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EXPERT VIEW

DIRECTIONS FOR WEARABLE ON-BODY INJECTOR SYSTEMS AND BEYOND

Matt Parker, Karthik Chellappan and David Cottenden discuss the current state of play for large-volume injection and look into the challenges that on-body delivery systems currently in development will need to overcome to find success in a changing marketplace.

WOULD YOU LIKE TO GO LARGE? KEY CONSIDERATIONS FOR LARGE-VOLUME INJECTORS

Malcolm Boyd discusses the factors that need to be considered early in the development of large-volume injectors, which will have a major influence on the performance, usability and cost of a device.

INJECTING INNOVATIVE SOLUTIONS INTO CONNECTED DELIVERY DEVICES

INJECTING INNOVATIVE SOLUTIONS INTO CONNECTED DELIVERY DEVICES

Roger Bohannan discusses the capabilities and design challenges of connected drug delivery devices.

INCORPORATING MOTION DESIGN AT EARLY STAGES OF WEARABLE INJECTOR DEVELOPMENT

Dave Beckstoffer

INCORPORATING MOTION DESIGN AT EARLY STAGES OF WEARABLE INJECTOR DEVELOPMENT

Dave Beckstoffer discusses the often overlooked importance of including motion system design considerations from the very earliest stages of wearable injector development, and how doing so can reduce costs, shorten timelines and improve patient outcomes.

REUSABLE WEARABLE INJECTORS: LESSONS FROM IN VITRO DIAGNOSTICS

REUSABLE WEARABLE INJECTORS: LESSONS FROM IN VITRO DIAGNOSTICS

Thomas James explores how insights from the development of successful in vitro diagnostic instruments can help guide the evolution of wearable injectors.

DFM & DFA: THE DIFFERENCES, BENEFITS AND HOW TO IMPLEMENT THEM

DFM & DFA: THE DIFFERENCES, BENEFITS AND HOW TO IMPLEMENT THEM

Phil Sampey discusses the principles associated with design-for-manufacture (DFM) and design-for-assembly (DFA) methodologies as applied to drug delivery device design, giving an overview of what each involves and key areas of focus to ensure that the full benefits of these approaches can be realised.

ENTERING THE UK MARKET: A GUIDE FOR US MEDICAL DEVICES COMPANIES

IMed Consultancy

ENTERING THE UK MARKET: A GUIDE FOR US MEDICAL DEVICES COMPANIES

Matthew Burton discusses the new EU Medical Device Registration and offers a guide for the UK Responsible Person within companies.

THE POTENTIAL OF CONNECTIVITY AND MONITORING IN MESH NEBULISERS

Carolina Dantas

THE POTENTIAL OF CONNECTIVITY AND MONITORING IN MESH NEBULISERS

Carolina Dantas and Ulf Krueger review the current connectivity and remote monitoring capabilities in mesh nebulisers – and their potential to impact patients’ healthcare journeys and the clinical development of inhaled therapies.

THE IRONIES OF AUTOMATION: LESSONS FOR REMOTE PATIENT MONITORING

THE IRONIES OF AUTOMATION: LESSONS FOR REMOTE PATIENT MONITORING

Dan Lock considers how to overcome potential pitfalls and make the most of remote patient monitoring for the benefit of both patient care and clinical trials.

MODIFIED-RELEASE MICROSPHERES: MAXIMISING COATING INTEGRITY AND OPTIMISING RELEASE

Dr Jonathan Cape

MODIFIED-RELEASE MICROSPHERES: MAXIMISING COATING INTEGRITY AND OPTIMISING RELEASE

Jonathan Cape discusses development considerations and workflows to select optimal enteric coat weights for modified release microspheres – balancing performance considerations with API stability and the excipient burden to patients.

INCREASE PRODUCTION SUCCESS THROUGH TABLET DESIGN TECHNIQUES

INCREASE PRODUCTION SUCCESS THROUGH TABLET DESIGN TECHNIQUES

Richard Ball considers the important features of tablet design and discusses its importance to the mass production of tablets.

HARD CAPSULES: A HOLISTIC APPROACH FOR ORAL DRUG DELIVERY AND FORMULATION

Dr Jnanadeva Bhat

HARD CAPSULES: A HOLISTIC APPROACH FOR ORAL DRUG DELIVERY AND FORMULATION

Jnanadeva Bhat and Manali Dalvi discuss how advances in capsule technology as an oral drug delivery method have opened up new avenues for the development of more effective and patient-friendly drugs.

ENSURING PATIENT SAFETY AMIDST MEDICAL DEVICE REGULATION DELAYS WITH PMS

ENSURING PATIENT SAFETY AMIDST MEDICAL DEVICE REGULATION DELAYS WITH PMS

Timothy Bubb discusses the five steps to setting up an effective post-market surveillance process.

