Nevro: MedTech Startup Story + Factory Tour

Andre Walker is a founder and Sr. VP at Nevro, a company developing a revolutionary implantable Neuro-stimulation system for treating chronic pain.

Geetha Rao is a Sr. Consultant focused on risk management and regulatory for medical devices.  She is an internationally recognized expert in risk management and has served on several international policy making bodies, and as an invited expert to regulatory agencies, including the FDA, ISO Technical Committees, GHTF, and European Notified Bodies.

Andre has been fascinated with electrical devices from an early age and has developed many implantable systems like pacemakers, defibrillators and Neuro-stimulators to treat people in need. 

Nevro was founded in 2007 and received CE mark to commercialize their product in Europe in 2010.  The company is seeking US FDA approval at the moment.

The system comprises of an implantable electrical stimulator and electrodes.  The patient also has a remote control and a transcutaneous battery charger.

Key Milestones:

•  2007:  Company founded with a $5 million seed round
•  2010:  Company receives CE mark and starts production
•  2012:  Company ships more than 1000 units
•  2014:  Company is running an clinical study to support US FDA approval

Learn about MedTech:

-  Funding Strategy
-  Product Development and Regulatory
-  Assembly and Test Implementation
-  Lessons Learned
-  Future Plans
-  Open Q&A

Agenda:

•  6:00 – 7:00 pm – Networking and Food
•  7:00 - 7:40 pm – The Nevro Story
•  7:40 – 8:00 pm – Tour of Hunter Technologies
•  8:00 - 8:30 pm – Networking and Close

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  • Bradley P.

    SV-NPIers,
    I dig this group!

    Hats off to Mike Keer and his team! I have been to several of these meet ups for SV NPI. They are all great! I can not say which one is better than the next because they have all been killer!

    For this event
    Chris, Andre & Geetha were excellent presenters.
    Thanks for taking all our questions. The value of learning from your experiences is like taking master class!
    There was good informed questions all around.
    Hunter is indeed a solid and trusted partner. Hunter's new facility is something for you all to be proud of. Excellent hosts too! When you all get to the point when you need PLM and configuration controls, please look me up. Maybe I can return the favor!

    Thanks all for doing this! 5 stars
    Yours respectfully,
    Bradley Persson

    1 · April 18, 2014

  • Brian B.

    It was interesting to hear Andre say if he had it all to do over again, he might not do have founded Nevro—at least in the States. I wrote up this article describing how the two firms were partnering together: http://www.qmed.com/mpmn/medtechpulse/how-ems-firm-and-lean-startup-are-taking-chronic-pain

    April 18, 2014

  • Barrett C C.

    Hi, Carol, I am VP QA, Regulatory for a contract medical device company. I spend my day working through solutions to regulatory/legal requirements placed on our industry by well-meaning lawmakers and regulators. We spend a huge chunk of our available cash flow and the time allotted to us by the Almighty on a daily basis dealing with these issues. Many of the regulations & their interpretations do not add to the safety and efficacy of product. The basic FDA Quality System Regulation, and basic European standards and directives are understandable and we comply, but every year, there are new regulations, standards, and laws created, and they are interpreted in an increasingly stringent manner, with no addition to better design and little (very little) actual addition to public safety, but with huge increases in costs. So, those of us who live with this, fight it on a daily basis on your behalf. I thought Geetha did a great job last night on the regulatory aspect, as did Andre in his talk.

    1 · April 18, 2014

    • Carol B.

      Thanks very much for your perspective, Barrett. Sure hope the new patent office in San Jose marks the pendulum swinging in the opposite direction and politicians and the electorate moving to repeal regulation.

      April 18, 2014

  • Barrett C C.

    By the way, the meetup was wonderful. Thanks to Hunter for excellent hospitality and to Chris, Michael, Geetha and Andre.

    April 18, 2014

  • Carol B.

    I'm a physician who cares for patients in pain. I had no knowledge of the extraordinarily challenging regulatory process or of current manufacturing processes. The event was a total eye opener and well worth my travel from Marin. Thank you MIchael, Andre, Geetha and Chris!

    April 18, 2014

  • Vince B.

    Interesting success story of start-up during lean times for device makers. Factory tour was interesting - good stuff!

    April 17, 2014

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