CE certification for DemcAir ventilator

The DemcAir ventilator received the CE certification last month. In March, we started an accelerated development process to realize a ventilation system that is suitable for corona patients in intensive care (IC). Thanks to intensive cooperation with the Dekra (the certification body), who, among other things, allowed us to monitor the preparation of the technical documentation and risk management, we were able to deliver the first systems within a month and 500 systems to the Dutch government soon after. These systems were not yet medically certified, but they were safe and functional. The certification follows exactly six months after the start of the development process.

Minister Van Rijn receives first ventilation system on behalf of the Dutch government at Demcon in Best

Today, Minister Van Rijn, responsible for Medical Care and Sport in the Dutch Ministry of Health, Welfare and Sport, visited the location of Demcon in Best. There, on behalf of the Dutch government, he received the first ventilation system from Dennis Schipper, CEO of Demcon. In total Demcon will deliver 500 ventilation systems that the government will distribute among the hospitals who need them. The ventilation systems are only meant for coronapatients on the intensive care.

Prior to the handover, Van Rijn was informed about the development and production process of the DemcAir ventilation system by, among others, Dennis Schipper and other employees from the project team. Representatives of some of the hospitals who participated in the (pre)clinical tests, namely the Catharina Hospital in Eindhoven, the Erasmus Medical Center in Rotterdam and the Isala in Zwolle, shared their experiences with the system. In addition, Van Rijn was given a tour of the production facilities where employees were fully engaged in the assembly of the systems.

First ventilation systems delivered by Demcon

Demcon develops, produces and tests complete system in the Netherlands within one month

Technology developer and producer Demcon delivered its first batch of ventilation systems. Within the space of one month, Demcon succeeded in developing, producing and testing a complete ventilation system in the Netherlands that is suitable for the respiration of coronavirus patients in intensive care. The Ministry of Health, Welfare and Sport will distribute the system among the nation’s hospitals. Soon, Demcon will supply a total of 500 ventilation systems. “The government took a leap of faith in placing an order for 500 systems with us, because although we already have a lot of knowledge of and experience with ventilation technology and modules, we have never supplied a complete ventilation system before,” says Demcon CEO Schipper. “Our employees have lived up to that trust, with every possible effort, sometimes working day and night. I am pleased that we can contribute to the great challenge of this moment – the optimal treatment of patients. This use of technological knowledge to solve social issues is in our DNA.”

The DemcAir ventilation system is based on the unique ventilation technology that Demcon macawi respiratory systems has developed for use in the treatment of every patient, from preterm to adult. The individual ventilation modules have been in production at Demcon for many years, but until now, Demcon was supplying these modules to manufacturers of respiratory systems in Germany, the US, Mexico, China and Japan. Demand from China had already increased strongly at the end of January, and now production has been scaled up considerably. Various measures have been taken to facilitate this: the expansion of the number of production lines, more intensive collaboration with suppliers, and the training of production employees, from Demcon and fellow companies.

Fully-fledged ventilation system
In addition to these modules, Demcon has now developed a fully-fledged ventilation system, in the Netherlands, for the treatment of (young) adults. Demcon started preparations on Thursday, 19 March, and on Sunday, 22 March, the ministry ordered 500 systems to be delivered. After successful clinical testing on several patients, the first units have now been delivered – within one month.

Medical product development
That one-month period is exceptionally short, says CEO Dennis Schipper. “Even though we had the ventilation module available and we built the complete system as simply as possible, it is and will remain complex. Such a ventilation system is vital for ICU care, must be 100% safe for the patient and easy to operate by doctors and nurses. We have therefore paid a lot of attention to its safety and ease of operation, and have tested it carefully. In doing so, we were able to build on the experience that we have gained over the past ten years with medical product development in projects that usually last many months to several years. In particular, our expertise in quality assurance and experience in certifying medical products were now crucial.”

