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 frustration has risen with teams and employees spread across geographical locations. In fact, 33% of […]
Decrease Overwhelm Increase Efficiency Read More »
News & Blog
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 Group celebrates Dr. Shi through highlighting his journey with Project Hope and the platform technology
Honoring Dr. Wenyin Shi Read More »
News & Blog, Project Hope
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 the field of thermobrachytherapy. Paul Stauffer and Thermobrachytherapy Paul Stauffer began his research over 40
Paul Stauffer Pioneer in Oncology Read More »
News & Blog, Project Hope
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 device” more often than not. As such, two options exist for unique devices with no
Denovo: A Path for Novel Devices Read More »
News & Blog
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 the health and medical device industry, thinking outside the box as a service provider matters.
Being Different Makes a Difference Read More »
News & Blog
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 get out of overwhelm. The burden of trying to do more and be more. There
MAE Group Gets You Out of Overwhelm Read More »
About Us, News & Blog
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 Cybersecurity in MedTech Hospitals need medical devices to connect to hospital networks and the Internet
Medtech and Cyber-Security Risks Read More »
News & Blog, Resources
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, summits, and professional training. The Marcus Evans Medical Device Summit leads the industry in providing
Summit Offers MAE Group Opportunities to Expand its Vision Read More »
News & BlogTruth 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 to prevent and mitigate them. In short, this article outlines the top mistakes made by
Top Mistakes Made by Startups Read More »
News & Blog
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 part of the Safe Medical Devices Act, the DHF contains all the product development documentation
What is a Design History File? Read More »
News & Blog, Resources