{"id":59868,"date":"2024-11-26T15:44:44","date_gmt":"2024-11-26T14:44:44","guid":{"rendered":"https:\/\/fhi.nl\/?post_type=news&p=59868"},"modified":"2024-11-27T13:11:56","modified_gmt":"2024-11-27T12:11:56","slug":"een-brug-tussen-zorg-en-industrie","status":"publish","type":"news","link":"https:\/\/fhi.nl\/en\/news\/een-brug-tussen-zorg-en-industrie\/","title":{"rendered":"A bridge between healthcare and industry"},"content":{"rendered":"
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By: Eline te Velde<\/h6>\n\t\t\t\t\n\t\t\t\t

\n\t\t\t\t\tBridging healthcare and industry: collaboration is key to medical technology\t\t\t\t<\/h1>\n\n\t\t\t\t
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The development of medical technology is complex. Manufacturers must comply with strict laws and regulations, including the European Medical Devices Regulation (MDR). At the same time, healthcare professionals are looking for practical solutions to challenges in the hospital. Erik Gelderblom is a clinical physicist at Radboudumc and sheds light on this dilemma.<\/strong><\/p>\n

Erik is a specialist in the field of medical technology. He notices that manufacturers of medical devices are becoming increasingly cautious due to the strict legislation of the MDR. \u201cCompanies are reluctant when we want to use medical devices slightly differently than the instructions for use prescribe,\u201d he explains. \u201cWe are often told that it is not possible without additional clinical evaluation, which in turn costs a lot of time and money. It is seen as a risk. People are now living very much according to the letter of the law and less according to the spirit of the law. We need to pay more attention to this together.\u201d<\/p>\n<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n\n

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Niche markets<\/h4>\n

Especially in niche markets, such as the children's ward, hospitals face limitations. Erik illustrates this with an example: "For ECMO procedures in neonatology, we used double-lumen veno-venous catheters, which require only one venous blood vessel. But because of the MDR, the manufacturer had to provide additional clinical evidence and therefore decided to withdraw the product from the market. As a result, we were forced to use alternative single-lumen venoarterial catheters for a period of time, which require a vein and an artery. For those newborns, this is drastic: sacrificing a carotid means that they have to live their entire lives with only one blood vessel to the brain."<\/p>\n

The consequences for the individual are enormous, but for manufacturers the small target group is often an obstacle. \u201cIn addition, it is difficult to collect clinical evidence for minors or incapacitated people because of strict regulations. And if the market is too small, companies prefer not to take risks,\u201d says Erik.<\/p>\n

\u00a0<\/strong>Another sticking point is the lack of clarity about why products are being taken off the market. \u201cHospitals don\u2019t get that information,\u201d says Erik. \u201cI understand that manufacturers can\u2019t consult with all hospitals, but you would expect that when they remove products, they would look at what hospitals need and what competitors offer. That way, you prevent essential resources from disappearing.\u201d<\/p>\n

Responsibility and safety<\/h4>\n

In his role as a clinical physicist, Erik answers questions from colleagues on a daily basis about the safe use of medical devices. \u201cA doctor or nurse may want to use a medical device slightly differently than stated in the user manual, or may have asked a technician to make a small adjustment. I then think along to see how we can do that in a responsible manner.\u201d<\/p>\n

According to Erik, the ultimate responsibility for the safe use of a device always lies with the healthcare institution or healthcare professional, not with the manufacturer. \u201cThe manufacturer is responsible for the product being safe, but how exactly is it used? That is ultimately up to the healthcare professional. Yet the MDR seems to place that responsibility with the manufacturer.\u201d<\/p>\n

He also emphasizes that clinical evidence should primarily focus on safety. \u201cToo much emphasis is placed on proving effectiveness, while demonstrating it is only relevant for a portion of all medical devices. I am thinking in particular of innovative devices such as a new type of implant, surgical robot or an AI-based prediction model. The rest has already proven itself or is simply indispensable for performing a medical procedure. The question of effectiveness should then be answered by the field, for example based on guidelines from the professional groups.\u201d<\/p>\n

Working together towards solutions<\/h4>\n

The challenges that Erik outlines require a joint approach by healthcare professionals and manufacturers. The Medical Electronics Event on January 30 is an opportunity to strengthen this collaboration. In the Experience Center of the Radboudumc, manufacturers present the latest technological innovations, while they discuss practical applications and joint solutions with healthcare professionals. Chairman Erik Gelderblom looks forward to providing inspiration: \u201cI hope that we can amaze the visitors with what is possible in healthcare.\u201d<\/p>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n

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