May 31, 2023
Flying Pig Designs LLC
The world is changing. Manufacturing is moving from Asia back toward North America. Artificial intelligence is finding its way into art, design, and even politics and music. Medicine, albeit more slowly, is no different. What will the next 10 years bring to medical devices and the people that use them? Below we will examine some of the trends that we are seeing in our work designing and launching Medical Devices and make some predictions about what to expect in the next decade.
Summary of Key Trends in Medicine 4.0
- Telemedicine is here to stay
- Growth of personalized medicine with be slow but steady
- Artificial Intelligence, Machine Learning, Robotics, and Automation will continue to merge and become more common in Med Device and diagnostics
- Augmented Surgery and Reality will provide information to providers on the move
- 3D printing and Bioprinting will take meaningful steps into the marketplace
Telemedicine
Telemedicine is truly here to stay. While this might not be news to most folks, thinking about the user needs that come with that might be. Medical personnel cannot diagnose some conditions as effectively over a Zoom call[1]. As a result, medical devices and services will need to increasingly incorporate compatibility by using remote monitoring and apps that patients can access easily. We expect the line between hospitals, outpatient clinics, and the home to blur over the next 10 years, with patient care moving increasingly to the home. More sophisticated integration with your phone will continue. Small, modular devices, not just apps, will continue to be more commonplace. Within 10 years’ time, on-demand homecare services will emerge that use handheld diagnostic equipment (think tricorder from Star Trek) to scan your complex malady while your physician remotely views your scans and recommends a course of treatment in real-time.
Security and privacy concerns will be a growing problem. Secure Electronic Medical Records (EMR) integration will be a necessity across not just devices, but across multiple EMR systems and patient care locations. We expect the emergence of software packages that will translate between multiple EMRs to facilitate patient transfer, such as from an ambulance to a hospital or from a general practice to a specialist or home.
[1] doi: 10.1097/01.ASW.0000669916.01793.93
Wearables seem to solve many of these dilemmas. While today, these devices may be prescribed as a post-incident monitoring or fitness monitoring solution, we expect medical personnel to prescribe these devices in advance. Further integration into clothing and jewelry will not only make monitoring less obtrusive, but also make it more fashionable. Within a decade, we expect that encrypted, remotely integrated wearables will provide real-time information over a period of multiple years and will eventually take the place of the routine physical. Tech-enabled glasses might provide your eye exam. Shirts with sensor-embedded fabric will conduct your next cardiology appointment. Shoes will check your gait, your weight, and remind you when it is time to exercise.
Personal Medicine
With the advent of genomics and tools like CRISPR, true precision medicine seemed to be just around the corner. Cancer treatments would be targeted to an individual’s biological processes. Hereditary gene diseases would be precisely cut and removed from a person’s DNA. These tools hold a ton of promise, and at FPD, we sincerely believe these tools will become life-changing for millions of people around the world within the next ten years.
Potential ethical issues aside, there are some severe technical, logistical, and legal hurdles to overcome before these technologies can become widely used[2]. For example, how do you validate a tool that is different for everyone? How do you safely store and regulate this type of data? Who should be able to see and use this technology? These are not easy questions to answer. It will take politicians, scientists, medical personnel, and engineers working together to form a solid, sustainable foundation from which to work. Laws need to be updated. Regulations to validate this emerging technology need to be properly and quickly codified. Technology needs to move out of the lab and into doctor’s offices. Partnerships between research universities and industry will make this possible.
The natural application of CRISPR in technology is diagnostics. Instruments for detection and treatment of cancers and pathogens, such as COVID-19, are already emerging[3]. However, in the next decade, we expect the leap from detection to treatment to occur on a wider commercial level. 2023 will be a milestone year, as the FDA is poised to approve a CRISPR-based treatment for sickle cell disease, with Phase 1 and 2 trials for further products related to other conditions such as hereditary angioedema and even cardiovascular disease[4].
At FPD, we fully expect progress on this technology to be slow, but steady, with the addition of other conditions such as epilepsy, cancer, and multiple sclerosis within the next decade. While no development process is linear, and there will undoubtedly be setbacks, the use of advanced genomics devices in medicine will be a game changer.
[2] https://doi.org/10.21775/cimb.026.103
[3] https://doi.org/10.1021/acssynbio.1c00107
Machines That Learn
In 2022, the FDA listed over 500 devices that used artificial intelligence and/or machine learning[5]. While cool, we don’t think the Terminator is just around the corner just yet. Sorry. However, here at FPD, we do fully expect artificial intelligence, machine learning, and robotics to continue to merge in the next 10 years. Regulatory bodies have a basis to start from, using ISO/IEC 23053: 2022 – Framework for Artificial Intelligence (AI) Systems using Machine Learning (ML). While not in humanoid form, but perhaps more closely resembling a large toaster, these smart devices will profoundly change the way that disease is detected, and even how patients are treated throughout their medical journey.
