Welcome to our 2023 Q4 Newsletter! We hope this finds you well and that you’re excited to find out what we’ve been up to. We’ve had an exciting year, including onboarding 18 new projects. We’ve relocated to a 70,000 sq ft headquarters in Woodbury, MN; increasing our office space twelvefold, and we’ve expanded our in-house manufacturing capabilities through our merger with I-Tek Medical. As always, we thank you for your continued support, and without further ado, here are our Q4 updates.
Company Updates
Buildout Plans for VitaTek’s 70k Sq Ft Headquarters
We’ve been settling into our new headquarters nicely! Next up in our buildout plan is the construction of an 11,000 sq ft modular clean room and a 2,000 sq ft white room manufacturing area, equipped with ten state-of-the-art 3M EO sterilizers. Once we complete the buildout, we plan to move over our manufacturing and sterilization services, which are currently operated in White Bear Lake, MN. We’ve created a detailed phased-in approach to maintain our customers’ promised timelines for the relocation.
Bringing Manufacturing In-House
We’ve officially merged with I-Tek Medical, a leading CM (Contract Manufacturer) with 30 years of expertise in medical device manufacturing. I-Tek currently operates from a 37,000 sq ft facility in White Bear Lake, MN, which includes a 2,000 sq ft white room. The 10,000 sq ft tooling and die mold shop, located in Blaine, offers in-house mold flow analysis, 3D modeling, custom mold building, and mold refinement for fast revisions. As mentioned above, these operating facilities are planned to relocate to our Woodbury, MN Headquarters, later in 2024.
The merger of Vita Group and I-Tek prompted the rebrand to VitaTek, incorporating both names and company offerings. This merger was part of our strategic, vertical integration plan to provide napkin sketch to commercialization services, all from under one roof. To learn more about the merger, view our recent press release: I-Tek Medical and Vita Group Join Forces to Create VitaTek
Sterilization Milestones and Unmatched Turnaround Times
Our EO medical device sterilization service is fully up and running and this quarter, we completed our first validation run in 12 hours, using our 3M GS8X Steri-Vac unit. We’ve also completed our first routine run, which lasted 7 hours; allowing us to place the product in our customer’s hands in just two days.
Quarter 4 also brings updates to our EO sterilization pricing and timelines. Our small batch routine runs are now priced at $826.00, for a rapid turnaround of 2-3 days, which is much faster than the industry standard of four weeks. Our accelerated validation runs are completed in four weeks, compared to the industry standard of 6-12 months.
To learn more or to book a medical device sterilization service, visit www.vitatek.io/sterilization
Expanding Reach and Impact in the Medical Device Sphere!
This quarter’s networking opportunities allowed us to reach new audiences and spread the word about how we’re disrupting the medical device industry.
Merge Medical Podcast
In October, VitaTek was invited as a guest on Dr. Jeff Brown and Dr. Jeff Cole’s podcast ‘Merge Medical’. “We appreciate the chance to tell our story to their audience, starting as a small incubator to a full-service medtech powerhouse.” – Jason Scherer, VitaTek CEO
View the full article: VitaTek Partnership Podcast – Merge Medical
Medical Alley Feature
We were also invited to join Medical Alley on their ‘For the Record’ segment to discuss the healthcare landscape and its future. The article highlights our strides as the only vertically integrated device development company in the nation and our mission for aggressive and rapid commercialization.
View the full article: For the Record with Jason Scherer, CEO, VitaTek - Medical Alley
JP Morgan Chase Dinner Event
In November, JP Morgan Chase hosted an exclusive dinner attended by 20 influential CEOs, a majority specializing in contract manufacturing. Many shared their negative experiences with sterilization providers, communication gaps and delays that led to additional fees, these comments aligned with our own previous experiences. Jason mentioned our mission to eliminate reliance on third parties by becoming an A to Z, in-house medical device development company. This resonated with the attendees, and we received a handful of referrals for our sterilization services, affirming the industry's need for a comprehensive solution.
Join Us In Anaheim for MD&M, Feb. 6-8
We’re excited to announce our plans to attend the MD&M event in Anaheim, CA! After our success at our first MD&M show in Minneapolis as an exhibitor, we're looking forward to building new connections and discussing our in-house capabilities. Representatives from our leadership team will be attending to network and discuss solutions around medical device r&d, prototyping, regulatory, manufacturing, tooling, final assembly, sterilization, sales, and more.
To book an in-person meeting during the show, please schedule a call with our President of Sales, Matt Newman: https://calendly.com/matthewnewman29
VitaTek’s OEM Medical Device Updates
The devices listed below are our OEM (Original Equipment Manufacturer) medical devices. If you’re interested in learning more or investing in any of these devices, please schedule a call with President of Sales, Matt Newman: https://calendly.com/matthewnewman29
We’re currently working with our engineers to refine the device for additional lubricity, and we expect a short-run quantity of 2,000 units in Q1 2024. More details are coming soon.
