Editor’s note: Dr. Michael Patton is co-founder and CEO of Texas-based Medical Innovation Labs.
The recent and successful human implantation of a 3D-printed vertebra at Peking University in China captured the public’s imagination. I read the news (and its quick spread) as evidence that medical devices are, dare I say, cool again.
I’ve never seen a flood of interest as we have enjoyed recently. This is a great thing; I love the idea that innovators the world over, from almost every discipline and industry, are carefully researching and ultimately choosing to pursue opportunities in the device field. We need all the help we can get.
3D printing technology has been used to create everything from knee cartilage to new drugs for treating cancer. A fully-functioning liver is expected in a few years. Or as the New Yorker put it recently: It is now possible to “print thyself.”
Perfecting the process of bioprinting human organs and bones, and engineering DNA scaffolding from which to develop precise medicinal compounds is a focus for universities, private labs, and venture-funded startups alike, and for good reason. We can even print metal as of today; we’re no longer limited strictly to polymers.
Colleagues have repeatedly inquired: what are the overarching implications of Peking’s result, and others’, for the future of device innovation? After so much fanfare, has 3D printing for healthcare finally arrived? What is the state of the union of these technologies in the U.S.? How close are we to widespread clinical use? Where should I place my chips?
These are the right questions to be asking, especially given that the United States is still the leader in medical device manufacturing. The domestic market is projected to reach $133 billion by 2016. This is one area in which jobs are not just secure, but multiplying. We have a natural advantage in devices, right here in our backyard.
Below is a summary of the medical device market, the context of which I think will be helpful whether you’re a clinician-turned-entrepreneur, a hardware or software engineer, an investor, or a healthcare provider or administrator. Then we’ll discuss 3D printing’s specific promise in greater detail.
Medical Devices 101
Despite its overall size, the medical device field has a disproportionately long tail, making it unique compared to other healthcare segments, which are characteristically dominated by large, heady incumbents. Of the 6,500+ medical device companies in existence in the U.S. today, more than 80 percent are small businesses with fewer than 50 employees.
These companies are leaner and meaner than most any venture-backed software play, especially considering the overhead involved. Think of device companies as risky, capital-intensive hardware plays. But instead of beaming Netflix to your TV, or tracking how many miles your car has driven in a given week, they’re healing wounds faster with liquid-free, thermo-regulating circuits that anyone can administer, dramatically reducing sepsis with smart catheters that guard against infection in ways never before thought possible and treating acne painlessly with the press of a single miraculous button.
It’s an exciting time to be working in devices, for sure. But any market overview should in fairness also detail the challenges facing the device community in equal measure.
The annual survey conducted by Emergo Group in January enumerated the top three challenges currently faced by medical device companies. Regulatory issues, access to funding, and the new product development are the biggest pain points for medical device innovators. The study confirmed what any entrepreneurs in our sector knows firsthand, but it was nice to see it validated empirically.
Product development, despite being No. 3 on the list, is where we need to focus if we’re to dramatically increase the odds of success for device companies and get more devices into the hands of patients who need them most.
The rate of new product development within the healthcare industry overall is too slow at a time when we need change more than ever. Devices are just the tip of the iceberg, but they’re a wonderful place to start. Devices are where speedups are most welcome and least political.
As innovators, however, we’re quick to gravitate towards sexy use cases. In so doing we often glaze over the first, and in many ways most important, phase of device innovation: prototyping. And that conveniently brings me back to 3D printing.
Prototyping the Future
If you take away nothing else from this article, take away this: 3D printing’s greatest utility for medical device entrepreneurship lies in prototyping, not manufacturing.
Although clinical-grade implants like Peking’s are exciting — as are new inventive areas like genomic bio-printing — the biggest pain points medical device entrepreneurs face sit considerably earlier in the product lifecycle and are rather basic.
That is, until now it has been impossible to iterate on medical device concepts at a speed anywhere near what our software-developing brethren can accomplish. The faster we can develop prototypes and the better each iteration can be, the sooner we can place effective new devices in hospitals and clinics and make a meaningful impact on patient care. Speeding time-to-market is the top motivation.
Capital requirements accordingly plummet. And best of all, our greatest talents can follow their nose; gone are the days of quixotically laboring on ultimately doomed projects, blind to their efficacy (or lack thereof) for years. 3D printing makes it easier to try new approaches, but it also makes it easier to kill a fruitless line of thought and move on, without existentially threatening an entire venture.
Rapid prototyping helps in the two other “problem areas,” as well. Working with regulators becomes more of a conversation instead of a months-long call-and-response if you can prototype quickly. Similarly, investors love the idea of further de-risking design and development by iterating on product in ways that again, until now, only software developers could.
What Now? What Next?
3D printing is here to stay. Here are three things that will take all of the energy and all of the interest in medical devices we’re seeing, and harness it for optimal technological progress.
Standards, and standards bodies. When one collaborating lab passes a schematic or calibration along to another, a common operating vocabulary is essential. Right now there are too many formats, and few technical standards. 3D prototyping looks a lot like the Wild West. This isn’t as acute a problem when research and development occurs exclusively within a single lab or team.
Still, from what I have seen, the most interesting stuff in terms of device innovation is the product of multi-site work comprising several expert teams, each of whom brings to the table a unique skill set. Device innovation is an interdisciplinary effort.
Open-sourced designs, configurations and software. Standards in turn make possible another level of abstraction in. Each team’s intellectual property lies in what we prototype, not the mechanics of prototyping itself. What software entrepreneurs today consider de rigeur, device entrepreneurs have lusted after longer than we are likely to admit. We should not have to reinvent the wheel every time out.
Too many groups are focused on developing their own printers, substrates and everything in between. Out-of-the-box prototyping systems are seldom customized for the task at hand; that fact, however, doesn’t mandate a proprietary-first mentality.
Prototyping labs. Right now, most prototyping happens in a dirty, dust-flecked corner of existing labs, and facilities, such as they are, are spread all over the place. There are few convening points for innovators in the midst of prototyping and right now it’s a lonely path. Edison Nation Medical, a Charlotte-based organization, helps healthcare workers bring their medical device ideas to life by designing and prototyping ideas with high potential for commercialization, and they’re one great, outlying example to follow.
Similarly, the MidMichigan Innovation Center and the Cambridge Innovation Center have created collaborative environments for entrepreneurs to work in close proximity to peers and experts who provide advice for startups that need help along the way. What we’re doing at Medical Innovation Labs in collaboration with Prof. Joe Beaman at the University of Texas is another great example.
I’m really happy that medical devices are cool again. But I want to make sure we take full advantage of our moment in the sun. The real opportunity of 3D printing in the medical field lies in prototyping — in the “how” of making devices even more so than the “what.”
In order to manifest this sea change, we ought to recognize, standardize and maturely support 3D prototyping as more than a fad or a speaking point. We have to become more than a loose network of moonshots and side projects, which is where we are today.
Your big takeaway is that with 3D prototyping, medical device innovators can iterate more rapidly and more often, which creates the same hyper-productive, hyper-creative mindset that led to so much software innovation over the past two decades. The means and methods of production have forever changed for the better.
The goal should be no less than a renaissance in device innovation, bringing to market myriad new solutions that patients all over the world have eagerly awaited for too long already.Featured Image: Crystal Eye Studio/Shutterstock