Question
Healthcare today is reactive, retrospective, bureaucratic and expensive. It's sick care, not healthcare. This post is about why the $3 trillion healthcare system is broken and how we are going to fix it.Exponential Medicine: Healthcare Is Broken, Her...
Bradley Merrill Thompson, RAC
Medical Device, Digital Health and Combination Product Regulatory Attorney
September 2015
In this paper, I outline in detail the structural biases against anything new in the medical technology realm, including novel software. I wholeheartedly support FDA regulation of risky technology, but the law places disproportionately large regulato...
CDRH published a list of guidance documents it is considering in fiscal year 2017. These include: Final Guidance Topics • Postmarket Management of Cybersecurity in Medical Devices • Medical Device Accessories: Describing Accessories and Classificatio...
In 2015, the Medical Devices Group surpassed 300,000 members. We gave eight free webinars, hosted the third annual 10x Medical Device Conference, and many of us met in person, talked here, and made valuable business connections. Here are the most pop...
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Despite emphasis on patient engagement, even the most committed patient can have trouble getting recordsOn trying (still) to access one's health data electronically | Healthcare IT NewsA few months back, our columnist shared her struggle to obtain el...
Roberta Goode
President at Goode Compliance International: Experts in Process Validation and FDA Compliance
September 2015
Why do customer complaints nonconformances continue to escalate to WLs and 483s at an alarming rate? Has something changed in the way companies are (mis)interpreting the regs, or is it more subtle? I'm curious to know what the group members think.sou...
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Back in the early 1990's when Medtronic developed the Reveal implantable cardiac monitor, I, a lowly physiologist, came up with what I thought was a nice alternative, a long-term wearable version. Why spend money on an operation and end up with a sca...
Louis Coenders
Experienced interim professional for European freight, warehousing & logistics assignments | Europe - NL - Venlo |
June 2016
Hi, I need your help. I would really appreciate to learn what channels/methods are suitable to make medical device manufacturers and distributors aware on European logistics and warehousing services for Medtech devices. Tradeshows like Medica, Arab H...