Regulatory

Should Medical Device Companies Pursue Regulatory Approvals in Europe Before the US? Interview with Marc Sanchez

In this interview with Marc Sanchez, we learn whether U.S. medical device companies should pursue regulatory approval in Europe first.

You May Like These Articles

  • Recent
  • Featured
  • Related

Key Mistakes to Avoid in Early-Stage Medical Device Development: Interview with Bob Paulson, CEO of VentureMed

In this conversation with Bob Paulson, CEO of VentureMed, he shares his vast medtech expertise, including capital fundraising tips, keys to early-stage medical device product development, and best practices when it comes to clinical evidence and insurance reimbursement.

How to Take Your Medtech Idea from Zero to One: Interview with Dr. Scott Wolf, Founder of Aerin Medical

In this interview with Dr. Scott Wolf, Founder of Aerin Medical, we break down the advantages of cash-pay versus insurance reimbursement, and get his advice for would-be founders hoping to turn a great medical device idea into a real prototype.

How to Transition from a Consumer Product to a Medical Device: Interview with Rohan Dixit, CEO of Lief Therapeutics

In this interview with Rohan Dixit, CEO of Lief Therapeutics, we discuss product development, how he approaches clinical research, and why they initially launched their device as an over-the-counter consumer product.

The Importance of Understanding Clinical Trial Design as a Medtech CEO: Interview with Nadim Yared, CEO of CVRx

In this interview with Nadim Yared, CEO of CVRx, we discuss his journey with the company, including Nadim’s expertise on clinical trial strategy, startup funding, and working with FDA & CMS.

Conquering the Coverage and Reimbursement Landscape: Interview with Bruce Shook, President of Intact Vascular

In this interview, Bruce Shook discusses medical device insurance coverage and reimbursement, as well as advice for other healthcare entrepreneurs that need to raise money.

Why Curiosity and Persistence are Crucial Characteristics for Medtech Entrepreneurs: Interview with the Legendary Dr. John Simpson, Executive Chairman of Avinger

In this interview, the legendary Dr. John Simpson shares what drew him to the field of cardiology, his approach to building a medtech team, and why knowing your strengths and limitations is key to making a difference in the lives of others.

After Selling 2 Cardiovascular Companies for Over $1 Billion, Duke Rohlen is Now Hoping to do the Same with Spirox and Advanced Cardiac Therapeutics

In this interview with Duke Rohen, he discusses how he successfully led two early-stage medtech companies at the same time and the major lessons he learned raising money for 4 different medical device companies.

Having a Heart Attack? There’s an App for That! The Incredible Story of How Dr. David Albert Brought the ECG iPhone App to Market

In this interview with Dr. David Albert, we learn about his incredible journey in bringing the first iPhone ECG app to market with AliveCor.

Clinical Trials as Revenue Drivers: Interview with Matthew Amsden, CEO of ProofPilot

In this discussion with Matthew Amsden, learn about the importance and feasibility of virtual clinical trials, how they can potentially become a revenue driver, the origin story of ProofPilot, and why their hybrid model is so popular.

How Remote Testing Can Change the Game for Patients and Clinicians: Interview with Katherine Ward of Healthy.io

In this conversation with Katherine Ward, we cover what Healthy.io does for the broader healthcare community, lessons from the COVID-19 crisis, and the value of decentralized remote diagnostic screening.

Is Off-Label Promotion Now Legal: What the Recent Criminal Case Against Vascular Solutions Means for Medtech

In this interview, Mark Duval discusses why the government's focus on speech vs. conduct is important when it comes to medical device off-label promotion.

Social Media Best Practices for Marketing Medical Devices: Interview with Dr. Mukesh Kumar

In this interview with Dr. Mukesh Kumar, we learn about common misconceptions around the use of social media to market and sell FDA-regulated medical devices.

Success! Your membership is now active.