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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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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...

Maintain Access Corridors for the Unfamiliar

June 4, 2017 | Posted by Dan Purvis
Deep immersion in a technical field is good and necessary in today’s world of hyper-specialization. How else would we develop expertise, hone skills, and discover the limits and possibilities of a...
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