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 spoke with PLM expert Oleg Shilovitsky, founder of BeyondPLM.com, to get his top three product lifecycle management (PLM) predictions for 2015. PLM vendors will encounter greater complexity when delivering cloud solutions New...
SPK and Associates co-founder Chris McHale spoke with PLM expert Oleg Shilovitsky of BeyondPLM, on the difficulty of BOMs across engineering disciplines. In part two of the discussion, they focus in on the difficulty of BOMs across the product life cycle.
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...
You need more than just an antivirus and security suite to keep your system safe. You need multiple, non-redundant solutions covering various aspects of network security. In our last blog, we discussed the role of whitelisting in keeping your network secure. Now we’re...
Security in the 21st century is a complicated game. The good guys are always playing catch up with the bad guys. Security is particularly important for medtech companies due to their specific compliance needs. Banking and fintech likewise have a high bar for security...
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...
In episode five of our podcast series "Can IoT Jump These Five Hurdles?", SPK's Director of Strategy, Rajiv Mistry, discusses systems standards and regulation challenges that could impede IoT's future growth and effectiveness. Think VCR v.s. Betamax or Blu-Ray v.s....
In the second episode of our podcast series "Can IoT Jump These Five Hurdles?", we transition from a broad introduction of these five hurdles to a deeper dive into each challenge facing the Internet of Things. Let's begin with the smart device itself and it's digital...
An important part of creating any product intended for use in the medical field is that the manufacturer should have identified all of the risks involved in using the device, and have done their best to mitigate those risks before their product ever sees a patient....
