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EXPERT VIEW

AUTOMATING UNDER UNCERTAINTY – GOOD PRACTICES
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.
THE CHALLENGES OF DELIVERING QBD IN NOVEL RESPIRATORY DEVELOPMENT
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.
IS THERE A FUTURE FOR THE RESPIRATORY DELIVERY OF BIOLOGICS?
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.
HAZARDOUS DRUG HANDLING AND INVESTIGATIONAL DRUGS: LESSONS TO LEARN
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.
SIX TECHNIQUES FOR RAPID EARLY-STAGE MEDICAL DEVICE DEVELOPMENT
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.
THE ROAD TO PREFILLED DEVICES IN NOVEL COMBINATION PRODUCTS
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.
SAFE, CONVENIENT AND EFFICIENT: INDIVIDUALISING PREFILLED SYRINGES
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.
HOW SAFETY FEATURES MAKE OR BREAK INFUSION PUMP DESIGN
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.
CONNECTIVITY USING CONSUMER TECHNOLOGY TO CREATE REAL VALUE FOR PATIENTS
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.
INTRAVITREAL INJECTION OF VEGF INHIBITORS – IMPACT OF DRUG CONTAINERS
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.
THE EYES HAVE IT – EYE TRACKING EVOLUTION IN MEDICAL DEVICE DEVELOPMENT
EXPERT VIEW
Dr Philip Lance
THE EYES HAVE IT – EYE TRACKING EVOLUTION IN MEDICAL DEVICE DEVELOPMENT
Philip Lance and Phil Seeney discuss the recent surge in the use of eye-tracking technology in the field of human factors, providing an overview of the technique’s history and how it may be applied to medical devices in the future.
WE’RE OFF TO SEE THE WIZARD: “USE-LIKE” PROTOTYPING OF DIGITAL CONCEPTS
EXPERT VIEW
Tom Lawrie-Fussey
WE’RE OFF TO SEE THE WIZARD: “USE-LIKE” PROTOTYPING OF DIGITAL CONCEPTS
Tom Lawrie-Fussey and Lucy Sheldon introduce “Wizard of Oz” testing, named after the classic novel and film, whereby experimenters can field test concepts at a very early stage by giving the illusion of a finished product, saving potential costly and time-consuming changes further along the development process.
NEBULISERS: TIME TO REINVENT THE WHEEL
EXPERT VIEW
Dr John N Pritchard
NEBULISERS: TIME TO REINVENT THE WHEEL
John Pritchard discusses the history of the nebuliser, its fall in popularity with the advent of DPIs and pMDIs, and its current resurgence due to the success of the mesh nebuliser, continuing on to how changing the development paradigm to utilise nebuliser technology more effectively can have significant benefits.
PIPELINE TRENDS AND CHALLENGES IN PULMONARY DELIVERY
EXPERT VIEW
Dr Gunilla Petersson
PIPELINE TRENDS AND CHALLENGES IN PULMONARY DELIVERY
Gunilla Petersson provides an overview of the inhalables sector from a pharma perspective, covering the three major device types – DPIs, pMDIs and nebulisers.
MARKET CHALLENGES AND OPPORTUNITIES FOR DELIVERY SYSTEMS AND INJECTION DEVICES
EXPERT VIEW
Massimo Mainetti
MARKET CHALLENGES AND OPPORTUNITIES FOR DELIVERY SYSTEMS AND INJECTION DEVICES
Massimo Mainetti presents a brief overview of the current state of play in the field of novel biologic medicines as they relate to drug delivery.
PLATFORM DEVICES AND THE PATIENT JOURNEY
EXPERT VIEW
Mark Tunkel
PLATFORM DEVICES AND THE PATIENT JOURNEY
Mark Tunkel discusses the benefits of mapping the patient journey when looking to select a platform device for a new drug-device combination product.
PATIENT-CENTRICITY – A WINNING FORMULA
EXPERT VIEW
Justin Schroeder
PATIENT-CENTRICITY – A WINNING FORMULA
Justin Schroeder discusses patient-centricity, particularly how it relates to clinical trials in the modern global landscape of the pharmaceutical industry.
2014 TO 2018: AN UPDATE ON THE STATE OF WEARABLE INJECTORS
EXPERT VIEW
Paul Jansen
2014 TO 2018: AN UPDATE ON THE STATE OF WEARABLE INJECTORS
Looking back on the developments in large volume injectors since his article in ONdrugDelivery’s 2014 issue on wearable injectors, Paul Jansen reflects on the state of this technology space today, how it has progressed and the value it is likely to offer.
MOBILE DEVICES AND USE-RELATED RISK – TIME TO REINSTATE DETECTABILITY?
EXPERT VIEW
Richard Featherstone
MOBILE DEVICES AND USE-RELATED RISK – TIME TO REINSTATE DETECTABILITY?
Richard Featherstone makes the case for designing detectability into the user interfaces of wearable devices, enabling the user to be an active part of ensuring the device operates safely, as intended.
ORAL THIN FILMS: NOVEL TECHNOLOGY & ITS CHALLENGES
EXPERT VIEW
Dr Nidhi Prakash Sapkal
ORAL THIN FILMS: NOVEL TECHNOLOGY & ITS CHALLENGES
Presented from both the technology and formulation perspectives, Nidhi Prakash Sapkal and Anwar Siraj Daud discuss the challenges of industrialising oral thin films, a promising but difficult dosage form.
BEYOND MANUFACTURING: INDUSTRIALISATION OF DRUG DELIVERY IN THE REAL WORLD
EXPERT VIEW
Napoleon Monroe
BEYOND MANUFACTURING: INDUSTRIALISATION OF DRUG DELIVERY IN THE REAL WORLD
When discussing the industrialisation of drug delivery, it is natural to focus on the processes and management of manufacture. Napoleon Monroe provides a different perspective on the idea of drug delivery’s “Industrialisation” and what that might mean in the modern world of service industry.
THE BIGGEST MISTAKES COMPANIES MAKE COMMERCIALISING DRUG DELIVERY – AND WHAT TO DO ABOUT THEM
EXPERT VIEW
Beth Blackburn
THE BIGGEST MISTAKES COMPANIES MAKE COMMERCIALISING DRUG DELIVERY – AND WHAT TO DO ABOUT THEM
It is difficult to successfully scale-up a product to industrial production and launch, but it is much harder if design fundamentals are not adhered to. Beth Blackburn details the need for setting down requirements early in device development in order to avoid inadvertently undermining a product’s successful commercialisation.
A “KODAK” MOMENT FOR THE PHARMA INDUSTRY?
EXPERT VIEW
Dr Pari Datta
A “KODAK” MOMENT FOR THE PHARMA INDUSTRY?
Pari Datta and Nick Rollings discuss the concept of personalised medicine, with particular reference to oncology, and how it represents both an opportunity and a threat.
INTEGRATING CONNECTED HEALTH IN RESPIRATORY: THE MANUFACTURING CHALLENGE
EXPERT VIEW
David Belton
INTEGRATING CONNECTED HEALTH IN RESPIRATORY: THE MANUFACTURING CHALLENGE
David Belton highlights an often undiscussed aspect of the move towards connected drug delivery devices, the impact on manufacturing. Using inhalers as a reference point, he runs through several of the concerns and decisions that will need to be addressed for successful mass production of such devices.
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