Implanted medical devices from companies that go under or discontinue them have a major impact on the humans those devices have been implanted into. How do we mange this as a society in ways that doesn’t inhibit innovation and progress?
Imagine you’ve got a high-tech implant in your retina that gives you a crude but effective form of vision. Now imagine the company that produced the implant suddenly goes out of business, and will no longer service or fix your implant
Glenn Zorpette, on twitter
He’s referencing this article:
THEIR BIONIC EYES ARE NOW OBSOLETE AND UNSUPPORTED
Second Sight left users of its retinal implants in the dark
spectrum.ieee.org, (article)
I read this article last night and I’ve been thinking about it ever since. I don’t have an answer I’m convinced is complete yet, but it does seem like this situation represents a strong vote for FDA approval of medical implant requiring an implant meet the following standards:
- Right to Repair requirements
- Open Source Hardware
- Open Source Software
But how do we do that in a way that doesn’t prevent companies making the massive R&D effort and incurring the corresponding expense to create these devices despite these requirements? Companies and investors will likely feel they’ll have insufficient time to earn back their investment, let alone the profit investors want, if their work can just be easily copied because it’s open source hardware/software.
I don’t have an answer, but the following come to mind as possibilities. I encourage you to add any practical ideas you have to the comments below.
- Federal R&D grants for companies that are working on products that meet these guidelines (pre-launch funding).
- R&D tax credits/incentives for companies that release products under this framework (pre- post-launch funding/incentives).
- Have the technology held in an escrow system for hardware & software source that automatically becomes public 5 years (say) after shipping the approved device so companies have time to make their investment plus profit back.
- Perhaps companies should be encouraged to patent what they create (discount the cost of that?) with a requirement that they also publish their hardware & software as open source restricted to non-commercial use only by others for as long as the company remain in business their patent is still in force (maybe limit patent duration to 10 years post product release or something)? They could still charge too much so as to make parts “available”, but not really available except to the super wealthy.
- Maybe only non-profit entities can make implantable medical devices for approval and they will be required to follow the guidelines above. Investors don’t “invest” in these companies in a traditional sense, but perhaps they can ‘donate’ the loan of capital with a maximum interest return specified by statute (or something like that).
Curious what ideas others have.
Seems like something we need to solve – probably through legislation, but I’m open to other ideas. If done via legislation, we need that legislation crafted by people who actually understand the technological and business dynamics sufficiently well and who care about the people in whom these implants are placed sufficiently more than a desire for profit; we want good laws that actually work and don’t inhibit R&D and innovation so much we make no forward progress but also don’t risk leaving patients out in the cold, suddenly unable to see.
Postscript
I did also think about how this isn’t the first such device – I have at least two friends/colleagues with pacemakers that have been surgically implanted into their bodies. So this isn’t an entirely new thing.
I’ve also been thinking about this in the context of electric vehicles – how many of the new electric vehicles / companies are going to go out of business or decide it’s not worth it for them to keep maintaining or supporting early models that didn’t sell well?
Do all those vehicles prematurely become garbage because the battery controller software is closed source and so can’t be updated to work with new battery technology? Or because the inverter goes bad and the specifications for it aren’t available any more and so no one can create an aftermarket replacement? Or vehicles that had too few for it to make financial sense for a third market parts manufacturer to bother? (See man blows up Tesla Model S because replacement battery is too expensive to justify).
I don’t think we can afford to be making so much garbage. There’s a lot of embodied energy in an EV and a massive level of promotion for people to switch to EVs from internal combustion engine (ICE) vehicles. Those ICE vehicles can be kept running for 20, 30, 40, even 50 years if they were popular when they were released and so third party parts manufacturers have figured out how to make parts for them.
Batteries in electric vehicles aren’t going to last even half the lower end of that spectrum.
This seems like an issue that needs to be addressed. Not as individually impactful as having your medical implant “End of Life’d”, but still.
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