Solopep bringing to market a disposable airway clearance device

Kevin J O’Sullivan admits he’s a bit obsessed with medical device design. It has been his life for over 10 years, and during that time he has had four patents granted, including one for a loading system for prosthetic heart valves and another for use in interventional cardiology. Three more are currently under review.

O’Sullivan has a BSc in product design and technology and an MSc in usability testing of medical devices. What fascinates him most about the subject is the combination of design, biology, hard-core engineering and problem-solving involved.

Following his primary degree, O'Sullivan gained industry experience working with Medtronic Cardiovascular in Galway, and he has been a research fellow at the University of Limerick since 2012.

His latest role is as a co-founder with professors Leonard O'Sullivan and Colum Dunne of medical device startup Solopep, which has developed a break-through disposable airway clearance system for people with chronic obstructive pulmonary disease (COPD), bronchiectasis and cystic fibrosis (CF).

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Those suffering with respiratory disease often need help to remove excess secretions from their airways, and at the moment the main method used is an oscillating positive expiratory pressure or OPEP device. It helps to loosen mucus and make it easier for secretions to be coughed up.

“The issue with these devices is that they require a very rigorous daily cleaning regime, and even with this regime they can still act as reservoirs for pathogenic organisms that can potentially reinfect patients after treatment with antibiotics,” says O’Sullivan.

“We have developed a range of disposable devices – there is currently no other disposable offering on the market – that provide exactly the same mechanical performance as existing systems but in the smallest form available. This allows patients to carry out airway clearance discreetly whenever and wherever they need to.

“Solopep is particularly suitable for short-term use – in acute settings or if someone wanted to go on holidays, for example, and not have to bring all their normal washing gear with them.

“The devices currently in use cost around €75 each, which makes them very expensive for short-term use, to treat chest infections for example. We’re still working on our pricing, but the ballpark figure will be €2-€2.50 per device.”

Discolouration

The idea for Solopep's product was triggered by an observant CF patient in University Hospital Limerick, who noticed a discolouration in their OPEP device that turned out to be caused by a potentially harmful bug. This led to a collaborative effort between University Hospital Limerick and the graduate entry medical school and school of design at the University of Limerick to examine and try to address the risks posed by reusable OPEP devices.

“There is really good co-operation between the hospital, the medical school and the school of design, and that’s how I became involved,” O’Sullivan says.

"We started looking at this problem in mid-2016, and I came up with a prototype which then allowed us to apply for an Enterprise Ireland commercialisation fund grant to take things to the next stage.

“We subsequently developed out the design, secured our patent and ran two Health Products Regulatory Authority-approved clinical studies with COPD and CF patients which finished up around Christmas last year and confirmed that our device is as effective as existing systems in maintaining pulmonary function.

“Solopep solves two distinct problems: It ensures that there is zero chance of reinfection from poorly cleaned devices and it removes the burden of daily, or in some cases twice daily, cleaning which takes about 20 minutes per cycle after only 10-20 minutes of use,” says O’Sullivan. “We believe that Solopep will open the market for OPEP devices for short term or transient use where this is not currently economically viable.”

He says the need for cost-effective airway clearance is a worldwide problem with an estimated value of around $2 billion when all of those with respiratory illnesses are included. For example, over 550 million people alone suffer from COPD.

Spun out

Solopep was set up in August 2018, and the company has recently been spun out from the University of Limerick. Investment to date has been in the order of €500,000, and the product was soft launched earlier this June at the European Cystic Fibrosis Society conference. The official European launch is set for Q1 of 2020. The device will be made in Ireland, and its manufacturer is becoming an investor in the business.

“At the moment we have just three employees in the company but we are in the process of building up inventory and by Christmas we will be recruiting for new roles in sales, administration and business development,” says O’Sullivan, who is the company’s CTO.

"We're not in a hurry to get further investment right now as we're more interested in finding the right investor and right distribution channels for the product. I cut my teeth selling suits to farmers in Sean Hussey Menswear in Tralee through school and college so I don't have a problem exercising my commercial skills, but truthfully I'd prefer to stay in a technical role and get on with working on our product pipeline."

While the company has chosen to launch with the airway clearance device, O’Sullivan says this is only the start, and that moving into allied areas, such as nebuliser devices, actually represents a much bigger market opportunity for the company.

“We have at least three other ideas in train and they are even more exciting and challenging because they are more exacting from a clinical viewpoint.”

Infringements

Patents take time and money to acquire, and one of the big problems for small companies is not having sufficient resources to fight infringements. However, O’Sullivan takes the view that despite this potential drawback they are absolutely worth having.

“We’re fortunate in being familiar with the patenting process because it’s something we do a lot at third level, so it’s not the big deal for us it might be for someone else.

“Of course, in theory a bigger company with plenty of money could reverse engineer our device if they really wanted to, but that’s the glass-half-empty approach. I prefer the glass-half-full one that lives with the fear and still goes for it, not least because the patent is an external validation of novelty and that’s huge and really important.

“In our case we’re also fortunate to have the backing of the university and of our OEM [original equipment manufacturer], and the benefit of cool and experienced heads who’ve been through all of this before.”