How to Boost Your Chances for Biocompatibility Approval
The FDA has introduced a draft guidance to help medical device developers simplify chemical analysis for biocompatibility testing.
By breaking down complex processes and offering alternatives to animal testing, the guidance aims to make biocompatibility assessments more consistent and reliable.
Senior Regulatory Specialist Ken Meyer POV: Tick, Tick, Tick...
Speed to market can be hampered by many things; among them is waiting for biocompatibility test results.
With this draft guidance, the FDA offers promise that in some situations, chemical characterization can reliably be used to address some risks during biocompatibility evaluation.
Medical device developers: This is a welcomed new guide that should be kept in mind as you strategize and execute your biocompatibility assessment.
3G Shutdown: Is Your Medical Device At Risk?
If you use older devices like pacemakers, CPAP machines, and wearable monitors, you may be impacted by recent 3G network shutdown.
Relying solely on 3G network can be risky, which is why device developers have the responsibility to use the latest and greatest technologies.
President of R&D and Engineering Rich Thompson POV: At VitaTek, we take the development of our medical products with wireless technologies very seriously.
We adhere to the latest industry standards, ensuring our designs prioritize safety through a comprehensive risk mitigation strategy.
You can't predict what will go wrong, but we look for redundant systems whenever possible to safeguard against potential risks and ensure reliable, fail-safe devices.
Featured Innovation: THINK Surgical’s Miniature Robotic System
THINK Surgical’s TMINI® Miniature Robotic System just earned top honors at the 2024 Medical Device Excellence Awards for Innovation and Product Launches.
This first-of-its-kind, handheld, wireless robot offers unmatched precision in knee surgery, allowing surgeons to make real-time adjustments while choosing from a broad range of implants.
CEO Jason Scherer’s POV: Medical devices are evolving everyday with the newest technology. The competition in the field is hot for innovative, high tech devices.
VitaTek is not an exception. The devices we develop are all groundbreaking with the newest technology to improve user and patient experience.
VitaCoat on Chamfr: A Better Way to Purchase Hydrophilic Coating
RVP of Sales Kristian Killian POV: For far too long many companies have made it way too difficult for knowledgeable engineers to source their medical device component needs effectively and efficiently.
Chamfr offers a one-stop marketplace where independent manufacturers and buyers can find each other instantly. By placing VitaCoat, an open-source UV hydrophilic coating, on Chamfr, VitaTek is disrupting the standard business model.
MTA's and secrets are not an efficient way to allow engineers developing devices to change patient care. Providing them with the knowledge and tools to do their jobs is essential.
VitaCoat is just one way that VitaTek is changing the medical device development arena for the better. There is a better way.
Keeping the Vampires Away At MEDICA Düsseldorf
We made a huge splash at MEDICA in Düsseldorf, Germany!
Our free garlic (perfect for keeping the “vampire consultants” away) drew lots of interest, and we connected with many innovators looking to bring their devices to market faster.
Next up is our final conference of 2024! Holly, Patrick, Frankie, and Luke will be in Palm Beach, FL, from December 12-14 for FSPS.
Be sure to stop by for a rundown on the Brekka 2-in-1 device!
Jason Scherer is a two faced scumbag who will try to sleep with your wife and take your money but never deliver any products.
this company is horrible and is unable to deliver any products
horrible company who only wants to steal your money and never deliver your products. Jason, Matt, Frankie, and Holly are all lying scum who need to be sued.
Your free garlic did not draw lots of interest, and people were laughing at you. You idiots do not understand Germans.
Is Jason Scherer ever going to treat his employees like humans and actually pay them???