I love a scavenger hunt as much as the next person.
However, when it comes to medical device documents and records, your system and approach should not be the makings of a scavenger hunt.
Whether you have been through this before or if this is the first time, I want you to take a few moments to consider the importance of the documentation of your medical device company.
"Medical device Design Reviews are critical steps within your design and development process.
They provide a systematic assessment of the current state within your product development process.
It's a necessary forum that allows your team to evaluate the designs, voice and resolve concerns, provide feedback, and assess the overall progress of the project itself.
The Design Reviews process serves a gatekeeper, a checkpoint, where your team decides to move forward, or go back, or stop all together."
Okay, that much is pretty straight forward.
But what is not nearly as clear are questions like…
Risk management will have the most significant impact on the medical device industry within the next 10 years.
Design Reviews are critical to the success of medical device product development.
So much so that the infamous Design Controls waterfall diagram shows a design review after every major design control stage.
Interestingly, there are a couple of schools of thought when it comes to the frequency of Design Reviews.
The “less is more” and the “more is better”.
Which camp are you in?
Medical device companies MUST have established risk management processes that comply with ISO 14971.
And it doesn't matter if you are developing medical devices in the U.S., EU, Canada, and so on.
EVERY INTERNATIONAL REGULATORY AGENCY YOU’VE EVER HEARD OF ACCEPTS ISO 14971 AS THE RISK MANAGEMENT STANDARD FOR THE MEDICAL DEVICE INDUSTRY.
ISO 14971 is a good standard. Informative and descriptive. Easy (enough) to comprehend.
Let's do a brief walk-through of the standard in plain English and provide an overview of key definitions and concepts.
Medical device product development and risk management are often treated as entirely separate processes.
Sure, there is usually acknowledgement and understanding that these two processes are related.
But it is important to realize that product development and risk management are more than just related.
These processes both have the same overall purpose and intent: to help make sure medical devices are designed, developed, and manufactured to be safe and effective.
Medical device design reviews - are more or less better?
What about independent reviews? Are they necessary? How do you get one done?
These are a few of the topics we touched upon in episode 3 of the Global Medical Device Podcast, How To Improve Your Medical Device Design Reviews.
And they seem to have struck a nerve.
That’s why today, we’re excited to release our first bonus episode, 3.5, so that we could expand upon these topics for you.
One area deals with getting those independent reviews of your product done and the other concerns comments about slowing down during the product development process.
Jon Speer and Michael Drues Ph.D. felt they owed it to you to explore these topics on a deeper level in this bonus episode of theGlobal Medical Device Podcast.
How much does it cost to address FDA 483 observation and warning letter issues?
Unless you have been through this, you probably have no idea.
Maybe you are involved with medical device product development and don’t think a FDA inspection is anything you need to be worried about.
You would be wrong.
And it might cost your company $400,000 to find out.
This is a story I recently heard from a medical device startup who lost over $400,000 dealing with the aftermath of a FDA inspection.
Risk management for medical devices from a regulatory and product development perspective is the topic of today’s podcast.
We take a look at a few tools to help in the process and liability as it relates to on-label vs off-label use (Some really interesting points on this topic).
I’d like to take a few minutes to share with you a story.
One where a CEO of a medical device startup does not seem to appreciate the time, effort, and energy his team is about to spend documenting Design Controls, Risk Management, and a Quality Management System.
While the names have been changed, these events are true . . .
Over the past several years, FDA has been more aggressive and active in performing medical device company inspections.
This has lead to a far greater number of companies receiving form 483 warning letters and citations.
483's are a good way for your medical device company to flush $400,000 down the drain.
Has it been a few years since your last inspection? You know an FDA inspection will happen.
FDA could call tomorrow to announce their plans to visit your facility next week.
Would you be prepared?
What do you need to do to get ready?
In today’s episode of the Global Medical Device Podcast Jon Speer welcomes Sara Naab to the show.
Sara is the co-founder and director of quality and marketing for Sandstone Diagnostics.
Sara shares with us insights into what it has been like going from idea, to raising funding, to being name one of the 40 most innovative life sciences companies in the Bay Area.
Pretty impressive and interesting stuff.
What are the most common mistakes a startup medical device company usually make?
Hear Ronny Bracken candidly disclose how to avoid some very expensive lessons when starting out in the medical device business.
With his 26 years of Research and Development experience for medical product development at the executive level, he will show us how to avoid a $20 million haircut on your valuation because your design controls and quality system are not up to speed.
This article was orginal published on Med Device Online.
Risk assessment and risk management in the medical device industry typically start with a brainstorming session.
Members of the product development team sit down together, start randomly rattling off riks as they come to mind, and write them all down on a piece of paper.
I call this the "cherry-picking" approach to risk, because it is an almost haphazard process.
Regardless of whether you spend an hour or a year brainstorming on risk, in the end you can never be certain you have captured all the potential risks.
What I am about to share with you is a guide to medical device regulatory classification.
In this guide, I will provide you with a step-by-step approach for determining how your medical device will be classified by U.S. FDA, European Commission, and Health Canada.
Getting a basic understanding of regulatory product classification will be invaluable to your efforts to bring new products to market.
Did you know that over 50% of medical device companies still use manual, paper-based approaches for managing documents and records?
It’s time to consider a new approach.
It’s 2015 and manual, paper-based approaches to managing documents and records for your medical device company are fraught with issues and “gotchas”.
On today's episode of the Global Medical Device Podcast, we’re discussing how startup entrepreneurs like you can remove the common regulatory obstacles your business faces and other tips and pointers you can use when developing new medical devices.
Our guest today – Mitch Levinson– is the CEO of Cerebrotech Medical, and with over 30 years experience as a startup CEO and executive for companies that have IPO'd like ZELTIQ Aesthetics and Thermage, he knows all about the ins and outs of FDA regulation.
