The Importance of “Alpha Surgeons” in Medtech

This article is brought to you by Equifund, LLC.

Share on facebook
Share on twitter
Share on linkedin

A few weeks ago, one of our portfolio companies Kleiner Device Labs (“KDL”) announced they’d officially received FDA 510(k) Clearance for their KG™2 Surge™ Flow-Thru Interbody System (“KG2”).

This means the KG2 is now “cleared” to be marketed, sold, and otherwise used in the operating theatre.

However, before the team is ready for a full-scale launch of the product, they’re going to run a small-scale roll out to a select group of surgeons.

In the medical device industry, this is known as an “Alpha Launch”… and it’s a key step in the company’s path towards full commercialization of this new technology.

If you are familiar with the software industry, “Alpha Testing” and “Beta Testing” refer to a type of User Acceptance Testing.

Broadly speaking, Alpha Testing is mainly performed by the in-house software team while Beta Testing is done by potential users or customers.

However, in the world of consumer and enterprise software, the mandate is often to “move fast and break things.”

Speed to market is key in the tech world. Even if there are bugs in the software, it’s generally more important to ship software as fast as possible to the end user and (hopefully) fix problems with continual updates.

The commonly held understanding is that the consumer will tolerate failures so long as they have access to the latest and greatest technology.

However, in the much higher stakes world of medicine, this attitude simply doesn’t work.

Risk management is a far greater consideration in the development cycle as efficacy, stability and predictability are key.

Unlike Alpha Testing in software, medical devices must be a “finished product” in order to earn 510(k) Clearance.

However, similar to software, the device still needs to be used in the operating theatre under real world conditions.

“Alpha Surgeons” represent an initial group who will be the first to use a new device in live patient procedures.

KDL has hand-picked a small team of orthopedic spine & neuro-surgeons who represent a cross section of surgical theaters, from hospitals to surgery centers.

Several of these surgeons participated in a cadaver testing laboratory exercise last April. This means they already have some familiarity with the device.

The first surgeries done by this group will document procedure processes and results, which will be presented to surgeons more broadly in the U.S., and will provide important proof points for the industry and the insurers who predominantly pay for the spinal fusion procedures for which the KG2 is specifically designed.

For all of our Equifund members who have invested – or are planning on investing – the Alpha Launch marks a critical inflection point in the life cycle of the KG2.

The same goes for other medtech companies you may be looking at. Keep that in mind when investing (especially in early-stage deals).

Sincerely,

Jake Hoffberg

Jake Hoffberg – Publisher
Equifund

Like this article? Share it with a friend:

Share on facebook
Share on twitter
Share on linkedin

This article is not an Equifund Crowd Funding Portal Inc communication. It is brought to you by Equifund, LLC.

More Articles:

The Era of Net-Zero Mining

28 mining and metals companies commit to a goal of net-zero direct and indirect carbon emissions by 2050 or sooner

Don't make another private market investment without reading this...

The 5 Mistakes

investors make that crush returns

Download this free report now:

Just enter your name & email to access this report for free.

By submitting your email address you will receive access to this report and a free subscription to Equifund’s private investment newsletter. You can unsubscribe at any time and read more about our privacy policy here.

More Articles:

Advertisement:

Kleiner Device Labs

Investment Highlights:

  • 1

    Proprietary devices that could revolutionize spinal surgery and greatly improve success rates, reduce pain, and lower costs.

  • 2

    Over 20 patents have been issued to protect the company's technologies.

  • 3

    Just received FDA clearance for their next-generation KG2 spinal fusion technology.

Pre-Investment Agreement

The next 8 slides will allow us to process your investment. Note that these next steps are a legal requirement – Thank you for your patience and financial support of this investment opportunity. Jordan Gillissie – CEO

Before we execute the investment, it’s important for us to make sure you’re comfortable and knowledgeable in early stage investing. We want to make sure that you:

    • Received and have reviewed the education materials sent to you.
    • UNDERSTAND; that there are restrictions on your ability to cancel your investment commitment and obtain a return of your investment.
    • KNOW; It may be difficult to resell securities acquired under Regulation Crowdfunding.
    • AGREE; investing in securities offered and sold in reliance on section 4(a)(6) of the Securities Act involves risk. Investors should not invest any funds unless he or she can afford to lose the entire amount of his or her investment. Your investment may not work out, and you must be in a financial condition to bear the loss.
  • Hidden
  • Hidden
  • Hidden
  • Hidden

We are currently upgrading our system. If you click submit and the process does not continue in a few seconds, please refresh this page manually, and click Invest Now again and you should be moved on to the next step.

Complete Your Registration

By verifying your account you agree with our terms of use, privacy policy and pre-dispute arbitration agreement. Please complete the registration process by clicking the link below:

Verify Your Email

Please wait a few minutes while we create your account. An email will be sent to you shortly to confirm your admittance. Should the email be delivered to your spam or promotions folder, we recommend you move it to your inbox and mark Equifund as a safe sender.

If you have not received the email in 5 minutes, please click here to have it resent.

Questions? Our customer service team is always here to help – (800) 879-7606

Thank you for your investment in Home Bistro! To view the status of your investment, click the button below to navigate to your Dashboard.

Enter your email address to get instant access to the video: