Below are some samples of our successful engagements over the years. How can we help you?
QUALITY SYSTEMS - DESIGN CONTROLS
Retooling and harmonization of product development processes.
Engaged with a large, global medical device manufacturer, we led a working group comprised of members from
4 domestic and 1 international site to take 3 different stage-gate processes and harmonize them into one common roadmap incorporating the best practices from each site. The result was a leaner, easier to understand process that met all requirements for FDA QSR, ISO 13485 and ISO 14971.
RESULT: The users had a simpler roadmap to follow, the company had a "common language' for their development organization and their notified body gave the system their highest marks.
DESIGN FOR SIX SIGMA
Real world application of Voice of the Customer
A major medical device company had a development project for a hemostasis clipping device but needed better focus on the input requirements. Utilizing a variety of Voice of the Customer (VOC) tools, we were able to identify the top customer needs and also define the value proposition. When one of the design features proved problematic, a review of the VOC data revealed that customers were not willing to pay the incremental amount that this feature would cost to develop.
RESULT: The project team was able to push forward with their stable design that was well received by the field and the product launch was an overwhelming success. Launched on time and within budget!!
Identifying the true root cause and implementing a lasting solution.
A market leader in minimally-invasive gastrointestinal devices had a problem with their biopsy forceps product; customers were complaining that the jaws weren't cutting as they had in the past. Using our proven 6-step problem solving process we were able to determine the root cause as a combination of external (vendor) and internal changes occurring at the same time with unexpected results.
RESULT: Not only was the problem resolved and the customers were happy again, but through the process a number of design improvements were also identified that were eventually patented by the company.
Developing and launching a new product platform in record time.
Applying a solid discipline of project management tools, this major in-vitro diagnostic manufacturer was able to develop a breakthrough hematology analyer that reduced sample aspiration volume 10 fold, reduced standard cost 10 fold and improved reliability 4 fold.
RESULT: Following the successful launch of this product only 18 months after project initiation, it quickly became the dominant leader in its market space.
QUALITY SYSTEMS - DESIGN TRANSFER
Moving manufacturing operations around the world, painlessly
A U.S. market leader in dialysis products developed partnerships with manufacturers in Asia, Western Europe and Eastern Europe to process their dialysis membrane into finished dialysis filters for the local markets. Using our strong project management skills coupled with a full understanding of process validation requirements, equipment was sourced, installed and qualified, workers were trained and product was rolling off of the production line.
RESULT: Each partner location was validated and fully functional within six months at yields at least equal to the parent location. These partnerships allowed the parent company to expand their business into markets previously difficult to penetrate.