Why The Epidemic In Quality Failures And What MedTechs Can Learn
This article originally appeared in Forbes on November 8, 2024.
It seems every time you refresh your newsfeed, there’s another company grappling with quality issues. These incidents aren’t just appliances breaking down or smartphones malfunctioning; they’re failures in safety-critical industries where mistakes can have severe consequences, even costing lives. Many prominent companies, once considered benchmarks of reliability, are now in the spotlight for the wrong reasons.
Tesla continues to face many complaints, while Boeing, a former symbol of engineering excellence, is enduring blow after blow. Boeing’s annus horribilis started with the infamous door panel flying off mid-flight in January and continued with the malfunctioning thrusters, which is part of the reason two astronauts are stuck in space until February 2025.
Medical device recalls are soaring: 62 FDA recalls took place in 2023 with more than 80 flagged in 2024, with a growing number linked to software problems. Philips, for example, has faced multiple Class I recalls for their Trilogy Evo ventilators. The software in these devices, which are critical for patient ventilation, exhibited serious defects such as inaccurate oxygen readings and false power loss alarms, among others. Philips issued software fixes to address these potentially fatal errors following earlier recalls in 2023 of these same ventilators and CPAP devices.
These types of quality failures can be attributed to a mix of factors: technological challenges, companies cutting corners in the race to market and a weakening of leadership and organizational culture. In today’s tech-driven environment, the pressure to deliver innovations faster than ever has created an imbalance where speed is often prioritized over safety and quality.
