Regulatory

How to Comply with the Sunshine Act: Best Practices and Critical Guidelines

In this interview with David Hoffmeister, we learn actionable rules regarding physician and HCP consulting arrangements.

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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.

3 Critical Goals Every New Medical Device Should Aim For: Interview with Doug Evans, CEO of Lungpacer Medical

In this interview with Doug Evans, CEO of Lungpacer Medical, we discuss tips for launching medtech startups, working with payers & regulators, commercializing novel technologies, and we'll learn more about Lungpacer's impressive system.

Why Medtech Founders Should Not Over-Focus on Dilution: Interview with Renee Ryan, CEO of Cala Health

In this interview with Renee Ryan, CEO of Cala Health, we discuss some common mistakes that medtech startups make, and talk about what she looks for as an investor in early-stage companies. She also shares tips on navigating the regulatory waters and obtaining insurance coverage & reimbursement.

The Biggest Mistakes to Avoid When Designing Medical Device Prototypes: Interview with Mike Wallace, CEO of DeVoro Medical

In this interview with Mike Wallace, CEO of DeVoro Medical, he tells about the mistakes medtech entrepreneurs often make in the early stages of their companies and how you can pivot when an idea doesn’t pan out.

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.

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