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Navigating the MDR Process

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There are new requirements established by the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) including expanded clinical evidence requirements, more regulatory oversight, additional requirements for IVD manufacturers, and stricter supervision of Notified Bodies. To help guide companies through what may be a challenging process of navigating the new regulations, a number of documents have been compiled …

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EUMDR Update

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Two more notified bodies have been designated in the EU to address the EUMDR (European Medical Device Regulation) re-certification process, but the overall pace lags as 20 are expected to be designated by the end of 2019. This is welcome news for the medial device industry concerned about capacity issues ahead of the EUMDR effective date on May 26, 2020. …

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Improving the Quality of Dietary Research

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Diets are complex and variations are numerous, making meaningful dietary research a very difficult problem to address.  In an article on dietary research published in the Journal of the American Medical Association, authors David S. Ludwig, MD, PhD, Cara B. Ebbeling, PhD, and  Steven B. Heymsfield, MD discuss a number of scientific challenges, including consistency, quality control, and interpretation and …

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European Notified Body Numbers Decrease ahead of MDR, IVDR

In Uncategorized by Michael WillisLeave a Comment

The European Notified Body (NB) is shrinking as additional organizations opt out of designation to the Medical Devices Regulation (MDR) and In-vitro Diagnostic Devices Regulation (IVDR). Ongoing lack of a Brexit resolution is also a factor in this NB exodus. Announced last month, UK NB LRQA will cease CE Mark certification services under current Medical Device Directives and not seek …

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Do Brain Health Supplements work?

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More than a quarter of adults in the United States age 50 and older take at least one supplement for brain-health reasons. Brain-health supplements generated $3 billion in sales globally in 2016 and are projected to reach $5.8 billion by 2023. Despite adults’ wide-spread use of brain-health supplements, there appears to be little reason for it. There is a new …

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Increased requirements for clinical evidence under the new Medical Devices Regulation (MDR)

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The uncertainties about a “No-Deal Brexit” may distract many manufacturers from preparing adequately for the new requirements associated with the new Medical Device Regulation (MDR), including clinical data rules. The need to provide clinical data for a significantly increased number of medical devices, whether the data is collected on a predicate device, during pre-CE clinical trials or during Post Market …

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Chronic Disease: Our Biggest Danger

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What is our biggest danger? Immigrants? Foreign governments? Religions we don’t understand? You could make a better argument that the largest threat to what we value most – a happy family and good  health –  is chronic disease. Other loudly and repeatedly publicized topics don’t come anywhere near the pervasive injury, number of lives lost, family strife, and enormous cost of our rapidly expanding burden …

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Having Access to More Studies Does Not Lead to a Better Understanding of Medical Evidence

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Presently, “systematic literature review,” followed by an analysis of the data derived from this literature review (Meta-Analysis) paints a myopic view of medical evidence. Keyword-based searches miss much of the available literature. And, depending on the area of research, the volume of available literature can be staggeringly large. There are over 23,000 journals publishing over one million medical research articles …

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EUMDR – The Early Compliance Advantage

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Peter Rose published a recent article that makes a compelling case for Medical Device companies to act sooner, rather than later, to comply with the new European Union Medical Device Regulation (EUMDR). Rose states: “Nobody is in any doubt that the new European Medical Device Regulation is on the agenda of compliance professionals in the medical devices industry. But is …

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How Much Salt Should You Really Eat

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Salt. A new skirmish has begun in the battle over how much we should eat, which is only going to strengthen the ongoing war on science. Scientific credibility is at an all-time low. Convincing the general public that medical research is not a conspiracy to sell snake oil to line the pockets of Big Pharma is a failing effort. But …

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Mega-analysis: Big data comes to the aid of medicine

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Is sodium restriction actually bad for you? (Probably)  Should we or shouldn’t we do screening mammograms (unsure) and colonoscopies (probably)?  Are the benefits of Alzheimer’s drugs worth the side effects and costs (iffy)?  Do vaccines cause autism (emphatically, no)?  Is eating steak destroying Western civilization (depends who you ask)?  All of these are familiar tropes in the press and are …

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Generosity and The Times in Which We Live

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On one of those disgustingly hot and humid New York summer days a couple weeks ago, I was climbing the stairs out of the subway. On the landing, in their mostly synthetic uniforms and bulletproof vests, and looking as if they were about to turn into pools of melt, stood three police officers. They were stationed there to perform random …

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Are nursing homes forcing unnecessary surgery?

