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Articles from 2013 In December

California Still Top U.S. State for Medtech

As high as California places in rankings of just about everything, Silicon Valley venture capitalist Tim Draper's Six Californias Initiative, which seeks to break up California into six smaller states, may seem like a good idea. "The status quo is just not going to work," Draper said in a press conference last week.  But unless this happens, the Golden State is one big entity, with one big medical device industry. 

California has "a lot of great ideas, huge amount of risk capital, preponderance of experienced entrepreneurs and managers and business people," Mir Imran, a medtech pioneer and venture capitalist who is CEO of San Jose, CA-based InCube Labs, recently told MPMN

California still has the nation's largest medical device industry.
California still has the nation's largest medical device industry. Image from Flickr.

The Los Angeles-San Diego corridor alone boasts a combined total of nearly 100,000 people in medtech and includes the headquarters of Irvine, CA-based Edwards LifeSciences and Allergan, and San Diego-based telecommunications giant Qualcomm and its Qualcomm Life subsidiary.

There are three main clusters, in Los Angeles, Orange, and San Diego counties. According to the California Biomedical Industry 2013 Report, Los Angeles County has attracted large medtech companies such as Johnson & Johnson's Biosense Webster and Medtronic, while device companies focusing on cardiology, interventional neurology, orthopedics, and ophthalmology have gravitated to Orange County. San Diego, on the other hand, has a strong biotech contingent and is emerging in the wireless space.

Meanwhile, the the San Francisco Bay Area/Silicon Valley nexus nearly equals the south in medical device jobs. While SoCal beats out the Bay Area for core medical device jobs, the north is on par with the south for overall jobs in the life sciences.

The Bay Area also attracts the largest share of venture capital investment in the country.

Northern California could play an important role in inventing the future of medical technology. There's a sense in Silicon Valley that almost anything is possible and it's easy to see why: The Bay Area is awash in innovative tech startups, wearable devices, and optimistic entrepreneurs. The latest tantalizing possibility to present itself is that the same communications device wizardry that gave us smartphones will seep into the medical device industry, bringing anything from on-the-go body monitoring to improved disease diagnostics.

The region is already unparalleled for using information technology for healthcare-related applications. For example, Redwood City-based Proteus Digital Health embeds sensing technology into pharmaceutical tablets, which won FDA approval last year. HeartFlow, also based in Redwood City, uses software to diagnose cardiovascular problems and optimize treatment.

California has some of the most prominent research entities in the world, including in the life sciences. The National Institutes of Health gives California more grant money than any other state, roughly 15% of the total NIH funding in the country. The Bay Area is home to Stanford University; the University of California, Berkeley; and University of California, San Francisco, while SoCal has the University of California, Los Angeles (UCLA); University of Southern California (USC); and the California Institute of Technology (CalTech).

UC San Francisco actually receives the most NIH funding among California universities, receiving about $500 million in the first nine months of 2012 alone, according to the California Biomedical Industry 2013 Report. Stanford brought in more than $334 million, and UC Berkeley netted nearly $119 million.

Novel Computers that Learn From Mistakes to Debut in 2014

Computers with a brain-inspired 'neuromorphic processor'--systems able to learn from their experiences--could transform the face of computing, potentially doing everything from advancing facial and speech recognition technology to rendering computer crashes obsolete. The breakthrough could also greatly simplify the task of programming.

Neurosynaptic Cores
A network using neurosynaptic cores is based on the monkey brain. Image courtesy of IBM.

Qualcomm, IBM, and Stanford University are among those pioneering the technology, which enables computers to actively learn from new data and dynamically adapt it in a manner similar to how organisms learn by interfacing with the external world.

Advances will obviously have implications in the medical field. Think how IBM's Watson supercomputer is already being used to help diagnose cancer, or how San Diego-based Qualcomm is involved in pretty much everything when it comes to the digital health revolution

Qualcomm says a commercial version of the neuromorphic processor could be out later in 2014, according to a recent New York Times story.

