Inside the magazine
A NEW VALUE PROPOSITION OF SMART DEVICES: ADVANCED MEDICATION ADHERENCE MONITORING IN CLINICAL TRIALS
Andreas Schneider explores a new value proposition of smart injection systems, introducing how advanced adherence monitoring services resolve some of the key challenges of clinical research practice regarding costs, adherence, data quality and integrity, Dr Schneider explains which technical features are needed for smart devices to provide value-adding adherence monitoring services, using SmartPilot for YpsoMate as a case study.
Using Noble’s recent partnership with BD to develop trainers for BD’s UltraSafe™ needle safety technology as an example, Joe Reynolds discusses the importance of training devices for the successful onboarding of patients beginning to use self-injected therapeutics, and how Noble’s training devices are designed to be faithful to the look and feel of the real product.
Helen Simons and Stephanie Ward describe how the new EU Medical Devices Regulation will impact on “grandfathered” devices that were approved under old regulation and are currently on the market, but do not necessarily comply with current/updated regulatory standards, and explain the potential implications for device manufacturers.
Theresa Bankston looks at the advantages of using an integrated system for drug-device combination products. As well as avoiding problems such as breakage and incompatibility, integrated products can offer solutions at every interface between the drug, container and delivery device and save significant amounts of time and money.
Torsten Maschke has been Chief Executive of the Sealing Solutions division of Datwyler and a member of the group’s Executive Board since October 2016. Before joining Datwyler Group, he was responsible for the worldwide distribution of sealing and damping solutions for the automotive industry at Freudenberg Group (Weinheim, Germany).
Christoph Hammer discusses the financial reasoning behind the selection of packaging equipment, taking into account real current and potential future requirements (paying particular attention to Industry 4.0 concepts), and highlighting the advantages of taking a modular approach, such as the solutions offered by Dividella and its sister companies.
Needlestick injuries remain a serious concern for pharmaceutical companies involved in injectable drugs. Biocorp has been developing NewGuard™, an integrated passive safety device to tackle this problem. Throughout the development phase, Biocorp defined key elements to ensure NewGuard™ will not require unnecessary changes to be made to the PFS manufacturing process. Philippe Lesaulnier and Eric Dessertenne explain more.
Dick Molin highlights some of the hazards that arise through the use of traditional lubricious coatings in parenteral delivery devices. Particular focus is paid to the problems of protein aggregation and trace impurities leaching from elastomeric components before describing how the polymer Parylene, applied as a very thin coating using SCS’ unique deposition method, avoids them.
The limitations of using glass-based auto-injectors, such as contamination, and the need for delivering complex, viscous preparations, have led to a new approach that uses polymeric PDC technology instead. Jonathan Lawson, Jonathan Bradshaw and Susie White look at what polymeric PDCs can offer in making auto-injectors truly patient-centric.