In the past, medical device design focused on a standalone unit or a group of a couple devices that worked together. While that was a great idea, the number of compatibility issues that could occur also blocked connectivity to other devices. With the stream of new...
With the push by big technology players (Cisco, Google, Intel, etc.) towards connectivity in everyday devices, cyber security is becoming more and more crucial. This push is even seen in medical device design as the industry begins to move toward cloud-integrated and...
Repeatability is a intuitive aspect of daily life. If you throw a ball up, it must come down. If you throw it twenty times, the same thing will happen, up and then down. When repeatability doesn't occur we get anxious. Repeatability is equally an essential quality in...
The technology industry loves buzzwords. The decade of the '80s was all about synergy and paradigm shifts. In the '90s, it was the web and the Internet. The turn of the century brought talk about virtualization and social media. Today it's all about the cloud. Of...
Whenever I get a chance to see any kind of motor racing I am amazed at how many displays the engineers use to watch and monitor all the data coming from the cars. Modern performance racing cars produce a lot of data about the engine, tires, fuel consumption,...
Automated development, rather than just automated builds, offers a more holistic approach to automating the development process including building, testing and deployment. It is the cornerstone of Continuous Integration (CI). CI uses a model of small incremental...
One of the common tasks for any system administrator is managing disk space on a server. It doesn't matter what operating system the server is running, free disk space is always something you keep an eye on. I won't go into a boring lecture on why managing disk space...
This article reviews what an FDA 483 Observation looks like, some of the more common issues flagged in medical device companies, and how to respond.
SPK and Associates routinely review warning letters to help our clients stay in step with FDA trends.  One of the problem areas most often cited in company audits continue to be the CAPA system/program.  This month we will take a look at some of the latest FDA...
SPK helps a tech manufacturer to increase security and availability of its CAD systems and data by moving them to the cloud—while helping them to save $30k per year. The Client A well-known maker of power distribution units for IT racks and related equipment...
SPK helps a leading nonprofit to streamline its internal IT support, while adopting best practice and saving money. The ClientA socially-conscious nonprofit research center found its internal IT staff overloaded. It’s a small group—just four people—who were tasked...
BackgroundA diversified medical device company has a leading position in the global endoscopy device space. In this market, the company generates growth and differentiates its products primarily through incremental innovations and investment in research and...