Development of "Instructions for Use" Documentation

Assignment:

A start-up company developing their first medical device was confronted by the complexity of the Instructions For Use (IFU) materials required for their product, as well as the critical timeframe for completion of these materials dictated by their regulatory submittal schedule.

The company engaged BMG to help them define, create and produce the required set of IFU documentation.

Approach:

This project began with exploratory phase of meetings between BMG and the client, to give BMG a solid appreciation of the product being developed, as well as for both parties to gain an understanding of what the client would be able to contribute and what BMG would have to create. At the conclusion of this exploratory phase, BMG was able to provide the client with a detailed estimate for the overall project scope.

BMG then conducted a series of interviews with prospective users of the new product, to discuss and identify the realistic needs of the user community with respect to the formal User's Manual as well as supplemental reference materials.

From this starting point, and working with technical input provided by the client's R&D group, BMG created an outline of a User's Manual and a supporting Quick Reference Guide. Graphics and photographs were important components of both pieces. BMG first worked with the client's project team to define artwork and photographic concepts, then coordinated the efforts of third-party artists and photographers to create the necessary visuals. Pulling technical content from various departments within the client organization, BMG composed the detailed copy for the IFU materials, and managed the process of reviewing and incorporating several iterations of comments from the client project team. BMG then worked with a graphics design firm to execute the final layouts in print ready format, then coordinated production of the IFU documentation with a production print house.

BMG’s attention to detail and oversight of production details provided IFU Documentation that withstood regulatory scrutiny without comment, and was available to manufacturers as needed to support the client’s production schedules.