Periodic Reporting for period 3 - Moore4Medical (Accelerating Innovation in Microfabricated Medical Devices)
Berichtszeitraum: 2022-06-01 bis 2023-09-30
The project addresses emerging medical applications and technologies that offer significant new opportunities for patients as well as for industry including: bioelectronic medicines, organ-on-chip, drug adherence monitoring, smart ultrasound, radiation free interventions and continuous monitoring. The new technologies will help fighting the increasing cost of healthcare by reducing the need for hospitalisation, helping to develop personalized therapies, and realising intelligent point-of-care diagnostic tools.
Moore4Medical brings together 66 selected companies, universities and institutes from 12 countries who will develop open technology platforms for these emerging fields to help them bridge “the Valley of Death” in shorter time and at lower cost. Open technology platforms used by multiple users for multiple applications with the prospect of medium to high volume markets are an attractive proposition for the European industry. The combination of typical MedTech and Pharma applications with an open platform approach will enhance the competitiveness for the emerging medical domains addressed in Moore4Medical. With value and IP moving from the technology level towards applications and solutions, defragmentation and open technology platforms will be key in acquiring and maintaining a premier position for Europe in the forefront of affordable healthcare.
Moore4Medical brings together 66 selected companies, universities and institutes from 12 countries who will develop open technology platforms for these emerging fields to help them bridge “the Valley of Death” in shorter time and at lower cost. Open technology platforms used by multiple users for multiple applications with the prospect of medium to high volume markets are an attractive proposition for the European industry. The combination of typical MedTech and Pharma applications with an open platform approach will enhance the competitiveness for the emerging medical domains addressed in Moore4Medical. With value and IP moving from the technology level towards applications and solutions, defragmentation and open technology platforms will be key in acquiring and maintaining a premier position for Europe in the forefront of affordable healthcare.
Moore4Medical covered many innovation activities. The main results and their exploitation and dissemination perspective are as follows:
Bioelectronic Medicines (WP 1):
• Developed biocompatible ultrasound technology to power smart, small, and specific implantable medical devices.
• Key components include pre-charged CMUT devices and a dedicated ASIC, offered as open platforms.
• Demonstrated two-way communication with implanted devices for applications like bone healing and deep implants.
• Compared favourably to an inductive power transfer platform, gaining international attention at the International Ultrasound Symposium.
Organ-on-Chip (WP 2):
• Contributed to the emerging field of Organ-on-Chip, reducing the need for animal experiments.
• Developed smart well plate platforms to bridge the gap between laboratory experiments and pharmaceutical industry needs.
• Promoted workflow integration and standardization, featured prominently at Organ-on-Chip conferences.
• Concepts influenced the Organ-on-Chip focus group of the European Committee for Standardization (CENELEC).
Smart Drug Delivery (WP 3):
• Addressed issues with drug administration through the creation of a smart injector pen.
• Innovations included the world's smallest silicon micro-pump, in-pen rehydration of lyophilized drug formulations, electronic sensors, and wireless connectivity.
• Received significant scientific and press attention, with potential for future projects and standardization efforts.
Personal Ultrasound (WP 4):
• Developed key components for next-generation ultrasound systems, making ultrasound more accessible outside of hospitals.
• Included mass-produced 2D MEMS ultrasound transducer arrays and advanced AI algorithms.
• Focused on enabling obstetric ultrasound even in rural areas.
• Negotiations with investors to bring these products to market independently.
X-ray Free Interventions (WP 5):
• Introduced the Philips Fibre Optic RealShape (FORS) technology to eliminate the need for fluoroscopy during minimally invasive procedures.
• Developed a high-precision optical fibre connector for broad compatibility with various catheter products.
• Adopted a low-profile approach for technology adoption and considered licensing to third-party users.
Unobtrusive Sleep Monitoring & Data Security (WP 6):
• Designed a system for unobtrusive sleep monitoring to detect atrial fibrillation among the elderly.
• Combined multiple bedside sensors and algorithms to collect and analyze data.
• Developed an end-to-end security and privacy framework for continuous patient monitoring, with potential interest from standardization bodies.
Bioelectronic Medicines (WP 1):
• Developed biocompatible ultrasound technology to power smart, small, and specific implantable medical devices.
• Key components include pre-charged CMUT devices and a dedicated ASIC, offered as open platforms.
• Demonstrated two-way communication with implanted devices for applications like bone healing and deep implants.
• Compared favourably to an inductive power transfer platform, gaining international attention at the International Ultrasound Symposium.
Organ-on-Chip (WP 2):
• Contributed to the emerging field of Organ-on-Chip, reducing the need for animal experiments.
• Developed smart well plate platforms to bridge the gap between laboratory experiments and pharmaceutical industry needs.
• Promoted workflow integration and standardization, featured prominently at Organ-on-Chip conferences.
• Concepts influenced the Organ-on-Chip focus group of the European Committee for Standardization (CENELEC).
Smart Drug Delivery (WP 3):
• Addressed issues with drug administration through the creation of a smart injector pen.
• Innovations included the world's smallest silicon micro-pump, in-pen rehydration of lyophilized drug formulations, electronic sensors, and wireless connectivity.
• Received significant scientific and press attention, with potential for future projects and standardization efforts.
Personal Ultrasound (WP 4):
• Developed key components for next-generation ultrasound systems, making ultrasound more accessible outside of hospitals.
• Included mass-produced 2D MEMS ultrasound transducer arrays and advanced AI algorithms.
• Focused on enabling obstetric ultrasound even in rural areas.
• Negotiations with investors to bring these products to market independently.
X-ray Free Interventions (WP 5):
• Introduced the Philips Fibre Optic RealShape (FORS) technology to eliminate the need for fluoroscopy during minimally invasive procedures.
