Digital atrial fibrillation (AF) screening and monitoring solution FibriCheck is facilitating better outcomes for AF patients, who suffer from this elusive condition that entails irregular heartbeat. The solution, developed by Qompium, allows patients to measure their heart rhythm via their smartphones or wearables. We had a chat with CEO Lars Grieten on the journey towards 350,000 users, the impact of Covid and what’s in the pipeline. This is a bonus piece in addition to our 2 part series (see part 1, part 2) for AF awareness month.
Summary
Ensuring scalability, physician trust and accuracy were 3 major challenges for FibriCheck.
Covid-19 has limited physician-patient contact. Physicians are now using FibriCheck to monitor patients, so they have actionable evidence in the next face-to-face or tele-consult.
Though the German DVG is a big step in the right direction, digital solutions need to position themselves appropriately in existing healthcare pathways for reimbursement.
Looking ahead, FibriCheck is investing into user customisation, integration into major wearables and linkage to hospital systems to alert physicians to high risk cases.
Atrial fibrillation is a competitive space, but also one where digital can make a big impact. What are the key challenges you face and how did you overcome them?
We faced 3 main challenges:
Scalability: How do you scale a new technology and get people to adopt it? From a technology perspective, we decided to use consumer devices as a technology platform to deliver our medical application instead of building our own medical hardware device. We use optical PPG sensors (photoplethysmogram sensor) to measure heart rhythm as they are easily available on smartphones which have 80% penetration (in developed countries).
The fact that we are a software and not a hardware company means that we are able to keep costs under control. We don’t have to set up a supply chain to deliver a single purpose hardware device. Instead we can deliver a healthcare benefit to a wider audience at far lower costs. Just to illustrate the idea, we have done a population screening of 65,000 users in under 48 hours and traditional studies have 2 to 3000 patients recruited in a year.
Trust: For adoption, we need doctors to perceive our technology as trustworthy. For us, it was all about knowing our position in the pathway. We do not claim to be something we are not - FibriCheck does not claim to be able to diagnose patients, but we help to triage patients and identify possible AF. This gives the doctor some data to already make a decision during the next consult. Doctors might use other patch-based solutions (that act like mini heart monitors) but they need information to know who to prescribe these solutions to, which is where we come in.
Accuracy: We invest a lot in generating clinical evidence to prove that our solution is accurate, be it by getting FDA clearance or showing equivalence to our competitors. This goes back to trust and having data to back it up.
Co-Founders of Qompium (Left to Right): Chief Technology Officer Kobe Leysen, Chief Operating Officer Bieke Van Gorp, our interviewee Chief Executive Officer Lars Grieten, Chief Quality Officer Jo Van der Auwera
How has the Covid-19 pandemic impacted your business?
During Covid, patients cannot make physical visits to their doctor as frequently. This means that doctors don’t have sufficient heart rhythm information to make clinical decisions. At first it started with a collaboration with a doctor in Maastricht University. His idea was this: He knows that he has a teleconsult next week, so this week he sends out an invitation to the patient to use FibriCheck, so that by next week he has information to make an actionable decision. It worked so well that within 2 months, we are onboarding more than 40 European Centres with 2,000 patients in this concept.
A user places his finger over the smartphone camera for 60 seconds. FibriCheck uses PPG sensors in smartphones to measure his heart rhythm.
User adoption is key to the success of a digital technology. How did you get 350,000 users onboard? Was there a lot of co-creation and user feedback sessions?
When we first started in 2014, doctors actually said we do not need this, everything we do is already fine as it is. Patients did not know what it was like to use a smartphone for AF. So, we had to start ourselves. Of course, we had iteration sessions with patients and doctors, but it did not radically change the concept.
Now we try to proactively do user feedback sessions twice a year and we have feedback forms integrated in our solution, so those also provide a good impression of what users think.
One very surprising piece of feedback we got from doctors – we need less data, keep it simple. Being a data-driven company, we have the urge to use data to prove the value of our solutions. But doctors were asking otherwise as they face a deluge of digital solutions.
For patients, we are now trying to customise our technology. The user experience of a 40-year-old would differ from a 70-year-old. Now that we have a substantial user base, large amounts of data and feedback, we are trying to optimise the user experience based on demographic profiles. With a 12 lead electrocardiogram (ECG) device, you build it and it sits in the office, but with a digital device you can evolve.
Germany has recently come up with the DVG, a reimbursement pathway for digital applications. What is your take on that and any concerns from the point of view of digital health companies?
The question for us is, for which indications should we get reimbursements? Attaining reimbursement of our technology on screening or diagnosis is very tricky because it involves a lot of health economics, acceptance in the guidelines and changing the usual practice. These are long term investments.
In German centres, FibriCheck is used very commonly for post-ablation monitoring. After an electrophysiologist does an ablation, he cannot prescribe a Holter to a patient. The patient is sent to the cardiologist and gets a Holter prescribed there. In our ideal pathway, electrophysiologists would directly prescribe FibriCheck for follow-up. This would simplify the pathway for the patient and avoids the need for a Holter by going first through their cardiologist. For electrophysiologists there are no existing codes to prescribe monitoring devices like Holters.
Having a good opportunity like DVG does not mean technologies are compatible with the way healthcare systems are organised, specifically in this narrow use case.
For now, we are taking a wait and see approach. But are reimbursement systems fit for the agility of digital? DVG is a big step in the right direction, at least you have a chance to prove your value in one year. But I think systems will evolve over time, even Payers and regulators are learning. But you need innovation in both the public sector (e.g. DVG) and private sector where economic competition drives innovation.
The team behind Qompium
So, what’s next for FibriCheck?
We are now working on 2 important advancements: the first is a background engine service connected to EMRs where you have risk profiling automated based on demographics, medical history and biomarkers. Patients with high risk are automatically invited to use FibriCheck, and in case possible AF is identified, they are referred to their doctor for further follow-up and clinical management.
This would allow you to scale relevant case-finding and significantly drop healthcare costs in the short and long-term. We are now testing this in 2 Belgium hospitals.
The second is a “diagnostics-as-a-service” model where the FibriCheck PPG algorithm will be made available for third party licensing.
First steps are taken by close collaborations with major wearables manufacturers to get our existing solution in there. This will unlock a significant number of users and data. For now, UK, Germany and Netherlands are our biggest markets. But digital innovation is taking off in Asia rapidly. The challenge there would be language, understanding the regulatory systems and how our intellectual property (IP) is protected.