Brekka Launches in Kentucky
We’d like to announce Dr. Salzman of Salzman Cosmetic Surgery and Spa as the first surgeon in Kentucky to use the Brekka Capture Delivery Device and thank him for his positive feedback. His testimonial commented on the clever design of the device’s handles that facilitate contact-free delivery and its user-friendliness. Our marketing team created an Instagram Reel to post on his practice's 56K follower account, which received 14K views. You can view the reel here: https://www.instagram.com/reel/CzUj8QfOl9b/
For the latest news and updates, follow and connect with us on Brekka’s social media platforms: Brekka LinkedIn: brekkamedical, Brekka Instagram: brekkamedical
StingRay Updates
Dr. Joe Gryskiewicz of Gryskiewicz Twin Cities Cosmetic Surgery successfully used StingRay's Implant Delivery Device in multiple breast augmentations this quarter. In our mission to make the best device possible, our engineers are further refining the device by integrating a hydrophilic coating for additional lubricity. More details on market release coming soon.
For the latest news and updates, follow and connect with us on StingRay's social media platforms: StingRay LinkedIn: Stingray Medical, StingRay Instagram: StingRay Medical
Nano Assist Begins Prototyping for a 1x Scale
Nano Assist is positioned to become the first device with dual-end effectors, tailor-made for use alongside a robotic-assisted bronchoscope, featuring a compact outer diameter (OD) of 2 mm. Our current focus revolves around refining the CAD development, to create a 1x scale high-fidelity prototype. We're also exploring metal injection molding options for the jaw component, preparing for the upcoming manufacturing phase.
LipoShot Prepares for Commercialization in 2024
LipoShot, our autologous fat grafting device, has reached the end of Phase 3, Design for Manufacturing, and was sent out for biocompatibility testing in mid-November. We estimate to receive the results in January 2024, and we'll submit our 510k at the beginning of February. Once we receive the results from biocompatibility, the next step is submitting for FDA approval, which projects an estimated commercialization date as early as Q3 2024.
Orchid’s Phase 3 Updates
Orchid, a gentle fat grafting syringe used to harvest, dry, and inject fat cells in one use, is in Phase 3 Design for Manufacturing. Our engineers are refining the over-molding of the handle to increase the device’s stability. To streamline our commercialization timeline, we’ve also decided to focus exclusively on the 25cc model. Once commercialization is achieved, we may continue the development of the 50cc model. More to come at a later date.
New Incubation & CM Projects
We’ve onboarded three exciting projects this quarter, two in incubation and one in DFM (Design for Manufacturing). We’ll apply our vertical integration services to bring these projects to market, as quickly as possible.
Project 34
Project 34 features a cord management system that reduces clutter from the sterile field in the OR, with a goal to increase safety and user-friendliness. The project started in Phase 0 Exploration, where our engineers brainstormed solutions to address the current limitations of the project’s competitors. We’re nearing Phase 1 Prototyping, where the inventors will receive a minimum of five prototypes created on our in-house J750 3D printer. This printer allows us to quickly customize color, texture, and material to create semi-realistic representations of the final product.
Project 35
Project 35 will integrate a smoke evacuation system and drape combination to reduce surgical smoke. This will keep smoke out of the eyes and respiratory system of all occupants in the operating room. This project is contracted for Phase 2a Product Design & Sourcing. We will generate concepts, source materials, create low-fidelity prototypes, provide a ballpark BOM (Bill of Materials), and offer a roadmap for commercialization.
Project 36
Project 36 is a vaginal dilator that helps manage the pain experienced by women around their pelvic region. The inventors have already finalized DFM (Design for Manufacturing) and the Design plan. Phases 1-2, focused on transferring their CAD drawings, vendor information, and product specifications to our engineers. We’re now in Phase 3 Manufacturing Setup, to finalize tooling, work with suppliers, and conduct design reviews. In the following steps, we’ll guide the inventors through Phase 4 for Validation Testing and FDA Submission. We estimate to complete our FDA review for this project at the end of Q3 2024.
Happy Holidays and Happy New Year!
The holiday season is all about reflecting on what you’re grateful for and spending quality time with your loved ones. We are grateful for you. Thank you for your support throughout our journey as a startup medical device incubator, to where we are now, becoming a leader in the industry. Happy holidays to you and your family, and we’ll see you next year.
P.S. Vote who you think wins the ugliest sweater contest here: https://www.linkedin.com/feed/update/urn:li:activity:7143694827732230146
We hope you enjoyed this edition of our quarterly newsletter. We look forward to sharing more in the new year after Q1. We’d love to quote your next medical device-related project. To learn more or to receive a quote for any of our services, please complete our online form or schedule a call with our President of Sales, Matt Newman: https://calendly.com/matthewnewman29
Book a call with Jason: Calendly - Jason Scherer
Request a quote with our online form.
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Sincerely, VitaTek Marketing Team
