Medical imaging devices like MRI's, CT and X-Ray machines are extremely valuable. They're also extremely expensive. So expensive, in fact, that health insurance companies typically require a pre-authorization for an MRI scan to make sure that it's "medically justified." The market is currently estimated at about $40 Billion a year, with more spent on proprietary PACS (Picture Archiving and Control Systems) for storing and managing the systems.
The medical imaging market is highly regulated, with the design and construction of the devices subject to detailed requirements for how the hardware and software should be designed and built. The result of the regulations is that a small number of large companies control the market, effectively preventing innovation and new companies from entering the market.
There is a proven path towards opening the market to innovation and dramatic cost reductions, while improving quality. We should break the iron grip of monopolistic companies and harmful government control to enable a medical imaging revolution.
The Software industry case
Something similar happened in the software industry. IBM mainframe computers and software once owned the world. Everyone bought from IBM, and were then required to buy IBM software and applications. They worked, but were incredibly expensive. A government anti-trust suit broke some of their monopolistic power, and new mini-computers changed the game. Then with computers built on multiple microprocessors, low cost, high quality and performance with intense competition ruled the roost in the computer industry. Separate companies built each part of the new world; each competed to be the best.
The crowning touch was that for important parts of the software such as operating systems, open source software emerged and became the norm. Even IBM acknowledged this by porting the Linux open source operating system to its IBM mainframe computers.
What should happen in medical imaging
Medical imaging machines are like specialized mainframe computers. In addition to the physical hardware that does the scanning, there are processors with operating systems and application software. Software controls each step of the scanning process, collects the data, stores it and displays it. Today, every bit of that computer hardware and software is built by the hardware supplier. Just like it was for IBM mainframes before the anti-trust suit.
The big difference is that no government agency exercised control over the details of how the IBM software was designed and built. Sadly, ignorant bureaucrats at the FDA exercise total control over this process, as I detail here. They require the use of methods that are so old and bad that even giant corporations have long-since moved on for their unregulated software.
The argument is that this is about your health. Do you want imaging devices that don't work or give bad results? The FDA performs the essential function of guaranteeing quality and safety, they say.
What they actually do is the equivalent of demanding that only hand saws be used for turning trees into lumber and refusing to allow nails or hammers to be used in house construction. Of course it can be done. But people using modern tools get far better results faster at lower cost. There is a simple way the FDA can assure quality, by shifting from lengthy HOW style regulations to simple WHAT style regulations as I explain here.
The Result
The result of this change will probably resemble what happened to IBM once their monopoly power was broken. IBM continues to this day to manufacture the successors of mainframe computers, now called the Z series. They support both their own operating system and a leading open source one. Applications that run on their systems are available from a wide variety of companies.
Similarly, major vendors such as GE and Siemens will continue to do what they do, but all of the hardware and software will be open to competition by both new and existing vendors, and possibly also by open source efforts. It's likely that Linux would be ported.
Image storage systems for imaging continue to cost many billions of dollars a year. They don't do much more than what you could with Dropbox or AWS S3 storage, for example. Each patient would have cloud folder that would hold all their records and images. The system would store each new file in the cloud, which would securely store it with full multi-site protection and backup. Sharing can be accomplished simply by creating and sending a link, something that can be done with a few lines of code or manually in seconds. The huge problem of medical imaging records storage and sharing that I demonstrated here would go away! Yes, you'd put some UI on top of the cloud storage to make it super-easy and not dependent on any one cloud storage vendor.
Conclusion
The essential and growing world of medical imaging and supporting systems form an indispensable part of modern medicine. It's long since time for them to catch up to the transformation of the computer industry four decades ago, dispense with harmful regulation and allow healthy competition to flourish. We would all benefit by the resulting increase in availability and dramatically lower costs. And yes, with better quality.
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