Advanced silicone manufacturing capability is why Romar is one of Australia’s most trusted and recognised scalable manufacturing businesses.
In modern healthcare, the demand for highly specialised medical devices is rising. These devices cater to individual patient needs and medical conditions, leading to more effective treatments and better outcomes. The driving force behind this trend is advanced silicone manufacturing, a pivotal component of bespoke medical device production.
Silicone, a versatile synthetic polymer, has gained immense popularity in the medical industry due to its exceptional properties. It is biocompatible, meaning it can interact with biological tissues without triggering adverse reactions.
One of the primary advantages of advanced silicone manufacturing is its ability to deliver precision and customisation. Traditional manufacturing processes often fail to provide bespoke solutions for patients with unique anatomical or medical requirements. Advanced silicone manufacturing, on the other hand, allows for the precise tailoring of medical devices to meet individual needs.
Romar has extensive proven expertise in the manufacture of medical devices. Our capabilities include solving manufacturing problems and finding solutions that are not only market-ready but that we can manufacture profitably and at scale.
Driven by science
The Romar team of silicone manufacturers employs a science-driven approach for every project. Silicone, with its remarkable characteristics – including low-temperature flexibility, resistance to weathering and excellent oxidative stability – demands a delicate touch during the manufacturing process. In-depth knowledge and comprehensive product analysis are essential to fully harness its potential.
At Romar, our team possesses advanced expertise in silicone manufacturing and leverages the principles of cure chemistry, particularly cross-link chemistry. This allows us to meticulously engineer the raw materials, meeting the stringent standards and regulatory certifications required for the intended application, while also ensuring a high-quality, aesthetically pleasing finished product that meets commercial expectations. Our rigorous silicone testing procedures are in place to guarantee the unparalleled quality of every product we produce.
Scalable medical device manufacturing
Romar has established itself as a prominent leader in the advanced design and manufacturing of medical devices and aids. Our dedicated biomedical engineering team leverages cutting-edge technology and premium materials, all within our state-of-the-art manufacturing facilities, including our class 8 clean room.
At Romar, we possess expertise in the scalability of medical device design and production, extending our influence on national and international fronts. Romar is a recognised authority in material selection and has an in-depth comprehension of the FDA’s case study approval process.
Scalability is inherently integrated into our processes from the very outset, and our experience and expertise with silicone manufacturing integrates into our medical device manufacturing processes, adding additional layers to Romar’s end-to-end product development capabilities.
A broad range of silicone applications
Romar’s capability in silicone manufacturing encompasses a broad spectrum of silicone applications, which include:
- Precision silicone mold crafting and custom silicone molds
- Silicone O-rings
- Medical-grade silicone
- Silicone sheets
- High-temperature silicone and heat-resistant silicone
- Food-grade silicone
- Industrial-grade silicone
- Silicone overmoulding
Our commitment extends beyond mere manufacturing: we offer an all-encompassing solution, addressing every facet of the manufacturing process, from initial design to the final stages of packaging and delivery.
An end-to-end solution
Our specialisation lies in bringing your innovative concepts to life. We oversee every phase of the intricate process, beginning with design and material selection, advancing to scalable manufacturing and concluding with seamless shipping.
Our team members are seasoned process experts, and when you initiate collaboration with Romar for your medical device or component, we transform your initial idea into an orchestrated process, encompassing device molding, assembly and final packaging.
In our commitment to ensuring your product’s adherence to regulatory procedures, Romar constructs a comprehensive technical file. To begin, our biomedical engineering team assembles the Design History File, consolidating all design inputs, design outputs documentation and testing analyses.
Next, our team compiles the Device Master Record, offering an intricate insight into the manufacturing process. This document comprises indispensable elements such as work instructions, bills of materials, quality control and assurance plans, and specifications, including packaging and labelling. The combination of the Design History File and Device Master Record guarantees that the medical device complies with all requisite regulatory standards.
We create a design validation process, a pivotal step in guaranteeing that the device fulfils its intended purpose. From inception, Romar takes a proactive approach by crafting clinical and user-need validation protocols. We meticulously devise these to ensure that the product aligns seamlessly with the requirements of clinicians and the ultimate end-users, the patients.
Upon the successful completion of bench testing, confirming the product’s safety, next is substantiating that it caters to the end-users’ needs. This necessitates generating clinical evidence, typically through human trials or a comprehensive collection of documented proof, substantiating the product’s safety and effectiveness.
Romar’s prowess in design validation represents a fundamental and invaluable service for the global medical device manufacturing community.
Our qualified and experienced experts in our team are known for their unwavering attention to detail. At Romar we are ready and equipped to empower your vision. When you are prepared to engage with top-tier biomedical engineers and experts who have access to premier facilities in Australia, reach out to Romar for a comprehensive and adaptable medical device manufacturing solution.
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