Guidance and assistance to the medical device industry since 1999
CASE STUDY: Product Specifications / Project Planning
A start-up biotech / molecular diagnostics manufacturer was working with an overseas automation OEM to develop an instrument to automate their manual test protocol. When negotiations were being hampered by their lack of internal familiarity with the design control process for medical devices, the diagnostics company brought BMG in to help.
BMG’s first step was to transform the existing set of Product Requirements into a detailed package of Product Specifications. We also developed a concrete Program Plan for the instrument development project, presented in terms and stages that the project team could embrace and implement on their own.
BMG continued on in an advisory capacity, participating in critical Design Review sessions with the OEM in a key role as a technical advocate for the client.
BMG guided the client through the process of clearly defining their needs, both in terms of the product and the medical device development process. Better educated, armed with clear design input documentation and the support of experienced technical advisors, the client was able to recover a stable negotiating position and get their OEM instrument program back on track.