September 2023 Published by SAE Media Group® n COLUMN 4 From the Editor n FEATURES 8 Inside the OEM: Smith & Nephew 13 Overcoming Blockers to Digitizing Manufacturing Operations 16 The Crucial Role of Cleaning in Achieving Process Validation for Electronic Medical Devices 20 Hydrogels as a Drug-Delivery Medium 23 BIOMEDevice Boston Show Preview n TECH BRIEFS 36 Radio-Frequency Identification (RFID) Improves Efficient Delivery of Healthcare Products to Where They Are Needed 38 Real-Time Guidable-Tip Wire Aids in Surgically Treating Strokes 40 Researchers Fabricate Health-Monitoring Sensors onto Ready-Made Wearables 41 AdvaMed: EPA's EtO Proposals Create Significant Risk of a Healthcare Crisis 42 Customizable Spun-Fiber Heart Valve Grows with Children 45 Dissolving Cardiac Device Monitors, Treats Heart Disease n DEPARTMENTS 34 R&D Roundup 47 New Products & Services 49 Advertisers Index 50 Global Innovations n ON THE COVER The ecosystem for developing breakthrough healthcare products calls for advanced manufacturing technologies and strategies. Picture a manufacturing operation with end-to-end digitization and a manufacturing execution system (MES) on every product line and in every site. Then add the full integration of all your other management systems, providing complete visibility up and down the supply chain. Using advanced data analytics within MES software equips OEMs with the necessary information to identify actual cycle times and exactly how long it takes to execute a device history record (DHR), making the production schedule complete and more accurate. Read the article on page 13 to learn how easy retrieval of data from a single source can help OEMs more easily determine how to change processes to continually improve production and optimize lead times. (Credit: Eduardo López/AdobeStock) MEDICAL DEVICE + PHARMA A Reputation for Extraordinary Packaging, Product and Materials Testing. DDL has over 30 years of experience navigating complex testing standards and regulations for medical device and pharma products. Our reliable quality, responsive attention, and on-schedule completion for packaging, product and performance and safety while achieving regulatory compliance. DDL is an ISO 17025 accredited laboratory 2 TESTING EXPERTISE * Packaging and Materials * Medical Devices * Combination Products * CCIT Testing (GMP Compliant) Partner with us and gain a reliable testing expert at your side! Visit us at DDLtesting.com or call us at 1-800-229-4235 Minnesota | California | New Jersey www.medicaldesignbriefs.com Medical Design Briefs, September 2023http://info.hotims.com/84483-803 http://www.medicaldesignbriefs.com