Medical Devices

Did you know that the invention of the very first electrocardiograms, external defibrillators, and implantable cardiac pacemakers may have been inspired by the story of Frankenstein? This monster may have helped save millions of lives. The late Medtronic founder, Earl Bakken, was intrigued when, as an eight-year-old child, he watched over and over Mary Shelley’s […]

If you have a novel idea, it makes sense to protect it. The term medical device covers any type of instrument used to diagnose, manage, or treat a medical condition. It’s a multi-billion-dollar industry covering everything from tongue depressors to insulin pumps and pacemakers. As the digital transformation shapes the future of healthcare, medical devices

The United States (US) Food and Drug Administration (FDA) mandates that medical device manufacturers must comply with quality management systems to guarantee consistency in their products and comply with any specifications or requirements. In the 1960s and 1970s, the US Congress responded to the public’s desire for more oversight over medical devices by eventually passing the Medical

“Oh no, we missed our primary clinical endpoint!” Do you have the courage to understand why? Fear kills more dreams than failure ever will. Learn three ways to salvage and redefine a new clinical strategy. Seeing the Primary Endpoint for the First Time A fever of enthusiasm spread as Kai-Lin, an employee and manager at Mythical Medical, looked

Introduction A perfect crime of clumsiness awaits those that stumble into hiring expert consultants. But be on the alert. They have the curse of knowledge, which can positively improve your organization. On the one hand, some may find hiring consultants to be complicated, unimaginative, and boring. On the other hand, it can be a simple,

A profound and eager hopefulness infects a medical device start-up staff. “No obstacle will be too big to conquer,” is heard during the weekly status meeting. The cold, hard, veiled fact is it is true for only a small group of funded start-ups. Let’s look at some numbers, set expectations, learn from successes, and search

What Is A Quality Management System (QMS)? That is a simple question and there is actually a simple answer. It is exactly what it sounds like. It is a formalized system that lets you define what quality means to your business. It is a simple way to make sure that your company is performing well and serving

The Long Path of Medical Device Biocompatibility Testing and Standards Created the Safest Medical Devices Today Science is the basis for developing standards. A Canadian medical historian, Jacalyn Duffin, recounted a story. In 1816, while examining a female patient with heart disease, Dr. René Laennec faced a conundrum: He needed to hear what was ailing

“Wait a minute. You want me to do what?” That was the first response from Kai Lin, an employee at Mythical Medical, after being asked by senior management to set up a system to proactively oversee “significant change” processes affected by MDR Article 120, Transitional Provision. She was convinced this would be a dead-end, career-limiting,