MezLight has developed a solid partnership with our contract manufacturer Bridgemedica. Our teams have built trust and confidence in each other and it’s a delight to be a part of. While parts sourcing and tooling revisions have delayed our launch timeline to 1Q 2021 we are holding weekly meetings to make sure we are a priority to all of our suppliers. Our team continues to collaborate daily with Bridgemedica to efficiently address any issues. After the final sourcing decisions were made, we are proud to say that all components are still fabricated by US suppliers, ensuring that MezLight will be 100% assembled and made in the USA, as promised.
Over the next few months we will be finalizing all injection molded parts, optimizing the assembly and test procedures on the production line, and building our DV&V (Design Verification and Validation) product. This set of 25 units will be used to conduct the testing necessary to satisfy our Quality System requirements and allow us to register with the FDA prior to production distribution. Our regulatory consultant Skip Farhina, of Strategic Device Solutions, has written our test protocols to include information needed to enable us to apply for European CE mark later in 2021. The details for labeling and packaging are also being finalized.
It has been a terrific experience working closely with Bridgemedica. Bridgemedica has been highly responsive to our request to consider hiring female and/or underrepresented minority engineers. They did not hesitate to make this a priority and the stand-out star on our project has been mechanical engineer Sabrina DiMartino, a
Mexican-American graduate of the Wentworth Institute of Technology. Within the last 60 days they have hired and trained a new supervisor of production and she will have responsibility for the MezLight production line.
Heidi and Karen will be the full-time sales team for MezLight, focusing on the 300 contacts already qualified to get us to revenue quickly. Concurrently we will be looking for a distributor partner or partners to scale up volumes and market coverage. While we have gathered leads on distributors, we feel we need to focus on the contact list first then when we start shipping we will be in a good position to negotiate a distribution contract. We also think our first surgeon clients and their procurement offices may help us to determine the best distributor for MezLight.
As you know, we’ve been working closely with the University of Wisconsin to follow their procedure to allow surgeons to start using the MezLight in surgery. The UW has a very involved committee-led process for the adoption of new products or practices in the OR. Not surprisingly we are finding that each healthcare organization has a different process, so we’re starting outreach now to our 87 ‘friends of Josh’ group that have already committed to supporting the MezLight. Karen and Heidi, with Josh’s lead, will carefully nurture each early adopter to gain valuable firsthand feedback, and get our sustainable revenue stream going as fast as possible. We have a second-tier group of surgeons identified that includes the next level of network contacts outside the "FoJ" and are in the process of developing relationships with these individuals as well. The third target group we are working, comprises the surgeons who’ve reached out, but with whom we do not yet have an established relationship.
Josh, myself, Craig, Heidi, and Bill appreciate your patience and continued support as we drive to launch the MezLight in spite of the ongoing challenges presented by 2020. With 2021 just around the corner we remain 100% focused on bringing our compelling alternative to the headlight to surgeons in the US and across the globe.
With gratitude,
Karen Christianson
MezLight CEO & Co-Founder
525 Junction Road
Suite 6500
Madison, WI 53717
f 608.960.4610
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