We’ve come a long way from leeches and bloodletting (though some doctors and scientists insist that leeches weren’t that far off). From the humble blood pressure cuff to robotic arms that can perform heart surgery more precisely than human hands, medical devices make what premodern medical professionals would call medical miracles.
Device developers and manufacturers don’t rest on the laurels of past successes, though. With diseases like cancer, type 2 diabetes, and viral pandemics still taking their tolls in terms of life and quality of life, the race is on to make medical devices better and better and to appease the regulators like the FDA watching at every turn.
According to Orthogonal, here are three ways medical devices are changing to meet evolving healthcare needs and incorporate unfolding tech breakthroughs …
1. Increased Reliance on Software
A medical device used to be a thermometer or a stethoscope. They did not stake their function on ones and zeros, but rather the physical properties of the element mercury or the propagation of sound waves. Welcome to medical devices, Age-of-Enlightenment edition.
Of course, the software found its place in the medical device world almost as soon as such a thing as “software” came to be. Sophisticated devices like MRI machines and ultrasound recorders still relied on ancient forces like magnetism and sound waves to do their work, but the software was needed to guide the magnet in the MRI machine or interpolate the ultrasound waves into imagery.
Today’s and tomorrow’s medical devices will depend more on software than ever before—to the point where the software does much of the work of recording and interpretation that used to be done by humans.
Whereas early medical devices had one function, the software allows them to perform multiple functions—for example, a blood glucose monitor that also measures heartbeats per minute and dispenses medication.
Or take the humble thermometer, no longer dependent on mercury. In addition to taking the patient’s temperature, the software could allow it to record the temperature and recommend treatments. In other words, instead of performing more than one function, the software allows a diagnostic tool to perform its one function more completely, creating a full function stack in one medical device.
Software as a Medical Device
More and more, the software itself is not dependent on an external medical device. Instead, the software is the medical device. The industry term “software as a medical device” (SaMD) is distinguished from “software in a medical device” (SiMD) in that SiMD is useless outside of the device it’s designed to operate. What good is an MRI magnet guidance software in a smartphone, for example?
Plenty of software coming to market is useful when they sit on a smartphone or tablet. Often these are software programs that talk to other medical devices via wireless technologies like Bluetooth Smart and IrDA to record and interpret patient data like blood pressure, blood glucose, blood oxygen, etc.
Intelligent Medical Devices
The incorporation of AI, pattern-recognition, and machine learning software will empower medical devices to do some of the work that used to require the brain of a doctor or technician—interpreting data, making diagnoses, recommending medication. IBM reports that the same intelligent supercomputer that once won a game of Jeopardy in 2011 is now assisting in making and confirming diagnoses.
This may seem like devices stand to put doctors out of work, but other experts believe that human confirmation will never go out of style. AI can shoulder much of the burden, but the creative intuition of a doctor to see between the lines of the medical data will always be necessary … unless developers figure out how to do that with software as well.
2. Data Systems
The medical device industry is one of the most heavily-regulated industries in the world. The FDA imposes numerous regulatory hoops that device developers and manufacturers must jump through to ensure the quality and safety of the resultant devices.
There is one notable exception—medical device data systems (MDDS). In 2015 the FDA relaxed restrictions on both hardware and software data storage systems for medical devices, assessing the risk to patients to be low enough to merit a lightening of its grip.
Of course, vulnerability to hacking and data theft will always loom big on the horizon of centralized storage of medical device data, but no more or less so than the storage of other types of sensitive data.
What do patients and providers stand to gain by advances in MDDS? Centralized, secure patient data repositories that AI diagnostic software can use to recognize patterns across large data sets, leading to advances in treatment and early detection of illness.
3. Remote Monitoring
In the past, most patients would not see the benefits of medical device technology unless they made an appointment with their doctor—often a cumbersome procedure in its own right. Even with medical devices like heart rate monitors or blood glucose monitors able to be installed with minimally invasive outpatient procedures and worn at all times, what to make of the data recorded until you had another appointment with your doctor? A lot can happen between appointments, by which time, it could be too late.
Remote monitoring of medical devices allows both patients and doctors to quickly and seamlessly adjust treatment plans based on real-time data. You don’t have to wait for your doctor’s appointment to adjust treatment if your doctor can read the data from afar.
The insertable cardiac monitor (ICM) by Confirm Rx is a perfect example of where remote monitoring in medical devices is going, incorporating both medical device data science and SaMD to improve the quality of patient care even between doctor visits. The ICP, inserted under the skin in a minimally invasive procedure, communicates by Bluetooth to the patient’s mobile device and records cardiac data on a dedicated mobile app. The app then transmits the data through the cloud to an app on the medical provider’s end where the doctor can recommend changes in treatment based on the data.
This is the wireless, software-driven medical device revolution in action—medical monitoring that fits in your pocket and travels with you everywhere, connecting you to your doctor wherever you have access to wireless data.
Every industry leaps forward at times of great innovation, like the one we find ourselves in. The implications of tech advances for the building of better, smarter medical devices makes now one of the most exciting (and healthiest) times to be alive.