Recently I chatted with Candace Roulo, managing editor of Advanced Manufacturing Now, about some of the most important trends in medtech and the technologies that are taking the industry to the next level. Click below to listen to the podcast, or read on for select highlights of the conversation – what I consider to be five trends medtech professionals should be talking about.
1. Much Ado About Sensors
Advanced Manufacturing Now: You mentioned connectivity. With the healthcare sector embracing the interconnectivity of the Internet of Things for more proactive patient management, what are the opportunities and challenges associated with using sensors in medical devices? And if you could, give us a couple examples of those medical devices.
Pedersen: I know this is going to sound a bit clichéd, but the opportunities for using sensors in medical devices really are endless, which is why at our upcoming event BIOMEDevice Boston we're actually shining a spotlight on the technology with a dedicated "Sensors Zone" on the expo floor and we have several conference sessions that will provide a deep dive into the technology. But to answer your question, I think one of the biggest opportunities that sensors provide in the healthcare setting is in taking the human variability out of treatment. So many times doctors have to rely on judgment calls, or self-reports from the patient, or even just estimations that happen in the clinical setting. Sensors can provide some much-needed accuracy and consistency to help doctors make more informed treatment decisions.
Some examples of where sensors are being used, probably the most common one is wearables, that's a big area where they've proven to be very useful. But sensors are also being used in more conventional medical tools like laparoscopic dissector tools to help doctors find or avoid hidden blood vessels or other anatomical structures during surgery, so that's one thing I think is pretty cool. There's even a group of scientists in Australia who have developed an ingestible sensor that's actually been dubbed the "fart pill" because it looks like a pill capsule and it is designed to detect gut gasses in the stomach and then transmit that data to a phone or computer and it sounds like kind of a funny device, but it really could have a big impact on how certain digestive disorders are diagnosed and treated.
2. The Future of Innovation in the Value-Based Care System
Advanced Manufacturing Now: My next question is about the U.S. healthcare system because it continues to shift from a volume-based to a value-based system, so I'm wondering what are some of the ways that medical device manufacturers can continue to be innovative through this new lens? What are the emerging trends in the industry from this push toward value-based care?
Pedersen: That's a really interesting area and one of the interesting trends that have been born out of that shift toward value-based care, as you talked about, is the use of risk-sharing contracts between manufacturers, providers, and in some cases even the payers. Basically, companies are beginning to put their money where their mouth is, so to speak, with programs that tie the cost of care directly to patient outcomes. Medtronic is a good example of a company that has been doing this really well. They actually started back in 2015 with a program based around the Tyrx absorbable antibacterial envelope. This is a mesh device used to hold a pacemaker or implantable defibrillator, and it releases antimicrobial agents over a period of seven days after the surgery, which is when the risk of a surgery-related infection is especially high. So what they've done is they've offered hospitals sort of a value guarantee as an enticement to buy the device, because hospitals know that they lose money if a patient ends up needing additional surgery or has a prolonged stay because of a hospital-acquired infection, so this risk-sharing agreement that Medtronic has offered to them kind of takes some of that burden off of them.
3. The Intel on Artificial Intelligence in Medtech
Advanced Manufacturing Now: I'm also curious about artificial intelligence, I know you mentioned that before. I'm wondering how is AI being applied to medical devices today, and what are some realistic expectations of how will AI play a role in the industry in the future?
Pedersen: It's really easy to get swept up in all the artificial intelligence hype, and I think part of the reason for that is a lot of people don't really understand what artificial intelligence is, it's hard to imagine if you've never worked directly with the technology. I think a lot of people picture a big machine or a black box or a robot that just does everything and replaces humans. But in most cases, AI will be more of a partnership between man and machine. I think AI will be a tool that allows people to address these really complex problems in healthcare, and it can be trained to recognize patterns in the data sets, but it is not a solution in and of itself, it's still going to require humans to train the system and kind of drive that.
That said, it is easy to understand why there is so much excitement over the technology and this is another area where the possibilities seem endless. FDA recently approved a clinical decision support software from Viz.ai that analyzes CT scans and can alert doctors of a potential stroke by sending a text if a large vessel blockage is suspected just by analyzing the image. There is a group of radiotherapy specialists in London who are studying ways to use machine learning to reduce the amount of time it takes to plan radiotherapy treatments for head and neck cancers. Other AI programs are being used to help identify people at risk of a whole host of conditions, including some cancers and metabolic diseases. Medical EarlySign has a tool that uses the technology to analyze routine health records and other clinical information to identify people with an elevated probability of lower GI disorders. So, to get back to the question, I really think that the possibilities of AI are endless, but it's not going this magic thing that some people might picture it to be.
