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Winner - Gold
Design Type: Product - Pre-production
Company / Organization / School: Mundipharma
With the global incidence of asthma and COPD (chronic obstructive pulmonary disease) on the rise, its never been more important to have simple, cost-effective treatments to make a positive difference in people’s lives. The K-haler is suitable for use with a wide range of inhaled respiratory medications and extends effective inhaler use to wider patient populations. Combining a breakthrough valve with a thoughtful and inclusive design, it addresses many of the issues that have persisted since the invention of the first pressurised metered dose inhaler (pMDI) in 1956. Studies show that people often don't use their inhaler properly, without even realising. It's difficult for people to coordinate pushing down on the inhaler canister and breathing deeply at just the right time. This means people often do not receive the full dose they need.* The K-haler is breath-activated, meaning it eliminates the need for patients to coordinate their breathing, along with addressing several other issues: Breakthrough technology is more than just a clever valve: the K-haler’s big idea revolves around the K-valve. The patented valve is a kinked tube that works on a garden hose principle. When a patient breathes in normally, the kink straightens, releasing a single dose right down into the lungs. It’s this valve that removes the need for co-ordination during inhalation. Works with lower forces: the idea of breath-actuated inhalers isn’t new; many asthma medications are now delivered in passive dry power inhalers (DPI). These require a higher force and speed of inhalation for optimal drug delivery, which can be a challenge at times for many patients with breathing problems. One study* suggests that nearly one in three patients used DPIs ineffectively and that while a dry power inhaler may be used correctly 90% of the time by a healthy 18-year old with normal lung function, this may reduce to as low as only 20% of the time by an 80-year old with moderate to severe obstruction. Because the k-valve requires a low inhalation force to trigger it, the inhaler is suitable for the majority of respiratory conditions. Putting people first, at every touch point: its inclusive design covers the entire patient and clinician experience, from the device design to the packaging, the patient information leaflet (PIL), integrated dose counter, labelling and material finishes. It’s designed to be easy to find, identify, use and understand, even with arthritic fingers or less than perfect eyesight. Always know how much medication you have: The inhaler design includes an integrated counter mechanism, which counts down individual doses from 120 to zero. The dose counter numerals use the Tiresias true type sans-serif font that has been specifically designed for clear legibility by people with impaired vision at the Scientific Research Unit of the RNIB (Royal National Institute of the Blind) in London. Together with the font, the contrast of text colour, together with the size and position of the window has been optimised to provide best-in-class legibility. Coloured warning flags that appear in the counter window provide two-weeks notice to patients, ensuring they can plan ahead for refills. A full red bar provides clear indication when the device is empty and should no longer be used. Working together with healthcare providers: Extensive colour research with clinicians and patients has ensured the device can be easily found and accurately described, even when on the phone. This helps eliminate the potential for confusion, particularly for sicker patients using a number of different medications and devices. Discretion and portability: the rounded form of the device makes it discreet and easy to carry – yet modern and optimistic. It’s designed to sit upright on a table top with a specially designed mouthpiece cover to enable one-handed opening. No more fluff: the device is also a “closed system”, preventing dirt and pocket fluff build-up that can clog devices and irritate sensitive airways. Clever manufacture: made with a smart combination of snap fits, a top loaded counter mechanism sub-assembly, and automated label application. The label design provides the window for the counter mechanism and allows for easy upgrade of colour ways, drug information and visual brand language for multiple drugs and therapies. Less waste in production: the device is currently being finalised with the majority of pre-production tooling complete and validated. The 3-sigma manufacturing process has been designed to produce a high rate of sustained improvement in component quality, defect reduction and cycle time, thus conserving materials and energy as much as possible. Optimised for global use: The device design has been considered from a global perspective, taking into consideration different regulatory authorities, prescribing habits and patient use preferences. It has been crafted to ensure that a wide patient population can easily use the device. * Siegfried Wieshammer, Jens Dreyhaupt. (2009) Dry Powder Inhalers: Factors Associated with Device Misuse RDD Europe 2009, Vol 1, pp 95-104