Periodic Reporting for period 1 - AIR3D (Minimum viable product for automated 3D imaging reconstruction of the bladder and the bladder cancer)
Reporting period: 2021-04-01 to 2022-09-30
Bladder cancer (BCa) is the ninth most common malignancy globally, with an estimated 430.000 new diagnoses annually, while it has the highest lifetime treatment costs per patient of all cancers. Cystoscopy, the gold standard for bladder cancer screening, is an invasive technique that can miss diagnose of small tumours and carcinoma in situ. Therefore, many techniques have been introduced using alternative imaging methods or Artificial Intelligence techniques. Ultrasound (US) is one of the alternative technologies that become widely used among physicians and researchers being non-invasive, faster, safer and cheaper than magnetic resonance imaging and computer tomography. US allows for real-time diagnosis, positioning of medical device and visualization of the efficacy of surgical removal of the lesion, and being non-invasive also for multiple investigations during the follow-up of the patient. In the case of three-dimensional (3D) Ultrasound (US) volume reconstruction and visualization are still time-consuming (in particular for high-volume organ as bladder), being manual or semi-manual processes and requiring well trained people.
In the AIR3D we aim to explore the business potential of the EDIT software in order to bring it closer to the market and to its commercialization by preparing the ground for clinical phase. zThe AIR3D will deliver the go to market roadmap involving manufacturers of imaging devices and researchers, while early adopters will be involved to evaluate the software for its usability, efficiency and effectiveness. The activities that will be performed towards to that objective are analysed in the following sections and are completely differentiate from the activities foreseen in the EDIT work plan that includes development, dissemination and validation activities of novel technological platforms combining ultrasound elastography and photoacoustic imaging on the bladder instilled with targeted plasmonic gold sensors in preclinical models.
To move towards the commercialisation stage, the objectives of the AIR3D are to:
• Increase the use readiness of the innovation.
• Identify a detailed commercialisation approach.
• Prepare for going to market.
In the AIR3D we aim to explore the business potential of the EDIT software in order to bring it closer to the market and to its commercialization by preparing the ground for clinical phase. zThe AIR3D will deliver the go to market roadmap involving manufacturers of imaging devices and researchers, while early adopters will be involved to evaluate the software for its usability, efficiency and effectiveness. The activities that will be performed towards to that objective are analysed in the following sections and are completely differentiate from the activities foreseen in the EDIT work plan that includes development, dissemination and validation activities of novel technological platforms combining ultrasound elastography and photoacoustic imaging on the bladder instilled with targeted plasmonic gold sensors in preclinical models.
To move towards the commercialisation stage, the objectives of the AIR3D are to:
• Increase the use readiness of the innovation.
• Identify a detailed commercialisation approach.
• Prepare for going to market.
The Lean Start-up approach was adopted for the go to market approach, using the Lean Canvas as the main tool to define the business model.
The following methodological steps were undertaken during the AIR3D:
• Engage with early adopters in order to evaluate the EDIT software and finalise the MVP. Eventually, the software was tested by early adopters in order to feed the business strategy or trigger another cycle of development. Besides user evaluation, activities included also a roadmap for a proper cost-effective analysis and Health Technology Assessment that is crucial to transform the early adopters to potential customers.
• Define the exploitation and commercialisation strategy with a specific focus on feedbacks from the early adopters. META Group supported LIME and OSR in such a critical task and acted as a mentor to the involved researchers. Exploitation options such as licencing the technology vs. selling the software was investigated and evaluated against availability of resources, commitment of the managing team, financial projections, etc.
• Using the investor readiness approach to access additional funding needed to go to market, after the end of the project. The AIR3D included activities to facilitate access to both investors and potential commercial partners, as well as activities towards the preparation of the establishment of a joint venture in order to exploit the innovative EDIT software, handling, also, IPR among involved partners.
• Finally, gender issues were taken into consideration and effort was taken to involve users with an equal male to female ratio in the evaluation studies of the early adopters.
AIR3D with the help of the Technology Transfer Office of the OSR developed the exploitation plan. A roadmap identifying the most important activities (with responsibilities, milestones and resources needed) was prepared to proceed to the next stage right after the end of the AIR3D. The AIR3D assessed the value of the IP asset to integrate the business plan with such information. The unique value proposition of the novel solution (using the value proposition canvas methodology) was prepared and validated to prepare the main dissemination materials. Channels to reach out early adopters connected to US and PA equipment manufacturers and providers and pre-clinical Research Institutes were defined. A pitch for presenting the solution to private investors was also prepared.
The following methodological steps were undertaken during the AIR3D:
• Engage with early adopters in order to evaluate the EDIT software and finalise the MVP. Eventually, the software was tested by early adopters in order to feed the business strategy or trigger another cycle of development. Besides user evaluation, activities included also a roadmap for a proper cost-effective analysis and Health Technology Assessment that is crucial to transform the early adopters to potential customers.
