Blog Posts by David Kern, RAC, MBA

FDA Announces New EUO Label
Draft guidance will lay out new path for devices
Tuesday, April 01, 2014
No Substitute for Planning
Expecting a miracle isn't the best strategy
Monday, December 23, 2013
The Hero We All Needed
Lessons from boy that wanted to be Batman
Tuesday, November 19, 2013
IDE Roulette
A little advice on when to file an IDE
Thursday, September 05, 2013
Making a difference in the lives of heart transplant patients
Thursday, May 30, 2013
HPV Tests
Helping to allay women's fears about a life-threatening disease
Wednesday, May 22, 2013
HIV Viral Load
The test that changed HIV treatment forever
Thursday, May 02, 2013
Waiting for LDT Guidance
What happens when Samuel Beckett, Tim Burton, and IVDs all meet at AMDM.
Tuesday, April 23, 2013
Life on the A-List
FDA seems to be sending mixed messages on LDTs and CoDx
Friday, March 22, 2013
The Pre-Submission Rosetta Stone
Translating FDA's Pre-Sub guidance into CoDx language
Friday, February 01, 2013
Once More Into the Breach Lads!
Is the time finally right for the CLIA lab to IVD business model?
Thursday, September 20, 2012
And in Other News, Nothing Really Changed
FDA draft guidance on In Vitro Companion Diagnostics documents what we've been hearing
Thursday, July 14, 2011
Lessons Learned in Project Management
Turns out even writing about project management can be a good lesson in the subject matter.
Tuesday, October 19, 2010
Relationships Really Do Matter
How you manage your partners is one of the first things an auditor looks for
Tuesday, September 07, 2010
The Wrong Raptor
Offering a successful LDT may be about the same amount of work as a full FDA submission.
Monday, July 12, 2010
The Perils of Time Travel
Some questions you should ask (and FDA will ask) about your frozen clinical samples.
Tuesday, April 13, 2010
Bells, Whistles, and the Quest for Clinical Utility
Increasingly, FDA is becoming reluctant to clear tests that have a vague or general clinical utility.
Thursday, November 05, 2009
A New, Tougher FDA?
The days of "black box" LDTs are likely drawing to a close.
Wednesday, July 29, 2009
Enlightened Empowerment
The concept of giving people the power to do their job is sound, but it is frequently not well implemented.
Thursday, July 09, 2009
Designed for (Future) Success
The consequences of a poorly developed IVD product go well beyond a few negative postings in a blog.
Wednesday, June 10, 2009
Turning Project Managers Into Project Leaders
A pack leader doesn't scream, get excited, or frustrated. They lead with what Cesar calls "calm, assertive energy."
Friday, April 03, 2009
Three Key Principles
Project Management in a Nutshell
Tuesday, March 24, 2009
What Do I Do With Project Management?
In an IVD firm, the project manager should be the de facto owner of the design control process.
Friday, March 20, 2009

Recent Blogs

The Staple That Changed an Industry LDT regulation and the perils of challenging Eminem to a rap battle
FDA Releases the Kraken Whichever way this breaks, it's long past time to have this conversation in a meaningful way
Illumina Acquires Myraqa Acquisition Strengthens Illumina’s Clinical Readiness
The Spirit of GLP A Best Practice for IVDs
Process Performance Qualification (PPQ) Lots So, how many lots are required?
The Case for Risk-based Monitoring Better the devil you know...
Form Follows Function OIR Reorganizes to Meet the Advancing Wave of Molecular Diagnostics
CDRH Unveils New PMA Guidance Documents Attention shoppers, it's two-for-one day!