May 25, 2021

IVDR becomes the new MDR.

For the last 5 years Medical Device companies have worried about the impact of the new Medical Device Regulations on their business, and what would happen May 26th, 2020, when the new law would be implemented within the EU. Then, when COVID hit, and implementation of the law was delayed with a year, companies got

September 6, 2020

CMS proposes automatic Medicare Coverage to FDA approved Breakthrough Devices

Medical Devices often have a difficult time entering the US market. A device which enters the market after getting regulatory approval using the 510(k) pathway faces the conundrum of being based on a predicate. It’s difficult to escape the label after it was touted as the reason why your device was just like the other.

June 20, 2020

Michael Porter’s Recommended Strategy to Compete in Healthcare.

Dr. Michael Porter, Dean of Strategic Thinking A few weeks ago, while researching information on strategy in the healthcare market, I noticed that Dr. Michael Porter, Professor at Harvard Business School, had been conferred an honorary doctorate by KU Leuven, one of the world’s oldest Universities – founded in 1425. Dr Porter, years ago, described

May 24, 2020

Why ISPOR’s 2020 conference on Health Economics and Outcomes Research concerns MedTech companies.

What is Health Economics and Outcomes Research (HEOR)? Companies in the MedTech space intuitively understand the importance of the importance of Health Economics and Outcomes Research. But in practice, I notice that few companies understand the logical implications. Often with negative consequences. For those who are not familiar with Health Economics and Outcomes Research (HEOR),

February 29, 2020

Health Economic and Outcomes Research (HEOR) Trends for 2020

Every year ISPOR publishes a Top 10 of Health Economics and Outcomes Research (HEOR) Trends. They did so again early January. ISPOR (International Society for Pharmacoeconomics and Outcomes Research) is an international organization dedicated to improving healthcare decision making. While the organization’s name explicitly refers to Pharma, they also cover Medical Devices I wanted to go

January 27, 2020

The UK Healthcare System and MedTech Market: an overview.

NHS: the UK Healthcare System While the UK healthcare system has both a private and a public component, only 11% of the population has private health insurance and most policies have upper spending limits or only cover specific medical conditions. Which makes the public sector by far the most important. The organization managing the provision

December 26, 2019

2020 Outlook: a Challenging Year for Medical Devices Companies?

May 26, 2020 is the Date of Application for the new EU Medical Device Regulations. The industry has not embraced these new regulations. They are found to be overly intrusive, to stymie innovation, to raise cost and result in products being taken of the market. Besides the fact that MDR itself is not ready: EUDAMED

November 25, 2019

Are you ready? MDR: May 26 2020.

The Date of Application for MDR is May 27th 2020. Will your company be ready when the date rolls around? MEDICA 2019 This is the third year I visit MEDICA, a global event held in Düsseldorf every mid-November, where more than 5,000 Medical Device companies exhibit their products. To give you an idea of the

October 28, 2019

The MedTech World descends on Düsseldorf: MEDICA 2019

MEDICA is the world’s largest exhibition for the medical devices industry. For over 40 years this exhibition has attracted companies, experts and buyers from all over the world. During last year’s event over 120,000 professionals visited from more than 70 countries. They met with in excess of 5,200 exhibitors. No other medical device event attracts

September 28, 2019

Can MDR be saved?

The anxiety of MDR We’re only 8 months away from MDR’s May 26th, 2020 application date, and KPMG just shared a study stating that more than 66% of Medical Device companies have yet to develop a plan for post-MDR sustainability. The report cites several reasons as to why companies are not ready and repeats several