National expert group
Speed and care must continue to go hand in hand, agrees Lieke Poot, clinical physicist at the Isala hospitals in the Zwolle region and president of the Dutch Association for Clinical Physics. Clinical physicists are responsible for the reliability and safety of medical equipment in hospitals. On behalf of the Federation of Medical Specialists, Poot is a member of the national expert group for respiratory equipment at the Ministry of Health, Welfare and Sport (VWS). “The expert group lists which devices from outside hospitals are suitable for intensive care, assesses offers from existing suppliers and guides manufacturing initiatives. A lot of smart people and companies want to help and come up with inventive ideas. It’s nice to observe that everyone is in solution mode. This is life-supporting equipment, so as an expert group we have to see whether something works well and contributes to patient treatment.” In that respect Demcon has a big lead, according to Poot. “They have a lot of experience with the mechanical part, the ventilation module that has been used in practice for years. We were confident that they could build a housing and software around it in a short time; that’s why we advised VWS to order 500 systems.”

Pressure cooker procedure
A manufacturing process for a medical device, including clinical tests and certification, can normally take up to a year or more, Poot explains. “Now we are following a kind of pressure cooker procedure, in which we cannot fully follow the applicable laws and regulations, yet we have to arrive at a safe and functional product. We developed this procedure gradually, in an intensive collaboration with Demcon. We are mutually very transparent and at our request they have had Dekra (the notified body, ed.) take part in the preparation of the technical documentation and risk management. As a result, some sort of certification has already taken place, while usually the documentation only goes to Dekra when a design has been completed. Everyone acknowledges the importance of speed, so we can realise things that normally cannot be realised in such a short time. We also asked Demcon to conduct the clinical tests in three hospitals, of course with the consent of the patients. This allowed people from different angles and with different protocols to participate in the tests. That broader view of end users is necessary, particularly now; they have to confirm whether a product can be used clinically.”

Intensive collaborations
The DemcAir ventilation system was created thanks to intensive collaborations, Schipper emphasises. “Firstly, within our company between numerous colleagues spread over different locations.” The same applies, as Poot declares, to Demcon’s close collaboration with the government as its commissioner. Schipper says, “Communication lines are short; we can consult quickly with the people of the National Consortium for Resources [Landelijk Consortium Hulpmiddelen] and the expert group at the ministry.” Poot adds, “Everyone puts their shoulders to the wheel; there is trust and openness towards each other. Normally, a company like Demcon would think more about the confidentiality of its documentation. This is not possible at this stage, because of the speed. That sharing of information is very nice.” In addition, a large number of partners have contributed to the realisation of the DemcAir. From the medical side, these are the Erasmus Medical Centre in Rotterdam, the Isala in Zwolle and the Catharina Hospital in Eindhoven.

Industrial partners
Suppliers must ensure the timely delivery of the essential components and submodules – the complete system, including the central module, contains over 200 different components. “We obtain them from a large number of suppliers. Together with our project buyers, the suppliers have used all possible creativity to ensure an adequate supply. Here I would like to mention especially SPIE, VDL, 2E Interconnection, Hoerbiger, tbp electronics and CE Persluchttechniek. Dekra’s test knowledge is also indispensable. Our thanks go to all of our forty-plus partners. The support we have received from other companies and individuals is also heart-warming.”

About Demcon
Demcon (700 employees) develops, produces and supplies technology and innovative products. The Demcon group has locations in Best, Enschede, Delft, Groningen, Münster (Germany) and Singapore. The company was born out of the founders’ passion for combining creativity and technical skills aimed at solving complex issues. These issues are of a technological and social nature, and often have a direct or indirect impact on people and their living environment. Whether medical solutions, sustainable innovations for themes such as water and energy, or systems that guard our safety, Demcon contributes – for current and future generations. In addition to developing technical solutions, Demcon is committed to stimulating entrepreneurship and investing in talent and education.

More information on www.demcon.com.

Queen Maxima visits manufacturer of ventilation systems

Her Majesty Queen Máxima paid a working visit to technology company Demcon in Enschede on Thursday afternoon, April 16. The visit took place in the context of the coronavirus outbreak (COVID-19). Demcon has developed, tested and manufactured a ventilation system that is suitable for patients on the intensive care.