Speaking in a sponsored talk at MIR Technology Review's EmTech conference in October, Qualcomm's chief technology officer Matt Grob mentioned applications ranging from artificial vision sensors to robot controllers and even brain implants.

"What is new now is the ability to drop down large numbers of these structures on silicon. The tools we can create are very sophisticated. The promise of this is a kind of machine that can learn, and be programmed without software--be programmed the way you teach your kid," Grob said at the conference, according to MIT Technology Review.

One of the scientists involved in neuromorphic processor research, Stanford's Andrew Ng, has long said that the software driving current-generation robotics technology greatly limits the scope of its applications.

For instance, Ng has pointed out that researchers have long predicted the development of domestic robots that are capable of cleaning people's houses, which are capable of doing everything from doing dishes and laundry to vacuuming. While some domestic robots have hit the market, like iRobot's Roomba vacuum cleaning device, the intelligence of such devices have been extremely limited.

Advances in artificial intelligence will, as Ng points out, enable smarter robots to accurately perceive and understand the world around them. They can then use this information to exert control over their environment.

This capacity is illustrated in researchers' failed attempts to write software that permits a remote-controlled helicopter to operate autonomously. Ng then worked to develop software that enabled a computer to learn how to fly such a helicopter through experimentation. The technique proved successful, and Ng's code enabled the computer to even learn how to perform stunt maneuvers comparable to those demonstrated by the best human pilots.

The field of machine learning could be further bolstered by what Ng terms the "one-program hypothesis," which assumes that a single algorithm could enable artificial intelligence to perceive visual, auditory, and tactile data. To support the hypothesis, he points to research into the brain's neuroplasticity, which enables neurons linked to tactile perception, for instance, to be rewired to be used for visual perception.

Using a Nanomaterial to Tackle Fake Pot Issue

United States Army researchers have found that a bio-nanomaterial can help solve a public health issue involving people showing up in emergency rooms with dangerous reactions to marijuana substitutes sold at gas stations and head shops, according to DOD Live. The Army researchers came up with an optoelectronic sensing system. It uses both light and electricity to detect an entire class of synthetic marijuana compounds that have an affinity for cannabinoid receptions in the human brain. The key to the sensing system involves nanocrystals called quantum dots and bacteriorhodopsin, which some forms of bacteria us to convert light into energy. When a target material binds with a sensor, a change in electrical output is induced. "Although this bio-nano sensing platform wasn't developed with drug sensing in mind, this program leverages our bio-nano sensor expertise towards a specific drug testing problem. The fact that our sensor platform has the potential to be small, lightweight, user-friendly, and fieldable in addition to being generic enough to be tailored towards synthetic cannabinoid detections made it a unique fit to fill this specific drug detection need," noted Dr. Mark Griep, principal researcher on the project. Synthetic marijuana overdoses have proved fatal in in some cases. First-line treatment for these drugs often includes administration of a benzodiazepine or another sedative. However, the many different types of synthetic marijuana can make toxicology testing a significant challenge.

Michael Sellers
Michael Sellers, PhD is one of the primary researchers at the Army Research Laboratory working on computational simulation support.
In most of the United States, possession of marijuana is considered a misdemeanor. Because of this, a significant number of adults and teenagers have turned to synthetic marijuana blends. These blends can often be found at gas stations and head shops. While manufacturers of these products rarely disclose the active ingredients in synthetic smoking blends, a number of users have experienced severe side effects following ingestion of synthetic blends. Over the past few decades, researchers have created hundreds of chemicals that can trigger the cannabinoid receptors in the human brain. While some forms of synthetic marijuana can trigger the same euphoric mental effects as natural marijuana, they often carry a significant number of risks. Synthetic marijuana products often include chemicals like HU-210, JWH-073, JWH-018, and cannabicyclohexanol. While many of these chemicals were made illegal, clandestine chemists can adjust the molecular structure of synthetic marijuana, allowing new varieties to circumvent existing laws. Some strains of synthetic marijuana have been associated with an increased risk of heart attacks, kidney damage, high blood pressure, vomiting and other symptoms. Long-term use of some synthetic marijuana strains has been associated with psychosis and addiction.

