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Design and Development

Developing medical products to prepare them for commercial production is commonly known as industrialisation. Regulators call this either ‘design transfer’ or ‘design and development transfer’, defined as ensuring that “the design and development outputs are verified as suitable for manufacturing” and that the “device design is correctly translated into production specifications” (1-2).

Industrialisation is the stage that bridges design functions and controlled production activity. It is where development activities transition to process-driven activities and design ownership passes from the design team to manufacturing. Typically, development activities continue until the completion of design verification, and, at this point, the product ownership passes on to manufacturing. Industrialisation of medical products is a complex stage in the overall development process, involving lots of preparation and coordination among multiple groups. As such, the resources and time needed to complete this phase are often underestimated. Even the most capable of companies can, and do, experience difficulties in turning prototype technology into a commercial product.

Product Progress

In the early stages of product development, responsibility lies with the design team. Progress at this stage is tangible and exciting: concepts are created, evaluated, and then reiterated rapidly, and prototyping methods are used to quickly produce models for evaluation. As the design develops, ‘proof-of-principle’ prototypes, closely resembling the final product, are necessary to prove the technologies’ robustness. A typical prototype may comprise of realistic electronics modules, even genuine components produced in the correct materials. These prototypes are convincing and can lead to a false sense of the development process being almost complete. However, these samples are still prototypes and a lot of work is still required to produce actual medical products.

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Brennan Miles is a Senior Consultant at Team Consulting. He is accomplished in developing successful concepts through to industrialisation. Brennan’s engineering background, combined with his experience of the healthcare sector, gives him an aptitude for managing high-value projects and delivering commercial success. Prior to his appointment at Team, Brennan was Senior Design Engineer with the pharma giant Pfizer. He has worked on a range of surgical and drug delivery products, including dry powder inhalers, injectors, and ophthalmic devices for a wide variety of therapies. Brennan has a BSc (Hons) de gree in product design and engineering. He is the named inventor on a number of patents.

Nick Salt is a Senior Engineering Consultant at Team Consulting. His role is to support client projects, anticipate potential manufacturing issues and requirements, and develop delivery systems that contribute to the launch of fully functioning devices. He has over 25 years’ experience, 15 of which have been in product development, complemented by product launch and on-going management. Nick joined Team in 2015 and has previously worked for GSK and Vectura. He has a BEng degree in mechanical engineering from Monash University, Australia. His postgraduate education was at Brunel University, UK, studying advanced manufacturing systems.
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Brennan Miles
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Nick Salt
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