This article demonstrates a plan to design the pen described in another article on Design Controls, and may not make sense if you haven’t read “Design a pen.” In that article I began with a quote from Leonardo DeCaprio from the movie Wolf of Wall Street where he challenged his team to “sell me this […]
Nov 11th is Veterans Day and I’d like to thank Veterans, First Responders, Police, Firefighters, and EMT ‘s who serve without regard to our race, religion, gender, or nationality. Veterans and first-responders may face challenges transitioning to civilian jobs where their skills may not be fully utilized. To help, here’s my advice for succeeding in […]
In the movie Wolf of Wall Street Leonardo DeCaprio challenged his team to “sell me this pen,” implying that a good salesperson could sell anything. This article helps teams “design a pen” using methods that benefit almost any project and includes tips for encouraging creativity and innovation. I wrote it for the biotech or medical […]
3-minute read. The new European Medical Device Regulation will be required for all medical devices sold in the EU. This was motivated by citizens demanding safer healthcare; the United States is considering similar changes. To learn more about the EU-MDR, do what Chuck Norris would do. You could also read the official MDR and guidance […]
Kristy asked me a question I couldn’t answer: How did she receive a risky spine implant two weeks after a class-action lawsuit was settled against the manufacturer of that device? After two days of thought I replied: What would it look like to ensure that doesn’t happen to anyone else? This is the result. Background […]
4 minute read. This article shows how to apply risk-control and perform Risk-Benefit analysis for the European Union Medical Device Regulation. You may have reached this from my article on the MDR big picture; Risk-Benefit analysis the final step in reducing risk As Far As Possible. I’ll use Harry “The Hat” Anderson to illustrate that […]
This is a work in progress. It’s my first attempt to link diverse topics from my work, and there’s likely an improved version on my blog. A client’s employee complained about something I said in a workshop. Since then I’ve said it in almost every workshop, monitored it for effectiveness, improved it, and built upon […]
This article shares the psychology of why teams resist change using an application of new medical device standards. Reducing risk As Far As Possible (AFAP) has been one of the most confusing parts of the European Union Medical Device Regulation (EUMDR). Officials have tried to offer guidance. First, they modified the international standard for risk […]
This article gives two steps your company can quickly take to prepare for the most confusing requirement of the new European Union Medical Device Regulation, reducing risk As Far As Possible. I use the Kaizen approach to continuous improvement of applying small steps that are likely to be understood rather than drastically new procedures that […]
This is an older version, kept on my site because other articles link to it. I recommend switching to the newer version. 7 minute read. Beginning in 2020 the new European Union Medical Device Regulation will protect patient safety by requiring healthcare companies to make products that are “state of the art,” a term that’s […]