R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

A Culture of Quality

As quality professionals, we are always looking for ways to improve the quality of products, and reduce the cost of quality mishaps. But how do you actually climb to the top of that mountain of high quality while still maintaining a marketable product?

Reliability – From Bike Racks to Medical Devices

Every once in a while, when I’m not running, I like to take my bike down to the river trails of downtown Pittsburgh. I throw my bike rack on my car, strap it in, and I’m ready to go. Being as I only used my bike rack about ten times since I got it, I was surprised when I went to secure the bike and the plastic strap was broken. The strap is not removable or replaceable, so for now I’ll have to stick to running. Luckily, I have my receipt and the manual that came with the bike rack – and it says there is a lifetime warranty. I wrote a short note to the company explaining my situation and am hoping to get a positive response.

Human Factors

Recently I had to get my annual mammogram. They were running behind like doctor’s offices sometimes do - there were seven women in dressing gowns in the waiting room with me. After a few awkward moments, we all started to talk to each other. Every single one of the ladies talked about how they hate to come and get their annual mammograms. They talked about the pain of it, joked about the embarrassment of it - there was even a suggestion that they should serve wine in the waiting room instead of coffee. But each also showed a deep appreciation for the necessity of breast cancer screening - telling stories of aunts and mothers who were saved by it. Finally one woman told us that she was 39 when a mammogram detected her breast cancer for the first time. She was able to get minor surgery and was put on a regimen of annual mammograms. Six years after, she got breast cancer again. Again the mammogram was able to catch it early. She said she was now 57 years old and she felt like she owed 18 years of life to her doctor who suggested she get a mammogram at 39. There is no doubt about it; mammograms save people’s lives.

Autonomy with Boundaries

I have a teenager that just passed his Driver’s Test. As he pulls out of our driveway, I see the freedom, the possibilities, the trouble that he could get into. Although a bit poetic and a bit melancholy, it’s also a bit exciting. His father and I cautiously trust him – he’s a good kid, full of promise…..and he knows the boundaries. No phone while driving, no friends in the car, follow the law and safety first.

Architect of Quality – Part 2: The Human Dimension

Welcome to the second installment in our blog series featuring Joseph Juran, “Architect of Quality.”1 Today, we’re going to take a deeper look at one of his major contributions – the addition of the “human dimension” to management theory.

Architect of Quality - Part 1

Have you ever wondered where quality management systems came from, or why these infrastructures are designed the way they are? In an effort to explore our roots at RQS, this post is the first in a series about Joseph M. Juran who was a dominant figure in the development and dissemination of quality related concepts that we use in manufacturing today. His autobiography is entitled Architect of Quality1, and his design influence can be seen in many aspects of current quality systems. Let’s take a look at Mr. Juran’s life and contributions to this field.

Setting Precedence

I sat down tonight, as I do every night that I write a blog post, and I started reading the prior posts from my colleagues. I had every intention of writing on a different topic tonight, but something struck a chord with me when I looked through the blogs. They all had something in common. It’s something that we as regulatory and quality folks struggle with and love at the same time. It’s the topic of precedence.

International Spotlight - China

When people ask my opinion of the most difficult country to register medical devices internationally, I would have to say it is China. China is considered to be an “emerging market”- it is getting more and more lucrative to register there as the population gets larger and wealthier. China accounts for 1/5 of the world’s population – about 1.3 billion people. Most marketing departments feel that this huge market is worth the incredible effort that it takes to register medical devices. China registration is therefore usually in the international registration strategies for most large medical device companies.

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