The Vitals: Exactech Lawsuit, Clinical Trial Diversity, & A New Remote Innovation

Featured Innovation: BioButton Remote Cardiac Device Cuts Hospital Times & Improves Patient Outcomes

BioInteliSense has introduced a new remote cardiac device that has been proven to cut hospital times, enhance early detection, and increase positive outcomes (Medical Device Network). According to a study published in the Journal of Clinical Medicine, the BioButton reduced 12,000 patients’ hospital time from 3.07 days to 2.75 days over 12 months. 

BioButton can also detect first vital signs 14.8 hours before a deterioration event which can be critical when addressing a serious adverse event. The device continuously measures heart and respiratory rate at rest, skin temperature, and activity levels, adding up to 1,440 measurements per patient per day.

President of Sales Matt Newman POV: I see tremendous potential for devices like the BioButton in reshaping how we approach patient care. Sales teams thrive when they can bring innovative, data-driven solutions to market—especially ones that show clear benefits like reducing hospital stays and improving early detection. 

The ability to deliver measurable outcomes, such as detecting critical changes nearly 15 hours in advance, is a game-changer for healthcare providers and patients alike. Devices like this set a new benchmark for what we aim to deliver at VitaTek: cutting-edge, patient-centric technology that addresses real-world challenges and drives positive outcomes.

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Exactech Files Bankruptcy Due to Sweeping Recall of Knee Implants

Exactech, a leading joint replacement implant manufacturer, is caught in a major recall lawsuit due to defects in their knee implants (Lawsuit Information Center). The knee implants caused acute pain and patients were required to have revision surgery to replace the implant.

As of December 2024, there are 1,839 pending lawsuit cases reported, and Exactech has now filed for bankruptcy.

CEO Jason Scherer POV: This situation with Exactech underscores the immense responsibility we bear as medical device manufacturers. A single oversight can have devastating consequences for patients and ripple effects throughout a business. 

At VitaTek, we are relentless in our pursuit of quality and patient safety. Our in-house manufacturing and regulatory experts prioritize rigorous testing protocols and comprehensive risk management strategies to ensure our devices exceed industry standards. While innovation is our driving force, trust and reliability are the foundation of our success.

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The Need for More Diversity in Medical Device Development Trials

According to the International Consortium of Investigative Journalists' "Implant Files" 83,000 deaths and 1.7 million injuries globally have been linked to inadequate medical device testing. 

One significant issue is the lack of diversity in clinical trials, which often excludes women, ethnic minorities, elderly patients, and those with rare conditions. This underrepresentation can lead to device failures and adverse outcomes once products reach the broader market. 

To address this concern, a new approach referred to as in silico trials (ISTs) allows for the use of virtual patients, or “digital twins” (Yorkshire Times). This technology combines characteristics from multiple real patients to reflect the full spectrum of users of a given device.

Regulatory Specialist Spandana Kaki POV: For FDA approval, integrating ISTs could mean a shift towards more robust, inclusive pre-market evaluations. Such advances may strengthen regulatory confidence, accelerate approval timelines, and mitigate post-market safety issues. 

By embracing ISTs, the industry can set a new benchmark for equity, innovation, and patient-centered device development.

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Join Us at the Florida Plastic Surgery Forum

One more event! We will be attending our last conference of the year at the Florida Plastic Surgery Forum from December 12-15th. 

Meet up with VitaTek Avengers Holly, Patrick, Frankie, and Luke to learn more about our two plastic surgery OEM devices, the Brekka 2-in-1 Implant Delivery Device and the StingRay Implant Placement Device. 

For those attending don’t miss our friend and device partner Dr. Joe Gryskiewicz, board certified by the American Board of Plastic Surgery and inventor of the Stingray Implant Delivery System, for his Saturday Keynote Session, “Beauty May Be Only Skin Deep, But for Most People, That’s Deep Enough.”