| Workshop from Garage to Market |
Tuesday, 12 May | 13:00 - 17:00
Registration required. € 80.00 additional fee applies.
The Workshop will provide a comprehensive learning experience on how to set up your mHealth business and lead it to market success. It will adopt the perspective of mHealth app and device developers and will consist of 2 parts.
The first part will show pathways to approval in the European Union, as well as in the US.
The Workshop will provide a comprehensive learning experience on how to set up your mHealth business and lead it to market success. It will adopt the perspective of mHealth app and device developers and will consist of 2 parts.
The first part will show pathways to approval in the European Union, as well as in the US.
Renowned experts on EU and FDA regulation and policies will show a number of examples and case studies. They will provide guidance on how different regulatory items may be successfully interpreted and dealt with. Amongst others, the following items are addressed and enhance participants’ knowledge:
• Understanding Intended Use and device / app definition
• Which apps do FDA and the EU regulate and what about hardware?
• The Clinical Decision Support (CDS) conundrum
• Privacy and data protection requirements
• Path forward for device and app developers
This part of the workshop will include panel discussions and case studies in order to make it as hands-on and interactive as possible for participants.
The second part of the session will examine and discuss how to create sustainable mHealth commercial cases which meet the needs of patients, clinicians and providers.
Participants will learn from successful start-ups how they managed to build and steer their business through turbulent times.
Speakers and panelists will be assembled from each of the stakeholder groups and address questions such as:
• What are the right business partnerships and how to find them?
• How to select the right market drivers and enablers within the healthcare ecosystem?
• How to deal with structural issues such as reimbursement, safety regulations or care processes?
• How to identify the sweet spot of consumers and patients?
• How to create a sustainable business case?
The overall objective of the workshop is to enable participants to develop successful go-to-market and business development strategies, including legal requirements and implications.
