Contract manufacturing
programme. To Alghazali, a lack of education and an inability to predict how products will fit within regulatory frameworks are major reasons why so many medical device design transfers fail. “Imagine you have an idea for a medical device and want to bring investors in. Then you decide you need to consult with the FDA to learn what exactly this medical device would be – is it type one, type two, type three? Based on their response, the study designs and manufacturing approach will have to be changed.” Alghazali highlights the manufacturing challenges that start-ups face and notes the stark contrast between producing units for research and scaling up dramatically to meet market demands once a product has cleared regulatory hurdles. “A start-up or research team might have the ability to produce ten units a week when in reality they’re going to need 10,000 a day,” Alghazali says. “Preparing to mass produce the same device over and over without losing the product identity is one of the biggest challenges.” Medical devices aren’t just the literal tools, implants and platforms that medical experts and patients interact with, cautions Alghazali, who includes packaging and labelling in the definition of a medical device.
“A medical device is the whole thing, not just the innovation part. It’s the tray that’s holding the package, the label, the artwork that you put outside – it’s everything,” explains Alghazali. “So if you are missing one piece, you miss the whole thing in the eyes of the FDA.”
From prototype to production at scale German medical technology company Siemens Healthineers is wellversed in tackling transfer gap challenges. Gianmarco Antonini is a senior global product manager at Siemens Healthineers and spearheaded development of CIARTIC Move, a robotic, self-driving mobile 2D and 3D C-arm. The device is equipped with a fully motorised chassis and holonomic wheels that enable float-like movement in every direction. According to Antonini, a crucial part of the product development process is identifying and engaging the right suppliers while determining what a company or team can accomplish internally and where outside expertise will be needed. “There is a lot of reasoning around what to make or buy – what is the core technology that we want to keep and what technology can we buy because suppliers are better than us at doing it and is therefore cheaper,” Antonini says.
Antonini explains that, with Siemens’ size and extensive history of partnering with trusted suppliers to build products, the company doesn’t have to worry as much about its ideas being stolen. But he cautions that forming partnerships is often more complicated and risky for start-ups, which typically have only one product idea and limited resources. “For us, it’s a more straightforward decision on whether we are capable of doing it in the time frame we want to have it and if we are capable of doing it within the budget constraints we have,” he says. Alexander Gemmel works on Siemens’ R&D and pre-development teams and manages collaborations
“A medical device is the whole thing, not just the innovation part. It’s the tray that’s holding the package, the label, the artwork that you put outside – it’s everything.”
Dr Karrer Alghazali, New York Institute of Technology
www.medicaldevice-developments.com
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