Advanced Manufacturing Now: It sounds like it could really be helpful with preventative medicine.
Pedersen: Definitely, because you know, right now we have all of this data ... the healthcare system is getting all of this information from, going back to sensors, wearable devices, and different remote monitoring technologies, so having the information isn't really the problem, the problem is being able to make it actionable and analyze it and do something about a problem when it's at it's earliest, most treatable stages, or even as you said, preventable.
4. The Robots are Coming to Medtech
Advanced Manufacturing Now: It's been nearly 20 years since Intuitive Surgical launched its first da Vinci system and now the surgical robotics pioneer faces competition from new players. Who are these new players, what do they bring to the table for robotic surgeons?
Pedersen: There are a number of companies, large and small, that are racing to give Intuitive a run for their money, so to speak, and bring more options to the surgical robotics market. TransEnterix got FDA clearance last year for its Senhance robot. One of the benefits of this system is that it provides force feedback to help the surgeon "feel" the stiffness of tissue being ... as the robotic arm is grasping the tissue they're getting feedback so that they know if they're applying too much pressure or not enough pressure. TransEnterix's system also has an eye-tracking feature, which helps the surgeon control the movement of the surgical tools based on where they are looking during surgery. Other companies that are working on surgical robotics systems are Medtronic, Stryker has the Mako system, Zimmer is close to bringing its Rosa system to the market for orthopedic surgery, and Verb Surgical (joint venture between Johnson & Johnson and Google). And then there's a company called Medrobotics and they have a really cool flexible robotic system that slithers like a snake.
One of the biggest adoption barriers in surgical robotics has been the cost of some of the legacy systems. Intuitive has responded to this problem by launching a lower-priced da Vinci model that includes some of the advanced features that surgeons need, without all the bells and whistles. But, customers can add more features as needed.
Advanced Manufacturing Now: What considerations inform the design of a new surgical robot?
Pedersen: Meghan Thorne from Medrobotics – that's the company I mentioned that has the flexible robotic system – she will be speaking at the BIOMEDevice Boston conference about the various design considerations involved with developing a surgical robot. I've heard Meghan give a similar presentation before and it's really interesting to hear what she has to say and her process, she likes to go into the clinical environment and be a fly on the wall, watching the procedure. She said that when she first started one of the things she noticed is that almost all of the robotic surgeons she met operated in their socks. When she asked them about it the answer she got was that the robot console on many systems has several foot-pedals that are all designed to control a different task. Shoes can make it harder to know which pedal they are putting their foot on without looking down at their feet, so a lot of robotics surgeons end up taking their shoes off so they can feel the pedals better.
5. The Realities of VR, AR, and MR in Medtech
Advanced Manufacturing Now: What role is virtual reality and augmented reality playing in the medical device industry?
Pedersen: That's another really exciting area, like AI there's a lot of hype around it, and for good reason. Augmented reality (AR) is content being overlaid onto a user's view of the real world. If you've ever played Pokemon Go, for example, you're probably familiar with augmented reality, that was my first experience with the technology. Another example is if you're watching football on TV and statistics pop up, that text is not actually on the field itself, it's not anchored in reality, so AR is intended to enhance human cognition. In the medical space, AR technology is very useful in surgical navigation. Virtual reality (VR) is very similar but different in the sense that it is designed to completely immerse a user into a virtual environment through the use of a headset. It's good for creating empathy and it's extremely useful for surgical training, either to train new surgeons on existing technology or to train more experienced surgeons on new technology and surgical techniques.
There's a company called Osso VR that has a virtual reality surgical training platform that offers hand-based interaction in an immersive training environment. Justin Barad, co-founder and CEO of Osso VR, will be giving demos of the technology at BIOMEDevice Boston.
There's actually a third type of technology, called mixed reality, which combines 3-D scanning of an environment with an information overlay. Some experts I've talked to believe this technology has the most opportunity to have an impact in healthcare because it's really useful in surgical settings. Let's say a surgeon is operating on a patient who has a tumor. The surgeon could take that patient's CT or MRI data and put it into a head-mounted display such as the Microsoft HoloLens, for example, and overlay patient-specific information on top of their body while they're on the operating table and be able to see exactly where that tumor is.