'Implant Files' Impact
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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.
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.
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.
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.
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.
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.
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?
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.
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?
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