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.

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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.

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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. 

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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.

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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.

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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.

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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.

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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.