Roughly 5 years ago our neighbor, Dr Josh Mezrich, transplant surgeon from the UW, was visiting on our porch. He was complaining about his back and his wife’s back.  Gretchen Schwarze is a vascular surgeon, also at the UW.  He told us about his idea for a snake light to be used in the operating room (OR) that would attach to the rails; it needed to be sterile; and most importantly have the same intensity as the industry standard surgeon headlight.  Josh basically desired to take the headlight off of the surgeon’s head and give the surgeon better light, better flexibility, and best of all give the surgeon relief of head/neck pain directly caused by the headlight. That became the concept for MezLight.  Gretchen, Josh, Craig and I self-funded the initial market analysis and the first rounds of design and prototype build.

Several very important things came to light, pun intended, while we went through the beginning of design.  On July 11, 2017 the FDA announced a list of class II devices that the agency determined to no longer require pre-market notification to provide reasonable assurance of safety and effectiveness.  These exemptions decreased regulatory burdens on the medical device industry by eliminating private costs and expenditures required to comply with Federal regulation.  Specifically, for these exempted class II devices, regulated industry no longer has to invest time and resources in pre-market notifications, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review.  The surgical light exempt classification is 21 CFR section 878.4580, product code FSQ.  In summary, prior to this exemption, the MezLight would have been subject to a process that costs on average $31 million prior to manufacture and sale.  Now the only pre-sale requirement is for the registration of manufacturer and listing of product(s) prior to manufacture and sale, which costs $5,236 in annual fees; and ongoing compliance with medical device labeling, good manufacturing practices (GMP) and unique device identification regulations.

Also, at the same time, several reports fed our enthusiasm for MezLight, including:

1. The depressing report that 68% of surgeons performing open surgery after 10 years suffer from some form of disability due to neck and back issues; and

2. A report on bacteria contamination from wiping down the headlight during surgery.

We filed for a patent for the light; we hired a team to help us get off the ground while we tended to our full time jobs; and we raised $1M of initial investment at a $20 million independent valuation, based on our business plan and pro forma projections. The initial investment came from friends and family and proved to be quite easy as they assessed the opportunity.  We designed an amazing marketing program using the Frantz Group out of Milwaukee to help get our messaging on target.  We built and launched our website, built an amazing trade show booth and attended our first tradeshow, the American Transplant Congress (ATC) show in Boston in June, 2019.

The June trade show allowed us to “soft-launch” the product.  We learned a ton and immediately tasked our head of design, Bill Dorr, to pull off a redesign in 5 months so we could be ready for the even larger trade show ACS Clinical Congress…for all general surgeons held in San Francisco Oct 27th through Oct 31st 2019.

Now today is Nov 1, 2019 and the MezLight team came back from the ACS trade show in San Francisco last night. Here’s where we are: