After playing many different roles in the SleepTech® industry, Ciaran McCourt is now the CEO of Belgium-based Ectosense, a health-tech startup with a new sleep diagnostic tool. NSF caught up with Ciaran to hear more about how Ectosense is launching its new product.
NSF: SleepTech is evolving rapidly. In the last few years we’ve seen a lot of interest in innovating the diagnostic space. Where does Ectosense fit?
Ciaran: I believe NightOwl® is a breakthrough device in this product category. No other device can match our combination of convenience, efficacy, cost and clinical accuracy. Our team focused on optimizing sensors and algorithms to deliver a highly accurate Home Sleep Test leveraging smart mobile technology (e.g. bluetooth and cloud analytics) with strong design appeal delivered cost effectively. Bringing this all together, validating it is no easy or inexpensive matter but the result the team has delivered is truly outstanding and changes the paradigm of home sleep testing. As one customer said ‘it is a game changer’!
NSF: Ciaran, you’ve had some interesting history with SleepTech. How’d you get together with Ectosense?
Ciaran: I have been lucky to be involved in a few startups in health tech and sleep medical devices. I also had a global role in ResMed and a recent role with SleepMed, one of the largest sleep diagnostics services companies in the US. That combination of experience meant that when I happened upon Ectosense there was a great synergy. I have always been on the lookout for new startup sleep technology ventures. At Ectosense, I found a great young team with a superb product and I knew I could help accelerate the necessary partnership discussions immediately. I could immediately see huge potential in bringing this device to market globally given its innovative qualities. My role is to manage the team and strategy as we scale up, create early revenues from device deployment and services and build out the correct business model through partnerships for longer term business growth. It is a very exciting opportunity.
NSF: How does Ectosense plan to enter the diagnostic market in the US and Europe? Is there one or multiple strategies?
Ciaran: We focus on three pillars. These pillars help us in our mission to be seen not just as a medical device company, but also a services company. The three pillars are product deployment, services, and capabilities. Our European deployment aim is to primary care physicians, sleep clinics, dental providers, hospitals and insurers in Europe. In the US we will initially aim at partnering and we have identified a number of players who wish to work with us. We are making significant strides in European markets with a service model, given our cost effectiveness and convenience for the patient, combined with the high clinical validation. As far as capabilities go, we develop advanced algorithmic processing of (biomedical) signals from raw data to actionable insights including PPG and others. We wish to leverage this experience and anticipate developing other devices to broaden our range
NSF: What challenges and lessons learned have you experienced as you work through the process of obtaining medical device certification and validation?
Ciaran: As of now we have secured our CE mark as a medical device Class 1 and Class 2a (for our software) in Europe and the process has been fair and efficient. We are now working on our 510k submission for the US and expect to have approval Q4 2018 or Q1 2019. The key was our team focusing on our quality management system from the very beginning and they documentation superbly ensuring a smooth application process. As we look towards new markets, we will face new challenges and we will rely on the help of some of our key advisors to overcome those.
NSF: How is Ectosense spreading the word about its new product?
Ciaran: We are working through our partner network. In the US we are building interest through diagnostic testing facilities, as well as the academic and clinical community. We also just published our first clinical study which we expect to see shortly in the Journal of Clinical Sleep Medicine. Given the novelty of our device we have received a good amount of natural curiosity and media attention and have gotten some television coverage in Belgium and France.
NSF: How have you seen the world of SleepTech change over the past few years?
Ciaran: Clearly, we are just at the beginning of personalized digital health and personal technology such as smart phones will play an important role as we move forward. We are arguably the first medical sleep diagnostic device that has embraced this but we certainly will not be the last! Over the past few years, we’ve seen an increasing number of articles on sleep in the national media, as well as an explosion of sleep devices and apps. Digital health is gaining more and more recognition. While awareness about sleep and its relationship to overall health is growing rapidly, challenges do remain. For example, awareness of obstructive sleep apnea is still relatively low across the patient population.
NSF: Why are you involved with NSF’s SleepTech group?
Ciaran: I am a part of the SleepTech program because I am interested in the cross over between consumer and medical sleep devices. As a wearable medical device company, Ectosense needs to be aware of developments in sleep technology as it continues to evolve.