ISO20072 Ready Specification Allows For Rapid Customisation And Development Of Inhalers, Enabling A Faster Route To Market

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Medical Devices / Diagnostics;  Respiratory / Asthma
Article Date: 30 Mar 2009 - 2:00 PDT

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Cambridge Consultants has released its latest Dry Powder Inhaler (DPI) generic specification to address recent regulatory requirements and technological developments, helping speed up the development process and time to market for inhalation devices.  The specification describes the requirements that guide the development of inhalers - including marketing needs, user experiences, up to date regulatory information, technological considerations such as the use of electronics, and safety and performance needs - providing a fast track to device development.  In addition, the specification conforms to the new ISO20072 standard.

Since the launch of the first version by Cambridge Consultants in 2002, the DPI generic specification has been shared with more than a hundred organisations interested in developing better inhalers.  Based on experience gained from Cambridge Consultants' ongoing projects in the sector, the specification has been updated to incorporate emerging technologies within the inhaler market.  These include the use of electronics in devices for high levels of functionality and performance.

This generic specification provides a framework within which each new DPI can be defined, thus reducing the workload and any knock-on delay to launch.  Furthermore, the legislative requirements that govern the development of Dry Powder Inhalers remain consistent in all cases, meaning that this generic specification can be customised for any DPI development, allowing for the rapid development of new devices. 

Cambridge Consultants has used the specification to develop a number of its proprietary DPIs including the revolutionary Gen-X platform launched in 2008.  Matthew Allen, Programme Manager at Cambridge Consultants, commented: "In the medical device industry we have come to expect that time to market for inhalation devices is often in the range of seven to ten years.  Anything that can be done to reduce product development time is hugely beneficial both for pharmaceutical companies and device developers.  The specification has been developed with this in mind and offers exactly these benefits.  We aim to share our knowledge, built up through numerous DPI projects, in order to continue to challenge the sector and push it forwards."

David Blakey, Head of Drug Delivery at Cambridge Consultants added:  "We are widely recognised as an industry leader and innovator for DPIs, and this generic specification gives others the opportunity to benefit from this experience.  The specification has always been an extremely valuable document for anyone wishing to develop an inhaler quickly, and this update makes it even more so, including up-to-date information about new standards and regulatory changes."

Cambridge Consultants has proven expertise in the DPI market having developed numerous respiratory delivery devices over the past 15 years for clients worldwide, and is therefore familiar with the legislation framework in each market.  In utilising this extensive knowledge of the DPI market, Cambridge Consultants has also included some non-mandatory requirements. 

The updated generic DPI specification document is available now through Cambridge Consultants' website.

Cambridge Consultants develops breakthrough products, creates and licenses intellectual property, and provides business consultancy in technology critical issues for clients worldwide. For nearly 50 years, the company has enabled its clients to turn business opportunities into commercial successes, whether launching first-to-market products, entering new markets or expanding existing markets through the introduction of new technologies.

With a team of over 270 engineers, designers, scientists and consultants, in offices in Cambridge (UK) and Boston (USA), Cambridge Consultants offers solutions across a diverse range of industries including medical technology, industrial and consumer products, automotive, transport, energy and wireless communications.

Cambridge Consultants is part of the Altran group. Altran Technologies, which is listed on the Paris Stock Exchange (FR:003463), employs over 16,000 consultants in 20 countries around the world. In 2007 the group generated a turnover of €1,591.4 million.

Source
Cambridge Consultants

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