An important part of creating any product intended for use in any regulated industry vertical is that the manufacturer should have identified all of the risks involved in using the device. Then, they must have done their best to mitigate those risks before their...
A COMPLETE OVERVIEW OF SMART MEDICAL DEVICES, THEIR DEVELOPMENT AND THEIR COMPLIANCE CONSIDERATIONS. While the Internet of Things offers great opportunities both for businesses and consumers, compliance and security must be thought through carefully from the very...
On October 2018, the MITRE Corporation and the Food and Drug Administration released their joint document, Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook. This is the new Bible for organizations designing and manufacturing connected...
In our last article we talked about the four steps your organization must go through when designing secure connected medical devices. With the increasing attention paid to product security in this era of connected medical devices, many companies are scrambling to keep...
SPK and Associates co-founder Chris McHale speaks with PLM expert Oleg Shilovitsky, founder of BeyondPLM.com, to get his insight on the difficulty of BOMs across engineering disciplines.
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...
The Internet of Things is revolutionizing the medical device field. However, it’s also introducing new compliance headaches. What’s more, large-scale medical hacks loom large in the background. Medical device manufacturers can’t ignore the Internet of Things, but nor...
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...
Overview In 2015, SPK and Associates co-founder Chris McHale spoke with Peter Thorne, Director at Cambashi, a Cambridge, England-based independent industry analyst firm. With his over 30 years of experience as a software engineer user, vendor, and now analyst, Peter’s...
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;...
