spacer
home > pmps > winter 2018 > design and development
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

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.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
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.
spacer
Brennan Miles
spacer
spacer
spacer
Nick Salt
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

PCI Pharma Services Announces Agreement to Acquire Sherpa Clinical Packaging

Philadelphia, USA – September 10, 2018 Leading global biopharmaceutical outsourcing services provider PCI Pharma Services (PCI) is pleased to announce the acquisition of San Diego-based Sherpa Clinical Packaging (Sherpa), which expands PCI’s U.S. operations to the West Coast. The acquisition of Sherpa, a provider of clinical trial supply services, further strengthens PCI’s position as a leader in outsourced clinical trial support services. The addition of Sherpa’s capabilities also enables PCI to better support customers from early phases of clinical development through to commercial launch.
More info >>

White Papers

Modifying MDI Canister Surfaces to Improve Drug Stability & Drug Delivery

Presspart Manufacturing Ltd

Hydrofluoroalkane (HFA)-based propellants are widely used in modern metered-dose inhalers (MDIs), due to their lack hazardous and environmentally-damaging effects. However, an HFA's active pharmaceutical ingredient can interact with the canister substrate, causing deposition of the drug to the canister walls, or interact with the solution, causing degradation and resulting in increased impurity levels. Over the past few years, a number of surface coatings have been developed that can be applied to MDI canisters and valve components, to protect the contents from deposition and degradation. More recently, plasma processes have been developed to modify and improve the surface energy performance of a MDI canister. This approach has a number of advantages to alternative coatings but requires careful optimisation to ensure the highest quality finish and MDI performance. Richard Turner, Business Development Director, Presspart Manufacturing Ltd, explains.
More info >>

 
Industry Events

Synthetic Biology Congress

8-9 November 2018, London, UK

Oxford Global is proud to present its Synthetic Biology Congress taking place on 8-9 November 2018 in London. As part of our Genomics and Synthetic Biology UK series, our congress will bring together Over 600 delegates representing internationally renowned research & academic institutions, clinical research institutions and pharmaceutical companies.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement