MedTech Business Review: Specials Magazine

What role does technical education play in medical device engineering performance improvement? Design Quality Services (DQS) exists to help medical device professionals perform their jobs more effectively by providing tools and technical development support. That focus is sharper now than ever. After years of hands-on consulting across design controls, risk management and usability engineering, DQS is deliberately shifting toward technical education, which it sees as a more lasting way to impact how devices are built and how project teams perform. As DQS puts it: “Knowledge is the shortest path between ingenuity and impact.” Its consulting practice supports development programs across the full lifecycle, from early-stage planning through FDA or notified body submissions and continues into post-market work when products already in use begin to show weaknesses. This experience heavily influences the educational content they provide. “I want to sharpen technical talent,” says John Salvato, Ph.D., Founder & President. “I want to enhance the tools in every technical person’s toolbox so when they go and create their next design, they’re doing it from a stronger position, with deeper capability and knowledge, meaning shorter development, with a more successful submission outcome.”

Every minute, someone in the U.S. experiences an out-of-hospital sudden cardiac arrest (OHSCA). It is our largest natural cause of death, and sadly, national OHSCA survival rates have remained stagnant for decades at less than 10 percent. Survival is a race against time. While administering CPR is critical to move blood to the brain and vital organs, the only cure is a ‘shock’ from an automated external defibrillator (AED) within minutes. In fact, survival rates can skyrocket to over 70 percent if CPR is administered and an AED is used within three minutes. But, as heroic as fire or emergency medical services (EMS) responders are, they take on average 8 to 12 minutes to arrive—simply too long for most victims. This is the urgency that SaveHeart by HeartNation addresses. It’s highly visible, all-weather, temperature regulated, 24x7 monitored cabinets bring essential life-saving technology directly to the public. Cabinets are placed outdoors wherever people gather- parks, athletic fields, schools, town centers, trails, pools, etc.—empowering bystanders to act immediately after an OHSCA emergency before professional first responders arrive. “EMS leaders are increasingly operating with a community care mindset. They see our outdoor AED cabinets as an extension of their response strategy,” says Dave Fritzsche, founder and CEO. “People notice SaveHeart’s attractive back-lit cabinets initially and remember them during a crisis.” Each smart-monitored cabinet is equipped with advanced sensors to ensure the lifesaving AED inside is always ready. Real-time alerts are sent to designated responders when the door is opened and the AED is accessed, accelerating coordination and response. Built-in ventilation systems and integrated heating elements maintain the AED’s optimal temperature, and the protected enclosure safeguards against moisture, temperature swings and environmental exposure—common culprits that degrade batteries, damage electrodes or compromise emergency functionality. Despite their sophistication, SaveHeart cabinets are remarkably easy to install, with comprehensive installation guides and a pre-wired set-up. Customers can access, view and manage cabinets in an intuitive cloud-based portal, providing real-time visibility and historical records for all aspects of their AED program, whether they have one cabinet or many across several locations.