MedTech in 2013: A Year of Disruptions and Debates

This year saw a lot of growth in emerging technologies and trends. But while some technologies are being hailed as the next great thing for medicine and healthcare, others are being touted as fads, passing fancies, or even outright snake oil. Time will tell just how disruptive these new developments are, but there was no shortage of new ideas in 2013. 

3-D Printing Takes Aim

Cody Wilson, a University of Texas law student, made national headlines in April when his company, DEFCAD, began freely distributing designs that would allow anyone to 3-D print working gun parts. It was controversial, but also the clearest demonstration of the power and potential of 3-D printing. 

Then, in June, Statasys, a company that manufactures and leases 3-D printers, demonstrated its belief in the technology's future with the purchase of MakerBot, a maker of several consumer-level 3-D printers. 

The real testament to the technology's potential, however, has been the breakthroughs in boundary-pushing research, particularly in medtech. Researchers have experimented with 3-D printing everything from ear and skull implants to organs. Momo Scientific has even used 3-D printing to cheaply prototype CryoPop, a device to provide Pap tests in developing nations. 

In a panel at the MD&M East conference and exposition in June, Ryan Klatte, principal research engineer at the Lerner Research Institute at Cleveland Clinic, praised 3-D printing's potential to help hospitals cut costs by providing surgical models for tests and dry-run surgeries. "If you save even a half-hour in the OR, you can potentially recover the entire cost of the 3-D printing technology," Klatte said. 

Enter the Robots 

In January, futurist Thomas Frey predicted that more than two-billion jobs will be lost to robots by the year 2030. But manufacturers say robotics isn't about replacing people; it's about helping them do their jobs better and taking the “three Ds” (dull, dangerous, and dirty) out of the human workplace, whether that's a factory or even the operating room. 

Earlier this year, Rethink Robotics rolled out Baxter, a friendly looking and easily programmable robot designed to assist with a variety of manufacturing tasks typically handled by human workers. Elaine Chen, vice president of product development for Rethink Robotics, says Baxter is designed to free factory workers to take on more responsibility and more important tasks. “A factory floor worker with only a high-school diploma, someone who has never seen a robot before, can learn to train Baxter to do simple tasks in five minutes,” she says. “A factory worker can do part of a task and set Baxter up to do the rest of the task. This means that factory workers are now empowered to be robot supervisors.”

According to Bloomberg, Intituitive Surgical's da Vinci robots performed 367,000 robot-assisted surgeries in 2012. But 2013 saw several lawsuits filed against the company alleging that it markets to doctors without providing adequate training. Competitors are no doubt seeing Intuitive's troubles as both a cautionary tale and an opportunity as they enter the robotic surgery space.

Corindus Vascular Robotics, on the other hand, is so confident that its CorPath system can enhance doctors' ability to perform angioplasty procedures it is offering to reimburse hospitals for any additional, unplanned stents. “Patients have a perception that a robotic procedure will be done more precisely than a manual procedure. . . I think they'll seek out hospitals that provide the robotic procedure,” says Brett Prince, Corindus's director of marketing, 

Many doctors. however, remain skeptical—or at the very least, cautious. “The question is not what you can do [with robotic surgery]. It's what can you do safely and effectively," A. Marc Gillinov, a staff cardiac surgeon at Cleveland Clinic, said at the annual TCT Conference in San Francisco in October. Gillinov's conclusions,  based on studies of the effectiveness of robots used for mitral valve repair surgery, were that surgical robots are effective but show no significant benefit over surgeons. 

But if robotics is showing any downsides, device makers seem to have faith that they can be overcome. In fact, Skyker spent a whopping $1.65 million in September to acquire Mako Surgical, a manufacturer of robots for orthopedic surgery. 

Digital Health and Consumerization

No trend has been more responsible this year for bringing nonhealthcare companies into the medtech space than mobile health (mHealth). It has been impossible to ignore the explosion of wearable devices and health/fitness trackers into the consumer market.  There are more than 40,000 health-related apps available for the iPhone. And with FDA's release of the final guidance on mobile medical apps clarifying that it will only regulate a small subsector of apps (mainly those with diagnostic purposes), it's not likely that app development will slow in the near future. 

In September, Samsung took a leap into the wearables market with its Galaxy Gear smartwatch. The device is designed to interface with a Samsung smartphone, but also contains a variety of sensors that could be used for health monitoring. 

