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Company insight


Opportunities and challenges ahead for medical innovation


There are significant opportunities for innovation in the medical tubing and catheter market, according to industry experts speaking at AMI’s recent virtual conference on the sector. But regulatory and production challenges won’t be easy to overcome.


n March 2021, AMI brought together some of the leading names in medical tubing and catheters from universities, manufacturers and research companies to discuss the opportunities and challenges facing the industry, and new innovations in design, materials, production and applications. The main event was a panel discussion on the future of the medical tubing and catheter market between Giuseppe Fiandaca, CEO and founder of consulting company Polyneers, Ganesh Rao of Johnson & Johnson’s innovation and insights group, Eric DiStefano, a manufacturing engineer at balloon and catheter developer Creganna Medical, and Jonathan Carr, a senior manufacturing engineer at Boston Scientific.


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can drive themselves now and I can see this exploration also in medical devices, with equipment being able to make on-the- fly decisions.”


Industry trends


The group also discussed what the industries drive towards lower profiles, thinner tubing and tighter tolerances means for the factory floor, concluding that the only way to enable the production of smaller, more advanced devices at existing line speeds would involve some level of automation and perhaps, ultimately, lights-out extrusion. With floor space at a premium in many factories, miniaturisation of extruders was another potential way forward.


When the conversation moved to the regulatory landscape, all four panellists


“It won’t be long until we see AI in our industry. Cars can drive themselves now and I can see this exploration also in medical devices, with equipment being able to make on-the-fly decisions.”


Eric DiStefano, Creganna Medical


Bringing perspectives from Germany, Ireland, the US and Costa Rica, they explored how device developers can move the market forward by playing an active role in ‘ongoing mega trends’, such as digitalisation. For example, many catheters are gaining more functionality thanks to the addition of sensors but, at present, these are being installed after the manufacture of the tubing. The more the assembly process can be brought upstream, the lower the cost. “It won’t be long until we see AI in our industry,” said DiStefano. “Cars


agreed that sustainability is going to be an increasingly important consideration in the next few years. While the move towards more environmentally responsible devices is currently driven by European regulatory bodies, this ultimately ends up impacting the entire global supply chain, stressed Rao. “Even if the product isn’t intended for the European market, all products will have to meet those requirements in product development,” he explained. The consensus was that PVC was on its way out, due to the harmful additives it


Medical Device Developments / www.nsmedicaldevices.com


contains – something that was confirmed by Fiandaca’s solo presentation, where he talked about the real-life challenges in replacing PVC for medical infusion lines. “It’s a mass product and it will remain indispensable for the next ten years,” he said. “But alternatives are coming and they will shine where PVC has bad performance.”


Overcoming challenges Other speakers explored opportunities for innovation within the industry, with Don Baumgarten, director of mechanical engineering at Product Creation Studio, dedicating his presentation to innovation opportunities and challenges in minimally invasive and implantable medical devices. He explained that major long-term trends – such as the increase in chronic disease, ageing population, pressure to reduce healthcare costs and patient demand for improved quality of life – had increased demand for innovation, which could be met if manufacturers were able to gain more specific insights into customer and end-user needs. Later, medical device engineer Ido Sadan of Coramaze Technologies, described how to set up a catheter R&D lab where this sort of innovation can take place quickly and effectively.


There was certainly an element of wishful thinking among the speakers. One day, Carr hopes to see a filter-less extrusion process. “I know it’s a tall ask,” he acknowledged. But overall, there was a sense that if regulatory and production challenges can be overcome, there are significant opportunities for growth and innovation within the industry, which could improve the quality of patient care in the years to come. ●


www.ami.international 19


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