DUE DILIGENCE CASE STUDY
CHALLENGE:
A large multi-national pharmaceutical company determined that the best strategy for a major pain-relief product was to expand associated synergistic product offerings. One product was a medical device from a small device company whose device applied a magnetic field with claims to alleviate pain and reduce inflammation. While targeting the device company for acquisition, the pharma company performed an assessment of clinical data. They quickly recognized the need to address some resource gaps in the due diligence team. Lacking technical engineering, quality and medical device regulatory expertise, AlvaMed was recruited to support the team.
APPROACH:
AlvaMed proposed a 4-person team comprising the following expertise:
- Quality
- Regulatory
- Clinical
- Engineering
AlvaMed was approved for a 3-month, $85,000 project that included:
- 3 visits to the target company
- Multiple visits to the client to work with the team
- Technical research to assess the veracity of the device’s claimed benefits
- In-depth review of company filings and regulatory submissions
RESULTS:
In retrospect AlvaMed was most likely contracted because the client company had already detected some inconsistencies in the target company’s business and needed an unbiased assessment. AlvaMed quickly highlighted inconsistencies and also uncovered FDA communications that highlighted a very tenuous relationship with FDA.
AlvaMed quickly uncovered the facts, confirming the suspicions of the pharma company’s team. The client team additionally requested AlvaMed to present our findings to the company’s “pain management” senior management. Our findings and communication were praised for being more informative and measured than prior efforts from major consulting companies such as Quintiles and Deloitte.
The results of AlvaMed’s efforts on this project prevented major pain for our client.
