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WEARABLES

KEY CHALLENGES IN SUCCESSFUL WEARABLE DRUG DELIVERY & PATIENT SELF-ADMINISTRATION

Enable Injections' Matthew Huddleston, Andrew Eibling and Jennifer King look at the key challenges involved in successful wearable drug delivery technology and patient self-administration.

A VIAL-BASED SOLUTION FOR WEARABLE DRUG DELIVERY

Mindy Katz and Michael Ratigan describe how, due to the inherent challenges of integrating vials into wearable devices, there has not been a viable, patient-centric option for wearable devices using vials ... until now.

MITIGATING RISK TO DELIVER SUCCESS IN HIGH-VOLUME WEARABLE DEVICES

Catherine Thacker and Bill Jaworski discuss risk reduction solutions in the manufacturing architecture for wearable injectors, including an example where autonomous intelligent vehicles and ATS‘s real-time industrial IoT manufacturing intelligence system, Illuminate®, were employed.

E3D – Elcam Drug Delivery Devices

EVOLUTION OF AN ON-BODY BOLUS INJECTOR: FROM DRUG-SPECIFIC DEVICE TO PLATFORM

Tsachi Shaked introduces E3D’s On-body Bolus Injector, OBI, a versatile platform that uses gas generating microcells as its engine, has no electromechanical components, and only one moving part.

Hans Peter Manser

LARGE-VOLUME WEARABLE DRUG DELIVERY: A VISION BECOMES REALITY

Hans Peter Manser, Christoph Egloff and Martin C King introduce LV DDS , a flexible-form, low-profile wearable injector platform, for large-volume drug delivery.

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.

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.

Stevanato Group

CAN WEARABLE DEVICES BRIDGE THE GAP BETWEEN PEN INJECTOR AND PUMP?

Steven Kaufman and Paolo Golfetto explore the potential for wearable injectors to be disruptive technologies in the drug delivery market.

BD (Becton Dickinson & Company)

THE CHANGING DRUG DELIVERY PARADIGM

Beth DiLauri sets out the fundamental case for the adoption of wearable injectors, outlines the specific barriers they overcome and describes how the design and development of the BD Libertas™ wearable injector platform make it an attractive proposal for pharma companies.

TRAINING PATIENTS IN THE USE OF WEARABLE INJECTORS

Joe Reynolds highlights the projected growth in popularity of wearable injector devices, and shows that it is imperative for healthcare providers (HCPs) both to train their patients properly in the office, and offer training devices that patients can take home and practice with.

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.

Claus Schmidt Moeller

DEVELOPMENT OF AN OSMOTIC LARGER VOLUME WEARABLE BOLUS INJECTOR

Claus Schmidt Moeller provides an overview of the mechanism, functionality and applications of the company’s osmotic, single-use, low-cost, versatile wearable bolus injector.

Mikron Automation

SCALABLE ASSEMBLY SOLUTIONS – FULLY INTEGRATED, TRULY GLOBAL

Rolf Rihs and Jean-François Bauer look at how Mikron has specialised in flexible, modular assembly solutions that are easy to evolve during the different stages of a product lifecycle: from development through to fully automated, maximum-performance production.

Hiroki Hasegawa

Mitsubishi Gas Chemical

ADVANCES IN MULTILAYER TECHNOLOGY FOR WEARABLE INJECTOR PRIMARY PACKAGING

Hiroki Hasegawa and Tomohiro Suzuki discuss how multilayer technology used in the drinks bottle industry can be used to create syringes and vials for biologics, avoiding problems such as oxidation and absorption that occur with other materials.

LARGE-VOLUME PATCH-INJECTION VIA YPSODOSE: SIMPLER FOR PHARMA COMPANIES & PATIENTS

Ian Thompson updates us on the company’s prefilled large-volume patch injector platform, YpsoDose, which simplifies the approach to wearable patch injectors for both pharma companies and patients.

Sensile Medical

COMPANY SHOWCASE: Sensile Medical

Sensile Medical has achieved a lot since its acquisition by Gerresheimer last year. Here they provide an update on two recent projects: the recent market launch of our first micropump, an infusion pump for Parkinson’s disease patients; and our latest project with SQ Innovation for a 3 mL furosemide patch pump.

Victoria Morgan

West Pharmaceutical Services

HOW LARGE-VOLUME WEARABLES REVOLUTIONISE THE PATIENT EXPERIENCE

Victoria Morgan looks at how the combination of large-volume medicines and the trend for wearable devices is transforming life for patients, highlighting the company's new-generation SmartDose 10 mL platform.

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.

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.

CONFERENCE SHOWCASE

2019 PDA UNIVERSE OF PRE-FILLED SYRINGES AND INJECTION DEVICES PREVIEW

PDA Europe presents the 16th edition of its signature event Universe of Pre-filled Syringes & Injection Devices – an important conference for people working in the fields of parenteral drug, and device, development, covering solutions to challenges regarding new developments, and regulatory and industry trends.

