In layman’s terms, post-market data means regulators want to know how your market is doing in the marketplace. Christine Zomorodian and Anne Leijsen gave an easy-to-follow talk about it at the 10x Medical Device Conference in October, 2018.

Before we discuss their talk, I need to thank our sponsors for next month’s 10x Medical Device Conference because their sponsorship provides the margin I need to lower the price to just $695 for students, the unemployed, and select start ups. Thank you to:

	Greenlight Guru is a modern quality management software platform built exclusively for the unique needs of the medical device industry.
	LexisNexis Risk Solutions provides data and advanced analytics to help you reduce risk and improve your decision-making processes.
	The Douglas Group is a private investment banking firm focused entirely upon representing business owners in the buying and selling of companies.
	Adept Packaging specializes in packaging engineering and serialization, and provides engineering services, business process tools, and technology.
	Offit Kurman is one of the fastest-growing, full-service law firms in the Mid-Atlantic, with 170 attorneys representing every legal category.

 

Christine and Anne’s 22-minute video

Click here for the slides and here for the transcript.

A few key takeaways:

1. How do you conduct your post-market surveillance? Regulators require surveillance of device-related adverse events, use errors, product quality issues, and device failures.

   But do you: Simply evaluate risks then reporting adverse events (event-driven surveillance) or evaluate all product experience and fold back into the product development lifecycle (review-driven surveillance). You know which one is better. 😉

2. Is risk management a ‘new product thing’ for you? If you consider risk management only when you change to the product, that’s not going to cut it anymore. Anne reports, “Certain notified bodies no longer will accept your technical file without a post-market clinical follow-up plan.”
3. What’s a UEF? Christine advises you design a UEF (Usability Engineering File, a subset of your Design History File) to continuously monitor and address your usability issues. 62366-2 (the guidance that accompanies 62366-1) is a great roadmap for setting it up.
4. Wow. This is scary: Up to one-third of “device failures” are likely failures of device use rather than failure of the device itself, estimates FDA.Christine rattled off a lot of guidances you should know about (see slide 7).
5. Wow. Interesting. Clinicians think every failure that happens in a hospital is their fault. Your device has to shut down or smoke before they think it’s your fault. At most, 20% of incidents are reported, Christine says.

   Implications: Can you imagine what your complaint roster would look like if it were five times higher than it is today? 😰

A lasting impression. In some concluding remarks, Christine hit upon something you’d be wise to consider. I copy it here, verbatim:

In terms of really looking at what their post-market data is telling them, most companies are not there yet. And I think one of the reasons is the tools they’ve been using.

Most companies have a tool, it’s for collecting customer service information. They had people who were paid not a whole lot more than minimum wage sitting and answering the phones and putting the most important information they’re getting into a free text field.

So guess what happens? That gets dumped into a big file; and it gets sent over to complaints department; and they have to read through every single file; and they don’t have good buckets to put things into.

So what they’re pulling out is MDRs. What they’re pulling out is obvious device failures. Beyond that, I think most companies are not doing a very good job getting their arms around this data.

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Three weeks ’til 10x – $695 pricing (if you qualify)*

Here’s the countdown-to-10x video clip of the week. We throw these in between sessions to keep it fun.

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

Make it a great week.

Joe Hage
Founding Principal,
Medical Devices Advisory Group

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