The House Energy and Commerce Health Subcommittee held a hearing in November on the bipartisan Sensible Oversight for Technology Which Advances Regulatory Efficiency (SOFTWARE) Act, which would amend the Federal Food, Drug, and Cosmetic Act to allow for regulation of medical software. Representatives Marsha Blackburn (R-TN) and Diana DeGette (D-CO) introduced the legislation, hoping to codify the provisions made in FDA's mobile apps guidance. However, other House committee members were concerned that the act was reaching too far, too soon.  “We have barely had an opportunity to see how [the FDA guidance is] working out and whether there are any instances of burdensome requirements stifling innovation in this area,” Representative Henry Waxman (D-CA) said. “It is not appropriate to legislate based on unfounded fears of what 'might' happen in the future.”

The big winner in this realm, however, was remote patient monitoring and electronic health records. In 2013, Qualcomm Life, a division of semiconductor manufacturer Qualcomm, announced a partnership with Web MD to leverage Qualcomm's 2net platform in conjunction with Web MD's mobile app to provide consumers with cloud-based access to aggregate data across multiple medical devices and apps. The company's hope is to create a standarized platform that all medical devices and apps can access to share and store data. Verizon made a similar bid this year when its Converged Health Management software solution was cleared by FDA, allowing data to be collected and transmitted in real time from devices to a secure, cloud-based server. 

All of this, of course, leads to greater concern for patients' privacy and access to their data. Cybersecurity has become such a concern on that FDA has called for device makers to consider it more strongly in their design process. On the other end of the spectrum, however, are patients who want easy access to their device data. In July, patient advocate Hugo Campos finally scored a victory in his ongoing battle with Medtronic, when CEO Omar Ishrak gave his blessing for Campos to get access to data from his implantable cardioverter defibrillator. Campos was given a two-page XML document of his device data—and was billed $797 for the inconvenience. 

The Structural Heart

This year also saw device makers increasingly entering the structural heart space and looking for novel alternatives to invasive heart surgery. Bioresorbable stents have gained a lot of attention as an alternative to traditional drug-eluting stents. Studies completed this year, such as the Absorb Cohort B Study conducted by Abbott Vascular, have shown bioresorbables to deliver comparable clinical outcomes to their drug-eluting counterparts like Abbott's XIENCE. Among advocates of bioresorbables there is debate as to whether metals or polymers are more effective. “Plastic is not metal. It is thick, hard to expand, and tends to break,” Dr. Ron Waksman, a professor of medicine at the Georgetown University MedStar Heart Institute in Washington DC, said in a panel at October's TCT Conference. While clinicians agree more data is needed, if data shows that metal and polymer bioresorbables are comparable to their nonbioresorbable counterparts, then the coming years may see  significant growth in their use.

In October, Medtronic announced the results of a study showing that its CoreValve transcatheter aortic valve product was found to be an effective treatment for extreme-risk patients with aortic stenosis. Based on this evidence, FDA has said it has sufficient evidence to evaluate the safety and efficacy of the CoreVavle without the need for an external expert panel. Back in July, the CoreValve was pulled off the market in Germany when a court declared that it infringed on a patent by Edwards Lifesciences. That decision was reversed by a higher German court in November. 

Tht same month, FDA surprised analysts by approving Abbott Vascular's MitraClip, a novel device for mitral valve repair. Back in March, FDA staff recommended that the agency reject Abbott's application for premarket approval, but a panel disagreed and approved the MitraClip for use in patients with significant symptomatic degenerative mitral regurgitation who are too sick to undertake the risk of open-heart surgery. 

Still, the MitraClip, which reduces mitral regurgitation by clipping onto the leaflets of a leaking mitral valve, still faces lingering questions regarding its real-world effectiveness, even with its ready availability in Europe. Speaking at the TCT Conference in October, Dr. Ralph Stephan von Bardeleben, of the University Medical Center Mainz in Mainz, Germany, said his research has found the MitraClip to be a safe procedure with survival and clinical benefits stable after four years, but that it is also less effective than surgery without the mortality difference. This question of effectiveness was what spurred the FDA advisory panel to recommend against its approval. The MitraClip debate is just another example of how, even as disruptive technologies move forward, device makers can't stop that disruption from raising at least a few eyebrows.

-Chris Wiltz, Associate Editor, MD+DI
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