If you’re an angel investor, this has probably happened to you. You’re sitting through a startup company’s pitch and they’ve got a very compelling medical device and go to market strategy. You’re doing the numbers in your head, considering how much you might like to invest, when you hear a dreaded phrase:
“We’ve just started the FDA clearance process.”
Your mind immediately puts on the brakes as you process what the speaker means by this statement. Is FDA clearance going to take months or years? What’s it going to cost? Is there a chance they don’t get clearance? The clarity of the pitch has just gone to mud.
On Thursday, November 30, VisionTech Angels is hosting a special event – Don’t Wine About the FDA Regulatory Pathway – to help angel investors, life sciences startup companies, and other special guests better understand the FDA’s processes. Leading the discussion is VisionTech sponsor, Pearl Pathways, an expert in FDA regulatory affairs.
Prior to the discussion, we’ll enjoy wine tasting and networking with vintages selected by Crossroads Vintners. This will be followed by Pearl Pathways’ presentation, which will focus on medical device development, the 501(k) process – a particular pain point! – and alternatives to this pathway. Pearl Pathways will draw upon their first-hand experiences on behalf of both startup and established companies in the medical device space. You will have the opportunity to ask questions.
Our goal is to give you greater understanding and insight into the FDA and its regulatory processes so that your, as an investor, can make better-informed decisions when considering investing in a life sciences company. We also want this event to give startups more confidence when working with the FDA.
Don’t Wine About the FDA Regulatory Pathway
Thursday, 11 /30, 5:30-7:30 pm
Katz Sapper & Miller, 800 East 96th Street, #500, Indianapolis, IN 46240