Navigating the FDA and Other Medical Regulators

Working Within the Red Tape:

Regulation is a hurdle for any medical tech company, but it’s even more difficult for startups.

 

Many early-stage biomedical startups get stymied by regulatory requirements, or fear they will be. 

 

While many companies hire consultants who specialize in or have contacts within the FDA who can help them to navigate the system, this isn’t always an option for early-stage companies.

 

This panel will feature biomedical startup founders recounting their tales of navigating the regulatory hurdles set up by the FDA. They’ll share what they learned and what they wish they knew going into it, so that you can save time and make the best decisions for your company.

This event was originally a part of Startup Boston Week 2020. It is perfect for founders, product owners, and other employees at idea-stage startups.

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Jennifer Jordan

EIR, Techstars Future of Longevity

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Tim Simard

CEO & Founder, AlyxHealth

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Nicole Palmer

Intellectual Property Attorney, Lando & Anastasi, LLP

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David Yusefzadeh

CEO & Founder, Cloud Creamery

The Highlights: 

The key takeaways from this panel:

  • Learn early and learn quickly. The sooner you start the conversation the better

  • Document everything

  • If you are stuck, work your way backwards from approval and see what actions you can take that don’t depend on the regulatory process

  • De-risk as much as possible

  • Many of the IP items take ~1-2 years to complete. Plan accordingly.

Notable quotes that stood out: 

  • “Build out the protection early and often”

  • “If you have a good sense for the landscape and your internal documentation, then the lawyers can be at their best to help you”

  • “Due to the pandemic, aspects of healthcare have jumped ahead 10 years”

We're partnering with AccelHub for this replay event - AccelHUB partners with international municipalities, universities, and corporations to develop bi-national acceleration programs that connect the U.S. with international innovation ecosystems.

 

AccelHUB's programming focuses on the scale-up of startups in the U.S. through cultural immersion, mentor matching, and client connections. They believe that by connecting the world's top startups with the most advanced innovation ecosystems, we can be an engine of growth for economies around the world. Learn more here.

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