Medical Device Manufacturing Articles

Scalable medical device manufacturing requires advanced manufacturing facilities, leading material experts and a proven 360-degree solution process. Romar has been at the pointy end of delivering manufacturing solutions for some of the most innovative medical devices in circulation today.

There are multiple factors that make medical devices a highly complex strand of manufacturing, from stringent government regulations and Standards to technology and materials selection. Here are four key ways that Romar Engineering overcomes the complexities of medical devices manufacturing to provide expert, innovative, robust and scalable manufacturing solutions.

Romar Engineering is delighted to once more be part of an award-winning program, as the manufacturing partner for Rapid Repair, a medical device developed by Southern Cross University’s Dr Rosemary Craig and Dr Nedeljka Rosic, with business partner Gerard Criss. This innovative wound healing technology may soon be elevated into orbit, thanks to an incredible win at NASA’s global iTech competition.

The medical industry is just one sector exploring advanced manufacturing techniques to enable faster and more cost-effective medical device manufacturing… and innovative solutions. With longstanding and broad expertise, Romar has robust capability for customised, commercially viable and compliant medical advanced manufacturing for diverse applications.

As a leader in manufacturing, Romar benefits from cutting-edge technology and facilities – and fruitful collaborations with national partners. Most recently, we were invited to join the NOTUS Emergency Invasive Ventilator Program, a Grey Innovation led initiative supported by the Australian Government, Victorian Government and Advanced Manufacturing Growth Centre.

In June this year we reported that we were working with Australian company BioAnalytics on a new device for sleep apnoea sufferers. We’re delighted to announce that BioAnalytics is commencing a six-month clinical trial for FDA certification. We worked closely with BioAnayltics through initial development and will continue to be involved at every step of production.

Earlier this year we brought you news that we were working with US company Madorra on a potentially life-changing medical device. We’re thrilled to announce that Madorra has moved to the next phase of development and commenced human trials in Australia. Romar is a global leader in medical device manufacturing and medical-grade silicone, so we were an ideal fit for Madorra.

In recent years, Romar Engineering has established itself as a leader in the contract manufacture of medical devices. We are very proud to be developing international partnerships with expert medical device companies and product owners from all over the globe, who seek out our expertise in silicone, plastic molding, micromolding and specialist medical device manufacturing.

BIOMEDevice brings together industry leaders and experts in medical device design and manufacturing. It is the premiere event for Silicon Valley’s thriving medical device manufacturing community. Attendees learn about the latest developments, trends, and technological breakthroughs in the industry. We recently attended this important event, and here’s what we discovered.