Initiatives of theHamburg Kreativ Gesellschaft
Medical technology products such as external ventricular drainage (EVD for short) sell well, not least because the manufacturer Spiegelberg, as a small medium-sized company, promises "Tradition Made in Germany". But tradition often also means high manufacturing costs and outdated design. Time for a change.
There are many medical devices: From simple plasters and surgical instruments to neurosurgical devices such as the EVD set from Spiegelberg - a medical technology manufacturer from Hamburg with 55 employees. EVD stands for external ventricular drainage and is used when things get tight in the skull. For accident victims, people with brain tumours or trauma patients, ventricular drainage can be a life-saving measure. If too much cerebrospinal fluid accumulates at one point in the brain, it can quickly become life-threatening. The EVD set is used to measure the pressure in the brain and drain excess water. The product is well known among neurosurgeons. The drainage system has been on the market for a long time and sells well, not least because Spiegelberg, as a small medium-sized company, also sells "Tradition Made in Germany". But tradition often also means high production costs and old design. In spring 2022, this combination of factors prompted Stefan Paschko, Managing Director at Spiegelberg, to give the EVD set a facelift. The aim was to make it smaller, more attractive and safer. He found a solution in the Cross Innovation Lab.
Eine äußerst ungewöhnliche Entscheidung für einen Medizintechniker zu diesem Zeitpunkt. Denn die Branche steht seit einem Jahr enorm unter Druck. Verantwortlich dafür ist eine EU-weite Verordnung, die die Zulassungskriterien für Medizinprodukte deutlich verschärft. Sie gilt jedoch nicht nur für neue Produkte, die auf den Markt sollen, sondern auch für alle Bestandsprodukte. Expert*innen schätzen, dass sich Zulassungskosten verdreifachen, der bürokratische Aufwand sogar verzehnfacht. Bis es zu der Verordnung kam, vergingen vier Jahre. Jetzt muss jeder Hersteller bis 2024 die komplette Produktpalette neu zertifizieren lassen, auch Spiegelberg. Für den Hamburger Mittelständler und seine Mitarbeiter*innen heißt das: Alles on hold, längst etablierte Produkte erneut testen, Daten überprüfen, Berichte schreiben und wieder testen. „Das sind wahnsinnige Kosten, und ich bekomme auch gar nicht all die Leute an Board, um das überhaupt zu schaffen,” erklärt Stefan Paschko. So wie ihm ergeht es vielen in der Branche.
Die verantwortliche EU-Kommission sieht mit Blick auf diese Entwicklung keinen Handlungsbedarf. Zuletzt äußerte sich die Brüsseler Behörde so: "Die neue Medizinprodukte-Verordnung ist […] reibungslos in Kraft getreten, und die Kommission erwartet, dass die neue Verordnung ein stabiles Umfeld für eine innovative und wettbewerbsfähige Medizintechnik-Industrie in Europa bieten wird." Wirtschaftsexpert*innen sehen das anders. Die neue Verordnung bedrohe die Existenz vieler KMU. Auch künftige medizintechnische Innovationen könnten ausgebremst werden.
„Ich möchte auch mal mutig an etwas herangehen und nicht immer gleich mit Einschränkungen konfrontiert werden.”
"I also want to take a bold approach to something and not always be confronted with restrictions straight away."
Stefan Paschko is also convinced of this. Even before the regulation, progress in medical technology was slow and conservative. Product launches in the industry usually take 5-10 years, not only in terms of production, but also in terms of the consumer system. Doctors and nursing staff have to be familiarised and trained with the new product every time it is launched. That takes time. The additional documentation of all existing products means that innovation in the company is now the exception. Every project, every new idea is put on the back burner. For employees in development, the additional bureaucratic work means missing out on key technological developments on the market. To give his employees' motivation a boost, Stefan Paschko therefore signed up for the Cross Innovation Lab with two developers and the sales manager. Here, the team met the two creative minds Gerrit Kuhn and Sophie Heins, who worked with Spiegelberg to realise the facelift of the EVD set. "We operate in a very small cosmos here, always swimming in our own soup, especially now with all the tests and additional documentation. However, I don't always want my employees to just work on documents and wanted them to be part of a different process in which they can work creatively and with external parties."
With this attitude, Stefan Paschko is one of the few managers in the SME sector to take the plunge and leave business as usual behind. For many, the hurdle to participating in externally led innovation processes is still a big one. Behind formats such as the Cross Innovation Lab, there are fears of unexpected costs and excessively long breaks in internal projects. Doubts quickly spread. Even among the employees. That's why Stefan Paschko deliberately put together his team. "I believe that the easiest thing for many people is to keep repeating what they are used to. Often out of fear of making decisions. I don't want that. I also want to approach things with courage and not always be confronted with restrictions."
He and his team have succeeded. In addition to providing impetus for sales, branding and sustainability, Spiegelberg emerged from the lab with two different prototypes. The first variant represents a refinement and clever reduction of the original product: Various design tricks made it possible to reduce components, support clear and safe handling and find a clear product language. The second variant promises a minimised pack size and a strong USP over the competition - more cannot be revealed at this point. The team was able to convince even critical voices at the company's internal final evening. The next goal is now to further develop the prototypes through various design and approval phases and bring them to market maturity.
Stefan Paschko is a graduate engineer and Managing Director at Spiegelberg. After studying mechanical engineering, he worked at the Laser Centre in Hanover, where he entered the field of medical technology through a research project on the use of Nitinol stents.
