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If you are here you probably have a working prototype and you are looking for more information about medical device manufacturing. First and foremost – congratulations on your device! But we hate to be the ones to break it to you – it is only the beginning of your journey. Scaling from prototype to production is where the true challenge lies. Not having it done properly has already driven countless startups to bankruptcy.
Choosing the right MedTech product components is one of the toughest decisions you face during medical device development. It is a choice that dictates your product’s entire lifecycle, regulatory path and budget. At first sourcing components might not seem as a life-or-death choice. But dig a little deeper and you uncover difficulties that can emerge during mass production, often compelling you to completely redesign your device.
Even the most promising medical devices can be derailed by critical mistakes that startups continue to make. They often fail to distinguish between a technology and a market-ready solution. It is easy to get lost in the technical details, but focusing only on the engineering means missing the real foundation of success – a clear strategy from the very beginning.
Developing a MedTech product means you need to connect many dots. Clinical, business, technical aspects and MedTech regulatory. But today I’d like to keep your focus on regulations that are essential to ensure the safety and effectiveness of medical devices, always keeping the patient’s well-being at the forefront.
If you’ve ever thought there should be a different technical solution in a medical practice, then you might be closer to becoming an inventor than you think. I’d like to help you with it by sharing our experiences in medical device development. Especially the ones we had with doctors specialized in different medical areas.
A new strategic MedTech alliance of the Faculty of Physics, Astronomy and Applied Computer Science, Centre for Technology Transfer CITTRU both from Jagiellonian University and Consonance has been formed in Krakow, marking an important step toward strengthening collaboration between industry and academia in the field of medical device development. “The partnership is built around a […]
Engineering medical innovations gave us two million medical devices across more than 7,000 categories (WHO), yet the demand for safer, smarter, and more innovative solutions never stops growing. Digital health technologies are transforming the way healthcare works, making it safer, more accessible, and more efficient. But behind every breakthrough device is an engineering team turning ideas into reality.
Have you ever wondered what it really takes to develop and certify an active medical device? Well, to narrow your broad imagination – it’s much more than just wires soldering and molding a case. Of course, every engineering project involves research and development, but in the world of MedTech startups, there are many additional challenges to face.