Flexible Electronics Firms Rakes in $20 Million in Funding

MC10 (Cambridge, MA) has announced that it has obtained $19.8 million in new equity funding for its bendable electronics technology. Earlier in December, the company announced that it had obtained $10 million in Series C financing, which was provided by Medtronic, several venture investors, and an unnamed consumer health company. Stephen Oesterle, MD, Medtronic's senior vice president of medicine and technology will collaborate with the company as a board observer. So far, the company has raised a total of $60.5 million in funding. The firm now has one product on the market: a mesh-based device that fits under a helmet to detect impact to the head in games like hockey. The product is the result of collaboration between MC10 and Reebok's Advanced Concepts group. Data gathered by such athlete-worn technology could be used to not just detect injury but also optimize performance. MC10's technology can be used to gauge temperature, hydration levels, brain activity, heart rate, and muscle function. Data gathered by the device can then be delivered wirelessly to a nearby device, like a smartphone. The company says its technology can be used to create "an entirely new class of intelligent medical devices." Early healthcare-related applications of the technology include monitoring of the temperature of infants, remote patient monitoring, and interventional cardiology. For the latter application, the technology could be embedded in balloon catheters to give them the ability to monitor temperature, blood flow, and electrophysiological data. In addition, it be used in conjunction with radio-frequency electrodes to provide localized tissue ablation.

Abbott Labs Shells Out $5.48 Million to Settle Kickback Suit

In 2010, The New York Times divulged that a Baltimore cardiologist had implanted 30 stents from Abbott Labs on a single day. Soon thereafter, Abbott rewarded the cardiologist, Mark Midei, MD, with a lavish meal at his home that cost the company $2159. The case set off an investigation by the Senate Finance Committee that alleged that the problem was widespread. Now, Abbott will pay the $5.48 million to resolve allegations that it had a track record of financially rewarding physicians who implanted its carotid, biliary, and peripheral vascular devices. The U.S. government accused the company of violating the federal Anti-Kickback Act and playing a role in rewarding doctors for submitting fraudulent Medicare claims. Two former Abbott employees Douglas Gray and Steven Peters, will be awarded over $1 million under the settlement. This development was made possible thanks to the qui tam provision of the False Claims Act, which enables whistleblowers to obtain compensation on on behalf of the United States. The U.S. government has been working for years to uncover inappropriate ties between doctors and device makers. In 2007, it found that five major orthopedic device firms were in violation of the Federal Anti-Kickback Statute: Stryker, Biomet, DePuy, Smith & Nephew, and Zimmer. The latter four of those firms paid $310 million to settle the allegations.

Colorado Is Nation's Sixth-Biggest Medtech State

The Colorado medical device industry is as diverse as the state's terrain. Centered, not surprisingly, along the metro corridor of Fort Collins, Denver, Boulder, and Colorado Springs, these companies range from a Sandoz unit of giant Novartis in Broomfield to Denver's Eldon James, whose BioMed cleanroom facility focuses on the manufacture of products designed for the life sciences, biomedical, pharmaceutical and similar applications.

Another global giant, Covidien PLC, employs about 1850 people at its Gunbarrel, CO, campus, which has roughly doubled in size since 2006. In 2012 it opened a new 63,000-sq-ft research and development center at the Gunbarrel location, which is roughly equidistant from Boulder and Longmont. And a trip to Longmont might find the medtech maven at Operator Interface Technology, which makes copper antimicrobial keyboards. 

