EDITORIAL COMMENT

Citation: Furness G, “Editorial Comment”. ONdrugDelivery Magazine, Issue 52 (Sep 2014), p 5.

Guy Furness, ONdrugDelivery Magazine’s Editor, takes a moment to reflect on the topic of Prefilled Syringes, what’s happening in the sector today and it’s special place in the publication.

Prefilled Syringes is just one of a range of drug delivery subjects across the board that we cover in the various issues of this magazine (see 2015 Editorial Calendar, p4), but our issues on this particular topic have a special place for us. Prefilled Syringes is the topic on which ONdrugDelivery Magazine was founded, almost a decade ago now, with our first ever issue back in January 2005, and every year throughout these past ten years, Prefilled Syringes has remained an essential issue topic on our annual schedule. Without exception, every issue on this subject has been strongly supported by excellent contributions from the industry, imparting fresh and engaging new ideas and concepts, including this edition, Issue 52.

“Prefilled Syringes is the topic on which ONdrugDelivery Magazine was founded, almost a decade ago now, with our first ever issue back in January 2005…”

Two broad themes that appear to be emerging as talking points in the parenteral drug delivery industry at present, reflected in the articles that follow, are: 1) the use of training devices; and 2) device companies developing their role as expert consultants to biopharmaceutical companies, rather than simply specialist product/technology suppliers.

Training devices are coming to the fore as part of the tide of parenteral products designed for self-administration at home rather than in the clinic. It’s desirable that the design of any product for the public should ensure that using the product is intuitive, so that following the correct steps is self-evident and, ideally, impossible to get wrong. However, self-injection of a medicine for the first time is an unfamiliar, intimate and potentially worrying process, yet for many disease indications, the medication is significantly life enhancing and sometimes life saving.

So self-injection training devices (“trainers”) that contain no drug and have no needle can therefore overcome an important hurdle, allowing patients to get familiar with the look, feel and operation steps of the device before going on to use the real thing. Trainers, their applications and benefits – including advantages for patients, pharma companies and in terms of health outcomes and cost – are described in two articles in this issue. In his article, Steven Kaufman of SHL Group highlights the trainer that is being launched with SHL’s Molly auto-injector, and states that the majority of new auto-injectors will be launched with a trainer. Focusing on the area of user learning, training and training device approaches in-depth, Ian Scrimgeour of Shore Design Consultancy (here) highlights the consequences of inadequate training, examines two styles of training device (precise replication of parent device and multi-sensory enhanced educational devices) and sets out in detail the manifold benefits of the right trainer device.

The second theme emerging in this issue is that of device companies emphasising to their existing and potential new pharma partners the value of their specialist and often extensive experience in the area of drug delivery device design and development. Ypsomed’s Andreas Schneider points out in his piece that “biotech and pharma companies working toward their first market introduction … may have little experience in evaluating drug delivery devices”. In contrast, long-established device companies like Ypsomed have done this many times and as such are well placed to guide customers through all stages from design to end-assembly, and including in particular the compilation of data required for regulatory approval. Likewise, Steven Kaufman points to SHL’s long experience as being a valuable resource available to its clients. He also touches on the key role of consultancy companies in device development too – especially in areas such as Human Factors studies, but raises a slight note of caution: “It is important to keep in mind that device companies may have some issues providing [consultants with] full access … If a device company offers both industrial and mechanical design services, and the consultant offers the same, then the device company would be cautious providing a third party the same level of access to their staff, facilities and technologies as they give a customer.”

“Training devices are coming to the fore as part of the tide of parenteral products designed for self-administration at home rather than in the clinic…”

We always try to maintain a balance of delivering content for you in ONdrugDelivery Magazine that comes both from regular, long-standing contributors, and also from companies featuring here for the first time. In this edition, I’m happy to be able to introduce no less than five companies that have never before appeared in ONdrugDelivery. First, Credence MedSystems, Inc, of Menlo Park, CA, US, presents the Credence Companion Safety Syringe System, a passive needle-safety technology with modular design that, uniquely in the market, snaps onto syringes of any needle size. The device avoids the need for any change to the primary drug container.

As mentioned, we have a detailed article on at-home training devices from Shore – this is the first of what I hope will be many contributions to ONdrugDelivery Magazine by Shore Design, based in Edinburgh, UK. Then we have two equipment manufacturers to introduce. Zahoransky AG (Freiburg, Germany), an automation systems supplier for delivery devices, showcases its Z.BLIZZARD system for the glueless production of staked-needle polymer syringes. “Well over 95% of all cannulas are still being glued in Europe,” the company calculates. “If new developments and interrelations of all parties consider design, engineering and technical safety features, the future will certainly belong to glueless plastic syringes.”

“The second theme emerging in this issue is that of device companies emphasising to their existing and potential new pharma partners the value of their specialist and often extensive experience in the area of drug delivery device design and development…”

The other equipment supplier new to the pages of ONdrugDelivery is Morristown, NJ, US-based Kahle Automation. However, Kahle itself is by no means a start-up but a very well established industry veteran, since this year Kahle Automation is celebrating 95 years in the business. The company states in its profile that it is “the only large-scale automation company in the world that focuses exclusively on automated assembly, process and packaging equipment for pharma, medical device and healthcare industries”.

Finally, a fresh identity for a well-known company. Nemera (Paris, France) is the new name for Rexam Healthcare Devices, following the acquisition in May by Montau Private Equity. Information about the new name, and Nemera’s capabilities and offering within drug delivery can be found in its profile.

These new contributors mentioned above, together with articles from familiar contributors such as teamtechnik (here), The Tech Group division of West Pharmaceutical Services, SHL, Ypsomed and Gerresheimer (here), come together in this edition to give what I hope will be a useful and engaging insight for you into what’s new, and what is going on in the global prefilled syringes industry today.

You’ll be able to meet the companies that feature here, and most of the other key players in the prefilled syringes industry, in Huntingdon Beach, CA, US, for PDA’s Universe of Prefilled Syringes conference there on October 6th-7th. It’s a must-attend event of the year, and I hope to have the opportunity see you there!

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