• Developed a high-precision optical fibre connector for broad compatibility with various catheter products.
• Adopted a low-profile approach for technology adoption and considered licensing to third-party users.
Unobtrusive Sleep Monitoring & Data Security (WP 6):
• Designed a system for unobtrusive sleep monitoring to detect atrial fibrillation among the elderly.
• Combined multiple bedside sensors and algorithms to collect and analyze data.
• Developed an end-to-end security and privacy framework for continuous patient monitoring, with potential interest from standardization bodies.
Within Moore4Medical the following demonstrators have been realized:
1. Implantable devices – a platform for ultrasound power transfer
The ultrasound power transfer system has been demonstrated in an implant that will monitor bone healing. The implant is part of a bone plate that is surgically attached to the bone. Deformation of the plate yields important information about the healing process. The implant uses biocompatible optimized MEMS ultrasound transducers to convert the acoustic pressure to electric energy. The system includes focused ultrasound to deliver the power, and power management ASICs. Finally, ultrasound power transfer was benchmarked against inductive power transfer.
2. Organ on Chip – a smart well plate platform
Using the smart well plate platform three demonstrator groups have been realized:
• The versatility of the smart well plate platform was demonstrated with a perfused MEA array, an organoid OoC and a skin-on-chip model;
• The advanced electrophysiology platform was demonstrated with a cardiotoxicity assay;
• The smart well plate lid was demonstrated with a multi-spheroid assay.
3. Drug adherence – intelligent drug delivery
A pen-based smart drug delivery demonstrator has been realized. The demonstrator is based on the drug delivery platform and contains a micropump, driving electronics, wireless communication, a drug reservoir, and embedded sensors. The drug will be administered through a needle for subcutaneous delivery. A smartphone app was developed for drug dose control and data feedback.
4. Next-generation ultrasound – Smart ultrasound
In this work package, adaptable ultrasound front ends have been developed. Combined with deep-learning algorithms, these create closed-loop ultrasound diagnostic systems that fully utilize the advantages of affordable 3D MEMS ultrasound platform technology. At transducer level, 3D MEMS ultrasound platform integration and industrialization is brought to the next level.
5. Towards X-ray free surgery – Advanced optical tracking
In this work package, two demonstrators were realized. In the first place, a backloadable optical shape sensing (OSS) system was demonstrated that is compatible with clinical practice (e.g. sterility requirements). The backloadable OSS system will truly make OSS a universal and open platform. Secondly, the optical instrument tracking system was demonstrated.
6. Continuous monitoring – A bed monitoring platform
The bed monitoring platform developed in Moore4Medical comprises an AI-based platform consisting of an array of sensing devices that jointly gather data from the same patient, and that make use of limited resources such as power. Next to the first use-case, namely the detection of atrial fibrillation, in another use-case the detection of sleeping disorders has been investigated. In addition, a smart, open E2E security and privacy platform has been demonstrated.
Realizing these demonstrators will be instrumental in the development, introduction, and acceptance of open technology platforms for emerging medical devices and these will:
• Expand Europe’s leadership as innovator in medical device technology
• Create new opportunities to increase the competitiveness of the ECS industry
• Help manage the increasing cost of healthcare.
1. Implantable devices – a platform for ultrasound power transfer
The ultrasound power transfer system has been demonstrated in an implant that will monitor bone healing. The implant is part of a bone plate that is surgically attached to the bone. Deformation of the plate yields important information about the healing process. The implant uses biocompatible optimized MEMS ultrasound transducers to convert the acoustic pressure to electric energy. The system includes focused ultrasound to deliver the power, and power management ASICs. Finally, ultrasound power transfer was benchmarked against inductive power transfer.
2. Organ on Chip – a smart well plate platform
Using the smart well plate platform three demonstrator groups have been realized:
• The versatility of the smart well plate platform was demonstrated with a perfused MEA array, an organoid OoC and a skin-on-chip model;
• The advanced electrophysiology platform was demonstrated with a cardiotoxicity assay;
• The smart well plate lid was demonstrated with a multi-spheroid assay.
3. Drug adherence – intelligent drug delivery
A pen-based smart drug delivery demonstrator has been realized. The demonstrator is based on the drug delivery platform and contains a micropump, driving electronics, wireless communication, a drug reservoir, and embedded sensors. The drug will be administered through a needle for subcutaneous delivery. A smartphone app was developed for drug dose control and data feedback.
4. Next-generation ultrasound – Smart ultrasound
In this work package, adaptable ultrasound front ends have been developed. Combined with deep-learning algorithms, these create closed-loop ultrasound diagnostic systems that fully utilize the advantages of affordable 3D MEMS ultrasound platform technology. At transducer level, 3D MEMS ultrasound platform integration and industrialization is brought to the next level.
5. Towards X-ray free surgery – Advanced optical tracking
In this work package, two demonstrators were realized. In the first place, a backloadable optical shape sensing (OSS) system was demonstrated that is compatible with clinical practice (e.g. sterility requirements). The backloadable OSS system will truly make OSS a universal and open platform. Secondly, the optical instrument tracking system was demonstrated.
6. Continuous monitoring – A bed monitoring platform
The bed monitoring platform developed in Moore4Medical comprises an AI-based platform consisting of an array of sensing devices that jointly gather data from the same patient, and that make use of limited resources such as power. Next to the first use-case, namely the detection of atrial fibrillation, in another use-case the detection of sleeping disorders has been investigated. In addition, a smart, open E2E security and privacy platform has been demonstrated.
Realizing these demonstrators will be instrumental in the development, introduction, and acceptance of open technology platforms for emerging medical devices and these will:
• Expand Europe’s leadership as innovator in medical device technology
• Create new opportunities to increase the competitiveness of the ECS industry
• Help manage the increasing cost of healthcare.