Periodic Reporting for period 1 - i-LiveRest (Intelligent control system based on smart textiles to reduce pressure ulcer risk by real time measuring of tissue viability and intelligent trigger of prevention strategies adapted to user and context)
Berichtszeitraum: 2015-09-01 bis 2016-01-31
Pressure ulcers (PU) are localised injuries in the skin and/or underlying tissue initiated by a sustained impaired blood flow, which are difficult to stop/revert and can penetrate until bone.
85% of Spinal Cord Injury (SCI) patients relying on wheelchairs (380,000 in Europe with 11,000 new cases per year) will develop a PU during their lifetime, and 7-8% will die out of the associated complications. SCI sufferers do not dispose of the natural mechanisms of healthy users that prevent the formation of PU. Suffering PU leads to: a) deterioration of health, b) social exclusion due to the pain and odour caused by PU, c) reduction of independent living, d) diminution of the quality of life, and e) depression (due to all the aforementioned problems).
Treating PU is difficult, risky and expensive. PU treatment costs are above €20 billion per year for the European Public Health System, and proportional costs for private insurances. However, prognosis is excellent at early stages because PU usually heal by itself once the risk is removed. While 95% of all PU are considered preventable, no concluding evidence confirms that current devices are effective in the prevention of PU (38.5% of PU appeared while the person was using one of those preventive devices). The cause is that current prevention devices rely on reducing pressure without measuring real Tissue Viability (TV), and perform predefined movement patterns instead of adapting strategies to each user and context. Nowadays, only specialised care provided by trained caregivers is proven to be effective. Nevertheless, this solution is time consuming and cause injuries to the caregivers (due to the need to lift high loads). For instance, nurse back injuries cost an estimated €16 billion annually in worker's compensation benefits; while the cost add-up of medical treatment, loss of work days, light duty and employee turnover cost an extra €10 billion.
In the aforementioned context, QIMOVA, one of the most innovative companies on personalised and adapted wheelchair solutions, solved the problem. Extensive research and development has been conducted by the company, giving as a result a validated prototype of ICT PU prevention system embedded on a wheelchair that demonstrated its unprecedented effectiveness for PU prevention. The objective of Qimova is to validate, produce and commercialise i-LiveRest system, a disruptive ITC project that is able to avoid the development of PU.
85% of Spinal Cord Injury (SCI) patients relying on wheelchairs (380,000 in Europe with 11,000 new cases per year) will develop a PU during their lifetime, and 7-8% will die out of the associated complications. SCI sufferers do not dispose of the natural mechanisms of healthy users that prevent the formation of PU. Suffering PU leads to: a) deterioration of health, b) social exclusion due to the pain and odour caused by PU, c) reduction of independent living, d) diminution of the quality of life, and e) depression (due to all the aforementioned problems).
Treating PU is difficult, risky and expensive. PU treatment costs are above €20 billion per year for the European Public Health System, and proportional costs for private insurances. However, prognosis is excellent at early stages because PU usually heal by itself once the risk is removed. While 95% of all PU are considered preventable, no concluding evidence confirms that current devices are effective in the prevention of PU (38.5% of PU appeared while the person was using one of those preventive devices). The cause is that current prevention devices rely on reducing pressure without measuring real Tissue Viability (TV), and perform predefined movement patterns instead of adapting strategies to each user and context. Nowadays, only specialised care provided by trained caregivers is proven to be effective. Nevertheless, this solution is time consuming and cause injuries to the caregivers (due to the need to lift high loads). For instance, nurse back injuries cost an estimated €16 billion annually in worker's compensation benefits; while the cost add-up of medical treatment, loss of work days, light duty and employee turnover cost an extra €10 billion.
In the aforementioned context, QIMOVA, one of the most innovative companies on personalised and adapted wheelchair solutions, solved the problem. Extensive research and development has been conducted by the company, giving as a result a validated prototype of ICT PU prevention system embedded on a wheelchair that demonstrated its unprecedented effectiveness for PU prevention. The objective of Qimova is to validate, produce and commercialise i-LiveRest system, a disruptive ITC project that is able to avoid the development of PU.
