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The Vitals: Issue 001

Updated: Oct 25


"The Vitals" by VitaTek

Connected Devices Ready to Help Battle Chronic Diseases

Connected Devices Ready to Help Battle Chronic Diseases


Chronic illness is on the rise (Medical Economics), and Bluetooth-connected devices are fighting back by empowering providers to monitor their patients' health from home. Medistante Hub introduced a cellular Internet of Things (IoT) system that overcomes Bluetooth’s connectivity and security issues for 24/7 surveillance.

VitaTek POV: Make sure your engineering teams are ready to address the growing need for these devices and understand the tradeoffs to something like Bluetooth technology vs. cellular/IOT-connected devices.


At VitaTek, our engineers have the expertise to work on connected device projects. We use Phase 0, the exploration phase of development, to help our clients understand the tradeoffs to the different technologies that can be used in a device.


 

AI vs FDA: Is Faster Really Possible?

AI vs FDA: Is Faster Really Possible?



In response, they’ve introduced a Predetermined Change Control Plan, allowing certain software updates to bypass the lengthy regulatory approval process.


VitaTek POV: Our CEO Jason Scherer, however, isn’t buying it. Scherer suggests that the key to speeding up the process lies in having an in-house regulatory team. Unless you line up as a breakthrough device, the FDA only works at one speed. Our regulatory experts are deeply involved in our clients' projects. The submission and approval process is 70% faster and 70% cheaper than the industry standard, as we do not rely on third-party regulatory consultants.



 

The Problem with EO Sterilization Regulations & VitaTek's Solution

The Problem with EO Sterilization Regulations & VitaTek's Solution


Problem: The EPA’s new mandate (The Minnesota Star Tribune) is shaking up the medical device industry, forcing companies to cut their use of ethylene oxide - the go-to sterilization method for nearly half of all medical devices.


Solution: Big sterilization companies are scrambling to manage their ethylene oxide emissions. Medical device companies, big and small, may face major delays.


Meanwhile, VitaTek's approach of using 3M GS8X sterilizers meets all future EPA, OSHA and FDA regulations. We can complete a full sterilization validation in one month and regular small batch routine runs in 2-3 days.


Result: VitaTek helps you stay one step ahead of regulations so your project needs are met without delays.


Have a Sterilization related need or question? Contact us today.



 

UX: The Heartbeat of Medical Device Design

UX: The Heartbeat of Medical Device Design


User experience (MedCity News) should always be at the heart of medical device design. UX-driven devices are not only safer and more efficient, but they also improve patient outcomes and provide cost-effective solutions. This approach catches issues and allows for adaptations early in development.


VitaTek's POV: UX is always a primary focus of our projects. Through weekly meetings with inventors and regular user testing, we collect feedback to refine our designs, always keeping the end user in mind.


 

The Boom of Implantable Medical Devices

The Boom of Implantable Medical Devices


The implantable medical devices market (Prophecy Market Insight) is surging at a 7.2% annual growth rate, putting it on pace to grow from $98.6 Billion in 2022 to $166.3 Billion 10 years later in 2032.

This expansion is driven by:

  • An aging population

  • The increase in chronic diseases

  • The lingering effects of COVID-19

  • Technological advancements

  • The industry's focus is on developing personalized treatments for a better, longer life.


VitaTek's POV: Our engineering team is ready for this booming trend. We are currently working with a company to develop a new implantable device, which is currently in the regulatory stage of development.

 

Another Shop Bites the Dust

Another Shop Bites the Dust


Carestream's Windsor, Colorado (Carestream) manufacturing site is closing and laying off over 200 employees.


This isn’t uncommon in the industry, MedTech Dive reported the medical technology sector already cut thousands of jobs in the first two months of 2024 alone and shops are constantly shutting down due to low margins and an expensive business model.


VitaTek POV: How does VitaTek plan to keep doors open?


We don’t limit ourselves.


Our unique business model is diversified through multiple business verticals by bringing everything in-house:

  • Weekly Rapid Prototyping

  • R&D

  • Hydrophilic Coating

  • Regulatory

  • Die Mold & Tooling

  • Balloons (coming soon)

  • Catheters (coming soon)

  • QMS (Quality Management System)

  • Contract Manufacturing

  • Sterilization

  • Packaging & Labeling

  • Warehousing/Distribution/Order Fulfillment

  • Merchant Services

  • Marketing

  • Medical Device Sales Team



 

Catching up with VitaTeK

Plastic Surgery the Meeting

Plastic Surgery the Meeting


Medical device inventors, join us for a one-hour webinar and Q&A on the Top 3 Pitfalls of Medical Device R&D. VitaTek President of Engineering & R&D, Richard Thompson will walk you through what to watch for and how to identify these project-halting pitfalls based on his industry experiences of 25+ successful products across the last 24 years!

Come prepared with your personal questions for the Q&A portion of the webinar and register today.


Thursday, August 29th, 1PM EST / 12PM CST / 11AM MST / 10AM PST






 


Glide into Savings with VitaCoat

Glide into Savings with VitaCoat


VitaCoat offers hydrophilic coating at an unbeatable price of $750 per liter.


Our expert team specializes in custom engineering and reformulation runs, tailoring solutions for medical devices, such as catheters, guidewires, stents, and plastics - and we do it for 70% less than the current market is charging.


Contact us for a free consultation on your customized formulation today.

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