10. Neurostimulation for everything
Medical device companies already had a few devices out in the early 2000s that used pacemaker technology to treat a few brain and nervous system disorders such as Parkinson’s. But the 2010s were the decade when they sought to harness neurostimulation or neuromodulation to treat a whole host of conditions.
Here’s just a sample of how it’s being used:
- In 2018, for example, FDA approved the Medtronic Deep Brain Stimulation for Epilepsy. Medtronic says the system can reduce the frequency of seizures in adults with medically refractory partial-onset epilepsy.
- Silcon Valley–based NeuroPace, meanwhile, touts its RNS System as the only closed-loop brain-responsive neurostimulation system designed to prevent epileptic seizures. The company is studying whether the system might also help treat binge eating in certain people.
- CVRx (Brooklyn Park, Minn.) scored a success last summer when it secured premarket approval to market its Barostim Neo device for heart failure in the United States.
- Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system for chronic pain treatment.
- SPR Therapeutics launched its Sprint peripheral nerve stimulation (PNS) system in November 2018, with indications for treating both acute and chronic pain.
9. Disposable endoscopes
The 2010s saw the rise of endoscopes that were inexpensive enough that they could be used once on a person and then thrown away — avoiding the reprocessing challenges and related infection risks that come with reusing scopes. The global market for disposable scopes reached $515.7 million in 2017, and it’s expected to grow to $3.1 billion by 2026, according to Acumen Research and Consulting.
8. Advances in treating hearing and sight loss
Thanks to biotech advances, device miniaturization and better computing power, the past decade has also seen potentially disruptive advances in treating the loss of hearing and sight.
Rising stars include Frequency Therapeutics, which priced an $84 million IPO in 2019. Frequency’s hearing loss treatment drug FX-322 is meant to activate progenitor cells — mature stem cells that can proliferate into different types of cells. A health provider injects the drug into the middle ear in a slow-release gel.
Early in 2019, Second Sight Medical announced the first trial implantation of its Orion cortical visual prosthesis system. The implanted Orion system converts images captured by a miniature video camera mounted on glasses into a series of small electrical pulses delivered to the brain — bypassing diseased or injured eyes.
“This is the first time that we’ve had a completely implantable device that people can go home with and use in their own living conditions without having to be plugged into an external device,” ULCA Health neurosurgeon Dr. Nader Pouratian said in a news release. “It helps them recognize, for example, where a doorway is, where the sidewalk begins or ends or where the crosswalk is. These are all extremely meaningful events that can help improve their quality of life.”
7. Tiny pacemakers
Medtronic (NYSE:MDT) scored a major advance in pacemaker innovation in 2016 when it achieved FDA approval of its Micra transcatheter pacing system, which is about the size of a vitamin pill. Implanted via catheter into the heart’s right ventricle, it delivers single-chamber pacing without the need for the wires and leads that have proved challenging for pacemaker manufacturers.
St. Jude Medical recalled its leadless pacemaker, Nanostim, in October 2017. Now part of Abbott, it’s competing with Medtronic to produce a leadless dual-chamber pacemaker. – CN
6. Brain-computer interfacing
People who have lost the ability to move or their sense of touch got a boost in March when the FDA released draft guidance to help developers of brain/computer interface (BCI) devices to pass regulatory hurdles on their way to investigational device exemptions
The FDA defines (BCI) devices as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. Examples of these devices are being developed worldwide.
Companies including NeuroSky and Emotiv have developed EEG headsets that not only work for gaming, but help people recovering from a stroke or who have neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS) to regain their independence.
Researchers at Battelle and The Ohio State University Wexner Medical Center worked together to develop a BCI called NeuroLife that helps paralyzed people to regain conscious control of their fingers, hand and wrist.
A Swedish woman with a hand amputation recently became the first recipient of an osseo-neuromuscular implant to control a dexterous hand prosthesis. In 2017, an international research team developed a BCI that can read brain chemistry to enable communication in patients who are paralyzed and unable to talk. The FDA has put a particular focus on helping paralyzed military veterans and those who have amputations to regain physical function.
Having clear direction early in the process may help device developers in this rapidly evolving field save money and reduce risk, then-FDA Commissioner Dr. Scott Gottlieb said in March.
“There are many ways we identify these areas,” Gottlieb added. “Once we do, we work to ensure that the tools are in place to advance the development of these new technologies, by providing clarity and direction to medical device developers to help reduce the barriers of bringing new treatments to patients.” – NC
5. 3D printing
3D printing, or additive manufacturing, has been around for decades. But it was only in the 2010s that medical device designers truly embraced it as an effective prototyping tool. Now it holds the promise to also enable the creation of customized medical devices.
3D printing company Carbon, for example, has a business partnership with Johnson & Johnson to develop “digitally printed material that serves a mechanical function in the body, but after a few months it’s fully bio-absorbed and transitions to your own tissue,” Carbon co-founder and executive chairman Joseph DeSimone told CNBC in November.
More than 100,000 hip cups have been made in Arcam printers and implanted in patients, according to GE Additive’s Arcam business. Smith & Nephew for the past few years has had its 3D-printed titanium Redapt revision acetabular fully porous cup with Conceloc technology. Stryker has invested heavily in 3D printing research, with the technology supporting its Trident II hip cup and much more.
“Next-generation approaches include Tissium‘s high-resolution 3D printing platform that harnesses fully synthetic, biomorphic and programmable polymers to create implantable devices that can guide tissue growth,” said serial medtech entrepreneur Jeff Karp, a professor of medicine at Brigham and Women’s Hospital and Harvard Medical School.
On top of customized medical devices, 3D-printed models are becoming an important presurgical planning tool. At Mayo Clinic, for example, the health provider’s Anatomical Modeling Lab makes thousands of models a year to help surgeons prepare, as well as educate the people who need the operations.
4. Digital health — and AI hype
More than a decade after the launch of the iPhone and Amazon Web Services, the greater access to ever-increasing computer power is rapidly transforming medtech. A cell phone with a camera has the potential to replace a bulky diagnostic machine. Health providers are also increasingly embracing telehealth.
“Hospital systems are setting up telehealth departments and reimbursement codes are being added and refined. The next decade will see us all receiving healthcare over our mobile devices,” Scott Thielman, CTO at Product Creation Studio (Seattle), told MDO.
It’s little wonder that this year’s CES has companies touting 546 digital health and 635 wearable devices.
Traditional medical device companies are also seeking ways to package sensors into a host of implantable medical devices in order to glean insights. Boston Scientific, for example, has its HeartLogic heart failure diagnostic sensors packaged into implantable CRT-Ds and ICDs.
Next on the horizon is artificial intelligence — with the open question of whether AI can deliver on what companies are promising when it comes to improving healthcare. – CN
3. Getting closer to an ‘artificial pancreas’
Researchers in the field of diabetes management have been working to create a closed-loop system that can measure glucose and inject insulin as needed. The idea is to have the system work as an “artificial pancreas” for people with diabetes, using a combined glucose sensor, control algorithm and an insulin infusion device.
The FDA describes an artificial pancreas as a system of devices that mimics the glucose-regulating the function of a healthy pancreas. Computer-controlled algorithms connect the CGM and insulin infusion pumps to enable continuous communication between the two devices. The system can monitor glucose levels in the body while adjusting insulin delivery to reduce high blood-glucose levels and reduce low blood glucose without the need for patient interference.
Medtronic was one of the first companies to win approval for a hybrid closed-loop system back in 2016. The MiniMed 670G system was the first system of its kind to win clearance globally. While it wasn’t a fully standalone artificial pancreas, the system was one step closer toward developing a fully capable closed-loop system.
Companies in the race to make the first artificial pancreas include Bigfoot Medical, which has a partnership with Abbott. Other companies include Tandem Diabetes, Insulet, Beta Bionics and more.
However, with the hype of closed-loop systems, some people have taken on the task of hacking and DIY-ing their own diabetes devices. The FDA warned in 2019 against using unauthorized devices for diabetes management as it could lead to incorrect insulin dosing, which can be fatal.
There’s also a rise in continuous glucose monitor clearances. Continuous glucose monitors, like the implantable Eversense system, could replace the tedious fingersticks diabetics are tasked with to measure blood glucose levels. Abbott has already seen success with its FreeStyle Libre glucose monitoring system; the company in early 2019 touted real-world data showing reduced prolonged hypoglycemia and better glucose control among system users. – DK
Transcatheter aortic valve replacement (TAVR) is a minimally invasive surgical procedure that replaces and repairs damaged heart valves. The procedure places a replacement valve where the aortic valve is, according to the American Heart Association. It is inserted similarly to a stent in that the valve is fully collapsible and delivered to the valve site through a catheter.
The procedure was initially used as a last-chance option for people with severe aortic disease, but the procedure saw ever-expanding indications through the 2010s. Recent studies suggest TAVR overall could be a safe alternative to traditional surgery. The FDA in August 2019 cleared heart valves made by Medtronic and Edwards Lifesciences for use in patients at low risk from open-heart surgery.
The success of TAVR has sparked a race to commercialize transcatheter mitral valve replacement devices. – DK
1. Robotic surgery expands
Pioneered by Intuitive Surgical through the early 2000s, robot-assisted surgery became a hot medtech area in recent years, with a host of major medtech companies seeking to break into the space.
“The 2010s served as validation of the robotic surgery hypothesis: Providers, payers and patients will embrace an expensive platform technology that effectively gives the surgeon superpowers in the operating room. The stage is set for a battle over platforms among the big players and a myriad of procedure-specific systems from smaller innovators,” said Thielman at Product Creation Studio.
Medtronic in 2019 unveiled its much-awaited Hugo RAS system — which the medical device giant touted as more flexible and cost-effective than systems currently on the market.
Johnson & Johnson closed the year by announcing its purchase of the remaining stake in Verb Surgical, following what J&J described as a successful strategic collaboration with the Alphabet life sciences unit Verily. J&J’s Ethicon subsidiary in February inked a $3.4 billion deal to pick up surgical robotics pioneer Dr. Fred Moll’s newest robotic surgical play, Auris Health, and its FDA-cleared Monarch platform.
Intuitive, meanwhile, continues to innovate when it comes to robot-assisted soft-tissue surgery. Its da Vinci SP robot for single-port surgery has a tube that is about an inch wide and delivers fully articulating instruments: three that can manipulate things and one that’s a steerable endoscope. The robot is in the process of launching in the United States.
Robots are also hot in the orthopedic surgery space. More than six years after spending $1.7 billion to acquire Mako Surgical, Stryker is leading the way. Big competitors including Johnson & Johnson’s DePuy Synthes business, Zimmer Biomet and Smith & Nephew, which have either launched or are preparing to launch their own robots.
In December 2018, Medtronic closed on its $1.7 billion purchase of Mazor Robotics and its robot-assisted surgery platform for the spine. A month later, Medtronic launched its Mazor X Stealth robotic-assisted spinal surgical platform in the U.S.