The objective of Qimova is to validate, produce and commercialise i-LiveRest system, a disruptive ITC project that is able to avoid the development of PU. T-SCI patients and their friends and family, caregivers, hospitals and public health system are the main beneficiaries of this development. To achieve this objective, during SMEI´s Phase 1 a project has been conducted with the following overall objectives:
• To obtain a commercial product with free marketability and to adapt conveniently the production system
• To optimize the market strategy and to grow the commercial network
• To achieve market recognition by making all players of the value chain aware of the benefits of the i-LiveRest system
The work performed and advances during Phase 1 project are:
A. Technical advances
The key competitive advantage of i-LiveRest system is the fact that allows a reliable real time monitoring of the tissue viability (impedance measurement has been validated with a gold standard), and if the risk level increases is able to propose and apply the best strategies, deepening on user characteristics and preferences and use context, to reduce the risk to a low level. A preclinical validation procedure took place during the FP7 PUMA Project. The results of the validation show that i-LiveRest system allows maintaining low levels of risk during long periods and without excessive use of the most reclined positions, which would hamper daily life activities.
During Phase 1, a more robust and controllable control system has been designed to increase precision in cushion´s pressure distribution and minimise failure risks. In addition, during PUMA´s the pre-clinical validation, usability comments were gathered, and they have been taken into account and tested separately during system optimization process held during SMEI Phase 1 i-LiveRest Project.
B. Regulatory aspects
i-LiveRest is classified in the field of medical devices as Class IIa (medium-low risk) because is an active device intended to administer or exchange energy in a non-hazardous way (pants with electro-stimulation), taking into consideration Rule 9 of Annex IX of COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices. During phase 1, the risk analysis was updated according to the Standard EN-ISO 14971:2012 “Medical devices. Application of risk management to medical devices”, which is the reference standard to perform a risk analysis in medical devices. The risk analysis identified the main risks related to the product and its proposed mitigation measures.
C. Clinical Investigation (Clinical Trials)
In order to get the most out of this opportunity, the clinical validation of the final product has to be thoroughly and accurately designed. In order to plan it, the strategy for the clinical validation of the commercial product has been developed during Phase 1 in close collaboration with 2 reference European hospitals : Toledo Hospital (Spain) and Stoke Mandeville Hospital (UK).
D. Commercial advancements
On site visits across Europe have been made to meet renowned personalities in well-positioned entities within the field of SCI and PU prevention and treatment. Several successful meetings took place, some of them resulting in agreements for direct collaboration in the clinical investigation work.
During the last year, Qimova’s CEO of the company (Mr. Henrik Grauslund) and his team performed high-level market research based on field work, and performed training activities related with the deployment of i-LiveRest business unit In addition, initial meetings with 10 of the top-ranked smart textiles producers and developers have been held in order to bring positions closer for a possible future alliance. After several joint meetings to discuss technical and partnership issues, two companies were selected and agreed in joining the project. Qimova’s distribution network has also been increased.
• To obtain a commercial product with free marketability and to adapt conveniently the production system
• To optimize the market strategy and to grow the commercial network
• To achieve market recognition by making all players of the value chain aware of the benefits of the i-LiveRest system
The work performed and advances during Phase 1 project are:
A. Technical advances
The key competitive advantage of i-LiveRest system is the fact that allows a reliable real time monitoring of the tissue viability (impedance measurement has been validated with a gold standard), and if the risk level increases is able to propose and apply the best strategies, deepening on user characteristics and preferences and use context, to reduce the risk to a low level. A preclinical validation procedure took place during the FP7 PUMA Project. The results of the validation show that i-LiveRest system allows maintaining low levels of risk during long periods and without excessive use of the most reclined positions, which would hamper daily life activities.
During Phase 1, a more robust and controllable control system has been designed to increase precision in cushion´s pressure distribution and minimise failure risks. In addition, during PUMA´s the pre-clinical validation, usability comments were gathered, and they have been taken into account and tested separately during system optimization process held during SMEI Phase 1 i-LiveRest Project.
B. Regulatory aspects
i-LiveRest is classified in the field of medical devices as Class IIa (medium-low risk) because is an active device intended to administer or exchange energy in a non-hazardous way (pants with electro-stimulation), taking into consideration Rule 9 of Annex IX of COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices. During phase 1, the risk analysis was updated according to the Standard EN-ISO 14971:2012 “Medical devices. Application of risk management to medical devices”, which is the reference standard to perform a risk analysis in medical devices. The risk analysis identified the main risks related to the product and its proposed mitigation measures.
