Why aren't more low cost Medical devices available easily and cheaply? Given the power/price ratio we have achieved with cellphones, why can't the same be done in the field of Medical devices?
For example, i was looking for a all-in-one monitoring device for an elderly patient and came across "PM6100" made by "Shanghai Berry Electronics" (https://shberrymed.com/products/patient-monitor-pm6100) Low-cost but still more expensive than many cellphones. These things should be commodity priced. It almost feels like there is some "organized cartel" preventing the invention and marketing of low-cost medical devices.
Red tape. Medical devices need to (depending on type and country) conform to medical device regulations, be approved by a medical device regulator, be sold only to medical professionals or people with a script from a medical professional. Liability in case something goes wrong because of your device is expensive, adversarial and dependent on crossing all the 'i's and dotting all the 't's. There are "lower levels" of this due to regulations being less for more harmless devices. E.g. you can nowadays get thermometer, pulse-oximeter or a blood pressure meter quite cheaply. But anything just mimimally more complicated or critical gets expensive very fast.
Reasons for this beside the red tape are imho the low number of customers (most slightly specialized medical devices are needed once per patient with $rare_disease, once per lab or once per doctors office), the high need for customization (one-size-fits-all doesn't even work for blood pressure cuffs, let alone prosthetics), localization (broken i18n can kill, most customers are elderly and therefore not as versed in engrish), higher component cost (sterilizable plastics are more expensive, bigger displays for vision-impaired elderly clients are more expensive) and acceptance of foreign/small/unknown manufacturers (won't trust my elderly mother's health to a device from "Corty's Refurbished Asbestos Plates, Health Equipment and Luxuries Ltd., Templestreet, HongKong (CRAPHEALLTH)").
There is also a cartel of each medical professionals, manufacturers, insurance companies/public insurance pools and politicians, complete with revolving doors, kickbacks, fake or real -but always suspiciously convenient- scientific data, and exclusionary legal situations. All cementing the status quo and the wealth and standing of all participants (except the patients' of course).
But anything just mimimally more complicated or critical gets expensive very fast.
"Critical" i understand, "Complicated" i dispute. Our existing technology has significantly brought down this threshold and it should no longer be a limiting factor.
There is also a cartel of each medical professionals, manufacturers, insurance companies/public insurance pools and politicians, complete with revolving doors, kickbacks, fake or real -but always suspiciously convenient- scientific data, and exclusionary legal situations. All cementing the status quo and the wealth and standing of all participants (except the patients' of course).
This is what i believe is the real reason. In fact sometimes i think i should spend the rest of my career/life to overturn the status quo with the help of professionals from the Open Source community many of whom would gladly spend their time and money in helping their fellow human beings get affordable healthcare.
These things couldn't be commodity priced (comparable to a smartphone) until they are manufactured at similar scale. You just don't need as much medical devices.
I don't buy this commonly given excuse at all. Companies like Omron/Rossmax etc. have made BP monitors dirt cheap (and now pulse oxymeters). Add a few more functionalities needed for patient monitoring, price accordingly and you have a market.
It is well within the capabilities of existing technologies (both HW and SW) and though there are stringent regulations i don't think they are the limiting factor. I am convinced the Companies involved in the manufacture of these devices (eg. GE Healthcare) are artificially keeping the prices of these high enough to deter widespread adoption.
though there are stringent regulations i don't think they are the limiting factor
This is exactly the limiting factor. I could build you a Pulse Ox device with a nice graph on a Raspberry pi in a few days/weeks quite easily and put it in a pretty case with battery power and connectivity to the internet and your phone if needed. A cool hobby project.
However, selling it as a Medical Device (those words have a specific meaning) will raise the price exponentially. Let's look at some of the things we need to take care of in order to keep the FDA happy.
Development process: the software & hardware needs to have been developed with a predefined process, with specific minimum steps taken and certain documentation needs along the way. This doesn't sound like a big deal until you realize just how much it can slow down the development process and add more cost. If I can't prove that those steps were all taken, then I have to create a validation process to prove that the part I bought off the shelf (like the Pi) is suitable for the task -- not a difficult thing to do, but all these little things add to the cost of producing something.
Supply chain: you need to be able prove the provenance of every item in your device back to the originating manufacturer. If the manufacturer changes something, there needs to be a mechanism so you can be alerted to evaluate if it has an impact on your product. No buying cheap parts from pulse0x7337 on Amazon.
