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EXPERT VIEW
EXPERT VIEW
LARGE-VOLUME INJECTORS: RISE IN BIOLOGICS BRINGS CHALLENGES
Developing devices capable of delivering highly viscous biologic drug formulations at high volumes does not come without its challenges. Paolo Fiorini, Gerard Linnane, Michael Kiely, Maciej Grygorczuk and Joshua Coyne discuss these challenges and the merits of various drive solutions.
EXPERT VIEW
HOW TO DESIGN A BODY-WORN INJECTOR
Body-worn injectors require you to understand your user, your drug and your technology – and there are numerous pitfalls for the unwary. Stephen Augustyn shares some insights.
EXPERT VIEW
Jos van Noort
CHOOSING THE RIGHT LABEL MATERIAL FOR PREFILLED SYRINGES
Jos van Noort outlines some of the key factors that must be taken into consideration when selecting a label for prefillable syringes.
EXPERT VIEW
Elizma Parry
EU MDR: ANCILLARY DELIVERY DEVICES FACE EQUAL SCRUTINY TO STANDALONE MEDICAL DEVICES
Elizma Parry offers her expertise and practical guidance to businesses hoping to achieve a CE mark for a medical device, with new EU regulations being implemented this year.
EXPERT VIEW
George I’ons
PREFILLED SAFETY SYRINGE MARKET THRIVES AMID SELF-ADMINISTRATION TREND
George I’ons looks at how the growing trend of patient self-administration is driving demand for prefilled safety syringes.
EXPERT VIEW
Dr Barbara Morgan
OPTIMISING OPHTHALMIC DRUG DELIVERY FOR THERAPEUTIC EFFECTIVENESS
Barbara Morgan discusses how eye physiology impacts product formulation and choice of dosage form, and how advanced delivery technologies are providing new options for formulators seeking to improve the bioavailability or stability of their ophthalmic treatments.
EXPERT VIEW
Dr Ulrica Sehlstedt
TRANSFORMING HEALTHCARE – HOW CURATIVE THERAPIES WILL DISRUPT THE MARKET
Ulrica Sehlstedt, Craig Wylie, Thomas Unger, Rebecka Axelsson Wadman, Vikas Kharbanda, and Satoshi Ohara, all members of Arthur D. Little’s Healthcare and Life Sciences Practice, explain how the shift to curative treatments promises to transform the entire healthcare ecosystem.
EXPERT VIEW
Dr Juan Nogueira
CHOOSING THE RIGHT CONNECTIVITY FOR DRUG DELIVERY AND MEDICAL PRODUCTS
Juan Nogueira; Tommaso Borghi and Marco Vergani discuss the factors that need to be taken into account in the selection of connectivity technology for a drug delivery device or other medical product.
EXPERT VIEW
Dr Matt Ash
HOW A DIGITAL APPROACH CAN UNPICK CLINICAL TRIAL CHALLENGES AND IMPROVE OUTCOMES
Matt Ash, Tom Lawrie-Fussey and Bastiaan De Leeuw look at the role digital technology can play in the development of drug-device combination products.
EXPERT VIEW
Dr Jeffrey Philippson
THE INTERFACE BETWEEN PREFILLED SYRINGE AND AUTOINJECTOR – A DEVELOPMENT FRAMEWORK
Jeffrey Philippson and Tom Kemp outline the challenges for autoinjector developers at the interface between the device and the prefilled syringe – and describe a framework to formalise analysis of the interface.
EXPERT VIEW
Napoleon Monroe
PATIENTS, MANUFACTURERS & PRACTITIONERS CAN LEAD ADOPTION OF CONNECTED COMBINATION PRODUCTS
Napoleon Monroe asks why connectivity has failed to advance rapidly, and argues that many stakeholders can benefit if the adoption of connectivity for drug delivery can be accelerated. While this article will centre on pharmaceutical combination products, the essential points also relate more broadly to pharmaceuticals and medical devices.
EXPERT VIEW
Chris Franzese
Matchstick
CO-PACKAGED COMPONENTS IMPROVE PATIENT EXPERIENCE AND ENSURE CONSISTENT DRUG DELIVERY
Chris Franzese and Amy Rinaldi explore the challenges and benefits of co-packaging for manufacturers, healthcare workers and patients.
EXPERT VIEW
Manuel Scherer
SHARING IS CARING: POLYMER SUPPLIERS AS MEDICAL DEVICE DEVELOPMENT PARTNERS
Manuel Scherer looks at whether the advent of wearable injectors calls for a more collaborative approach between polymer suppliers and medical device developers.
EXPERT VIEW
Dr Neal Carty
WEARABLE INJECTORS: CHOOSING & TESTING OPTIMAL ADHESIVES
Neal Carty and Deepak Prakash highlight the importance of choosing and testing adhesives for optimal wearable drug delivery device performance.
EXPERT VIEW
Dominique Bauert
PRIMARY PACKAGING FOR WEARABLE INJECTION DEVICES
Dominique Bauert and Anil Kumar Busimi provide an overview of existing wearable injector solutions and new requirements, with a focus on the role of the primary packaging inside the devices.
EXPERT VIEW
Michael Penman
THE CHALLENGES OF VERIFYING A WEARABLE INFUSOR
Michael Penman shows why it is important to verify body-worn infusor performance, highlighting the challenges and learnings from an example where Team Consulting was tasked with the design and verification of one such wearable device.
EXPERT VIEW
Cory Costantino
A QUICK GUIDE TO USABILITY FOR WEARABLE INJECTORS
Cory Costantino and Lauren Fennelly list some typical steps a user might take while using wearable injectors, providing tips and points to note at each step, including design tips that might pre-empt potential interaction problems, and points to consider when conducting usability testing.
EXPERT VIEW
Jamie Clayton
3D PRINTING DRUGS: LEARNING FROM THE PIONEERS
Jamie Clayton reviews the potential of 3D printing as a pharmaceutical production method and looks at the associated implications for formulation development, focusing on powder-based printing. He examines what leading experts now understand about how to specify powder feeds for 3D printing.
EXPERT VIEW
Dr Aline Moulin
COMPACTION SIMULATION / INDUSTRIAL PRESS CORRELATION: TWO CASE STUDIES
Aline Moulin and Lucile Kowalski examine two case studies comparing compaction simulation with industrial compression.
EXPERT VIEW
Robin Heath
INDUSTRIALISATION OF INHALATION PRODUCTS: OVERCOMING HURDLES AT COMMERCIAL SCALE
Robin Heath discusses the typical challenges in scaling-up drug products from small-scale production to commercial manufacturing – and how these can be overcome.
EXPERT VIEW
Shaul Eitan
CUSTOMISED INFUSION PUMPS: THE FUTURE OF SELF-ADMINISTRATION?
Shaul Eitan explores the challenges of home infusion and examines how customisation and connectivity could help provide a solution.
EXPERT VIEW
Napoleon Monroe
CONNECTIVITY RESTORING TRUST IN PHARMA COMMUNICATIONS
Napoleon Monroe analyses connectivity coverage at recent drug delivery conferences and, more broadly, in various publications, to evaluate the current direction, and explore the scope for connectivity to effect changes benefiting multiple stakeholders across a range of treatment categories.
EXPERT VIEW
Mark Tunkel
USER-CENTRED DEVICE CONNECTIVITY
Mark Tunkel and Carolyn Rose discuss the benefits of taking a user-needs approach, and mapping the patient journey, in a connectivity strategy.
EXPERT VIEW
Tim Frearson
PUSHING THE BOUNDARIES OF INFUSION PUMP INTEROPERABILITY
Interoperability is not a new concept for infusion pumps. But in many cases hospitals have been slow to embrace the full potential of connectivity. When is this likely to change? What will hospitals need when it does? And where should infusion pump manufacturers focus innovation efforts in the meantime? Tim Frearson considers the options.
EXPERT VIEW
Allison Strochlic
SIMULATING STRESSFUL, EMERGENCY-USE SCENARIOS DURING USABILITY TESTS OF INJECTION DEVICES
Allison Strochlic highlights the importance of simulating environments that are as realistic as possible when conducting usability tests of emergency-use injection devices, and provides case studies with examples of how to create more realistic tests.
EXPERT VIEW
Dr Gautam N Shetty
MICROLITRE DOSING WITH PREFILLABLE SYRINGES – WHEN DOES A DEVICE MAKE SENSE?