C. Clinical Investigation (Clinical Trials)
In order to get the most out of this opportunity, the clinical validation of the final product has to be thoroughly and accurately designed. In order to plan it, the strategy for the clinical validation of the commercial product has been developed during Phase 1 in close collaboration with 2 reference European hospitals : Toledo Hospital (Spain) and Stoke Mandeville Hospital (UK).
D. Commercial advancements
On site visits across Europe have been made to meet renowned personalities in well-positioned entities within the field of SCI and PU prevention and treatment. Several successful meetings took place, some of them resulting in agreements for direct collaboration in the clinical investigation work.
During the last year, Qimova’s CEO of the company (Mr. Henrik Grauslund) and his team performed high-level market research based on field work, and performed training activities related with the deployment of i-LiveRest business unit In addition, initial meetings with 10 of the top-ranked smart textiles producers and developers have been held in order to bring positions closer for a possible future alliance. After several joint meetings to discuss technical and partnership issues, two companies were selected and agreed in joining the project. Qimova’s distribution network has also been increased.
Pressure ulcers (PU) are localised injuries in the skin and/or underlying tissue initiated by a sustained impaired blood flow. An excessive or long-lasting pressure, shear or friction over the bony prominences trigger a vicious cycle with a set of stressors that is difficult to stop/revert and penetrates until bone (Grade 4).
85% of Spinal Cord Injury (SCI) patients relying on wheelchairs (380,000 in Europe with 11,000 new cases per year) will develop a PU during their lifetime, and 7-8% will die out of the associated complications. SCI sufferers do not dispose of the natural mechanisms of healthy users that prevent the formation of PU due to a) their lack of pain perception; b) their alterations in the Autonomous Nervous System (ANS); c) and their impossibility to perform postural changes. Suffering PU leads to: a) deterioration of health, b) social exclusion because of the pain and odour caused by PU, which are a stigma, c) reduction of independent living, d) diminution of the quality of life, and e) depression (due to all the aforementioned problems) .
Treating PU is difficult, risky and expensive. PU treatment costs are above €20 billion per year for the European Public Health System, and proportional costs for private insurances. However, prognosis is excellent at early stages because PU usually heal by itself once the risk is removed. Therefore, prevention and early detection are the most effective strategies with PU. While 95% of all PU are considered preventable, no concluding evidence confirms that current devices (from tilting systems to dynamic pressure release devices) are effective in the prevention of PU (38.5% of PU appeared while the person was using one of those preventive devices). The cause is that current prevention devices rely on reducing pressure without measuring real Tissue Viability (TV), and perform predefined movement patterns instead of adapting strategies to each user and context. Nowadays, only specialized care provided by trained or professional caregivers, which include frequent postural changes and physiotherapy sessions, are proven to be effective. Nevertheless, this solution has several drawbacks: they are time consuming (a postural change must be done every 20 minutes), and they cause injuries to the caregivers and/or health/social professionals that perform them, due to the high loads that they have to lift. For instance, nurse back injuries cost an estimated €16 billion annually in worker's compensation benefits; while the cost add-up of medical treatment, loss of work days, light duty and employee turnover cost an extra €10 billion.
In the aforementioned context, QIMOVA, one of the most innovative companies on personalised and adapted wheelchair solutions, solved the problem. Extensive research and development has been conducted by the company, giving as a result a validated prototype of ICT PU prevention system embedded on a wheelchair that demonstrated its unprecedented effectiveness for PU prevention. i-LiveRest system, the commercial product based on the PUMA prototype, will provide the following benefits:
• To Patients: To avoid the aforementioned health and social problems.
• To Caregivers: Ease the caregiving process and avoid injuries due to load manipulation.
• To health system: To minimize costs due to PU prevention & treatment (≈€20 billion/year)
• To society: To integrate T-SCI patients to society.
Economic benefits for stakeholders:
There are key features of our PU prevention system which can result in direct or indirect pecuniary benefits for the different players related to this product. Hereunder we summarize the most relevant i-LiveRest selling points that provide an added value to these segments as well as other related economic advantages.
1. Public Authorities:
• Reduction of public healthcare system costs: Estimated PU reduction due to i-LiveRest of 20% (20 million €) and leave free over 3,200 hospital beds per year. It is based on mean PU cost of 1.6-16.6 k€ per day (PU Grade 1-2) and mean PU heal days of 28-155.
• Reduction of 25% of injuries on health professionals due to repositioning of users.
