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Comment by wcedmisten | Hacker News Reader

Hey everyone! Author here, happy to answer any questions about this project!

I'm not sure how this would translate into a query, but have you thought about analyzing the longest chain of devices and comparing their PDFs? I feel like that would potentially demonstrate the game-of-telephone effect you're getting at.

That's a good idea! There's actually a paper [1] that does something very similar with the "device description" and "indications for use" sections. They use Word2Vec on these sections and compare similarity.

Fig 2 [2] shows a graph of similarity of all devices to their predicate for each year.

However the discussion sections mentions difficulty with using Word2Vec because of the jargon used to describe these devices, so I'm not totally sure how to interpret the graph.

[1]: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8496833/

[2]: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8496833/figure/...

Do you think it's any better in Europe?

I'm not super familiar with the regulatory landscape in Europe, but I did find this article [1] while I was researching for this project.

I believe the EU has a similar pathway (in the EU Medical Device Regulation) for new devices relying on equivalence to a predicate, but the requirements for demonstrating equivalence are a higher bar. Joint prostheses (like the one causing cobalt poisoning in the US) are not allowed through this process in the EU.

[1]: https://www.sciencedirect.com/science/article/pii/S002013832...

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