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'Implant Files' Impact

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Germany Puts Implant Files In Perspective, As Industry Looks Towards 2019

Europe's biggest medtech industry and market, Germany, was in the crosshairs of the Implant Files and its ICIJ reporters, and predictably it caused a major stir. The episode has been a wake-up call for medtech, but industry hasn't let it develop into the crisis it briefly threatened to become, and is now looking beyond it and to the commercial challenges of 2019.

Germany Commercial

Opinion: The Great Implant Scandal Or 7.7 Billion Reasons To Celebrate Medical Devices?

Investigative journalists, tort lawyers, the judicial system and public opinion all provide checks and balances on medical research, industrial innovation and commercial exploitation of health-care technologies. Whether those affected like it or not, these well-intentioned elements of society demand accountability of an industry that has a profound effect on all our lives. The "Implant Files" episode is a reminder for medtech stakeholders across the world that nothing can be taken for granted, says medtech industry and regulatory consultant Trevor Lewis in this guest column for Medtech Insight.

Implant Files Regulation

US Medtech Lobbyists Say They're Not Worried About Political Backlash From 'Implant Files'

The International Consortium of Investigative Journalists started publishing the findings of its "Implant Files" investigation last month, but the two main industry groups in the US have not picked up any significant political backlash resulting from the reporting so far.

Implant Files Safety

EU Regulatory Roundup, November 2018: 'Implant Files' Dominate, While Brexit/New Reg Issues Rumble On

The medtech sector was already quite overwhelmed with the new EU regulations and Brexit uncertainties. Now add into the mix the impact of the global journalistic Implant Files investigation.

Europe United Kingdom

Health Canada To Accelerate Device Reforms In Face Of Media Reports

The Canadian government wants to strengthen its oversight of medical devices, both on the pre-market and post-market sides, partially in response to recent Canadian news reports on safety issues with implantable devices, the country's health minister says.

Canada Implant Files

Patient Advocates Look To Leverage New Industry Scrutiny To Seek Publicity, Reforms

The Facebook group Essure Problems has sprouted a spin-off, Medical Device Problems, that attempts to serve as a central resource for patients who say they were injured by medical devices. Medtech Insight spoke to two leaders in the group about their ongoing advocacy efforts and the Medical Device Safety Act, and what they think about the "Implant Files" investigative reports that have embarrassed industry.

Safety Implant Files

10 EU-Based Key Medtech Opinion Leaders React To The 'Implant Files'

Nov. 25 was the halfway mark in the three-year transition toward full implementation of the new EU Medical Devices Regulation. It was also the day the International Consortium of Investigative Journalists (ICIJ) dropped a bomb on the medical device sector, and it has been shelling the industry every day since. How are key industry experts reacting?

Europe Medical Device

Pendulum To Swing To More Congressional Oversight Of FDA Device Regs, Hill Experts Say

In the context of a global investigation of the device industry and a change in power in the US House, health-policy experts say oversight by Congress of FDA's regulation of devices in 2019 is likely to swing incrementally away from ensuring innovation of products and easy market access, toward greater assurance of product safety before devices reach the market.

Legislation FDA

Implant Files: Attempt To Undermine Top UK Device Regulator In Public Eye

Is it OK for someone who worked for industry to then take up a position as a regulator? This question is rightly asked in the context of reporting of the Implant Files. But has biased wording attempted to undermine the integrity of John Wilkinson, one of medtech's most committed regulators?

Medical Device Implant Files
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