Welcome to our Q2 2024 newsletter! We’re excited to share the latest updates and achievements as we’re rapidly growing in the medical device development industry. Meet our new team members, learn about important events we’ve attended, and find out about our OEM project developments! As always, we appreciate your continued support and thank you for being part of the VitaTek community.
Onboarding New Members Fuels Rapid Growth
We’re excited to introduce the new members of our team! Each individual plays a key role in growing our in-house capabilities and supporting our aggressive approach to bringing medical device projects to market as fast as possible.
Mark Newsome, Chief Financial Officer
Mark has three decades of financial leadership experience specializing in tailoring financial strategies. He has held leadership roles on both the company and capital side of transactions and served on FASB’s ITAC, Chair of CFA New York’s Improved Corporate Reporting Committee and its Financial Reporting Conference. His experience guides organizations through strategic growth plans and M&A, with expertise across sectors including manufacturing, MedTech, and financial services. Having led about $3B in capital raised for start-up and middle-market companies, he provides unbiased counsel in navigating challenges and ensuring effective financial strategies for success.
María Gómez, Regional Sales Manager, Southwest
María brings over 14 years of experience in client relations and navigating competitive markets, including medical aesthetics. Starting her career in communications in Caracas, Venezuela, where she graduated from the Universidad Católica Andrés Bello, she quickly transitioned into the sustainability sector after moving to the United States. She has won the prestigious Pure Energy award for her exceptional performance in retail energy. She consistently achieved elite status in territory sales with Ideal Image for over nine consecutive months. She is bilingual in English and Spanish, and her ability to form meaningful connections makes her a valuable asset to our clients in the southwest U.S.
Frankie Mead, Vice President of Business Development
Frankie's wealth of experience includes 25 years as a sales leader at Mentor Worldwide, and most recently Sientra, Inc., where he gained extensive knowledge and skills in selling and marketing medical devices such as breast implants, facial aesthetics, body contouring, and operating room equipment. His background in plastics, coupled with his collaborative, customer-oriented approach makes him an invaluable addition to VitaTek as we launch new OEM accounts across the country and overseas.
Kaki Spandana & Ken Meyer, Regulatory Specialists
Ken has been in the medical device industry for over 15 years with experience in a broad range of regulatory services. Some of his expertise includes 510k submissions, International Medical Device Submissions for multiple markets, ISO 13485 and ISO 9001, New Product Development (NPD), Biocompatibility, Global Medical Device Nomenclature (GMDN), Labeling and Unique Device Identification (UDI), Vigilance and Post Market Surveillance, and Corrective and Preventive Action (CAPA).
Kaki has conducted internal audits, implemented corrective action plans, and classified medical devices. She has also worked alongside cross-functional teams to complete technical files and perform GAP analysis. She is currently pursuing a Master's degree in Regulatory Affairs and Services for Medical Devices at Saint Cloud State University.
Optimizing Production with Mold Flow Analysis
Mold flow analysis is a software simulation that evaluates resin flow, within the mold, during injection molding. This analysis identifies potential design issues and optimizes the production of high-quality plastic parts. Our engineers use this tool during Phase 3 Design for Manufacturing before defining the tooling needs and freeze design. This saves on costs and time, while ensuring the project receives high and consistent quality.
Learn more about our manufacturing services: https://www.vitatek.io/device-manufacturing-services
Project Updates, Milestones, and Awards
Brekka Continues Expansion with User-Driven Enhancements
User feedback is very important to Brekka’s success in capturing market share, and under the suggestions of leading plastic surgeons, we’ve implemented three design changes. We reduced the distal opening to 4.4cm to accommodate smaller incisions, updated the welding design, and modified the distal tip shape to a curved line for a smoother delivery.
With our in-house engineering and manufacturing capabilities, we applied these design changes immediately. For context, this would take other companies an entire year to release. These units are being manufactured now and will be available for sale soon.
Learn more or order your own Brekka now at: www.brekkamedical.org
For the latest news and updates, follow and connect with us on Brekka’s social media platforms: Brekka LinkedIn: brekkamedical, Brekka Instagram: brekkamedical
StingRay Receives Glowing Reviews & Promotional Pricing
StingRay’s Implant Delivery Device completed its fifth quarter on the market since its Q2 2023 release. We’ve received glowing feedback from medical professionals, including Dr. Jeremy Warner. Dr. Warner is double-board certified by both the American Board of Plastic Surgery and the American Board of Facial Plastic & Reconstructive Surgery. In his testimonial, he stated, “As far as I’m concerned, there’s not a better device on the market for implant delivery.”
Dr. Jim Grotting, a board-certified plastic surgeon with Grotting Plastic Surgery & Medspa in Birmingham, Alabama, also provided a thoughtful review, “I’m very impressed with the device and I’ve converted completely over to the StingRay. I find tremendous value that you can use any sized implant or incision size.”
To build awareness and incentivize first-time users, we’ve released a promotional price of $50 per unit. We’ve already seen a very positive response from surgeons interested in converting from their current delivery device to StingRay.
Learn more or order your own StingRay now at: www.stingraymedical.org
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
LipoShot Phase 4 DV Progress and Path to Commercialization
We’re making great progress with LipoShot in Phase 4 Design Verification (DV) Testing. This includes working on DV Units, documentation, supply chain approval, and 510k submission.
