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Prioritizing Complex Markets, Products, Regulations and Reimbursement with Karen Zaderej

Mastering Medical Device

CHAPTER

How to Be a Successful Startup in a Changing Regulatory Environment

As a startup company you need to be nimble but you need to have deep domain expertise in a lot of different areas. We're focused on peripheral nerve repair which means we allow regulatory pathway with the notable exception of systemic drugs just that's that is out of our skill set. In many other fields software apps whatever um fail fast is something that  you don't necessarily want to fail in medical device you you want to. You can take what you can't fail at is patient safety and so you can't compromise on that in any way.

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