ARTICLES BY JON SPEER
Determining Significant Vs. Nonsignificant Risk In Medical Devices
Knowing how to classify your device as either SR or NSR is not a clearly defined task. There are implications for each decision made as you proceed through development, and the burden is on you to understand and to provide what the FDA will require.
7 Common Mistakes That Sink FDA 510(k) Clearance
The 510(k) clearance process is often met with a mix of trepidation and anticipation by medical device companies, and medtech companies’ desire to bring products to market quickly can lead to a few common mistakes.
How to Prepare Your Design History File For An FDA Inspection
For some medical device companies, an FDA visit can be scary and stress-inducing — if you don’t have your ducks in a row.
4 Reasons Your 510(k) Submission Will Be Rejected (And How To Avoid Them)
After countless hours putting together your 510(k) submission, the last thing you expect is to get a rejection letter from the FDA. However the odds are against you — between January and June of 2015, 69% of 510(k) applications were rejected their first time. Here are four reasons why your submission might get rejected, and tips to avoid making these mistakes.
First-In-Human Studies - What's The Rush?
Today's medtech developers seem intent on getting to actual use -“first-in-human” (FIH) - as soon as possible. But, what motivates the race to FIH? Why is it so important and meaningful to quickly achieve that first actual use case of a new medical device? Furthermore, are the motivations guided in a way that aligns with safety and efficacy?
8 Reasons Design Controls And Risk Management Processes Fail
Year after year, design control deficiencies rank as the top reason medical device companies receive 483 observations; such deficiencies also rank in the top three reasons for warning letters. Most, if not all, of these FDA actions are avoidable. Let’s dive deeper into why your design control and risk management processes may be failing, and discuss what you can do about it.
Are Design Control Myths Holding Back Your Product Development?
“Make sure you document all those design controls,” said maybe no boss ever. You’re trying to meet aggressive deadlines, getting a new prototype ready for testing, or preparing for your animal study. But design controls exist to help your efforts, not to hinder them.
6 Development Steps To Fast-Track Your Medical Device's Path To Market
You have an idea for a new medical device. You could choose the traditional path of product development, or you could employ a different approach, one that engages and involves end-users along the way. One that incorporates the use of prototypes to help you discover what is meaningful and important.
The Design Controls + Risk Management Connection — Using Design Reviews Effectively
Design controls and risk management are key to the success of a medical device, in that they demonstrate that your product is safe and effective for its intended uses. In this installment, I will discuss best practices regarding design reviews, and how to incorporate risk management as a critical element helping to drive decisions.
The Design Controls + Risk Management Connection — Verification, Validation, & Risk Controls
The first article in this series addressed design control and risk management connections through intended use and user needs. Here, I’ll tie in the connections that medical device design inputs, design outputs, design verification, and design validation have with risk controls.