Articles by Bob Marshall

  1. 3 Bad Ideas For FDA Pre-Sub Meetings 2/27/2017

    The FDA currently handles about 1,500 pre-subs per year - a number expected to grow to about 2,350 in the next five years. Here I present three sure-fire ways to make your pre-sub meeting stand out for all of the wrong reasons. 

  2. A Life Sciences Lesson From Lake Oroville 2/21/2017

    Over time, a steady trickle of water can result in a flood; similarly, a steady stream of investment and ingenuity can result in a flood of medtech innovation. 

  3. Medtronic's CardioInsight, A Nanocoated Stent, And A Hug 2/14/2017

    Thinking about flowers, candy, and cards? (If not, your Valentine’s Day may be in jeopardy.) While you’re thinking, why not explore some good news for the traditional Valentine symbol, the heart?

  4. 50 Shades Of FDA: Some 2017 Guidance Documents Will Require Clarity 2/7/2017

    Among the dozen "A-List" guidance topics that FDA has slated for finalization in 2017, three already have been released. That's good progress. But, at least three of those guidance initiatives put forth directives that medical device companies may find difficult, if not impossible, to follow.

  5. Qualcomm Partner Provides Telehealth Simplification 1/31/2017

    Integron's president discusses how his company developed a growth strategy to approach companies with existing in-home therapies looking to connect their devices. The end result was remote patient monitoring and connected health offerings that have been deployed to 56 countries around the world.

  6. Missed Diagnosis Motivates Entrepreneurial Response 1/23/2017

    In his final year of medical school, Matt Kesinger realized that a clinical examination was never going to be good enough for early stroke detection, and he began to develop the technological solution that would become Forest Devices’ ALPHASTROKE.