Guidance and assistance to the medical device industry since 1999
CASE STUDY: Design Review / Contract Development Supplier Assessment
As part of a due diligence effort surrounding the acquisition of distribution rights to a product that was still under development, a diagnostic device utilizing a newly developed detection technology, a Fortune 100 company needed an objective evaluation of the development status of the product in question.
BMG was hired to perform a detailed Preliminary Design Review of the device development program. The client also wanted an objective assessment of the third-party product design firm that had been contracted to develop the instrument, and their ability to complete the project on schedule.
Immediately following confirmation of this assignment, BMG and the client discussed the general project background via teleconference. Additional background information provided by the technology owner and the third-party development firm was reviewed by BMG in preparation for assessment site visits.
With the client, BMG made site visits to the technology owner and the contract development services firm. BMG led each group through detailed Program / Design Reviews of the device development program.
A comprehensive written report was delivered to the client, detailing BMG’s findings and areas of concern. The report also included a recommended course of action for the client to mitigate risk areas identified by our study. The written report was supported by a follow-up teleconference with the client to discuss BMG findings and concerns.
(With the approval of the client, copies of the report were submitted to both the technology owner and the instrument developer. Both parties indicated that they were in full agreement with BMG’s findings and recommendations, and expressed appreciation for both the fairness and thoroughness of BMG’s assessment reviews.)