Ask a medical device engineer if their product is FDA “approved,” and you might see them twitch. That’s because, in FDA-land, ‘approved’ and ‘cleared’ aren’t synonymous. They’re different regulatory universes. Mix them up in a submission or investor meeting, and you’re not just in for some awkward course corrections, but also potential delays and misunderstandings […]
Cleared vs. Approved: What Does the FDA Mean? Read More »
Developing a medical device is no walk in the park. It’s more like a hike through regulatory mountains, clinical valleys, and a few budget cliffs. The path from concept to FDA clearance is notoriously complex. However, computational modeling is the relief, the beacon of hope that innovative companies are using to navigate this complexity, reaching
Simulation has always been an engineer’s best friend. Now, it’s becoming a regulatory ally, too. From the FDA to the EMA, agencies are increasingly open to in silico evidence to support design validation, safety assessment, and performance claims for medical devices. If you’re using COMSOL Multiphysics, you’re sitting on a mountain of valuable, submission-ready data,
Simulations That Stick: How In Silico Evidence Is Winning Over Regulators Read More »
Over the past two decades, I have attended the COMSOL Conference, presented technical sessions, taught workshops, and participated in panel discussions alongside some of the brightest minds in multiphysics modeling. But this year marks a first for me. Not only is AltaSim Technologies returning as a Platinum Sponsor of this year’s conference in Boston, but
Creating Knowledge with COMSOL: A Preview of My Keynote at the 2025 COMSOL Conference Read More »
Every year, hundreds of thousands of people in the U.S. undergo life-changing knee replacement surgeries. These procedures, while meant to restore mobility and ease chronic pain, can lead to a postoperative battle with infections, particularly those surrounding metal implants. These infections remain one of the most serious and urgent complications. Traditionally, treatment involves invasive revision
Revolutionizing Post-Surgical Infection Treatment with Multiphysics Simulation Read More »
Sterility is everything in the OR, and orthopedic implants are no exception. Whether it’s a hip prosthesis, spinal rod, or knee replacement, even a microscopic contaminant can lead to infection, inflammation, or rejection. Enter laser ablation: a precise, residue-free sterilization technique gaining traction for orthopedic components. And COMSOL, a leading simulation software, is playing a
Clean Implants, Zero Residue: Laser Ablation for Orthopedic Sterilization Read More »
Pacemakers have long been a marvel of medical engineering, but for decades, they had one fatal flaw: MRI machines. Strong magnetic fields and radiofrequency (RF) energy can heat leads, distort images, or cause dangerous malfunctions. That’s no longer acceptable. Today, engineers must design pacemakers to be MRI-safe, and simulation is their most powerful tool. The
Heart of the System: Designing MRI-Compatible Pacemakers Using Simulation Read More »
Automatic dosing isn’t just about saving time; it’s about saving lives with unparalleled precision and safety. From insulin delivery to chemotherapy to hormone therapy, closed-loop systems are bringing precision medicine to the bedside and beyond. And it’s simulation that plays a crucial role in validating these systems, ensuring their safety and efficacy. Closed-Loop 101 In
Smarter Systems: Automatic Dosing in Closed-Loop Therapies Read More »
When creating something built to last, it is imperative to have the right tool for the job. A four-year-old once told me that while wearing a Fisher-Price Tool Belt and helping his grandpa sand his grandma’s kitchen worktop. It was sage advice then, and it is sage advice now. Having the right tool for the
Insulin pumps have come a long way from pager-sized clunkers. Today’s designs are slim, smart, and powered by microliters, not milliliters. At the core? Microfluidics, the epitome of precision in insulin delivery. Engineers using COMSOL Multiphysics are not just using simulation, they are leveraging it to perfect fluid dynamics, sensor integration, and closed-loop control in
Mini, Mighty, Precis: Microfluidics and the Evolution of Insulin Pumps Read More »