Beware the Unknown Unknowns.
As a medtech investor, you know that startups can offer exciting, industry-changing innovation and advanced science, which are what make them such appealing investments in the first place.
But caveat emptor – a flashy pitch deck does not guarantee a sound investment, and this is where some robust due diligence can really pay off.
Steer clear of potential bankruptcy
Start by looking behind the curtain to the real meat-and-potatoes of the startup’s culture. Only then will you be able to determine whether the company is destined to succeed – or doomed to fail.
How well defined is their regulatory strategy? Do they have a robust quality management system? Do they have a quality manual? A design history dossier? What do the rest of the technical files look like?
You also need to know who is involved in determining the startup’s go-to-market strategies.
Hint: if the regulatory team doesn’t have a seat at that table, you may want to pass on the investment opportunity.
Heed the red flag warning
Even if the startup assures you that everything is as it should be, you should still consider getting a second pair of independent and objective eyes onto the documentation.
And that’s where I come in.
Having worked as a regulatory consultant for over twenty years, I can spot a dodgy investor pitch at fifty yards, and I can tell at a glance if there are major gaps in a startup’s submission plans.
I’ve worked with investors, and I’ve been an investor myself, so I know what red flags to look for in the pitch deck.
I can help you uncover the things that really matter, so you can perfect your investment strategy while protecting your wallet.
In due diligence, there are the known knowns – the information that is easy to discover.
There are also the known unknowns – the details on manufacturing practices and quality management systems that take some digging to uncover.
And then there are the unknown unknowns – and that is where the hidden dangers are.
We know a thing or two about these known and unknown things – and how to know them.
So, if you’ve got a question about due diligence, just ask me already.