At the EU level, there are also a number of good reasons for manufacturers of digital health solutions why entering the market in different ones can be advantageous. As an example, the Netherlands and Sweden are presented by Björn Ursing (PhD Senior Project Manager Life Science & Health, Embassy of the Kingdom of the Netherlands) in the second part of the workshop. Both countries have a high level of digital readiness in healthcare and have a good market size (read more). In addition, the procurement systems of the two countries differ. In Sweden, regions are responsible for procurement and use public tenders, while in the Netherlands, hospitals and insurers procure directly. Dual market entry allows companies to test their business models in two compatible but different markets.
The workshop is limited to three SMEs and is divided into two sessions. In the first session, the three SMEs will receive a two-hour introduction to multi-market entry of medical devices. In the second session, a 1:1 meeting (up to 30 minutes) can be arranged directly after the workshop if participants wish to ask confidential questions. A confidentiality agreement can be exchanged before each 1:1 conversation.
This workshop will include:
- System Comparison - What are the differences for marketing applications in the US and conformity evaluations in the EU?
- How to navigate FDA resources for identification of special controls, endpoints and extend of clinical investigations, illustrated using examples
- Identification of specific items requiring clinical data for conformity evaluation in the EU, illustrated using examples
- Consolidation and provision of a step-by-step approach for gathering FDA and EU requirements for clinical investigations of medical devices
Section
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Duration
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Content
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Part I
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System Comparison - Differences for marketing applications in the US and conformity evaluations in the EU
Amko Groeneveld, Consultant, novineon CRO GmbH
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Introduction
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5 minutes
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- Rising regulatory requirements for generating clinical data
- Workshop outline and goal
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System comparison
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5 minutes
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- Key aspects of the US- and EU-market for medical devices
- Medical device classification
- Device submissions in the US – logic/approach
- Conformity evaluation in the EU – logic/approach
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FDA
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30 minutes
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Navigation of FDA resources using example devices for a 510(k) submission and a PMA submission
- How can available information be used to shape a clinical investigation/animal trial?
- Considerations for De Novo devices
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FDA – recap
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10 minutes
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- Specific questions regarding the identified FDA resources, their navigation and use of the available information can be addressed here
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EU
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30 minutes
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- Specific items requiring support from clinical data are identified, “to dos” for manufacturers are provided and an example per item is used for illustration
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EU – recap
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10 minutes
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- Specific questions regarding items requiring support from clinical data can be addressed here
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Consolidation
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30 minutes
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- Based on the previous sections, a step-by-step approach is discussed for identification of aspects eligible for clinical testing to meet requirements of the US- and EU-market. Note that this cannot be an all-inclusive recipe but may serve as guidance.
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Part II
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#dualmarketentry - a dual first market for digital health
Speaker: Björn Ursing, Embassy of the Kingdom of The Netherlands in Stockholm
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Market entry in the Netherlands & Sweden
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30 minutes
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- New business development strategy with MDR
- Good and bad
- Start market access early – more at stake when doing trials under MDR
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