The evolution of a medical device from concept to one widely used by patients follows a long and winding road. According to Tomas Walker, senior U.S. medical director at Dexcom, Inc. such devices have three common characteristics: The devices address an unmet need in a new way, the engineers behind the devices persevere in researching what works, and the constant improvement of existing technology.
The landscape is filled with engineered solutions that have reshaped human health in ways both small and large.
Quality of life improvements
The continuous monitoring of glucose levels as part of diabetes management is a prime example. Previously, patients with Type 1 diabetes had to rely on finger pricks at least six times a day. Dexcom’s engineered device is a subcutaneous wire that continuously monitors electrical activity related to glucose levels and relays necessary information to a smartphone. This avoids the pinpricks and provides a more accurate picture for better disease management, according to Walker. Engineers revolutionized diabetes management by devising the subcutaneous wires, the membranes and coating involved, and the ways of working with data signals generated by those materials.
Bioengineers are also working on bettering prostheses to create a new neural interface so human brains can better interface with robotic prosthetic devices. Tyler Clites, Ph.D., postdoctoral fellow at the University of Michigan and a graduate of the Massachusetts Institute of Technology, has come up with a double-pronged solution where the wearer can control how the prosthetic device moves with their mind. Even better, the neural interface, which includes a new method for performing amputation surgery, makes the device feel like an extension of the person’s body. Clites’ device and associated surgical technique delivers proprioception for amputees, which means they can sense where their limbs are in space, a sensation amputation has traditionally taken away. Such a leap in medical device technology comes in part from significant strides in robotics and electrical circuitry in recent years.
AI, robotics and 3D printing
Advances in robotics and artificial intelligence (AI) have also contributed to another significant medical advancement: remote surgery. XSurgical is working on robots that can perform open surgeries (ones that do not work solely with the use of a guided catheter) remotely with a doctor guiding next steps. Future iterations of XSurgical’s robots will perform these surgeries autonomously, drawing on internal banks of deep neural networks to discern next steps in routine procedures and using machine learning as a critical element in its intelligence.
The field of biomedical devices is being transformed by robotics, AI and 3D printing. According to Keith Cook, professor of biomedical engineering at Carnegie Mellon University, the cost of testing is the biggest challenge to the introduction of new medical devices. Once devices are conceived, computational modeling can make the process easier.
“[3D printing] has significantly cut down the amount of time it takes to prototype and test devices,” Cook says. “In the past, you had to drop the models off at a machinist before you could do anything else. These days almost everyone has their personal 3D printer in the lab.” Cook adds that the technique has also morphed to bioprinting.
For these devices and others, focus on the patient continues to drive success.
“There is an old saying in medicine that you should talk to the patient because the patient will tell you what is wrong and what your diagnosis will be,” Walker says. “It is the same thing with technology: We come up with great ideas that work in the lab and then when we show them to patients, we get the feedback we need to make those systems work for them.”