Smart Diagnostics will review slides and imaging far quicker and much more accurately than a human can. Combined with novel telemedicine techniques, patients can be diagnosed in their homes or in the waiting room before a physician is even engaged. Multiple indicators, when taken individually, may not signify a disease state, but by employing pattern recognition and AI, a Smart Diagnosis could be made much earlier than today’s standard of care could achieve. In the next ten years, if not much sooner, FPD expects smart diagnostics to emerge in radiology, cardiology, and neurology at a minimum.
Combined with the current nursing and senior care shortage, the expected increase in diagnosed diseases will undoubtedly worsen wait times, among other issues. Nursing staff can be augmented using SmartTech-enabled robots and devices to engage and monitor patients. While not a replacement for proper nursing care, these devices can be a second set of eyes and ears, flagging an overloaded nurse to any negative trends emerging in their patients before an emergency occurs. The next decade is going to be very cool indeed.
Augmented Medical Reality
Shortages of medical personnel, from EMTs and nurses to surgeons are going to be a big deal, especially as the population ages. As older workers retire or existing personnel quit medicine, remaining staff will need ways to keep track of patient records, learn new information, and increase efficiency. Ideally, higher quantities of graduates will emerge from medical schools, but until then, we think augmented reality will help to fill a potentially Grand Canyon-like gap.
Virtual reality is great. It’s fun. But it’s tough to employ in the real-world treatment of patients. VR can aid in training, but we think augmented reality will become the standard of care. AR’s aim is not to replace medical personnel, but to enhance them. Surgeons can see a patient’s scan laid over their body or see a video from a laparoscope without taking their eyes off the patient. Nurses can be alerted to a negatively trending patient as they walk down the hallway or be reminded to administer medication to a forgetful patient. Army medics and EMTs can have virtual conversations with physicians as they work on a patient. First aid providers can have a 911 operator show them how to administer CPR in real-time.
Things really start to get cool when AR is combined with advanced robotics/AI. As these advanced systems gather more information through pattern recognition or faster cycle times, that information can be relayed to a physician’s AR. In turn, physicians can manipulate the robot to aid in their task. For example, a solo surgeon could be augmented by a small team of robots, humanoid or otherwise, controlled by the physician’s AR glasses. The robots could hand the surgeon tools, hold scopes or other tools, adjust lights, and even directly assist in the surgery. Granted, this scenario is likely much farther than ten years out, but we think the basic building blocks for these advancements will be firmly in place by then.
Tissue Printing
Printing organs and limbs sounds great. Simply remove the old, used tissue and replace it with some brand-new tissue that has been newly printed using your own cells. Great, sign me up! Unfortunately, these are complex structures utilizing many types of cells and layers of tissue. Likely, these are not going to grace our hospitals in the next decade or so. However, major steps in this direction are sure to occur.
Simple tissues such as bone grafts and corneas are already in the works[6] [7]. In the next decade, more complicated structures like a knee, complete with cartilage cushion atop the femoral head, will start to make traditional knee and hip replacements obsolete. Simplified versions of skin with embedded medicine will help burn victims recover faster and with less pain.
Furthermore, research and device development will be greatly aided with tissues acceptable for testing. Standard biocompatibility testing, which currently utilizes animals toward the end of development, will be revolutionized with printed tissue. These tissues can serve as an early indicator of problematic device materials. While not a complete replacement for traditional biocompatibility testing, materials will be able to be evaluated early on and provide a higher level of confidence before thousands of dollars are invested later in development.
At the Intersection of Robotics, AI, and Medicine
While each of the above sections is lifechanging by itself, medicine will be exponentially changed when these groups merge. Take the following situation, for example. We see a dramatic car crash. Twisted metal is everywhere, and one of the cars is on fire. A witness calls 911 and the video call allows the 911 Operator to survey the scene, provide directions on how best to help, and instruct the witness on how to provide first aid. As first responders arrive and put out the fire, they have already seen the video of the scene and have been in touch with the ER physicians at the hospital, and they are assessing patient injuries in real-time and prepping the correct equipment. As patients are transported via ambulance, real-time monitors are sending patient data to the hospital and identifying trends in their health. Patients are already triaged, and their statistics are in the hospital’s EMR before the ambulance even arrives. As patients are rolled into the ER, the burn victim’s stem cells are collected for later bioprinting to replace damaged tissue. Emergency physicians are helped by AI-enabled overhead lighting, and AR glasses provide indicators of broken bones and punctured lungs. As patients recover, learning-enabled devices trend a patient’s recovery and help physicians determine the optimum time to release their patients back home. Once home, a variety of smart textiles and consumer products monitor the patients’ progress and help further direct their recovery without ever stepping foot back into the hospital. At FPD, we think this is all possible, and we are here to help.
[6] https://doi.org/10.1002/jbm.a.35107 [7] https://doi.org/10.1016/j.eurpolymj.2020.109744
“I have been in product development for over 18 years, with all but 5 of those being in the medical device industry. During that time, I worked on a variety of devices from handheld electrosurgical products and semi-autonomous robots to automated monitoring products. I have worked for large companies like Covidien and BD, as well as some very small companies. When I am not running things at FPD, I am often running on the trails or running after my two girls!” – Keir Hart
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