MedTech Outlook Magazine: Specials Magazine

How are health systems modernizing healthcare technology management for distributed care environments? Health systems face increasing pressure to manage more devices across more care settings, often with fewer resources and rising cybersecurity risk. Traditional HTM models have struggled to keep pace, remaining reactive, hospital-centric and constrained by siloed data. Healthcare technology portfolios now span ambulatory centers, imaging suites, hospitals and specialty clinics — creating a distributed oversight challenge. Devices exchange data, connect to networks and require continuous cybersecurity monitoring. Maintaining visibility, performance and protection across this expanding footprint presents a growing operational responsibility for healthcare administrators. For many hospitals and large health systems, the strain is tangible. The focus has moved beyond maintaining equipment to understanding how healthcare technology management strengthens processes, creates labor efficiencies, and supports better asset management across every site. As Compass Healthcare’s signature HTM solution, the team behind Intelas has long delivered an intelligent, data-driven asset management approach that provides real-time visibility, smarter asset planning and proactive service at system scale. Anchored on a connected technology ecosystem, this approach centralizes oversight and improves financial predictability. Administrators gain clear control across care environments, clinicians experience fewer interruptions, downtime declines and capital decisions become more informed and deliberate. Though the scale and sophistication were already in place, the existing identity did not reflect what the work had become or make its value clear to healthcare leaders. The rebrand to Intelas aligned identity with capability — emphasizing the intelligence behind the model. “We bring clarity, connection, and smart decision-making to complicated medical technology environments,” says Jim Cheek, president of Intelas. “We needed a brand that conveyed what we do.”

Why has cybersecurity become a decisive factor in medical device regulatory clearance? For years, medical device manufacturers could get a product through regulatory review with minimal cybersecurity evidence. Cybersecurity mattered, but it often wasn’t the deciding factor in whether a device could enter the market. That has changed. Today in the U.S., cybersecurity is mandated as part of FDA clearance. And globally, regulators are moving in the same direction. If you can’t demonstrate that you’ve designed cybersecurity into the product and validated it with defensible evidence, your submission can get delayed or rejected. When that happens, the impact includes lost revenue, burned runway, frustrated engineering teams, and often, a difficult conversation with investors about why the timeline just moved. Christian Espinosa, Founder and CEO of Blue Goat Cyber, has seen companies get caught off guard by this shift. Sometimes they don’t take cybersecurity seriously until they watch a peer’s submission get rejected for missing or weak cybersecurity content. Other times, they assume it’s mostly about protecting data, and they miss what regulators are really evaluating: patient safety. That’s where Blue Goat Cyber comes in. They treat cybersecurity as regulated infrastructure, and a key determination of whether a device reaches the market and whether clinicians can trust it once it’s deployed. “We’re not looking at cybersecurity as a paperwork exercise,” says Espinosa. “It’s patient safety. If a device can’t be trusted in real clinical workflows, that’s not a technical issue. It’s a patient safety issue.” Cybersecurity Isn’t Just Data Protection Why does medical device cybersecurity extend far beyond protecting sensitive data? One of the biggest misconceptions Espinosa still hears is that medical device cybersecurity is mainly about protecting sensitive data, such as patient health records, protected health information (PHI) and credit card numbers. Data protection matters, but when it comes to medical devices, it’s not the primary lens. If someone can compromise an implanted defibrillator, a drug infusion pump or a surgical robot, the consequence isn’t a data breach. The consequence can be patient harm. That’s why regulators are raising expectations, and why cybersecurity gaps are increasingly tied to recalls, not just compliance findings. The industry is starting to connect those dots, but it’s still not understood as widely as it should be..

What risks exist in trocar port-site closure during minimally invasive surgical procedures? New Wave Endo-Surgical is solving one of minimally invasive surgery’s (MIS) most persistent and under-engineered risks— safe trocar port-site closure from inside the abdomen to prevent long-term complications like hernias and immediate catastrophic injuries. These small incisions, essential for laparoscopic and robotic procedures, are notoriously difficult to seal. Surgeons have to navigate with limited visualization, risking severe injuries like bowel perforations, visceral organ injuries, and vascular damage, issues that often go undetected during the operation especially at the procedure’s end when teams are fatigued. This problem struck a chord with Alexander Gomez, CEO of New Wave Endo-Surgical, whose journey began with a personal invention, a defogging device used in millions of procedures worldwide. After selling that business to Medtronic, Gomez dedicated himself to working with medical professionals with innovative ideas. One such innovator was Dr. Manoj Patel, a passionate urologist who identified flaws in existing closure methods. Tragically, Dr. Patel was diagnosed with leukemia at 48 and passed away within a year, leaving his concept unfinished. Moved by Patel’s vision to prevent patient suffering, Gomez reassembled his team to bring it to life, founding New Wave Endo-Surgical to deliver technologies that improve outcomes, reduce complications, and eliminate unnecessary postoperative opioid use. From Blind Closure to Controlled Closure How does the M-Close Kit improve safety and precision in trocar closure procedures? The flagship product, M-Close Kit, born from Dr. Patel’s insights, is a tube-like device inserted through the port site after trocar removal. It deploys protective wings inside the abdomen, shielding organs from harm. The needles remain concealed throughout, allowing precise fascia penetration on both sides. Gomez emphasizes that this eliminates the trade-off; patients no longer choose between hernia prevention and injury risk. The process is repeatable and efficient, enabling quick suture placement even by trainees. A perfect example is in obese patients, where traditional needles are nearly impossible to control. Bariatric and pediatric surgeons previously struggled, leading to inadequate closures and increased complications. With M-Close, even residents achieve reliable results, including extreme bariatric cases; closures that were once unfeasible now prevent hernias without added risk. .