Written by Eric Sugalski

In the complex world of medical device development, one area that often causes confusion is understanding the division of responsibilities between design, quality, and...

Many organizations believe that the Q-Sub process should be completed after a design is relatively mature. The belief is that sufficient technical detail needs to be shared to gain substantive...

Picture this -- you've raced to the airport and found yourself at the end of a massive security line. You do the truffle shuffle with shoes off, belt off, keys out, laptop out, while the security...

Written by Eric Sugalski

I know what you're thinking - this is a sales pitch in disguise. Not the case. The intention of this article is to help you understand when to steer clear of outsourcing....

Written by Eric Sugalski

Consider this analogy..  You are driving across the US, planning for a week to travel from coast to coast. With elevated gas prices you want...

Most of the time, quality (as in “quality management”) is only considered after a design concept is mature, if not finalized. Design control, document control, risk management –...

- Written by Aidan Hyde & Eric Sugalski

Defining the right use case, ensuring a positive user experience, and mitigating user related risks are critical parts of the medical device design...

- Written by Sam Menasha & Eric Sugalski

Most medical device companies operate using the waterfall method. But most medical device companies don’t operate as quickly as they could or...

What is your manufacturing strategy? There are several options to consider. Sometimes it makes sense to engage a large CMO early, whereas other times it makes sense to launch manufacturing with a...

Most companies run product development under the Hero model. This is where a highly experienced medical device developer gives play-by-play direction on product development...

Medtech teams have a critical decision to make at the early stages. Should the strategy be to build a robust in-house team or leverage outsourced experts to achieve medtech milestones. Here's...

Written by Eric Sugalski

Meetings. When you hear the word, what comes to mind?

You're probably imagining a large assembly of colleagues listening to a self-promotor...