An international partnership making a new medical device a reality.
Romar is well established as a contract manufacturer in the medical device space. International companies seek us out again and again because of our expertise in silicone molding and micromolding. Our case studies and reputation speak for themselves.
We recently partnered with an exciting medical device company in the US called Madorra. Their new product aims to change the lives of women, in particular those who are post-menopausal and breast cancer survivors. Romar is currently working with Madorra to develop the volume manufacturing process for the disposable gel element for this product.
The Madorra Product
Madorra is a women’s health device to treat extreme vaginal dryness. The company’s aim is to give post-menopausal women and breast cancer survivors the power to choose a non-hormonal treatment option.
Previously women only had pharmaceutical solutions on offer. Madorra is currently in the design and development phase. The projected outcome is that patients will use the Madorra Therapy System daily in the privacy of their own home. The device is intended to drive the body to deliver its natural lubrication without harsh medication. Its non-invasive, non-hormonal and non-stimulating.
The Madorra and Romar match, how did it happen?
Seeking Investment in Australia
Madorra discovered Romar through contacts while raising a round of funding in Australia.
One of Madorra’s meetings was with an Australian venture fund called OneVentures.
OneVentures turned out to be the perfect investment match for Madorra because of their newly established $170M Healthcare Fund III.
This Fund invests in therapeutics, devices and diagnostics at or near clinical development.
The Commonwealth Government’s Biomedical Translation Fund (BTF) contributes to this Fund, with aim of Australia becoming a centre of excellence in the medical device space. Madorra’s technology excited OneVentures. They went about ensuring that Australia learnt as much as possible from this new product. Madorra will spend some of this investment money on development work in Australia.
Finding a Commercially Viable Manufacturer with Silicone Expertise
Currently in the US, Madorra makes their product by hand using a small assembly line to support development experiments.
They sought a company with silicone molding and micromolding expertise, who can also scale up production as needed.
OneVentures trusted Romar as a contract manufacturer of medical devices in Australia and introduced Madorra to them.
Madorra’s COO, Stephanie Kaplan, met with Romar and visited our facilities in early 2018.
Right away, she knew this was going to be the ideal partnership.
“My very first impression of Romar was that these guys can do it and they’ll knock it out of the ball park. There won’t be a lot of fanfare, they will just do a great job for us”
Stephanie initially met with Alan Lipman, Carlo Cartini and Romar’s technical team.
For her, the decision was easy.
The team impressed her with their breadth of knowledge across all things ‘squishy’ (silicones and rubber) and their full understanding of how to work with different materials. This was vital because Madorra’s disposable element is gel, which is notoriously hard to work with.
“I was impressed that they were low-key about their accomplishments and experience. They were down to earth and really only told us what we wanted to know. They have a quiet confidence in themselves.”
The experience so far...
The first brainstorming session – “Let’s do this, let’s do this together”
Madorra and Romar’s first brainstorming session was a teleconference. Madorra came prepared with a variety of solutions for the volume manufacture of the disposable component.
Romar came with one solution, a solution they knew would work and be cost effective. To say that the Madorra team were impressed would be an understatement…
Developing the process together in Australia
Stephanie travelled to Australia again in December 2018 to test out the manufacturing process with Romar. She spent several days at Romar’s offices working through each step of the process with their technical team.
This trip left her confident that Romar would manufacture the Madorra product to a high quality. She now had a solid partner in Romar who offered clear and honest communication.
“It felt like we had been working together for a thousand years. We all made suggestions at one point that didn’t work…we all laughed and moved on. It gave us that sense that if something goes wrong there will not be any hiding. We will brainstorm together to get back on track”
What does the future hold?
Madorra intends to run its first clinical trial in Australia for about 12 months. They will then run a larger trial in the US likely with half the patients in Australia. Romar will supply the product’s disposable element for the duration of the trial.
After the trial, who knows what the future may hold for this product? We predict great things for this life-changing product. Romar is able to increase production capacity as necessary to meet demand.
“ I feel like we are one company, we just happen to be on opposite sides of the Pacific”
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.