Naveen Agarwal, Ph.D.

Let’s Talk Risk! is all about connecting, sharing and learning together. Because there is more than one way to manage risk and no one has all the answers.

[Naveen Agarwal, Ph.D. @Lets_Talk_Risk]

@DeviceEvents Thank you, makes sense. I do see under-reporting as an issue in many warning letters. I wonder how widespread this problem is across the industry and if FDA is really taking serious action against these violations.

[Naveen Agarwal, Ph.D. @Lets_Talk_Risk]

I hate jargon - that is why I take time to clarify terminology in my Let's Talk Risk! conversations.
This one is about the subtle, but important difference between AI and ML.

[Naveen Agarwal, Ph.D. @Lets_Talk_Risk]

@DeviceEvents @propublica @UCSF_HVC @SenatorDurbin @ConsumerReports Thank you for sharing, I saw it this morning. FDA cites a "sharp increase" in the number of MDRs reported recently compared to the prior 3 years. FDA needs to move from passive to a more active and responsive surveillance system quickly. What happened to NESTcc?

[Naveen Agarwal, Ph.D. @Lets_Talk_Risk]

This Thanksgiving, I am thankful to the 1200+ members of the Let's Talk Risk! community for their support and active engagement.

Generously sharing our own challenges and insights is helping all of us get better at risk management.

It is working.

[Naveen Agarwal, Ph.D. @Lets_Talk_Risk]

Since we practically cannot do anything about off-label use of our medical device, there is no need to include it in our risk analysis.

[Naveen Agarwal, Ph.D. @Lets_Talk_Risk]

If you are surprised to “wake up to 1000 followers”, you didn’t believe you had anything worth sharing with 1000 people.

Start believing in yourself.

Have something worthwhile to say.

Followers will come in time.

[Naveen Agarwal, Ph.D. @Lets_Talk_Risk]

https://t.co/58vRvWU5jq

[Naveen Agarwal, Ph.D. @Lets_Talk_Risk]

Let's Talk Risk!: It's time to start applying system safety to medical devices https://t.co/Wybt4kRkbV

[Naveen Agarwal, Ph.D. @Lets_Talk_Risk]

Who gets to decide whether a medicinal product is safe?

The FDA or a political hack?

Can’t believe we are having to confront this question.

[Naveen Agarwal, Ph.D. @Lets_Talk_Risk]

Let's Talk Risk!: When compliance leaves the customer stranded https://t.co/PAEGvpPdkn

[Naveen Agarwal, Ph.D. @Lets_Talk_Risk]

@princsaz Thank you for sharing! I hope you find it useful.

[Naveen Agarwal, Ph.D. @Lets_Talk_Risk]

Let's Talk Risk!: It's time to start applying system safety to medical devices https://t.co/Wybt4kRkbV

[Naveen Agarwal, Ph.D. @Lets_Talk_Risk]

Regulatory requirements often feel like taxes.

They seem to only go up.

[Naveen Agarwal, Ph.D. @Lets_Talk_Risk]

@QARACG @FDADeviceInfo @US_FDA How did they get on the market in the first place?

[Naveen Agarwal, Ph.D. @Lets_Talk_Risk]

What I would like to know is how these devices were on the market in the first place.

[Naveen Agarwal, Ph.D. @Lets_Talk_Risk]

Expand your toolbox.

Use the right tool for the job.

[Naveen Agarwal, Ph.D. @Lets_Talk_Risk]

It is not useful to use a microscope when you need a telescope.

[Naveen Agarwal, Ph.D. @Lets_Talk_Risk]

That is exactly what you are doing when you start your risk analysis with an FMEA rather than hazard analysis.

[Naveen Agarwal, Ph.D. @Lets_Talk_Risk]

Risk is not a four letter word.

[Naveen Agarwal, Ph.D. @Lets_Talk_Risk]

You should put your money where your mouth is.

That is why today I am making a pledge to invest in Substack when they start their next round of fundraising.

#substack

[Naveen Agarwal, Ph.D. @Lets_Talk_Risk]

Let's Talk Risk!: Medical Device News Update - February, 2023 https://t.co/j0vRiCmwdt