Have you ever hear the saying 'if you want something doing, do it yourself'?
Meet Aadil Diwan, the co-founder and CTO of SafKan Healthcare - he's a perfect proponent of that philosophy. He was 13 years old when ear wax impactions in his left ear would begin to see him join the 12 million Americans regularly in a clinical practice with a syringe sticking out of his head. A painful process, he recalls. A messy one too.
“Fast forward ten years and I’m a biomedical engineer,” Aadil picks up the story. “So, we,” that’s him and his brother, CEO Sahil, “set out to improve this procedure and we did so by combining the irrigation, which is what a primary care physician will do, with micro-suction, which is what an ENT specialist will do. And we wanted to make this a hands- off automated procedure. Designing this device like a pair of headphones accomplished that.”
The wacky idea to invent a pair of ear- cleansing headphones won SafKan the Protolabs' Cool Idea! Award, thus earning the company a grant to turn conception into real-life product. In their endeavour to do that, Aadil and Sahil have utilised an in-house Formlabs Form 2 and Protolabs' 3D Systems equipment to validate their design, prototyping the ear pads, casing, and the four containers that hold the solution and waste, in an ABS-like material. The tips were printed in a soft flexible material, while the top head strap was CNC machined in ABS for added strength.
Design locked down for manufacture, SafKan’s OtoSet headphones, from across a room at least, look like a standard pair of designer headphones. But rather than firing one’s guiltiest of pleasures deep into the eardrums, they are instead soothing the wearer with a cocktail of room temperature water and hydrogen peroxide or saline. This solution is held in the top containers of the ear pads, while the waste is pulled into the bottom containers, which are to be disposed of along with the tips. In between, the irrigation is directed at the walls of the ear canal to dislodge wax wherever it is located, before continuous suction then withdraws the outpour liquid and wax. This is all independent of a healthcare assistant who, oftentimes, isn’t trained to perform the traditional procedure, which itself isn't even the most productive method, per SafKan.
“[Using a syringe] is difficult because it’s a blind procedure,” explains Sahil. “You don’t really know where the wax is inside of the ear and you’re shooting a jet stream straight in the eardrum which has a high complication rate. We wanted to take those big risk factors out and a pair of headphones allows you to do that. We’re the experts at cleaning ears so we’ve put all that research into the design of the tip and how the firmware operates with the pulse irrigation married with continuous suction.”
One cycle of this automated procedure lasts roughly 35 seconds. Aadil says he used to be in the clinician’s for up to 30 minutes. He’s hoping to return to those practices to sell his alternative, new-tech method.
SafKan is currently going through the FDA clearance process and is hoping to start taking orders within the next six months – a wish list of physicians for its beta programme has already been drawn up. The company is a beneficiary of new- tech methods too, pointing to 3D printing, and with it the support of Protolabs and guidance of an eight-strong advisory team of clinicians, as to how the company is in this position after just two and a half years. The plan is to supply OtoSet directly to consumers in the long-term, which means, for now at least, injection moulding will be called upon to produce one-size-fits-all devices at big scales with medical-grade plastic.
But with 3D printing technology continuing to develop and the company conceding everybody’s ears are different, that mightn’t always be the case.
“We’re starting with one standard size, similar to how an otoscope has a standard size for adults and children, but we’ve seen a lot of other companies focus on personalisation and customisation. It’s something we’re open to and something we’ll have to figure out,” says Sahil.
“I think at some point we’re going to see a tipping point where we would be able to do production 3D printing,” Aadil offers.
