The Challenge: During the development of new packaging for a Ready-To-Use parenteral container component, concerns emerged from the marketplace about the design's compatibility and machinability with closed isolator Flex Filler automated filling equipment. 

The Solution: To address this, our team held video conferences with major OEM equipment manufacturers globally to share the designs, gather Voice of Customer feedback, and discuss the impact of either keeping the current design or implementing proposed changes. 

The Result: Based on these insights, our team recommended to the sponsor's Executive Leadership team to invest in redesigning the packaging to enhance market acceptance and minimize the need for custom format parts for Flex Filler equipment. The redesigned product was successfully launched and easily qualified on various manufacturers' automated filling equipment. 

The Challenge: After months of in vitro and in vivo testing on a complex Class III active implantable system, the initial clinical implantation went smoothly. However, complications arose on the first evening after surgery. Despite several days of efforts to resolve the issue, the system was explanted, and the patient successfully transitioned to an alternative therapy. 

The Solution: Our team analyzed the explanted system and compared its performance with other systems manufactured at the same time. We worked with an academic center to utilize a benchtop in vitro test apparatus they developed that accurately replicated the clinical scenario, surpassing traditional in vivo models. Collaborating with engineers, statisticians, and clinical experts, we identified three interdependent design factors causing the poor clinical performance. Using reliability engineering analysis and the in vitro model, we redesigned the system, eliminated the issue, and established manufacturing tolerances. 

The Impact: After 200 experiments and two years of work, the system was successfully implanted and operated in several dozen patients without flaw. 

The Challenge: A publicly held company received a corporate-wide FDA action related to cGMP compliance issues at multiple manufacturing facilities.  The project team implemented a complete set of policies and procedures to re-engineer the global quality system to be strictly compliant to 21 CFR Part 820.  However, the resultant Quality System was not sustainable.  

The Solution: Our team, working in conjunction with the Executive Leadership team, integrated the original project team and independent FDA consultants to streamline the global policies and procedures resulting in the creation of compliant Quality Records and sustainable Quality processes. Further, our team organized and facilitated a 3-day workshop at the Corporate headquarters with the plant managers, heads of Quality, and inspection leads from each of the global manufacturing locations.  The workshop provided a forum for the site teams to participate in mock FDA audits with the 3rd party consultants using real procedures and Quality Records.  

The Impact: When the FDA inspected the manufacturing sites, all sites passed their respective inspections, and the corporate-wide FDA action was lifted.