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Leistungen
Lead clinical studies regarding the design, placement of sensors and patient experience, analyse data. Insel will perform a clinical study with volunteer pregnant women in order to test the functional prototype of UC2 (wearable pregnancy monitoring garment), after collecting EC approval.
Final remote monitoring device specification (öffnet in neuem Fenster)The report will describe all sensoric and electronic functions of the devices for monitoring of babys in beds. The specifications for all devices will be summarized in the report.
A study on national and international ethics requirements and guidelines for remote monitoring solutions for pregnant women, the fetus and new-born babies. (öffnet in neuem Fenster)The Newlife fetal patch expands the heart rate monitoring functionality of current CTG applications (based on Doppler ultrasound) to include real-time fetal imaging and enables home use. Since this is a new workflow, we need to work closely with clinical partners globally to define requirements for this new solution.
Test report with conclusions from intermediate solution (öffnet in neuem Fenster)The functionality of the sensing elements at this stage of project work will be evaluated. The report will conclude about the further system development for monitoring of newborn babys in bed.
User research workshop findings and considerations for remote monitoring in clinical workflows (öffnet in neuem Fenster)A summary of the findings generated from the user research workshop and the considerations that this will have on the products. Expected content are descriptions of user profiles, context of use, users needs and tasks as well as usage scenarios.
MDR training workshop for all partners (öffnet in neuem Fenster)Philips will organize a course for all NEWLIFE partner to be aware of regulations/requirements to work on medical devices.
Document on general recommendations and learnings on device qualification of health care solutions (öffnet in neuem Fenster)Philips Medical Systems has a well-developed global distribution network to sell fetal monitoring solutions to delivery rooms and maternity wards in hospitals. This also means the knowledge and experience exists to launch such products which we will be able to leverage in the Newlife project.
Smart wearables concept definition (öffnet in neuem Fenster)An application for a long-term remote infant monitoring for parents based on MEDrecord platform.
Pre-clinical usability and usefulness assessment results for UC1-5 (öffnet in neuem Fenster)Insel will perform an usability study among pregnant/non-pregnant women using non-functional prototypes. The purpose is to increase acceptance among the targeted population. An Ethical Approval will be obtained before conducting the study.
Usability report of baby cap (öffnet in neuem Fenster)Usability report of the baby capbased on usability testing environments and clinical experts evaluartions. Initial usability evaluation with dummy devices. Final demonstration and evaluation using smart cap prototypes for feedback and improvement evaluations
Concept description of pregnancy companions (öffnet in neuem Fenster)Descriptions of how the three different pregnancy companions in UC1 will work at a higher level describing e.g. interactions with users and other technical systems, components, functions and other building blocks.
Second year report for dissemination and exploitation including communication activities (öffnet in neuem Fenster)Philips will deliver the second year report for dissemination and exploitation including communication activities.
Plan for dissemination and exploitation including communication activities (öffnet in neuem Fenster)Philips will deliver the plan for dissemination and exploitation including communication activities.
Concept definition for smart baby cap (öffnet in neuem Fenster)The concept for the new-born cap and the optical sensors will be defined and documented. Parameters and requirements for auxiliary sensors, optical sensor module will be conceptualized, and adaptation to other use cases will be defined. Requirements based on end user expectations, customer journey and clinical assessment will be taken into account.
Concept definition for smart body suit (öffnet in neuem Fenster)The concept for the new-born body suit with sensors will be defined and documented. Parameters and requirements for sensors and adaptation to use cases will be defined. Requirements based on end user expectations, customer journey and clinical assessment will be taken into account.
The planned demonstrator will show the principle functionalities for monitoring of newborns in beds. At this stage the demonstrator will not show the final formfactor and the electronic modules will be based on preliminary assemblies.
Smart pregnancy garment demonstrator (öffnet in neuem Fenster)At least 10 working prototypes of UC2 smart garment to be produced and delivered to clinical partner for evalaution
Updates to the data management plan to reflect the current situation of the project.
Data management plan (öffnet in neuem Fenster)A data management plan needed to ensure GDPR compliancy and data privacy and country and hospital specific regulations and guidelines and national laws will be studied and taken into account.
Philips will create and maintenance all communication tool in NEWLIFE.
Veröffentlichungen
Veröffentlicht in:
Gynecologic and Obstetric Investigation, Ausgabe 89, 2024, ISSN 0378-7346
Herausgeber:
S. Karger AG
DOI:
10.1159/000539163
Autoren:
Ismail Elnaggar, Sepehr Seifizarei, Jonas Sandelin, Olli Lahdenoja, Antti Airola, Matti Kaisti, Tero Koivisto
Veröffentlicht in:
IEEE/ACM conference on Connected Health: Applications, Systems and engineering Technologies (CHASE) 2025, 2025
Herausgeber:
Association for Computing Machinery
DOI:
10.1145/3721201.3724416
Autoren:
Birgit Brunklaus, Yoon Lin Chiew, Anna Axelin, Susanna Likitalo, Petra Sommarlund, Julia Jockusch.
Veröffentlicht in:
SETAC EUROPE 26TH LCA SYMPOSIUM 21–23 OCTOBER 2024 | GOTHENBURG, SWEDEN MAKING LCA MEANINGFUL: GOOD DATA, BETTER MODELS, SUSTAINABLE DECISIONS, 2024
Herausgeber:
SETAC EUROPE 26TH LCA SYMPOSIUM
Autoren:
Susanna Likitalo, Anni Pakarinen, Anna Axelin
Veröffentlicht in:
CIN: Computers, Informatics, Nursing, 2025, ISSN 1538-9774
Herausgeber:
Ovid Technologies (Wolters Kluwer Health)
DOI:
10.1097/CIN.0000000000001255
Autoren:
Kristina Stricker, Anda-Petronela Radan, Daniel Surbek
Veröffentlicht in:
European Journal of Obstetrics & Gynecology and Reproductive Biology, Ausgabe 305, 2025, ISSN 0301-2115
Herausgeber:
Elsevier BV
DOI:
10.1016/J.EJOGRB.2024.12.018
Autoren:
Suokanerva and Vuorjoki.
Veröffentlicht in:
2025
Herausgeber:
Finnish universities of applied sciences web-page: https://www.theseus.fi/handle/10024/874570
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