Medical device testing is serious business. Big business. The medical device market in the USA alone produces over $148 Billion in revenue annually (pre-2017), according to SelectUSA. The market for these devices comes from everything from contact lenses to insulin pumps to Ventricular Assist Devices, to syringes and many, many more products.
Optimation has been certified in ISO 9001 since 1996 There have been several revisions to the standard since that time, with the current ISO 9001:2015 being the latest with the most significant changes. Knowing that the changes were significant, I did some research to help us prepare for the audit. I have included some visual comparisons of the standards that I found helpful as noted below.
Rockwell hosted a recent webinar highlighting its batch technology. It introduced the new capabilities of FT Batch V13 which were summarized as follows:
About a year ago I visited the University of Rochester sports medicine group and met with a n orthopedist for a diagnosis of the pain in my right knee. I had tried weeks of my usual stretching and rolling without achieving any results. After an x-ray was taken the orthopedist sat me down and showed me the advanced arthritis in the knee and the bone on bone. He said I needed a total knee replacement and offered to schedule it. I asked if there were any alternatives. He offered to give me a cortisone injection which he said would delay the need for knee replacement by four or five months. I declined both of his offers and left the medical center determined to find alternatives.
Early in my career I learned about and then was tasked with writing capital appropriation requisitions and justifications. When dealing with vendors I often encountered specifications, and technical minutia that overwhelmed me with data that provided little helpful and useful information. Reqs and justifications require compelling, substantiated, and specific facts that define a positive business PROPOSITION meeting the criteria as set by company policy—payback period, breakeven, Return on Asset/Equity/Investment, etc. Today, as I read and write more of these, I am still encountering many examples that miss the mark.
I remember celebrating the first Earth Day back in 1970. As part of the celebration I ran a marathon in Central Park. It went six laps around the park. Marathoning wasn’t popular back then like it is today. There were only 200 participants and the entry fee was $2. There were other more popular attractions in Central Park that day. They included kite‐flying, skits, Frisbee throwing, band performances and chanting by the International Society for Krishna Consciousness.
I am honored to be sworn in as president of the Rochester Engineering Society. For me it holds a special significance. We have had past presidents serve two terms, including the most recent, Jon Kriegel; however, I don't believe we’ve ever had a father and son both serve as president. And while it goes back thirty years, I certainly recall my dad’s selection as Engineer of the Year. This tradition of celebrating the profession in this way continues as one of the hallmarks of the Society.
Back in the 70s when I graduated with an engineering degree, a large percentage of the new graduates went to work for manufacturing companies. A certain percentage went on for advanced degrees and ended up in research positions and academia, but much of the research was carried out by private companies building their own IP portfolios. The exception to this was civil, structural and architectural graduates who might end up working for private engineering and design firms.
We are a business that executes hundreds and hundreds of projects every year. These span the spectrum from simple to complex, urgent to critical, and small to large. As a vendor in industrial automation, we participate in these interactions as a supplier to prospective clients wishing to accomplish business goals. There are about as many ways to go about this as there are projects; however, there are certain parameters that yield more likely success more often. Let's look at them.
Brick and mortar stores are in a steep decline. Every day we hear about another chain closing down dozens of retail outlets and at the same time malls are being shut down or repurposed. Shopping patterns are changing rapidly. We no longer go out to shop. We check out products, compare prices and do a one click purchase from our cell phones. And after we click we have an expectation that the item will be delivered to us in a day or two. It is not uncommon to get an email or text saying our item has been shipped less than an hour after we place the order.