CEA Technologies, headquartered in Colorado Springs, designs and manufactures disposable and reusable electromechanical devices used in critical care applications. Vention Medical's Boulder design and development facility supplies various heat-shrink and multilayer tubing, as well as catheter balloons. Morton Bowen Inc., a contract manufacturer, is sited in Broomfield. Value Plastics supplies the world with the plastic fittings from Fort Collins. And there's About Packaging Robotics in Thornton, 10 mi. from Denver, and Particle Measuring Systems in Boulder.

The Colorado Bioscience Association (CBSA) says the state's medtech industry is the sixth-largest in the nation and creates over 27,000 jobs. CBSA partnered with the state government to create the Bioscience Discovery Evaluation Grant Program which awards funding for emerging and early-stage companies and commercialization infrastructure. The program is considered a model of innovative state life-science economic development legislation. In 2011, credited the grants with having created almost 600 jobs in the state. CBSA also publishes Bioscience Colorado, an annual roundup of the state of the state's biotech industry.

Colorado's leading educational institutions in the medtech space are the University of Colorado at Colorado Springs, said to be the fastest-growing university in the state, and the University of Colorado at Boulder, which claims the largest research university in Colorado. Colorado State University at Fort Collins is home to the School of Biomedical Engineering, the first of its kind in Colorado. The school says its "crossfunctional program integrates physical, chemical, and mathematical sciences with engineering principles and clinical studies to address society's current and emerging needs in the health fields." It offers a dual-degree program combining a Bachelor's degree in Biomedical Engineering with a second in one of several other engineering specializations, and also offers a regulatory affairs certification program. These schools ensure that Colorado's medtech future will remain bright.

Boston Scientific to Expand in China

After seeing its revenue fall over the past years, Boston Scientific is looking to boost its bottom line in China. The company is adding employees in China and is debuting surgeon-training centers there, according to a Wall Street Journal report.

The move comes even as the Natick, MA-based medical device giant slashes hundreds of jobs in the United States and elsewhere, with savings from the "strategic growth initiative" going toward developing new products and other initiatives.

Boston Scientific, then, is hiring where it expects growth. A recent Motley Fool report drove home the point that countries such as Brazil, Russia, India, and China (the BRICs) are where Boston Scientific can expect growth in coming years.

Expanding inside China presents its own challenges, though.

China's more than 1000 distributors present complex logistical and managerial challenges, Warren Wang, vice president and managing director of Boston Scientific's China division, tells WSJ. Local governments are also pushing for lower medical device prices.

Boston Scientific is seeking more direct interaction with Chinese doctors through an undisclosed number of training centers it is opening inside the East Asian giant.

The company has plenty of competition from Chinese device companies, as well as rivals from back in the United States. Medtronic is presently leading the pack among 14 multinational medical technology companies in China, according to an analyst report by Morningstar.

In 2012, Medtronic acquired Kanghui Holdings, a Chinese conglomerate, for a price tag of $816 million. In addition to joint reconstruction devices, Kanghui manufactures spine and trauma devices. Armed with its distribution network, Medtronic will be well-positioned to distribute its products in China.

"Medtronic faces far more upside than other device manufacturers because of its extensive product portfolio," notes the Morningstar report. "With the addition of Kanghui's strong distribution network, Medtronic now has an avenue through which to move all of its devices into Chinese hospitals, including pacemakers, implantable cardioverter defibrillators, insulin pumps and heart valves."

Getting Aging Down Right

Sticking a plastic medical device part or some plastic packaging in an oven to figure out how it will age years from now--it sounds like a good idea.

But there are plenty of ways to botch up the testing, says Karl Hemmerich, president of Ageless Processing Technologies in Sandy, UT.

"One of the shortcomings is using a temperature that's too high," Hemmerich says.

Hemmerich recalls a resin company that had a propylene part that was supposed to age well, but it actually had problems down the road because the testing had been conducted at a too-high temperature of 80 degrees Celsius, or 176 degrees Fahrenheit.

