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MedCity Influencers

CE mark or FDA approval? Medical device professionals weigh in

With the ever-increasing stringency, time, and expense associated with FDA approval for medical devices, debate is sharpening in the medical devices industry over whether it is actually better business strategy to prioritize getting a CE mark for your product. This article gives an overview of a recent iteration of a robust debate within the Medical […]

MedCity Influencers

How to stay current and connected in the medical device industry

Sharing best practices. Bridging knowledge. Identifying resources. Providing access to expertise. Is all of this possible within the medical device space? Answer: it can be! In this interview with Frank Jaskulke and Ryan Baird, we learn how LifeScience Alley is helping its members build and sustain their medical device careers and respective organizations. INTERVIEW HIGHLIGHTS […]

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

MedCity Influencers

Forget the FDA and launch your medical device in the UK

Why do some many medical device companies struggle when trying to launch their products in the UK? Michael Branagan-Harris has some answers. Before starting Device Access UK Ltd., Michael set up VNUS Medical Technologies UK in 2006, a subsidiary of VNUS Inc. (acquired by Covidien in 2009). With a small sales team, Michael grew it into […]

MedCity Influencers

How to enhance your medical device approval process

We all know relationships matter.  They matter at work.  They matter at home.  But are relationships important when it comes to getting medical devices approved through the FDA? Beyond relationships, what else matters when it comes to improving the medical device regulatory process? In this interview with Sheila Hemeon-Heyer, President of Heyer Regulatory Solutions, we […]

Health IT

Can social healthcare replace clinical trials?

Every day, data is lost between the clinician-patient interaction. Given the fact that physicians under report over 50% of the symptoms and side effects their patients experience, this is a significant amount of information. This is data that could otherwise be used to formulate new pharmaceutical drugs or design innovative medical devices. In this interview […]

MedCity Influencers

Fuelling Business Decisions for Medical Device Companies

Do you know what the real-time market share of your medical device is?  Or what about this: Which hospitals are performing the procedures where your medical device is used the most? Perhaps better yet, where are the facilities that will have the largest procedure volume growth? Okay, enough of the questions.  How about some answers. […]

MedCity Influencers

How to Adapt within the Changing Healthcare Landscape

Have you heard of the OODA cycle?  Okay, neither had I before my conversation with Arun Ranchod.  What if more medical device companies adopted principles from the OODA cycle? Could this be the single most important factor in successfully maneuvering through today’s rapidly changing healthcare landscape?  If you’re interested in a heavy dose of wisdom, […]

MedCity Influencers

The Ugly Truth about Scrubs and Lab Coats

According to the U.S. Center for Disease Control and Prevention, nearly 1.7 million hopsital-acquired infections occur every year. The result: 100,000 unnecessary deaths and an extra $6.5 billion in healthcare costs per year.  In this interview with Dr. Charles Kinder, we learn how his company, Doc Froc, is trying to reduce those numbers through unique […]

MedCity Influencers

The Secrets of Effective Medical Device Sales Training

Can you measure the ROI of medical device sales training? Mark Wilson is the Director of Training and Development for Advanced Biohealing. In this interview, he tells us why medical device sales training is vastly underrated and why you should be paying closer attention to it. INTERVIEW HIGHLIGHTS WITH MARK WILSON The importance of immersing […]

MedCity Influencers

There Has to be a Better Way

Dr. Michael Rosenberg, an Interventional Radiologist at the University of Minnesota, had seen enough. Yet another catheter had pulled out accidentally from one of his patients. To solve this problem, Dr. Rosenberg would then have to re-insert the catheter and secure it in place with sutures. In order to alleviate this burden, he invented what […]