Manufacturing: basically set out a process for building it and make sure there are no deviations from that process and be able to prove that you are always following that process.
Complaints: you need to have in place a method for users of your device to report issues with it and to be able to respond quickly and correctly, in some cases within a federally mandated time (if in the US) depending on how serious the complaint is.
Compliance: ensuring compliance with 21CFR is such a huge task that there are entire companies that are dedicated to doing this for you if you can't afford your own team.
Support: can't remember details off the top of my head but you are required to provide support for your device for xx years after you remove it from the market. This means the capability to answer user questions and perform repairs if needed.
So yeah, it might seem like an excuse, but it really isn't!
However the points you raise need not be that stringent towards "non-critical" and "mass use" medical devices. Add proper disclaimers to the sale of these devices and everybody benefits. In particular, the people in the developing world many of whom lack even the most basic medical support. Use these in the field (eg. underdeveloped villages) and at homes to get an approximate reading after which you can be referred to a proper diagnostic lab/hospital. Incidentally, some of these diagnostic labs in the developing world are a absolute scam with completely broken, unmaintained and error-prone devices. If the cost is brought down they can actually afford to buy decent devices.
For example, at one point you couldn't even afford home BP monitors and Pulseoxymeters. But now they are common place in particular the latter which before the Covid-19 pandemic were expensive. This in turn has resulted in the public getting better educated in learning to measure and monitor basic health signs which is very good.
In the end it's always a Regulatory issue depending on the regulations of the country where the device is sold. I'm sure there are countries where regulations are very lax, but those will tend to be countries where the market is tiny, so most reputable manufacturers will avoid them.
I guess what I'm trying to get at is that I think these Open Source Hardware/Software medical device projects are great. I really do. However people need to understand why they can't be considered the equivalent of a device that's built following the necessary regulations so they can make informed decisions about how they can be used.
the Companies involved in the manufacture of these devices (eg. GE Healthcare) are artificially keeping the prices of these high enough to deter widespread adoption
One of the ways this will happen is the regulatory burden required to bring a product to market, which they will be keen to keep in place as a competitive moat.
which they will be keen to keep in place as a competitive moat.
This is exactly it. Their size/money/monopoly gives them the advantage if they can keep "disruptive" competitors at bay by mere red tape/regulations/paperwork. Common business strategy but deplorable.
Comments
Why aren't more low cost Medical devices available easily and cheaply? Given the power/price ratio we have achieved with cellphones, why can't the same be done in the field of Medical devices?
For example, i was looking for a all-in-one monitoring device for an elderly patient and came across "PM6100" made by "Shanghai Berry Electronics" (https://shberrymed.com/products/patient-monitor-pm6100) Low-cost but still more expensive than many cellphones. These things should be commodity priced. It almost feels like there is some "organized cartel" preventing the invention and marketing of low-cost medical devices.
Red tape. Medical devices need to (depending on type and country) conform to medical device regulations, be approved by a medical device regulator, be sold only to medical professionals or people with a script from a medical professional. Liability in case something goes wrong because of your device is expensive, adversarial and dependent on crossing all the 'i's and dotting all the 't's. There are "lower levels" of this due to regulations being less for more harmless devices. E.g. you can nowadays get thermometer, pulse-oximeter or a blood pressure meter quite cheaply. But anything just mimimally more complicated or critical gets expensive very fast.
Reasons for this beside the red tape are imho the low number of customers (most slightly specialized medical devices are needed once per patient with $rare_disease, once per lab or once per doctors office), the high need for customization (one-size-fits-all doesn't even work for blood pressure cuffs, let alone prosthetics), localization (broken i18n can kill, most customers are elderly and therefore not as versed in engrish), higher component cost (sterilizable plastics are more expensive, bigger displays for vision-impaired elderly clients are more expensive) and acceptance of foreign/small/unknown manufacturers (won't trust my elderly mother's health to a device from "Corty's Refurbished Asbestos Plates, Health Equipment and Luxuries Ltd., Templestreet, HongKong (CRAPHEALLTH)").
There is also a cartel of each medical professionals, manufacturers, insurance companies/public insurance pools and politicians, complete with revolving doors, kickbacks, fake or real -but always suspiciously convenient- scientific data, and exclusionary legal situations. All cementing the status quo and the wealth and standing of all participants (except the patients' of course).