Right now, we’re focusing on a process called conditioning, the first part of DV testing. First, we’ll use our in-house Herrmann Ultrasonic welder to assemble the entire device as it will be sold. Then, we’ll perform accelerated aging testing to determine its shelf life, and environmental testing to evaluate performance, durability, and safety. Finally, the units move onto DV testing, which ensures its ability to function as intended and meet safety standards and requirements during normal use.
Once we’ve gathered all information from DV testing, Adam Johnson, President of Quality and Regulatory, will compile the 510k submission for FDA approval. We’re targeting Phase 5 commercialization in Q4 2024!
Orchid Phase 4 Design DV Testing Progress and Milestones
Orchid is in the early stages of Phase 4 Design Verification (DV) testing. We’ve received the remaining molds needed for full assembly, allowing us to produce high-quality parts faster than the initial 3D-printed prototypes from Phase 0 and Phase 1.
Our next step is a full build for DV testing. The entire medical device is manufactured according to its final specifications. Every component is produced and assembled as it would be in the final product. This provides a comprehensive assessment of functionality. Once this full build is ready, Adam will send out the biocompatibility submission. This crucial process assesses the safety of our device's materials when interacting with living tissue.
After we receive the results, our next step is DV testing, and we'll compile the 510k submission. Once we have approval from the FDA, we’ll be ready for commercialization.
In other exciting news, physician inventor and board-certified plastic surgeon, Dr. David Kirn won the AIS (Aesthetic Innovation Summit) Shark Tank Competition in Vancouver, Canada on May 3rd! Orchid was entered in the Innovation Shark Tank with Early-Stage Companies with several other new technologies in development and won the vote! All of the feedback received endorsed the speed and simplicity of the device.
Dr. Matus Wins the RAB Startup Shark Tank Competition
One of our clients Dr. Ismael Matus, Director of Interventional Pulmonology at Christiana Care Health System, recently participated in the second International Congress on Robotic Assisted Bronchoscopy & Transbronchial Ablation Update. Dr. Matus’ device is in Phase 2 Refinement and Testing of our development timeline. Among the other devices presented, Dr. Matus’ won both voting categories – the audience vote and the independent shark vote. This is an amazing accomplishment for Dr. Matus, who dreamed up the innovation, and VitaTek as his development and manufacturing partner.
New Promotion: Client Appreciation Summer Series
From June 1st to August 31st, we are offering six different categories of services for free and we are accepting five applicants per category. The categories include Device Animations, Investor Profiles, Business Plans, Package Designs, Mold Flow Analysis, and a 10-Minute Regulatory Consultation.
We are committed to helping innovators achieve their development goals and experience a sample of the wide range of in-house services we offer. Don’t miss this opportunity to bring your ideas to life!
If you would like to discuss your medical device idea during a live one-on-one meeting, please book a time with our President of Sales, Matt Newman.
Events & Networking Opportunities
Jason Scherer Shares Business Insights on Sales Leadership Show
VitaTek CEO, Jason recently appeared on the Sales Leadership Show to share his approach to running the company and fostering a unified team culture. He discussed the importance of having a clear and memorable power statement to make a company stand out i.e., VitaTek being the only vertically integrated medical device company in the U.S. The episode provides an insightful look into Jason’s leadership style and the strategies that drive our growth and industry impact.
Listen to the episode here: https://podcasts.apple.com/us/podcast/jason-scherer-shares-what-is-working-today-in-b2b-sales/id1534428489?i=1000654429554
The Aesthetic Meeting, Vancouver, B.C.
Unlike other manufacturing and design conferences we’ve attended, this show connected us with medical device companies, and surgeons in the plastics/aesthetic space. Over the three-day event, we expanded the awareness of our OEM Brekka and StingRay devices, and explored new R&D/Manufacturing opportunities. This experience highlighted our ability to work with a diverse range of professionals, not just one specific type of client.
The 23rd Annual MedTech MVP Conference
We recently had the privilege of presenting at MedTech MVP, this conference is a gathering of medtech innovators, investors, and executives from across the country. Our President of R&D & Engineering Richard Thompson, and CEO Jason Scherer presented to over 300 attendees on our all-in-house business model. Leading companies like Medtronic, Boston Scientific, Mayo Clinic, and J&J Innovation attended the event and learned how VitaTek is disrupting the industry as the only vertically integrated medical device company in the U.S.
The Aesthetic Show in Las Vegas, June 28-30th
We will be attending The Aesthetic Show at the Wynn in Las Vegas from June 28-30th. Our sales and regulatory leadership team will be available at booth #243 to discuss development services and explore potential collaborations with medical device companies and physicians in the aesthetic space. This event is a great opportunity for healthcare and industry professionals to learn more about our vertically integrated approach and commitment to innovation.
If you would like to discuss your medical device idea during a live one-on-one meeting, please book a time with our President of Sales, Matt Newman.
We hope you enjoyed this edition of our quarterly newsletter. We look forward to sharing additional updates at the end of Q3! To learn more or to receive a quote for any of our services, please complete our online form at www.vitatek.io/contact or book a call with our President of Sales, Matt Newman.
Visit our socials for daily updates on device development and milestones: https://linktr.ee/vitatekmedical
Sincerely, VitaTek Marketing Team
why am I getting emails about this garbage????
I unsubscribed already