Guidance and assistance to the medical device industry since 1999
This is a sampling of some of our past projects. Read the Case Studies for more about each assignment, our approach and the results we delivered.
Corporate Due Diligence / Project Risk Assessment
BMG was contracted by a Fortune 50 healthcare company to participate in a corporate-level due diligence assessment of a proposed distribution partnership. Click to read this case study.
P&L Project Coordination / Supplier Management
BMG provided project management leadership and technical and logistical support to development and implementation of medical device packaging and labeling across a complex supply chain involving multiple contract manufacturers. Click to read this case study.
Design Review / Contract Development Supplier Assessment
BMG led a Preliminary Design Review of a device development program, and delivered an objective assessment of the third-party design firm contracted to develop the product. Click to read this case study.
Contract Manufacturer Recovery
BMG expertise in troubleshooting and leadership in problem resolution were instrumental in recovering delivery schedules and increasing production yields of mission-critical components for a NASA space telescope. Click to read this case study.
Strategic Supplier Search
BMG guided a medical device development company through the timely selection of a critical contract manufacturing partner. Click to read this case study.
Product Design Review / Program Assessment
BMG assessment work on a proposed licensing deal for an instrument launch in an alternative market uncovered timeline problems as well as incompatibility of the proposed device with intended Product Requirements. Click to read this case study.
Design & Implementation of Production Facility Plan
BMG developed and executed a plan to construct a pre-production medical device assembly & test facility. Click to read this case study.
Product Specifications / Project Planning
BMG’s expertise with the medical device design control process helped a start-up biotech / molecular diagnostics manufacturer successfully contract out development of an instrument to automate their manual test protocol. Click to read this case study.
Development of Instructions For Use (IFU) Materials
BMG defined, created and produced IFU material for a new medical device, coordinating involvement of the client, third-party artists, photographers, graphic designers and print production. Click to read this case study.
Hospital Pilot Study
To determine user group acceptance and validate the concept of a proposed new medical product, BMG designed and implemented an in-hospital “beta-test” study. Click to read this case study.
Business Process Development
In conjunction with a client’s implementation of a mid-level ERP software system, BMG provided process development and documentation support, as well as team building, user training and implementation assistance. Click to read this case study.