What To Know
- 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 normally take 12 to 18 months by any other standard.
- HTEC’s deep understanding the 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,” stated Sava Marinkovich, Head of HealthTech at HTEC Group.
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. 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 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 normally 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. HTEC’s deep understanding the 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,” stated Sava Marinkovich, Head of HealthTech at HTEC Group.
Karina Candrian, CEO of Effectum Medical, said:
“The project with DBI and HTECH is a great proof of our vision, ‘We make innovation happen!’ With our regulatory expertise and the quality management system as 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 CE mark.”
Christian Zwicky, Chief Executive Officer at Deep Breath Intelligence, emphasized that this is a major milestone for DBI, as a startup that has invested so much in researching and developing this revolutionary method: “This initiative is a critical step in our mission to broaden the range of medical application 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 CE mark, accomplish this project on time and within the targeted budget.”