"It was crap. ... In real time aging it was actually less stable than competitive resins. They drove a stabilizing reaction inappropriately," Hemmerich says.

See Hemmerich deliver a talk on accelerated aging tests on Thursday, Feb. 13, 2014, at MD&M West in Anaheim, CA.

The Association for the Advancement of Medical Instrumentation with its TIR 17 rules in the 1990s recommended 60 degrees Celsius, or 140 degrees Fahrenheit, as a limit for using heat to speed up aging and figure out whether knit lines or other issues could cause problems down the road, Hemmerich says.

Obviously, the melting temperature should be avoided when using heat to test a polymer's aging properties. But Hemmerich points out two other important temperatures: the glass transition temperature, at which the molecules inside the polymer start moving and potentially relieving stress to a part; and the crystalline temperature, which will cause the polymer's properties to change after it is cooled.

Issues can crop up with other age acceleration techniques, too, such as high oxygen environments.

"It's a question of understanding materials or resins and potential reaction pathways," Hemmerich says.

On top of that, Hemmerich finds that few companies understand sample size, either by having too large of a sample and driving up costs or having too small of a sample and not being able to properly define the quality of a part.

"If the potential defect is life threatening (critical defect), a larger number of samplings needs to be tested. If it's a minor defect (cosmetic, etc.), you can keep costs down by testing fewer samples," Hemmerich says. Sampling plans need to be primarily designed around the criticality of the defect and the variance of the attribute in the population," Hemmerich says.

Hemmerich, though, says there are good reasons to use accelerated aging tests: "You're trying to project forward in time ... and can't wait for the product to sit around five years before you launch." 

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker and Google+

Outsourcing Outlook on Cleanroom Manufacturing and Assembly Services: Interview

A common job interview question goes something like this: What is the most difficult challenge you encountered and how did you address it? We put a similar version of that question to Michael P. Driscoll, operation manager at Precision Tool & Die (Derry, NH), and received a blow-by-blow example of the need for a solid engineering plan to produce an unusual cleanroom-molded medical device part. In addition, Driscoll also shares insights into how to evaluate a contract manufacturer's cleanroom operations and the benefits of Autodesk Moldflow Insight & Adviser software.

MPMN: The cleanrooms used by manufacturers of electronics, optical products, and so forth can be considerably different than those used for medical device applications. How can a medical device firm be certain that a contract manufacturer's cleanroom facilities meet the standard required by the medical device industry?

Michael P. Driscoll

Driscoll: Medical device OEMs should audit the manufacturers' cleanroom procedures and processes, paying close attention to schedules and records showing daily, weekly, and monthly cleaning, particle counts, viable and non-viable particulates (non-viable includes yeast, mold bacteria, and others) as well as the general cleanroom design. They should also include looking for controlled environments for gowning and material pass through rooms.

Medical device molding has life and death consequences. OEMs should pay close attention to the small details of the selected manufacturer's methods and controls. It is important to use a manufacturer who is experienced with the type of devices or implants to be produced.

MPMN: Could you briefly describe the benefits of Autodesk Moldflow Insight & Adviser software and how it relates to cleanroom manufacturing and assembly?

Driscoll: The use of mold filling analysis software starts in the engineering department. New medical devices and implants often evolve from machined prototypes without regard for the eventual process of injection molding. By the time these devices are ready for molding and we get involved, the devices will often need geometry adjustments just to make them moldable with any level of stability.

This software helps analyze and optimize device geometry, as well as runners and gating options, in a way that eliminates the time and cost disruption of a mold needing to go in and out of a cleanroom process to make tool adjustments.

MPMN: What was the most difficult cleanroom-manufacturing related request you ever had from a medical device OEM and how did you address it?

Driscoll: We have had a lot of tough projects, but one of the more recent ones was a thin wall insulator skirt for an implanted left ventricular assist device (LVAD).

