The d-LIVER project responded to European Commission FP7 ICT Call Objective 5.1 – Personal Health Systems which emphasized the target outcome of “Minimally invasive systems and ICT-enabled artificial organs” and in particular the requirement to address the need for artificial liver support through continuous detoxification as remote transient therapy at point of need, as stated in Target Outcome a3) Liver Failure.
The specific project impacts are discussed in detail below. However, in general, these can be summarised as follows:
- Reduced hospitalisation and improved disease management and treatment at the point of need, through more precise assessment of health status.
- Improved quality of life for liver patients.
- Economic benefits for health systems without compromising quality of care.
- Reinforced leadership and innovation of the industry in the area of Personal Health Systems and medical devices.
- Improved links and interaction between patients and doctors facilitating more active participation of patients in care processes.
- More effective bioartificial liver support as a result of having a viable, effective, economical, high quality source of human hepatocytes.
- Demonstrated potential for spin-offs with protected IP through several patent applications.
The liver is a complex organ with various vital functions in synthesis, detoxification and regulation; its failure therefore constitutes a life-threatening condition. Liver failure can either occur without preceding liver disease (acute liver failure), or as decompensation of a chronic liver-related illness.
The only long-term therapy in most cases is orthotopic liver transplantation, unless the liver is able to regenerate. Many patients, especially those who are not listed for high urgency transplantation, may not survive until a suitable donor organ is available, since donor organs are rare. In other cases, contraindications do not permit liver transplantation.
d-LIVER has fundamentally advanced an ICT-enabled system to remotely monitor and manage liver patients in their home, such that patient monitoring is continuous and intervention can be both swift and beneficial, leading to improved patient health and survival along with a significant enhancement of patient quality of life.
The innovative liver patient management system (LPMS) supplied with the sensor and instrumentation systems could lead to a completely new dimension of home care for the patient and a concomitant reduction in morbidity and mortality. The management and therapy of patients with chronic liver disease will thus be taken to a new level. As such, this system can control and adapt the dosage of specific drugs with or without confirmation by the physician according to up-to-date health data obtained from the patient. The LPMS can also alert the patient and the hospital when additional interventions or the next liver support session are required. Complications can be prevented by this strategy and costs conclusively reduced when the patient does not need to be admitted to the hospital.
Potentially, this could also be supplemented by the innovative and functioning bio-artificial liver system based on human progenitor cells which have been developed. This possibility would have an enormous impact on the bio-artificial liver field. Furthermore, it is envisaged that the progenitor cells would have exploitable opportunities in drug discovery, screening and toxicity studies in the pharmaceutical industry.
The success of d-LIVER will enhance the quality of healthcare at a European level and will improve European competitiveness in medical device technology.
The dissemination activities in d-LIVER achieved their goals in various ways; by collecting, collating and managing the information developed during the project, by disseminating the information as widely as possible via the production and distribution of press releases, newsletters, project flyers and technology updates throughout the course of the project. More specifically, these goals have been achieved through the organisation of Showcase Workshops in conjunction with a strong presence at major Trade Fairs and exhibitions such as AACC, MedTec, Mobile World Congress and Korea Eureka Day as well as a number of presentations and posters at major international conferences e.g. EASL and BASL and publication of articles in high quality scientific journals. As part of these activities an assessment of a Business Development Framework, including a Freedom to Operate analysis, has allowed the production of the Final Exploitation Plan and Technology Roadmap for the future commercialization of d‑LIVER results.
The concepts and ideas behind the d-LIVER project have also been disseminated on a broader level to general audiences through video interviews about d-LIVER which are available on the project website, Futuris and YouTube. Finally, news articles were published on the Futuris and Cordis websites and in national and local newspapers describing the concepts behind the project and its vision for the future of remote monitoring and management of chronic liver disease.
The d-LIVER systems can be viewed as disruptive technologies which could confer new breakthroughs in the world of information-enabled monitoring and management tools. As a consequence it was of particular importance to the project to undertake a coordinated effort to understand the marketplace, the barriers to entry and the competitive position, with the ultimate aim of producing a confidential d-LIVER Final Exploitation Plan and Technology Roadmap. IP protection has been continued for critical components of the systems, including aspects of a Freedom to Operate analysis in line with recommendations at both the systems and component levels. In order to carry this out effectively, d-LIVER needed to:
- Investigate how d-LIVER could impact the management of chronic liver disease and improve patient quality of life
- Assess how d-LIVER could address the economic burden of chronic liver disease
- Determine the most appropriate methods for commercial exploitation from the laboratory, through to remote management and therapy at the point of need
- Investigate market potential in the targeted clinical application area and for applications outside the area investigated in the project, bearing in mind that the d-LIVER approach might be regarded as a series of platform technologies
The Final Exploitation Plan was prepared which contained an overview of the potential for d‑LIVER monitoring and bioartificial liver support systems, along with details on the category drivers and competitors. Some of the main issues that need to be overcome were discussed and potential business models presented. Final commercialization recommendations were included and these, along with details of exploitation plans, were presented to the European Commission at the final Technical Review.
The complete public summary is available from here: Final (Periodic) Report (public summary).
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