Contents 27 Contract manufacturing


27 Can quality be outsourced? Medical device OEMs are increasingly taking advantage of the services offered by specialist consultancies that provide end-to-end support for quality by design (QbD) services, choosing to outsource rather than develop these capabilities in-house. Jim Banks looks at how software vendors are incorporating QbD into their quality management system offerings and how this helps OEMs to optimise complex manufacturing processes.


31 Optimise fluid control in modern medical devices Qosina


32 Chemical reaction: How PCE is catching the eye of manufacturers Fotofab


35 Precision, persistence and disruption Accumold


37 Global CDMO accelerating healthcare innovation MGS


39 Catheter innovation for pulsed field ablation Phillips Medisize


www.medicaldevice-developments.com


41 Continuous gains Continuous manufacturing is beginning to transform how medical devices are made, promising faster development, greater efficiency and improved compliance. To explore what this means for medtech, Sachin Rawat speaks to Anne Vanhoestenberghe, director of MAISI, and medical device executive Sean Gilligan.


47 Global reach, local precision Rosti


48 Life-saving seals enhancing medical precision Apple Rubber


51 Breaking glass Merit


Manufacturing technology


52 Precision in motion From micron-scale parts to fully automated cleanrooms, the future of medical device manufacturing is being reshaped by precision robotics, additive technologies and AI-driven inspections. Sachin Rawat speaks with Jay Lee of the University of Maryland and Dustin Vaughan of Asensus Surgical about how these advances are enabling safer, faster and smarter production.


55 A journey: The assembly of a medical auto-injector Mikron Automation


56 Contact-free precision Kistler


58 Additive manufacturing’s expansion


Bioprinting is progressing towards clinical success. Liam Critchley speaks to Professor Jianfeng Zang of the Huazhong University of Science and Technology to explore how additive


52 7


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