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The Vitals 004 - Human Factors, Supply Shortages, & Regulatory Answers

Updated: Oct 25



Human Factors Drive the Future of Medical Devices


The human factors and usability engineering services market, valued at USD 0.94 billion in 2024, is expected to grow at a 6.9% CAGR through 2035. 


A 15% increase in medical device recalls in early 2024, driven by user errors in design, training, and improper use, highlights the need for human factors engineering to ensure regulatory compliance and minimize errors. This demand is fueling the growth of outsourced services in the medical device industry.


VitaTek POV: Human factors and usability are at the forefront of our design process. Our in-house engineering and regulatory teams collaborate from the start to make user-centered design decisions that ensure compliance with FDA regulations, minimizing the need for costly revisions and delays. 


We routinely conduct formative and summative usability studies to ensure compliance with IEC 62366 and ISO 14971 for our history files and FDA submissions. 


Additionally, our engineering team regularly visits the OR to conduct their own testing on new device projects—a practice that’s exceedingly rare in the industry. 


This hands-on approach, combined with our close collaboration with physician inventors through our weekly meetings, ensures that every design choice is thoroughly vetted and optimized for real-world use.


 

Tackling Supply Shortages Head-On in Response to Hurricane Helene


In response to U.S. IV fluid and peritoneal dialysis product shortages caused by Hurricane Helene, Fresenius Medical Care is boosting production and implementing supply management strategies. 


Other manufacturers like B. Braun are also increasing production to address the disruption, with both companies coordinating with government agencies.


VitaTek POV: We understand that supply chain resilience is crucial, especially during times of crisis. We are always dual-sourced across our supply chain, ensuring that we can respond immediately to disruptions like the ones recently caused by Hurricanes Helene and Milton. 


Our diversified approach allows us to continue delivering critical medical products without delays, even when facing industry-wide challenges.


 

RIO Paves the Way for Global MedTech Innovation


The UK government has launched the Regulatory Innovation Office (RIO) to reduce red tape and speed up access to new technologies, including AI systems. 


The initiative aims to streamline regulations and accelerate approvals, supporting businesses and regulators in pushing for updated rules and faster technology rollouts.


VitaTek POV: As a company focused on international growth, we see the launch of the Regulatory Innovation Office as a positive step toward making global expansion easier for MedTech companies. 


We have our own plans for international growth in the near future. With faster access to new markets and technologies, VitaTek can continue to innovate and reach more patients around the world. 


Stay tuned to see what we do next in the global medical device industry!


 

Join us for a one-hour live workshop and Q&A as we guide you through the Top 3 Regulatory Hurdles in Medical Device Development.


VitaTek Senior Regulatory Specialist Ken Meyer will walk you through the most common hurdles when it comes to getting your medical device through the regulatory process - bring your toughest questions you didn’t want to have to pay a regulatory consultant to answer!


The workshop will consist of a short presentation on the most common hurdles and leave at least 30-min for the Q&A session.


Tuesday, October 29th


3PM EST / 2PM CST / 1PM MST / 12PM PST



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stop overcharging customers for regulatory affairs and pay your engineers. expanding into the EU, while using former employee's plans and not giving the credit. now bro is fighting with Brighton Ashford, when vitatek is the one cheating its customers.

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