Guidance and assistance to the medical device industry since 1999
CASE STUDY: Product Design Review / Program Assessment
A small diagnostic company was developing an automated diagnostic instrument system, built around their proprietary magnetic detection technology. Our client, a Fortune 100 company, was in negotiations to license the new system for launch in an alternative market.
BMG was hired to perform a high level assessment of the design maturity and manufacturability of the diagnostic instrument platform, and to validate the timeframe built into the Business Plan for the commercial launch of the alternative product.
BMG first conducted telephone interviews with the client’s New Product Team, to gain a clear understanding of their Business Plan as well as the Product Requirements of their alternative instrument application.
The diagnostic company was developing the core detector technology themselves, and was working with a third-party contract development firm to integrate the detector module into the instrument platform. BMG made site visits to both the diagnostic company and the third-party developer, conducting intensive Program / Design Reviews with both design groups.
Both design groups were following sound Design Control practices in the development of the instrument platform, and the design work was solid, but our client’s Business Plan was dependent upon an aggressive development and launch schedule, and their presumed timeline for full product realization could not realistically be accomplished.
Our assessment work also uncovered a more elemental concern – an incompatibility between the Product Requirements of our client’s intended alternative market and the Product Requirements of the original diagnostic application, which were driving the design of the instrument.
BMG provided a preview of our findings to our project liaison. A full project summary was delivered to the client’s New Product Team via teleconference, followed by a comprehensive written report.