Queen Máxima spoke to the developers of the ventilation systems and the employees who work on the production of the equipment. During a tour, Queen Máxima was informed about the ventilation systems Demcon has developed, about the clinical testing of the system and the new production lines. Queen Máxima also spoke with representatives of suppliers, other companies involved in the development of the system and the national expert group for ventilation equipment. This final discussion included the steps taken to be able to develop, test and produce a complete system in a short amount of time, and the training of production employees was discussed.

Demcon focuses on using technological knowledge to solve social issues. The company already produced separate ventilation modules and is also working on medical solutions, systems to monitor safety and sustainable innovations for water and energy.

Through telephone calls and, if possible, working visits, King Willem-Alexander and Queen Máxima of the Netherlands inform themselves about the consequences of the corona outbreak and express their support and appreciation for the efforts of so many in the fight against the pandemic. Measures are taken in consultation with the organizations involved to allow the working visits to take place.

Photo credits: Mischa Schoemaker | Dutch Press Photo Agency

Ventilation modules from Demcon are vital in the fight against coronavirus

The ventilation modules from Demcon macawi respiratory systems save lives now that the coronavirus is present around the world. Never before has the need for ventilation systems been so great. We are thankful that we can contribute directly to the treatment of thousands of coronavirus patients with breathing problems because we can meet this need.

We are making every effort to continue to meet demand in this situation. The demand is now so great that we are setting up a second production line at Demcon production to be able to double the production. We depend on various (external) factors. The commitment and dedication of our employees is of great value and we keep in close contact with our suppliers about delivery of their components. We all go to great lengths so that we can deliver the equipment to the hospitals as quickly as possible.

International Journal of COPD
Does high inspiratory pressure lead to respiratory muscle unloading?

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4 key benefits using a high-dynamic centrifugal blower in ventilation systems

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Ventilation systems need a pressure source, some systems still rely on pressurized gas, and many already use a centrifugal blower. Did you know there are large differences between blowers? Selecting the right one provides significant benefits for ventilation systems. Here we mention 4 key benefits when using a highly dynamic blower.

  1. >200% Lifetime

Typical of a highly dynamic blower is the immediate response to breathing demand so to create a fully synchronised pressure waveform, often with high pressure ramp, to the patient.  Design of such a blower requires as small as possible and extremely lightweight rotating parts and driving motor. As a result critical components responsible for blower lifetime are much less responsive to wear. This immediately results in longer lifetime. Typical a lifetime of >200% compared to average blowers is achieved.

  1. <40% power consumption

When using a high dynamic blower there is a direct relation between output pressure and the rotational speed of the blower therefore directly controlling the desired fluctuating pressure waveform. As opposed to blowers which provide a continuous flow, the power consumption characteristic of a high-dynamic blower has the same shape as the pressure waveform.
Combined with the reduced weight the resulting power consumption is <40% compared to blowers providing continuous pressure. How attractive is it to provide >2 times longer battery time?

  1. Simple design and control system

Most blower driven ICU ventilators use a so called pneumatic system to control flow, pressure and Oxygen concentration. It requires a blender which is a valve systems that mixes oxygen and air and buffers this in a volume at a preset and controlled pressure. It consists of one or several flow valves.
However, when making use of a high-dynamic blower such complex pneumatic system is not required, leaving a much less complicated design and control system.

  1. Reduced costs bill of material

As a direct result of the above mentioned, the costs of such a system, even apart from a strong reduction in development man-hours and maintenance, is much less. A minimum cost saving for the bill of material is expected of >80 USD.

Inbiolab and partner ItoM are participating in the FICHe accelerator program to develop new telemonitoring solutions for the Smart Jacket project.

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At MEDICA 2015 our CTO Geert van Dijk showed a real live demo that his own breathing muscles could successfully trigger the MACAWI OEM ventilation module. In the picture the monitor shows a snapshot of Geert’s diaphragm electrical activity and the test-lung which is ventilated by this signal. We like to thank all visitors for showing such a great interest in our mechanical ventilation and sEMG developments.

Medica, macawi, 2015, semg technology