From insight to impact: The procedures behind the project’s framework

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Developing EVOLVE2CARE’s framework means first of all crafting a solid foundation of meaningful Key Performance Indicators (KPIs) that support the efficient and evidence-based integration innovations into healthcare. Such effort might be interestingly similar to a professional athlete’s preparation! Before stepping into a major event, an athlete undergoes a series of procedures—from training sessions with targeted practice to blood tests and stress assessments—to ensure peak performance. These procedures help highlight what’s effective, what needs improvement, and what’s essential for success.

Likewise, as it is analytically written in Deliverable 1.2 ‘Stakeholder Needs Analysis and KPI framework’, EVOLVE2CARE consortium applied multiple procedures to ensure that the framework of key indicators of the project is adequately accurate and relevant to foster successful innovations of HealthTech solutions for patients transitioning between care settings; which is called Transitional Care.

The primary goal, highlighted on previous blog, was to understand the needs of primary stakeholders—such as researchers, Living Labs, end-users, and regulators—and translate these insights into a practical framework of key indicators. Building on the barriers and enablers identified in Deliverable 1.1 “Roadmap on Navigating the Complexities of Enabling Innovative Technologies in Transitional Care”, we outlined the needs across two major dimensions: (1) collaboration between Living Labs and innovators, and (2) the implementation of HealthTech solutions in Transitional Care. As a result, we developed two distinct key indicators repositories:

  • Use Case Evaluation KPI Repository, which focuses on individual collaborations and end-user alignment.
  • Impact Assessment KPI Repository, which evaluates broader impacts such as regulatory readiness, financial sustainability, and social inclusion.

In practical terms, the accuracy and relevance of the framework were validated through a stakeholder-driven process. To make it more concrete, internal feedback was gathered via an online workshop involving the project partners. On top of that, three webinars conducted in March 2025 titled ‘Accelerating Innovation in Transitional Care – Identifying Key Needs & Meaningful Impact’, featuring distinguished professionals, designed to engage healthcare providers, experts, innovators, and stakeholders in co-developing solutions that enhance patient care during transitions from hospital to home. In addition to the valuable insights regarding the repositories of indicators that arose during the workshops’ discussions, further feedback came from a live session at the 14th Medical Conference at the Aristotle University of Thessaloniki, and from the collaboration with the GILL project supported the development of social key indicators, especially around gender-responsive innovation and inclusive healthcare.

Next Steps: Engaging stakeholders and ensuring continuous improvement

To make sure the framework of key indicators keeps evolving and finds its way into real-world use, we are focusing on expanding its reach, getting feedback from the relevant stakeholders and to foster adoption, and making it as practical and user-friendly as possible. To keep the framework relevant and aligned with the dynamic needs of stakeholders, we will set up feedback channels to refine the framework of key indicators over time. In particular, here’s how we are moving forward by channeling our efforts towards three dimensions:

  • Living Labs Engagement: The Living Lab KPI Repository will be shared with the Health & Wellbeing Working Group of the European Network of Living Labs (ENoLL), helping us align the framework with the needs of real-world testing environments and innovators.
  • End-Users Integration: Keeping work on a user-centric approach, we will connect with EIT Health to explore how the End-User KPI Repository can be circulated within their network. We will also collaborate with HADEA (Health and Digital Agency) of the European Commission to assess the framework’s relevance to ongoing and future initiatives.
  • Wider Impact and Solution Deployment: To proliferate real-world adoption, the framework will be presented to organizations such as EHTEL (European Health Telematics Association) and the Era4health partnership since these entities play a critical role in shaping policy and practice around digital health solutions.

At EVOLVE2CARE, we think of the framework of key indicators as a magnifying glass that helps us check whether the project is able to make a difference in the healthcare sector! We aim to make sure that the framework is effective and relevant for all stakeholders involved.

Third project workshop on regulatory requirements for medical devices in Digital Health

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As part of the Online Workshop Series to Explore Innovation in Transitional Care, the third and final session brought together healthcare professionals, researchers, and innovators to tackle one of the most challenging aspects of bringing medical innovations to market: regulatory compliance. The series, organized under the framework of the EVOLVE2CARE project (learn more here), aimed to support those working at the intersection of healthcare and technology by providing actionable insights from leading experts.

In this final workshop, Mrs. Katerina Zisaki, Quality and Regulatory Director at PKNM Solutions, delivered an in-depth presentation on the regulatory pathways for medical devices and digital health solutions in Europe. Her talk shed light on the complexities of CE certification, the Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and the upcoming Artificial Intelligence Act (AI Act), offering practical advice for researchers and startups on how to successfully navigate these processes.

Understanding the CE Certification Process

Mrs. Zisaki emphasized the importance of CE certification, which ensures that a medical product meets general safety and performance requirements under European medical device regulations. She highlighted that beyond the 27 EU member states, several other countries—including Switzerland, Turkey, and Serbia—also recognize CE-certified products, expanding market access for compliant innovations.

A key takeaway was the broad definition of medical devices under European law. These can include:

  • Instruments and implants
  • Standalone software
  • In vitro diagnostic tools
  • Digital health solutions embedded in healthcare systems

To qualify as a medical device, the product must serve a medical purpose such as diagnosis, treatment, monitoring, or rehabilitation. She also discussed the two main regulations governing these products: the Medical Device Regulation (MDR – 2017/745) and the In Vitro Diagnostic Regulation (IVDR – 2017/746).

The Regulatory Pathway for Medical Devices

The certification process involves several critical steps:

  1. Defining the Intended Use: If a product falls within the legal definition of a medical device, the regulatory pathway applies automatically.
  2. Establishing a Quality Management System (QMS): A structured QMS (typically based on ISO 13485) is mandatory for compliance.
  3. Technical Documentation: Detailed records on product design, functionality, and risk assessment are required.
  4. Notified Body Involvement: For higher-risk devices (Class IIa, IIb, and III), an external Notified Body must evaluate compliance before the product can enter the market.

Mrs. Zisaki pointed out that the AI Act, which will be fully enforced by 2026, introduces additional requirements for artificial intelligence-driven medical devices, reinforcing the need for robust validation processes.

From Lab to Market: The Innovation Roadmap

The transition from research to market-ready innovation follows a structured process, starting with early-stage technology readiness levels (TRLs):

  • TRL 4-5: Proof of concept in a laboratory setting
  • TRL 6: Design verification and initial regulatory steps
  • TRL 7-9: Clinical validation and certification for market access

One critical point she stressed was the importance of locking the design at the verification stage. Continuous modifications during the validation process can delay certification and increase costs, making early regulatory alignment essential.

Digital Health & Software as a Medical Device (SaMD)

Mrs. Zisaki elaborated on the growing role of digital health solutions, noting that most software-driven healthcare products now fall under Rule 11 of the MDR. If software influences medical decisions, it is classified as a medical device and requires compliance with MDR standards.

Key challenges for software-based medical devices include:

  • Cybersecurity & Data Privacy: Compliance with GDPR and cybersecurity standards (ISO 27001, 27701)
  • Software Lifecycle Management: Ensuring a structured software development and maintenance process
  • Clinical Validation: Demonstrating that the software meets real-world medical needs

For startups and research teams developing digital health solutions, Mrs. Zisaki emphasized the importance of working with regulatory specialists early in the development phase to avoid costly compliance roadblocks.

Overcoming Regulatory Barriers: Industry Perspectives

During the Q&A session, participants raised concerns about regulatory complexity, high certification costs, and slow approval timelines. Key insights from the discussion included:

  • Engaging regulatory experts early can prevent costly redesigns.
  • Investors are hesitant to fund startups without a clear regulatory pathway.
  • Europe’s regulatory environment differs from the U.S., with fewer fast-track approval options.

Industry expert Mr. Petros Malitas highlighted the need for more structured regulatory science education to bridge the knowledge gap between researchers and compliance experts.

Wrapping up the Workshop Series

As the final event of the Online Workshop Series to Explore Innovation in Transitional Care, this session provided participants with the tools and knowledge needed to navigate one of the most challenging aspects of healthcare innovation. Throughout the series, participants gained perspectives on fostering innovation, collaboration, and compliance across multidisciplinary teams.

Mrs. Zisaki’s keynote presentation was a powerful reminder that regulatory readiness must be part of the innovation strategy from the very beginning, not an afterthought. Success in bringing medical technologies to market depends on a clear understanding of the regulatory landscape, early planning, and collaboration between innovators, investors, and compliance experts.

The EVOLVE2CARE team thanks all participants, speakers, and contributors to this engaging workshop series and looks forward to continuing the conversation around innovation and impact in transitional care.