"Critical" i understand, "Complicated" i dispute. Our existing technology has significantly brought down this threshold and it should no longer be a limiting factor.
This is what i believe is the real reason. In fact sometimes i think i should spend the rest of my career/life to overturn the status quo with the help of professionals from the Open Source community many of whom would gladly spend their time and money in helping their fellow human beings get affordable healthcare.
These things couldn't be commodity priced (comparable to a smartphone) until they are manufactured at similar scale. You just don't need as much medical devices.
I don't buy this commonly given excuse at all. Companies like Omron/Rossmax etc. have made BP monitors dirt cheap (and now pulse oxymeters). Add a few more functionalities needed for patient monitoring, price accordingly and you have a market.
It is well within the capabilities of existing technologies (both HW and SW) and though there are stringent regulations i don't think they are the limiting factor. I am convinced the Companies involved in the manufacture of these devices (eg. GE Healthcare) are artificially keeping the prices of these high enough to deter widespread adoption.
This is exactly the limiting factor. I could build you a Pulse Ox device with a nice graph on a Raspberry pi in a few days/weeks quite easily and put it in a pretty case with battery power and connectivity to the internet and your phone if needed. A cool hobby project.
However, selling it as a Medical Device (those words have a specific meaning) will raise the price exponentially. Let's look at some of the things we need to take care of in order to keep the FDA happy.
Development process: the software & hardware needs to have been developed with a predefined process, with specific minimum steps taken and certain documentation needs along the way. This doesn't sound like a big deal until you realize just how much it can slow down the development process and add more cost. If I can't prove that those steps were all taken, then I have to create a validation process to prove that the part I bought off the shelf (like the Pi) is suitable for the task -- not a difficult thing to do, but all these little things add to the cost of producing something.
Supply chain: you need to be able prove the provenance of every item in your device back to the originating manufacturer. If the manufacturer changes something, there needs to be a mechanism so you can be alerted to evaluate if it has an impact on your product. No buying cheap parts from pulse0x7337 on Amazon.
Manufacturing: basically set out a process for building it and make sure there are no deviations from that process and be able to prove that you are always following that process.
Complaints: you need to have in place a method for users of your device to report issues with it and to be able to respond quickly and correctly, in some cases within a federally mandated time (if in the US) depending on how serious the complaint is.
Compliance: ensuring compliance with 21CFR is such a huge task that there are entire companies that are dedicated to doing this for you if you can't afford your own team.
Support: can't remember details off the top of my head but you are required to provide support for your device for xx years after you remove it from the market. This means the capability to answer user questions and perform repairs if needed.
So yeah, it might seem like an excuse, but it really isn't!
Nice writeup, appreciate it !
However the points you raise need not be that stringent towards "non-critical" and "mass use" medical devices. Add proper disclaimers to the sale of these devices and everybody benefits. In particular, the people in the developing world many of whom lack even the most basic medical support. Use these in the field (eg. underdeveloped villages) and at homes to get an approximate reading after which you can be referred to a proper diagnostic lab/hospital. Incidentally, some of these diagnostic labs in the developing world are a absolute scam with completely broken, unmaintained and error-prone devices. If the cost is brought down they can actually afford to buy decent devices.
For example, at one point you couldn't even afford home BP monitors and Pulseoxymeters. But now they are common place in particular the latter which before the Covid-19 pandemic were expensive. This in turn has resulted in the public getting better educated in learning to measure and monitor basic health signs which is very good.
In the end it's always a Regulatory issue depending on the regulations of the country where the device is sold. I'm sure there are countries where regulations are very lax, but those will tend to be countries where the market is tiny, so most reputable manufacturers will avoid them.
I guess what I'm trying to get at is that I think these Open Source Hardware/Software medical device projects are great. I really do. However people need to understand why they can't be considered the equivalent of a device that's built following the necessary regulations so they can make informed decisions about how they can be used.
One of the ways this will happen is the regulatory burden required to bring a product to market, which they will be keen to keep in place as a competitive moat.
This is exactly it. Their size/money/monopoly gives them the advantage if they can keep "disruptive" competitors at bay by mere red tape/regulations/paperwork. Common business strategy but deplorable.