BIOEMTECH Success Story: Imaging system for preclinical research and advanced software for children radiation protection

We are happy to present the successful collaboration between BIOEMTECH and smartHEALTH. Through this partnership, BIOEMTECH effectively addressed its digital challenges, accelerating the preclinical research, for promising drugs, through high-quality services and products.

Key Information

BIOEMTECH is a preclinical CRO that aims to bridge the gap between ex vivo studies and in vivo molecular imaging, by providing cost effective solutions in terms of instrumentation and services. BIOEMTECH has developed and commercialized the “eyes”, the first desktop cameras, suitable for whole-body, real-time imaging of PET and SPECT isotopes in mice. In addition, BIOEMTECH undertakes full studies for evaluating new compounds in our authorized laboratories that include animal facility, in vitro lab, radiochemistry lab and in vivo imaging with microPET/SPECT/CT and optical imaging. BIOEMTECH clients include both Universities and Pharma companies. The company is GLP accredited for performing Toxicological studies and is licensed to use radioisotopes, hence capable of evaluating diagnostic and therapeutic radiopharmaceuticals.

• Technologies Used: Internet Services & Applications; Software Architectures, Preclinical Imaging systems
• Collaboration Period: April 2024 – February 2025
• Services Provided: Technical Guidance to assess the pre-clinical optical imaging system, Requirement Analysis, Consulting Services for the non-functional characteristics of its software, mainly for privacy and interoperability with other systems, as well as for the need for proper certification.

The Challenge

The vision of BIOEMTECH is to accelerate the preclinical research, for promising drugs, through high quality services and products. BIOEMTECH designs and manufactures a series of novel breakthrough imaging systems for preclinical studies, with small footprint, yet with increased capabilities. BIOEMTECH develops an application for clinicians to calculate the optimal safe dose for children, for medical imaging examinations with ionizing irradiation. The application exploits advanced Monte Carlo simulations, anthropomorphic computational phantoms and AI techniques to develop a realistic, simulated dosimetry database. The goal is to offer clinicians the possibility to assess internal pediatric dosimetry and optimize Nuclear Medical Imaging clinical protocols, in terms of personalized prediction models. For this application BIOEMTECH needed consultation for the non-functional characteristics of the software, mainly for privacy and interoperability with other systems, as well as to know about the need for proper certification.

The second challenge was to assess the pre-clinical optical imaging system that company offers, called “φ-eye”. The company requested from FORTH to evaluate the system in a variety of situations and work with the company’s scientists and engineers to design and implement features that could be added to optimize the system and test them on site. For the software used in the system, advise needed on the functionality, develop more system control capabilities and data analysis. For the testing, measures needed to improve drawbacks and limiting factors.

The Analysis

After discussing the needs, analyzing the BIOEMTECH‘s requirements and implementing the Digital Maturity Assessment (DMA) process, smartHEALTH experts proceeded with a systematic assessment of the existing situation.

The Solutions

smartHEALTH experts from two separate departments of FORTH dealt with the challenges. First, experts from CeHA, with extensive knowledge in developing software solutions for the health sector dealt with the needs of the company for the software. The experts provided consultation for 3 categories: 1) Scalability, Portability and Performance, 2) Compatibility and Interoperability, 3) Security and Privacy. 3 interviews took place in which the company representatives discussed these topics in detail. The experts provided a detailed report with the identified facts, potential risks, gaps and the standards needed to comply.

Second, for the “φ-eye” imaging system the Laboratory for Biophotonics and Molecular Imaging (LBMI) of FORTH took over. The laboratory worked on assessing the systems in terms of the ease of handling, functionality and performance in specific scenarios and under certain requirements. An “φ-eye” system was sent to the premises of LBMI for testing. An open communication was kept throughout the process with the company, with 6 online meetings and 1 in-person meeting organized. During these meetings feedback was provided on identified issues and new hardware add-on was proposed prompting the company to design and manufacture and was then implemented during the contract period. LBMI tested the system thoroughly for its functionality and performance, in realistic situations with in vivo and in-vitro (phantom) experiments. In vitro experiments were performed using a realistic three-layered mouse head phantom with a fluorescent inclusion at 3mm depth. During this process, the mouse was periodically scanned to assess tumour formation and for proof-of-concept visualization of tumour expansion. Detailed recommendations were also provided for the software, which will significantly enhance the operation of the imaging system.

The Implementation

First, the company received a detailed report for covering all aspects of proper software development. Out of this report we could mention the following results and benefits. The experts from EDIH concluded that the software should be certified as a Medical Device, under the Regulation (EU) 2017/745 – MDR. More specifically the software is falling under the class IIa. The company should also seek to comply with ISO 13485, for designing, developing and provide software for Health application. It will be also beneficial for the company to comply with ISO 9001 (already in place) and ISO 27001 for the safe management of information. The privacy issues should respect the articles 44, 45, 46 and 47 of the GDPR. The technical interoperability should follow the international standards set by HL7 and IHE.

Moreover, as far as concern the preclinical optical imaging system φ-eye, the company received detailed description related to end user workflow in preclinical studies and scientific guidance related to fluorescence and bioluminescence imaging optimizing quantification in the visible and NIR I window. Specific hardware components (i.e. ND filters, adjustable excitation intensity) will be included in the next version of the scanner along with major modifications in the SW that will provide new features related to workflow and post processing of the acquired data.

Lastly, an important added value to the system through this collaboration is a new feature that enhances the capabilities of the scanner by providing 3D information. Via a customized add-on setup and related scientific software implementation, the scanner will be able to provide 3 views of the imaging animal enhancing overall information in the final image.

The company has already taken measures to follow the recommendations regarding the compliance with the ISO/IEC 27001 (information security management) which is expected to be in place during the first semester 2025. In addition, the company is aiming to comply with ISO 13485 for medical devices.

The Benefits

The launch of the application is expected to offer a great social benefit. The application will allow clinicians to calculate the optimal safe dose for children, for medical imaging examinations with ionizing irradiation. This will have a significant impact for the health of children, protecting them from sore consequences of radiation.

The imaging system, with the advanced features, small footprint, low price and high accuracy allows more effective preclinical research, with less cost. This enables the development of more effective compounds that will lead in better drugs. Since the imaging system is small and highly automated allows scientists to work easily with it at their laboratories. The system is purely designed and produced in Europe, contributing also to the development of EU economy and competitiveness.

Lessons Learned

This case was delivered in a very smooth and efficient way. The EDIH worked with the many challenges posed by the company, rather successfully. The Key Account Manager who dealt with this case brought proper experts for working together with the people of the company and coordinated the process. The collaboration was also much beneficial for the company, helping the company to become more competitive.

A challenge that hasn’t yet worked is that the company is also interested to receive in the future one more service, for improving more the imaging system by comparing it to an advanced and expensive imaging device of FORTH. This wasn’t included in the action plan since it wasn’t mature enough at that time, but we hope that EDIH would be in the position to provide it in the next phase of it’s operation.

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