Situation:
A large, diversified medical device company had grown a division through acquisitions over a number of years without integrating clinical organizations.
Solutions:
An organizational and quality system assessment of the various clinical groups revealed inefficiencies and non-compliant operations.
- Separate quality systems at each facility led to conflicting procedures and variability in functional skills. Team members were not easily transferable from project to project as staffing needs arose.
- Inconsistent hiring, training, and staff development led to placement of staff in roles they did not have the skills to perform and very high turnover led to project delays. Halloran provided clinical leadership for a key development program.
- A lack of a medical writing and quality assurance resources resulted in unsuccessful regulatory submissions. Halloran developed key regulatory documents and responses to FDA issues.
Value:
Clinical leadership was presented with actionable findings from the gap analysis to improve operations and make progress on key programs for the company.