I know a guy who got a $500,000 grant to make FDA data easier to search. As it neared completion, it was scuttled by two employees whose jobs would be jeopardized.

Infuriating.

So the answer to “which is the most frustrating FDA database” is probably:
“whichever one you’re using today.”

I think I found a solution and I’m inviting you along to discover it with me.

If my understanding of the product is right, compiling and analyzing FDA data will be so much easier.

Navigator from Reed Tech

I signed up for a product demo and set it up so you could join me on the call. Please join me for the live demonstration.

It will be on December 11 at 2 p.m. Eastern Daylight Time, recorded for later viewing.

Navigator saves search time and effort

Again, as I understand it, Reed Tech built a platform to make using FDA data much easier. They pull in data from:

• MAUDE (adverse event reporting)
• The FDA recall database
• Device approvals and clearances (for 510(k)s, HDEs, PMAs, and de novos)
• The product classification database and
• The GMDN database

They also use data from the GUDID and device listings databases behind the scenes.

What’s the big deal?

If you routinely access FDA databases, you know it’s a hassle searching multiple sites and matching the data up get a holistic view of the issue.

Navigator lets you look up by product to get everything you need: Adverse events, recalls, approvals and clearance information associated with that product. You can also compare to the industry for all those data points.

If you don’t use FDA databases, here’s how that data can help you:

1. Risk management. See if there are recalls for your or your competitors products. If a competitor’s product failed, your product might also, depending how similar they are. So you need to plan for that. Or if you’re in the design stage, you might invent a way to avoid that failure.

   You can also set up alerts and get notified by email for adverse events, new recalls, and new device problems.

   

2. Post-market surveillance. Similar to risk management but focuses more on your product (versus competitors’). See industry trends.

3. Regulatory intelligence. Search directly for 510(k)s. You can search by intended use and indications for use. That’s helpful for predicate searching. You can discover successors to predicates as well.

FDA data is more than regulatory and quality

Other uses for FDA data:

Legal and Insurance. For product liability and product lawsuit research. Is this a product they want to insure?

Medical device investors. For due diligence. Anything lurking there in product quality? Industry trends?

Healthcare providers. For due diligence. Anything you should know before you approve that capital investment? Are you sure the product has been cleared by FDA? Are there any active recalls in that category? Any usability issues?

That registration link again

If you’d like an easy way to use FDA data, click here to join our call.

Special thanks to Rachel Benway for the education.

I’m looking forward to the demo and I believe Reed Tech will be at the 10x Medical Device Conference in May.

Three FDA Safety Stories

Thanks to Robyn Barnes and Ken Smyth for bringing these to my attention.

• Updates to Medical Device Safety Action Plan to enhance post-market safety. Click for the Nov 20 press release. Of note, new funding for the National Evaluation System for Health Technology (NEST), and an emphasis on women’s health.

  From the release, “In particular, we’re focusing on addressing clinical questions on device therapies that are unique to women, such as treatment of uterine fibroids, pelvic floor disorder, female sterilization and long-acting reversible contraception.”

• Breast Implant Cancer Risk. As reported by NBC Nightly News, “A cancer of the immune system linked to breast implants called a ALCL, was only first identified by the FDA in 2011, who now new fears it’s an emerging risk.”

• Steps to Modernize the 510(k) Program for Safety and Effectiveness. Click for the Nov 26 press release. Of note, FDA believes manufacturers will gravitate toward de novo applications.

  From the release, “To be clear, we don’t believe devices that rely on old predicates are unsafe, or that older devices need to be removed from the market.

  However, we believe encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device.

  It would promote greater competition to adopt modern features that improve safety and performance, and help make sure newer devices reflect more modern technology and standards that can improve patient care and outcomes.”

+++

In Other News: Crispr Babies!

After regular IVF (after sperm inseminated eggs), an embryologist sent in CRISPR/Cas9 protein and instructions to perform a gene surgery intended to protect the girls from future HIV infection.

As I understand it, it’s the first reported case of gene surgery in embryos intended for pregnancy.

+++

Thank you for being part of our Medical Devices Group community!

If you’re looking for work, check out the newly posted jobs here!

Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. I probably spent more time on this post (eight hours?) than any in my seven-year history with the Group. If you appreciate it, email me or – better yet – spread the word! Tell colleagues to join our community. Invite them to the December 11 webinar, perhaps!