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 biggest challenge for healthcare innovators, whether they are manufacturers of new medical devices, advanced physicians with the support of hospitals, and even large established companies, is meeting the regulatory framework. In other industries, the two main functions in companies are technological on the one hand, and marketing on the other, while in healthcare the regulatory function is actually more important than the first two. At DIH.HealthDay.si, we tackled the challenge in 2019, and this workshop will be an important step forward for all companies that want to meet all requirements as quickly and efficiently as possible and then successfully enter hospitals, health centers and pharmacies. At this workshop we present an exceptional set of speakers:
This workshop is intended for companies registered in DIH.HealthDay.si, but we also accept unregistered guests, especially foreign. For more information or suggestions on cooperation write to email@example.com.
20.5., From 9 am to 11 am CET, on zoom, apply here.
Presentations will be held in English, round table discussion in Slovenian.
9:00 Welcome address: Mojca Cvirn, HealthDay.si and Jakob Gajšek, LUI
9:05 Mateja Urlep, TikhePharma & Think Tank HealthDay.si: Roadmap from innovation to patients, case: Slovenia
9:20 Igor Rogelj, ArrowFast by Cosylab, new partner of HealthDay.si: Go to market with medical device, roadmap
10:00 Round table with Q&A:
Moderated by Mojca Cvirn, HealthDay.si
10:30 Q&A with companies and innovators
Follow up of HealthDay.si and partners with companies and innovators after the webinar.
You are welcome to participate in other DIH.HealthDay.si workshops in collaboration with LUI.
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.
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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