Sarah Trenfield

PERSONALISING DRUG PRODUCTS USING 3D PRINTING

Sarah Trenfield and Abdul Basit look at the potential applications of 3D-printing technology to create personalised drug therapies in fields such as multiple drug therapy and paediatric/geriatric care and introduce FabRx’s 3D-printing system, which can produce formulations to suit a variety of situations.

INDUSTRIALISATION

Gilbert Fluetsch

EXPANDING AUTOMATION CAPACITY FOR HIGH AND LOW VOLUMES

Gilbert Fluetsch and Lucy Chung look at how automation and assembly services can best evolve and adapt to industry standards and market demands, whilst delivering consistently at high quality and in a timely manner.

INDUSTRIALISATION

Berthold Schopferer

Z.BLIZZARD AUTOMATION SYSTEM – IT DOESN’T GET MORE TAILOR-MADE THAN THIS

Berthold Schopferer explains how the Zahoransky’s integrated syringe manufacturing and assembly equipment allows maximum customisation and full customer involvement.

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.

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.

BD (Becton Dickinson & Company)

Cecile Halte, BD

In this interview, Cécile Halté, Senior Program Manager, Acute Care Segment, for BD Medical – Pharmaceutical Systems. discusses validation studies of the BD Sterifill Advance™ plastic prefilled syringe, which is intended for use in the hospital setting by healthcare professionals either for manual bolus injections, or with infusion pumps.

Bob Tilling, Kallik

In this interview, Bob Tilling, Business Development Manager at Kallik, shares his insights on best practice for factory labelling.

INDUSTRIALISATION

Michael Wiglenda

Gerresheimer AG

A FIVE-STEP APPROACH TO INNOVATION IN DRUG DELIVERY SYSTEMS

Michael Wiglenda explains Gerresheimer’s industrialisation offering and the five-step Gate-Model that guides its innovation process.

INDUSTRIALISATION

Jose Luis Encinas

QUALI-V EXTRA DRY: A NOVEL CAPSULE FOR DELIVERING HYGROSCOPIC FORMULATIONS

Jose Luis Encinas and Susana Ecenarro explore how the use of Quali-V^® Extra Dry capsules can help improve product stability and, crucially, lead to efficiencies and savings in drug product manufacture.

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.

Dr Ramin Rafiei

MACRO TRENDS ACCELERATING THE ADOPTION OF CONNECTIVITY IN DRUG DELIVERY

Ramin Rafiei argues that connected therapeutics – the augmentation of drugs through sensors and connectivity – are now a clinical source for real-world data and provide an opportunity to bridge the efficacy-to-effectiveness gap. This next frontier in drug delivery, powered by connected therapeutics, will be data-driven, personalised, outcomes-based and accessible.

Eric Dessertenne

COMPLETING ITS TRANSITION FROM GENESIS TO MATURITY, BIOCORP OPENS NEW HORIZONS

As Biocorp prepares for the market launch of its connected injector pen add-on, Mallya, Eric Dessertenne and Arnaud Guillet share insights about key steps in the company’s development. The article discusses the many partnership Biocorp has entered in to, and includes a mini-interview with Sergio Monti, Plant Manager for one such partner, V.A.R.I.

CONNECTED DEVICES – MEDICATION DELIVERY JUST GOT PERSONAL

Thierry Decock and Hadrien Gremillet explore how the obstacles to the adoption of connectivity can be overcome and how connected devices can deliver truly patient-centric care that will clearly improve adherence rates, whilst demonstrating a clear cost benefit to the pharmaceutical partner.

Dr Mircea Despa

BD (Becton Dickinson & Company)

MIRCEA DESPA & DOUG McCLURE, BD

In this interview, Dr Despa and Mr McClure discuss BD’s approach to connecting devices in its portfolio to meet patient, pharma and other stakeholder requirements. Their discussion focuses in particular on safety and security, highlighting the connected wearable injector, BD Libertas™ with Smart Option, as an example.

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.

DON’T DEVELOP A CONNECTED DRUG DELIVERY DEVICE WITHOUT READING THIS

Matt Jones summarises some of the key challenges and opportunities in the development of connected drug delivery devices, focusing in detail on deciding what a connected drug delivery device should do, designing for a coin cell, direct cellular connection and antenna design.

USER-CENTERED 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.

Phillips-Medisize

LOW-COST CONNECTIVITY MEETS PATIENT & PHARMA MEDICATION MANAGEMENT NEEDS

Neil Williams describes the potential connected drug delivery systems hold to address serious challenges in healthcare, including poor adherence, and also deliver substantial value, and outlines the company’s highly scalable enterprise platform, the Connected Health Platform.

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.

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