DESIGNING FOR USABILITY IN EMERGENCY-USE COMBINATION PRODUCTS

DESIGNING FOR USABILITY IN EMERGENCY-USE COMBINATION PRODUCTS

Thomas James highlights the importance of early user engagement, as well as continuous refinement of information and workflow design, for efficient development of drug-device combination products for emergency use.

TACKLING DESIGN CHALLENGES IN EMERGENCY-USE AUTOINJECTORS

TACKLING DESIGN CHALLENGES IN EMERGENCY-USE AUTOINJECTORS

John Burke considers the challenges that manufacturers need to overcome when designing emergency-use autoinjectors.

STRATEGIES FOR TEST METHOD VALIDATION OF DRUG DELIVERY PLATFORMS

STRATEGIES FOR TEST METHOD VALIDATION OF DRUG DELIVERY PLATFORMS

Deepu Asok discusses the importance of test method validation for drug-device combination product development and how a common mistake is to design the validation process for a specific device rather than to accommodate the potential variety of a device platform.

MITIGATING CONTAINER CLOSURE INTEGRITY CHALLENGES FOR INJECTABLES

MITIGATING CONTAINER CLOSURE INTEGRITY CHALLENGES FOR INJECTABLES

Eugene Polini discusses the importance of container closure for the parenteral drug market, including some of the consequences of compromised container closure and what steps manufacturers can take to ensure that primary packaging systems remain sealed for a product’s entire shelf life.

RETHINKING PLASTIC: HOW ECO-FRIENDLY DESIGN IS DRIVING SUSTAINABLE CHANGE

RETHINKING PLASTIC: HOW ECO-FRIENDLY DESIGN IS DRIVING SUSTAINABLE CHANGE

Giorgio Sardo discusses sustainable material selection and the results of tests comparing the performance of sustainable bio-based plastic resins with their fossil-based equivalents.

DESIGNING SUSTAINABILITY INTO PHARMACEUTICAL DEVICES

DESIGNING SUSTAINABILITY INTO PHARMACEUTICAL DEVICES

Will Davies discusses in detail how to address the challenges of designing sustainability into pharmaceutical devices.

SUSTAINABILITY IN DRUG DELIVERY: HOW DO WE GET THERE?

SUSTAINABILITY IN DRUG DELIVERY: HOW DO WE GET THERE?

Tim Wooller discusses the urgent need to transition away from disposable models of drug delivery device design and move towards reusables, providing insights into the reasons why and the methods by which this can be achieved.

IMPROVING RECYCLABILITY IN DRUG DELIVERY

Julien Tremblin

IMPROVING RECYCLABILITY IN DRUG DELIVERY

Julien Tremblin looks at the recyclability challenges facing the drug delivery market and considers how companies can enhance the recyclability of their packaging and devices.

DUE DILIGENCE – THE KEY TO SUCCESS IN DRUG DELIVERY DEVICE SELECTION

DUE DILIGENCE – THE KEY TO SUCCESS IN DRUG DELIVERY DEVICE SELECTION

Matt Jones and Rob Veasey consider the process of matching the drug with the right delivery device and look at the importance of due diligence when “licensing in” technology.

CONSIDERATIONS WHEN SWITCHING FROM CURRENT pMDI PROPELLANTS TO NEW LOWER-GWP PROPELLANTS

CONSIDERATIONS WHEN SWITCHING FROM CURRENT pMDI PROPELLANTS TO NEW LOWER-GWP PROPELLANTS

Mark Parry discusses the considerations that need to be made when switching from current pressurised metered dose inhaler propellants to new alternatives with lower global warming potential, including formulation, regulatory and analytical standpoints.

THE NEXT GENERATION OF MICRONEEDLES: HARNESSING A BILLION YEARS OF EVOLUTION

Dr Gabriel Villar

THE NEXT GENERATION OF MICRONEEDLES: HARNESSING A BILLION YEARS OF EVOLUTION

Gabriel Villar and Ethan Miller consider examples of nature’s solutions to four challenges faced by microneedles for drug delivery. For each challenge, the authors explain how a natural organism has tackled it and what lessons may be directly applied to microneedle design.

OVERCOMING CHALLENGES WHEN DEVELOPING OLIGONUCLEOTIDES FOR OPHTHALMIC DRUGS

OVERCOMING CHALLENGES WHEN DEVELOPING OLIGONUCLEOTIDES FOR OPHTHALMIC DRUGS

Shiyan Chen and Binbin Tian discuss the use of oligonucleotides for ophthalmic applications, including their potential uses, advantages, challenges and difficulties when it comes to pharmacokinetic and drug metabolism studies.

TOPICAL DRUG ADMINISTRATION FOR THE POSTERIOR SEGMENT

Dr David Bingaman

TOPICAL DRUG ADMINISTRATION FOR THE POSTERIOR SEGMENT

David Bingaman explores the potential benefits of topical administration for diseases affecting the posterior segment of the eye.

