Recording of 1st DIH.HealthDay.si webinar 2020

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The biggest challenge awaiting startups in healthcare is how to meet the regulatory requirements. Startup companies generally do not possess the systems and knowledge to manage the entire development process within regulatory frameworks. Typical time-to-market for a medical device is 3 to 5 years, while it can be even longer for bio innovations or new drugs.

The webinar was organised by EIT Health (LUI) and HealthDay.si and featured:

  • Mateja Urlep, author of the Guidelines for the Inclusion of Innovations in the Slovenian Health System (book in the making), and president of the Think Tank DIH.HealthDay.si

  • Igor Rogelj and Diego Casadei of ArrowFast, Cosylab's new special unit to help innovators in the field of medical devices, also a new partner of HealthDay.si

  • representatives of Slovenian health insurance companies on the new reality of digital healthcare (not recorded)

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Mateja Urlep, TikhePharma, Think Tank HealthDay.si

She is the “mother of biosimilar drugs” - a key role in designing specific EMA and FDA regulations and introducing these drugs into clinical practice in the EU and the US as a global manager in Sandoz. At the same time, she is the mother of Lek's Biopharmaceuticals in Mengeš. Adviser to global companies in introducing innovations in health care.

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Igor Rogelj is the Head of ArrowFast Medical Device Engineering, a Swiss-based group formed within Cosylab d.d. Over his 25-year long career, he has built his business development and B2B marketing profile in high-tech startups that went to market with specialized niche products, especially in the MedTech industry. Igor is also one of the owners and directors in Plasmait Group – a machine builder for medical and other industries.

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Diego Casadei is the General Manger of Cosylab Switzerland, which he joined in 2018 after 20 years of research in the field of particle and radiation detectors for space (AMS-01, AMS-02, SolarOrbiter/STIX, MiSolFA) and underground (ATLAS at the CERN LHC) experiments. He has long experience in project management, system engineering, and quality management. Within Cosylab worldwide, he is running an initiative to support startups moving from proof-of-concept to first product and promotes the ArrowFast initiative to provide dedicated support for medical device development and certification with top priority.

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