webinar

COMFORTage CCF TA1: Dementia and Frailty Service Delivery Models for affected patients and their carers

Webinar 5:  Evidence and innovative digital health services - a square in a circle       

This series of webinars explores how people living with dementia are supported and what short-term or medium-term opportunities - including the use of digital technologies - can improve the well-being of themselves and their carers.

In the EU, dementia prevalence in people over 60 increased from 5.9 million in 2000 to over 9 million in 2018. However, behind the words “dementia” and “frailty”, are very different clinical conditions. Furthermore, the personal and social environments play critical roles. Every person with dementia is unique and needs a personalised approach to his or her needs. Starting with the patients, COMFORTage explores the solutions proposed and viewpoints of all the main actors who can make a difference: social and healthcare professionals, industry, policymakers, and researchers.

A focus on AI, technologies and evidence collection

A previous CCF webinar explored the types of technologies and products currently used or tested in ageing and dementia. They were mainly proposed as Class 1 medical devices (this is partially related to their lower regulatory barriers, as opposed to Class 2a devices).

Class 1 devices’ key requirements include technical documentation, a Quality Management System (QMS), clinical evaluation, and registration with regulatory authorities. 

They are, however, often more related to lifestyle in the dementia and frailty context. Their drawback is their lack of integration into clinical workflows and the absence (or rarity) of reimbursement. This limits their uptake even when innovative business models are developed.

Class 2a applications and products usually offer better integration into clinical workflows since they contribute to diagnosis, monitoring, or treatment of conditions. These applications are still considered low/medium-risk. The related regulatory obligations are more rigorous, requiring proactive Notified Body involvement, extensive technical documentation, and a functioning quality system.

AI is increasingly incorporated in innovative applications, extending significatively the number of Class 2a or 2b (medium/high risk) applications which need to collect additional evidence to comply with the AI Act regulation. 

In all cases, innovators are confronted with the challenge to collect the evidence needed to demonstrate the safety, efficacy and cost-efficiency of the solutions developed (be it for legal/regulatory compliance or qualification for reimbursement). The production of this evidence is time- and resource-intensive as it requires wide-scale testing. This “time to evidence” also increases the risk of not seeing new and more advanced products arriving on the market. Today, instead, the innovation cycle has to be shortened.

What’s in this webinar?

In this webinar, we:

• Explore whether the production of evidence is stimulating adoption. If yes, what evidence is most required? Which strategies can be implemented to produce the evidence needed to allow innovative products to be used more quickly and extensively (in particular, Class 2a – and above - devices)?
• Analyse some possible strategies to collect evidence rapidly. 

Rapid evidence collection strategies include:

• Designing the app to be a data collection tool from day one:
• Partnering early with healthcare systems and Healthcare Professionals
• Running pragmatic trials instead of “pure” RCTs
• Using adaptive and hybrid study designs
• Thinking “evidence lifecycle,” not “one-time study”

People attending the webinar will hear about:

• Lessons learnt from existing schemes to apply for early access / pilot reimbursement schemes
• Stories from innovators' successful and less successful experiences