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Bina Is Working to Make Personalized Medicine a Reality

Genomic analysis startup Bina Technologies (Redwood City, CA) has emerged from stealth mode and is planning its first official commercial launch in February. “Now, we have a proof of concept and a pilot product on the market,” says Bina’s CEO, Narges Bani Asadi. “We have been testing the product, validating it, and now we are getting ready for our official commercial launch.”

Bina BoxThe firm grew out of a multidisciplinary research project spanning three departments at Stanford and another at UC Berkeley, which project brought together computer science, electrical engineering, statistics, and medical researchers. While working towards a PhD in electrical engineering at Stanford, Asadi began working on developing a computing and data analysis platform for systems biology. “I got fascinated by learning about biology and how it is related to Big Data analysis,” she recounts.

While at Stanford, Asadi won a multi-million dollar grant from the National Cancer Institute for her research. “The goal was to build a graphical model that encodes causal relationships between proteins and how the interactions get disrupted with cancer,” she says. “The goal was to understand cancer at the molecular level.” Asadi’s research team went on to win several awards for their research and eventually started thinking about forming a startup to support the burgeoning field of genomic medicine.

A little over a decade ago, generating a genomic sequence remained a huge challenge, taking years to accomplish and hundreds of millions of dollars. “Now the challenge is not generating the data,” Asadi says. “The bigger challenge is how do you interpret the data. What does the genome mean? That is a Big Data problem,” she adds. “You need to look at the genome and put it in the context of many genomes correlated with diseases, treatments, outcomes, and so on. We look at it as both a statistical problem as well as a computational problem that needs the brightest minds in computer science and statistics.”

With that conclusion in mind, the Stanford researchers began working on a project that would evolve into its Bina Box product. Asadi describes it as a “self-contained plug-and-play solution for genomic analysis.” The platform takes the lowest form of information that the sequencing machines output assembles them, determining how they compare to a reference genome.

The platform is being piloted at several institutions. “One of the customers is the Stanford University’s genetics department. “Without our solution, it used to take them weeks to do the analysis. Now it takes a matter of hours. It has been a one-hundred-fold improvement.”

“What Bina has elected to do is to tackle some of the biggest and hardest problems first, which is what do you do with these billions of short reads that are coming off the sequencers today and the goal there is to assemble those into high quality finished genomes,” explains Mark Sutherland, the company’s senior vice president, business development. “That is a problem that we have largely solved,” he says. “The next challenge we want to do is tertiary analysis where you assemble many genomes and put them in the context of each other through a database environment where the key traits of each of those genomes will be compared with each other and correlated with diseases, patient groups, symptoms, etc.,” he adds. “

“There has been a lot of discussion beyond the outset of personalized medicine; really it has been waiting for two things: costs to drop, and that is largely happening; the other is for the information to be manageable, portable, and mineable,” Sutherland says. “And that largely hasn’t happened yet. That is the Bina opportunity.”

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

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This Week in Devices [1/25/2013]: A Rough Week for Hip Implants

 

Johnson & Johnson Was Aware of Metal Hip Implant Failure

Newly disclosed court records show that Johnson & Johnson conducted a never-released internal analysis in 2011, after recalling its metal-on-metal hip implant, that estimated the device would fail in nearly 40% of patients in five years [QMed]
 

FDA Releases Safety Communication on Metal-on-Metal Hip Implants

FDA has released a safety communication warning against the hazards of metal-on-metal hip implants. Among the noted issues are soft tissue damage, and the potential of releasing harmful metal ions and particles into a patient's bloodstream. [FDA]
 

3-D Printer Redefines Reconstructive Surgery

Orthopaedic surgeon Justin Cobb is applying 3-D printing technology to a surgical procedure that could revolutionize orthopaedic adult reconstructive knee operations. [EMDT]
 
 

Stryker Buys Trauson for $685 Million

Stryker, a healthcare products manufacturer based in Kalamazoo, Michigan, announced that it had acquired Trauson, a Chinese spine-products manufacturer. In a conference call with investors, executives at the company detailed how the acquisition is part of the company's emerging market strategy. According to executives at Stryker, the purchase of Trausan will help the company expand its product portfolio in the orthopedic trauma market. While the company offers several products in the premium sector, it has limited products in the "value segment" of the Chinese orthopedic device market. With the new all-cash $685 million purchase, Stryker will have access Trauson's "value segment" brands, patents and production facilities. Trauson's portfolio includes 120 medical devices currently available on the market. In addition, the company has an expansive distribution network and R&D pipeline. Katherine Owen is the vice president of strategy at Stryker. In prepared remarks, she said, "To date, Stryker's presence in China has been focused on the premium segment, which is dominated by multinational players. However, the value segment of the market is growing at a faster rate, with local manufacturers the key players." She continued, "We have prioritized China and the value segment of the market in particular as a critical market, given that the device segment is growing at roughly 20% annually, with the overall market expected to more than double in the next 5 years." References www.stryker.com/en-us/corporate/PressNews/index.htm

Should FDA Ask For Financial Data from Product Sponsors?