Second project workshop on aligning innovation with healthcare stakeholder needs

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On March 11, 2025, the EVOLVE2CARE project continued its online workshop series, bringing together experts, researchers, and healthcare professionals to explore innovative approaches in Transitional Care.


The workshop titled “Aligning Innovation with Healthcare Stakeholder Needs” was the second under the whole name of “Accelerating Innovation in Transitional Care – Identifying Key Needs & Meaningful Impact” series.


Dr. Kostas Bakogiannis, a renowned Medical Doctor & Cardiologist, shared his expert insights into the challenges facing the healthcare sector. He focused on how innovation can better align with the needs of healthcare stakeholders, providing valuable perspectives on the evolving landscape.


Dr. Bakogiannis posed a critical question: Could digital health tools and innovations be a catalyst for improvement? He explored how these technologies might bridge the gap between clinical trial expectations and real-world healthcare realities.


Developing digital solutions for patient engagement


Reflecting on his work in digital cardiology, Dr. Bakogiannis shared his experience leading the Cardiovascular Prevention and Digital Cardiology Lab, founded in 2018. His team aims to create digital tools that enhance patient adherence to treatment and improve communication between patients and healthcare providers. One of their first projects, developed a patient-centered app “ThessHF” for heart failure patients.


The app was designed to be user-friendly, supporting adherence to treatment plans while strengthening the patient-clinic relationship. Clinical validation through the study showed that:

  • Self-care levels significantly improved within the first three months.
  • Quality of life showed slight improvements.
  • However, adherence to the app dropped significantly after the second month, highlighting usability challenges.


These findings underscored the importance of designing digital tools that are not only effective but also engaging for long-term patient use.


Challenges in implementing digital health solutions


Dr. Bakogiannis emphasized the challenges in integrating digital health solutions into everyday clinical practice. Healthcare professionals face overwhelming workloads, time constraints, and burnout—issues exacerbated globally, particularly after the COVID-19 pandemic.


While many digital solutions promise transformation, real-world implementation often falls short of expectations.


Key barriers include:

  • Regulatory & Legal Challenges – Issues such as data privacy, cybersecurity, and the lack of a harmonized health technology assessment process hinder widespread adoption.
  • Lack of Standardization & Interoperability – Many digital tools lack seamless integration with existing healthcare systems and require standardized validation frameworks.
  • High Costs, Lack of Cosy-Effectiveness Studies & Lack of Reimbursement Models – Digital health solutions remain costly, and healthcare administrators often demand cost-effectiveness studies before approving new technologies.


AI in Healthcare: Endogenous & Existing Challenges

  • Lack of trust in AI-driven decision making – Many healthcare professionals remain skeptical about AI-based recommendations, fearing errors.
  • Bias linked to lack of harmonized & qualitative data – AI models require high-quality, standardized data, but inconsistencies and biases in datasets can lead to unreliable results.
  • The “Black Box” problem & lack of transparency – AI decision-making processes can be opaque, making it difficult for clinicians to understand or validate AI-generated conclusions. The push for explainable AI is critical in overcoming this challenge.


Proposed solutions for overcoming challenges

  • Aligning innovation with clinical needs – Co-designing solutions with all stakeholders to ensure digital tools are human-centered, user-friendly, and seamlessly integrated into clinical workflows.
  • Policy & regulatory adaptation – Establishing fast-track approval pathways while aligning with existing policies for data privacy and security.
  • Financial & reimbursement models– Developing cost-effectiveness studies to support value-based reimbursement models and encourage investment in digital health solutions.
  • AI & data ethics optimization – Implementing explainable AI and bias mitigation strategies to enhance trust and transparency in AI-driven healthcare solutions.
  • Physician & patient education & digital literacy – Integrating digital health training into medical education and expanding workshops for patients, caregivers, and healthcare professionals to improve adoption and engagement.


The EVOLVE2CARE’s KPI Framework


One of the biggest challenges in healthcare innovation is ensuring that new solutions meet the expectations of real-world healthcare realities. To bridge this gap, the EVOLVE2CARE project has developed a KPI framework that evaluates the development and real-world impact of health tech innovations within Living Labs.


The 4 Key Stakeholder Categories


EVOLVE2CARE’s KPIs are structured around the four primary groups impacted by health innovation:

  • Healthcare Professionals – Measuring how digital tools improve clinical efficiency, reduce workload, and enhance decision-making.
  • Patients – Focusing on individualized care and digital health literacy. KPIs in this category assess whether patients are empowered, informed, and confident in using digital tools for their health management.
  • Hospitals & Organizations – Evaluating interoperability, cost-effectiveness, and system-wide adoption of digital health solutions. EVOLVE2CARE emphasizes value-based impact assessments, helping hospitals and policymakers determine which innovations deliver both economic and clinical benefits.
  • Caregivers – Recognizing the essential role of family members and informal caregivers in transitional care. KPIs in this category assess whether digital health tools help caregivers provide better support, reduce stress, and enhance communication with healthcare teams.

What’s next?
The final session of the EVOLVE2CARE workshop series will focus on one of the most pressing aspects of healthcare innovation: regulatory requirements. Bringing together experts in digital health and medical device compliance.
Join us as we tackle the complexities of regulation and discuss strategies for successfully navigating the evolving landscape of digital health compliance.

AV & SPLORO at Mobile World Congress 2025

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From 3–6 March 2025, EVOLVE2CARE partners Anthology Ventures (AV) and SPLORO attended and contributed highly to the Mobile World Congress (MWC2025) in Barcelona, Spain!

As the world’s largest and most influential connectivity event, MWC2025 featured 48 keynote speakers and over 1,200 speakers across MWC and 4YFN (Four Years From Now), bringing together innovators, industry leaders, and technology enthusiasts — all essential players in today’s thriving digital startup ecosystem. This year’s speakers were bold thought leaders from diverse industries, who addressed directly how technology and global challenges are reshaping the world and the business landscape.

Adriane Thrash (AV), together with Miguel García González and Virginia Gómez Oñate (SPLORO), promoted the project’s opportunities for innovators and Living Labs, and highlighted the launch of the Open Call.

Building on this engagement, SPLORO experts contributed to several panels, demonstrating their commitment to supporting startups and innovators across sectors, while showcasing key initiatives in funding, deeptech, and innovation. In parallel, AV held meetings with health-tech startups to publicise the Open Call and also connected with ECHAlliance leadership to explore potential synergies.

The two partners also collaborated in the high-profile panel discussion “The Future of Women in Tech: What’s Next?”. Virginia Gómez Oñate led the session on empowering women entrepreneurs, highlighting funding opportunities under Women TechEU, the EmpoWomen Programme, Open Horizons, and EVOLVE2CARE, while Adriane Thrash, as a panelist, shared her experiences and strategies for increasing female representation in deeptech.

EVOLVE2CARE’s presence at MWC2025 marked an important step in building visibility, partnerships, and momentum for the project’s insightful upcoming activities.

Navigating through multiple barriers to HealthTech for the Transitional Care

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While HealthTech holds immense potential to transform transitional care, the challenges don’t stop at legal, regulatory, and fiscal barriers. Even with clear policies and sustainable funding, technical, operational, social and economic obstacles continue to hinder widespread adoption. Issues like interoperability, provider resistance, and patient trust must also be addressed to ensure these innovations can thrive.

The Evolve2Care Project is committed to tackling these challenges head-on. As outlined in Deliverable D1.1, “Roadmap on Navigating the Complexities of Enabling Innovative Technologies in Transitional Care,” a structured approach is needed to help stakeholders—healthcare providers, innovators, policymakers, and investors—overcome these hurdles. In this second part, we dive into the technical, operational, social and economic factors that stand in the way of seamless HealthTech integration.

3. Technical Challenges

Integrating HealthTech innovations into existing healthcare systems brings various technical hurdles that must be resolved for well-tempered implementation.

Interoperability Issues

HealthTech solutions rely on seamless data exchange between electronic health records (EHRs), diagnostic tools, and monitoring devices. However, varying formats and standards create inefficiencies, errors, and delays, making it difficult to ensure continuity of care.

Scalability and Customization

Innovators face challenges in making HealthTech solutions adaptable to different healthcare environments. What works in a small clinic may not suit large hospitals, and vice versa. Additionally, tailoring solutions to meet the diverse needs of patients, healthcare professionals, and institutions remains a key hurdle.

User-Centred Design and Accessibility

HealthTech solutions must prioritize user-friendly design to ensure accessibility for all users, especially patients with limited technical expertise. If a technology is difficult to use or understand, patients may disengage, reducing its impact on transitional care.

4. Operational Challenges

Healthcare providers often struggle to integrate new HealthTech solutions, especially in transitional care, where continuity is key.

Integration into Existing Care Pathways

Integrating new technologies into healthcare workflows is challenging, often facing resistance due to changes in care pathways. Successful adoption requires effective change management and alignment with existing processes.

Training and Support for Healthcare Professionals

Lack of adequate training hinders the effective use of new tools. Comprehensive training programs and ongoing technical support ensure that healthcare professionals can confidently integrate new technologies into their practice.

Patient Engagement and Adoption

For HealthTech solutions to succeed, patients must understand and engage with them. User-friendly design, patient education, and trust-building are essential to driving adoption and achieving better health outcomes.

5. Economic and Social Challenges

Beyond legal, regulatory, fiscal, technical and operational hurdles, economic and social factors also impact the success of HealthTech innovations in transitional care.


Economic Viability and Long-Term Sustainability


Many stakeholders have raised concerns about the long-term sustainability of HealthTech solutions. Ensuring cost-effectiveness in improving patient outcomes and reducing healthcare costs is crucial. A thorough evaluation of their economic impact is necessary to align with healthcare system budgets and ensure financial viability.

Social Acceptance and Trust

Public trust is essential for the adoption of HealthTech solutions. Concerns about data privacy, care dehumanization, and potential misuse of patient information must be addressed through trust in HealthTech solutions.

What needs to be done to overcome these hurdles?

Overcoming these challenges requires collaboration between innovators, healthcare providers, policymakers, and regulators. By addressing legal, financial, technical, operational, and social barriers, stakeholders can create an ecosystem where HealthTech innovations thrive.

Evolve2Care is committed to driving change—because better technology means better outcomes for patients and a more efficient healthcare system.

HealthTech in transitional care: What’s standing in the way?

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HealthTech innovations hold great promise for improving transitional care, enhancing patient outcomes, and streamlining healthcare processes. However, their implementation faces significant challenges, including regulatory hurdles, financial constraints, technical limitations, and social acceptance issues.

The Evolve2Care Project is dedicated to identifying and addressing these obstacles through collaboration and evidence-based strategies. As part of this effort, Deliverable D1.1, “Roadmap on Navigating the Complexities of Enabling Innovative Technologies in Transitional Care,” provides a structured framework to support stakeholders—including startups, researchers, investors, healthcare professionals, and policymakers—in recognizing and overcoming barriers to HealthTech adoption. Let’s dive into the challenges!

1. Legal and Regulatory Challenges:

Fragmented and Inconsistent Regulations

Regulations differ across regions, slowing down approval and market entry. Some countries have clear policies, while others lag behind. In Europe, complex regulatory frameworks make scaling innovations difficult and add compliance burdens.

Regulatory Uncertainty in New Technologies

Technologies like AI diagnostics and telemedicine often do not fit neatly within existing regulatory structures, creating uncertainty for innovators. Rapid technological advances often outpace the ability of regulators to adapt, making approval processes unpredictable and slow and innovators unsure of the approval process.

Data Privacy and Security Concerns

Strict regulations like GDPR in Europe require strong data protection measures. Innovators must ensure compliance while safeguarding patient data, especially when using cloud storage or cross-border transfers.

Liability and Accountability

Determining responsibility when a HealthTech solution fails is complex. Who is accountable? The lack of clear liability frameworks increases risks for innovators and discourages investment in new technologies.

2. Fiscal Challenges

Financial constraints slow down the adoption and scaling of HealthTech solutions, limiting innovation and access.

Lack of Sustainable Funding and Investment

Innovators face difficulties in securing long-term funding. While some early-stage funding is available, there is a notable gap in financial support for scaling up innovations.

High Upfront Costs of Implementation

HealthTech solutions offer long-term cost savings, but high upfront costs often discourage healthcare providers from adopting new technologies. Hospitals and clinics with limited budgets struggle to allocate funds for new systems, especially when immediate returns on investment are unclear.

Reimbursement Issues

Unclear reimbursement policies prevent many HealthTech innovations, especially in transitional care, from being covered by traditional insurance or public funding. Without financial incentives, healthcare providers hesitate to adopt new technologies, limiting their potential to improve patient transitions and care quality.

Conclusion

Regulatory frameworks, fiscal limitations, and legal uncertainties create significant hurdles for HealthTech adoption in transitional care. But even if these hurdles are overcome, will the technology be technically feasible, operationally sustainable, and socially accepted?

In Part 2, we’ll explore how HealthTech innovations must tackle technical, operational, and social challenges to truly succeed in transforming patient care.