Medical Devices

“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,

Sharing information and insights internally from either regulatory agencies or Notified Bodies is healthy behavior. Knowledge is power, several believe. It can change the world, your company, and your personal leadership behavior, but only when it is communicated in a timely manner and shared in the right ways. Break out of your self-imposed jail today.

The coronavirus pandemic is causing hiring uncertainties. It may become more difficult to conduct face-to-face hiring interviews. Also, laws, regulations, standards, and guidance documents are changing worldwide. Expectations are, too. Yet an encouraging, long-standing, and reassuring truth remains that can help with these challenges. Identify specific, key qualifications so that your team can be strengthened.

Benefit-to-Risk Analyses Some things make sense. They are easy, balanced, symmetrical, and predictable. That’s why Jae, an employee at Mythical Medical, liked mathematics, engineering, chemical reactions, and physics. Rules or laws are in place, and, for the most part, you follow them. Equations made sense, and he loved them. He also joined a debate club because