In Uncategorized by Michael WillisLeave a Comment

There was an enormous outcry against the forced placement of temporary feeding tubes in the noses of prisoners on hunger strikes in Guantánamo. Dramatic and inaccurate representations of the tubes as torture appeared on the internet. We ethicists wrung our hands and worried as much about the rights of the prisoners as we did about the false message that was being delivered: that nasal …

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Stop Telling the Obese to Lose Weight

In Uncategorized by Michael Willis1 Comment

Few things in biology and medicine are predictable without research. If they were, we could sit under trees, think deep thoughts, and come up with the cure for cancer. We can’t and we won’t. A study published in the journal Obesity this past week has confirmed, yet again, what we have known for years: going on a weight loss diet …

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Reducing Healthcare Waste: Don’t Expect Patients To Take The Lead

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Lena Wright’s best friend was hunched over like a character from a French novel, with spinal bones so thin they would fracture with a fit of sneezing. Determined to avoid that fate, Wright (a pseudonym) asked her primary care doctor to test her for osteoporosis with a DEXA scan, also known as Dual Energy X-ray Absorption. The scan would send …

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Electronic Medical Records: Ready for primetime, or tower of Babel?

In Uncategorized by Michael WillisLeave a Comment

A few years ago, the government in its inimitable wisdom, decided that computerizing medicine would cure all of the ills medical care was facing, from illegible doctor handwriting to medication errors. They implemented a significant financial penalty if the doctor or hospital did not install an electronic medical record (EMR). The penalty was not excused just by installing and using the …

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An obesity penalty would be legalized discrimination

In Uncategorized by Michael WillisLeave a Comment

A study published earlier this month in the International Journal of Obesity has found that our common wisdom about the relationship between obesity and the risk for cardiovascular disease is possibly overstated. The U.S. Equal Employment Opportunity Commission (EEOC) has been considering rules that would, in effect, allow health insurers to charge obese people more for coverage if they fail …

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Why Good Science is Hard

In Uncategorized by Michael Willis1 Comment

Have you heard? New dietary guidelines are out!  Do you care?  Probably not much. Should you? I’m honestly not sure.  Even I have had trouble keeping track of what is in and what is out of these current guidelines, given how much we’ve fought over them in the media.  But more importantly, we experts keep changing our minds about what …

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Health care is about relationships. Health IT fails to understand that.

In Uncategorized by Michael WillisLeave a Comment

The promise that information technology holds for health care is, quite literally, amazing. So far, it has enabled us to get rid of paper charts (not to mention the age-old problem of illegible doctors’ handwriting), negated the need to trawl through mountains of files to find old clinical data, and introduced much-needed safety improvements such as medication alerts. But anyone …

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Can being an expert be in itself a conflict of interest?

In Uncategorized by Michael WillisLeave a Comment

With expertise comes certain benefits.  An expert has the ability to make a living, to make an impact, and to exercise influence based on their expertise.  But expertise has limits, as knowledge is never absolute or complete.   Do the benefits of expertise blind us to these limits? If so, doesn’t this create an inherent conflict of interest? What defines an …

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How the abundance of information online alters a physician’s decision making

In Uncategorized by Michael Willis

Driven by the ready availability of inexpensive but low quality information from the internet, healthcare has been undergoing a dramatic transition. But this surge in information, rather than augmenting the physician-patient partnership and empowering each to make better decisions, is replacing the traditional model of the physician-patient relationship, and changing it from that of an expert advisor counseling the patient, to …

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