Periodic Reporting for period 2 - VDS (VDS Validated Disinfection System: Revolutionary Automated Thermal system for Surface Disinfection of Hospital equipment)
Período documentado: 2021-06-01 hasta 2022-05-31
Healthcare Associated Infections (HAI) are a growing problem. More and more patients who receive care in a hospital are becoming ill because of an infection they contract in that hospital. So they get sicker than they already were. Many of these infections are preventable. According to WHO reports, next to (the lack of good) hand hygiene, are the bed and mattress part of the second most important reason that bacteria are transmitted and patients get an infection.
Patients deserve the best care in the safest environment. And care providers also want to provide the best care. In order to be able to continue to guarantee this in the future, preconditions are needed so that this is possible. If this is not done, there will be a further increase in the number of patients who will become ill and may even die. The European Centre for Disease Prevention and Control estimate that on any given day, about 80,000 people across Europe contract at least one HAI. The World Health Organization states every year 37,000 people in Europe die (99,000 in the USA) as a result of an infection contracted in a hospital. Annual financial losses are estimated at ~€7 billion in Europe, reflecting 16 million extra days of hospital stay and $6.5 billion in the USA.
The COVID-19 pandemic claimed millions of lives and changed the ways in which we live, work and travel. A positive effect is that it has really become clear that good hygiene is of vital importance. It is too early to substantiate, but we trust that infection prevention and control will become an even more important topic on the agenda of hospitals. And that hospitals will not miss an opportunity to further minimize the risk of infections.
Our goal is to make a substantial contribution to creating that safe environment in which the best care can be provided. Patients should receive their care in the best bed that is cleaned and disinfected to the highest standard. We do this with the VDS (Validated Disinfection System). We use the VDS to clean and disinfect all types of beds and mattresses that are used in hospitals in a validated manner.
By utilizing robots and steam, we are able to kill micro-organisms by applying surface disinfection from 3 centimetres away. The steam has a contact temperature of no less than 85 degrees Celsius.
By this, we fight against passing HAI's via the bed and mattress. By using steam we ensure that all type of beds, even the most advanced beds equipped with electronics can be processed in the VDS. As the VDS follows the same cleaning program every time, the results can be reproduced and validated.
As the efficient cleaning process uses steam for thermal disinfection rather than chemicals we are able to operate at a much lower carbon footprint. Consumption of both energy and water is up to 80% lower than traditional solutions. On top the VDS is the only bed washing system in the world that does not use any chemical cleaning agents.
Patients deserve the best care in the safest environment. And care providers also want to provide the best care. In order to be able to continue to guarantee this in the future, preconditions are needed so that this is possible. If this is not done, there will be a further increase in the number of patients who will become ill and may even die. The European Centre for Disease Prevention and Control estimate that on any given day, about 80,000 people across Europe contract at least one HAI. The World Health Organization states every year 37,000 people in Europe die (99,000 in the USA) as a result of an infection contracted in a hospital. Annual financial losses are estimated at ~€7 billion in Europe, reflecting 16 million extra days of hospital stay and $6.5 billion in the USA.
The COVID-19 pandemic claimed millions of lives and changed the ways in which we live, work and travel. A positive effect is that it has really become clear that good hygiene is of vital importance. It is too early to substantiate, but we trust that infection prevention and control will become an even more important topic on the agenda of hospitals. And that hospitals will not miss an opportunity to further minimize the risk of infections.
Our goal is to make a substantial contribution to creating that safe environment in which the best care can be provided. Patients should receive their care in the best bed that is cleaned and disinfected to the highest standard. We do this with the VDS (Validated Disinfection System). We use the VDS to clean and disinfect all types of beds and mattresses that are used in hospitals in a validated manner.
By utilizing robots and steam, we are able to kill micro-organisms by applying surface disinfection from 3 centimetres away. The steam has a contact temperature of no less than 85 degrees Celsius.
By this, we fight against passing HAI's via the bed and mattress. By using steam we ensure that all type of beds, even the most advanced beds equipped with electronics can be processed in the VDS. As the VDS follows the same cleaning program every time, the results can be reproduced and validated.
As the efficient cleaning process uses steam for thermal disinfection rather than chemicals we are able to operate at a much lower carbon footprint. Consumption of both energy and water is up to 80% lower than traditional solutions. On top the VDS is the only bed washing system in the world that does not use any chemical cleaning agents.
With the granting of the subsidy, we were able to develop the VDS from prototype to product. The developments that we have implemented in focus on a number of areas:
• Mechanical completion
• Finalize software development
• CE marking for medical devices (MDD)
• Implement QMS ISO 13485 implementation and certification
• Perform external validation such as ISO 15883-6
• Patent application for (parts) of the VDS
• Elaborate go-to-market strategy as part of our sales & marketing strategy
By going through the above parts, we should be able to put the VDS on the market in a checked and validated manner.
