In the medical devices industry, 2013 has been a year of major transition. That shift from volume to value is finally starting to gain momentum and meaning. The word “innovation” has lost its meaning according to a PwC analysis, and 2014 will hopefully be the year medtech redefines the corporate buzz word, offering it new meaning. In spite of these challenges and others (cough, cough: funding and taxes, cough), there has been truly jaw-dropping innovation in 2013 that will build the future of healthcare. But what of it will we remember 10 years from now?
Awe-inspiring or awesomely bad, here are my predictions on what our Internet-rattled minds will keep for a whole decade.
The year artificial organs and 3-D printing took quantum leaps
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The Carmat artificial heart is still beating along inside the chest of the first patient to receive such a device. The French startup has created the “world’s first fully artificial, self-regulating” heart, and from the glimpse given in this one patient, it’s likely to also be the first successful fully artificial human heart. What makes it self-regulating?
“If your loved one came through the door [and you had a Carpentier artificial heart], it would start to beat faster, just like a real one,” company founder Alain Carpentier told USA Today.
Holy holy.
The part-cow, part-sensor implant still has many hoops to jump through, but to see such a device working in a patient at all is something we won’t forget in 2023, no matter how far tech has come. If it proves successful in its trials, this is on par with the pacemaker for innovation.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Of course, the heart isn’t the only artificial organ breakthrough made this year. Medtronic‘s (MDT) artificial pancreas device system shows promising achievement in the Type 1 diabetes space, although it will take the industry about four more major steps to get a device to function as a true artificial pancreas. (Click here to read what those steps are.)
And all this without even touching on 3-D printing’s contribution to artificial organ creation. Organovo printed a tiny liver. The body-on-a-chip project at Wake Forest Baptist Medical Center has Department of Defense backing it and has obvious pharma implications, as well as potential to lead to printing full-scale organs. This Louisville research team even bets it will be able to print a fully-functioning “bioficial” human heart by 2023.
The medical 3-D printing industry is expected to hit $1.9 billion by 2025. (Need a refresher course on 3-D printing in healthcare? Check out this infographic.)
(This year also saw a lot of money thrown at impressive ablation tech and renal denervation results, so fingers crossed for more in 2014/2015.)
The pivotal year the FDA tries to define its role in an app-driven, instant-gratification society
In 10 years, this will be seen as the year the industry’s relationship with the FDA began to change to retrofit an Internet-based society that wants access to the most cutting edge technology. At Advamed 2013, FDA Commissioner Dr. Margaret Hamburg suggested lab development tests, which include mobile apps, need a “critical baseline.” This implies a shift, or at least an acknowledgment of attitude toward such apps, which CLIA currently monitors. However, CLIA doesn’t ensure they are properly designed, consistently assembled or clinically valid, Hamburg said.
In a panel following the speech, WSJ columnist and American Enterprise Institute Resident Fellow Dr. Scott Gottlieb disagreed with FDA’s movement into this area.
“A lot of these issues around laboratory development tests can be addressed through CLIA properly,” he said. “I think we have to ask hard questions about whether CLIA–or the FDA for that matter–should be judging clinical utility.”
Many medtech entrepreneurs and thought leaders wait on the sidelines to see which route their apps must take and how quickly they’ll be able to be released. While erring on the side of caution, at least one has told this reporter about the difficulties if the FDA does tighten its grasp. The main problem being by the time an app is cleared, the operating system for the technology (or the medium itself) has changed. The other question is one purely of capacity — does the FDA have the manpower to test all these apps to its standards in a timely fashion?
TBA.
The other major FDA quest for identity issue we’ll remember in 2023 is the 23andMe saga. Whether you (seemingly like most in the medtech industry) believe the FDA was right to step in and require 23andMe to seek approval for its genetic tests or not, what shakes out will have a resounding impact on the industry. It could once and for all settle a hard-and-fast rule about genetic testing as medical device (and perhaps push such innovation outside U.S. borders) or limit the scope of what the agency has the right to regulate. Smart takes on this issue here.
Remember the smartwatch? LOL.
In 2023, we’ll remember the smartwatch in the quaint way CBS Sunday Morning does retrospectives of how we thought the 2000s would be in the 1960s. The clunky and overly showy wearable promised not much to a lot of fanfare. But when Samsung launched its version, an orchestra of thousands of tiny violins played a sad song to the tune of far less than 1 million units shipped. (Note I didn’t say units sold.) Some predict by 2018, the amount shipped will hit 36 million a year.
Why won’t the smartwatch be a hit in healthcare?
As Christopher Mims said at Quartz, “Smartwatches are going to be big. As in physically large.”
The clunky screens look more like fancy wrist weights than seamless tech. Even those with promising medical applications scream “I look like I just came from a hospital!” But patients want to look cool. Wearables are becoming more fashionable and to be successful will need to fit into modern life rather than add to it another constraint. Some biosensors are even taking the form of adhesive tattoos.
The other question: How will smartwatches be better than smartphones or Google Glass in a significant way in medicine? For remote patient monitoring, something like Jawbone’s UP, which interacts with smartphones and apps (without that large Inspector Gadget/George Jetson screen), seems more viable. Rather than working to reinvent the wheel for the wrist, using it to gather metrics and vitals and send it somewhere else, with more the appearance of a bracelet than a computer, may show more success.
Of course, Apple is at work on a smartwatch, and regardless of its utility, it could become an “it” tech timepiece. But it will need to do much more in the often sluggish medtech market to keep from being part of a 2023 healthcare gag reel. (Which probably will also include this oversized gen-1 ear clip for a noninvasive glucose monitor.)
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