Application of risk management frameworks to medical device production development

Effective risk management is critical when manufacturing medical products to avoid any potential impact to patients due to supply disruptions or quality excursions. As Flex LTD, an end-to-end manufacturing solutions provider, continues to grow its medical device portfolio, they have a need to take a more proactive and systematic approach to managing project risks. This research applies several project risk management frameworks and interventions to one of Flex's medical device programs as a pilot study. First the current state of existing risk management practices is evaluated. The frameworks and interventions are then implemented over a period of 6 months and their effectiveness analyzed at the end of the study. The results found that the interventions and frameworks applied during the pilot study improved overall understanding of fundamental risk management concepts.

Name thesis:degree_name

Master

Department dc:contributor.department

Sloan School of Management

Grantor dc:publisher

Massachusetts Institute of Technology

Year dc:date.issued

2019

Author dc:creator

• Kehne, Emily Templin.

Advisor dc:contributor.advisor

• Warren Seering and Retsef Levi.

• Sloan School of Management.
• Mechanical Engineering.
• Leaders for Global Operations Program.

Statement dc:rights

• MIT theses are protected by copyright. They may be viewed, downloaded, or printed from this source but further reproduction or distribution in any format is prohibited without written permission.

Licence dc:rights.uri

• http://dspace.mit.edu/handle/1721.1/7582

Language dc:language.iso

eng

Handle dc:identifier.uri

https://hdl.handle.net/1721.1/122574

OAI identifier oai:identifier

oai:dspace.mit.edu:1721.1/122574