Periodic Reporting for period 2 - Newlife (New remote non-invasive monitoring solutions for ensuring the health of mothers and babies beforeand after birth)
Reporting period: 2024-01-01 to 2024-12-31
There is increasing focus on the well being of mothers and babies, both before and after delivery and early detection of pathologies to prevent mother and perinatal morbidity and mortality. The overall well being of mothers also has longer term impact: women who remain healthy during pregnancy and after birth are more likely to stay healthy later in life and have better birth outcomes, also influencing the infancy, childhood and adulthood of their children. Although it is important, the cost of care and health care staff shortage in hospital leads to high rate of preterm labor.
The Newlife project develops new remote non-invasive monitoring solutions for ensuring the health of mothers and babies before and after birth. The target is to develop emerging non-invasive methods for gathering vital data and analyzing it with advanced AI/ML methods, to be able to secure life in its most vulnerable phase. For clinical acceptance, the developed solutions need to be well integrated to the clinical workflows, with proper data integration, security, safety, and medical qualification.
The technologies and solutions developed are demonstrated in five use cases for both hospitals and personalized monitoring in home environments: 1) Pregnancy & parent companion, 2) Smart garment for monitoring of pregnancies
& complications, 3) Fetal monitoring patch for high-risk pregnancies, 4) Newborn monitoring with smart clothes, and 5) Newborn monitoring -well being in bed. With the developed solutions, NewLife project will contribute to the disruption of the health care models: by focusing on preventive actions rather than treating diseases, and moving healthcare from hospitals to home.
With the Newlife project European healthcare and technology industry will maintain and extend its leadership position in the global markets by creating new market opportunities in the areas of digital health and medical technology. Formation of a European ecosystem around digital healthcare will also enhance the creation of new companies and the uptake of new digital solutions by the users.
The Newlife project develops new remote non-invasive monitoring solutions for ensuring the health of mothers and babies before and after birth. The target is to develop emerging non-invasive methods for gathering vital data and analyzing it with advanced AI/ML methods, to be able to secure life in its most vulnerable phase. For clinical acceptance, the developed solutions need to be well integrated to the clinical workflows, with proper data integration, security, safety, and medical qualification.
The technologies and solutions developed are demonstrated in five use cases for both hospitals and personalized monitoring in home environments: 1) Pregnancy & parent companion, 2) Smart garment for monitoring of pregnancies
& complications, 3) Fetal monitoring patch for high-risk pregnancies, 4) Newborn monitoring with smart clothes, and 5) Newborn monitoring -well being in bed. With the developed solutions, NewLife project will contribute to the disruption of the health care models: by focusing on preventive actions rather than treating diseases, and moving healthcare from hospitals to home.
With the Newlife project European healthcare and technology industry will maintain and extend its leadership position in the global markets by creating new market opportunities in the areas of digital health and medical technology. Formation of a European ecosystem around digital healthcare will also enhance the creation of new companies and the uptake of new digital solutions by the users.
RP1:
To start, it is important to understand the needs of solutions developed in Newlife, several surveys with the participating of healthcare professional (obstetricians, midwives, nurses) have been conducted for both high-risk pregnancy and newborn baby monitoring. The insights are collected and reported in several deliverables. One important aspect for medical solution development is to understand the medical regulation. One training on medical device regulation was organized for all partners.
In the first year, all use cases (WPs 4-8) mainly focus on defining the concept for each solution, system architecture and system requirements, which are reported in several deliverables. Plans for prototype preparation and demonstrations to de-risk the final outcomes are in place. Validating the concepts/solutions in hospitals are planned as well. Due to the long process of clinical studies ethical approval, two studies are granted by Ethical Committees in Finland and Switzerland. All partners start working on concept development based on the technical requirements and clinical insights.
Next to the use cases, two workpackages operate cross all use cased regarding to clinical insights and solution integrations. WP2 in Newlife focuses on coordinating and assuring synergies between the use cases on common issues related to usability design, integration to clinical workflows, ethics, and medical regulations as well as sustainability and getting a solid clinical base for all use cases. WP3 provides a secure cloud integration platform as a service (IaaS) for integration of the diverse remote healthcare solutions in Newlife easily into hospital environments. The platform will establish a security and privacy framework for medical data and end-to-end solution data integrity.
A technical meeting series “AI-Taskforce meetings” were held monthly with different topics relating to developing trustworthy AI. During the first year, the meeting was held seven (7) times with presenters from PEN, Noldus, ams OSRAM, PHC, UTU and Insel.