• Define the exploitation and commercialisation strategy with a specific focus on feedbacks from the early adopters. META Group supported LIME and OSR in such a critical task and acted as a mentor to the involved researchers. Exploitation options such as licencing the technology vs. selling the software was investigated and evaluated against availability of resources, commitment of the managing team, financial projections, etc.
• Using the investor readiness approach to access additional funding needed to go to market, after the end of the project. The AIR3D included activities to facilitate access to both investors and potential commercial partners, as well as activities towards the preparation of the establishment of a joint venture in order to exploit the innovative EDIT software, handling, also, IPR among involved partners.
• Finally, gender issues were taken into consideration and effort was taken to involve users with an equal male to female ratio in the evaluation studies of the early adopters.
AIR3D with the help of the Technology Transfer Office of the OSR developed the exploitation plan. A roadmap identifying the most important activities (with responsibilities, milestones and resources needed) was prepared to proceed to the next stage right after the end of the AIR3D. The AIR3D assessed the value of the IP asset to integrate the business plan with such information. The unique value proposition of the novel solution (using the value proposition canvas methodology) was prepared and validated to prepare the main dissemination materials. Channels to reach out early adopters connected to US and PA equipment manufacturers and providers and pre-clinical Research Institutes were defined. A pitch for presenting the solution to private investors was also prepared.
The main impacts generated from the AIR3D are:
- Increased value creation from FET projects by picking up innovation opportunities: The results obtained in the EDIT project are used to release a precommercial prototype that is tested in a market environment and finalized to be offered as a stand-alone product (AIR3D).
- Improved societal and market acceptance of concrete high-potential innovations from FET projects: Acceptance of the new software is verified with early adopters through an MVP. The extent of economic and societal benefits resulting from the new software is multiple. It will:
• reduce the rate of error in the interpretation of the biomedical imaging allowing easier recognition of otherwise poorly recognizable neoplasia. This leads to increase early diagnosis of tumours and assist monitoring of bladder cancer progression
• reduce the use of animals in experiments (saving resources and money)
• reduce time needed for diagnosis due to the elimination of the preparation and extraction of 2D frames and their reconstruction into a 3D model (this step is generally performed by well-trained staff)
• reduce costs of hospitals/medical centres for use of “skilled operators” for management of 3D US devices, since the process is fully automated
- Stimulating, supporting and rewarding an open and proactive mind-set towards exploitation beyond the research world: Staff of LIME and OSR were supported through capacity building provided by META to cultivate their entrepreneurial mind-set and improve their business skills. The current R&D team was structured into a business-oriented team. The experience of LIME and OSR teams and related lessons learned will be disseminated to the wider FET-OPEN and research community to raise awareness on exploitation of research results.
- Contributing to the competitiveness of European industry/economy by seeding future growth and the creation of jobs from FET research: The project included suitable measures for taking the newly developed software beyond the research dimension, including through engagement with early stage adopters, investors and potential customers. The establishment of a new joint venture will be investigated among LIME and OSR.
- Increased value creation from FET projects by picking up innovation opportunities: The results obtained in the EDIT project are used to release a precommercial prototype that is tested in a market environment and finalized to be offered as a stand-alone product (AIR3D).
- Improved societal and market acceptance of concrete high-potential innovations from FET projects: Acceptance of the new software is verified with early adopters through an MVP. The extent of economic and societal benefits resulting from the new software is multiple. It will:
• reduce the rate of error in the interpretation of the biomedical imaging allowing easier recognition of otherwise poorly recognizable neoplasia. This leads to increase early diagnosis of tumours and assist monitoring of bladder cancer progression
• reduce the use of animals in experiments (saving resources and money)
• reduce time needed for diagnosis due to the elimination of the preparation and extraction of 2D frames and their reconstruction into a 3D model (this step is generally performed by well-trained staff)
• reduce costs of hospitals/medical centres for use of “skilled operators” for management of 3D US devices, since the process is fully automated
- Stimulating, supporting and rewarding an open and proactive mind-set towards exploitation beyond the research world: Staff of LIME and OSR were supported through capacity building provided by META to cultivate their entrepreneurial mind-set and improve their business skills. The current R&D team was structured into a business-oriented team. The experience of LIME and OSR teams and related lessons learned will be disseminated to the wider FET-OPEN and research community to raise awareness on exploitation of research results.
- Contributing to the competitiveness of European industry/economy by seeding future growth and the creation of jobs from FET research: The project included suitable measures for taking the newly developed software beyond the research dimension, including through engagement with early stage adopters, investors and potential customers. The establishment of a new joint venture will be investigated among LIME and OSR.