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Improving Lives for a Better World, One Device at a Time

Thought and Commentary for the Medical Device Industry

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Don't Govern to the Bottom Performer

August 19, 2019 | Posted by Dan Purvis
When it comes to day-to-day operations, we don't need a bunch of rules to police the bottom performer. The only rules we have exist to motivate and inspire the top performer. To combat “rule...

Introduction to Design Controls

August 15, 2019 | Posted by Ben Trombold

The Values

August 12, 2019 | Posted by Dan Purvis
  Seven years ago, Tim Carroll, myself, and one other leader sat in a room with a blank whiteboard. I asked them, "Give me the names of any hero in your life. Friends, family, colleagues, people...

Introduction to Velentium Culture

August 5, 2019 | Posted by Dan Purvis
  In this blog series, Dan Purvis, Velentium’s CEO and Co-Founder, will walk you through the fundamentals of how he has built a company from the culture up.

7 Additional HFE Resources

August 1, 2019 | Posted by Mark Kraft
When developing a new device using Human Factors Engineering (HFE), researching known use- and design-related issues and hazards that have already been identified for devices similar to yours – or...

Configuring Parasoft for Secure Development of Medical Devices

July 29, 2019 | Posted by Satyajit Ketkar
Welcome back to our final installment of the series on Static & Dynamic Analysis, including Unit Testing. This last blog post will focus on the basics of the Parasoft testing tool, as well as...

Human Factors Validation Testing

July 25, 2019 | Posted by Mark Kraft
In our previous posts, we looked at the importance of integrating human factors engineering (HFE) processes throughout product development. FDA approval for your device may require a Human Factors...

Introduction to Dynamic Analysis

July 22, 2019 | Posted by Satyajit Ketkar
Welcome back to our series on static & dynamic analysis and unit testing. In this post, we discuss dynamic analysis, which is when you actually execute the program on a real or virtual machine to...

Human Factors Engineering: Reorder for Safety

July 18, 2019 | Posted by Mark Kraft
As we resume our discussion of Human Factors Engineering (HFE) for medical devices, it's worth repeating that HFE should be thoroughly incorporated into the development process. HFE is about...

Static Analysis Regulations, Standards, & Best Practices

July 15, 2019 | Posted by Satyajit Ketkar
Welcome back to our series on Static & Dynamic Analysis, including Unit Testing. Our previous post provided a brief introduction to static analysis, what it is, and how it has developed. Today...

An Introduction to Human Factors Engineering for Medical Devices

July 11, 2019 | Posted by Mark Kraft
When it comes to medical device safety, having fully-integrated human factors engineering (HFE) processes in place throughout development is absolutely critical.

Introduction to Static Analysis

July 8, 2019 | Posted by Satyajit Ketkar
Regardless of industry, any company writing code understands the need for standardization and proof-checking, and the medical device sector is no different. What is different is the emphasis on...

Four Goals of a Valuable QMS

July 1, 2019 | Posted by Randy Armstrong
The principal objective of a QMS for a medical device company is patient safety. Patient safety is well understood and communicated throughout the medical device industry, leading to an almost...

Root of Trust #10 - Why BLE?

June 27, 2019 | Posted by Chris Gates
There are a large number of wireless solutions available, each with their own positive and negative attributes. Identifying the optimum wireless choice to employ for a given use case is critical...

Simple is Hard, but Simple is Worth it

June 24, 2019 | Posted by Randy Armstrong
In the second blog post in this series, we explained that a lean QMS results in less complicated devices, which in turn decreases development time, cost, and, in many cases, patient risk. Less is...

Root of Trust #9 - An Uncomfortable Question

June 20, 2019 | Posted by Chris Gates
The other day I was participating in an InfoSec working group when one of the participants asked a pertinent and uncomfortable question:

Standards-centric vs. Product-centric in Lean QMS

June 17, 2019 | Posted by Randy Armstrong
In the 4th part of this series, we are going to talk about the differences between a QMS that is standards-centric and one that is product-centric.

