Tone Wheeler
Last week’s column outlined a city plan at the heart of a radically different approach to the start of architecture studies. Instead of a series of ‘design exercises’, this first semester has students looking at the design of a whole city, then a building within that city and finally a room within that building. And that city was called ‘Opus Musivum’ or OM, Latin for ‘mosaic work’.
The usual way
Most architecture courses start with small design composition problems, based on the teachings of the Bauhaus, but this approach has also been widely criticised, notably as promoting the idea of ‘the decorated diagram’ in the book of the same name by Klaus Herdeg, discussed in A+D here.
Trends In FDA Quality System Inspections: 3 Takeaways To Ensure Future Success
By Adam Atherton, KEB, LLC
The FDA conducts thousands of quality system inspections each year. The FDA performs inspections of medical device quality systems for products planned for or already on the U.S. commercial marketplace and publishes summaries of the inspection observations here. In this article, I present background and high-level observations on the inspection data over time. My next article will analyze FY2020 data and how it compares to previous years.
FDA inspections of medical device quality systems are driven by either the older, but still relevant, quality system inspection technique (QSIT) or the more recently developed medical device single audit program (MDSAP) model. It is unknown if these different audit approaches result in different outcomes, but it is unlikely. I expect the MDSAP methodology identifies quality system gaps quicker due to the more rigorous and systematic approach,
And with that, I ask the question for which this post is named:
“Can design controls accelerate medical innovation?”
While this question may seem out of place, there is logic to it. This logic is based on a 20-year observation brought to into focus with 2020 vision.
Innovation begins at the fuzzy front end of design, so that is where this journey begins. From this vantage point we can see significant hurdles. They are in front of us, and we clearly see them. We know that one day, down the road, we’ll need to produce our solutions under good manufacturing practices. We will have to do verification and validation testing to get there. We have a complex ecosystem to navigate with barriers to entry including market considerations, intellectual property, regulatory pathway to approval, and medical economics.