28 min listen
Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey
FromGlobal Medical Device Podcast powered by Greenlight Guru
Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey
FromGlobal Medical Device Podcast powered by Greenlight Guru
ratings:
Length:
25 minutes
Released:
Nov 7, 2019
Format:
Podcast episode
Description
In episode 10 of the Global Medical Device podcast we welcome Matt Romey from the Azzur Group. Matt is a project manager for the Azzur Group and has been involved with many medical device projects. He was a founding employee and executive team member at GluMetrics, a venture-backed startup that raised over $67M.
Matt has 20 years experience in the medical equipment design industry and has plenty of knowledge to share with new startups. During today’s conversation Matt and Jon will discuss the importance of Design Controls, which they both share a passion for.
"Design controls are yes, required by law, but they also represent good business practices." - Matt Romey
Matt believes so much in the importance of design controls that at one of his companies he had a line from the FDA Design Control guidance document taped to his wall that stated, “It is a well established fact that the cost to correct design errors are lower when errors are caught earlier in the design and development process.”
"The 1 - 10 -100 rule. That's where if you catch it early in the process it may cost you a dollar to fix, then a little bit later in the process it will be maybe 10 dollars. Once you get into production... 100 dollars." - Jon Speer
The most important thing to keep in mind while working on medical device design is user needs. These user needs will guide you to the right questions so that design inputs are effective and relevant.
Today’s highlights include:
● Matt explains how good quality design control is just part of good business practices.
● You will hear why the classic “waterfall diagram” may not be the best guideline for a project.
● Why when you find design inputs, they need to be testable.
"Design inputs should be a translation of your user needs to some sort engineering specification that can be measurable." - Matt Romey
Matt has 20 years experience in the medical equipment design industry and has plenty of knowledge to share with new startups. During today’s conversation Matt and Jon will discuss the importance of Design Controls, which they both share a passion for.
"Design controls are yes, required by law, but they also represent good business practices." - Matt Romey
Matt believes so much in the importance of design controls that at one of his companies he had a line from the FDA Design Control guidance document taped to his wall that stated, “It is a well established fact that the cost to correct design errors are lower when errors are caught earlier in the design and development process.”
"The 1 - 10 -100 rule. That's where if you catch it early in the process it may cost you a dollar to fix, then a little bit later in the process it will be maybe 10 dollars. Once you get into production... 100 dollars." - Jon Speer
The most important thing to keep in mind while working on medical device design is user needs. These user needs will guide you to the right questions so that design inputs are effective and relevant.
Today’s highlights include:
● Matt explains how good quality design control is just part of good business practices.
● You will hear why the classic “waterfall diagram” may not be the best guideline for a project.
● Why when you find design inputs, they need to be testable.
"Design inputs should be a translation of your user needs to some sort engineering specification that can be measurable." - Matt Romey
Released:
Nov 7, 2019
Format:
Podcast episode
Titles in the series (100)
Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner: Standards are absolutely critical when you are developing a medical device. You need to understand why these standards are important when developing your product for your regulatory submission. You need to know what they are and understanding how to i... by Global Medical Device Podcast powered by Greenlight Guru