Root of Trust #8 - It's All About the Vulnerabilities!

June 13, 2019 | Posted by Chris Gates
What should we in the world of Embedded InfoSec be focused on?

Balancing Empowerment Against Control in a Lean QMS

June 10, 2019 | Posted by Randy Armstrong
In the 3rd part of this series, we address how to balance empowering a design team to create a medical device that provides safe and effective therapy or diagnostic, while still ensuring adequate...

Root of Trust #7 - Lightening the Load for End Users

June 6, 2019 | Posted by Chris Gates
I recently attended a presentation on “Risk-based Cybersecurity”. I’ll admit I was skeptical before I even sat down - the title sounded like it was going to be a way to paper over ‘doing nothing’...

Developing a Lean QMS

June 3, 2019 | Posted by Randy Armstrong
Implementing a lean QMS is not about cutting corners. It is about corporate focus, which in our case means being risk-driven to create safe and effective devices as quickly and cost-effectively as...

Root of Trust #6 - Collapsing SEP: the Hitchhiker's Guide to Securing the Galaxy

May 30, 2019 | Posted by Chris Gates
I just returned from a large trade show (it doesn’t matter which industry this was, this applies to almost all of them), and was struck by what Douglas Adams, author of The Hitchhiker’s Guide to...

Introduction to Lean QMS

May 27, 2019 | Posted by Randy Armstrong
In the medical device industry, every company knows the necessity of a Quality Management System (QMS) for managing internal processes and tracking work to regulatory requirements. Many companies...

Root of Trust #5 - How Safe are your Firmware Over-the-Air Updates?

May 23, 2019 | Posted by Chris Gates
“Firmware Over the Air” updating, also known as FOTA or sometimes OTA, is a double-edged sword when it comes to security.

Transformational Leadership - Teachability and Speed

May 20, 2019 | Posted by Dan Purvis
At Velentium, we place a high value on quick learners who are resourcefully able to teach themselves and learn quickly from others how to rapidly work through problems until a solution is found....

Root of Trust #4 - InfoSec Mythbusting

May 16, 2019 | Posted by Chris Gates
Like any organized activity, InfoSec has its share of myths. These things are like “idea zombies” because they just don’t die. Here are a few of the more pernicious ones I’ve encountered:

Transformational Leadership - Challenge Skeptics to Invest

May 13, 2019 | Posted by Dan Purvis
Whether your team is floating new ideas during a brainstorming session or seeking approval on a controversial proposal, skepticism is inevitable. But is skepticism an obstacle... or an opportunity?

Root of Trust #3 - What's In a Name?

May 9, 2019 | Posted by Chris Gates
“What's in a name? That which we call a rose by any other name would smell as sweet.”

Transformational Leadership - What is Leadership?

May 6, 2019 | Posted by Dan Purvis
A 2017 business journal article asked, “How can you be a good leader if you don’t know what leadership really is?” In an effort to answer this question, the article attempts to synthesize from...

Root of Trust #2 - Cybersecurity for MIS/IT vs. Embedded Systems

May 2, 2019 | Posted by Chris Gates
Embedded device cybersecurity is relatively new compared to our friends with the “big iron” in Managed Information Systems (MIS), so while there are many differences between the two domains, there...

Transformational Leadership - Navigating Miracles

April 29, 2019 | Posted by Dan Purvis
Sometimes, your boss or client will ask for a miracle, such as a deliverable before you're ready. Like many of us, you'll probably feel tempted to avoid conflict and nod agreement. Under pressure,...

Root of Trust - Introduction

April 25, 2019 | Posted by Chris Gates
Welcome to my first blog posting on Embedded Systems Security.

Transformational Leadership - Acknowledge Who You're Not

April 22, 2019 | Posted by Dan Purvis
It may feel counter-intuitive, but referring potential clients to companies that operate just outside your specialty or overlap with you can actually be a great way to build your network, develop...

