LeanRAQA News

Caveat emptor – not all startups are created equal, and if you want to get the biggest bang out of your venture capital dollar, you need to focus on the answers to three simple questions.

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.

And if you’re a more established organization, then these startups can be the target of your acquisition and expansion plans, offering patented technologies and ready-made devices ripe for market introduction.

But neither a flashy pitch deck nor a previously marketed product do a sound investment make. You need to look behind the curtain to the real meat-and-potatoes of the startup culture that can determine whether the company is destined to succeed – or doomed to fail.

Here are three questions to that will uncover any regulatory uncertainty within the startup:

1. Is the regulatory strategy well-defined?
2. How robust is the quality management system?
3. Who are the key players in determining the product’s go-to-market strategy?

If the answer to any one of these is unclear, then the company may not be worthy of your investment.

But even if the startup’s regulatory representative assures you that everything is as it should be, you should 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, performing the due diligence that can uncover discrepancies in the quality system, and I’ve been an investor myself, so I know what red flags to look for in the pitch deck.

Those three simple ways to protect your investment?

1. Know that you need to look beyond the pitch deck before committing to funding a startup
2. Ask my three basic questions to help you suss out a subpar regulatory plan
3. Put some time on my calendar and learn how I can help you make better medtech investments

Being in love with your own science – bad. Failing to comply with good manufacturing practices – bad. Making unsubstantiated or incorrect product claims – very bad. Waiting to build your QMS and technical documentation file until the FDA makes you do it – very, very bad. 😒 I see startups make these regulatory mistakes (and many others) all the time, and it ALWAYS takes time to make them see sense.

If you’re planning on bringing a product to market, you need to know about the design history file (DHF) and the device master record (DMR). In this clip, Michelle explains why startups need the DHF and DMR, and how they can impact your FDA submission. (October 7, 2021)

Your intended use helps you choose the right FDA product code, and that points you toward the right submission pathway. The intended use should be finalized long before you start looking at submitting to the FDA – not after. In this clip from a recent presentation, Michelle uses surgical masks to highlight how the chosen intended use directly impacts submission strategy, and the testing you’ll need to be successful. (August 19, 2021)

Computer-aided devices have different regulatory requirements than standard medical devices, despite the lack of consistency in FDA guidance. I spoke about these devices during my presentation on FDA submission pathways for the West Coast Consortium for Technology & Innovation in Pediatrics (CTIP) (August 10, 2021)

No matter the risk management question, Edwin Bills will likely have the answer. He’s been involved in the medical device quality and regulatory space for many, many years. Give him a tricky compliance situation or example, and chances are he has been there and done that – probably more than once. Ed sat down with Michelle to talk about ISO 24971, MDR and the risk of radiation exposure in a sun-filled hospital room. (June 3,2021)

Does the idea of your product falling under the FDA purview keep you awake at night? Does the very thought of the process send your ulcer into overdrive? Take heart, weary viewer, because it is possible to have a positive FDA experience – as long as you are fully prepared. (May 20,2021)

Is your notified body up to the task for your medical device? Michelle Lott breaks down the yes/no questions you need answered today! (July 2,2019)