Concise communications management is essential due to the fact that the pandemic irrevocably changed the way people work and communicate. As an example, people working remotely increased from 29% before the pandemic to 57% post pandemic. Subsequently, communication issues and…
Recently, Dr. Wenyin Shi, an integral member of Project Hope’s Advisory Team, received the 2021 Sidney Kimmel Medical College Outstanding Clinician Award. The Kimmel award honors physicians distinguished in the evidence-based, clinical practice of medicine in the doctor-patient relationship. MAE…
To be a pioneer means to “develop or be the first to use or apply (a new method, area of knowledge, or activity)”. As such, Paul Stauffer, an essential part of Project Hope‘s Advisory Team, is truly a pioneer in…
There are many reasons the FDA’s De Novo applications grow monthly. Simply put, the more innovation in the medical field, the more distinct new medical devices become compared to what has come before. And “more distinct” means “no obvious predicate…
Being different makes a difference. That’s why I began MAE Group, to use my own outside-the-box thinking to help others bring life-saving devices into the world. In other words, bring purpose into my business. In the climate of innovation in…
First, being a key decision maker and leader in any company becomes a challenge when you don’t have the bandwidth. Whether it’s an expansion of tasks due to company growth or new demands on your own time, you need to…
The need for the medical device industry to consider cybersecurity risks grows exponentially every year. In short, every company of any size risks ransomware attacks. However, it’s the products of medtech companies specifically that require more attention. The Need for…
MAE Group’s CEO Janet Kwiatkowski and Jay Wigley, Manager of QA and RA participated in one of the premiere summits in the medical device industry. For over twenty-five years the Marcus Evans Group has provided the world’s leading organizations conferences,…
Truth be told, medical device startups make preventable mistakes. Learn first how to avoid the common mistakes mitigating disaster, saving time, and preventing costly delays. This article breaks down why medical device startups make these mistakes. Then, we’ll outline how…
Why Do You Need a Design History File? In short, the FDA requires a Design History File (DHF) as part of the application and marketing process for medical device manufacturers. First required by the United States FDA in 1990 as…