Requirements management isn’t optional in many fields. Medical technology and finance are just two fields where regulatory compliance necessitates requirements management. You and other stakeholders simply must be in total agreement about the requirements of a given...
Traditional medical devices are quickly going the way of the ear horn for one simple reason: their valuable data is confined to the device. Some have short-term storage capabilities. None, however, capture data over time for long-term analytics or storage. Intelligent...
One of the major points of pain in any development process is how do you prove that the product you’ve built for the marketplace actually does everything you want it to do. The simple answer of course is “Why you test it to make sure.” But the simple answer isn’t...
When you first purchase PTC Integrity Lifecycle Manager, what you are getting is pretty much a blank canvas. To assist you in getting your operation off the ground, PTC also provides a number of different pre-built solutions. These solutions have been designed to...
In the world of fast competitive marketing, a lot of attention goes to the first company who develops a creative breakthrough and comes out with a cool new device first. New technology in the medical device market has resulted in several new products which include;...
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...
As humans, we depend on feedback. Everyone likes feedback, whether a glance in the mirror, a friendly compliment or financial reward for a great job. Now thanks to the advancement of medical device design, high tech trends, and use of micro-computers, you can get...
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...
The use of open source software (OSS) within the medical device industry is a double edged sword. On one end of the spectrum, you have freely available code that is available for the world to scrutinize. In the process, one would hope that bugs are more easily...
Device manufacturers have until this summer to ensure their devices comply with the EU's Restriction of Hazardous Substances Directive – commonly called the RoHS Directive – to be able to earn CE Marking. In short, no RoHS compliance, no CE Marking, no selling in the...
The value system and practices that embody Agile Software Development have been around for well over a decade, and have been touted as having "crossed the chasm" by organizations such as the Agile Alliance, Gartner, and Forrester Research. Numerous studies indicate...
Greater medical device interoperability and the adoption of commonly accepted standards could save the US in excess of $30B, suggests a West Health Institute report published in March. Lack of device interoperability creates significant waste and risk to patient...