Insights / HTEC News / Deep Breath Intelligence Teams with HTEC Group and Effectum Medical to Accelerate the Launch of CE-marked Device under IVDD


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Deep Breath Intelligence Teams with HTEC Group and Effectum Medical to Accelerate the Launch of CE-marked Device under IVDD

Deep Breath Intelligence (DBI), a MedTech company unleashing the huge potential of exhaled breath analysis through machine learning, has selected HTEC Group and Effectum Medical as primary innovation facilitators to help them achieve greater speed in meeting both software and documentation requirements to ensure IVDD compliance of their medical software, DBI-EPIbreath®.  DBI-EPIbreath® is a unique easy-to-apply breath test that can provide reliable estimates of circulating concentrations of the antiseizure medication valproic acid to aid patient management. Fast diagnosis and quick medication decisions are essential for epileptic seizure control. Standard therapeutic drug monitoring (TDM) approaches are based on measuring drug concentrations in plasma or serum, but this has limitations and can take several days to turn around results. DBI-EPIbreath® is the first non-invasive test, CE-marked under IVDD, that allows real-time measurement of the total and free concentrations of valproic acid in a breath sample, delivering results in just 10 minutes. 

Considering a very strict regulatory deadline that Deep Breath Intelligence had to meet to make DBI-EPIbreath® compliant, they approached HTEC to help them speed up their product launch considering the regulatory requirements of IVDD in conjunction with Effectum Medical AG, the official legal manufacturer of the medical device. Effectum Medical gathered a team of professionals with extensive regulatory and compliance domain knowledge to help HTEC to meet the regulatory requirements for medical device software development and DBI to achieve product launch in a record time of just 6 months, which would typically take 12 to 18 months by any other standard.

Every medical venture or initiative would like a speedy launch, but only the right skill set and partnership with a client can deliver. It requires teams that work well together, understand regulatory expectations and demands, and deliver in a way that aligns with product-market fit. HTEC’s deep understanding of MedTech space and unique approach to determining a direct-line path to getting a market-oriented medical product certified was mission-critical in the process of accelerating the launch of this revolutionary medical device. This success is a testimony to HTEC’s ability to develop innovative and life-changing medical software and hardware products that enable faster innovation in a healthcare space.

Sava Marinkovich

Head of HealthTech at HTEC Group

The project with DBI and HTEC is great proof of Effectum Medical’s vision “We make innovation happen!” In everything we do, the focus is on the entrepreneur and the innovative medical device product. Our mission is to accelerate market access for start-ups to save time and money, which are both critical factors for their success. With our regulatory expertise and the quality management system as a service, we are the ideal sparring partner to avoid typical pitfalls on the way of product development and regulatory approval. Within an incredibly short time we achieved the CE mark and enabled a perfect interaction between the three key stakeholders – DBI as the innovator, HTEC as the software supplier and Effectum Medical as the legal manufacturer. We are proud that DBI has chosen us as its legal manufacturer. Our joint journey continues and we will ensure their compliance with our lean post-launch processes.

– Karina Candrian

CEO of Effectum Medical

This is a major milestone for us as a start-up that has invested more than 45 years in researching and developing this revolutionary method. And this is only the start. This initiative is a critical step in our mission to broaden the range of medical applications for early disease testing in the years to come. We really enjoyed the close and professional collaboration with Effectum Medical and the HTEC team, which allowed us to identify early critical topics for the CE mark, and accomplish this project on time and within the targeted budget.

– Christian Zwicky

Chief Executive Officer at Deep Breath Intelligence

HTEC, Effectum Medical, and DBI will continue to collaborate on future projects with the ambition to develop a broad range of products in different disease areas to take precision medicine to the next level and improve people’s health. 

About Deep Breath Intelligence 

Deep Breath Intelligence is a MedTech company unleashing the huge potential of analyzing exhaled breath by applying machine learning algorithms. They provide non-invasive solutions for the early diagnosis of diseases and therapeutic drug monitoring – enabling better treatment by precision medicine. Their first product, DBI-EPIbreath®, is a test for drug monitoring in epilepsy which is CE-certified under IVDD. They are working hard on developing a broad range of products in different disease areas to take future precision medicine to the next level and improve people’s health. 

About HTEC Group 

HTEC Group is a global digital product development and engineering services firm powering the technological evolution of the world’s most impactful organizations – from disruptive start-ups to Fortune 500 companies. Founded in 2008 in Belgrade, Serbia, the company is now headquartered in San Francisco, with more than 2,000 experts spread across the traditional engineering hotspots of Central and Southeast Europe and consulting, innovation, and product design offices in Silicon Valley, New York, and London. With the highest level of expertise and extensive experience in a multitude of business domains – including Healthcare, Retail, Transportation and Smart Mobility, Logistics, FinTech, Green Energy, Media, and Deep Technology – HTEC is both an ideal technology partner for its clients and the ultimate growth platform for its employees. 

About Effectum Medical 

Effectum Medical is a Swiss leading MedTech service partner that accelerates time to market by offering an outsourced quality management system to “buy or rent”. Innovators can trust in a thoroughly audited and certified infrastructure to gain speed and significantly reduce costs. A team of Medical Device Experts combines hands-on support with state-of-the-art advice to make product development a success. The vision “We make innovation happen!” comes true by supporting start-ups, medical doctors, SMEs and international pharmaceutical companies or suppliers on their MedTech venture. In addition, Effectum Medical collaborates with leading Swiss and European Healthcare incubators and accelerators as coaches, judges, and experts. 


To learn more about how we help medical companies drive innovation in the Healthtech space, reach out to one of our health experts. They are always ready to explore new opportunities how we can leverage the power of technology to provide better health outcomes for all, together.