News
08/07/2025
Innovation Sprint
Q&A #1
Navigating MDR and Digital Health Innovation
We are excited to launch the first edition of our Q&A Series, where we speak with pioneering medtech and digital health companies about their product development and regulatory journeys. For this inaugural feature, we sat down with Sofoklis Kyriazakos, founder and CEO of Innovation Sprint, the creators of Healthentia, a certified software medical device (SaMD) designed for remote patient monitoring and digital coaching of patients with chronic conditions. Their story offers real insight into the challenges of scaling a research tool into a fully compliant, high-performing medical device under the EU MDR.
From early regulatory planning to achieving Class IIa certification, Sofoklis shares how they’ve balanced innovation with compliance, alongside COVARTIM’s technical and regulatory support every step of the way.
Sofoklis Kyriazakos
Can you describe your technology in simple terms and what makes it unique?
Healthentia is a certified software medical device that helps monitor and coach patients with chronic conditions remotely. Patients use a mobile app to report symptoms, receive lifestyle guidance, and sync data from wearables, while healthcare professionals monitor their condition through a clinical dashboard.
What makes Healthentia unique is its ability to combine validated medical logic with virtual coaching support. Healthentia does not just collect data; it helps patients act on it. The platform bridges clinical research and real-world care, offering both medical-grade compliance and personalized coaching.
What were some of the biggest technical challenges you've overcome so far?
One of the biggest challenges was transforming a research-oriented ePRO tool into a fully compliant SaMD under the MDR. That meant redesigning our architecture, enhancing data privacy and security protocols, and ensuring traceability across multiple system layers.
Another major effort was to operate as a medical device software and continuously updating the platform to meet demanding requirements to reach the highest levels of usability and performance. Balancing innovation with compliance was - and still is - a complex challenge.
At what stage did you begin thinking about regulatory strategy, and why?
We started thinking about regulatory strategy early - around 2018 - when we realized our technology had the potential to move beyond research use and into real clinical care, but also the challenge of the MDR. That is when we decided to transition from an ePRO device to an MDD, and later on to MDR for Class IIa certification.
We knew that gaining clinical and market trust would require not only a functional product, but one that met the highest safety and performance standards. Early regulatory planning was key to making that vision achievable.
How has your partnership with COVARTIM supported your regulatory journey?
COVARTIM has been an essential partner throughout our MDR journey. From refining our quality system and reviewing documentation to performing gap analyses and supporting our FAHMP and MDR submission, they have brought structure and clarity to a highly complex process.
Their hands-on support and regulatory expertise helped us navigate the transition with confidence—and ultimately achieve Class IIa certification under MDR, a first in Belgium for this type of solution.
How are you building confidence among early adopters and clinical users?
We are doing this in three ways:
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Evidence: We generate clinical data and real-world evidence that demonstrate Healthentia’s safety, usability, and impact.
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Certification & Reimbursement: Our Class IIa MDR certification and reimbursement by RIZIV/INAMI serve as strong endorsements.
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Partnerships: We work closely with clinicians, pharma, and hospitals to co-develop features, ensuring the product fits seamlessly into real workflows. By aligning with both regulators and end users, we build trust from both sides of the equation.
Find out more
Discover how COVARTIM supported Innovation Sprint in bringing Healthentia to market, covering regulatory strategy, QMS implementation, and SaMD compliance. Read our case study.
