G. Wayne Moore, B.Sc., MBA, FASE 1/14 /2020 Someone once commented that the trouble with predicting is that it’s always about the future. Well, I am not going to let that caveat keep me from making a handful of wild-eyed predictions for 2020. But first an observation about the year itself; if you made 2020 … Continue reading
G. Wayne Moore, B.Sc., MBA, FASE 12/10 /19 I have amazing memories of Christmas. My Dad was career Navy and because of that we moved around the country – a lot. Most of the places we lived did not have snow. When my Dad retired from the Navy we moved to Boise, Idaho. It was … Continue reading
11/12/2019 During the last 45 days three separate lawsuits have been filed in Federal courts by Philips Healthcare. These lawsuits are against; 626 Holdings Inc. (Case 9:19-cv-81263-RS), Summit Imaging Inc. (Case 2:19-cv-01745-MLP), and KPI Healthcare Inc. (Case 8:19-cv-01765-JVS-JDE). One of the main claims in each of the above lawsuits is the alleged violation of certain … Continue reading
10/08/19 Hello fellow travelers: On August 2, 2019 the FDA released Draft Guidance for testing and labeling medical devices in the magnetic resonance environment. As with the Ultrasound Guidance recently released, I read the FDA Draft MRI document for hints of how it may inform the 3rd Party service issue. For example, the Guidance could … Continue reading
9/10/2019 In my discussions with HTMs over the past three years about the FDA 3rd party service docket I have found systemic confusion about what the FDA does, and doesn’t do. The FDA allows medical devices and pharmaceutical into the market through either the substantial equivalence 510(k) process (cleared for sale), meaning the device is similar … Continue reading
The Lake Wobegon Effect 08/13/19 “The Lake Wobegon effect is a natural tendency to overestimate one’s capabilities and see oneself as better than others. Research psychologists refer to this tendency as self-enhancement bias and have found evidence for its existence in many domains.” Psychology Wiki Garrison Keillor (A Prairie Home Companion) made a hugely successful … Continue reading
Section 5.2.6.1.8 – Does this Change the 3rd Party Service Question? G. Wayne Moore, B.Sc., MBA, FASE 07/09 /19 The new ultrasound Guidance document, https://www.fda.gov/media/71100/download, addresses, at least in part, two key issues related to the 3rd Party service docket that began some three years ago; specifically who can do service and remanufacturing and … Continue reading
Converging Medical Technologies G. Wayne Moore, B.Sc., MBA, FASE 06/11 /19 Ok, time to come clean; I am a Trekkie. There, I said it and I can get on with this month’s article – the convergence of rapidly evolving technology toward a real- life Tricorder; and it’s about time. In the 1986 movie Star Trek … Continue reading
Acertara is participating in the State of Colorado’s Innovative Industries Internship Program, providing internship opportunities for two software interns this year and we are thrilled to have Ben Gillett and Alice Lundberg join our team for the summer. Ben just completed his sophomore year at Colorado State University where he is earning a Bachelor of … Continue reading
Rules, Regulations, Compliance, Substantial Equivalence, or What? G. Wayne Moore, B.Sc., MBA, FASE 05/14/19 As an ultrasound medical device regulatory expert, I receive a great many questions throughout the year regarding exactly what the FDA Guidance documents are. For example, are they requirements, rules, suggestions, or regulations? Below you will find the link to the … Continue reading
