Guidance and assistance to the medical device industry since 1999
CASE STUDY: Corporate Due Diligence / Project Risk Assessment
A Fortune 50 healthcare company was negotiating a distribution partnership with a start-up medical device company involving a complex automated instrument / consumable system still under development.
BMG was contracted to participate in a corporate-level team assessment of the proposed partner’s instrument development program.
BMG’s objectives were to:
a. evaluate the product development program, identifying risks and true status
b. appraise the maturity, robustness and manufacturing readiness of the product design
c. critique the proposed manufacturing supply chain
BMG analyzed advance materials provided by the client, and participated in advance strategy sessions with other members of the due diligence team via teleconference. We worked closely with the client team leader in structuring the agenda for the upcoming site visit, and conducted preparatory interviews with senior management of the start-up to explore general program issues and properly set expectations for the detailed on-site review.
BMG was an active participant in a two-day site visit, driving the detailed Program Review / Design Review sessions with the development team and senior staff. At BMG’s recommendation - and with the client’s endorsement - the site visit was conducted as a constructive working session. Findings and concerns were discussed interactively, and in many cases were resolved during the visit.
BMG independently conducted follow-up site visits with two key manufacturing partners.
BMG's findings were summarized for the client in PowerPoint format, providing a condensed executive level assessment for senior management review. Supporting detail was provided in a concise 15-page report, including delineation of specific risk areas and solid recommendations for resolving areas of concern.