Engineering for medical, automotive, and aerospace is highly regulated. It’s not difficult to see why: lives are often at stake when devices in these fields fail. The cost of certifying and working within established regulations is not insignificant and this is likely the main reason we don’t see a lot of work on Open Hardware in these areas.
Ashwin K. Whitchurch wants to change this and see the introduction of simple but important Open Source medical devices for those who will benefit the most from them. His talk at the Hackaday Superconference explores the possible benefits of Open Medical devices and the challenges that need to be solved for success.
Ashwin discusses a sobering statistic from the World Heath Organization to start off his presentation: about 90% of the world’s investment in medical research benefits only the most affluent 10% of its population. This is likely related to what is known as the 10/90 gap, a finding in 1990 that less than 10% of health investment worldwide was put into developing countries where 90% of preventable deaths occur. This statistic is debated by some, but we think all can agree that applying science and technology to help the sick — no matter their position in life — is a virtue. How can we focus our Open Hardware movement to make advances in medical care available for more people?
We’re delighted that a few of Ashwin’s products which try to address this need were entries in the 2017 Hackaday Prize. His HealthyPi V3 claimed 2nd place and is a patient monitor that records ECG, respiration, pulse-ox, skin temp, and blood pressure. It’s a “hat” for a Raspberry Pi and can be run with or without a screen for the readout. His HeartyPatch project was a Best Product finalist. Based on an ESP8266, it is a wearable single-lead ECG monitor.
These two are interesting products to compare to devices you would find in hospitals in high-income countries. FDA approved patient monitors will cost between $2,000 and $10,000. There are unbranded machines available on markets like AliExpress which cost between $200 and $1,000 but these do not come with certifications and they’re not open source — when they need to be calibrated or repaired what are your options? An ideal Open Source solution would be independently certifiable and calibrated by the care giving institution since proper documentation on doing so would exist. And there is another cost benefit: they can utilize generic consumables, items that can be very expensive if locked into one manufacturer’s brand.
HealthyPI V3 “hat” board shown in front of the version that includes a display.
Ashwin mentions that his devices are using the same ICs that are often found in the certified gear. For the patient monitor that’s the AFE4400 for heart rate and pulse oximetry and the ADS1292R multichannel ADC for respiration and ECG. With these silicon solutions available to Open Hardware developers, the concerns for safety and responsible engineering become a matter of established design and verification.
The biggest need for low-cost medical equipment is in places that also have a shortage of specialized medical practitioners. Ashwin envisions low-cost fetal heart monitoring devices for low-income countries where an alarming number of fetal deaths occur during labor. He suggests a device with a user interface simplified for midwife or non-medical birth helpers could do something as simple as indicate that something is normal, or not normal in which case having the mother reposition herself could make the difference.
The challenges here are many, and we’ve moved rather hastily through a lot of the topics Ashwin discusses so make sure you set aside some time to watch his talk. He sees a need for a few things to make Open Source medical devices possible. There must be buy-in from the medical and engineering communities. The products need to be made usable by those without advanced medical degrees and safeguards against misdiagnosis from false positives and negatives need to be addressed. Perhaps the biggest hurdle is to reconcile certification and regulation standards with a new breed of devices not meant to replace what we have, but to fill a need currently not addressed.
If these barriers can be overcome, we will see these devices which are currently developer-grade become consumer-grade and lead to a better quality of care for a large part of the world’s population.