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7 ways you can doom your medical device startup

May 4, 2018 By Chris Newmarker

FDA medical device startup regulatory

3. Not having a regulatory strategy early on

Medical device startups need to quickly understand what the regulatory requirements are so that they can plan for it, according to Nelson. “I’ve seen that hold up companies, and in one case, it killed a company.”

The startup that went under, which Nelson described as a neurostimulator company, didn’t want to talk with U.S. FDA until it was absolutely necessary. “By that time, it was too late to understand what the FDA required them to do. … They didn’t have enough money to go back and address what the FDA wanted,” Nelson said.

People starting medtech companies can fool themselves into thinking that they understand FDA regulations. “People try to say they have a 510(k). Sometimes they’re right. Sometimes they’re wrong.”

It’s good to have a regulatory consultant involved at the beginning, even if they just start out helping a bit here and there, providing input on strategy and planning, according to Nelson.

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  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • Subscribe to Print Magazine
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech