David Kern, RAC, MBA

Senior Director

Dave has more than 20 years of experience developing IVD and life science products.  His experience in product development, project management, business development and relationship management grants him a wide view of the entire life-cycle management process.  

Dave has designed and implemented product development processes for both FDA and ISO environments in both large and small companies. He also has extensive experience in creating and implementing governance structures to manage co-development and outsourcing relationships within both the IVD and therapeutics industries.

Dave came to Myraqa from XDx, where he was served as Director of Project Management and was part of the team that implemented the development process for one of the very first IVDMIA products.  Prior to that, Dave spent six years with Affymetrix in a variety of capacities, including managing the strategic alliances between Affy and their IVD partners.  Dave also served as Research Specialist and Project Manager during more than six years at Chiron, where he led the product development process for the HIV viral load test.

Dave holds a BS in Biochemistry from SFSU and MBA from SJSU.  He also has extensive training in project management, facilitation and conflict resolution.

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Recent Blogs

Great New Companion Diagnostics E-Book Released Today A valuable resource in a hot, but under-informed segment of the market
Oragene Clearance Shows DNA Stabilization is Class II Clearance could have a significant impact on DTCG providers
My Screening Test for Screening Tests Offering up a rare bit of regulatory certainty
The Abolish OIVD Act of 2011 A torches-and-pitchforks approach to LDT regulations

Glossary Terms

In Vitro Diagnostic (IVD)
In Vitro Diagnostic Multivariate Index Assay (IVDMIA)
International Organization for Standardization (ISO)