All activities/deliverables are reviewed and receive feedbacks from CAB (Clinical Advisory Board), which consist several KOLs cross European countries.
RP2:
Below an overview is provided of the work and progress that has been accomplished by the consortium during months M13-M24.
The major events during M13-M24 are:
1. RP1 Technical and Financial reporting (in M14)
2. M12 Consortium meeting (held in M13)
2. M18 Consortium meeting
3. M12 (held in M13) and M18 CAB meeting
4. Assessment of Innovation level and purpose of Use Cases 1-5
5. First prototypes finished, testing continues
6. System architecture for the technologies further established and developed
8. Ethical approval for clinical studies
9. 1st Review meeting
10. M18 extra review
12. M24 CAB-review meeting
14. M24 Consortium meeting in Neuchatel
The main technical achievements are:
- Harmonized technical way of working (Introduction of the V-model)
- Harmonized documentation for user needs, intended uses and requirements
- Development of a layered architectural framework with clear API and interfaces
- Defined and published harmonized data model and data ingestion structure
- Development of multiple sensors in various stages of maturity.
In the coming reporting period, project implementation will continue. Additionally an extension to the Newlife project of 6 months, due to more time needed to define, plan and execute of the clinical trials takes more time than expected, has been agreed upon.
To start, it is important to understand the needs of solutions developed in Newlife, several surveys with the participating of healthcare professional (obstetricians, midwives, nurses) have been conducted for both high-risk pregnancy and newborn baby monitoring. The insights are collected and reported in several deliverables. One important aspect for medical solution development is to understand the medical regulation. One training on medical device regulation was organized for all partners.
In the first year, all use cases (WPs 4-8) mainly focus on defining the concept for each solution, system architecture and system requirements, which are reported in several deliverables. Plans for prototype preparation and demonstrations to de-risk the final outcomes are in place. Validating the concepts/solutions in hospitals are planned as well. Due to the long process of clinical studies ethical approval, two studies are granted by Ethical Committees in Finland and Switzerland. All partners start working on concept development based on the technical requirements and clinical insights.
Next to the use cases, two workpackages operate cross all use cased regarding to clinical insights and solution integrations. WP2 in Newlife focuses on coordinating and assuring synergies between the use cases on common issues related to usability design, integration to clinical workflows, ethics, and medical regulations as well as sustainability and getting a solid clinical base for all use cases. WP3 provides a secure cloud integration platform as a service (IaaS) for integration of the diverse remote healthcare solutions in Newlife easily into hospital environments. The platform will establish a security and privacy framework for medical data and end-to-end solution data integrity.
A technical meeting series “AI-Taskforce meetings” were held monthly with different topics relating to developing trustworthy AI. During the first year, the meeting was held seven (7) times with presenters from PEN, Noldus, ams OSRAM, PHC, UTU and Insel.
All activities/deliverables are reviewed and receive feedbacks from CAB (Clinical Advisory Board), which consist several KOLs cross European countries.
RP2:
Below an overview is provided of the work and progress that has been accomplished by the consortium during months M13-M24.
The major events during M13-M24 are:
1. RP1 Technical and Financial reporting (in M14)
2. M12 Consortium meeting (held in M13)
2. M18 Consortium meeting
3. M12 (held in M13) and M18 CAB meeting
4. Assessment of Innovation level and purpose of Use Cases 1-5
5. First prototypes finished, testing continues
6. System architecture for the technologies further established and developed
8. Ethical approval for clinical studies
9. 1st Review meeting
10. M18 extra review
12. M24 CAB-review meeting
14. M24 Consortium meeting in Neuchatel
The main technical achievements are:
- Harmonized technical way of working (Introduction of the V-model)
- Harmonized documentation for user needs, intended uses and requirements
- Development of a layered architectural framework with clear API and interfaces
- Defined and published harmonized data model and data ingestion structure
- Development of multiple sensors in various stages of maturity.
In the coming reporting period, project implementation will continue. Additionally an extension to the Newlife project of 6 months, due to more time needed to define, plan and execute of the clinical trials takes more time than expected, has been agreed upon.
- One key result in the first year is clinical insights of remote high-risk pregnancy and newborn baby monitoring collected from several surveys. These insights support all use cases define the system architecture and system requirements.
These will help to define the market for each use case in the future.
These will help to define the market for each use case in the future.