An LVAD is a mechanical pump that is used to support heart function and blood flow in people who have weakened hearts. They can be used to take stress off the heart while heart muscles heal, or while waiting for a heart transplant, or even as a long-term solution in the event someone is not eligible for a transplant.

This particular part is cup shaped and approximately 1.750 in. diameter by 0.750 in. deep with a series of internal shoulders and skirts. Wall thicknesses vary between 0.004 and 0.008 in. in different areas (similar to a sheet of copy paper). tolerances are down to +/- 0.001 in. in several areas.

We knew we were being asked to mold a very difficult part, so we approached it in stages. The first focused on engineering. We corrected and cleaned up the customer supplied solid model and used mold filling analysis to see if we could develop a gate layout that would completely fill the part with sound knit lines. Six sub-gates were required. Once this was done, a balanced runner system was developed to feed those gates. At this point, we presented the results to the customer and got approval to make holding fixtures and machine 15 prototype parts from solid rod stock for testing. The parts performed well and met all functional requirements.

Stage two was to design and build a prototype mold setup in a way to allow working out the thin wall molding and tight tolerance concerns, as well as having it evolve into a production mold. The mold was built, and using data from the mold filling analysis, the Cleanroom molding process was developed.

Cleanroom molding for a human implant cannot use mold release sprays or material release agents. We had trouble with one of the thin walled skirts pulling and distorting as the mold opened, and another area of the part distorting as the ejectors came forward to eject the part. Adjustments in mold temperature, injection pressure, speed, and melt temperature did minimize, but could not completely eliminate these two areas of distortion. However, even though these molded parts had slight distortion, they were useable for preliminary testing in assembled devices and worked well.

The third stage of the project was to add features to the mold for elimination of the distortion and bring the mold to production quality.

Articulation was added to the A-side skirt cores. This allowed them to retract from the molded part before the parting line opened. The part is fully supported while the parting line remains closed and this change worked to eliminate the distortion. Air assist was added to the B-side coring. The air assist breaks the initial vacuum of the molded part to the core as the stripper plate advances, and was successful in eliminating molded part distortion during ejection. The mold has since gone through a complete validation, high and low process conditions are documented, and the mold runs fully automatic in the cleanroom environment.

Difficult projects like this one are served greatly by approaching them with a sound engineering plan, as well as having the necessary tools, talent, and creativity to work through any problems that occur along the way.


Sales of Networked Medical Devices Will Climb to 14 million units in 2018

Sales of Networked Medical Devices Will Climb to 14 million units in 2018

By 2018, sales of networked medical devices will jump to 14 million units, up from 3.5 million units in 2013. Revenue from those devices will climb to $2.5 billion, up from $830 million in 2013 according to a report from Park Associates. That represents a 34% compound annual growth between 2013 and 2018.

What are these networked devices? Parks Associates categorizes them into eight kinds - weight scale, blood pressure monitor, glucometer, insulin pump, diagnostic ECG, pulse oximeter, sleep apnea test device, and home INR (international normalized ratio) test device.

“"The addressable market for networked medical devices includes 68 million Americans with hypertension and 26 million with diabetes," said Harry Wang, Director, Health & Mobile Product Research, Parks Associates, in a news release "Consumers are also demanding more autonomy in managing their care, which will drive the market in 2014 to improve patients' self-care experience. Network connectivity will enable new business models built on health software and services instead of hardware and consumable sales."

The Affordable Care Act is one of the driving factors behind the growing demand for networked devices as is a growing aging population.

Consider this: Over a third of U.S. broadband households own a digital weight scale, and 12% own a glucometer. Here is a chart showing what types of devices owned by U.S. broadband households.

“With networking technology integrating into devices that capture patient vital signs and help diagnose health conditions, health professionals are able to extend the point of care to locations more convenient to patients, most notably the household," Wang said. "Networked medical devices enable patient-centered care and drive care cost away from the most expensive premises."

[Photo Credit: MASTER/]

-- By Arundhati Parmar, Senior Editor, MD+DI