• Labour force of a) SCI due ensuring the working capacity of 3,500 T-SCI people 30% of people with SCI retake labour after the injury, of whom 36% full-time, 25% part-time and the remaining 39% non-remunerated; b) T-SCI relatives who are expending most of their time, especially in the South of Europe, providing support and provide care to T-SCI.
2. Insurance companies and private hospitals: Proportional expense savings to Public Authorities due to health costs and time off work of their professionals and relatives with private insurance.
3. T-SCI users: Increases sitting time of TSCI (70%), which enhances independent living, social inclusion, employment and health preserving; as well improves quality of life and employability of relatives who support T-SCI users most of their time.
85% of Spinal Cord Injury (SCI) patients relying on wheelchairs (380,000 in Europe with 11,000 new cases per year) will develop a PU during their lifetime, and 7-8% will die out of the associated complications. SCI sufferers do not dispose of the natural mechanisms of healthy users that prevent the formation of PU due to a) their lack of pain perception; b) their alterations in the Autonomous Nervous System (ANS); c) and their impossibility to perform postural changes. Suffering PU leads to: a) deterioration of health, b) social exclusion because of the pain and odour caused by PU, which are a stigma, c) reduction of independent living, d) diminution of the quality of life, and e) depression (due to all the aforementioned problems) .
Treating PU is difficult, risky and expensive. PU treatment costs are above €20 billion per year for the European Public Health System, and proportional costs for private insurances. However, prognosis is excellent at early stages because PU usually heal by itself once the risk is removed. Therefore, prevention and early detection are the most effective strategies with PU. While 95% of all PU are considered preventable, no concluding evidence confirms that current devices (from tilting systems to dynamic pressure release devices) are effective in the prevention of PU (38.5% of PU appeared while the person was using one of those preventive devices). The cause is that current prevention devices rely on reducing pressure without measuring real Tissue Viability (TV), and perform predefined movement patterns instead of adapting strategies to each user and context. Nowadays, only specialized care provided by trained or professional caregivers, which include frequent postural changes and physiotherapy sessions, are proven to be effective. Nevertheless, this solution has several drawbacks: they are time consuming (a postural change must be done every 20 minutes), and they cause injuries to the caregivers and/or health/social professionals that perform them, due to the high loads that they have to lift. For instance, nurse back injuries cost an estimated €16 billion annually in worker's compensation benefits; while the cost add-up of medical treatment, loss of work days, light duty and employee turnover cost an extra €10 billion.
In the aforementioned context, QIMOVA, one of the most innovative companies on personalised and adapted wheelchair solutions, solved the problem. Extensive research and development has been conducted by the company, giving as a result a validated prototype of ICT PU prevention system embedded on a wheelchair that demonstrated its unprecedented effectiveness for PU prevention. i-LiveRest system, the commercial product based on the PUMA prototype, will provide the following benefits:
• To Patients: To avoid the aforementioned health and social problems.
• To Caregivers: Ease the caregiving process and avoid injuries due to load manipulation.
• To health system: To minimize costs due to PU prevention & treatment (≈€20 billion/year)
• To society: To integrate T-SCI patients to society.
Economic benefits for stakeholders:
There are key features of our PU prevention system which can result in direct or indirect pecuniary benefits for the different players related to this product. Hereunder we summarize the most relevant i-LiveRest selling points that provide an added value to these segments as well as other related economic advantages.
1. Public Authorities:
• Reduction of public healthcare system costs: Estimated PU reduction due to i-LiveRest of 20% (20 million €) and leave free over 3,200 hospital beds per year. It is based on mean PU cost of 1.6-16.6 k€ per day (PU Grade 1-2) and mean PU heal days of 28-155.
• Reduction of 25% of injuries on health professionals due to repositioning of users.
• Labour force of a) SCI due ensuring the working capacity of 3,500 T-SCI people 30% of people with SCI retake labour after the injury, of whom 36% full-time, 25% part-time and the remaining 39% non-remunerated; b) T-SCI relatives who are expending most of their time, especially in the South of Europe, providing support and provide care to T-SCI.
2. Insurance companies and private hospitals: Proportional expense savings to Public Authorities due to health costs and time off work of their professionals and relatives with private insurance.
3. T-SCI users: Increases sitting time of TSCI (70%), which enhances independent living, social inclusion, employment and health preserving; as well improves quality of life and employability of relatives who support T-SCI users most of their time.