BEYOND THE EYEDROPPER BOTTLE – THREE WAYS TO IMPROVE ADHERENCE

Dr Nathan Wilkinson

BEYOND THE EYEDROPPER BOTTLE – THREE WAYS TO IMPROVE ADHERENCE

Nathan Wilkinson, Catherine Wyman and Matt Parker discuss the future outlook of ophthalmic drug delivery beyond the traditional eyedropper bottle, including new delivery technologies, sustained-release therapeutics and digital healthcare applications.

A SIGHT FOR SORE EYES: CHALLENGES & INNOVATIONS IN OPHTHALMIC DRUG DELIVERY

Dr Ethan Miller

A SIGHT FOR SORE EYES: CHALLENGES & INNOVATIONS IN OPHTHALMIC DRUG DELIVERY

Ethan Miller and Kristien De Clercq discuss recent advancements and current challenges in the field of ophthalmology, including the trend towards preservative-free multidose delivery systems, delivering smaller topical volumes with increased drug efficacy, slow-release injections for delivery to the posterior of the eye and the exciting field of gene therapy.

EXTRACTABLES/LEACHABLES TESTING CONSIDERATIONS FOR SINGLE-USE SYSTEMS

EXTRACTABLES/LEACHABLES TESTING CONSIDERATIONS FOR SINGLE-USE SYSTEMS

Sandi Schaible discusses testing considerations for extractables and leachables along with the regulatory environment for single-use systems.

CONNECTED DRUG DELIVERY DEVICES: BENEFITS AND CYBERSECURITY

João Budzinski

CONNECTED DRUG DELIVERY DEVICES: BENEFITS AND CYBERSECURITY

João Budzinski discusses the benefits of connected drug delivery devices and the importance of cybersecurity when developing them, including the threats, key considerations and potential solutions.

EXPANDING THE DESIGN OF CHARACTERISATION STUDIES FOR ACCURATE HANDLING-ERROR ASSESSMENT

Dr Yannick Baschung

EXPANDING THE DESIGN OF CHARACTERISATION STUDIES FOR ACCURATE HANDLING-ERROR ASSESSMENT

Yannick Baschung discusses the importance of a comprehensive and accurate assessment of patient handling errors when it comes to inhaled product development.

THE INFLUENCE OF UNCERTAINTY ON CHEMICAL CHARACTERISATION

THE INFLUENCE OF UNCERTAINTY ON CHEMICAL CHARACTERISATION

James Silk discusses the importance of accounting for uncertainty when characterising the extractables profile of a medication, with particular reference to the ISO 10993 standard.

THE INNOVATIONS TACKLING CHALLENGES & MAXIMISING OPPORTUNITIES IN INHALATION

THE INNOVATIONS TACKLING CHALLENGES & MAXIMISING OPPORTUNITIES IN INHALATION

Marco Franza and Nadine Khoury look at how the latest digital technologies, manufacturing techniques and packaging materials are combining to take the manufacture of inhalers to a new level.

TAKING THE STING OUT OF VACCINES

Dr Heather Jameson

TAKING THE STING OUT OF VACCINES

Heather Jameson, Juliette Ngan and Omar Shah discuss the potential advantages and challenges of intranasal and inhaled vaccines in the context of global respiratory pandemics.

SOLVING COMPLEX FORMULATION & DELIVERY CHALLENGES FOR INTRANASAL DRUGS

SOLVING COMPLEX FORMULATION & DELIVERY CHALLENGES FOR INTRANASAL DRUGS

Paul Kippax discusses the analytical techniques used for in vitro characterisation of nasal sprays, and how their use can accelerate and de-risk both innovator and generic nasal drug development.

NASAL DELIVERY – A GALAXY NOT SO FAR AWAY… A BRIEF MARKET HISTORY OF THE NASAL DELIVERY LANDSCAPE

NASAL DELIVERY – A GALAXY NOT SO FAR AWAY… A BRIEF MARKET HISTORY OF THE NASAL DELIVERY LANDSCAPE

Mark Ignaczak provides an insight into the history of nasal drug delivery and looks at the advantages of the nasal delivery route.

SUSTAINABLE DESIGN & MANUFACTURE IN MEDICAL DEVICES: WHERE TO START

SUSTAINABLE DESIGN & MANUFACTURE IN MEDICAL DEVICES: WHERE TO START

Cormac O’Prey discusses the challenges and advantages of implementing circular economy principles in the medical device sector, with a particular consideration of the difficulty of making remanufacturing work for high-volume, low-value devices.

THE ENVIRONMENTAL IMPACT OF GLOBAL SUPPLY CHAIN LOGISTICS & SUPPLIER SELECTION

Alastair Willoughby

THE ENVIRONMENTAL IMPACT OF GLOBAL SUPPLY CHAIN LOGISTICS & SUPPLIER SELECTION

Alastair Willoughby looks at the factors affecting sustainability when considering global supply chain logistics and supplier selection.

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