In a continuation of the previous episode, Mike Drues joins the podcast to further discuss LDTs, IVDs, and how those related to the ongoing Theranos situation.
Mike is the president of Vascular Sciences, has a Ph.D. in biomedical engineering, and has extensive experience with Regulatory Strategy.
In today\u2019s episode, he begins by reviewing some of the information in Part 1 of this discussion. He discusses how the current regulations and language around LDTs relate to the Theranos situation and what companies should be doing to ensure they\u2019re ready when the VALID act goes through.
Listen to this episode to hear what Mike has to say about the risks of LDTs, the engineering work that should go into LDTs, and how the regulations could be changed to close the Theranos loophole.
\u201cEven from a technology perspective, the technology of these LDTs is becoming much much more complicated.\u201d
\u201cLong story short, I think Theranos took a fairly liberal interpretation of the words surrounding the LDT.\u201d
\u201cI\u2019m a biomedical engineer first and a regulatory consultant second. And that\u2019s the order we should think about these things.\u201d
\u201cEven though I\u2019m a regulatory consultant, I\u2019m not a fan of creating new regulation.\u201d