From the Desk of Dawn Lissy - Change Is All Around Us

Some changes, such as the summer leaves turning to the brilliant colors of fall (one of the things I miss from Ohio) and the start of football season, are most welcome.  Others, including the start of another school year and trying on last years's winter coat that miraculously "shrunk" two sizes over the summer, less so.  Omnipresent in nature, change constantly influences our lives, and while more often than not, we cannot control the actual act of change, we can do our best to understand why it is happening and what we can do to deal with the effects.

One area of all of our professional lives that seems to be constantly changing these days is the regulatory controls set forth by FDA and other regulatory agencies.  Last year, CDRH set out to revamp the 510(k) process, and some of the new controls are just starting to be rolled out.  While we can do our best to influence the change through forums and town hall style meetings, the most proactive approach is to quickly deal with the effects as they come.  Working with qualified vendors and suppliers is an effective way to arm yourself with the experience you'll need to weather the storm and adapt to changes surrounding regulatory approval in the U.S.  With more OUS regulatory authorities requiring additional mechanical testing and requirements more stringent than ever before, ensuring that your partners have internationally recongnized accreditation and are maintaining current knowledge about international markets is more critical now than ever before.

Some changes come at opportune times, though, and are greatly welcomed.  I'm proud to announce that Empirical Testing Corp. is changing locations!  Don't worry - we're still in Colorado Springs, but we have annexed the office space next door and are expanding into an additional 10,000 sq. ft. of space for more staff and more equipment.  This expansion will allow us to continue to add to our selection of services while still keeping the same level of quality you have come to expect from ETC.  Our ability to partner with you from design freeze to commercialization of your device is stronger than ever, and we're extremely excited about the changes happening all around us here.

I've found that to successfully combat the effects of adverse change, we must adapt to them and grow in spite of them.  Adaptation is a key strategy to staying relevant in an industry that is constantly evolving, and one way that we hoped to help you adopt a proper strategy was to share our experience at this year's annual NASS conference.  Empirical Testing Corp. hosted a satellite event during the conference.  (Did I mention the event was FREE and lunch was PROVIDED!).  Four top industry experts in assessment, testing and validation presented and discussed with you how to optimize use of their respective fields in the constantly changing regulatory environment.

ETC Satellite Event Presentations - November 3, 2011

Thank you to everyone who helped make the recent ETC Satellite Event, “Avoiding Pitfalls in Product Development: Advice from the Testing and Validation Experts” a huge success!  If you were unable to join us in Chicago on November 3, 2011 and are interested in learning more about the four presentations that were given, please click the appropriate link below:

• Developing a Risk Profile for Medical Devices: The Role of Clinical Evaluations and Risk Assessment by Linda Braddon, Secure BioMed Evaluations
• Key Points for Successful Mechanical Testing During Product Development by Dawn Lissy, Empirical Testing Corp.
• Cost Effective Particle Analysis: What ISO and ASTM Standards Require and Why by Nadim Hallab, Ph.D., BioE Solutions, Inc.
• Contamination, Packaging and Sterilization Processes by Meredith May, Empirical Testing Corp.

With the accomplishment of our first experience of this kind behind us, you can be sure that we will be hosting similar occasions in the future.  Don’t forget to join our mailing list to be notified of all the happenings at ETC and as always feel free to contact us with suggestions on what topics you’d like to see discussed at future events!