November 16, 2012

FDA Scrutiny of Medical Device Firms' Quality Systems Continues

This week I attended a review of recent FDA activities presented by the law firm Pepper Hamilton.  It was an interesting presentation, and while several topics were discussed, one that caught my attention  was the continued concerns for quality system deficiencies, especially for medical device manufacturers.

In 2011, 70% of FDA warning letters sent to medical device firms were for quality system deficiencies, with the most common related to Corrective and Preventive Action (CAPA) requirements.  Consistent themes included CAPA procedures that were lacking or inadequate, the lack of verification/validation of CAPAs,  and the inadequate implementation of CAPAs.   Inadequate CAPA procedures included:
  1. Failure to analyze all sources of quality data (e.g., complaints, adverse events, non-conformances, or deviations) with appropriate statistical methods to detect quality problems;
  2. Failure to initiate CAPAs in response to possible quality problems, and
  3. Inadequate documentation of CAPAs. 
Similar trends are recurring for 2012.

Much of my career has been spent in a manufacturing environment (not in medical devices), and these types of quality issues have been around for more than 30 years.  While good quality systems can be expensive to implement, the ultimate savings, good customer will, and improved plant (and company) culture they provide can be eye-opening.  These programs usually also require a culture change throughout the organization (not just in manufacturing), and they must be driven from top management to be effective.  Perhaps these commitments are why quality system efficiencies still exist today? 

The author of this blog, Mike Fisher, is the President of The CECON Group, Inc.  and has a background in engineering, marketing, and strategic planning.


November 1, 2012

Punkin Chunkin: Where Your Engineering Experts Go for Fun

Can’t find your mechanical engineering expert witnesses this weekend?   Maybe they’re in Delaware.

Sure, people spend four years in college and maybe more in graduate school to get engineering degrees so they can work, teach, consult, and maybe even utilize their training and expertise to become expert witnesses. But, what do they do for fun? 

They may spend their time designing a machine to propel an 8-10 pound pumpkin as far as possible.  If so, they will be in southern Delaware this weekend for the 27th annual World Punkin Chunkin Championship.

In case you have not heard of this event, what began as four men devising a method to propel a pumpkin 126 feet in 1986 has now grown to a weekend event with nearly 100,000 visitors and 115 competing teams from across the U.S.  While there is no prize money awarded, the bragging rights have provided enough incentive to elevate the engineering required to compete and win.

There are now several levels of competition, with the adult category having seven categories of propulsion: (compressed) air, centrifugal, catapult, trebuchet, human power, human power centrifugal, and torsion catapult. These categories are ripe for engineers - and any person with a technical bent – to provide creativity and ingenuity (including the use of components such as garage door springs and clotheslines).

However, all machines must meet required safety standards, and all pressure vessels must meet A.S.M.E.  (American Society of Mechanical Engineers) construction codes, have the manufacturer’s nameplate, and be inspected by the Delaware Division of Boilers. The engineering and sophistication of these devices has produced the current world record of 4,483.51 feet (air category).  

For more information on this unique tradition, check your local Science Channel or On-Demand Listings. The event website can be found here.

Interesting details about the event can be found here.