Agile Development for Medical Devices - Part II

April 18, 2019 | Posted by Jason Swoboda
Our last agile development post focused on the big picture: when, how, and why to depart from the classic waterfall development model in favor of lean and agile practices. But what does that look...

New FDA Pre-Market Submission Guidelines for Cybersecurity in Medical Devices - Part VII - Cybersecurity Documentation Required for Submission

April 15, 2019 | Posted by Ben Trombold
Welcome to the final installment of our breakdown of the new FDA cybersecurity standards In this post, we’ll look at required documentation manufacturers need to include in their premarket...

Agile Development for Medical Devices - Part I

April 11, 2019 | Posted by Jason Swoboda

New FDA Pre-Market Submission Guidelines for Cybersecurity in Medical Devices - Part VI - Cybersecurity Labeling

April 8, 2019 | Posted by Ben Trombold
Labeling is any written text that identifies any part of a medical device. This includes a label directly on the device, user manuals, instructions for use (IFU), labels present on the outside of...

Quality Management for Software as a Medical Device

April 4, 2019 | Posted by Sean Carroll
Successful quality management for Software as a Medical Device (SaMD) will have 3 preeminent distinctives:

New FDA Pre-Market Submission Guidelines for Cybersecurity in Medical Devices - Part V - Trustworthy Devices (Cont'd)

April 1, 2019 | Posted by Ben Trombold
Welcome back to our continued breakdown of the new FDA Cybersecurity guidance. In this post, we will conclude our analysis of the “Trustworthy Devices” section of the document.

A Summary of Medical Device Standards - Part IV - Digging Deeper: How to be Compliant

March 28, 2019 | Posted by Tim Carroll
Part 820 is wide-reaching. In order for a medical device company to fully understand what compliance with Part 820 means, further elaboration is required. Two of the most important areas this...

New FDA Pre-Market Submission Guidelines for Cybersecurity in Medical Devices - Part IV - Trustworthy Devices (Cont'd)

March 25, 2019 | Posted by Ben Trombold
This post resumes our discussion of the FDA’s new cybersecurity guidance for medical devices surrounding the design and development of trustworthy devices.

A Summary of Medical Device Standards - Part III - Earning (And Keeping!) FDA Approval for Your Device

March 21, 2019 | Posted by Tim Carroll
FDA approval can be achieved in two ways: The 510(k) process, in which the manufacturer must provide evidence that the device they intend to market is “substantially equivalent” to a device...

New FDA Pre-Market Submission Guidelines for Cybersecurity in Medical Devices - Part III - Trustworthy Devices

March 18, 2019 | Posted by Ben Trombold
Designing and developing trustworthy medical devices, according to the new FDA guidance on cybersecurity, will be our focus for the next two posts. 

A Summary of Medical Device Standards - Part II - Understanding CFR Part 820

March 14, 2019 | Posted by Tim Carroll
CFR Part 820, often referred to as simply Part 820, delineates the requirements for a quality management system that must govern the design and manufacture of any device sold in the United States....

New FDA Pre-Market Submission Guidelines for Cybersecurity in Medical Devices - Part II

March 11, 2019 | Posted by Ben Trombold
Our first topic concerns classification of medical devices according to the new FDA guidance. Two separate tiers of classification are described:

A Summary of Medical Device Standards - Part I - Know Your Bodies

March 7, 2019 | Posted by Tim Carroll
Federal standards governing the safety and efficacy of medical products have been overseen in the United States by the FDA since the original 1906 Food and Drugs Act. The approach to medical...

New FDA Pre-Market Submission Guidelines for Cybersecurity in Medical Devices - Part I - Introduction

March 5, 2019 | Posted by Ben Trombold
FDA 2016 Guidance on Cybersecurity within Medical Devices

Know Your "Why"

June 20, 2017 | Posted by Randy Armstrong
At the outset of a project, natural momentum will tend to move engineering and development teams very quickly from “What” (problem and requirements) to “How” (methods and solution details). This...
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