First ventilation systems delivered by Demcon
Demcon delivered his first ventilation systems. Within a month, Demcon succeeded in developing, producing and testing a complete ventilation system in the Netherlands that is suitable for the ventilation of coronary patients in intensive care. The Ministry of Health, Welfare and Sport takes care of the distribution among the hospitals.
Soon Demcon will supply a total of 500 ventilation systems. “The government has had the nerve to place an order for 500 with us. We have already gained a great deal of knowledge and experience with ventilation technology and modules, but we had never delivered a complete ventilation system”, says Demcon-CEO Dennis Schipper. “Our employees have lived up to this trust, with all possible dedication and sometimes working day and night. I am pleased that we can thus contribute to today’s great challenge, the optimal treatment of patients. This is in our DNA, the use of technological knowledge to solve societal issues”.
The DemcAir ventilation system is based on the unique ventilation technology developed by Demcon macawi respiratory systems for use with every patient, from preterm to adult. The individual ventilation modules have been in production at Demcon for many years. To date, Demcon has supplied these modules to the manufacturers of ventilation systems in Germany, the USA, Mexico, China and Japan; demand from China was already rising sharply at the end of January. In the meantime, production has been scaled up considerably. Various measures have been taken to achieve this: expansion of the number of production lines, more intensive collaboration with suppliers and training of production workers, both in-house and at fellow companies.
Fully-fledged ventilation system
So now, in addition to these modules, Demcon has developed a fully-fledged ventilation system, in the Netherlands, for the treatment of (young) adults. On Thursday 19 March, Demcon started the preparations and on Sunday 22 March, the order came from the Ministry for the delivery of 500 pieces. After successful clinical trials on several patients, the first specimens have now been delivered – within a month.
That period of one month is exceptionally short, says CEO Dennis Schipper. “Because even though we had the ventilation module available and built the complete system as simple as possible, it is and remains 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 great deal of attention to safety and ease of operation and have carefully tested it. In doing so, we were able to build on the experience we have gained over the past ten years with medical product development in pathways that usually last many months to several years. In particular, our expertise in quality assurance and experience in the certification of medical products was now crucial”.
Nationwide expert group
Speed and care must continue to go hand in hand, agrees Lieke Poot, clinical physicist in the Isala hospitals in the Zwolle region and chairman 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. “The expert group makes an inventory of which devices from outside hospitals are suitable for intensive care, assesses offers from existing suppliers and supervises manufacturing initiatives. Many smart people and companies want to help and come up with inventive ideas. It’s nice to see that everyone is in the solution mode. This does involve life support equipment, so as an expert group we have to see if 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 for years. We were confident that they could build a housing and software around it in a short period of time; that’s why we advised VWS to order 500 systems”.
Pressure cooker procedure
A manufacturing process for a medical device, including clinical research and certification, can normally take a year or more, explains Poot. “Now we’re following a kind of pressure cooker procedure, in which we can’t fully follow the applicable laws and regulations, while we do have to come up with a functional and safe product. We have gradually designed this procedure, in close collaboration with Demcon. We are very transparent on both sides and at our request they have had Dekra (the certification body, ed.) take part in the drafting of the technical documentation and risk management. As a result, some kind of certification already takes place anyway, while usually the documentation only goes to Dekra when a design is completely finished. Everyone sees the importance, so we can realize things that normally cannot be realized in such a short period of time. We also asked Demcon to do the clinical tests in three hospitals, of course with the consent of the patients. In this way, people were able to see things from different angles and with different protocols. This broader view of end users is necessary, even now; they have to say whether a product can be applied clinically”.
The DemcAir ventilation system was created thanks to intensive cooperation, emphasises Schipper. “First of all within our company between numerous colleagues spread over different locations. The same applies, as Lieke Poot indicates, to Demcon’s collaboration with the government as client. Skipper: “The lines are short, we can quickly switch at the ministry with the people of the National Consortium of Tools and the expert group. Paw’s replenishing: “Everyone puts their shoulders to it, 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 incredibly nice.” In addition, a large number of partners contributed to the realization of the DemcAir. From the medical corner, these are the Erasmus Medical Centre in Rotterdam, the Isala in Zwolle and the Catharina Hospital in Eindhoven.
Suppliers must ensure the timely delivery of the essential components and sub-modules – the complete system, including the central module, contains more than 200 different components. “We source these from a large number of suppliers. Together with our purchasers, the suppliers have used all possible creativity to ensure sufficient supply. I would especially like to mention Allied Motion, SPIE, VDL, 2E Interconnection, Hoerbiger, tbp electronics and CE compressed air technology. The test knowledge of Dekra is also indispensable. Of course we would like to thank all our more than forty partners. Heartwarming is also the support we are offered by other companies and individuals.