1. A major push for regulatory reform

“2018 brought about an awakening at the FDA and the medical device industry due, in large part, to the release of ‘The Bleeding Edge’ and ICIJ’s ‘Implant Files.’ Patients and providers now have a clearer picture of the weaknesses of the flawed FDA approval process, and a better understanding of potential long-term side effects of under-regulation. This will bring about global change in 2019. Countries that have relied on FDA approval and the CE Mark on devices now realize that some are riskier than originally thought and will seek better, more complete data. Social media platforms, driven by patient advocate groups such as Essure Problems and Breast Implant Victim Advocacy on Facebook, will enable better communication among patients who seek information about medical devices they are considering or already have. Patient-centered efforts to take back their health and well-being will re-shape regulations and precedents that were outdated even 10 years ago. The efforts of these groups to change how the system favors the manufacturers will be continued by the reintroduction of the Medical Device Safety Act in the 116th US Congress. This law will simply restore the consumer’s rights and take the cloak of protection off of manufacturers. The whole of all of these efforts will allow for safe and innovative products to flourish.” – Madris Tomes, CEO, Device Events

“The medical device industry should never underestimate the power of the press nor the impact of product liability lawsuits. Not only do both go hand-in-hand, both are the ‘root cause’ of many of the changes in the medical device regulatory requirements being proposed by FDA and already being implemented in the E.U. Remember the adage… those who forget their history (and those who don’t acknowledge their history) are doomed to repeat it!” – Michael Drues, regulatory consultant

“With a new Democratic House that was elected in part based on their healthcare messaging, we expect the debate on improving patient access to high-quality, affordable care to remain spirited. Since medical technology has such a crucial role to play in improving care and lowering costs, we’ll be pushing our ideas for CMS reform – including automatic coverage for breakthrough devices and process efficiencies for coverage decisions – to eliminate bureaucratic obstacles to patient access to new medtech. We’re also bullish on reforms to the Anti-Kickback Statute, which could allow medtech companies to fully participate in emerging value-based care arrangements to the benefit of patients and providers.” – Greg Crist, chief advocacy officer, AdvaMed

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