OIG says FDA should ensure sponsors submit complete financial information for all their clinical investigators. Sponsors must also ensure reviewers consistently monitor financial information and take action in response to disclosed financial interests by using a review template and providing guidance and training to reviewers. OIG says the recommendations would improve the agency’s ability to identify financial conflicts between clinical investigators and drug sponsors that could create a potential for bias.

The report notes that an earlier OIG investigation found FDA had approved 42% of marketing applications in FY 2007 that were missing financial information. It also says that in about one-third of marketing applications, FDA reviewers did not document a review of financial interest information, and neither FDA nor sponsors took action on 20% of marketing applications with disclosed financial interests. “When FDA did act, it did not consistently take action in response to disclosed financial interests,” it says.

OIG does say FDA has made some progress in implementing certain aspects of the recommendations. For example, in 2011 a the draft guidance “Financial Disclosure by Clinical Investigators” was released. “We continue to recommend that sponsors submit financial information as part of the pretrial application process and will monitor FDA’s progress in implementing this recommendation,” it says.

On medical device safety, the report notes that a 2009 report “revealed that FDA has not documented follow-up on adverse events, nor does it consistently perform its first-time reading of adverse event reports in a timely manner. In addition, FDA rarely acts when manufacturers and user facilities submit reports late. The inability to obtain complete and usable information in adverse event reports hinders analysts’ review of the reports, and FDA makes limited use of annual reports. Overall, FDA received twice as many adverse event reports for medical devices in 2007 as in 2003; however, the number of some types of reports, such as 5-day reports, decreased. Although manufacturers submitted most adverse event reports on time, many 5-day manufacturer reports and 5-day user facility reports were late.”

The report says a clear protocol is needed to ensure all responsible parties report and take appropriate action in response to device adverse events. “We recommended that FDA seek legislative authority to eliminate the requirement for user facilities to submit annual reports because, other than a count of total adverse event reports, all the information in the annual reports is redundant to the originally submitted reports,” it says.

 

More Washington Wrap-Up

CDRH Says It has Improved Its Processes. Do you Agree?

FDA-Industry Consortium to Speed Device Reviews

CDRH Answers Slowness Critics on Patient Blog

CDRH Says It has Improved Its Processes. Do you Agree?

The first, “Improvements in Device Review,” is 24 pages long, including references. It contends that in the two years since the center announced its action plan, “the speed and predictability of device review have improved for the first time in almost a decade, including significant reductions in the time it takes FDA to review applications and the size of application backlogs.” 

Better than glossy reports is more meaningful transparency from the center.

CDRH rounded the numbers up when it comes to the time frame in that statement. First, the “almost a decade” is really eight years (the benchmark year is 2005). Further, the period of improvement is likely somewhat short of two years because the report says it “began” happening in 2011 but doesn’t say precisely when.

Management’s eagerness to polish the center’s public image through Web-based, one-way communication channels is understandable. Unverifiable reports say there is low internal morale stemming from the public abuse from Congress and the media generated by whistleblower complaints dating back to 2005. But exaggerating achievements with fuzzy numbers—if that’s what’s going on—is an unnecessary tactic.

Overlooking the shaky timeline, this report tells us CDRH’s 510(k) backlog has dropped by almost two-thirds since 2010, and PMA decision times have been reduced by about one-third. Further, the percentage of submitted 510(k)s cleared and PMAs approved has also increased.

The report says these results have been achieved even though its revamp plan is not yet fully implemented. The center expects review times and reductions in backlogs to continue to improve, particularly because the recently renewed user fee program includes additional enhancements.

For six consecutive years, the percentage of 510(k) substantial equivalence (SE) determinations “steadily decreased,” reaching a low of 73% in 2010,  according to the report. “In 2011, SE determinations rose to 78% and in 2012, SE determinations rose to 80%,” it says. “This has occurred without any decrease in the standards for clearance, suggesting that the increase may be due to better quality 510(k) submissions and more consistent decision making.”

The percentage of 510(k)s for which CDRH requested additional information from the manufacturer during the first review cycle has begun to decrease, the report says. From 2002 through 2010, more information requests were issued, caused by increasing device complexity, mid-stream changes in data requirements, and poor-quality applications, the center says. Its revamp plan “addresses each of those problems and the number of requests for additional information has now begun to decrease,” it says.

The center said in conclusion that its plan of action “has successfully increased the predictability, consistency, transparency, efficiency, and timeliness of premarket review.” Further, the report notes, “Over the previous decade, important indicators of the efficiency of the FDA’s device review program, including the average length of review and the size of the backlog of overdue applications, had steadily worsened. Since the FDA began implementing the Plan, almost every major indicator has reversed and is now pointing in the right direction for the first time in many years.”

Better than glossy reports is more meaningful transparency from the center. The second CDRH publication released is its “2013 Strategic Priorities.” That report, at least, features hard action dates for the center’s targeted accomplishments this year. The 12-page document lists six priorities:

  • To ensure U.S. patients have access to high-quality, safe, and effective medical devices of public health importance first in the world.
  • To ensure the U.S. is the world’s leader in regulatory science, medical device innovation and manufacturing, and radiation-emitting product safety.
  • To make sure U.S. postmarket surveillance quickly identifies poorly performing devices, accurately characterizes real-world performance, and facilitates device approval or clearance.
  • To make sure devices are legally marketed in the United States and remain safe, effective, and of high quality.
  • To ensure consumers, patients, their caregivers, and providers have access to understandable science-based information about medical devices and use this information to make healthcare decisions.
  • To strengthen the CDRH workforce and workplace.

The priorities have hard action dates, an example of the center sticking its neck out. For example, under Priority 1, the document says that in 2013, CDRH will continue to strengthen its premarket review plan of action. By March 31, the center will improve management of premarket review content and processes by incorporating commercial technologies and standardized information management practices. By August 31, CDRH will collect public input on deciding when to submit a 510(k) for a change to an existing device (i.e., 510(k) modifications). One exception is the guidance on deciding when to submit a 510(k) for a change to an existing medical device. By September 30, the center has said it will finalize all already issued draft guidance documents identified in the plan of action to strengthen premarket review. By December 31, CDRH will take steps to modernize the infrastructure and processes for the review of premarket applications. The December-31 deadline also marks the date in which CDRH will launch a pilot with industry for the electronic submission of 510(k)s.

Is it time to stop beating up on CDRH? Is the center as good as it says it is? I suspect the people who know best might not be able to discuss. 

More Washington Wrap-Up

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CDRH Answers Slowness Critics on Patient Blog

When It Comes to Nanoparticles, Size (along with Shape and Charge) Matters

Nanoparticles are among the most promising medical materials, with applications spanning imaging, diagnostics, drug delivery, and infection control. Nanoparticles, however, also have the potential to be toxic, altering cellular machinery, potentially altering gene expression and causing transgenerational damage. Their toxicity can also be used for good, however, to selectively target and destroy cancer cells.

Whether a given nanoparticle is toxic or not depends largely on a few principle physical variables: size, shape, and surface functionalization charge. In fact, those three variables were found in a recent study to influence the translocation of nanoparticles through cell membranes by as much as 60 orders of magnitude.

In the study, which was performed by researchers at Syracuse University, the translocation rates of cone-, cube-, rod-, rice-, pyramid-, and sphere-shaped nanoparticles through lipid membranes were analyzed. The most damaging nanoparticle configuration was positively charged, faceted, and rice-shaped. Particles with those attributes translocated instantaneously, causing substantial damage to membranes in the process. Negatively charged nanoparticles on the other hand are electrostatically repelled from the cell membrane.

The study, titled "Effects of nanoparticle charge and shape anisotropy on translocation through cell membranes," was published in Langmuir . It was authored by Shikha Nangia, Syracuse assistant professor of biomedical and chemical engineering and Radhakrishna Sureshkumar, department chair of the aforementioned department and physics professor.

Brian Buntz is the editor-in-chief of MPMN. Follow him on Twitter at @brian_buntz.

How a Bad IV Pump Got into Nancy Stark's Home

Just before the year’s end, FDA released the draft guidance “Design Considerations for Devices Intended for Home Use.” The document aims to assist manufacturers in designing and developing medical devices for home use that comply with applicable standards for safety and effectiveness and other regulatory requirements. But before we get into the document, I want to share with you why medical device designers should never, ever, lose sight of the home user. 

In April 2012, I received a heart-breaking letter from one of MD+DI’s editorial advisory board members. I had asked Nancy Stark to comment on a story about medical device safety. The response I got was not what I expected.

Nancy’s husband, Frank, who was dying of cancer, had developed a systemic staph infection. After a critical week in the hospital, he was sent home with an IV pump for six weeks of home antibiotic therapy. Nancy’s experience with the IV pump was nothing short of dangerous. 

“The number of adverse events, device failure, and unrealistic demands placed on the home user are uncountable and inexcusable,” she says.

Here is why this story is particularly upsetting: Nancy Stark is a clinical research and biological safety-testing expert. She is the founder of a medical device consultancy, Clinical Device Group Inc., and has 30 years of experience in the industry. Her husband was a mechanical engineer. If anyone who was not a licensed caregiver could have figured out how the device worked, it was them. 

Nancy relayed some of the most torturous moments to me via e-mail. The first night, the pump beeped loudly and incessantly. They called the support hotline for the pump and got an answering service. After 15 minutes (the alarm did not stop), a representative from the company returned their call and said the batteries needed to be changed. The lock on the battery door was jammed, and Nancy, who has arthritis, could not open it. She had to use a hammer and screwdriver to jimmy the door.

Several times over the next few days, the pump displayed the error message “down occlusion.” Nancy never saw the instructions for use (there was a photocopy of a photocopy of the instructions in a binder she found later, tucked under several pages of billing and product information) and had no idea what “down occlusion” meant. Again, she called the toll-free number and awaited a call back. The representative explained that there was a kink somewhere between the pump and the bag. Nancy never found a kink, but she removed tubing from the pump, massaged it, and reinserted it. The problem continued to occur at least once per day, so Nancy continued with the make-do technique.

Nancy and Frank in 2001.

The disturbances were enough that on Easter, when the couple attended evening mass, Frank shut off the pump and forgot to turn it back on. Nancy didn’t realize the pump was off until noon the next day, and by then Frank was compromised. Nancy called an ambulance to take him to the emergency room. The event nearly cost him his life and resulted in a weeklong stay in the hospital, followed by hospice care. 

Frank died April 20, the day after she sent the letter to me.*

 “I would trade the first year of our marriage to get the extra two weeks I could have had without the faulty pump,” Nancy says. 

Manufacturers can’t monitor how instructions for use get passed on to the user, nor can they ensure both the user and caregiver receive instructions appropriate to the level of device complexity. Likewise, FDA can’t interfere with the practice of medicine. But manufacturers can design user-friendly error notifications, install shut-off buttons or volume controls for alarms once they have been acknowledged, offer easy-to-access online instructions for use, and incorporate visible battery-life gauges, just to name a few applicable solutions. 

FDA tackles some of these problems in the new guidance. Key to the document is the agency’s attention to design controls. The document recommends using quality system regulations in addition to risk-management systems per ISO 14971, usability per IEC 62366, and human factors analysis per HE 74 and HE 75. Software per IEC 62304 should be controlled through design control processes. The guidance asks manufacturers to “broaden your existing concept development and preliminary testing processes to account for the needs of home users and requirements for straightforward device operation, obvious interface layouts, and appropriate alarm methods.” There is also a lengthy discussion on labeling.

“The draft guidance document is a big step in the right direction,” Leo Eisner, an MD+DI editorial advisory board member and president of Eisner Safety Consultants, wrote on his blog. Still, there is more to be done, specifically in the area of labeling. “I am disappointed the guidance doesn’t refer to other sections of IEC 60601-1-11:2010 as there are other important areas to consider for marking and labeling,” he wrote.

IEC/ISO 60601-1-11 states that labeling must be understandable by an 8th grader. But in many cases, caregivers and patients need instructions at a much lower level of understanding. “The AMA says that people under stress and terror in a caregiver situation comprehend like 4-year-olds,” Stark says. 

The guidance touches on other issues, such as environmental considerations, user considerations, human factors, and postmarket considerations. The document essentially refers readers to existing standards and other guidance documents to increase the likelihood that a device for home use is safe and effective. 

FDA’s new guidance doesn’t solve all problems, however. As Nancy's anecdotal struggles with an IV pump illustrate, some problems derive from factors outside of the realm of design controls. Such a heartbreaking tale underscores the need for cooperation at all levels of the system and a reassessment of the costs of such devices to solve. But medical device designers are in the unique position to lead by example and solve as many problems as possible through good design and effective risk-management control.

Heather Thompson

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FDA’s Home Use Draft Guidance Is Good, But It's Not Gospel 

Corrections

*The original article said that the pump was recalled. The model used by Frank and Nancy has not been recalled.

FDA's Home Use Draft Guidance: Good But Not Gospel

In December, FDA issued a draft guidance for the medical device industry and FDA staff on Design Considerations for Devices Intended for Home Use to address growing concerns about medical devices being misused in a home setting.

The draft guidance document is a step in the right direction. A key idea of the guidance is that the home is not the only place that these devices will be used, and that significant design brain cells should be spent on imagining and planning for multiple use environments.

Devices such as the One Touch are likely to already be following the FDA's steps for home device development. 

The draft considers the risks for over-the-counter and prescription devices, the use environment, the device or system, human factors, and labeling. It provides recommendations for design and development, as well as postmarket considerations.

The document essentially operates to provide known standards and recommended practices in a single, unifying guidance for home use. As such, the nitty gritty of the guidance should be largely intuitive if you follow or plan to follow 21 CFR 820.30, AAMI HE 74, AAMI HE 75, ISO 14971, IEC 62366, and IEC 62304, to name a few.

The guidance is not dogma, nor is it intended to be. “It would actually be impossible for a manufacturer to follow all of the recommendations contained within the guidance,” says Steve Wilcox, principal of Design Science. “Some of them directly contradict each other.” Instead, says Wilcox, companies should seek to review the guidance and use the applicable practices for their own development. There aren’t hard and fast requirements, says Wilcox. “Manufacturers should not think they have to conform to everything.”

In some cases, the contradictions worry experts. For example, FDA's new guidance does not consider nursing homes to be home use environments. This is a departure from one of the source documents of the guidance, IEC 60601-1-11, which addresses medical electrical equipment in home settings. The IEC standard considers nursing homes to be home healthcare environments.

“It doesn't make sense for [FDA] to rely on the standard, and then go so off book from the scope of the standard,” Leo Eisner, president of Eisner Safety Consultant explains.

Eisner isn’t sure why FDA would make this change, but he thinks that it could cause problems for manufacturers. Essentially, he says, any departure from a known standard should be accompanied with a thorough explanation, because it causes confusion for both FDA and IEC reviewers. “It could set a manufacturer back if FDA's interpretation of product specs is different from the standards committee interpretation,  because the Safety Agency may certify a Home Use Device for the Nursing Home Environment whereas the FDA's draft guidance doesn't allow for this.”

Eisner is currently drafting his comments to FDA on the discrepancy. A source from FDA confirmed that the Agency plans to update the guidance in its final version to better reflect recognition of IEC 60601-1-11. FDA recognizes a nursing home to be a clinical facility, but the nuance is in the enhanced definition of home use. Specifically, the device is designed and intended for use in a clinical facility, it is not be considered a home use device. However, if it is designed and intended for use in both a clinical facility and a non-clinical facility, it is considered a home use device.

On the whole, the home use guidance is a valuable resource for manufacturers. The 23-page document seeks to clarify options for manufacturers, and aid them in identifying and overcoming the myriad challenges of designing for a home use device. FDA acknowledges that there is more work to do.

The guidance is part of a larger initiative to provide resources to manufacturers to encourage the safe use of home medical devices. Key areas of this Initiative are as follows:

  • Issue a draft guidance document for manufacturers recommending actions they should take to receive FDA approval or clearance of devices intended to be used in the home.
  • Develop a labeling repository for medical devices that have been approved or cleared for home use (FDA will hold a labeling workshop April 29-30).
  • Increase public awareness of the use of medical devices outside a clinical setting.
     

 —Heather Thompson

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When Opposites Attract

In 2007, Steve Jobs proclaimed that the "iPhone changed everything." And while this bold claim may sound like marketing hyperbole, it isn't necessarily untrue. After all, the design of the iPhone has had a significant impact on the look, feel, and user experience of products far beyond just smartphones. Thanks to Apple's innovative spirit and demand from patients, consumerization is making its mark on medtech.

In the past year, that trend has become especially pronounced in the diabetes device space. In many ways, the diabetes market is a good fit for medical devices that borrow from consumer product design. Because diabetes is a chronic disease managed by patients, for example, usability and intuitive features of treatment devices are paramount. And in this iPhone/iPad era, many patients already expect the same kind of functionality and ease of use from their medical devices that they experience with their mobile devices.

Innovative diabetes device companies are taking note. Late last year, for instance, the Apple-inspired t:slim insulin pump from Tandem Diabetes Care and the Dexcom G4 Platinum continuous glucose monitors were introduced to the U.S. market. A year earlier, FDA approved the iBGStar blood glucometer from Agamatrix that can connect directly to the iPhone or iPod touch.

Consumerization is picking up in the broader medical device market as well. Ernst & Young noted in its Progressions 2012 report the rise of "personal health technologies" resulting from the "the consumerization of medical devices and the medicalization of consumer devices." The line between the two worlds is likely to continue to blur.

Yet despite these converging interests, the design philosophies in the consumer and medical device sectors remain poles apart. "The merging of consumer and medical brings together two cultures that don't have a lot in common other than the laws of physics," says Bill Betten, medical technology director at UBM TechInsights.

Among the most pronounced distinctions is the pace of the development process, which is slower and more deliberate in the medical sector. Furthermore, the longevity of supply at a component level in the medtech domain is key, whereas engineers tend to seek out the most horsepower for the lowest reasonable price in consumer electronics.

"If you run out of a component--even if it is roughly comparable--it can force you to redo, at a minimum, some of your documentation. It is not as trivial as buying the latest DRAM from the lowest-cost supplier and throwing it into a smartphone. You need to pay a lot more attention," Betten says. "Software upgrades are another killer. You can't have a medical system malfunction because you push new firmware to it."

The intersection between the consumer and traditional medical device spaces remains fairly narrow. Engineers in the two sectors are accustomed to markedly different quality systems, regulatory systems, and documentation processes in design, for example. For that reason, it is rare for engineers to move back and forth between the two industries. Someone who is used to working on the next generation of a product every eighteen months might not be attracted to a market that may not see a new product introduction for five years or longer. Having said that, the intersection between the two spaces is growing, and cross-pollination is sure to yield exciting medical device innovations.

Brian Buntz is the editor-in-chief of MPMN. Follow him on Twitter at @brian_buntz.

Billions of Jobs to Disappear by 2030. What Does that Mean for Manufacturing?

By 2022, one billion jobs will evaporate as a result of advances in automation technology, says futurist Thomas Frey. That accounts for one out of every four jobs. By 2030, that number will reach two billion, he predicts—roughly half of all jobs on the planet.
 
There could be an upside, however, as billions of new types jobs could potentially be created within the next two decades, potentially even exceeding the number of jobs lost. Catalytic innovations will emerge, creating entirely new industries in the process. Perhaps the Internet itself serves a model for predicting what will happen as other industries are disrupted thanks to technology breakthroughs. In 2011, McKinsey & Company found that “the Internet created 2.6 jobs for each lost to technology-related efficiencies.” In the future, new technologies may emerge with similar employment benefits.

3D Printing: The Manufacturing Technology of the Future

Thomas Frey, who will be giving a keynote at MD&M West, is especially optimistic about the potential of 3D printing technology to revolutionize manufacturing. In that belief, he joins Chris Anderson, former editor-in-chief of Wired magazine, who has predicted that 3D printing will ultimately be more important than the Internet. Indeed, it may have a bigger impact on manufacturing than Henry Ford's assembly lines, Frey believes.
 

Global employment is being disrupted at a pace never before seen in history, says Thomas Frey, who will speak on at MD&M West on February 12 in Anaheim, CA.

3D printing is poised to become an engineering discipline unto itself, and workshops devoid of workers will become common in nearly every manufacturing sector. Outsourcing will decline as the demand for 3D printing technicians surges. 3D printing undermines economies of scale in that it makes it as inexpensive to produce single parts as it is to produce thousands of parts.

In the medical realm, 3D printing is already used for a variety of applications such as producing scaffolds for tissue engineering, and producing custom prosthetic limbs and hearing aids. Ultimately it could be used to produce artificial organs as well.

In addition to 3D printing, robotics technology also stands to advance greatly in the coming decades. Automating our physical world is easily half a century behind the digitization era that was ushered in with mainframe computers back in the 1960s. Frey likens the robotic arms used in manufacturing to the mainframes of the 1960s adding that "the coming decades will be far less about humans competing against machines and far more about how we can leverage them to our advantage."

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

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