Gautam Shetty and Bernd Zeiss outline factors that need to be weighed when considering a device-based approach to microlitre injections.
EXPERT VIEW
Jennifer King
PATIENT TOLERABILITY WITH HIGH-VISCOSITY, LARGE-VOLUME SUBCUTANEOUS INFUSIONS
Jennifer King and Matthew J Huddleston discuss the advantages of subcutaneous drug delivery and how these have yet to be fully harnessed in currently marketed therapeutics.
EXPERT VIEW
Simon Drexler
AUTOMATING UNDER UNCERTAINTY – GOOD PRACTICES
Simon Drexler discusses lessons learned and good practices when dealing with uncertainty at the various stages of automation development for drug delivery device manufacturing.
EXPERT VIEW
David Belton
THE CHALLENGES OF DELIVERING QBD IN NOVEL RESPIRATORY DEVELOPMENT
David Belton discusses the meaning of quality by design in novel respiratory drug delivery device development. He covers how, with more novel devices, prior knowledge may be insufficient for a standard FMEA-style risk analysis, and alternate science-based methods, such as functional mapping and knowledge scoring, can help in achieving QbD.
EXPERT VIEW
Dr Igor Gonda
IS THERE A FUTURE FOR THE RESPIRATORY DELIVERY OF BIOLOGICS?
Igor Gonda covers the field of nasal and pulmonary delivery of biologics, considers past failures and successes, and proposes answers to the challenges faced, from biological, biopharmaceutical and commercial standpoints.
EXPERT VIEW
Marino Kriheli
HAZARDOUS DRUG HANDLING AND INVESTIGATIONAL DRUGS: LESSONS TO LEARN
Marino Kriheli discusses the need for closed-system transfer devices when handling hazardous drugs, particularly as they relate to investigational drugs, not only as key to patient and healthcare practitioner safety, but also in the context of upcoming US regulation.
EXPERT VIEW
Stuart Curtis
SIX TECHNIQUES FOR RAPID EARLY-STAGE MEDICAL DEVICE DEVELOPMENT
Stuart Curtis runs through six techniques which, in his experience, are invaluable for accelerating the early development stages of drug delivery device design and can therefore be of great use when trying to accelerate a product’s time to market.
EXPERT VIEW
Lior Shtram
THE ROAD TO PREFILLED DEVICES IN NOVEL COMBINATION PRODUCTS
Lior Shtram discusses three approaches to delivering novel combination products – user-filled, user-loaded and prefilled – through the lens of sterilisation processes and requirements at the industrial manufacturing scale.
EXPERT VIEW
Ursula Hahn
SAFE, CONVENIENT AND EFFICIENT: INDIVIDUALISING PREFILLED SYRINGES
Ursula Hahn discusses the value of individualised prefilled syringes and explains how small changes in design or components can make a huge difference for doctors, patients and pharmaceutical manufacturers alike.
EXPERT VIEW
Charlotte Harvey
HOW SAFETY FEATURES MAKE OR BREAK INFUSION PUMP DESIGN
Charlotte Harvey and Tim Frearson overview the safety systems required when designing an infusion pump system, with a focus on free-flow prevention, occlusion detection and air-in-line detection.
EXPERT VIEW
Natalie Shortt
TO SUBSTITUTE OR NOT TO SUBSTITUTE? THAT IS THE ANDA QUESTION
Natalie Shortt, Maija Smith and Venetia Dickinson discuss the US FDA’s Draft Guidance on how human factors relate to the ANDA process, and how its encouragement to stay close to the reference product may result in some negative consequences.
EXPERT VIEW
Napoleon Monroe
CONNECTIVITY USING CONSUMER TECHNOLOGY TO CREATE REAL VALUE FOR PATIENTS
Napoleon Monroe presents the case for the C-Container, a collective term for a theoretical class of consumer product designed to work with various drug delivery combination products.
EXPERT VIEW
Douglas Cusato
INTRAVITREAL INJECTION OF VEGF INHIBITORS – IMPACT OF DRUG CONTAINERS
With the increasing use of intravitreal injections of vascular endothelial growth factor inhibitors in the treatment of numerous serious ocular diseases, Douglas Cusato provides a detailed comparative analysis of the issues at play.
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