There currently seems to be two main camps: those who simply wish to deliver generic compounds using known (and proven) device technologies; and those who wish to deliver novel APIs, often for therapies beyond the typical asthma and COPD, using new, innovative devices. The understanding of the science behind such devices continues to grow – demonstrated by the large number of thought-provoking scientific presentations and posters, and also by the number of new instruments. Dekati debuted their ‘Bolar’ instrument that can independently measure the positive and negative charge on an aerosol; and Copley Scientific showcased their BRS 3000 that can run realistic inspiratory flow profiles through inhalers connected to an NGI.

A few new devices were on show too. Manta Devices had their Torus DPI technology, and we showed off our Occoris API-only DPI concepts, all three of which use the same active aerosolisation engine.

There were three and a half days of quality presentations, with sessions covering Emerging Markets through to Evaluating Patient Use – including an interesting presentation on the rapidly evolving regulatory requirements in China by Maozhong Li of the State Food and Drug Administration. It was great to hear such a diverse range of talks, clearly demonstrating the growth in the sector, both geographically and in knowledge.

RDD will return to Europe for 2013, and is to be held in once again in Berlin on May 21-24. So a big thanks to the organisers (Joanne, Richard and Peter) for another fantastic event – and we all look forward to 2013…

Outside of Team, i’m a keen photographer and here are a couple of my personal photos that I took before the conference started.

Cambridge, UK – May 1st, 2012 – At this month’s Respiratory Drug Delivery (RDD) conference in Phoenix, Arizona (13th May – 17th May), Team Consulting will be unveiling three inhaler concept designs based upon its revolutionary Occoris™ technology. Designed primarily for delivering systemic treatments beyond the typically inhaled topical asthma and COPD, such as vaccines, pain relief and insulin, the Occoris™ ‘engine’ is ultra-small, active and achieves very accurate and repeatable delivery of API-only formulations.

At the conference, Team will be showcasing prototypes for a single-use disposable inhaler, a multi-unit dose inhaler and a multi-dose inhaler – demonstrating the technology’s multi-platform credentials, and to illustrate the numerous design possibilities afforded by Occoris™.

The Occoris™ technology was developed by Team after the company identified a number of factors that are likely to shape the respiratory drug delivery market of the future:

Firstly, asthma and COPD inhalers typically use an inert carrier fraction to dilute the small quantities of active pharmaceutical ingredient (API). Inhalers that treat conditions beyond asthma and COPD will need to deliver a wide range of dose sizes which do not require a carrier fraction.

Secondly, inhalers for treating conditions such as diabetes, pain relief or delivering vaccines will require very different design approaches. The simplicity and small size (around the same size as a garden pea) of the Occoris™ engine gives designers incredible flexibility in form factor and materials. For example, one of the concepts on show at RDD will be for mass vaccination and can be produced largely out of recyclable cardboard.

Finally, regulators will demand much tighter dose content uniformity, higher delivery efficiencies and better independency of flow rate from inhalers. Early indications are that inhalers that use the active Occoris™ engine will deliver highly accurate dosage and repeatable performance.

“Delivering drug via the pulmonary route offers so many advantages over needles and tablets. The drug is quickly absorbed by the body, in powder form it doesn’t require cold storage and there is no user anxiety or danger of needle-stick injuries. With our Occoris™ technology we are opening up a wide range of new opportunities beyond the traditional and highly competitive asthma and COPD market, which will help our pharmaceutical clients to establish new revenue streams,” says David Harris, Head of Respiratory Drug Delivery at Team. “We are in the process of optimising the technology, and at this month’s RDD conference we’ll be sharing three novel inhaler concepts with the industry – and I’m looking forward to discussing the range of potential applications for the ground-breaking technology.”

–ENDS—

High-res (300 dpi) images of the three inhaler concepts (click on the image to load it, then right click and ‘save as’):

Above – the multi-dose inhaler concept, based on Team’s Occoris™ technology

Above – the disposable inhaler concept, based on Team’s Occoris™ technology

Above – the multi-unit dose inhaler concept, based on Team’s Occoris™ technology

Above – the full range of inhaler concepts, all based on Team’s Occoris™ technology

Media contacts:

Neil Cooper

Head of Marketing

Team Consulting

Mobile: +44 (0)7581 210 919

neil.cooper@team-consulting.com

David Harris

Head of Respiratory Drug Delivery

Team Consulting

Tel: +44 (0)1799 532767

david.harris@team-consulting.com 

About Team Consulting

Team Consulting is focused on medical device development and has a global reputation for integrity, creativity and excellence. We believe devices should save lives, enhance wellbeing and reduce pain. Formed in 1986 we are a fee-for-service business, helping clients to turn concepts and needs into viable and commercially successful devices.

Naturally, all new standards have a ‘bedding in’ period, where the industry discovers what the requirements mean in practice. This standard contains a new aspect which is leading to greater uncertainty than some, though many other aspects of the standard are thankfully clear.

