Advocating for open source medical devices

Medical, automotive, and aerospace engineering is highly regulated. It’s not hard to see why: lives are often at risk when devices in these fields fail. The cost of certifying and working within established regulations is not insignificant and this is probably the main reason why we don’t see much Open Hardware work in these areas.

Ashwin K. Whitchurch wants to change that and see the introduction of simple but important open source medical devices to those who will benefit the most from them. His Hackaday Superconference talk explores the potential benefits of open medical devices and the challenges that need to be addressed for success.

Ashwin discusses a disturbing statistic from the World Health Organization to start his presentation: about 90% of the world’s investment in medical research benefits only the richest 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 investment in health worldwide has been put into developing countries, where 90% of preventable deaths occur. That statistic is debated by some, but we think everyone can agree that applying science and technology to help the sick – no matter where they stand in life – is a virtue. How can we focus our Open Hardware movement on making advances in healthcare available to more people?

We are delighted that some of Ashwin’s products attempting to address this need were entered into the 2017 Hackaday Awards. Their HealthyPi V3 won 2nd place and is a patient monitor that records ECG, respiration, pulse-ox, skin temperature and blood pressure. It is a “hat” for a Raspberry Pi and can run with or without a screen for reading. His HeartyPatch project was a finalist for Best Product. Based on an ESP8266, it is a wearable single-lead ECG monitor.

These two are interesting products to compare with 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 marketplaces like AliExpress that cost between $200 and $1,000 but don’t come with certifications and aren’t open source – when they need to be calibrated or repaired, what are your options? An ideal Open Source solution would be independently certified and calibrated by the caregiving institution, as there would be adequate documentation for this. And there’s another cost benefit: they can use generic consumables, items that can be very expensive if locked into one manufacturer’s brand.

HealthyPI V3 “hat” plate shown on the front of the version that includes a display.

Ashwin mentions that their devices are using the same ICs that are often found in certified equipment. For the patient monitor, it’s the AFE4400 for heart rate and pulse oximetry and the ADS1292R multi-channel ADC for respiration and ECG. With these silicon solutions available to open hardware developers, security concerns and responsible engineering become a matter of established design and verification.

The greatest need for low-cost medical equipment is in places that also lack specialist doctors. Ashwin envisions low-cost fetal heart monitoring devices for low-income countries where an alarming number of fetal deaths occur during labor. He suggests that a device with a simplified user interface for midwives or non-medical birth attendants could do something as simple as indicating that something is normal or not normal, in which case the mother repositioning herself could make a difference.

The challenges here are many, and we skim through many of the topics discussed by Ashwin, so be sure to take the time to watch his talk. He sees a few things need to be done to make open source medical devices possible. There must be buy-in from the medical and engineering communities. Products need to be used by people without advanced medical degrees, and safeguards against misdiagnosis of false positives and negatives need to be addressed. Perhaps the biggest hurdle is reconciling certification and regulatory standards with a new generation of devices not intended to replace what we have, but to fill a currently unmet need.

If these barriers can be overcome, we will see these devices that are currently developer-grade become consumer-grade and lead to better quality of care for much of the world’s population.

Advocating for open source medical devices

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