Contents
In this issue 12
Analysis
10 Medtech’s cautious optimism A new GlobalData survey suggests confidence is returning to medical devices. But the coming year will favour companies that can turn digital promise into reimbursable outcomes, treat cybersecurity as a patient-safety discipline and stabilise supply chains in a less predictable trading environment, as Thom Atkinson reports.
Regulatory
12 The recognition and reliance map
As global regulators pivot from bilateral pathways to structured reliance and recognition frameworks, medical device developers are rewriting their market-entry playbooks. Jim Banks maps out how international recognition and reliance programmes are compressing approval timelines and trimming duplication.
15 Ready for the next phase? From greening operations to life-cycle stewardship, end-of-life mandates and circular-economy design constraints, Ellie Philpotts speaks to Sigrid Linher, director of sustainability and environment at MedTech Europe, and RMIT University’s Pranay Kumar about how global firms can operationalise
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action across multi-jurisdictional supply chains while maintaining safety, performance and access to life-saving and life-sustaining medical technologies for patients.
Contract manufacturing
20 Repairing a fragile supply chain
From rare earth choke points and geopolitical flashpoints to paediatric device shortages, the medical device supply chain has never been more exposed. Partnering with contract development and manufacturing organisations (CDMOs), OEMs are
reshoring production, navigating complex regulations and building in redundancy – trading capex-heavy plants for flexible, localised networks that promise greater resilience when the next disruption hits. Liam Critchley speaks to Professor Tinglong Dai of Johns Hopkins University about contract manufacturing and supply chain resilience.
26 Designing reliable fluid paths in medical devices Qosina
29 Global CDMO accelerating healthcare innovation MGS
31 Advanced PFA devices Phillips Medisize
33 Going niche
Start-ups and specialist OEMs pioneering advanced wound-care platforms or retail-distributed rapid diagnostics often require ‘bridge’ manufacturing runs – short-batch, agile and GMP-compliant. Sachin Rawat speaks to Jonathan Treiber, CEO at Skil-Care, and Pujitha Gourabathini, a quality assurance manager at Becton, Dickinson and Company (BD), about the landscape of contract manufacturers that specialise in rapid scale-up for niche lines.
39 Life-saving seals: Why o-rings are indispensable Apple Rubber
41 When scale, precision and trust align Accumold
42 Redefining development Sanner Group
Manufacturing technology 33
44 The digital twin comes of age From product design to patient- specific clinical decision support, digital twins are rapidly reshaping how medical devices are developed and deployed. Claire Read speaks to Dr Adelaide de Vecchi, head of the Department of Digital Twins for Healthcare at King’s College; Dr
www.medicaldevice-developments.com
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