The BS EN ISO20072:2010 standard fits with the apparent trend in pushing responsibility for defining, as well as managing, risk to the device developers. In pushing this aspect even further, this standard now states that the developer needs to establish a “device functionality profile” (DFP) that “consist[s] of identified critical functions and design features, test methodology, tolerance limits and acceptance criteria”. This is intentionally separate from drug delivery performance, which is explicitly excluded from all but a final “system verification test”.

This ‘DFP’ allows the standard to be applicable to the different types of inhaler and might, at first, appear to be a subset of the requirements -those that are critical to function. In addition, the standard states that this DFP should also be “based on the outcome of the risk assessment” and, hence, it should be assumed that some risk mitigations (from FMEAs etc.) will also be used. It is good to see the specification of requirements for device performance taking into account the nature of the medication – and the risk of not delivering it successfully – but the way in which this is incorporated is open to interpretation.

Therefore, the standard effectively asks the developer to create a statement that, if the device does everything listed in the DFP, within acceptable limits, the device ’works’. This is inevitably open to significant differences in opinion about how much is incorporated into the DFP as well as being largely dependent on the organisation’s general attitude to risk. There is also some ambiguity as to what the DFP ‘looks like’, and whether or not it is the set of requirements for the device or the summed description of what performance profile the device actually achieves.

It will be interesting to see how the regulatory agencies react to these initial interpretations of the term DFP, and whether the trend is towards large sections of the requirements and large numbers of mitigations being included…or the reverse. It does, at least, force the developers to keep questioning what it is that defines how their device actually works, outside of drug delivery performance.

Inhalers currently on the market present many challenges to the user – devices may require co-ordination of breath and operation, need to be shaken, held in a particular orientation or rely on a sequence of actions for the dose to be successfully taken. The Prohaler™ is a breath-actuated inhaler that simply requires the user to open it, breathe in, and close it again. Critically, the dose is only released when the user inhales, so the device can be opened and closed with no drug wastage, and the powder remains fully protected even if a user breathes into the device.  This makes it particularly suitable for the broadest range of asthma and COPD patients.

Key to the project success was the user-centred approach. A ‘user champion’ on the project team ensured that the user was represented and considered throughout the rigorous engineering design process. Usability trials and task analyses were undertaken from the very beginning to guide early concept development, and repeated throughout the development process. This enabled the project team to refine all aspects of the design with feedback from potential users and healthcare professionals. The intuitive use of the inhaler is seen as a key competitive advantage by Valois Pharma’s partners.

Complementing the device’s user appeal is a unique dispersion technology that gives excellent aerosolisation and high fine particle fraction even when operating at relatively low inspiratory flow rates. Numerous novel (and patentable) mechanical solutions were generated through this process highlighting the benefits of the Valois Pharma-Team collaboration.

The pure, clean visual language of the design was realised within the demands of design for high-volume, managed component cost and a risk-based assessment of product and processes. The Prohaler™ was designed for worldwide market regulatory compliance and looks set to redefine the standard for DPI user interaction and performance.

Guillaume Brouet, Director – Business Development Pulmonary, comments: “Valois Pharma’s drug delivery device expertise combined with Team’s extensive experience in device development and unique approach to user and usability research have delivered an exciting new inhaler which offers genuine benefits to the user.”

Media Contact:

Neil Cooper, Marketing & Communications Manager, Team Consulting Ltd

neil.cooper@team-consulting.com

Mobile: +44(0)7581 210 919 | Direct dial: +44(0)1799 532 781

Twitter: @team_medical

About Team Consulting

Team Consulting is a leading designer and developer of medical products. The organisation is contracted by its clients, which range from multinational pharma companies to start-ups, to help them create, refine, design, engineer and industrialise cutting-edge products. Team’s expertise includes drug delivery (inhalation, injection, nasal, transdermal), surgical tools, regenerative medicine and medical systems. Many of the products that Team has developed are in wide use today, however due to confidentiality we cannot always talk about our clients and the products we have developed for them. For more information, visit www.team-consulting.com.

The ‘Bead Inhaler’ will utilise a unique dispersion technology proven to deliver excellent aerosolisation performance, reproducible emitted dose and high fine particle fraction. A novel drug storage and release technology is also being developed. In addition to offering excellent delivery performance and moisture protection with a wide range of formulations, the inhaler will be compact and simple to use.

This programme reflects a strong relationship between Valois, the pharmaceutical manufacturing and packaging experts, and Team, who have a depth of experience in medical and drug delivery device development.

Salim Haffar, Associate Director, Business Development Valois, said, “Team’s skills and proven track record in developing inhalation devices make them an ideal partner to help Valois in achieving its development milestones for the ‘Bead Inhaler’.”

Helen Slaski, Commercial Director, Team, added, “We’re very excited to be working on this innovative development. The combined expertise of Valois and Team and our established relationship will deliver a product which offers great benefit to users.”