Contents In this issue 20 12 News & numbers


The headlines and vital statistics impacting the market.


Regulatory


14 Software knows best Regulating software is one thing, but when it’s designed to think for itself, it’s quite another. AI isn’t new to medical devices, but as products that use it grow more ambitious, regulators need a framework that prioritises patient safety without stifling progress. Lynette Eyb asks Pat Baird, head of global software standards at Philips, and Sara Gerke, associate professor at Penn State Dickinson Law, where the challenges to regulating AI lie and what such a framework might look like.


20 A delicate balance Regulatory and compliance requirements are seen as necessary hurdles that need to be cleared by manufacturers if they’re to bring products to the marketplace – especially in highly-regulated industries like the pharmaceutical and medical device sectors. But in times of emergency, even the strictest regulators must balance an enduring


Medical Device Developments / www.nsmedicaldevices.com


need for safety, quality and efficacy with both public and clinical needs. Regulatory expert Dr Gabriel Adusei explains the risk-benefit calculations regulators have had to make during the Covid-19 pandemic, and why relaxing the rules too much during a health crisis can be catastrophic.


25 Lean medical writing: Story not storage Trilogy Writing & Consulting


Contract manufacturing 29 Taking stock


For years former US President Donald Trump was banging the drum for a return to American production and reducing the country’s dependence on China. His successor, President Joe Biden has continued to push for the country to “decouple” from China, albeit using less inflammatory rhetoric. Since the Covid-19 pandemic revealed just how pronounced is the global medical device industry’s dependence on China and other parts of Asia for certain components and products, politicians and supply chain experts alike have been calling for manufacturing to be brought closer to home – but are medical device


companies heeding the call? The answer is more complex than a yes or no, Jamie Davies, head of pharmaceuticals, healthcare and medical devices, Fitch Solutions, tells Peter Littlejohns.


33 What does it take to bring a medical device to life? Tegra Medical


34 A hub for medical device success BMP Medical


36 Overcome supply and sterilisation challenges Qosina


39 A global manufacturing network for customers Carclo


41 The science of sourcing Building outsourcing relationships into a business model has become a key trend. The degree of manufacturing that happens through contract development and manufacturing (CDMO/CMO) partners on the Asian continent, despite the fact the world’s largest medical device companies are in the US and Europe, is testament to this. In this Q&A session, supply chain veteran Jack Sandahl tells Peter Littlejohns how the relationship between outsourcing partners and medical device companies has been and is still unfolding. Sandahl is fellow, global sourcing, at Boston Scientific and is an adjunct professor at the University of Minnesota, where he teaches “The Science of Sourcing”.


46 Transform development with 3D-printed injection mould tooling Addifab


48 Partnering with micro moulders Accumold


Manufacturing technology


49 The electronic executive Automating a production line is a task


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