spacer
home > pmps > spring 2019 > using short-run manufacturing to solve design transfer challenges
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Using Short-Run Manufacturing to Solve Design Transfer Challenges

The challenges of design transfer are well known in the medical device industry. The innovation process starts by designing and getting the few prototypes of a new device working. However, if an approach has not anticipated the challenges of volume production, then the struggle really starts when that product is sent to a manufacturing partner, often in another country, asking for it to be made in scale.

There are many complexities to consider beyond the device design itself when dealing with highperformance medical devices such as component cost, performance, assembly, and inspection at the high speeds required for serial production. Designers who develop new products from a clean sheet have many issues to consider, and, often, they rely on a manufacturing engineer to sort out production issues later on.

Unfortunately, ‘sorting it out’ can be a tortuous process because each design change can have many unintended knockon effects. When the practicalities of making a design work on a production line delays the launch of a product, the direct costs and financial damage can be significant. In the field of medical devices, the window of opportunity in which to sell a product while it is still under patent is likely to be curtailed significantly, causing unforeseen harm to a company’s potential income. In these situations, the pressure is on.

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
Carl Pullen is a versatile and creative Engineer with extensive experience in a variety of market sectors and a wealth of skills designing components and devices with precision and high quality. He has a strong background of computer-aided drafting design and comprehensive experience of injection-moulding design and manufacture all the way through to commercial production, including process optimisation and validation. Carl focuses on robust production techniques and efficient assembly processes to ensure long-term manufacturing at high-quality standards. He is also an experienced Project Manager and engages fully with all parties in complex projects to ensure cross-functional collaboration.

Wade Tipton has 20 years’ experience in the medical device industry, working in product design and development and process engineering. He has been responsible for gaining and maintaining International Organization for Standardization 13485 accreditation and technical file submissions and gaining Conformité Européenne and 510K approval for several Class 2 medical devices. Wade has led successful projects in new product introduction, high-volume manufacturing scale-up, and Lean Six Sigma. He has complete business process experience, from product design and development through design verification and validation and into process validation, product launch, manufacturing scale-up, and process improvement. Wade has a physics degree, a master’s degree in applied optics, and an MBA.
spacer
Carl Pullen
spacer
spacer
spacer
Wade Tipton
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Introducing Signant Health [Formerly CRF Bracket] and the Industry’s Most Comprehensive Patient-Centric Suite for Clinical Research

Philadelphia and London – June 10, 2019: CRF Bracket, formed by the 2018 merger of CRF Health and Bracket, today launched as Signant Health (signanthealth.com). Uniting eCOA, eConsent, Patient Engagement, IRT, Clinical Supplies and Endpoint Quality into the industry’s most comprehensive patient-centric suite, Signant makes it easier to participate in – and sites and study teams to run – clinical trials. This intense focus on the patient experience, deep therapeutic area expertise and global operational scale enable sponsors and CROs to extend the reach of drug development, expand patient opportunities and improve data quality.
More info >>

White Papers

Advanced BioDesign Outlines Solutions

Advanced BioDesign

Launching an immunisation programme is an important experimental step that needs care. With Advanced BioDesign, clients may develop and produce antibodies according to customers' specific needs. The company offers: real support and advice from a dedicated team all along your project; large and modern SPF animal facility; ethical treatment of animals. The evaluation of a project is free-of-charge and with no obligation. Dedicated project managers will work with clients from the beginning to the end of a custom antibody project to ensure the highest level of quality and service.
More info >>

 
Industry Events

SAPHEX 2019

23-24 October 2019, GALLAGHER CONVENTION CENTRE, 10 RICHARDS DRIVE, HALFWAY HOUSE, MIDRAND, 1685, SOUTH AFRICA

SAPHEX 2019 will be held on the 23rd-24th October at the Gallagher Convention Centre, Johannesburg, South Africa.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement