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The Health Innovation Hyperloop Is Here: FDA, Freelance Experts, and Fab Labs

For those who are weary of reading, and writing, about healthcare’s glacial pace of innovation, 2017 is delivering a bolus shot of hope and excitement.

 

The Big Bang

While you’ve heard of the Big Bang Theory, what you probably haven’t heard of is 2017’s big bang; after so many decades of “someday,” the age of healthcare innovation is finally here. Having stealthily crept toward the spotlight after the quicksand of Y2K, the pace of 21st-century health innovation has hit its stride this year. With apologies to Elon Musk, health innovation is about to go a hell of a lot faster.

Imagine a digital health inventor-penned, app-supported, smartphone device that predicts epileptic seizures with startling accuracy. Let’s examine two scenarios:

October 2015: Expensive prototypes are built in China – first dummy concepts, then working models developed over several months. Investors insist an FDA application must be filed, and a testing firm begins searching for willing patients for trials. Projected launch date: 2020

October 2017: A Boston-based inventor prints 3-D prototypes himself in the Fab(rication) Lab, located in a co-working space at 50 Milk Street in Boston. He hires 10 epilepsy patient experts as freelancers to test the prototypes as they’re printed. The device meets FDA’s new definition of low-risk and bypasses formal approvals; working models go into the field with his freelance Patient Experts who line up pre-orders in their online communities. Projected launch date: December 2017

The latter scenario will likely happen in the next year. With smartphone apps that detect diseases such as pancreatic cancer in development, and the introduction of mobile apps like Seizario detecting falls and seizures, interactive health-monitoring technology is here to stay.

A host of market, regulatory, and technology forces have come together to make that happen – here are three that may top the list:

 

Loop 1: FDA Streamlines Digital Health Regulations

Newly appointed FDA commissioner, Dr. Scott Gottlieb, spoke to one such development. Detailing the need to decrease regulation of health technologies, he said,

“FDA will provide guidance to clarify our position on products that contain multiple software functions, where some fall outside the scope of FDA regulation… In addition, FDA will provide new guidance on other technologies that, although not addressed in the 21st Century Cures Act, present low enough risks that FDA does not intend to subject them to certain pre-market regulatory requirements.”

That clarity and guidance include:

  • Reducing development costs
  • Modernizing FDA tools and policies to increase efficiency
  • Providing more opportunities for entrepreneurs to develop products

And, not a moment too soon – digital health is rattling its cage with anticipation. StartUP Health’s most recent investment report shows that 500 companies were funded in 2016 alone, with some $8 billion invested, including four of the six largest monetary deals since 2014.

StartUp Health’s projections on increasing quarterly investment spanning from 2010.

Director of the University of Colorado Innovations, Kimberly Muller, commented on the trend saying:

“We’re in the midst of a revolution. Every 50 years you see a massive revolution in healthcare and the next one is due for 2020.”

A host of new companies stand to benefit:

Complete Ortho is an anatomically accurate software presenting data to, and consulting with, the patient by way of technology found in patient homes via smartphones and tablets.

This technology aims to increase the accessibility of patient records and visually to aid in the explanation of patient conditions and treatments. An Apple Design Award 2016 Winner, Complete Ortho intends their product to lead “to better patient understanding and informed decision-making.”

Another smartphone-adaptable device, the TRI Analyzer, hopes to combine the presence of smartphones in daily life with health and medical diagnostics. Described as the “Swiss Army knife of biosensing,” this tech is low-cost and promises potential applications in health diagnostics, animal health, and food safety.

Loosened regulations and the coming revolution leave such companies with more room to modernize their technology and compete in health markets.

Adam Thierer of the Mercatus Center at George Mason University believes “this is a signal that the FDA is waking up to the realities of the Information Age and are willing to let consumers take advantage of the many life-enriching—and potentially even life-saving—technologies that could be at their disposal if not for excessive bureaucratic red tape.”

His comments were echoed by PhRMA, who expressed their belief that streamlined regulations seek to modernize the drug discovery and review process, and advance competition within the biopharma markets.

 

Loop 2: Freelance Patient Experts and the Liquid Workforce

Even with a smoother path through FDA approval, digital health innovation won’t pick up real speed until innovators of all shapes and sizes can connect with the insight and talent they need. From inventors and startups to Google Calico, finding the right expertise at the right cost has been a substantial roadblock.

Enter the liquid workforce – a trend that is reinventing our very concept of work, and perhaps the most powerful accelerant of digital health innovation. 

As detailed by WEGO Health’s chief strategy officer, David Goldsmith, this collection of freelancers is characterized by on-demand labor platforms, crowdsourcing, and other online work management solutions that enable companies to hire people with deep expertise for highly specialized tasks.

While consulting firms, including Accenture, have sourced freelance talent by embracing marketplace platforms, healthcare had stood firm in its industrial hiring model. This year marks a change in this stance and matches the increase in the number of highly specialized designers, managers, engineers, caregivers, and patient experts on the market.

The trend is made possible by two forces:

  • Technology platforms enabling companies to hire specialized talent on demand
  • A burgeoning freelance economy changing the labor market

As reported by the Department of Labor, by 2020, independent workers will comprise upwards of 50 percent of the workforce. That’s quite a change from past surveys vaguely defining independent workers and attributing freelance work to something done on an as-needed basis.

In order to understand this shift, consider workplace interactions and telehealth communications. Where barriers are lower, talent can be organized efficiently to meet time and location needs.

WEGO Health Experts is an on-demand platform matching specialized talents with freelance engagements from healthcare organizations. Specialized talents (in the form of Patient Experts) enjoy the flexibility of freelance consulting while offering a unique combination of knowledge and experience from managing chronic and complex health conditions.

These experts bring the expertise of navigating the healthcare system from the inside – as caregiver or patient – alongside their professional credentials. And for health innovators, on-demand means on-budget, as-needed human capital to match their funding.

 

Loop 3: Fab(rication) Labs and the Maker Movement

The FDA has cleared the path, the liquid workforce is running hard, and now even manufacturing can keep the pace. A host of new models are equalizing technology – slashing costs and putting sophisticated tools into anyone’s hands. 

Created to make technology production easier, more accessible and more immediate, a global network of fabrication laboratories is springing to life.

As explained by the Fab Foundation, spanning more than 78 countries, the Fab Labs Network was created to “share the goal of democratizing access to the tools for technical invention.”

Each lab maintains a set of core capabilities. As detailed in Impact Boston, those included in the FAB@CIC include:

  • A computer-controlled laser cutter, for press-fit assembly of 3D structures from 2D parts, cutting, and engraving.
  • A precision (micron resolution) milling machine to make three-dimensional molds and surface-mount circuit boards.
  • A vinyl cutter, to make signs, stickers, printing masks, flexible circuits, and antennas.
  • A precision milling machine to make three-dimensional molds and surface-mount circuit boards.
  • 3d Printers
  • Dye Sublimation Machine to print and cut fabric to create flags, signage, polyester apparel, custom printed fabrics, and other personalized objects like mugs.

With the capability to turn “information into things, and things into information,” these laboratories possess the ability to capitalize on both limited regulation and a liquid workforce, making our example all too possible. But who is going to operate them?

Enter the Maker Movement. A collection of individuals or groups of independent designers, inventors, and tinkerers, Makers create marketable products and offer technological solutions without the backing of traditional infrastructure.

Yet another modern solution to specialized demand, those participating in the movement are flourishing in the absence of overbearing regulation. Maker Movement product concepts can be theorized, tested and brought to market faster than other mass-production outfits.

The tools of this proposed revolution, the 3D printer, the Fab Lab, and public-private collaboration, make use of previously untapped technologies and partnerships. What once may have required months to present for FDA approval and outsourcing deals may now be done locally or through web platforms.

And don’t think this watershed is reserved only for startups and individuals – tech giants will propel us all.

 

Bonus Loop: Tech Giants Enter the Health Industry

Known for Prime shipping, its acquisition of Whole Foods, and its revolution of the marketplace, Amazon dominates multiple industries. And now it has set its gaze on yet another: healthcare.

Titled 1492, Amazon’s secret project was advertised on career sites including LinkedIn as looking for “talented group of software engineering (especially expertise in computer vision, a/v, hardware, web dev), machine learning & natural language processing specialists, designers, and product managers.”

Later on, talent listed their affiliation with use of keyword “a1.492.” All references, spare one last call to employment, referencing the keyword were taken down shortly after.

So, what is Amazon’s business in health? Will it revolutionize medical record data, introduce new telehealth platforms, or continue health applications for various Amazon software? One thing is certain: with decreased regulations, a liquid yet specialized workforce, and the existence of fabrication labs, Amazon has the upper hand on introducing innovative projects capable of revolutionizing healthcare.

One such application is already underway. Virtual Nurse for Alexa is in development to become the non-emergency, advice giving application for illnesses and injuries including appendicitis, arthritis, and asthma attacks.

Another notable involvement is Amazon’s investment in health startup, Grail. Expected to launch in 2019, Grail is a “deep sequencing technology to detect the earliest signs of cancer in the blood, while it’s still treatable.”

Google’s health industry intent remains under wraps, to the frustration of consumers and the scientific community alike. Secrecy around Calico, a speculated aging research project, has led to further speculation about the industrial giant’s motives.

Upon Calico’s partnership with biomedical research laboratory and non-profit, The Jackson Laboratory (JAX), chairman Karl Gunnar Johansson said:

“We are bringing a genetic approach to discovering the mechanisms of aging, with the goal of identifying interventions that can increase maximal lifespan and improve health in late life.”

 

Health Innovation – It’s Finally a Thing!

While the healthcare industry in general has been slow to hop on the digital innovation bandwagon, or to recognize the wide-ranging benefits of the freelance economy, its time has finally come. There’s a vast population of healthcare-focused freelancers who are ready and available to bring this industry into the here and now. And, while baby steps have been taken thus far, healthcare as a whole remains virtually untouched on so many levels. Now is the time to step out from the crowd and make it happen.

Don’t know where to start? Here’s a hint – WEGO Health Experts.  

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