exhibit exceptional stability over a wide range of temperatures, lending themselves to use in applications requiring repeated sterilisation.
Broad scale application expertise
Romar has been delivering scalable, approved medical devices for decades. A few examples of our application expertise include:
- Dental and surgical devices
- Diagnostic imaging
- Fluid and drug delivery devices
- Septa/Stoppers laboratory accessories
- Advanced wound care and scar management
- Medical tubing
- Wound drains and bulbs
- Sterilisation mats
- Pharmaceutical closures
- Instrument grips
- Dialysis O-rings
- Positioning devices
- Catheters
- Seals, O-rings and valves
- Respiratory and anaesthesia devices
- Medical equipment keypads
We are one of only a handful of manufacturing companies in the world with the expertise, facilities, technology and team to bring together a collective of engineers, scientists and technologists to create world-class medical device solutions.
A total solution
Romar specialises in bringing your vision to life. We take care of each phase in the complex cycle – from design and material selection to scalable manufacturing and shipping. Our team members are process experts. When you first engage Romar for your medical device or component, we take the initial idea and design a process that results in molding the device, assembly and finally packaging.
To ensure your product is fit for approval under the regulatory procedures, Romar develops a comprehensive technical file. Firstly, our biomedical engineering team develops the Design History File, collating the design inputs and design outputs documentation and the testing analysis.
Secondly, the team develops the Device Master Record detailing the manufacturing. Work instructions, bill of materials, quality control and assurance plan and specifications including packaging and labelling are essential elements of this documentation. The Design History File and Device Master Record ensure the medical device complies with the regulatory requirements.
Design validation
We create the design validation process to ensure the device meets the intended use. At the commencement of the design process, Romar develops the clinical and user-need validation. This is prepared to ensure the product meets the needs of the clinician or the end-user (patient).
Once bench testing has proven the product safe, we must demonstrate that the product meets the end-user’s needs. It is a requirement that the product can provide clinical evidence. Clinical evidence is by way of a human trial or documented evidence that the product is safe and effective.
Romar’s expertise in design validation is an essential service to medical devices manufacturing worldwide.
Partner with a qualified and technically professional team
It pays to work with the best. Our team members are highly qualified and experienced with the attention to detail required to ensure success. When you’re ready to collaborate with the very best biomedical engineers and experts who have access to world-class facilities in Australia and Southeast Asia, contact Romar for a complete and scalable medical device solution.
Want to know more? Read through our medical manufacturing articles.
Case Studies
AEM Aircraft Safety
Romar has created two key components for state-of-the-art anti-crack technology that for the last five years has been tested across multiple Boeing 737 aircraft.
BioAnalytics and Romar
BioAnalytics and Romar, as an Australian start-up, are changing the lives of sleep apnoea sufferers with a new device that is one tenth the cost of current therapies.
Romar and Madorra
Romar partnered with a medical device company in the US called Madorra. Their new product aims to change the lives of women who are breast cancer survivors.
Nanopatch by Vaxxas
A new patch, smaller than a postage stamp, is a game changer in vaccinations. Nanopatch gives people across the globe access to needle-free vaccinations.
Frank Green
Paying for your coffee with a Visa payWave chip on a KeepCup is now a reality. Innovative company Frank Green created an award-winning reusable cup with our help.
ResusiSure
Midwife Debbie Ritz was working at a new facility in Sydney when she found a major problem with the resuscitation masks used on premature and newborn babies.
Ready to Step into the Future of Manufacturing?
Contact Romar today to start the conversation.
Advanced Manufacturing News & Articles
Romar’s contract manufacturing model
Romar’s contract manufacturing model creates significant advantages for aerospace companies looking for a component manufacturer with specialist engineers to collaborate for scalable solutions.
Medical Silicone for a Happy Sleep
Medical silicone for a happy sleep. Romar’s expertise with medical devices ensures an anti-snoring mouthpiece becomes a commercial product. The Happy Sleep anti-snoring mouthpiece is helping thousands of people rest easy.
Modern Manufacturing for All Sectors
Romar’s approach to modern manufacturing for all sectors is why we remain a market leader in high quality and scalable manufacturing for Australian and international customers.