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

August 31, 2019

Reimbursement and payment are critical to the success of your MedTech product.

The path to commercial success for device companies is fraught with complexity. Often developers of novel products do not consider the obstacles they will encounter as part of the commercialization of their product. Yet, reimbursement and payment are absolutely critical to their success. Not only do these companies have to obtain FDA market approval, they

July 27, 2019

Did you set up your Q-Sub/Pre-Sub meeting with the FDA?

Let the Q-Sub (or Pre-Sub) be your first contact with the FDA Every medical device company entering the US market, comes in contact with the FDA. Even if only to register the company or a Class I device on the FDA database. If you have a product that’s Class II or III, the Q-Sub or

June 7, 2019

Cross Cultural Business Communication: Holding Hands

Many years ago, I found myself in a foreign city at a conference, spending a few minutes on my company’s booth, when all over sudden a man walks up, grabs my hand, leads me to a display on our booth and starts asking questions about my company and our products. All the while, for the

May 28, 2019

Compliance with ISO 14155 serves the safety of patients during clinical trials

Meet Danielle Giroud, convener of the ISO expert group on clinical investigations, at the OCRA Orange County Regulatory Affairs Discussion Group, June 19th event on ISO:14155:2019   Register: https://lnkd.in/enqdjCd   Medical devices may only be placed on the market if their performance and safety have been clinically evaluated. The harmonized standard ISO 14155:2019 “Clinical testing of medical

April 30, 2019

EU MDR Implementation: A Presentation To OCRA, Orange County Regulatory Affairs Discussion Group (Part 3 Of 3)

Presentation to OCRA – March 13th, 2019 – on EU MDR Implementation, at the Allergan Auditorium (Part 3)   Economic Operators   Most Medical Device companies understand the issues surrounding notified bodies. They have been well documented and are often discussed at MDR events. But I’d like to draw your attention to the multiple economic