65 results
Posted on 23.05.2018
Value-based procurement: a users’ guide to improving outcomes and delivering efficiencies in the UK
This blog is part 9 of a series on the MEAT value-based procurement project, an initiative that advocates towards a shift from price-based procurement towards value-based procurement. It does so by defining a Most Economically Advantageous Tendering (MEAT) framework that includes the value of medical technologies, services and solutions in procurement processes across Europe. Read part 1, part […]
Posted on 05.03.2018
Invest! Lead! Engage! Let’s Make Europe’s New Regulatory System Work
We are now over 15% of the transition period of the new European IVD Regulation (IVDR) and over 25% of the Medical Devices Regulation (MDR) transition. That said, transitioning to the new system comes with highly-ambitious timelines, and success will require great effort, by industry and authorities alike. Last week, at the Association of the […]
Posted on 03.05.2017
Considerations on European transparency rules for the future
Following on the footsteps of our American colleagues, MedTech Europe would like to offer some thoughts on the issue of transparency and disclosure laws and how certain adaptations could help to frame transparency for a new reality. Over the last few years, a number of European countries have passed transparency or disclosure (sometimes also called “Sunshine”) laws […]
Posted on 26.04.2017
A Bridge Towards Convergence Of Ethical Standards In Medtech
The Advamed Latin America Compliance Conference and the upcoming Global MedTech Compliance Conference Sometimes I feel that compliance is like a jigsaw puzzle where every new piece brings us closer to the complete picture: Codes of Ethics. After being heavily involved in the adoption of the MedTech Europe Code of Business Ethical Practice, during my […]
Posted on 04.04.2017
Building MedTech Compliance for Tomorrow
Each fall the two of us meet to discuss global healthcare legal and compliance developments and to assess implications on the medical technology industry, patient care and innovation. When we first began collaborating the iPhone was just invented (healthcare apps were unimaginable) and, since that time, quite a bit has changed! When we annually meet, […]
Posted on 29.03.2017
Looking the Other Way: What About Upstream Corporate Considerations?
As a medtech lawyer, my focus naturally gravitates to assessing “downstream” relationships and risk; that is, analysis of the legal arrangements between manufacturers, distribution agents, and health care providers that together bring medical technologies to the patient’s bedside. These relationships can be complex, as are the legal issues they raise. But ensuring ethical standards in these relationships […]
Posted on 08.03.2017
Code of Ethical Business Practice: Impressions from interviews with Healthcare Professionals
The MedTech Europe Code of Ethical Business Practice entered into force on the 1st January 2017, with the phase-out of direct sponsorship that needs to be implemented in less than a year from now. The Code has been the topic of many conversations. However, until recently, we did not have the opinion of individual Healthcare […]
Posted on 11.01.2017
Great expectations for 2017
As ‘thinking season’ kicks off, the focus is on how technology and big data can deliver better value healthcare to more people than ever before. January is a time for reflection, planning and predicting what lies ahead. It’s the season for assessing the mega-trends that will shape our future and working out how we will […]
Posted on 21.09.2016
How Public Procurement can Drive More Sustainable Healthcare
This blog is part 8 of a series on the MEAT value-based procurement project, an initiative that advocates towards a shift from price-based procurement towards value-based procurement. It does so by defining a Most Economically Advantageous Tendering (MEAT) framework that includes the value of medical technologies, services and solutions in procurement processes across Europe. Read part 1, part […]