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aij5 replied to the topic Discussion Topic: The critical path in the forum Project Management Process and Medical Device Development 7 years, 1 month ago
Within my company there was a project I worked on where we looked to have a new titanium bone screw system used with foot for bunionectomies, fractures and osteotomies released. The system was acquired through a product acquisition. There were lots of eyes on these components of the project however one aspect that seemed rather irrelevant was an update to the packaging of this system. There was to be an additional bubble bag introduced within the system that would not however come into contact with the implants. Now to just introduce this bubble bag into the packaging of this device there were numerous steps that needed to be followed. The main task was on-boarding the suppliers and approving them from use. This took lots of time and documentation to do which took more time than expected.There were updates to the work instruction that needed to be incorporated as well and adjusting the supply chain. This unfortunately the disadvantage with larger companies that even something as simple as this led to lots qualification and documentation that normally would be overlooked by upper management.