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Entering medical market requires investment, planning

Posted by Andrea Larocque

April 30, 2010

Michael Pereira, Ximedica's Vice President of Program Management, recently spoke at the Plastics in Medical Devices 2010 conference held earlier this month in Ohio.

 

Entering medical market requires investment, planning

 

From the design stage through product trials to full-blown manufacturing, the lucrative medical device market is one fraught with difficulties for companies that don’t do their due diligence before starting out.

 

Several experts at the Plastics in Medical Devices 2010 conference, held April 12-14 in Westlake, reinforced that in their presentations.

 

Read the full article:  http://www.plasticsnews.com/headlines2.html?id=18492&channel=136

 

When Constraints Become Liberating

Posted by Sharon Mulligan

October 30, 2009

My latest "aha moment" related to product development came during a recent training class on Customer Requirements. The familiar model for medical device development dictates that we start with customer (user) requirements, translate them into design inputs, design the product, develop design outputs, and then build the device. In the end, we try to get them all to line up so that we can perform verification and validation per FDA requirements. Often, there is some other requirement that isn't really a customer requirement—be it an internal business requirement or desired product feature—that we must try to fit it into this model. In my experience, it often feels awkward labeling these requirements that don't necessarily come from the customer, but still must be included in the device design. My "aha" came when the instructor put a name to these nebulous requirements: "design constraints." Of course they are! I knew what design constraints were, but had never used that terminology in conjunction with the FDA model. For example, a surgical instrument may require a size restriction to fit in the instrument case. This size restriction is not necessarily a user need, but really a design constraint that will limit the final design of the instrument to that size or smaller. Or perhaps the device maker wants to use a particular technology for product. Alternative technologies may solve the problem; however the solution is limited to the technology of choice—i.e. it is simply a design constraint. 

A Great Course on Problem Solving and Root Cause Analysis

Posted by Michelle Wu

October 21, 2009

I recently attended the Advanced Problem Solving and Root Cause Analysis Workshop provided by Worchester Polytechnic Institute. Jim Leonard taught a structured root cause methodology for problem solving, which I found very useful. The steps in this comprehensive method include:
  • to name the problem by creating the problem statement
  • to gather information by asking a series of problem specifying questions
  • to note distinctions and changes in the information gathered
  • to brainstorm possible causes
  • to test the possible causes against the problem specification, verify the true cause, and fix the problem
Emphasis was placed on gathering information to specify the problem through a series of control questions related to the "what, where, when, and size" of the problem. Multiple case studies demonstrated that the problem is usually half solved once the control questions are answered (which reminded me of the ending of the G.I. Joe cartoons from my childhood—"Now you know, and knowing is half the battle"). I have studied other root cause techniques including the 5 Whys,Ishikawa fishbone, events and casual analysis, and the informal interview. While I still believe these techniques are valid, I see each one as alternatives to the different steps of Leonard's problem solving process, but none as a complete structured methodology.