A device to streamline grommet insertion during ENT surgery
Olive O'Driscoll, CEO AventaMed
What is your idea?
Our product is a hand-held medical device to streamline the placement of grommets in the ear-drum during ENT surgery, thereby reducing operating times and potentially eliminating the need for general anaesthetic.
What problem are you solving and what is innovative about your approach?
Children are particularly prone to inflammation of the middle ear, which results in pain and fluid build-up in the inner middle ear.
To help treat chronic inner middle-ear inflammation in susceptible children, grommets (tympanostomy tubes) can be surgically implanted into the ear-drum, providing an ‘escape route’ for the fluid to drain out.
Grommet surgery is the most common surgery in children, with around 2 million placements surgeries are carried out each year in adults and children in the US and Europe.
The surgeon typically uses several surgical implements and typically needs the support of several theatre staff to carry out the procedure and the patient is under a general anaesthetic, which carries its own small but appreciable risk.
Precision is important: if the incision is too big, the grommet can fall out too early, and if the incision is too small the surgeon has to go back in and make it bigger.
Our hand-held device gets the grommet into the ear-drum first time, every time. The grommet deploys precisely in about one second, thereby reducing surgery times and, in adults and compliant children, potentially avoiding the need for a general anaesthetic.
What’s the backstory here and how did you get involved?
Both myself and AventaMed co-founder and CTO John Vaughan are based at the Medical Engineering Design and Innovation Centre (MEDIC) in Cork Institute of Technology, where we look for clinical problems in need of a solution.
We were observing ENT surgeries and we thought there has to be a better way to place these tiny grommets, which are about the size of half a grain of rice.
With funding from Enterprise Ireland we surveyed the market and saw that there was a huge clinical opportunity here and a niche in the IP landscape to address it.
Both John and I have experience in designing products and medical devices, bringing them through clinical trials and getting regulatory approval.
We designed and prototyped our device in CIT and we worked with surgeons in Ireland, the UK, Europe and the US to refine the design and test its usability.
Highly successful cadaver trials gave us confidence that the device works, and we are moving into first-in-man trials.
How is this idea commercially attractive?
Our product addresses a massive clinical need in ENT surgery. Around 2 million grommet placement operations are carried out in Europe and the US every year, and we estimate the market is worth more than $5 billion annually.
From the outset we have worked with surgeons to ensure the device is user friendly, useful, and our development process complies with ISO 13458, the highest standard for medical device development.
Trials to date show that our single-use device is both easy to handle and effective. Our novel device is patent-protected and licensed from CIT.
We plan to receive CE-mark and FDA approval to market our device to ENT clinics and surgeons who want to reduce the complications and time involved in grommet placement.
Revenue will be based on sales of the device, which is single-use per patient.
What are you looking for at the Big Ideas event?
We are currently fundraising for investment to meet ambitious clinical milestones, and we are also interested in meeting potential sales partners for our product.