We have achieved the following results:
• VDS production 0-model completed (mechanical)
• Software to control VDS is completed
• Start use the VDS in hospital in Denmark and Germany enables us to focus on reliability and durability. So far, with the normal mechanical issues and software bugs, expected, the VDS works completely autonomous and meets the standards we have set.
• The VDS has been successfully certified as a Medical Device under the MDD. By this, it can officially be sold in the EU market.
• Weber Hospital Systems QMS has a certified Quality Management System for the design and manufacture of Medical Devices under the ISO13485
• ISO 15883-6 has been validated by Agidens Belgium.
• Two patent applications have been submitted.
• We are now successfully selling the VDS in Denmark, Norway, Germany and Switzerland in particular. The VDS is now in use in Denmark and Germany and we will install it in other countries in the coming months. In 24 months we will have 10 VDS machines in use and we expect to have signed new contracts.
• There is a demand from hospitals for complementary products such as automatic (un)loading of the beds, for which we have immediately introduced a solution
• We have developed a strategy whereby we will start the roll-out of our proposition, especially in DACH, Scandics and Benelux. We do this together with a marketing agency that helps us set up and roll out activities that will lead to new contracts. Unfortunately, Covid-19 has thwarted our original plans and we have had to adapt our strategy. Where we first wanted to get in touch with our target group mainly through trade fairs and conferences, we now have to do that online. Together with our partner the first campaigns are prepaired.
• The first distributor contracts are signed for the UK and Hungary.
• Mechanical completion
• Finalize software development
• CE marking for medical devices (MDD)
• Implement QMS ISO 13485 implementation and certification
• Perform external validation such as ISO 15883-6
• Patent application for (parts) of the VDS
• Elaborate go-to-market strategy as part of our sales & marketing strategy
By going through the above parts, we should be able to put the VDS on the market in a checked and validated manner.
We have achieved the following results:
• VDS production 0-model completed (mechanical)
• Software to control VDS is completed
• Start use the VDS in hospital in Denmark and Germany enables us to focus on reliability and durability. So far, with the normal mechanical issues and software bugs, expected, the VDS works completely autonomous and meets the standards we have set.
• The VDS has been successfully certified as a Medical Device under the MDD. By this, it can officially be sold in the EU market.
• Weber Hospital Systems QMS has a certified Quality Management System for the design and manufacture of Medical Devices under the ISO13485
• ISO 15883-6 has been validated by Agidens Belgium.
• Two patent applications have been submitted.
• We are now successfully selling the VDS in Denmark, Norway, Germany and Switzerland in particular. The VDS is now in use in Denmark and Germany and we will install it in other countries in the coming months. In 24 months we will have 10 VDS machines in use and we expect to have signed new contracts.
• There is a demand from hospitals for complementary products such as automatic (un)loading of the beds, for which we have immediately introduced a solution
• We have developed a strategy whereby we will start the roll-out of our proposition, especially in DACH, Scandics and Benelux. We do this together with a marketing agency that helps us set up and roll out activities that will lead to new contracts. Unfortunately, Covid-19 has thwarted our original plans and we have had to adapt our strategy. Where we first wanted to get in touch with our target group mainly through trade fairs and conferences, we now have to do that online. Together with our partner the first campaigns are prepaired.
• The first distributor contracts are signed for the UK and Hungary.
Based on the first sales we foresee growth as an employer in the region. In concrete terms, this means that we will create employment from which our region should benefit. Because we have to take care of the production of the machines that have already been sold for the next 24 months and we also expect to conclude new contracts in the coming months, we will have to invest in setting up our organization.
As the market is getting to know our solution we see an increasing interest in applying steam in disinfection processes rather than chemical cleaning agents. This gives us the confidence that we have a right to exist, can grow further and can market products using steam technology.
On the other hand, we do feel the effects of COVID-19 in the short term. Over the last 12months+ hospitals have been focusing on the pandemic, limiting us in reaching the market to the extent we want. Next to this, people are hard to find and we face delivery issues with suppliers due to shortages in the market. Delays in delivery are today unfortunately common, meaning we have to anticipate on demand to prevent production disruptions.
It is positive to report that the hospitals we come in contact with are in almost all situations incredibly positive in their response to the VDS. Meaning creating awareness in the market should lead to a very good competitive position for selling the VDS.
As the market is getting to know our solution we see an increasing interest in applying steam in disinfection processes rather than chemical cleaning agents. This gives us the confidence that we have a right to exist, can grow further and can market products using steam technology.
On the other hand, we do feel the effects of COVID-19 in the short term. Over the last 12months+ hospitals have been focusing on the pandemic, limiting us in reaching the market to the extent we want. Next to this, people are hard to find and we face delivery issues with suppliers due to shortages in the market. Delays in delivery are today unfortunately common, meaning we have to anticipate on demand to prevent production disruptions.
It is positive to report that the hospitals we come in contact with are in almost all situations incredibly positive in their response to the VDS. Meaning creating awareness in the market should lead to a very good competitive position for selling the VDS.