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European Biopharmaceutical Review

Combined Efforts

Convergence therapies have been defined as “the combination in a single product of device and pharmaceutical and/or biological therapies” and have been referred to as the medical device industry’s “most promising opportunity ever” (1). There is no denying that this area holds the potential for delivering major benefits, not just in regard to better treatments, but also significant financial reward to successful developers of combination products. However, before leaping into this space it is important for device companies to recognise the increased technical and commercial challenges that are faced when developing this type of product. How can device companies learn from the experiences of early pioneers in this field, develop a strategy that is able to see past the core science and focus on delivering the full business package necessary for commercial success? This article explores some of the opportunities and challenges (technological, regulatory and marketing) in developing device strategy through to implementation.

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Based at PA Consulting’s Technology Centre in Cambridge, Stephen Blatcher is a chartered Mechanical Engineer who specialises in material selection, component design and risk management activities for surgical products and processes. Whilst at PA, Stephen has helped many companies develop innovative products and processes with particular emphasis on the multidisciplinary skills necessary for delivering combination products such as drug eluting implants and biotherapeutic delivery devices. Stephen has also undertaken a number of studies to understand the technologies required to commercialise combination surgical products and regenerative therapies.

Ian Rhodes is a member of PA’s Management Group World Wide and leads the technology group. His background is in the design and development of new products, processes and services, primarily within the healthcare and medical industries. Ian has become widelyrecognised for bridging the gap between commercial/business development/strategic issues, and the implementation of engineering/operations. He has led and provided input to a number of due diligence assignments within the sector. Ian has an MBA from the London Business School and more recently was the founding CEO of Aegate Ltd, a PA venture company which he led for the first two and a half years of its growth and development.

Dr Angus Forster is a Principal Consultant at PA Consulting Group, Cambridge, UK. He earned his PhD in Pharmaceutics and BPharm from Otago University, New Zealand. Angus has been involved in the Pharmaceutical industry for over 10 years and has experience in Drug Development, Pharmaceutical Manufacturing Technology and Drug /Device combination products. He has published over 15 articles and presented at a number of pharmaceutical conferences on the subject of solid dispersion formulation and characterisation.

Jennifer Vondran is an Analyst in the Global Technology Group of the PA Consulting Group. Jennifer’s interests include biocompatible materials, drug delivery design and development, tissue engineering, medical device product development and risk management, and nanotechnology. Prior to becoming an analyst, Jennifer completed a dual BS/MS degree in Biomedical and Materials Science and Engineering from Drexel University in Philadelphia. Her research was recently published in the Journal of Applied Polymer Science.

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Stephen Blatcher
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Ian Rhodes
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Dr Angus Forster
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Jennifer Vondran
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