Innovation Area

The view from an investor and how we invest in upgrading healthcare

Lecturer: Magnus Bergman

New technologies has been introduced into healthcare, but I think its fair to say that the uptake has been slow compared to the opportunities at hand. This talk will describe why we need to invest massively to improve the effectiveness of our healtcare system. Examples will be given from several of the healtcare projects that Luminar has invested in where some have found product market fit and gained a lot of momentum lately.

Clinical Evidence for Mobile Health Applications

Lecturer: Przemek Grzywa

The presentation will provide a comprehensive overview of how to establish credible clinical evidence for mobile health apps, focusing on both regulatory compliance and real-world application. Attendees will learn about the importance of clinical validation in demonstrating app safety, efficacy, and usability, which are essential for regulatory approval and integration into healthcare systems. 

Key topics include the different types of clinical studies—such as randomized controlled trials and observational studies—that are most effective for digital health validation, along with an examination of metrics commonly used to measure health outcomes in digital applications.

The session will also address specific regulatory requirements and guidelines, such as those from EMA, that mobile health developers should consider when designing their clinical validation plans. Additionally, a real-world case study will highlight successful strategies and common challenges faced in bringing clinically validated apps to market. By the end of the presentation, participants will gain practical insights into building a clinical evidence base that supports both patient trust and healthcare provider adoption.

Perspectives and Challenges for EU Market Access of Digital Medical Devices

Moderator: Louisa Stuwe
Panelists: Jari Haverinen, Jérôme Fabiano, Mikael Rinnetmäki

The integration of Digital Medical Devices (DMDs), including AI-driven technologies, into healthcare systems is expanding rapidly. These innovations hold the potential to enhance patient care, refine diagnostics, and improve operational efficiency. However, several barriers hinder their seamless adoption:

• Regulatory Heterogeneity: Complex national regulatory landscapes across EU Member States

• Lack of Standardized Evaluation Criteria: Disparate assessment frameworks across different nations and regions represent hurdles for EU-wide market access of DMDs

• Economic and Financial Constraints: Existing reimbursement and funding models struggle to adapt to the rapid pace of technological progress.

• Limited Integration into Healthcare Practice: The absence of DMDs in healthcare pathways leads to hesitancy among professionals in adopting these solutions

This session will present preliminary findings from the European Taskforce for Harmonised Evaluation of Digital Medical Devices (EvalEUDMD), focusing on:

• Exploring the regulatory differences between EU Member States and strategies to navigate these frameworks effectively
• Presenting the development of a standardized EU classification and evidence matrix to assess DMDs based on their function, application, and required supporting data.
• Evaluating the implications of the Health Technology Assessment Regulation (HTA R) on market access