“Closed-loop” therapeutic systems are systems in which relevant biological conditions are continuously monitored in real time and used to continuously adjust a therapy in order to maintain or achieve a particular physiological state.
A highly relevant example of this is an “artificial pancreas” system that links continuous glucose monitoring with an insulin pump to optimize the delivery of insulin for diabetics. Other examples include closedloop systems for deep brain (DBS) treatment of various neurological conditions, such as epilepsy or Parkinson’s disease.
There may be additional benefit to selfadjusting systems beyond the obvious. However, a treatment regimen based on a patient’s actual need (versus continuous stimulation) would change frequency and intensity (dose) of stimulation, which could extend longevity of the therapeutic effect as well as battery life of the device. (This is speculation.)
Medtronic will launch the world’s first hybrid closed-loop diabetes therapeutic system, the MiniMed 670G system, in spring 2017. This system uses an algorithm to tie glucose monitoring with insulin delivery, enabling greater glucose control with reduced input from the diabetic patient. Given the prevalence of diabetes and its “first” status, this product launch is bound to be high-visibility.
As previously described, Medtronic is at the forefront of this work in the artificial pancreas space. The company is also currently working toward a closed-loop DBS system; its Activa PC+S system includes a standard DBS therapy and a sensor to record electrical activity in key regions of the brain. Collecting these data is a stepping stone to developing the algorithmic portion of the closed loop. There are also systems in development for treatment of other chronic conditions, such as pain. Neuropace also has an approved system to treat a specific subset of epilepsy patients, the RNS System.
An increasing number of clinical trials of closed-loop systems for various indications is highly likely in 2017.
—Herb Bresler, senior research leader, consumer, industrial, and medical products, Battelle
We are seeing a trend in personalization in every sector. One area that has seen a lot of progress is in the mapping of the human genome and the understanding of how individuals react to specific drug treatments. Increased technical power and understanding of the human genome is now allowing targeted therapy to become a reality.
Additionally, 3-D printing is now being utilized to tailor medical treatment to individual characteristics or needs of the patient. Technology has allowed the mapping of internal organs or implants that can be translated to 3-D printed objects. Organs and tissues fabricated by 3-D printers are on the horizon. And, to a lesser impact, we are even seeing connectivity and the Internet of Things creating ways to track and report individual behaviors and treatment leading to personalized healthcare.
For 3-D printing, look to the radiological community to be able to capture computed tomography and magnetic resonance images into stereolithography files compatible with 3-D printers. The 2016 Radiological Society of North America annual meeting’s exhibit floor had multiple sections dedicated to the collaboration of radiological companies partnering with 3-D printing companies.
On a more long-term view, look at stem cell research and therapeutic companies to make breakthrough discoveries. For example, Celprogen just announced they successfully finished printing a 3-D pancreas from a flexible polylactic acid material scaffold that was populated with adult human pancreatic stem cells.
—Tor Alden, MS, principal, HS Design
Surgical robotics is an undeniable major trend and so cannot be ignored. Interest in surgical robotics has grown over the last 18 months and will ramp up through 2017.
There is a combination of supply and demand factors that are converging into 2017. On the supply side, the value of the market has attracted new entrants, creating greater competition. Corporate developments through 2015 and 2016 have also set the stage for a number of product and commercial developments in 2017. Additionally, there is an increasing body of evidence supporting the safety and utility of robotic surgery compared to traditional methods. Moreover, technological advances have enabled a step change in the services, like imaging and data analytics, that will support the next generation of robotic systems.
On the demand side, there is growing patient and clinical demand for minimally invasive surgery, coupled with increasing procedure rates more generally. Providers also need solutions that will streamline surgery and relieve the pressure on burdened health systems. Finally, payers are transitioning to value-based reimbursement models that mandate the use of efficient technologies.
Intuitive Surgical is the market leader and has been for over a decade; however, largecaps like Stryker, Smith & Nephew, Johnson & Johnson, Medtronic, and Zimmer Biomet will be responsible for the most interesting developments in 2017 on the back of their acquisitive entry into the market.
The full commercial launch of Stryker’s Mako robotic system for the total knee indication will be one of the headline events of the first half of 2017. There may also be an R&D update from Verb Surgical (backed by Johnson & Johnson and Google), although a commercial event is unlikely.
Observers should compare and contrast the financial results of Mazor Robotics’s Mazor X and Medtech’s Rosa Spine system. Mazor Robotics received multiple tranches of equity investment from Medtronic through 2016, and Medtech was acquired by Zimmer Biomet in July.
On the startup side, UK-based Cambridge Medical Robotics raised a $20 million Series A round in July 2016. The company is building a modular system and could prove to be an acquisition target for established device manufacturers looking to enter the surgical robotics market.
—Dougal Adamson, medical device industry analyst, BMI Research
We’ll be hearing a lot more about sensors in 2017. We hear a great deal about body-worn sensors, but sensors are being incorporated everywhere—not only because of the data gathering possibilities, but also the ability to drive better outcomes. Sensors are evolving at a staggering rate and are being made smaller, faster, more sensitive, and with lower energy needs than ever before. The applications are endless.
Besides the data potential, the main driver to developing disruptive sensor applications is to take the human variability out of treatment. This is not to say caregivers and clinicians will lose the control or physical feedback they need; instead, it will provide accuracy and consistency to devices and systems, enabling clinical users to make more accurate and informed decisions. Sensors will show up in places where human “judgement” and “experience” have been traditionally used to make critical treatment decisions.
In the past five years, startups and earlystage companies have been developing and driving many of the medical device technology breakthroughs we’ve seen. Disruptive sensor technologies are no different. Briteseed has developed a smart surgical tool technology that employs a sensor within the jaws of laparoscopic dissector tools to help surgeons find and avoid hidden blood vessels, ureters, and bile ducts. Output Medical has developed its sensors and algorithms to automatically chart urine output, eliminating the need for a clinician to estimate the volume in the collection bag manually. Urine output is a significant indicator of overall health and the first indication of kidney failure for patients in the ICU. Finally, sensors provide “GPS” information on sub-dermal anatomy to physicians when inserting a spinal tap needle in the new IntuiTap Medicaltechnology.
Those companies are just a few of the thousands of startups that are driving medical technology breakthroughs. We will see an explosion of acquisitions of these companies by all the big-name medical OEMs. Most large medical device companies have created groups focused solely on the vetting and acquisition of these technologies. We believe 2017 will bring with it record numbers of acquisition and licensing deals of these startups providing disruptive technology solutions for their innovation initiatives by OEMs.
— Craig Scherer, cofounder, Insight Product Development; director, Insight Accelerator Labs