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ASTUTE 2020

Image: Industry and University Collaborative Research in the Medical Diagnostics Sector

Industry and University Collaborative Research in the Medical Diagnostics Sector

Business: Ortho Clinical Diagnostics

Expertise: Manufacturing Systems Engineering Duration: Three projects over several years

Location: Bridgend

Industry: Medical Diagnostics

Background


Ortho Clinical Diagnostics relocated from the centre of Cardiff to a purpose built factory in Pencoed in the Wales Convergence area, which comprises West Wales and the Valleys, in October 2010. OCD was one of the first companies ASTUTE-Cardiff collaborated with, initially through our facilitating an innovation workshop to identify and then develop a roadmap to meet the research requirements and industrial needs of Ortho Clinical Diagnostic's, and to match those with the skills of ASTUTE.

Project


Initially a collaborative scoping study was undertaken to evaluate the technical viability of a proposed process to modify the surface characteristics of their immunoassay wells prior to coating. After successfully demonstrating that the technology could provide the required modification, a longer term joint study was undertaken to show it could be effective for Ortho Clinical Diagnostics’s full range of immunoassay products under the full range of expected processing conditions.

During the course of this study, some technical obstacles were identified which prevented full demonstration of this new technology by the ASTUTE officer in the time permitting.  It has, however, since been possible to identify potential resolutions to these issues with enough confidence to permit Ortho Clinical Diagnostics to continue to resource investigative work with the ultimate aim of incorporating these advances into the mainstream production process.  

A further project was initiated by Ortho Clinical Diagnostics, who were looking to develop a local supplier for a new product introduction.  Supply chain partnerships in the medical devices industry are necessarily very conservative; any potential new entrants need to be assessed for their ability to meet rigorous quality standards. Working closely with Ortho Clinical Diagnostics, this involved surveying over 40 suppliers to ascertain their capabilities, undertaking visits and auditing companies in order to identify a shortlist of potential suppliers.

Challenges


Both projects have achieved the intended outputs, but the nature of the medical device industry results in long lead times to introduce and validate any new product or process and this validation process is currently ongoing both for the production process enhancements and the shortlisted suppliers.

Impact


Ortho Clinical Diagnostics has openly identified that their association with ASTUTE and other academic and Welsh Government initiatives has had a measurable impact on their ability to be successful in securing continued investment in facilities, staff and processes. During this period, for example, new skilled posts have been created and apprenticeships initiated for the first time. Ortho Clinical Diagnostics are poised for further investment in production capacity and product support expertise to enable the introduction of a new product line in 2014, which will create 24 new positions most of which will be for highly skilled personnel.

"The micro / nano technical assistance obtained [from the ASTUTE team] was not available in house at Ortho Clinical Diagnostic’s South Wales facility. Centralisation of high-tech capabilities in a corporate structure can sometimes result in inertia unintentionally limiting the agility of the business. The accessibility of the technical expertise through ASTUTE meant that local decisions could be made regarding deployment of resources onto potentially game changing manufacturing opportunities” 

- Kevin Doran, Engineering Manager

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